NB Publications-Vitek 2 9308339008gba Web

VITEK 2 ®
Selection of publications
2014 EDITION
INTRODUCTION CONTENTS
With the rise of pressing healthcare challenges like multi-drug resistant organisms (MDRO), microbiology VITEK® 2 – MICROBIAL IDENTIFICATION
labs play an ever-more critical role. When it comes to fighting infectious organisms, microbial identification
(ID) and antibiotic susceptibility testing (AST) are key to providing the right information for targeted clinical GRAM-NEGATIVE ORGANISMS
responses and better patient-care outcomes. Evaluation of the New VITEK® 2 Card for Identification of Clinically Relevant 6
Combining an innovative, automated platform with an expansive database, VITEK 2 offers the confidence
®
Gram-Negative Rods.
of fast, accurate results. Its smart design helps ensure better overall laboratory workflow with fewer repetitive Funke G. and Funke-Kissling P.
tasks, higher safety (closed disposables), improved standardization, and rapid time-to-results and reporting. JOURNAL OF CLINICAL MICROBIOLOGY 2004;42(9):4067-4071
It provides microbiologists the confidence of rapid, accurate ID/AST testing through full automation. GRAM-POSITIVE ORGANISMS
VITEK 2 uses unique ID and AST cards the size and shape of a playing card. Based on this innovation,
®
Performance of the New VITEK® 2 GP Card for Identification of Medically 7
VITEK® 2 can provide identification and susceptibility results in as little as 5 hours. Relevant Gram-Positive Cocci in a Routine Clinical Laboratory.
Ready-to-use VITEK® 2 cards offer a comprehensive menu of available tests: Funke G. and Funke-Kissling P.
JOURNAL OF CLINICAL MICROBIOLOGY 2005;43(1):84-88
Identification Cards:
• GN (Gram-negative) HAEMOPHILUS, NEISSERIA AND OTHER FASTIDIOUS ORGANISMS
• GP (Gram-positive) Multicenter Evaluation of the New VITEK® 2 Neisseria-Haemophilus Identification Card. 8

Rennie R.P., Brosnikoff C., Shokoples S., Barth Reller L., Mirrett S., Janda W., Ristow K., Krilcich A.
• YST (Yeast) JOURNAL OF CLINICAL MICROBIOLOGY 2008;46(8):2681–2685
• NH (Neisseria and Haemophilus) ANAEROBES, CORYNEBACTERIUM, etc.

• ANC (Anaerobe and Corynebacteria) Evaluation of the New VITEK® 2 ANC Card for Identification of Medically Relevant 9
Susceptibility Cards: Anaerobic Bacteria.
• Gram-negative (AST-GN, AST-N) Mory F., Alauzet C., Matuszeswski C., Riegel P., Lozniewski A.
JOURNAL OF CLINICAL MICROBIOLOGY 2009;47(6):1923–1926
• Gram-positive (AST-GP, AST-P)
• Anti-fungal (AST-YS) Multicenter Evaluation of the VITEK® 2 Anaerobe and Corynebacterium
• Streptococci (AST-ST) Identification Card. 10
Rennie R.P., Brosnikoff C., Turnbull L., Barth Reller L., Mirrett S., Janada W., Ristow K., Krilcich A.
The Advanced Expert System™ sets the VITEK 2 apart from other systems. The Advanced Expert System™
®
YEASTS
is an integral part of the VITEK® 2 and automatically validates every susceptibility test result. It signals
when results are ready, saving time and giving an accurate phenotypic profile of resistance mechanism(s) for Multicenter Evaluation of the New VITEK® 2 Advanced Colorimetric Yeast 11
each isolate tested. Easy-to-read color-coded indicators help distinguish between results that require further Identification Card.
Hata J.D., Hall L., Fothergill A.W., Larone D.H., Wengenack N.L.
review from those that can be reported. VITEK® 2 generated and Advanced Expert System™ validated ID/AST JOURNAL OF CLINICAL MICROBIOLOGY 2007; 45(4):1087–1092
results assist laboratories in providing clinicians with the information needed to select the most appropriate
antibiotic treatment. Evaluation of VITEK® 2 and RapIDTM Yeast Plus Systems for Yeast Species Identification: 12
Designed to fit the needs of any clinical laboratory, the VITEK 2 System helps labs deliver – with
® Experience at a Large Clinical Microbiology Laboratory.
confidence – the right analysis to guide timely, relevant treatment options. Sanguinetti M., Porta R., Sali M., Lat Sorda M., Pecorini G., Fadda G., Posteraro B.
JOURNAL OF CLINICAL MICROBIOLOGY 2007;45 (4):1343-1346
CONTENTS CONTENTS
VITEK® 2 – ANTIMICROBIAL SUSCEPTIBILITY TESTING Evaluation of the VITEK® 2 AST-ST01 card for Streptococcus pneumoniae susceptibility testing 27
compared to ETEST® and broth microdilution.
GRAM-NEGATIVE ORGANISMS Longtin J., Berube E., Gervais P., Sabri M., Boissinot M., Moineau S., and Bergeron MG.
ICAAC 2013 - Poster D-590
Comparison of the VITEK® 2, MicroScan, and ETEST® Methods with the agar dilution Method in 14
assessing colistin susceptibility of bloodstream isolates of Acinetobacter species from a Korean New Streptococcus AST Product on an Automated System. 29
university hospital. Griffith R., Messina-Powell S., Creely D., Dante M., Theodorakis P., Burnham C., Doern C., Collins R., Dunne W., Shortridge D.
ICAAC 2010 - Poster D-172
Lee SY., Shin JH., Lee K., Joo MY., Park KH., Shin MG., Suh SP., Ryang DW., Kima SH.
YEASTS
Evaluation of three automated systems for susceptibility testing of Enterobacteria containing 15 Multicenter Evaluation of the New VITEK® 2 Yeast Susceptibility Test Using New CLSI 31
qnrB, qnrS, and/or aac(6’)-Ib-cr. Breakpoints for Fluconazole.
Calvo J., Cano M.E., Pitart C., Marco F., Rodríguez-Martínez J.M., Pascual A., Martínez-Martínez L. Pfaller MA., Diekema DJ., Procop GW., Wiederhold NP.
JOURNAL OF MEDICAL MICROBIOLOGY 2011;49(9):3343-3345 JOURNAL OF CLINICAL MICROBIOLOGY 2014;52(6):2126-2130
Evaluation of the New VITEK® 2 Extended -Spectrum Beta-Lactamase (ESBL) 16 Multicenter Comparison of the VITEK® 2 Antifungal Susceptibility Test with the CLSI 32
Test for Rapid Detection of ESBL Production in Enterobacteriaceae Isolates. Broth Microdilution Reference Method for Testing Caspofungin, Micafungin,
Spanu T., Sanguinetti M., Tumbarello M., D’Inzeo T., Fiori B., Posteraro B., Santangelo R., Cauda R., Fadda G. and Posaconazole against Candida spp.
Peterson J.F., Pfaller M.A., Diekema D.J., Rinaldi M.G., Riebe K.M., Ledeboer N.A.
Evaluation of VITEK® 2 for Antimicrobial Susceptibility Testing of Enterobacteriaceae. 17
Bobenchik A.M, Hindler J.A., Maldonado M., Desai H.B., Deak E., Giltner C.L., Humphries R.M.
ASM 2013 - Poster C-562
Multicenter Comparison of the VITEK® 2 Yeast Susceptibility Test with the CLSI Broth 33
Microdilution Reference Method for Testing Fluconazole against Candida spp.
VITEK® 2 Reliability for Antimicrobial Susceptibility Testing of non-Enterobacteriaceae. 20 Pfaller M.A., Diekema D.J., Procop G.W., Rinaldi M.G.
JOURNAL OF CLINICAL MICROBIOLOGY 2007; 45(3):796-802
Deak E., Hindler J.A., Bobenchik A.M., Maldonado M., Desai H.B., Humphries R.M.
Multicenter Comparison of the VITEK® 2 Antifungal Susceptibility Test with the CLSI Broth 34
GRAM-POSITIVE ORGANISMS Microdilution Reference Method for Testing Amphotericin B, Flucytosine,
Evaluation of the Automated VITEK® 2 System for the Detection of Various Mechanisms of 22 and Voriconazole against Candida spp.
Macrolides and Lincosamides Resistance in Staphylococcus aureus. Pfaller M.A., Diekema D.J., Procop G.W., Rinaldi M.G.
Filippin L, Roisin S, Nonhoff C, Vandendriessche S, Heinrichs A, Denis O.
Performance of VITEK® 2 for Antimicrobial Susceptibility Testing of Staphylococcus spp. 23

and Enterococcus spp.
Bobenchik A.M., Hindler J.A., Giltner C.L., Saeki S., Humphries R.M.
VITEK® 2 – ADVANCED EXPERT SYSTEM™
Maximizing the Use of the Advanced Expert System™ to Improve Patient Care. 36
Use of VITEK® 2 antimicrobial susceptibility profile to identify mecC in methicillin-resistant 24 LaBombardi V.J.
White Paper, 2011
Staphylococcus aureus.
Cartwright E.J., Paterson G.K., Raven K.E., Harrison E.M., Gouliouris T., Kearns A., Pichon B., Edwards G., Skov R.L.,
Larsen A.R., Holmes M.A., Parkhill J., Peacock S.J., Török M.E. Multicentre evaluation of the VITEK® 2 Advanced Expert System™ for interpretive reading 37
JOURNAL OF CLINICAL MICROBIOLOGY 2013;51(8):2732-2734 of antimicrobial resistance tests.
Livermore DM., Struelens M., Amorim J., Baquero F., Bille J., Canton R., Henning S., Gatermann S., Marchese A.,
BD Phoenix and VITEK® 2 Detection of mecA-Mediated Resistance 25 Mittermayer H., Nonhoff C., Oakton KJ., Praplan F., Ramos H., Schito GC., Van Eldere J., Verhaegen J., Verhoef J., Visser MR.
in Staphylococcus aureus with Cefoxitin. JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY 2002;49(2):289-300
Junkins A.D., Lockhart S.R., Heilmann K.P., Dohm C.L., Von Stein D.L., Winokur P.L., Doern G.V., Richter S.S.
JOURNAL OF CLINICAL MICROBIOLOGY 2009;47(9):2879-2882 Potential Impact of the VITEK® 2 System and the Advanced Expert System™ 38
on the Clinical Laboratory of a University-Based Hospital.
Evaluation of the VITEK® 2 AST-P559 Card for Detection of Oxacillin Resistance 26 Sanders CC., Peyret M., Moland ES., Cavalieri SJ., Shubert C., Thomson KS., Boeufgras JM., Sanders WE.
in Staphylococcus aureus. JOURNAL OF CLINICAL MICROBIOLOGY 2001;39(7):2379-2385
Torres E., Pérez S., Villanueva R., Bou G.

JOURNAL OF CLINICAL MICROBIOLOGY 2008; 46(12):4114-4115
CONTENTS
VITEK® 2 – IMPACT OF RAPID REPORTING
Clinical and economic impact of rapid reporting of bacterial identification and antimicrobial 40
susceptibility results of the most frequently processed specimen types.
Galar A., Yuste J.R., Espinosa M., Guillén-Grima F., Hernáez-Crespo S., and Leiva J.
EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY AND INFECTIOUS DISEASES 2012;31 (9):2445-2452
Clinical and economic evaluation of the impact of rapid microbiological diagnostic testing. 41
Galar A., Leiva J., Espinosa M., Guillén-Grima F., Hernáez S., Yuste JR.
JOURNAL OF INFECTION 2012;65(4):302-309
Clinical and Financial Benefits of Rapid Bacterial Identification and Antimicrobial 42

Susceptibility Testing.
Barenfanger J., Drake C., and Kacich G.
Microbial
VITEK® 2 – WORKFLOW ANALYSIS

VITEK® 2 – MICROBIAL IDENTIFICATION
Identification
Ergonomic Analysis Comparison of the VITEK® 2 and VITEK® 2 Compact 44
with the Microscan WalkAway® 96 and Phoenix™ For Work Flow Efficiency
and the Likelihood of Distal Upper Extremity Strain.
Heller-Ono A.
White Paper, 2008
Comparison of bioMerieux VITEK® 2 XL, BD Phoenix™, and Siemens MicroScan 45

Walkaway® 96 plus: choosing an identification and antimicrobial susceptibility testing
system for a medium sized microbiology laboratory.
Hooper M., Hill C., Hadwell V., Blondel-Hill E.
ECCMID 2013 - Poster P-1536
Analysis of the Comparative Workflow and Accuracy of the VITEK® 2 Compact 47

and the Combination Mini-API®/Agar diffusion SIRSCAN® Method.
Doat V., Roubille M., Turner R.
ECCMID 2007 - Poster P-1727
Analysis of the Comparative Workflow and ID/AST Test Result Accuracy of 49

the VITEK® 2 compact and the Phoenix™ Systems.
Rommler W., Beer L., Kessler M., and Kaehler K.
VITEK® 2 - MICROBIAL IDENTIFICATION VITEK® 2 - MICROBIAL IDENTIFICATION
GRAM-NEGATIVE ORGANISMS GRAM-NEGATIVE ORGANISMS
JOURNAL OF CLINICAL MICROBIOLOGY JOURNAL OF CLINICAL MICROBIOLOGY

2004;42(9):4067-4071 2005;43(1):84-88
Evaluation of the New VITEK® 2 Card Performance of the New VITEK® 2 GP Card
for Identification of Clinically for Identification of Medically Relevant Gram-Positive
Relevant Gram-Negative Rods. Cocci in a Routine Clinical Laboratory.
Funke G. and Funke-Kissling P. Funke G. and Funke-Kissling P.
This study evaluated the VITEK® 2 GN Gram negative identification card by comparing it to conventional This study evaluated the VITEK® 2 GP Gram positive identification card by comparing it to conventional
biochemical testing using 511 fermenters and 144 non-fermenters (655 strains in total), representing 54 taxa. biochemical testing using 217 Streptococcaceae and 147 Micrococcaceae strains (364 strains in total), representing
Discrepancies were resolved with API®, Biotype 100, and 16S rRNA gene sequencing. 31 taxa. Discrepancies were resolved with ID 32 STAPH, rapid ID 32 STREP, and 16S rRNA gene sequencing.
Isolates from the 655 strains were derived from fresh routine primary isolations (n=157), primary isolation plates A total of 364 isolates were tested, and of these, 105 were derived from fresh routine primary isolations.
which had been stored at 4°C to 8°C for less than 1 week (N=301), and stock cultures (n=197). The VITEK® 2 The VITEK® 2 GP card correctly identified 344 (94.5%) isolates to the species level, 17 (4.7%) were identified
GN card correctly identified 637 (97.3%) isolates to the species level, 14 (2.1%) were identified with low with low discrimination, 1 (0.3%) was incorrectly identified, and 2 (0.5%) were unidentified. Identifications were
discrimination, 4 (0.6%) were incorrectly identified, and 0 (0%) were unidentified. Identifications were available available for 90.7% of the isolates within 7 hours.
for 91.6% of the isolates within 7 hours.
These results demonstrate that the VITEK® 2 GP identification system is robust since isolates were grown on
These results demonstrate that the VITEK 2 GN identification system is robust since isolates were grown on
® 3 different types of media prior to testing, and good results (97% correct identification) were obtained when testing
4 different types of media prior to testing, and good results (96.2% correct identification) were obtained when was performed on 105 Gram positive cocci sourced from primary isolation plates. Overall, the VITEK® 2 GP
testing fresh routine isolates with 157 Gram negative rods. Overall, the VITEK® 2 GN identification card appears identification card provides reliable results for the identification of Gram positive cocci in the routine clinical lab.
to be a promising addition to the routine clinical lab for rapid identification of Gram negative rods.
“… more than 97% of the isolates were correctly identified to the species level “Overall, we were impressed by the performance of the system,
without the use of additional tests.” since more than 94% of the isolates were correctly identified to species level
without […] additional tests”
KEY POINTS KEY POINTS

97%The
➔ of VITEK ® 2 GN card shows good performance for identification of the most frequently found and clinically relevant
all isolates included in this study were correctly identified with the use of the study’s extraction protocol. ➔ T he VITEK® 2 GP card shows good performance for identification of the most frequently found and clinically relevant
Gram negative rods. Gram positive cocci.
The VITEK MS used in conjunction with this extraction method can significantly reduce the time of diagnosis.
®
➔ Results
were available for > 90% of the isolates tested in 7 hours or less. ➔ Results
were available for > 90% of the isolates tested in 7 hours or less.
6 7
HAEMOPHILUS, NEISSERIA AND OTHER FASTIDIOUS ORGANISMS ANAEROBES, CORYNEBACTERIUM, etc.

2008;46(8):2681–2685 2009;47(6):1923–1926
Multicenter Evaluation of the New VITEK® 2 Evaluation of the New VITEK® 2 ANC Card for
Neisseria-Haemophilus Identification Card. Identification of Medically Relevant Anaerobic Bacteria.
Rennie R.P., Brosnikoff C., Shokoples S., Barth Reller L., Mirrett S., Janda W., Ristow K., Krilcich A. Mory F., Alauzet C., Matuszeswski C., Riegel P., Lozniewski A.
Three clinical laboratories assessed the quality, reproducibility, and accuracy of the VITEK® 2 NH identification The performance of the VITEK® 2 ANC identification card was assessed by testing 261 anaerobic clinical
card using 16S rRNA sequencing as the reference method. Reproducibility was assessed at each site by testing 9 isolates belonging to 43 medically relevant taxa that had been previously identified using conventional reference
ATCC® quality control strains 20 times over a period of 10 or more days. In addition, 371 fresh or frozen recently identification methods. Discrepant results were resolved with 16S rRNA gene sequencing.
isolated clinical strains and 30 well characterized challenge isolates were tested to determine the quality and
accuracy of identification. Of the 261 isolates tested, 257 (98.5%) were correctly identified by the VITEK® 2 ANC identification card to the
genus level. Only 251 of the 261 isolates tested have species-level claims in the VITEK® 2 ANC database, and
Reproducibility testing gave the expected results within a 95% confidence interval, and 98% of the challenge of these 217 (86.5%) were correctly identified at the species level, 2 (0.8%) strains were not identified, 8 (3.1%)
strains yielded an overall correct identification, with 8% being identified with low discrimination, 2% were strains were incorrectly identified, and 24 (9.6%) strains were identified with low discrimination. Furthermore,
incorrectly identified, and 0% were unidentified. Regarding the clinical isolates, the VITEK® 2 NH identification 17 of the 24 strains identified with low discrimination were correctly identified to the species level by using the
card gave an overall correct identification to the species level for 96.5% (358 of 371 isolates), including 10.2% (38 of recommended additional tests.
371 isolates) with low discrimination, 2.7% (10 of 371 isolates) incorrectly identified, and 0.8% (3 of 371 isolates)
unidentified. In addition, 7 of the 10 incorrectly identified clinical isolates gave correct identification results to the The VITEK® 2 ANC identification system is a simple, rapid, and satisfactory method for identification of the most
genus level. VITEK® 2 NH card results differed from 16S rRNA sequencing results for 27 isolates, all of which frequently encountered anaerobes in the clinical microbiology lab.
are not included in the VITEK® 2 database.
The performance criteria set forth in this clinical trial of >95% overall correct identification, < 25% low discrimination,
<2% incorrect identification, and <5% unidentified organisms were met by the VITEK® 2 NH identification card
with a >95% confidence interval when compared to the 16S rRNA sequencing reference method. These results
indicate that the VITEK® 2 NH identification card is acceptable for routine use in clinical labs.
“With a 95% confidence interval, the VITEK® 2 NH card gave correct results “This system is a satisfactory new automated tool for the rapid identification of most
over 95% of the time at all three laboratory test sites.” anaerobic bacteria isolated in clinical laboratories.”

➔ The
VITEK® 2 NH card demonstrated excellent performance, and is acceptable for routine use in a clinical microbiology ➔ T he VITEK® 2 ANC card is a simple, rapid, and satisfactory method for identification of anaerobes.
laboratory.
8 9
ANAEROBES, CORYNEBACTERIUM, etc. YEASTS

2008;46(8):2646-2651 2007;45(4):1087–1092
Multicenter Evaluation of the VITEK® 2 Anaerobe Multicenter Evaluation of the New VITEK® 2 Advanced
and Corynebacterium Identification Card. Colorimetric Yeast Identification Card.
Rennie R.P., Brosnikoff C., Turnbull L., Barth Reller L., Mirrett S., Janada W., Ristow K., Krilcich A.. Hata J.D., Hall L., Fothergill A.W., Larone D.H., Wengenack N.L.
The purpose of this study was to validate the performance of the VITEK® 2 ANC identification card for its ability This multicenter study evaluated the accuracy, reliability, and reproducibility of the VITEK® 2 YST identification
to accurately identify corynebacteria and anaerobic species at three clinical trial laboratories by comparing results card for identification of yeast and yeast-like organisms compared to the API® 20C AUX (API®) system using 12
to 16S rRNA sequencing as the reference method. Reproducibility was assessed at each site by testing 9 ATCC® quality control, 64 challenge, and 623 clinical yeast isolates. Discrepancies were resolved by using API® as the
quality control strains 20 times over a period of 10 or more days. In addition, 365 fresh or frozen recently isolated comparator method.
clinical strains and 50 well-characterized challenge isolates were tested to determine the quality and accuracy of
identification. The VITEK® 2 YST identification card correctly identified 100% of the challenge strains, and 98.5% of the cli-
nical isolates. Furthermore, amongst the clinical strains 1.0% of the isolates were incorrectly identified and 0.5%
Reproducibility testing gave the expected results within a 95% confidence interval, except Corynebacterium were unidentified, with the YST card resulting in fewer low-discrimination results than the API® comparator
striatum ATCC® 6940 was incorrectly identified at a single trial site. In addition, 98% of the challenge strains method (18.9% versus 30.0%, respectively). Reproducibility testing gave the expected results >95% of the time
yielded an overall correct identification, when including 5% that were identified with low discrimination, 2% within a 95% confidence interval.
were incorrectly identified, and 0% were unidentified. Regarding the clinical isolates, the VITEK® 2 ANC
identification card gave an overall correct identification for 95.1% (347/365), including 4.9% (18/365) with low The VITEK® 2 YST identification card reduced time-to-identification to 18 hours from 48 to 72 hours with API®
discrimination, 4.6% (17/365) incorrectly identified, and 0.3% (1/365) unidentified. Fourteen of the 17 incorrectly while producing objective, automated results. It was simple to set up, required less technologist time than API®,
identified clinical isolates gave correct identification results to the genus level. is less prone to operator error, and produces timely, accurate identification of medically encountered yeast species
in the clinical microbiology laboratory.
All performance criteria were met by the VITEK® 2 ANC identification card with a >95% confidence interval
when compared to the 16S rRNA sequencing comparator method. These results indicate that the VITEK® 2 ANC
identification card is acceptable for routine use in clinical labs.
“Successful identification of [more] difficult species may have important benefits “… overall, the VITEK® 2 with the updated colorimetric YST card is a valuable addition in
such as separating pathogens from commensal species and the identification of medically encountered yeast species”
choosing appropriate therapies when required.”

➔ The
VITEK® 2 ANC card identifies the large majority of corynebacteria and anaerobes seen in a clinical setting. ➔ The
VITEK® 2 YST identification card has good performance for identification of clinically significant yeast species.
➔ The
VITEK 2 ANC card demonstrated good performance for all identification claims indicated.
® ➔ T he YST card is simple to set up, requires less hands-on time, is less prone to operator error and has significantly less
time to identification than API®.
10 11
VITEK® 2 - MICROBIAL IDENTIFICATION
YEASTS
JOURNAL OF CLINICAL MICROBIOLOGY

2007;45 (4):1343-1346
Evaluation of VITEK® 2 and RapIDTM Yeast Plus Systems

for Yeast Species Identification: Experience at a
Large Clinical Microbiology Laboratory.
Sanguinetti M., Porta R., Sali M., La Sorda M., Pecorini G., Fadda G., Posteraro B.
Antimicrobial
This study compared the performance of the VITEK® 2 YST identification card to the RapID™ Yeast Plus system
using 750 clinical yeast isolates, representing 24 species and 6 genera. 16S rRNA sequence analysis was used as
the reference method.
737 of the 750 (98.2%) isolates were correctly identified to the species level by the VITEK® 2 YST card, including
isolates identified with low-discrimination that resolved upon supplemental testing. In addition, 2 isolates
(0.3%) identified with low discrimination did not resolve with supplemental testing, 8 (1.0%) isolates were
Susceptibility
misidentified, and 4 isolates (0.5%) were unidentified by the VITEK® 2 YST card. RapID™ Yeast Plus correctly
identified 716 of 750 (95 .5%) isolates to the species level including isolates identified with low discrimination that
resolved with supplemental testing. Another 18 (2.4%) isolates were misidentified, and 16 (2.1%) isolates were
unidentified by RapID™ Yeast Plus.
Both systems are rapid and accurate methods for identification of yeast species seen in clinical mycology labs.
Testing
“98.2% [of isolates] were correctly identified to the species level
by the VITEK® 2 system.”
KEY POINTS
➔ The
VITEK® 2 YST identification card is an accurate method for identification of yeast species.
➔ Greater
than 98% of the most commonly encountered yeast species were correctly identified.
12
VITEK® 2 - ANTIMICROBIAL SUSCEPTIBILITY TESTING VITEK® 2 - ANTIMICROBIAL SUSCEPTIBILITY TESTING
JOURNAL OF CLINICAL MICROBIOLOGY JOURNAL OF MEDICAL MICROBIOLOGY

2013;51 (6):1924-1926 2011;49(9):3343-3345
Comparison of the VITEK® 2, MicroScan®, and ETEST® Evaluation of three automated systems for susceptibility
Methods with the Agar Dilution Method in assessing testing of Enterobacteria containing qnrB, qnrS,
colistin susceptibility of bloodstream isolates of and/or aac(6')-Ib-cr.
Acinetobacter species from a Korean university hospital. Calvo, J., Cano, M.E., Pitart, C., Marco, F., Rodríguez-Martínez, J.M., Pascual, A., Martínez-Martínez, L.
Lee SY., Shin JH., Lee K., Joo MY., Park KH., Shin MG., Suh SP., Ryang DW., Kima SH. A total of 68 clinical Enterobacteriaceae isolates obtained from two hospitals, one located in northern and one
in southern Spain, were identified as containing qnrB, qnrS, and/or aac(6')-Ib-cr plasmid-mediated quinolone
A total of 213 Acinetobacter species bloodstream infection isolates, including 13 colistin-resistant isolates, resistance (PMQR) markers by multiplex PCR and sequencing of the obtained amplicons. The isolates were
were used to evaluate the performance of the VITEK® 2, MicroScan WalkAway® 96 Plus, and ETEST® for then tested with the BD Phoenix™, Siemens MicroScan WalkAway®, and bioMérieux VITEK® 2 systems, and
colistin susceptibility testing using agar dilution according to CLSI guidelines as the reference method. the resulting quinolone and aminoglycoside MICs were compared to reference broth microdilution (BMD)
using CLSI interpretive criteria.
Overall performance of the VITEK® 2 and ETEST® was good when compared to the agar dilution reference
method. The VITEK® 2 exhibited 99.1% category agreement, 0.9% very major errors and no major errors. Category and essential agreement (CA and EA, respectively) for all combinations of agents and automated
ETEST® had 99.1% category agreement, no very major errors and 0.9% major errors. MicroScan® had 87.3% systems was >90%, with the exception of two cases with the WalkAway® involving EA of nalidixic acid (88%)
category agreement, 0.9% very major errors and 11.7% major errors. and ciprofloxacin (75%). MicroScan® had one very major error (VME) resulting in a VME rate of 0.21%,
whereas BD Phoenix™ and VITEK® 2 had no VMEs. Major errors were 0.21% for MicroScan®, 0.88% for
In conclusion, the authors found ETEST® and VITEK® 2 to be useful methods to discern susceptibility of BD Phoenix™, and 0.59% for VITEK® 2, whereas minor errors were 3.57% for MicroScan®, 5.00% for BD
colistin against Acinetobacter isolates. Phoenix™, and 2.06% for VITEK® 2.
In conclusion, the authors considered all systems to be reliable for susceptibility testing of quinolones and
aminoglycosides against Enterobacteriaceae with the qnrB, qnrS, and/or aac(6)Ib-cr gene.
“… ETEST® and VITEK® 2 are useful methods for discrimination “… the three systems […] evaluated in this study (MicroScan®, BD Phoenix™, and VITEK® 2)
of colistin-resistant and –susceptible Acinetobacter isolates.” can be considered reliable for susceptibility testing of quinolones and aminoglycosides
against enterobacteria with the qnrB, qnrS, and/or aac(6’)-Ib-cr gene.”

➔ Excellent
category agreements were observed using VITEK® 2 and ETEST® as compared to the agar dilution reference ➔ VITEK® 2 accurately predicts aminoglycoside and quinolone susceptibility against Enterobacteriaceae isolates.
method.
14 15
➔ ASM / 2013 Poster C-562
Evaluation of VITEK® 2 for Antimicrobial Susceptibility

2006;44(9):3257-3262
Testing of Enterobacteriaceae
Bobenchik A.M.1, Hindler J.A.2, Maldonado M.2, Desai H.B.2, Deak E.1, Giltner C.L.1, Humphries R.M.1
Evaluation of the New VITEK® 2 Extended -Spectrum

1Department of Pathology and Laboratory Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
2UCLA Health System, Los Angeles, CA, USA
Beta-Lactamase (ESBL) Test for Rapid Detection of ESBL

Production in Enterobacteriaceae Isolates. REVISED ABSTRACT MATERIAL AND METHODS
Background: VITEK® 2 is a widely used commercial antimicrobial Clinical isolates: 258 fresh and stock clinical isolates of Enterobacteriaceae
susceptibility testing system. We compared MIC results obtained using VITEK® 2: VITEK® 2 AST-GN69 and AST-XN06 cards and software
VITEK® 2 to those obtained using a CLSI broth microdilution reference version 5.04 used as recommended by the manufacturer
Spanu T., Sanguinetti M., Tumbarello M., D’Inzeo T., Fiori B., Posteraro B., Santangelo R., Cauda R., Fadda G.
method (BMD) for testing Enterobacteriaceae clinical isolates. (bioMérieux, Durham, NC)
Materials: VITEK® 2 AST-GN69 and AST-XN06 cards and software Reference method: Broth microdilution (BMD) performed
In this study 1,129 isolates were used to evaluate the performance of the VITEK® 2 ESBL test to detect ESBL- version 5.04 (bioMérieux, Durham, NC) were used for testing 258 fresh according to CLSI guidelines (M07-A8 and M100-S23) using in-house
producing Enterobacteriaceae* isolates. A total of 312 of the 1,129 isolates tested were ESBL positive by and stock clinical isolates of Enterobacteriaceae selected to represent prepared frozen panels.
the reference method (identification of beta-lactamase genes by isoelectric focusing and sequencing of PCR a variety of susceptibility profiles, including 26 carbapenem-resistant Data analysis: For the 25 antimicrobial agents evaluated, Essential
amplicons), and were found to harbor one or more SHV, TEM, SHV/TEM, CTX-M, or CTX-M/SHV/TEM Enterobacteriaceae (CRE). In-house prepared panels were used for Agreement (EA), Categorical Agreement (EA), Very Major (VME), Major
genes. BMD. Isolates tested included: Escherichia coli (N=58), Klebsiella spp. (ME), and Minor (mE) errors were calculated as previously described
(N=64), Proteus mirabilis (N=28), Enterobacter cloacae complex (Clark, 2009). Results were evaluated using FDA breakpoints and also
The VITEK® 2 ESBL test results matched the molecular testing reference method for 1,121 (99.3%) of (N=29), Enterobacter aerogenes (N=14), Serratia marcescens (N=17), CLSI breakpoints for carbapenems, aztreonam, cefazolin, cefotaxime,
the 1,129 isolates evaluated. In addition, 306 of the 313 ESBL-producing isolates were correctly identified Providencia stuartii (N=12), Morganella morganii (N=9), Citrobacter spp. ceftazidime, and ceftriaxone.
(sensitivity, 98.1%; positive predictive value, 99.3%), whereas 2 of the 817 ESBL-negative isolates were called (N=20), Proteus vulgaris (N=4), and Salmonella spp. (N=3). Twenty-five
positive (specificity, 99.7%; negative predictive value, 99.3%) by the VITEK® 2. antimicrobial agents were evaluated using FDA breakpoints and also
Study design: Each isolate tested concurrently with both methods.
Isolates with VME or ME using FDA breakpoints were retested using both
CLSI breakpoints for carbapenems, aztreonam, cefazolin, cefotaxime,
The VITEK® 2 ESBL test was found to be reliable for routine identification of ESBL-producing isolates ceftazidime, and ceftriaxone.
methods. Results from repeat testing were used for analysis.
containing various SHV, TEM, SHV/TEM, CTX-M, and CTX-M/SHV/TEM genes. It also produced results in Results: Out of ~ 6,000 drug/organism combinations there were
Carbapenem resistant: defined as a meropenem MIC ≥ 2 μg/mL for
6 to 13 hours, with a median time to result of 7.5 hours. 14 very major errors (VME) and 15 major errors (ME) using FDA
the purpose of this study.
breakpoints. 11 of 14 VMEs corrected upon repeat testing, resulting
in 1 VME with cefazolin, 1 VME with cefpodoxime, and 1 minor error Organism N= Carbapenem Resistant
* Note that the authors tested other Enterobacteriaceae, but the VITEK® 2 ESBL test only has susceptibility performance claims for E. coli, K. pneumoniae, and K. oxytoca.
(mE) with cefotaxime. 4 of 15 MEs corrected upon repeat testing, Citrobacter amalonaticus 1
tresulting in 6 ME and 5 mEs. 11.7%, 10.1% and 7.8% mEs occurred with Citrobacter freundii 13 3
nitrofurantoin, cefoxitin, and piperacillin-tazobactam, respectively.
Citrobacter koseri 6
VITEK® 2 consistently had the higher MIC value compared to BMD for
Enterobacter aerogenes 14 6
these mEs. Using CLSI breakpoints, there were 5 mEs for carbapenems
among 4 of the 26 CRE isolates. Overall categorical agreement (CA) Enterobacter cloacae 29 1
using FDA breakpoints was 95.8%. Essential agreement (EA) for all Escherichia coli 58 1
drug/organism combinations was 98.9%. Klebsiella oxytoca 13 1
Conclusions: Overall there was excellent CA and EA between the
“… our experience with this large series of Enterobacteriaceae isolates VITEK® 2 and a CLSI reference BMD method. There was 7.8% mEs
Klebsiella pneumoniae 51 13
Morganella morganii 9
indicates that the VITEK® 2 ESBL test system is a reliable time-saving tool with the new formulation of piperacillin-tazobactam, but no VME or
Proteus mirabilis 28
MEs, and only 1 ME with imipenem (FDA breakpoints). Using 2010
for routine identification of ESBL-producing strains.” CLSI breakpoints for carbapenems resulted in 5 mEs for the CRE. Both Proteus vulgaris 4
the AST-GN69 and AST-XN06 cards are reliable for testing of clinical Providencia stuartii 12
isolates of Enterobacteriaceae.
Salmonella spp. 3
Serratia marcescens 17 1
TOTALS 258 26
Reference: Clark, R.B., M.A. Lewinski, M.J. Loeffelholz, and R.J. Thibbetts, 2009. Cumitech
31A, Verification and Validation of Procedures in the Clinical Microbiology Laboratory.
Coordinating ed., S.E. Sharp. ASM Press, Washington, D.C.
KEY POINTS
VITEK® 2 ESBL test reliably detects ESBL-producing E. coli, K. pneumoniae, and K. oxytoca*.
➔ The
16 17
Evaluation of VITEK® 2 for Antimicrobial Susceptibility Testing of Enterobacteriaceae Evaluation of VITEK® 2 for Antimicrobial Susceptibility Testing of Enterobacteriaceae
RESULTS Performance of CLSI carbapenem, aztreonam, cefazolin, cefotaxime, OVERALL PERFORMANCE

Performance using FDA breakpoints: There were 14 VME, 15 ME and ceftazidime, and ceftriaxone breakpoints in all isolates: There were 10 Of 258 isolates tested, 1 (0.4%) terminated due to failed growth in the
258 mEs. 11 of 14 VME and 4 of 15 MEs corrected upon repeat testing VME, 5 ME, and 71 mEs. Repeat testing was performed on select isolates control well. EA and CA were 98.9% and 95.8%, respectively.
(Table 1) resulting in 2 VME and 6 MEs: cefazolin (1 VME and 1 ME); (Table 1) resulting in 3 VME and 4 MEs: cefazolin (1 VME); ceftazidime (1
cefpodoxime (1 VME); amikacin (1 ME); gentamicin (1 ME); imipenem VME); ceftriaxone (1 VME); ertapenem (3 ME); imipenem (1 ME) (Table 1). Table 2: Essential and Categorical Agreement using FDA Breakpoints
(1 ME); and meropenem (2 ME) (Table 2). Performance of CLSI carbapenem breakpoints in CRE isolates:
EA CA VME ME mE
There were 5 mEs among 4 of the 26 CRE isolates.
Antimicrobial N= N= % N= % N= % N= % N= %
Amikacin 257 254 (98.8) 243 (94.6) 0 (0) 1/249 (0.4) 13/257 (5.1)
Table 1: Initial Discrepant Results and Outcome of Repeat Testing
Amoxicillin-clavulanic 257 256 (99.6) 249 (96.9) 0 (0) 0 (0) 8/257 (3.1)
acid
Results Error with Breakpoints Method Ampicillin-sulbactam 257 255 (99.2) 245 (95.3) 0 (0) 0 (0) 12/257 (4.7)
Antimicrobial Organism Initial Repeat FDA CLSI Error Source Ampicillin 257 257 (100) 255 (99.2) 0 (0) 0 (0) 2/257 (0.8)
E.cloacae ME mE x VITEK Aztreonam 257 254 (98.8) 243 (94.6) 0 (0) 0 (0) 14/257 (5.4)
Amikacin
P.stuartii ME ME x Cephalothin 257 256 (99.6) 239 (92.9) 0 (0) 0 (0) 18/257 (7.0)
Aztreonam E. cloacaea VME corrected x x BMD Cefazolin 257 254 (98.8) 254 (98.8) 1/139 (0.7) 1/117 (0.9) 1/257 (0.4)
K. pneumoniae VME VME x x Cefepime 257 252 (98.1) 247 (96.1) 0 (0) 0 (0) 10/257 (3.9)
E. aerogenes VME corrected x x VITEK Cefotaxime 257 253 (98.4) 237 (92.2) 0 (0) 0 (0) 20/257 (7.8)
E. aerogenes VME corrected x x VITEK Cefoxitin 257 249 (96.9) 231 (89.9) 0 (0) 0 (0) 26/257 (10.1)
Cefazolin
E. coli VME corrected x BMD Cefpodoxime 231 231 (100) 227 (98.3) 1/84 (1.2) 0 (0) 3/231 (1.3)
K. oxytoca ME ME x
Ceftazidime 257 255 (99.2) 242 (94.2) 0 (0) 0 (0) 15/257 (5.8)
E. coli ME corrected x x VITEK
Ceftriaxone 257 256 (99.6) 246 (95.7) 0 (0) 0 (0) 11/257 (4.3)
Cefpodoxime K. pneumoniaeb VME VME x
Cefuroxime 257 254 (98.8) 239 (92.9) 0 (0) 0 (0) 17/257 (6.6)
E. colic VME mE x BMD
Cefotaxime Ciprofloxacin 257 257 (100) 253 (98.4) 0 (0) 0 (0) 4/257 (1.6)
E. cloacaea VME corrected x x BMD
Doripenem 204 200 (98.0) 201 (98.5) 0/25 (0) 0 (0) 3/204 (1.5)
E. cloacaea VME corrected x x BMD
Ceftazidime Ertapenem 257 254 (98.8) 251 (97.7) 0/24 (0) 0 (0) 6/257 (2.3)
P. stuartii VME VME x
E. colic VME corrected x VITEK Gentamicin 257 255 (99.2) 252 (98.1) 0 (0) 1/206 (0.5) 4/257 (1.6)
Ceftriaxone E. cloacaea VME corrected x x BMD Imipenem 257 247 (96.2) 247 (96.1) 0/13 (0) 1/238 (0.4) 9/257 (3.5)
K. pneumoniae VME VME x Levofloxacin 257 257 (100) 253 (98.4) 0 (0) 0 (0) 4/257 (1.6)
P. mirabilisd ME mE x VITEK Meropenem 257 254 (98.8) 253 (98.4) 0/17 (0) 2/238 (0.8) 2/257 (0.8)
C. amalonaticus ME corrected x VITEK Nitrofurantoin 257 255 (99.2) 227 (88.3) 0 (0) 0 (0) 30/257 (11.7)
Cefuroxime
C. koseri VME corrected x BMD Piperacillin-
tazobactam 257 247 (96.2) 237 (92.2) 0/43 (0) 0 (0) 20/257 (7.8)
M. morganii ME mE x VITEK
Tobramycin 257 257 (100) 251 (97.6) 0 (0) 0 (0) 6/257 (2.3)
E. cloacae ME ME x
Trimethoprim- 257 257 (100) 257 (100) 0 (0) 0 (0) 0/257 (0)
Ertapenem E. cloacae ME ME x sulfamethoxazole
E. cloacae ME ME x Totals 98.9 95.8 2 6 258 (4.0)
Gentamicin K. pneumoniaeb ME ME x
E. colic ME ME x
EA= essential agreement, CA= categorical agreement, VME= very major error (total number of resistant isolates is the denominator), ME= major error (total number of susceptible isolates
P. mirabilis ME corrected x VITEK is the denominator), mE= minor error (total number of isolates is the denominator)
Imipenem
P. stuartii ME mE x VITEK Total number of resistant isolates using CLSI breakpoints; doripenem (25); ertapenem (27); imipenem (27); meropenem (22)
E. cloacae ME ME x
E. colic ME ME x
Meropenem CONCLUSIONS
K. pneumoniae ME ME x
Piperacillin-tazobactam E. coli ME mE x BMD • There was excellent EA (98.9%) and CA (95.8%) between • There were 3 MEs with ertapenem and 1 ME with imipenem in 4
the VITEK® 2 and the CLSI reference BMD method. non-CRE isolates using CLSI breakpoints.
Tobramycin E. coli VME corrected x VITEK
P. mirabilisd ME corrected x VITEK • There were 2 MEs with meropenem and 1 ME with imipenem • There was 7.8% mEs with the new formulation of piperacillin-
Trimethoprim- in 2 CRE isolates using FDA breakpoints. These isolates all had a tazobactam and no VME or MEs. The mE trend was consistent
sulfamethoxazole E. coli VME corrected x VITEK
BMD MIC of 4 μg/mL (FDA interpretation S) and a VITEK® 2 MIC with an intermediate BMD and a resistant VITEK® 2 result, the EA
K. pneumoniae VME corrected x BMD
of 16 μg/mL (FDA interpretation R). Implementation of 2010 CLSI was 96.2%.
breakpoints for these antimicrobials (MIC ≤ 1 μg/mL interpretation S) •
Both the AST-GN69 and AST-XN06 cards are reliable for
would correct these errors. testing of clinical isolates of Enterobacteriaceae.
VME= very major error, ME= major error, mE= minor error, BMD= broth microdilution
a-d same isolate, Bold= carbapenem resistance (eg, meropenem MIC ≥ 2 μg/mL)
18 19
➔ ASM 2013 Poster C-564 VITEK® 2 Reliability for Antimicrobial Susceptibility Testing of non-Enterobacteriaceae
GRAM-NEGATIVE ORGANISMS RESULTS OVERALL PERFORMANCE

Performance using FDA breakpoints: For P. aeruginosa, there was 1 VME, Table 2: Essential and categorical agreement
VITEK® 2 Reliability for Antimicrobial Susceptibility Testing 9 MEs and 51 mEs. 5 of the 9 MEs were corrected upon repeat testing
(Table 1) resulting in 1 VME and 5 MEs: ticarcillin-clavulanic acid (1 VME EA CA VME ME mE
of non-Enterobacteriaceae and 2 MEs); doripenem (1 ME); piperacillin-tazobactam (1 ME) (Table 2).

For A. baumannii, there were 6 VMEs, 1 ME, and 27 mEs. 5 of the 6 VMEs Antimicrobial N= N= % N= % N= % N= % N= %
Deak E. , Hindler J.A. , Bobenchik A.M. , Maldonado M. , Desai H.B. , Humphries R.M.
1 2 1 2 2 1 and the ME were corrected upon repeat testing (Table 1) resulting in Amikacin 95 95 (100) 95 (100) 0/3 (0) 0/87 (0) 0/95 (0)
1Department of Pathology and Laboratory Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA
1 VME: tobramycin (Table 2). Ceftazidime 95 95 (100) 85 (89.5) 0/18 (0) 0/69 (0) 10/95 (10.5)
2UCLA Health System, Los Angeles, CA, USA Performance of CLSI doripenem, imipenem, meropenem, and pipe- Cefepime 95 95 (100) 87 (91.6) 0/15 (0) 0/62 (0) 8/95 (8.4)
racillin-tazobactam breakpoints for P. aeruginosa isolates: There were Ciprofloxacin 94 94 (100) 89 (94.7) 0/26 (0) 0/63 (0) 4/94 (4.3)
Pseudomonas aeruginosa
3 MEs and 24 mEs; 1 ME was corrected upon repeat testing resulting in Doripenem 93 88 (94.6) 83 (89.2) 0/16 (0) 2/55 (2.2) 8/93 (8.6)
2 MEs in doripenem. Gentamicin 95 93 (97.9) 79 (83.2) 0/12 (0) 0/82 (0) 16/95 (16.8)
REVISED ABSTRACT MATERIAL AND METHODS Imipenem 91 91 (100) 83 (91.2) 0/33 (0) 0/53 (0) 8/91 (8.8)
Overview: For the 1028 drug-P. aeruginosa combinations tested, EA and
Background: VITEK 2 is widely used for routine antimicrobial
® Clinical isolates: 134 fresh and stock clinical isolates of Levofloxacin 93 93 (100) 85 (91.3) 0/25 (0) 0/56 (0) 8/93 (8.6)
CA were 99.2% and 92.7%, respectively. For the 364 drug-A. baumannii
susceptibility testing. We compared MIC results obtained using VITEK® 2 non-Enterobacteriaceae Meropenem 92 92 (100) 89 (96.7) 0/35 (0) 0/56 (0) 3/92 (3.3)
combinations tested, EA and CA were 90.3% and 84.8%, respectively. For
to those obtained using a CLSI broth microdilution reference method VITEK® 2: VITEK® 2 AST-GN69 and AST-XN06 cards and software version the 22 drug-Stenotrophomonas maltophilia combinations tested, EA and Piperacillin- 90 88 (97.8) 82 (91.1) 0/20 (0) 1/61 (1.8) 5/90 (5.6)
(BMD) for testing non-Enterobacteriaceae. tazobactam
5.04 used as recommended by the manufacturer (bioMérieux, Durham, CA were 100% and 95.5%, respectively. Tobramycin 95 95 (100) 94 (98.9) 0/10 (0) 0/85 (0) 1/95 (1.1)
Materials: VITEK® 2 AST-GN69 and AST-XN06 cards and software version NC). All drugs cleared by FDA for testing P. aeruginosa, A. baumannii,
Table 1: Initial Discrepant Results and Outcome of Repeat Testing Ticarcillin-
5.04 (bioMérieux, Durham, NC) were used for testing 125 fresh and and S. maltophilia were included. Clavulanic 95 95 (100) 91 (95.8) 1/40 (1.1) 2/12 (2.1) 4/95 (4.2)
stock clinical isolates of non-Enterobacteriaceae selected to represent Acid
Reference method: Broth microdulution (BMD) performed according
Results Error with Method
a variety of susceptibility profiles. In-house prepared panels were used to CLSI guidelines (M07-A8 and M100-S23) using in-house prepared Breakpoints
1123 99.2 92.7 1/253 (0.3) 5 /741(0.7) 75/1123 (6.7)
for BMD. Isolates tested included: Pseudomonas aeruginosa (N=95), frozen panels Antimicrobial Initial Repeat FDA CLSI Error Source
Ampicillin- 28 28 (100) 22 (78.6) 0/7 (0) 0/17 (0) 6/28 (21.4)
Sulbactam
Acinetobacter baumannii (N=28), and Stenotrophomonas maltophilia Data Analysis: Essential Agreement (EA), Categorical Agreement (EA), ME ME x Cefepime 28 24 (85.7) 24 (85.7) 0/10 (0) 0/12 (0) 4/28 (14.3)
(N=11). Twelve, 14 and 2 antimicrobial agents were evaluated for Very Major (VME), Major (ME), and Minor (mE) errors were calculated Doripenem
ME ME x x Cefotaxime 28 28 (100) 28 (100) 0/14 (0) 0/8 (0) 0/28 (0)
P. aeruginosa, A. baumannii, and S. maltophilia, respectively. as previously described (Clark, 2009) for the 14 agents. Imipenem ME mE x BMD Ceftazidime 28 27 (96.4) 24 (85.7) 0/14 (0) 0/10 (0) 4/28 (14.3)
Pseudomonas aeruginosa
Results: For P. aeruginosa, there was 1 very major error (VME) and Study Design: Each isolate tested concurrently with both methods. ME corrected x BMD Ceftriaxone 28 27 (96.4) 21 (75.0) 0/25 (0) 0/0 (0) 7/28 (25.0)
Acinetobacter baumannii
2 major errors (MEs) for ticarcillin-clavulanate, 2 MEs for doripenem, Isolates with VME or ME using FDA breakpoints were retested using both ME corrected x BMD Ciprofloxacin 28 28 (100) 28 (100) 0/14 (0) 0/14 (0) 0/28 (0)
1 ME for piperacillin-tazobactam. Five additional MEs were found for methods. Results from repeat testing were used for analysis. Piperacillin- ME corrected x Gentamicin 28 28 (100) 28 (100) 0/11 (0) 0/17 (0) 0/28 (0)
piperacillin-tazobactam, but 2 of these resulted in minor errors (mEs), and Tazobactam
ME mE x BMD Imipenem 28 28 (100) 28 (100) 0/10 (0) 0/18 (0) 0/28 (0)
3 were corrected upon repeat testing. All drugs tested for P. aeruginosa Organism N=
produced <10% mEs except for gentamicin (16.8%) and ceftazidime ME ME x Levofloxacin 28 28 (100) 28 (100) 0/14 (0) 0/14 (0) 0/28 (0)
(10.5%), where VITEK® 2 MICs were consistently higher than BMD Pseudomonas aeruginosa 95 ME ME x Meropenem 28 28 (100) 28 (100) 0/10 (0) 0/17 (0) 0/28 (0)
MICs. There was categorical agreement (CA) of 92.7% and essential Ticarcillin- ME ME x Piperacillin-
Piperacillin-tazobactam Resistant 20 Clavulanic Acid tazobactam 28 28 (100) 25 (89.3) 0/13 (0) 0/10 (0) 3/28 (10.7)
agreement (EA) of >99% for all drugs with P. aeruginosa and 2 isolates VME VME x
Tobramycin 28 27 (96.4) 25 (89.3) 1/9 (3.6) 0/18 (0) 3/28 (10.7)
did not grow in the VITEK® 2. For the 28 A. baumannii there was 1 VME Meropenem Resistant 35 Ciprofloxacin ME mE x VITEK Trimethoprim-
(tobramycin) and 27 mEs including multiple for the cephalosporins: Amikacin Resistant 3 sulfamthoxa- 28 28 (100) 28 (100) 0/13 (0) 0/15 (0) 0/28 (0)
Ampicillin-Sulbactam VME corrected x BMD zole
ceftazidime (4), cefepime (4), and ceftriaxone (7). No VMEs or MEs and
Acinetobacter baumannii
only 1 mE were seen for S. maltophilia. Overall, categorical agreement Acinetobacter baumannii 28 Ciprofloxacin VME corrected x BMD 364 90.3 84.8 1/164 (0.6) 0/170 (0) 27/364 (7.4)
(CA) using FDA breakpoints was 91.0%. Essential agreement (EA) for Levofloxacin VME corrected x BMD
Meropenem Resistant 10
Stenotrophomonas
all drug/organism combinations was 96.5%. Levofloxacin 11 11 (100) 10 (90.9) 0/1 (0) 0/10 (0) 1/11 (9.1)
Piperacillin-
maltophilia
tazobactam ME corrected x VITEK
Conclusions: Overall, there was excellent CA and EA between the Stenotrophomonas maltophilia 11
Tobramycin VME VME x Trimethoprim-
VITEK® 2 and a CLSI reference BMD method. There was 6.8% mEs Trimethoprim-sulfamethoxazole Resistant 2 sulfamthoxa- 11 11 (100) 11 (100) 0/2 (0) 0/9 (0) 0/11 (0)
with the new formulation of piperacillin-tazobactam and only 1 ME VME corrected x BMD zole
Trimethoprim-
(FDA breakpoints). Both the AST-GN69 and AST-XN06 cards are reliable Total Number of Isolates Tested 134 Sulfamethoxazole VME corrected x BMD 22 100 94.4 0/3 (0) 0/19 (0) 1/22 (4.5)
for testing of clinical isolates of non-Enterobacteriaceae. Note: Resistance was based on FDA breakpoints. VME= very major error, ME= major error, mE= minor error, BMD= broth microdilution
Total 1509 96.5 91.0 2/420 (0.4) 5/930 (0.5) 103/1509 (6.8)
Reference: Clark, R.B., M.A. Lewinski, M.J. Loeffelholz, and R.J. Thibbetts, 2009. Cumitech EA= essential agreement, CA= categorical agreement, VME= very major error,
31A, Verification and Validation of Procedures in the Clinical Microbiology Laboratory. ME= major error, mE= minor error
Coordinating ed., S.E. Sharp. ASM Press, Washington, D.C.
CONCLUSIONS
• There was 96.5% EA and 91.0% CA when testing those drugs • There was 97.8% EA and 91.1% CA for piperacillin-tazobactam
approved by the FDA for P. aeruginosa, A. baumannii, and with P. aeruginosa. There were no VMEs and only 1 ME (1.8%).
S. maltophilia when testing fresh clinical and stock isolates • Overall, there was 1 VME and 5 MEs for P. aeruginosa and
including those with specific resistance phenotypes. 1 VME (tobramycin) for A. baumannii.
• For P. aeruginosa, there was 99.2% EA and 92.7% CA. • Both the AST-GN69 and AST-XN06 cards are reliable for
testing of clinical isolates of non-Enterobacteriaceae.
20 21
GRAM-POSITIVE ORGANISMS GRAM-POSITIVE ORGANISMS

2014;52(11):4087-4089 2014;52(2):392-397
Evaluation of the Automated VITEK® 2 System for the Performance of VITEK® 2 for Antimicrobial Susceptibility
Detection of Various Mechanisms of Macrolides and Testing of Staphylococcus spp. and Enterococcus spp.
Lincosamides Resistance in Staphylococcus aureus.
Bobenchik A.M., Hindler J.A., Giltner C.L., Saeki S., Humphries R.M.
Filippin L, Roisin S, Nonhoff C, Vandendriessche S, Heinrichs A, Denis O.

The study compared MIC results obtained by VITEK® 2 software version V2S 5.01 to those obtained by
the CLSI broth microdilution (BMD) reference method for 134 staphylococcal and 84 enterococcal isolates.
Clinical and Laboratory Standards Institute (CLSI) and the European Committee on Antimicrobial Nineteen antibiotics were included in the study. Resistant organisms tested included methicillin-resistant
Susceptibility Testing (EUCAST) both recommend the double disk diffusion method (D-zone test) for the Staphylococcus aureus (MRSA) (N=58), S. aureus with inducible clindamycin resistance (N=30), SXT resistant
phenotypic detection of macrolide-inducible resistance to clindamycin. This study compared the performance MRSA (N=10), vancomycin resistant Enterococci (N=37), high-level gentamicin resistant Enterococci (N=15),
of VITEK® 2 to the D-zone test for the detection of various macrolide, lincosamide, and streptogramin (MLS) linezolid resistant Enterococcus (N=5), and daptomycin non-susceptible Enterococcus faecalis (N=6).
resistance mechanisms. A total of 67 methicillin-resistant Staphylococcus aureus (MRSA), and 43 methicillin-
sensitive S. aureus (MSSA) non-duplicate isolates well characterized by 16S rRNA PCR for the presence of For the Staphylococci, there was 98.9% category agreement (CA) between the VITEK® 2 and BMD, 98.8%
various methylases or an efflux system were tested. essential agreement (EA), 1.7% very major error (VME), 0.2% major error (ME) and 0.8% minor error (mE).
There was 1 VME for gentamicin and a S. hominis, 6 VMEs for inducible clindamycin resistance in S. aureus,
VITEK® 2 and D-zone test results had 100% agreement for the detection of MLS resistance in S. aureus. and 2 MEs for daptomycin in a S. aureus and a S. epidermidis. For enterococci, there was 97.3% CA, 99.5%
VITEK® 2 also had complete agreement with genotypic testing. The D-zone test had a median time to final EA, 0.7% VME, 0.5% ME and 2% mE. There were 2 VMEs for daptomycin in E. faecalis and 2 MEs, 1 for
susceptibility reporting of 18 hours, whereas the VITEK® 2 accomplished the same task in a median time of high-level gentamicin resistance and 1 for nitrofurantoin, both in E. faecium.
8hr 15 min.
Overall CA for all organisms studied and all antibiotics tested was 98.3% with 99% EA agreement. Eight of
To summarize, the VITEK 2 successfully differentiated between inducible-clindamycin resistance (ICR) due the 218 (3.7%) isolates tested terminated due to insufficient growth in the positive control well and one isolate
to the inducible Macrolide-Lincosamide-Streptogramin B (iMLSB) phenotype and MLS resistance due to an terminated because the species was not included in the AST database. These results show that VITEK® 2 is
efflux system. very comparable to the BMD reference method for susceptibility testing of Staphylococcus and Enterococcus.
“Overall the VITEK® 2 AST-GP71 and GP72 performed comparably to BMD.

“The fully automated VITEK 2 ICR [test] is a good alternative
®
Performance was reliable for organisms with significant resistant phenotypes such as MRSA,
to the D-zone test providing faster results in a working day.” high-level gentamicin-resistant enterococci, and vancomycin resistant Enterococcus.”

➔ VITEK® 2 is reliable for phenotypic detection of various macrolide, lincosamide, and streptogramin (MLS) resistance ➔ VITEK® 2 is reliable for antimicrobial susceptibility testing of Staphylococci and Enterococci.
mechanisms, including inducible-clindamycin resistance (ICR).
➔ VITEK® 2 ICR test results are available significantly sooner than D-zone test results (8hr 15 min versus 18hr).
22 23

2013;51(8):2732-2734 JOURNAL OF CLINICAL MICROBIOLOGY
2009;47(9):2879-2882
Use of VITEK® 2 antimicrobial susceptibility profile

BD Phœnix™ and VITEK® 2 Detection of mecA-Mediated
to identify mecC in methicillin-resistant
Resistance in Staphylococcus aureus with Cefoxitin.
Staphylococcus aureus.
Junkins A.D., Lockhart S.R., Heilmann K.P., Dohm C.L., Von Stein D.L., Winokur P.L., Doern G.V., Richter S.S.
Cartwright E.J., Paterson G.K., Raven K.E., Harrison E.M., Gouliouris T., Kearns A., Pichon B., Edwards G., Skov R.L.,
Larsen A.R., Holmes M.A., Parkhill J., Peacock S.J., Török M.E. This study examined the accuracies of the BD Phoenix™ and the VITEK® 2 systems for the detection of
mecA-mediated resistance in Staphylococcus aureus using 620 clinically significant isolates (448 MRSA and
172 MSSA). Results were compared to oxacillin MICs determined by BMD following Clinical and Laboratory
Methicillin resistant Staphylococcus aureus (MRSA) harboring the mecC gene present a potential diagnostic Standards Institute (CLSI) guidelines and mecA gene detection by PCR.
problem, because they produce negative results both by the latex agglutination test and by the polymerase chain
reaction (PCR) assay for mecA. The ability of the VITEK® 2 to detect mecC MRSA is unknown. A collection The two comparative methods had 100% agreement with each other. Category agreement was 99.8% for the
of 896 S. aureus isolates comprised of 455 MRSA (mecA positive), 62 MRSA (mecC positive), and 379 MSSA BD Phoenix™ and 99.7% for VITEK® 2 relative to the comparative methods. Each instrument had a single
(mecA/ mecC negative) were used to assess the ability of the VITEK® 2 to identify mecC and mecA positive very major error (VME) with different MRSA isolates, and the VITEK® 2 had one major error (ME). Also,
MRSA strains. Genome sequencing was considered the gold standard. 9 isolates on the BD Phoenix™ and 7 on the VITEK® 2 had susceptible oxacillin MICs, but were changed to
resistant by the expert systems on the basis of the cefoxitin result.
The VITEK® 2 was found to have a sensitivity of 88.7% and a specificity of 99.5% for the identification of
mecC MRSA isolates when using an oxacillin susceptible and cefoxitin resistant profile, whereas the specificity The presence of cefoxitin on the BD Phoenix™ and VITEK® 2 test panels improves detection of MRSA in
and sensitivity of identifying mecA/ mecC negative MSSA was 98.9% (4 false positives out of 379 MSSA these systems. The combination of cefoxitin and oxacillin used by these systems affords reliable detection of
tested) and 100% (no false positives), respectively. MRSA when testing isolates typically found in a clinical laboratory.
MRSA strains were predicted using VITEK® 2 with a high level of sensitivity based on the combined
interpretation of the oxacillin MIC and cefoxitin screen test results. Of the 62 mecC positive strains tested,
87.7% were susceptible to oxacillin and resistant to cefoxitin, and 11.3% were resistant to both oxacillin and
cefoxitin. Of the 455 mecA positive strains tested, 0.9% were oxacillin susceptible and cefoxitin resistant,
98.0% were resistant to both cefoxitin and oxacillin, and 1.1% were oxacillin resistant and cefoxitin susceptible.
“Our findings demonstrate the improved accuracy of the BD Phoenix™ and VITEK® 2
“… the VITEK® 2 system […] could provide a zero-cost screening method for identification
systems with the addition of cefoxitin to the test panels for the detection of
of mecC positive MRSA strains, and could potentially be used to monitor changes in the
mecA-mediated resistance among S. aureus isolates.”
prevalence of mecC positive MRSA over time.”

➔ The VITEK® 2 reliably detects MRSA. ➔ The VITEK® 2 reliably detects MRSA.
➔ Both mecA and mecC MRSA strains can be predicted using VITEK 2 AST cards.
®
24 25
➔ ICAAC 2013 Poster D-590
Evaluation of the VITEK® 2 AST-ST01 Card for Streptococcus

2008; 46(12):4114-4115
pneumoniae Susceptibility Testing Compared to ETEST®
and Broth Microdilution
Evaluation of the VITEK® 2 AST-P559 Card for Detection Longtin J.1,2, Bérubé E.2, Gervais P.1,2, Sabri M.3, Boissinot M.1, Moineau S.3, and Bergeron MG.1,2
of Oxacillin Resistance in Staphylococcus aureus.

CHU de Québec, 2Centre de Recherche en Infectiologie de l’Université Laval, 3Faculté des sciences et de génie de l’Université Laval, Québec City, (Québec), Canada
1
ABSTRACT INTRODUCTION
Torres E., Pérez S., Villanueva R., Bou G. Background: Antimicrobial resistance in Streptococcus pneumoniae Antimicrobial resistance in Streptococcus pneumoniae is increasingly
is increasingly becoming a major concern. Accurate antimicrobial becoming a major concern. Accurate antimicrobial susceptibility testing
(AST) is essential for appropriate antimicrobial treatment and most
In this study 301 Staphylococcus aureus isolates were evaluated with the VITEK® 2 AST-P549 card and results susceptibility testing (AST) is essential for appropriate antimicrobial
laboratories are currently using manual, labor-intensive AST methods
were compared to mecA PCR for the detection of MRSA. A total of 51 of these isolates were found to be mecA treatment and most laboratories are currently using manual, labor-
for SP. VITEK® 2 is a well-established automated system for AST of
negative, whereas the remaining 250 where mecA positive by PCR. intensive AST methods.
Method: The performance of the automated VITEK® 2 AST-ST01 card commonly encountered bacteria but standard cards cannot be used for
S. pneumoniae because of it’s particular growth requirements. A new
Sensitivity and specificity of VITEK® 2 to predict mecA status was demonstrated to be 98.8% and 100%, (bioMérieux) was compared to those of ETEST® (bioMérieux) for AST of
card (AST-ST01) was recently introduced to determine the susceptibility of
respectively. The positive and negative predictive values were 100% and 94%, respectively. The values for all 74 clinical isolates of Streptococcus pneumoniae mostly collected through
S. pneumoniae, beta-hemolytic Streptococcus and viridans Streptococcus.
parameters increased to 100% when the discrepant strains (total of 3) were analyzed with the VITEK® 2 after the Canadian Bacterial Surveillance Network (CBSN). Discordant results
The purpose of this study was to evaluate the AST-ST01 card performance
induction (preincubation with agar containing 6 µg/ml of cefoxitin). were resolved by the broth microdilution method (BMD). Interpretation
was performed using CLSI criteria (CLSI M100-S23). against S. pneumoniae and to assess its clinical interest.
The VITEK® 2 AST-P549 card contains both the cefoxitin screen and oxacillin, and as a result, the Advanced Results: The overall essential agreement (EA) between VITEK® 2 and
Expert System™ (AES) utilizes the results of both to determine mecA status. This card also offers the the reference method was 98.3%. The overall essential agreement (EA) METHODS
advantage of simultaneously providing susceptibility information for a number of antimicrobials against gram- between ETEST® and the reference method was 98.5%. For VITEK® Strains: We tested 74 Streptococcus pneumoniae clinical strains isolated
positive microorganisms. 2, the EAs of individual antimicrobial agents ranged from 95.9 % (all mostly through the Canadian Bacterial Surveillance Network (CBSN 2005,
penicillin criteria) to 100% (erythromycin, levofloxacin, and vancomycin). 2007 and 2011). We completed the panel with reference strains chosen
The EA of ETEST® ranged from 89.2% (TMP-SMX) to 100% (penicillin, for their resistance profile. MIC distribution are presented in Table 1.
ceftriaxone, erythromycin and vancomycin). The categorical agreements Each strain was passaged three times. AST was determined in parallel
(CA) of VITEK® 2 and ETEST® are respectively: penicillin (oral) 89.2% and by ETEST® and VITEK® 2. Discrepant results were test subsequently by
95.9%, penicillin (meningitis) 100% and 95.9%, ceftriaxone (meningitis) Broth Microdilution method (BMD). MICs were interpreted as being
98.6% and 97.3%, ceftriaxone (non-meningitis) 97.3% and 100 %, TMP- in susceptible, intermediate or resistant categories according to the
SMX 98.6% and 97.3% No very major error (VME) were observed with breakpoints recommended by the CLSI standards (M100-S23).
both methods. The overall CA for VITEK® 2 was 97.3% (1 major error
Table 1: MIC distribution of strains used in this study
(ME) and 17 minor errors (miE)), that for ETEST® was 98.0% (3 ME
and 10 miE). Erythromycin and vancomycin were in perfect agreement. Antibiotic Average MIC MIC range ST-01 Calling
(abbreviation) (mcg/mL) (mcg/mL) range
Conclusion: The VITEK 2 AST-ST01 card results demonstrated a high
® (mcg/mL)
degree of agreement with ETEST® and BMD. Fewer ME were observed Penicillin (PCN) 0.73 <= 0.015 - 4 <= 0.06 - >=8
with the VITEK® 2 than ETEST®, but VITEK® 2 had high number of miE Ceftriaxone (CTX) 0.53 <=0.03 - 8 <= 0.12 - >=8
for oral penicillin. Performance was excellent for both methods for
ceftriaxone, vancomycin, and erythromycin. Erythromycin (EMC) 1.53 <= 0.03 - >=256 <= 0.12 - >=8
“The main advantage of the card is its promptness in detecting Levofloxacin (LVX) 1.51 <= 0.5 - >=256 <= 0.25 - >=16
methicillin resistance, as it is possible to interpret the results of a cefoxitin screen TMP-SMX (SXT) 0.25/4.75 <=0.5/9.5 -
>=32/608
<=0.5/9.5 -
>=32/304
after 4 h of card inoculation.” Vancomycin (VAN) 0.47 <=0.12-1 <= 0.12 - >=8
ETEST: Overnight cultures isolates were adjusted to a 0.5 McFarland

standard suspension in a Mueller-Hinton broth. Mueller-Hinton agar
plates with 5% sheep blood (BD Diagnostics Systems) were inoculated
with the suspension. The ETEST® strips (bioMérieux) were applied to
the inoculated agar surface. All plates were incubated at 35°C with 5%
CO2 for 20 to 24 hours. MIC values were determined by the point where
the edge of the inhibition ellipse intersects with the side of the strip.
Broth Microdilution (BMD): BMD was performed according to the

KEY POINTS Clinical and Laboratory Standards Institute (CLSI) standards (M07-A9).
Microdilution panels were prepared in-house and contained the antibiotic
➔ The VITEK® 2 reliably detects MRSA. concentrations in serial twofold dilutions.
➔ Cefoxitin screen results are obtained in as little as 4 hours with the VITEK® 2.
26 27
Evaluation of the VITEK® 2 AST-ST01 Card for Streptococcus pneumoniae Susceptibility ➔ ICAAC 2010 Poster D-172
Testing Compared to ETEST® and Broth Microdilution
GRAM-POSITIVE ORGANISMS
VITEK® 2: Overnight cultures plates of the isolates were adjusted to a were 98.6% and 97.3 %, respectively and the CA of VITEK® 2 and
McFarland standard of 0.5 to 0.63 in 0.45% sodium chloride using the ETEST® for non-meningitis ceftriaxone were 97.3% and 100 %. The
VITEK® DensiChek densitometer. AST-ST01 cards (bioMérieux) were
inoculated with the suspension vial using the Smart Carrier Station and
overall CA for VITEK® 2 was 97.3% (no VME, 1 major error (ME) and
17 minor errors (miE)), that for ETEST® was 98.0% (no VME, 3 ME
New Streptococcus AST Product on an Automated System
loaded into the VITEK® 2 automated reader-incubator (software version and 10 miE). Erythromycin and vancomycin were in perfect agreement. Griffith R.1, Messina-Powell S.1, Creely D.1, Dante M.1, Theodorakis P.1, Burnham C.2, Doern C.2, Collins R.2, Dunne W.2,
4.02). AST-ST01 calling ranges are reported in Table 1. The lower CA of VITEK® 2 for oral penicillin is worrisome since 10% of Shortridge1.
strains would have been misclassified because of minor errors. VITEK® 2 bioMérieux Inc., Hazelwood, MO. 2Washington University School of Medicine, St. Louis, MO, USA
1
Analysis: Performance was established by comparing the VITEK® 2 and

also had a lower EA for penicillin. We feel this is a clinically important
ETEST® methods. Discrepant results were asserted by BMD. Essential
aspect since penicillin is cornerstone in S. pneumoniae treatment. MATERIALS AND METHODS
agreement (EA), category agreement (CA), very major errors (VME), REVISED ABSTRACT
major errors (ME), and minor errors (miE) were determined for all Background: The VITEK 2 Systems provide rapid, automated suscep-
® Bacterial strains. Approximately 630 streptococcal isolates were tested.
strains. Essential agreement occurs when the MIC is within a two-fold tibility testing for a wide variety of clinical bacterial isolates including The strains tested were from the bioMérieux stock collection and fresh
CONCLUSIONS
dilution of the comparative method. Category agreement occurs when Streptococcus pneumoniae and S. agalactiae. With the increasing clinical isolates from the development trial at Washington University
• The VITEK® 2 AST-ST01 card results demonstrated a high degree
the interpretive result is in agreement with the comparative method. of agreement with ETEST and BMD. prevalence of antimicrobial resistance, the ability to quickly and easily School of Medicine in St. Louis, MO.
VME, ME and miE were determined as indicated in Table 2. perform susceptibility testing on other species of streptococci is becoming Antimicrobial susceptibility tests. Each organism was prepared from
• Fewer ME were observed with the VITEK® 2 than ETEST®, but
Table 2: Error definitions VITEK® 2 had high number of miE for oral penicillin. more important. The purpose of this study was to develop chloramphe- a pure culture of bacteria cultivated for 18-24 hours on trypticase soy
nicol (C), gentamicin (GM), meropenem (MEM), moxifloxacin (MXF), agar with 5% defibrinated sheep blood at 35ºC. Suspensions were
• ETEST performance was lower for SXT.
BMD Reference method VITEK® 2 or ETEST® Discrepancy rifampicin (RA), teicoplanin (TEC), and tigecycline (TGC) MIC tests* for prepared in sterile saline (aqueous 0.45% NaCl) to a turbidity equal to
• Performance was excellent for both methods for ceftriaxone, the VITEK® 2 Systems for the following streptococci: S. pneumoniae a 0.5 McFarland standard. The same suspension was used for both the
R S Very Major Error (VME) vancomycin, and erythromycin.
(SPN), S. viridans group (VIR) and beta-hemolytic streptococci (BS). reference methods and the VITEK® 2 method.
S R Major Error (ME)
REFERENCES: Methods: Approximately 600 isolates representing 34 species were Broth Microdilution (BMD). This method was performed according
S or R I Minor error (miE) tested in VITEK® 2 investigational use only (IUO) cards containing varying to CLSI guidelines(1). Microdilution panels were prepared in-house
Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically;
I S or R Minor error (miE) Approved Standard–Eighth Edition, M07-A8, Vol. 29, No. 2, January 2009. Clinical and concentrations of the different antimicrobials. All strains were tested with and contained the following concentrations in serial twofold dilutions :
Laboratory Standards Institute, Wayne, PA.
both IUO cards and the CLSI broth microdilution reference method. C 0.125-64 g/ml, GM 2-512 g/ml, MEM 0.015-8 g/ml, MXF 0.015-8 g/ml,
Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational
Supplement, M100-S23, January 2013. Clinical and Laboratory Standards Institute, Wayne, PA.
Growth data were collected from the VITEK® 2 cards and compared to RA 0.008-8 g/ml, TEC 0.008-8 g/ml, and TGC 0.008-8 g/ml.
RESULTS the reference results. Analyses were then developed using these data.
Table 3 lists the percent (%) correlation of VITEK® 2 and ETEST® results to the reference
VITEK® 2 method. A dilution in sterile saline was prepared for card
results for EA, VME, ME, miE and overall CA. Results: Essential agreement for the development isolates is shown inoculation. Sixty-four well IUO cards were then loaded into the
in Table 1. VITEK® 2 instrument. Cards were filled and read automatically, and the
Table 3: Correlation (%) of VITEK® 2 and ETEST® to Reference Method
data expressed as MICs.
Table 1
Quality control. The CLSI quality control (QC) strain Streptococcus
Penicillin parenteral
Penicillin parenteral
(nonmeningitis)
(nonmeningitis)
Penicillin oral
Erythromicyn
%EA C GM MEM MXF RA TEC TGC pneumoniae ATCC 49619 was used for BMD testing. QC was performed
Levofloxacin
Vancomycin
(meningitis)
(meningitis)
Ceftriaxone
Ceftriaxone
TMP-SMX
Overall
SPN 97.9 100 98.2 98.9 100 100 100 each day of comparative testing. Test results were accepted only if the
QC results were within the acceptable limits as published by the CLSI(2).
VIR 99.5 100 94.2 96.8 NA 100 96.3
Analysis of results. Performance was established by comparing the
BS 98.0 100 99.3 98.0 97.3 100 95.3
VITEK® 2 results to the broth microdilution reference results. Essential
EA ETEST 98.5 100 100 100 100 100 100 97.3 89.2 100 Combined 98.4 100 97.2 97.8 99.1 100 97.8 agreement (EA), category agreement (CA), very major errors (VME),
EA VITEK 2 98.3 95.9 95.9 95.9 98.6 98.6 100 100 100 100 major errors (ME), and minor errors (mE) were then determined for
VME ETEST 0 0 0 0 0 0 0 0 0 0 Conclusion: The combined essential agreement for all antimicrobials all strains. Essential agreement occurs when the VITEK® 2 MIC result is
exceeded 97%. These development data indicate that the VITEK® 2 Systems within a two-fold dilution of the reference result. Category agreement
ME ETEST 0.5 0 4.1 0 0 0 0 0 0 0
can accurately determine MICs for the abovementioned antimicrobials occurs when the interpretive result of the VITEK® 2 test is in agreement
miE ETEST 1.5 4.1 0 4.1 0 2.7 0 0 2.7 0 for various Streptococcus sp. with the interpretive result of the reference method. Minor, Major and
VME VITEK 2 0 0 0 0 0 0 0 0 0 0 Very Major Errors were determined as indicated in Table 2.
ME VITEK 2 0.2 0 0 0 1.4 0 0 0 0 0
INTRODUCTION Table 2. Error Definitions
miE VITEK 2 2.6 4.1 0 10.8 1.4 1.4 0 4.1 1.4 0
In the current healthcare environment, it is increasingly important for Reference VITEK® 2 Discrepancy
CA VITEK 2 97.3 95.9 100 89.2 97.3 98.6 100 95.9 98.6 100 rapid and accurate diagnosis of infectious diseases. The VITEK® 2 is an
R S Very Major Error
CA ETEST 98.0 95.9 95.9 95.9 100 97.3 100 100 97.3 100 automated system designed to provide rapid and accurate identification
and susceptibility results for common clinically encountered bacteria S R Major Error
and yeast strains. S I Minor Error
The overall essential agreement (EA) for VITEK® 2 and ETEST® were The VITEK® 2 System rapidly determines an MIC by applying a unique R I Minor Error
similar (98.3% and 98.5% respectively). However the two methods algorithm to growth kinetics monitored by the system. I R, S Minor Error
performed differently for EA with some antibiotics. ETEST® performed
Antimicrobial resistance has been increasing in streptococci. The purpose
better for beta-lactams EA (PCN 100% vs 95.9%, CTX 100% vs 98.6%)
of this study was to evaluate if an AST card for streptococci could be
whereas VITEK® 2 was superior for SXT (EA 100% vs 89.2%) and LVX
incorporated into the current VITEK® 2 system menu for automated
(EA 100% vs 97.3%).
susceptibility testing. REFERENCES
Overall no very major error (VME) was observed with both methods.
1. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically;
The categorical agreements (CA) of VITEK® 2 and ETEST® for oral Approved Standard–Eighth Edition, M07-A8, Vol. 29, No. 2, January 2009. Clinical and
penicillin were 89% and 96%, respectively and the CA of VITEK® 2 and Laboratory Standards Institute, Wayne, PA.
ETEST® for meningitis penicillin were 100% and 96%. The categorical 2. Performance Standards for Antimicrobial Susceptibility Testing; Twentieth Informational
Supplement, M100-S20, January 2010. Clinical and Laboratory Standards Institute, Wayne, PA.
agreements (CA) of VITEK® 2 and ETEST® for ceftriaxone (meningitis)
28 29
New Streptococcus AST Product on an Automated System
RESULTS Table 5 lists the percent (%) correlation of VITEK® 2 MIC results to the YEASTS
Table 3 lists the streptococci species that will be claimed on the reference results for CA, EA, mE, ME and VME. (Note: Errors listed are
VITEK® 2 susceptibility card. EA errors only.)
Table 5. Correlation of VITEK® 2 MICs to Reference.
Table 3. AST-ST Claims
% C GM, HL MEM MXF RA TEC TGC JOURNAL OF CLINICAL MICROBIOLOGY

Streptococcus agalactiae Streptococcus infantarius ssp coli
2014;52(6):2126-2130
Streptococcus infantarius ssp 98.7 99.8 96.2 98.1 91.2 100 99.4
Streptococcus alactolyticus CA (623/631) (634/635) (611/635) (622/634) (394/432) (635/635) (631/635)
Multicenter Evaluation of the New VITEK® 2 Yeast

infantarius
Streptococcus anginosus Streptococcus intermedius 98.4 100 97.2 97.8 99.1 100 97.8
EA (621/631) (635/635) (617/635) (620/634) (428/432) (635/635) (621/635)
Susceptibility Test Using New CLSI Breakpoints

Streptococcus canis Streptococcus mitis
0
EA mE (0/631) NA NA 0.2 0.9 NA NA
Streptococcus constellatus Streptococcus mitis / Streptococcus oralis (1/634) (4/432)
Streptococcus constellatus ssp.
constellatus Streptococcus mutans
0.3
EA ME (2/574) 0 0.4
(0/633) (2/485)
0 0 0 0.5
(0/603) (0/371) (0/635) (3/631) for Fluconazole.
Streptococcus constellatus ssp. EA 0 0 0 0 0 0 0
Streptococcus oralis
pharyngis VME (0/55) (0/2) (0/150) (0/17) (0/1) (0/0) (0/4) Pfaller MA., Diekema DJ., Procop GW., Wiederhold NP.
Streptococcus cristatus Streptococcus parasanguinis Time to Call. Table 6 describes the percentage of streptococcal
isolates that finalized by hour 8. The lower percentage for viridans
Streptococcus downei Streptococcus pneumoniae
is due to the fact that although species such as S. mitis grow quickly, In this study the performance of the VITEK® 2 AF03 Investigation Use Only (IUO) yeast susceptibility card*
Streptococcus dysgalactiae ssp. Streptococcus pneumoniae
microaerophilic strains such as S. intermedius require a longer was validated against the CLSI broth microdilution (BMD) method using the new species-specific clinical
dysgalactiae ATCC 49619
incubation time. breakpoints and epidemiologic cutoff values for fluconazole and Candida spp. The evaluation was conducted
Streptococcus dysgalactiae ssp. Streptococcus pyogenes in 3 independent labs with a broad range of 746 Candida isolates and 44 Cryptococcus neoformans isolates,
equisimilis Table 6. Isolates (%) completed in <=8 hours. including an additional 10 reproducibility strains. Notably, 82 Candida and 4 C. neoformans isolates were
Streptococcus equi ssp. equi Streptococcus salivarius
% C GM, HL MEM MXF RA TEC TGC either resistant or non-wildtype to fluconazole using the new CLSI species-specific interpretive criteria.
Streptococcus equi ssp. zooepidemicus Streptococcus sanguinis
Streptococcus equinus Streptococcus sobrinus
SPN 86.3 97.9 85.9 97.2 98.2 97.9 82.0
Essential agreement (within 2 doubling dilutions) was 94% for Candida spp. and 86.4% for C. neoformans
VIR 50.0 61.4 55.0 74.1 not clai- 61.4 39.7 when comparing the VITEK® 2 to BMD against fluconazole. On the other hand, category agreement between
the VITEK® 2 and BMD was 92% for Candida spp. with 0.3% very major errors (VMEs) and 2.6% major
Streptococcus gallolyticus ssp med
gallolyticus Streptococcus suis
BS 85.0 88.7 88.6 94.0 89.1 88.7 57.7 errors (MEs), whereas category agreement for C. neoformans was 84.1% with 4.5% VMEs and 11.4% MEs.
Streptococcus gallolyticus ssp
pasteurianus Streptococcus suis I The development data for the first 12 tests for the new VITEK® 2 Intra- and inter-laboratory reproducibility was 100% for all 10 reproducibility strains. Mean time to results
AST-ST card were presented in part in an abstract for the European for the VITEK® 2 system was 9.1 hours (range of 7.5 to 11.2 hours) and 12.1 hours for Candida spp. and C.
neoformans, respectively.
Streptococcus gordonii Streptococcus suis II
Congress of Clinical Microbiology and Infectious Diseases
Streptococcus Group A Streptococcus thermophilus
(ECCMID) in April 2010. The EA results from that study are in
Streptococcus Group B Streptococcus uberis Table 7. The tests are : amoxicillin (AMX), cefotaxime (CTX), ceftriaxone The VITEK® 2 AF03 IUO yeast susceptibility card was found to have excellent essential and category
Streptococcus Group C Streptococcus vestibularis (CRO), clindamycin (CM), erythromycin (E), inducible clindamycin agreement with the reference BMD method in three independent laboratories, while reliably identifying
resistance test (ICR), levofloxacin (LEV), linezolid (LNZ),penicillin (P), fluconazole resistance among Candida species isolates. The use of the VITEK® 2 system provides a highly
Streptococcus Group G Streptococcus viridans group except
S. pneumoniae trimethoprim/sulfamethoxazole (SXT), tetracycline (TE), and vanco- automated, rapid, and standardized means of performing antifungal susceptibility testing in the clinical
mycin (VA). microbiology laboratory.
Table 7. Performance of previously developed AST-ST tests
Performance. The interpretive breakpoints listed in Table 4 were used
% EA AMX CTX CRO CM E ICR LEV LNZ P SXT TE VA * Note, the version of fluconazole (flu02n) used in this paper is not available as of the time of this writing. Contact your bioMérieux representative for availability.
to evaluate performance.
SPN 94.5 95.6 99.3 95.8 98.9 NA 99.6 100 100 97.9 99.6 97.7
Table 4.
VIR 98.4 97.4 94.7 98.5 99.5 NA 100 100 97.4 NA 95.5 93.3
Antibiotic Committee Organism groups <=S I >=R Calling
range BS 100 99.4 100 97.6 98.2 100 98.8 100 100 98.5 95.1 97.6
CLSI S. pneumoniae 4 - 8
“The VITEK® 2 AF03 IUO yeast susceptibility test […] reliably identifies fluconazole
C 1-16
CLSI Beta and Viridans 4 8 16
GM EUCAST All streptococci 128 - 256 64-512 CONCLUSIONS resistance among Candida spp. and demonstrates excellent quantitative and qualitative
Based on the results from this development study: agreement with the reference BMD method…”
FDA S. pneumoniae 0.12 - - • The new VITEK® 2 Streptococcus AST tests showed excellent
MEM FDA Beta 0.5 - - 0.06-4 correlation with the broth microdilution reference method.
CLSI Viridans 0.5 - -
• Although most streptococci are susceptible to many antibiotics,
isolates that were considered resistant to chloramphenicol,
MXF FDA All streptococci 1 2 4 0.06-4 meropenem and moxifloxacin by the reference method were also
called resistant by the VITEK® 2 tests.
EUCAST S. pneumoniae 0.06 0.12-0.5 1 • The rapid time-to-call allows early institution of effective
RA 0.06-4
EUCAST Beta 0.06 0.12-0.5 1 antimicrobial therapy along with the implementation of appropriate
infection control precautions.
TEC EUCAST All streptococci 2 - 4 0.125-4
KEY POINTS
➔ The VITEK® 2 performs antifungal susceptibility testing in a highly automated, rapid, and standardized way.
FDA S. pneumoniae 0.06 - -
TGC 0.06-1 ➔ The VITEK® 2 reliably identifies fluconazole resistance among Candida species isolates.
FDA Beta and Viridans 0.25 - -
➔ Mean time to result was 9.1 hours (range of 7.5 to 11.2 hours) for Candida species.
30 31
YEASTS YEASTS

2011;49(5):1765-1771 2007; 45(3):796-802
Multicenter Comparison of the VITEK® 2 Antifungal Multicenter Comparison of the VITEK® 2 Yeast
Susceptibility Test with the CLSI Broth Microdilution Susceptibility Test with the CLSI Broth Microdilution
Reference Method for Testing Caspofungin, Micafungin, Reference Method for Testing Fluconazole against
and Posaconazole against Candida spp. Candida spp.
Peterson J.F., Pfaller M.A., Diekema D.J., Rinaldi M.G., Riebe K.M., Ledeboer N.A. Pfaller M.A., Diekema D.J., Procop G.W., Rinaldi M.G.
Three clinical sites compared VITEK® 2 caspofungin and micafungin susceptibility results to reference broth This study evaluated the performance of the VITEK® 2 compared to CLSI reference broth microdilution (BMD)
microdilution (BMD) using 112 challenge strains and 755 clinical Candida isolates. In addition, another 452 with 426 Candida spp. in three independent clinical laboratories against fluconazole. Fluconazole BMD MIC
clinical Candida albicans isolates were tested with the VITEK® 2 against posaconazole and compared to BMD. determinations were taken after 24 and 48 hours of incubation.
Caspofungin and micafungin BMD MIC determinations were taken after 24 hours of incubation, whereas
posaconazole BMD MIC determinations were taken after 48 hours of incubation. Excellent essential agreement (within two doubling dilutions) was observed between the VITEK® 2 and the
24- and 48-hour BMD MICs with overall essential agreement of 97.9% and 93.7%, respectively. Overall
Essential agreement between the VITEK® 2 and BMD for caspofungin, micafungin, and posaconazole was categorical agreement between VITEK® 2 and BMD was observed to be 97.2% and 88.3% for the 24-hour
99.5%, 98.6%, and 95.6%, respectively. Overall category agreement was 99.8%, 98.2%, and 98.1% between and 48-hour BMD, respectively. The lower 88.3% categorical agreement for 48-hour BMD was mostly due to
the VITEK® 2 and BMD for caspofungin, micafungin, and posaconazole, respectively. All drug-organism minor errors arising due to a shift in the MICs for C. glabrata from susceptible at 24 hours to susceptible dose
combinations, with the exception of micafungin and C. parapsilosis (84.1%), had categorical agreement in dependent at 48 hours with the BMD method. Reproducibility of the VITEK® 2 was excellent with an intra- and
excess of 98%. Mean time to results for the VITEK® 2 was 8.2 hours (range of 5.6 to 19.2 hours), 8.4 hours interlaboratory agreement of 100%. In addition to highly reproducible results, the VITEK® 2 produced results
(range of 5.5 to 19.2 hours), and 9.0 hours (range of 8.2 to 13.6 hours) with caspofungin, micafungin, and with a range of 10 to 26 hours, and a mean of 13 hours.
posaconazole, respectively.
The VITEK® 2 was found to have excellent qualitative and quantitative agreement relative to BMD for
The VITEK 2 antifungal susceptibility test was found to provide highly reproducible and accurate MICs
® fluconazole with Candida spp. Also, it eliminates subjectivity and minimizes the effect of trailing growth that
compared to BMD. It is a fully automated system that eliminates the inherent bias of manual MIC determination compromises the performance of methods that rely on visual MIC determination.
while producing timely results.
“… , the VITEK® 2 system provides […] MICs for caspofungin and micafungin against “… the MICs of fluconazole can be determined […] in less than 15 h for most
Candida spp. and for posaconazole against C. albicans, […] thus eliminating the subjectivity species of Candida with the VITEK® 2 yeast susceptibility test. […] each test is
that is inherent in systems relying on visual MIC determination.” performed in a highly standardized manner and provides quantitative MIC results
that are reproducible and accurate.”

➔ The VITEK® 2 performs antifungal susceptibility testing in a highly automated, rapid, and standardized way. ➔ The VITEK® 2 system reliably identifies fluconazole resistance among Candida spp.
➔ The VITEK 2 reliably generates MICs for caspofungin, micafungin, and posaconazole for Candida isolates.
® ➔ The VITEK® 2 provides accurate results with excellent reproducibility and standardization.
ean time to result was 8.2, 8.4, and 9.0 hours with caspofungin, micafungin, and posaconazole, respectively for Candida species.
➔M ➔ The VITEK® 2 was rapid with mean time to results of 13 hours for fluconazole against Candida spp.
32 33
VITEK® 2 - ANTIMICROBIAL SUSCEPTIBILITY TESTING
YEASTS

2007;45(11):3522-3528
Multicenter Comparison of the VITEK® 2 Antifungal

Susceptibility Test with the CLSI Broth Microdilution
Reference Method for Testing Amphotericin B,
Flucytosine, and Voriconazole against Candida spp.
Pfaller M.A., Diekema D.J., Procop G.W., Rinaldi M.G.
VITEK® 2 was compared to CLSI reference broth microdilution (BMD) with 426 Candida spp. isolates in
three independent clinical laboratories against amphotericin B*, flucytosine, and voriconazole. BMD MIC
Advanced
determinations were taken at both 24- and 48-hours.
Good essential agreement (within 2 doubling dilutions) was observed between the VITEK® 2 and the 24- and
48-hour BMD MICs for all three antifungal agents with overall agreement of 99.1% and 97% for amphotericin B,
respectively; 99.1% and 98.8% for flucytosine, respectively; and 96.7% and 96% for voriconazole, respectively.
Overall categorical agreement between VITEK® 2 and 24-hour and 48-hour BMD was observed to be 98.1%
and 96.9% for flucytosine and 98.6% and 97.4% for voriconazole. CLSI lacks interpretive breakpoints for
Expert System™
amphotericin B making it necessary to forego assessment of category agreement for this antifungal agent.
Highly reproducible MIC results were generated by the VITEK® 2 with intra- and interlaboratory agreement of
>98% for all three antifungal agents. Mean time to result for the drugs tested ranged from 12 to 15 hours, with
a minimum and maximum time to result of 9.1 and 27.1 hours, respectively.
The VITEK® 2 was found to have excellent qualitative and quantitative agreement relative to BMD for the
generation of amphotericin B, flucytosine, and voriconazole susceptibility data with Candida spp. It produces
highly reproducible, rapid results that reliably produce MICs that are comparable to BMD while ensuring that
each test is performed in a highly standardized fashion.
* Amphotericin not available in the US
“… the MICs of amphotericin B, flucytosine, voriconazole, and fluconazole can now be

determined […] in less than 15 h for most species of Candida with the VITEK® 2 system.”
KEY POINTS
➔ The VITEK® 2 has excellent performance with amphotericin B, flucytosine, and voriconazole against Candida spp.
➔ The VITEK® 2 provides accurate results with excellent reproducibility and standardization.
➔ The VITEK® 2 was rapid with mean time to results for the drugs tested ≤15 hours.
34
VITEK® 2 - ADVANCED EXPERT SYSTEM™ VITEK® 2 - ADVANCED EXPERT SYSTEM™
White Paper, JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

2011 2002;49(2):289-300
Maximizing the Use of the Advanced Expert System™ Multicentre evaluation of the VITEK® 2 Advanced Expert
to improve Patient Care. System™ for interpretive reading of antimicrobial
LaBombardi V.J.
resistance tests
Livermore DM., Struelens M., Amorim J., Baquero F., Bille J., Canton R., Henning S., Gatermann S., Marchese A.,
Laboratories are continually striving to improve the quality of susceptibility data being provided to the
Mittermayer H., Nonhoff C., Oakton KJ., Praplan F., Ramos H., Schito GC., Van Eldere J., Verhaegen J., Verhoef J., Visser MR.
clinician. In addition, the need to have this information quickly is becoming more and more obvious. This paper
examines how the Advanced Expert System™ (AES) can be used by laboratories to help improve the quality
of susceptibility data. This study evaluated the Advanced Expert System™ (AES), which automatically performs interpretive
reading* of the MICs generated by the VITEK® 2 System. Ten European laboratories tested 42 reference strains
Automatically releasing a preliminary report based on the AES review of the results (auto-posting) reduces the and 76-106 of their own strains with important resistance mechanisms and compared the AES results to the
time to report AST results to the clinician. This practice has the ability to impact the quality of patient care genotypic data.
by decreasing turn-around time for identification and susceptibility results. By auto-posting results that show
consistency between the identification and susceptibility profiles obtained, time to report results was reduced Interpretive reading by the VITEK® 2 AES achieved full agreement with genotype data for 88-89% of strains,
from 54.3 hours to 34.9 hours for positive blood cultures. When comparing the time required to identify with the correct mechanism identified as one of two possibilities for an additional 5-6%. Of the organisms tested,
non-albicans Candida species, the time to result was reduced from 91 hours to 44 hours by changing from AES showed 90% agreement with reference data for methicillin resistance in Staphylococci, glycopeptide
conventional methods of identification to the use of VITEK® 2 and auto-posting VITEK® 2 results. resistance in enterococci, quinolone resistance in Staphylococci and Enterobacteriaceae, AAC(6’)-APH(2”)-
mediated aminoglycoside resistance in Gram-positive cocci, erm-mediated macrolide resistance in Pneumococci,
In addition to auto-posting, the AES gives microbiologists tools that they need to manage the ever increasing extended-spectrum beta-lactamases (ESBLs) in Enterobacteriaceae and Pseudomonas aeruginosa, acquired
plethora of resistance mechanisms. Using a simple traffic light (red, yellow, green) approach, it allows them penicillinases in Enterobacteriaceae. VanA, VanB and VanC phenotypes in Enterococci were distinguished
to sort results where the identification and susceptibility profiles are consistent with expected results from reliably, and ESBL production was accurately inferred in AmpC-inducible species as well as Escherichia coli
those requiring further workup and the expertise of the microbiologist. Since the results have been thoroughly and Klebsiella spp.
checked by the extensive AES database, the microbiologist can feel comfortable releasing a preliminary result.
Auto-posting is a way to provide faster results to clinicians. Mechanisms identified, but only as possibilities among several, included IRT-type beta-lactamases and
individual aminoglycoside-modifying enzymes in Enterobacteriaceae. Disagreements with reference data
were seen in Pneumococci that were found to have high-level penicillin resistance by the AES but had been
previously shown to have intermediate resistance phenotypically.
AES will suggest editing the antibiogram based on the inferred resistance mechanism. When ESBL production
was inferred in E. coli and Klebsiella, the AES modified susceptible results for cephalosporins to be resistant;
when an acquired penicillinase was inferred in Enterobacteriaceae, piperacillin results were modified to
resistant; and when Staphylococci were found to be methicillin resistant, resistance was reported for all beta-
lactams.
* Interpretive reading refers to analyzing the complete resistance profile of an organism to multiple antibiotics and inferring the resistance mechanisms present.
“The decrease in turn-around-time (TAT) is significant “… this study demonstrated the capacity of VITEK® 2 to detect and interpret resistance
and has been acknowledged by our clinicians.” mechanisms with a high level of accuracy and standardization.”

➔ The Advanced Expert System™ can help improve quality of results and can reduce the time it takes to get results to ➔ T he Advanced Expert System™ demonstrates good performance in inferring the resistance mechanism present for a
clinicians. number of common, clinically important resistance mechanisms.
➔ By implementing auto-posting, significant reduction in reporting time can be accomplished. ➔ F ollowing the recommendations of antimicrobial standards committees, AES is able to make recommended editing to
36 reports when resistance is detected. 37
VITEK® 2 - ADVANCED EXPERT SYSTEM™

2001;39(7):2379-2385
Potential Impact of the VITEK® 2 System and

the Advanced Expert System™ on the Clinical Laboratory
of a University-Based Hospital.
Sanders CC., Peyret M., Moland ES., Cavalieri SJ., Shubert C., Thomson KS., Boeufgras JM., Sanders WE.
This study was designed to assess the impact of the VITEK® 2 and the associated Advanced Expert System™
(AES) in detecting resistance in bacterial isolates in a typical university-based hospital. A total of 259
Impact
consecutive, non-duplicate isolates of Enterobacteriaceae, Pseudomonas aeruginosa, and Staphylococcus
aureus were collected and tested by the VITEK® 2 System for identification and antimicrobial susceptibility.
The results were analyzed by the AES and by a human expert to determine the resistance phenotype present.
Of the 259 isolates tested, 245 (94.6%) were correctly identified with little input from the microbiologist. For
194 (74.9%) isolates, no inconsistencies between the identification and the susceptibility were detected by the
AES, thus no input was needed from the microbiologist.
of Rapid
The AES suggested one or more corrections to results obtained to remove inconsistencies with 65 strains. The
human expert thought that most of these corrections were appropriate. Resistance phenotypes given by the
AES for beta-lactams, aminoglycosides, quinolones, macrolides, tetracyclines, and glycopeptides were similar
to those assigned by the human expert for 95.7 to 100% of strains. These results indicate that the VITEK® 2
system and AES can provide accurate information for most of the clinical isolates examined and remove the
need for human analysis of results for many isolates.
Reporting
“… these new systems remove the need for human analysis of results
for many isolates, freeing personnel for other activities
and improving the overall quality of the information generated,
especially in laboratories without a human expert.”
KEY POINTS
➔ VITEK® 2 and AES provide accurate results for the majority of clinical isolates that are found in the university-based
hospital.
38
VITEK® 2 - IMPACT OF RAPID REPORTING VITEK® 2 - IMPACT OF RAPID REPORTING
EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY AND INFECTIOUS DISEASES JOURNAL OF INFECTION

2012;31 (9):2445-2452 2012;65(4):302-309
Clinical and economic impact of rapid reporting of Clinical and economic evaluation of the impact of rapid
bacterial identification and antimicrobial susceptibility microbiological diagnostic testing.
results of the most frequently processed specimen types. Galar A., Leiva J., Espinosa M., Guillén-Grima F., Hernáez S., Yuste JR.
Galar A., Yuste J.R., Espinosa M., Guillén-Grima F., Hernáez-Crespo S., and Leiva J.
This study evaluated the clinical and economic impact of rapid reporting of results from the clinical
microbiology lab. It included 574 hospitalized patients with bacterial infections, 284 of which were included
This study evaluated the medical and economic impact of rapid microbiological identification and susceptibility in a control group where the laboratory’s normal practice made results available to clinicians one day after
reporting on the most frequently encountered specimens isolated in the clinical microbiology lab. The scope of the analysis was initiated. The remaining 290 patients made up the experimental group, and they had their
testing was limited to hospitalized patients with bacterial infections. The VITEK® 2 System was used for both respective microbiology results reported to clinicians the same day of the analysis using a rapid, same-day
identification and susceptibility testing throughout the evaluation, and testing was divided into two groups: workflow. The VITEK® 2 System was used for both identification and antimicrobial susceptibility testing for
1) the control group in which results were reported the day following the analysis, and 2) the test group with all results in this study.
workflow resulting in same-day (rapid) reporting.
The data generated showed that reporting microbiology results faster allowed the clinician to provide antibiotic
The median time needed to report results by sample type for the control and rapid reporting “test” group were treatment sooner (P<0.001). For the group whose results were reported according to the rapid protocol, there
as follows: was significant reduction in the duration of hospital stay, decreased reporting turnaround time (17.6 hours), a
reduction in the number of tests performed, and lower intubation rates for patients. Additionally, costs incurred
Control Group Rapid Reporting Group P Value for the patients including those associated with microbiology testing, antibiotic costs, length of hospitalization,
Wound/Abscess 23.5 hours 9.5 hours <0.001 and miscellaneous patient costs were lower (mean savings of 3,588€ or $4,542 USD* per patient) for the
Blood 23.5 hours 9.2 hours <0.001 group of patients whose results were reported via the rapid protocol. Mortality rates did not differ significantly
between the two groups.
Urine 23.4 hours 9.3 hours <0.001
In conclusion, the authors described that rapid reporting of microbiology results was associated with quality
Though the mortality rates did not differ significantly between the two groups, the faster reporting seen with improvement as seen by earlier optimization of patient antibiotic therapy, an improved clinical outcome and
the rapid “test” group was associated with a significant reduction in length of hospital stay (>2.5 days) and financial benefits.
an overall cost savings by up to 40% (5,695€ or $6,982 USD* versus 9,367€ or $11,484 USD*) for patients
hospitalized with urine and wound/abscess infections, but not sepsis infections. Length of hospital stay and
hospital cost savings likely were not significant for sepsis patients in this study because the lab routinely
reported Gram stain results directly to the physician responsible for the patient at the moment at which the
automated system detected a positive blood culture.
* USD calculated using exchange rate of $1.226 USD per 1.0€
* USD calculated using exchange rate of $1.226 USD per 1.0€
“… significant savings […] observed in antibiotic expenses […] coupled with the reduction
“Faster reporting of ID/AST results was associated with a significant reduction in the length of hospital stay and the number of microbiological and biochemical tests
in hospital stay and overall costs for patients from whom wound, abscess and urine performed, support the usefulness of earlier reporting of microbiological results.”
specimens were analyzed.”

➔ Faster reporting reduced length of hospital stay by more than 2.5 days and total hospital costs by up to 40%. ➔ Rapid microbiology results from the VITEK® 2 significantly reduced hospital costs, improved clinical outcome, and
reduced length of stay
40 41
VITEK® 2 - IMPACT OF RAPID REPORTING

1999;37(5):1415-1418
Clinical and Financial Benefits of Rapid Bacterial

Identification and Antimicrobial Susceptibility Testing.
Barenfanger J., Drake C., and Kacich G.
This study evaluated the clinical and financial benefits attributed to rapid reporting of bacterial identification
and susceptibility results. The analysis compared culture results obtained utilizing the laboratory’s standard
methods versus those obtained more rapidly due to a minor change in workflow.
Using the standard laboratory methodology technologists were available to process samples using a VITEK®
system* during a daily 8-hour shift (7am to 3:30pm), and results for a given work day could only be reported
for isolates that completed testing during this time frame. Alternatively, the rapid susceptibility testing
methodology differed from the aforementioned standard laboratory methodology in that a technologist on the
evening shift verified and reported results that became available after 3:30pm, thus resulting in same day result
reporting.
Workflow
For patient samples tested with the VITEK® system using the rapid reporting workflow, the majority of
bacterial identification and antimicrobial susceptibility testing results (>90%) were reported on the same day
the instrument’s analysis was complete. In contrast, only approximately 50% of the cultures processed in the
routine manner were reported on the same day of susceptibility testing.
The findings associated with samples tested utilizing rapid reporting methods versus those tested using the
routine workflow are as follows:
Analysis
Rapid Reporting Routine Workflow P Value
Average Turn Around Time for AST Reporting 39.2 hours 44.4 hours .001
Mortality Rates 7.9% 9.6% .45
Average Length of Stay 10.7 days 12.6 days 0.006
Average Variable Cost per Patient $4,927 $6,677 0.001
Additionally, clinicians were able to initiate antimicrobial therapy sooner for patients whose samples were
tested using the rapid reporting workflow (P value =0.006). Moreover, the institution extrapolated their average
variable costs using rapid versus routine reporting methods over the time period of one year and calculated a
savings at $4,000,000 USD.
*N
ote that this evaluation used a VITEK® instrument which has since been replaced with the VITEK® 2 instrument.
This study remains relevant for the VITEK® 2 since the concept of same-day versus next-day reporting remains valid.
“[Rapid reporting utilizing the VITEK® system] results in

over $4 million in savings in variable costs per year in our hospital.”
KEY POINTS
➔ Average turnaround time for reporting AST results was 5.2 hours faster using the rapid reporting workflow compared to
the routine workflow.
➔ Mortality rates using the rapid reporting workflow were 1.7% lower than those seen with routine reporting methods.
➔ Average length of stay was reduced 1.9 days for patients in the rapid reporting group.
➔ Average variable cost was $1,750 USD lower per patient when microbiology results were reported via the rapid instead
of the routine workflow.
42
VITEK® 2 - WORKFLOW ANALYSIS VITEK® 2 - WORKFLOW ANALYSIS
➔ ECCMID 2013 Poster P-1536
WHITE PAPER, WORKFLOW
2008
Ergonomic Analysis Comparison of the VITEK® 2 and Comparison of bioMerieux VITEK® 2 XL, BD Phoenix™,
VITEK® 2 Compact with the Microscan WalkAway® and Siemens MicroScan Walkaway® 96 plus: Choosing
96 and Phoenix™ For Work Flow Efficiency and the an Identification and Antimicrobial Susceptibility Testing
Likelihood of Distal Upper Extremity Strain. System for a Medium Sized Microbiology Laboratory
Hooper M.1,2, Hill C.1,3, Hadwell V1, Blondel-Hill E1,4
1 Interior Health-Kelowna BC, 2 University of Victoria BC, 3 University of British Columbia-Okanagan, 4 University of British Columbia-Vancouver, Canada
Heller-Ono A.
The purpose of this study was to evaluate and compare the ergonomic risk factors, number of steps, and ABSTRACT INTRODUCTION
the time needed to prepare isolates on the VITEK® 2, VITEK® 2 Compact, MicroScan WalkAway® 96, and Objectives: Performance of an automated identification (ID) and In British Columbia, laboratories are mandated to justify their
Phoenix™ instruments. A specialized test called “strain index” was used to measure repetitive and exertional antimicrobial susceptibility testing (AST) instrument is not limited to choice of automated instruments through a rigorous process not
stress of the set up process of each instrument. The resulting data was used to predict the risk of distal upper accuracy of ID and AST results. Other parameters must also be taken limited to accuracy and cost but also by parameters such as impact
extremity muscle strain to technicians. into consideration. This study evaluated three automated systems on workflow, continuous quality improvement and environmental
(bioMèrieux VITEK® 2 XL [VTK], BD Phoenix® [PHX] and Siemens footprint. The purpose of this study was to determine which
Data was collected from 19 laboratory scientists and 4 laboratory assistants from different facilities to assess MicroScan Walkaway96 plus® [MS]) based on inoculum preparation, test automated ID/AST instrument was the best fit for the Larissa Yarr
the setup preparation steps for both identification and susceptibility testing for each instrument. Results were menu, requirement for manual testing, time to reporting, biohazardous Microbiology Laboratory, a medium sized clinical microbiology
as follows: waste, space requirements and environmental footprint. laboratory in Kelowa, BC. The instruments evaluated in this study
were the bioMèrieux VITEK® 2 XL (VTK), the BD Phoenix® (PHX)
Methods: All three instruments were evaluated simultaneously over a
VITEK® 2 VITEK® 2 Compact Phoenix™ MicroScan WalkAway® 96 and the Siemens MicroScan Walkaway96 plus® (MS). Accuracy of
2 month period at the Larissa Yarr Microbiology Laboratory at Kelowna
Identification(ID) and antimicrobial susceptibility testing (AST) were
2 laboratory scientists General Hospital, British Columbia, Canada. Set up time and biohazardous
Number of Users 11 laboratory scientists 3 laboratory scientists 3 laboratory scientists evaluated along with sample preparation time (TTP), test menu,
4 laboratory assistants
waste results were determined using groups of 10 isolates to simulate
Average Number of Steps in Test Setup 9 11 18 21*
workflow, ergonomics, requirements for manual testing, ergonomics,
a typical workflow situation.
time to reporting (TTR), production of bio-hazardous waste, storage
Average Time to Complete a Work Cycle for one 60 64 72 90* Results: Inoculum preparation time (in minutes for 10 samples) was and space requirements and environmental footprint.
isolate (sec)
18.5 for VTK, 19.3 for MS and 21.5 for PHX. For the MS, its most rapid
Average “Strain Index” Score: sample preparation method was used (PROMPT™) and for the PHX METHODS
0-1 hour use 2.25 0.75 7.5 Not assessed extra time required for the AP system to prepare dilutions and add
1-2 hour use 4.5 2.25 26.5 6.75 (laboratory scientists) All three instruments were evaluated simultaneously throughout the
AST indicator was not included (as more samples or other work could
2-4 hour use 6.75 Not assessed- Not assessed 60.75 (laboratory assistants) summer of 2012 at the Larissa Yarr Microbiology Laboratory, Kelowna,
be done during this time). No manual testing was required for VTK or
Canada. All organisms were collected from frozen clinical and study
PHX, for MS oxidase or beta-lactamase tests were routinely required.
*Cumulative results for both laboratory scientists and laboratory assistants performing the setup isolates and sub-cultured twice to ensure purity prior to setting up
Time to result of final ID/AST was 4-18h for VTK, 4-16h for PHX and 16
on all three instruments simultaneously. ID and AST results were
or 24h for MS (preliminary ID resulted earlier for both VTK and PHX).
compared to the previously reported results by VITEKII (current system
The VITEK® 2 and VITEK® 2 Compact demonstrated 40-50% fewer steps compared to the Phoenix™ and The VTK produced the least biohazardous waste in kg per samples at Larissa Yarr laboratory) as well as multiple previously characterized
MicroScan WalkAway® 96 instruments. As a result, the “strain index” analysis showed that technicians using (0.048) with an estimated annual cost in CAD of $2628.00, the PHX was isolates (16sRNA). Any discrepant results due to operator error (e.g.
a Phoenix™ or MicroScan WalkAway® 96 instrument were at a significantly higher risk of muscle strain (e.g. 0.109 ($5967.50) and the MS 0.122 ($6679.50). The PHX instrument insufficient growth in positive control well, contaminant on purity plate
repetitive motion injury) relative to those using VITEK® 2 instruments. Furthermore, the reduced number of steps with the AP system required the most bench space. The PHX and the etc.) were re-set up. Set up time and biohazard waste results were
seen with the VITEK® 2 systems translated to an average productivity gain of 8-30 seconds per work cycle (i.e. MS required more storage space for their ID/AST panels and reagents/ determined using groups of 10 isolates to simulate a typical workflow
12-30% more efficient work cycle setup time). supplies than the VTK. The VTK has a larger ID test menu including situation.
aerobic Gram-positive (GP) and Gram-Negative (GN) organisms along
with fastidious GNs, anaerobes and yeast while the PHX does not include RESULTS
fastidious GN, anaerobes or yeast and the MS test menu includes aerobic All three systems tested were reliable for the identification of
GP cocci, and aerobic GN and fastidious GN. Staphylococcus spp. (VTK-100% [27/27], PHX- 95.7% [22/23],
“The results indicate that the VITEK® 2 and VITEK® 2 Compact Conclusions: Accuracy of ID/AST was similar for all three systems. The MS- 96.2% [25/26]) and for Enterobacteriaceae (VTK-92.4% [61/66],
offer more efficient work cycles with less exposure to ergonomic risk factors resulting in a VTK was deemed the best fit for a medium sized clinical microbiology PHX- 92.4 [61/66], MS- 89.4% [59/66]). All three instruments had
laboratory given its larger ID test menu, rapid inoculum preparation, limitations in Streptococcus speciation. There were inconsistencies
reduced risk of injury to laboratory staff.” minimal manual testing, ability to use inoculum for offline testing, time for all three instruments in ID of previously characterized unusual/
to resulting, ability to test ID and AST separately, reduced biohazard fastidious GN organisms; however VTK had a slight advantage given
waste cost and favorable environmental footprint. its more extensive test menu. (Table 3). Overall AST results were
comparable for all three systems especially for Staphylococci spp while
VTK and PHX were marginally better for Enterobacteriaceae and MS
KEY POINTS had an advantage for Streptococci spp. Inoculum preparation time per
10 samples was 18.5min for VTK,19.3min for MS (using (PROMPT™
➔ VITEK® 2 and VITEK® 2 Compact use 40-50% fewer steps than other systems to prepare isolates for testing.
➔ The average time to set up an isolate was 8 to 30 seconds faster with VITEK® 2 systems relative to other systems resulting
in a 12-30% efficiency gain.
➔ Laboratory staff have a reduced risk of injury when using VITEK® 2 and VITEK® 2 Compact as opposed to other systems.
44 45
Comparison of bioMerieux VITEK® 2 XL, BD Phoenix™, and Siemens MicroScan ➔ ECCMID 2007 Poster P-1727
Walkaway® 96 plus: Choosing an Identification and Antimicrobial Susceptibility Testing
System for a Medium Sized Microbiology Laboratory WORKFLOW
preparation method) and 21.5min for PHX. Although the PHX requires
extra time for preparation of dilutions by AP system and adding AST
DISCUSSION Analysis of the comparative worflow and accuracy of the
VITEK® 2 Compact and the combination mini-API® / Agar
Although accuracy and cost are important factors in the selection of
indicator, this was not included in inoculum preparation time as more ID/AST instruments for clinical microbiology laboratories, other factors
samples or other work could be done during this time. Annual cost
Diffusion SIRSCAN® Method.
affect the choice of instrument selecti®on.
difference in technologist time for organism inoculation is shown in
The MS offers the ability to set up manual offline testing in the event
Table 1. Ergonomically the VTK was easiest to use followed by the
of instrument failure and the PROMPT™ system can fit well into lab Doat V. 1, Roubille M.1, Turner R.2
PHX and then MS. Time to reporting (TTR) in hours was 4-16 (PHX)
work-flow. However, the number of reagents required with their CH Pierre Oudot, Laboratoire de Biologie Polyvalente, Bourgoin Jallieu, France, 2 bioMérieux, St Louis, USA
4-18 (VTK) and 16-24h(MS). Biohazard reagents are used routinely 1
biosafety concern were deemed as a disadvantage as were the slower

for MS but not by other systems (Table 3). There was a significant
sample set up time (1.93min), the slowest TTR (18-24h) and the most INTRODUCTION II - ID, AST and expert system performance
difference in biohazard waste (per 10 tests) between the three
biohazard waste produced per sample (0.122kg/sample). Primary identifications were performed with routine manual methods,
systems (VTK- 0.048kg, PHX- 0.109kg and MS- 0.122kg). Annual cost The aim of this study was to analyse the impact of introducing the
for disposing of this biohazard waste is shown in Table 2. In order of The PHX had excellent TTR (4-16h), limited need for VITEK® 2 Compact (V2C), (bioMérieux, France), an automated e.g. chromogenic media, latex, rapidec-STAPH, etc., or mini-API and
extra reagents (only AST indicator) leading to less biosa- identification (ID) and susceptibility testing (AST) system into a with V2C. Repeat testing with each method was performed if either
most refrigerator space required VTK required the most (all ID/AST
fety concerns and capability for automated sample dilution laboratory that is currently using manual (chromogenic media) and system gave no identification result. At the end of the study period, the
panels), followed by MS (3% Laked Horse Blood in Mueller Hinton
preparation (except for Strep panels). The major disadvantages of semi-automated (mini-API®) identification methods and AST by results from all methods were compared.
broth used for MicroStrep, peptidase and indole reagents, HNID and
the PHX included the slowest sample set up time (2.15min), the SIRSCAN® (SIR) (i2a Perols, France) agar diffusion. AST testing was performed by SIR and V2C and results were analyzed
RNID3 panels) Refrigerator space is minimal for PHX (AST indicator). by each system‘s expert software [(reading of the inhibition zone
Requirement for extra manual /off line was significant for MS but not limited test menu, the significant bench space requirement for the AP
MATERIAL AND METHODS diameters by the SIR camera and expertised by the SIR software
for VTK or PHX. Bench space requirements were most significant for instrument and the significant biohazard waste produced (0.109kg/
We performed this prospective study in a general laboratory of a (DOS Version 1999) and the V2C Advanced Expert System™ (Version
PHX followed by MS then VTK. sample).
390-bed hospital from January to April 2006. Routine isolates were 1.01)]. The result proposals from both systems - resistance phenotype
The VTK demonstrated the fastest set up time (1.845min), no need and antibiotic category changes - were analysed. Repeat testing was
Table 1. Comparison of Annual Cost in Technologist Time for Inoculum Preparation. tested using the manual method or mini-API for ID and SIRSCAN
for extra reagents, the least biohazard waste produced per sample performed with each method if either system gave no result. All AST
Instrument Time/ test Annual Time Cost ($) agar diffusion AST method. The results were compared to results
(0.048kg), the most extensive test menu and the least bench and phenotype results were compared and the microbiologist, who
(min)* ( 120 tests/ Technologist obtained by the V2C. One microbiologist, trained on all techniques,
day ) salary space requirement. The availability of separate ID and AST panels performed the comparative study in ”real time“. The systems were was designated as the expert, resolved any discrepancies.
was also deemed an advantage. The major disadvantage was the given alternating priority and results were interpreted independently. III - Patient benefit of rapid results
Vitek II 1.845 1346.85 40,405.50
requirement for storing all ID/AST panels in the refrigerator. Quality control was performed according to the manufacturers‘ The benefit of rapid results on patient management was estimated
Phoenix 2.153 1571.93 47,157.90 by a retrospective analysis of 10 patient files in collaboration with an
recommendations. Data were collected on three study parameters.
MicroScan 1.928 1407.68 42,230.40 infectious disease physician.
I - Workflow
CONCLUSIONS An independent industrial productivity consultant audited and
Table 2. Comparison of Annual Cost of Biohazardous Waste RESULTS
Although accuracy of all three systems were relatively similar, performed chronometric time studies of the laboratory‘s current
Instrument Weight/10 tests Annual mass Annual Cost In total, 300 routine isolates were included in the study - 175 of
(kg) (kg) ($)*** the bioMerieux VITEK® 2 XL was deemed the best fit for the workflow process with the API/SIR and with the introduction of the V2C.
the IDs were performed on both systems. This included 90 (51%)
(120 tests/day) medium sized Larissa Yarr Microbiology Laboratory in Kelowna, Each step in the workflow process was timed. This included workbench
Enterobacteriaceae (ENB), 14 (8%) non-Fermenters and 71 (41%)
Vitek II 0.048 2102.4 2628.00 BC Canada. organization, inoculum preparation, panel or card set-up, introduction
Gram-positive cocci (GPC). Rapid manual methods were used to
of panels or cards into the instruments, result validation (including
Phoenix 0.109 4774.2 5967.50 perform 125 IDs.
expert system analysis) and referral. Five strains were repeated three
MicroScan 0.122 5343.6 6679.50 times for both systems on the same day by the same operator, i.e. the ASTs were performed for 300 strains on both systems: 160 (53%)
microbiologist performing the study, to measure these times. Enterobacteriaceae, 30 (10%) non-Fermenters and 110 (37%) GPC.
Table 3. Comparison of Major Differences Between VTK, PHX and MS Systems I. Workflow
Table 1: Hands on time to perform one ID/AST test (min)
Instrument
Steps VITEK 2 compact API / SIR
Vitek II Phoenix MicroScan
1 Go to the V2C menu and start the program (virtual cassette mode) 0.74 Remove the material from storage: API strips, susceptibility agar 2.05
Test Menu Gram positive cocci Gram positive cocci Gram positive cocci Remove ID and AST card from -4°C, organise work bench, label purity
Gram negative bacilli Gram negative bacilli Gram negative bacilli 2 plates, Dispense 3 ml saline into each of 2 tubes, Label ID tube with 0.36 Open strips, label ID strip and susceptibility plate, strain tube and saline tube 4.00
Fastidious Gram Fastidious Gram accession # and place tube into cassette + second tube for AST
negative bacilli negative bacilli Take the colony with a transfer pipette. Prepare a homogenized ID Prepare bacterial suspension for ID in ID medium (2ml), Adjust the inoculum with the
Gram positive bacilli Anaerobes 3 suspension, Adjust with the Densicheck to appropriate McFarland 1.19 Densimat, Transfer the necessary ID suspension volume to the saline tube 1.54
Anaerobes Yeast
4 Inoculate conservation agar 0.23 Inoculate conservation agar 0.24
Yeast
Place the tubes into rack. Place pipette tip on correct pipettor. Transfer
Set up Time/ 1.845 min 2.153 min 1.928 min 5 appropriate amount of ID suspension to AST tube 0.10 Inoculate the ID strip , add paraffin oil if necessary, put the cover on the strip 1.22
Sample 6 Open pouche, place card in cassette 0.35 Mix the diluted solution, inoculate the 5 susceptibility agar (in 3 directions) and allow to dry 0.94
Biohazard 0.048 kg 0.109 kg 0.122 kg 7 Enter the ID/AST card barcodes 0.12
Place the susceptibility disks on each agar plate with the semi-automated applicator
0.75
Waste / and tweezers (Augmentin)
Sample
Put the ID strips in a closed box (to maintain humidity), Put the ID strips and the
Required None AST indicator Kovacs Reagent, 8 Link ID/AST card by entering isolate number, Save the work list 0.19 susceptibility agar in the incubator 1.65
Reagents a-Napthol, KOH, 9 Take cassette to V2C filler, introduce cassette, press fill button 0.11 Remove the ID strips from the incubator 0.84
Sulfanic acid,
N-N-dimethyl-a- 10 Remove cassette and place into reader incubator 0.12 Remove the lid, add reagents if needed respecting the reaction time (max 10 minutes) 0.65
Napththylamine, Start the miniAPI system, put the ID strips in the API reader and follow the reading
11 Put the tubes in the incubator 0.39 procedure, print the results 5.11
Ferric Chloride,
NaOH, Peptidase Remove the lid and put the susceptibility plate in the SIR reader, and follow the
12 Remove cassette from reader and through the tubes away 0.18 reading procedure, perform the Cefinase test if needed 2.61
Reagent, Xylene,
Ehrlichs Reagent, Verify final result 1 (verification by the biologist : comparison plate and SIR result), sign
Iodine Reagent, 13 Validate the results 0.85 all the pages, throw away the plate 0.59
Rapid indole reagent, 14 Print and transmit the results to the Informatics department 2.07 Archive the laboratory reports and transmit the originals to the office 2
HNID indole reagent
7.00 24.26
46 47
Analysis of the comparative worflow and accuracy of the VITEK® 2 Compact and the ➔ ASM 2006 Poster C-123
combination mini-API® / Agar Diffusion Sirscan® Method.
WORKFLOW
II. ID, AST and expert system performance DISCUSSION
A-ID performance
The percentage of overall ID results between the two systems is not
For ID, V2C gave very good identification for 97% of microorganisms
(3% low discrimination for coagulase negative staphylococci and Analysis of the Comparative Workflow and ID/ AST Test
significantly different. (see Tables 2 and 3 below)
Overall correct Low
3% mis-ID for 90 strains of Enterobacteriaceae). For AST, V2C is in
agreement with agar diffusion for 98% of the antibiotics tested. The Result Accuracy of the VITEK® 2 compact and the Phoenix™
GPC
mini API
Total*
70
ID
67 (96%)
discrimination
3 (4%)
V2C performance is comparable to mini-API/SIRSCAN taking into
account the limitations of AST by agar diffusion for the GPC and the Systems
non-Fermenters. Römmler W.1, Beer L.1, Kessler M.1, Kaehler K.2
V2C 70 68 (97%) 2 (3%)
The benefits of introducing V2C are as follows: MVZ im Sonnenblock, Munchen, Germany, 2bioMérieux Deutschland GmbH, Nürtingen, Germany
1
*One Staphylococcus strain for which the identification result was discrepant (S. aureus by
• rapid results and rapid on-line result validation,
Rapidec Staph and S. lugdunensis by V2C) was tested by molecular methods, considered
as the reference method. The result obtained was a S. aureus with an atypical phenotype • one third less manipulation time,
(manitol and lactose negative strain). Retesting with API 32 Staph gave S. hominis and • reduced cost of reagents and consumables, MATERIAL AND METHODS
V2C gave S. aureus. • reduction of waste disposal, REVISED ABSTRACT
Objectives: The aim of this study was to analyse the impact of introducing We tested 215 Gram-negative (55%), 175 Gram-positive (45%)
• reduced risk of biohazard exposure.
Overall Low discrimi- into our laboratory the VITEK® 2 compact (V2C), (bioMérieux, France), routine isolates in parallel using the PHX (V4.05W) and V2C systems
ENB Total* Mis ID
correct ID nation Rapid result availability to the clinician is of interest especially in cases for ID and AST performance.
a new automated identification (ID) and susceptibility testing (AST)
mini API 90 87 (97%) 1 (1,1%) 2 (2.2%) of S. aureus and P. aeruginosa in severe infections. Rarely isolated in system. The study consisted of two parts i) measurement of potential The panel set up was given alternating priority between the two
blood cultures, the multi-resistant Enterobacteriaceae are not yet a productivity gain, time and cost and; ii) analysis of ID and AST accuracy instruments and results were interpreted independently for each system.
V2C 90 87 (97%) 0 (0%) 3 (3.3%)
major problem in our hospital. after Expert Systems validation. Methods: In total, 390 routine clinical Quality control was performed according to each manufacturer’s
The ID performance showed 100% agreement for the 14 non-Fermenters tested.
isolates were tested: 215 Gram-negative (55%), 175 Gram-positive (45%) recommendations.
using our in-house method, Phoenix™ (PHX; Becton Dickinson, U.S.A), Laboratory organization
B-AST and expert system performance in parallel with the V2C. The strains were isolated from routine clinical a) Process
AST and Expert System results are represented in the Table 4: samples; urine and blood cultures, stools, throat and genital samples. Independent industrial productivity consultants audited and performed
The following parameters were studied: time measurement of the laboratory’s current workflow process
Number of antibiotics Number of antibiotics with the PHX and the V2C. Each step of the process was timed. The
Number Number of Number of antibiotics in Productivity: Consultants audited the laboratory and performed time
Microorganisms with minor with major
of strains antibiotics tested agreement
disagreement disagreement measurement of the general laboratory routine: from specimen reception, consultants were asked to suggest laboratory organizational changes
culture set up, ID/AST set-up and result validation. ID and AST accuracy: for productivity improvements using the V2C.
Non-Fermenters 30 480 456 (95%) 22 (4.6%) 2 (0.4%)
tests were performed in parallel on both systems and discordant results b) Productivity
Enterobacteriaceae 160 2560 2495 (97.5%)) 53 (2%) 12 (0.5%)
were tested by molecular technique and E-test (bioDisk). AST results The consultants timed by stopwatch the individual steps for each
Gram-positive cocci 110 1760 1736 (98.6%) 15 (0.9%) 9 (0.5%) were validated using the PHX Expert rule software and V2C Advanced system. This included panel set up, result validation and referral. Set
Total 300 4800 4687 (97.6%) 90 (1.9%) 23 (0.5%) Expert System™(AES) for results agreement. The medical microbiologist up time was measured and averaged for 15 isolates in 3 separate
expertise provided final results on any discordant results. runs of 5 isolates each: [E. coli, E. coli, E. coli, E. coli, K. pneumoniae];
Results: The global process time difference between V2C and PHX was [M. morganii, S. aureus, S. aureus, E. coli, E. coli]; [E. coli, Streptococcus
III. Patient benefit of rapid results mainly due to mean time to result for V2C being 7-13 h compared to Group B, Enterococcus, Streptococcus Group B, S. aureus].
CONCLUSION
Providing that result accuracy is maintained, rapid availability to the 10-16 h for PHX. ID/AST test manipulation time was (1.53 min vs. 3.20 Identification performance
•
Both systems gave good results for the majority of strains
clinician offers significant benefits in patient treatment. Therapeutic min). The overall identification agreement between the systems was Primary identifications were performed with the PHX and V2C
encountered in our medium size hospital.
choice is guided by these results. In our study, we retrospectively greater than 97% for Gram-negative and 97% for Gram-positive. AST and routine manual methods, e.g., chromogenic media, latex, etc.
• The reduced manipulation times, rapid time to results, as well overall category agreement was more than 98% with both systems. Repeat testing was performed if either system gave no identification
examined 10 cases where results were delivered rapidly - 7 patients‘
as the easy-to-use platform of the VITEK® 2 Compact provide result or the results between the two systems did not agree. Simple
results were delivered within 2 days and 3 results were delivered Conclusion: The VITEK® 2 compact provided labor gains in our routine
benefits for both the laboratory and the patient. identification methods were performed in cases where the primary
within 3 days of specimen receipt. In 7 cases, a treatment was initiated setting due to less manipulation steps and a faster time to result.
or changed to more tailored therapy based on the availability of the • Time saved is dependent on the laboratory organization and Performance between two systems were comparable. identification result was low discrimination. At the end of the study
results. Two of these changes were made because the AST results direct communication with the wards. period, the results from both systems were compared and all discre-
showed the causative agent was resistant to the current treatment. •
The advantages of V2C contributes towards the control of pant IDs were tested by molecular methods, which was considered
In 1 case, appropriate therapy was initiated based on the AST results. infections and the optimization of risk management in our the reference method.
For 4 patients, the current treatment was maintained because the hospital. OBJECTIVE AST and Expert system performance
bacteria was sensitive. Two patients were removed from unnecessary MVZ im Sonnenblock is a private laboratory that accepts specimens from AST test results were analyzed by the systems’ expert software:
preventive isolation, and 2 patients were moved to preventive isolation both hospitalized patients as well as outpatients from physician office the PHX Epicenter (V4.01A/V3.81C) and V2C AES (version 1.02).
due to infection with multi-resistant organisms. practices. In the interest of patient care and due to the transit time for Test results from both systems including phenotype and antibiotic
Availability of the AST results in a shorter period of time allows the specimens, rapid reporting is important in this setting. Therefore, category changes were analyzed. Repeat testing was performed if
clinicians to make better judgment and initiate or tailor therapy we began this study to assess the impact of the new automated either system gave no result or the results between the two systems
as appropriate. This helps improve patient outcome, reduce the VITEK® 2 compact (V2C) to reduce time to results and compare the did not agree.The VITEK® and E-test® were used as back up methods
possibility of hospital acquired infections, as well as providing cost accuracy of the ID and AST results to the currently used PHOENIX (PHX) when the primary AST result discrepancies were not resolved. All
savings for the hospital. system. AST and phenotype results were compared and the microbiologist,
The study is presented in two parts measuring the impact on laboratory designated as expert, resolved any discrepancies. Minor discrepancies
organization (process and productivity), and ID and AST results accuracy, were considered acceptable and were not studied further.
including Advanced Expert System™ (AES) validation.
48 49
Analysis of the Comparative Workflow and ID/ AST Test Result Accuracy of the VITEK® 2 Analysis of the Comparative Workflow and ID/ AST Test Result Accuracy of the VITEK® 2
compact and the Phoenix™ Systems compact and the Phoenix™ Systems
RESULTS Table 1. Hands on time to perform one ID/AST test
Laboratory organization
b) Productivity Step VITEK 2 compact Step PHOENIX
a) Process
In the current organization and using the PHX system, specimens Time to perform the set up of one ID/AST test is 3.20 min for the 1 Remove ID and AST card from -4°C, organise 00:12 1 Organise bench, label purity plates 00:09
PHX and 1.53 min for the V2C (Table 1). Based on our daily average work bench, label purity plates
arrive on Day 0 at T0 (11:00 AM) and final paper copies of the ID/
AST results are sent throughout Day 3 (T0 +71h30m). With the V2C, workload (100 ID/AST) this represents a savings of 2.4 hours of 00:00 2 Remove AST indicator and leave on bench to come to RT 00:04
results can be obtained from 8:30 PM on Day 2, but the current technical hands on time per day. 2 Dispense 3 ml saline into each of 2 tubes and 00:08 3 Take out combo panel, ID broth and AST broth 00:06
place into rack
organization does not allow for validation and referral until Day 3 (T0
+71h30m) (Figure 1). 3 Label ID tube with accession # & place tube into 00:10 4 Label ID tube with accession #, place into inoculation 00:00
cassette station
By implementing the suggested organizational changes (concurrent
inoculation and reading of plates), test results can be referred starting 4 Prepare isolate using applicator stick, suspend 00:23 5 Using applicator stick, inoculate bacteria into ID broth, 00:36
bacteria in saline, adjust with Densi Check adjust inoculum with Crystal Spec, votex, wait for bubbles
from 2:00 PM on Day 1 with V2C (Figure 1). This allows for a to dispense, place into tray
37h30min reduction in time to result with the V2C. The majority of this Subtotal 00:54 Subtotal 00:56
time savings is due to the reduced incubation time [mean detection
5 Place pipette tip on pipet tor, transfer ID suspen- 00:08 6 Add 1 drop of indicator in AST broth to the tube (AST broth 00:12
time of 6.49 – 11.57 hours for V2C versus 9.33 to 15.58 hours for PHX sion to AST tube predi spensed in screw cap tube)
for 95% of 363 strains tested (see table 4)].
6 Open pouche, place card in cassette position and 00:13 7 Close cap and invert tube 00:05
discard trash
Figure 1. Diagram of current and future organizational settings
Phoenix in the current organization setting
00:00 8 Open pouche, place panel on tray, remove rubbi sh 00:13
VITEK® 2 Compact in the current organization setting 00:00 9 Open bag of caps, remove 1, label it with accession 00:09
number, place
Suggestion for a future organizational setting with VITEK® 2 Compact loosely on the panel
Day 0 Day 1 Day 1 Day 2 Day 2 Day 3 Day 3 00:00 10 Pipette 25ul from ID broth to AST broth, invert tube, put 00:29
tube back into tray. Inoculate purity plate with tip
(24h00) (24h00) (12h00) (24h00) (12h00) (24h00) (12h00)
1. Specimen receipt in the
00:00 11 Pour isolate ID suspension in ID section of panel , AST 00:18
07h00 19h00 broth into AST panel and wait for filling, then wipe off any
laboratory reception area droplets on exterior of port
2. Specimen distribution in the 12h00 20h00 00:00 Place caps on ID and AST sections to seal 00:04
12
bacteriology laboratory 08h00
3. Specimen accession 00:00 13 Visually inspect to ensure properfilling & place panel in 00:04
12h00 20h00 transport tray
08h00
4. Specimen receipt at the 00:00 14 Place AST indicator in refrigerator 00:04
12h00 20h00
Bench called « Modifiant » 08h00 Subtotal 01:15 Subtotal 02:33
5. Prepare the bench for plate
inoculation 11h00 12h30 7 At the PC, start worklist, scan cassette number 00:03 15 Carry transport tray to Phoenix instrument 00:01
6. Inoculation of the plates+tubes 12h30 20h00 8 Scan ID/ AST card barcodes 00:02 16 Press the Login icon 00:00
08h00
9 Link ID/AST card by typing isolate number ; save 00:13 17 Scan panel, type accession number, put panel back into 00:14
7. Incubation 15h00 08h00 worklist tray, press
08h00 accept icon
8. Prepare the bench for plate 10 Take cassette to V2C filler, enter cassette, 00:01 18 Press the Load Panel icon for reader access 00:00
07h30 08h00
reading press fill button
9. Reading of the plates at 24 h 10h30 13h00 11 Remove cassette and place into reader incubator 00:01 19 Place panel into reader and close door 00:05
08h00
10. Set up of PHX panels 12 Remove cassette from reader 00:01 20 00:00
10h30 13h00 13 Prepare purity plates with pipette tips 00:06 21 00:00
10. Set up of V2C cards 08h00
Subtotal 01:41 Subtotal 02:53
11. Process PHX panels 05h00
10h30 20h30 00:00 22 Press Unload Panel icon & and open door 00:04
11. Process V2C cards 08h00 17h30
00:00 23 Remove completed panel 00:00
12. Reading of 48 hour plates 08h00 10h30
Subtotal 01:41 Subtotal 02:57
13. Technician result validation 08h00 10h30
14h00 18h00 23 Go to navigation tree and select results to 00:13 24 At PHX operating screen - press icon to send all panel data 00:06
to Epicenter
14. Chart report validation 18h00
10h30 24 Print results and deliver to different benches 00:00 25 At Epicenter, modify/ accept results 00:00
14h00 18h00
15. Result printing 18h00 19h00 25 Send validated to LIS (batch) 00:00 26 Print results for review and deliver to different benches 00:12
18h30 19h00 00:00 27 Send validated to LIS (batch) 00:04
15. Result sent out by courier 10h30
08h00 Total 01:53 Total 03:20
18h30 19h00
50 51
VITEK® 2 - WORKFLOW ANALYSIS
Analysis of the Comparative Workflow and ID/ AST Test Result Accuracy of the VITEK® 2
compact and the Phoenix™ Systems
Identification performance Table 5. AST performance for GN

The % of overall correct ID results between the two systems is not GN AST Total Agreement Disagreement No Result
significantly different (Tables 2 and 3).
PHOENIX 2590* 2581 (99.6%) 7 (0.3%) 2 (0.1%)
Table 2. Identification performance for GN
VITEK 2 compact 2590* 2558 (98.7%) 2 (0.1%) 30** (1.2%)
GN Total Overall correct Low Mis ID No
ID Discrimination ID *7 strains removed from calculation, no result by one or both instruments
(includes low ** VITEK 2 compact gave only SXT result for S. maltophilia
discrim)
PHOENIX 215* 208 (97.6%) 3 (1.4%) 5 0
(2.4%) Table 6. AST performance for GP
VITEK 2 215* 209 (98.1%) 4 (1.9%) 4 0 GP AST Total Agreement Disagreement No Result
compact (1.9%)
PHOENIX 1738 1723 (99.1%) 9 (0.5%) 6 (0.3%)
* two isolates were removed from the calculation as they could not be resolved by molecular methods
VITEK 2 compact 1738 1718 (98.8%) 4 (0.2%) 16 (0.9%)
Table 3. Identification performance for GP
Table 7. MRSA performance for S. aureus
GN Total Overall correct Low Mis ID No
ID Discrimination ID S. aureus PHOENIX VTK 2 compact mec A gene
(includes low
discrim) MRSA 31 32 32
PHOENIX 175* 169 (97.1%) 0 5 0 MRSA 50 49 49
(2.9%)
VITEK 2 com- 175* 173 (99.4%) 5 (2.9%) 1 0 Table 8. ESBL performance for E. coli and Klebsiella
pactisolate was removed from the calculation as it could not be resolved by molecular methods
* one (0.5%)
E. coli / Klebs PHOENIX VTK 2 compact Synergy screen
ESBL + 4 3 3
Table 4. Time to result for AST testing in hours for 95% of 363 strains tested
ESBL - 125 126 126
PHOENIX VITEK 2 compact
Total min. mean max. min. mean max.
time time
CONCLUSIONS
Enterobacteriaceae 172 6.58 9.62 15.92 5.00 6.49 13.50 • The VITEK® 2 compact provided significant labor savings in our
Non-Enterics 31 12.35 15.58 16.00 7.50 11.57 14.25 routine setting due to less manual manipulation during test set up.
Staphylococci 77 6.19 12.04 16.10 5.75 6.70 8.50 • A faster time to result was realized due to faster set up and
shorter instrument incubation periods.
Enterococci 41 5.96 9.33 18.90 6.25 9.35 10.50
• Performance between the two systems was comparable.
S. agalactiae 24 8.08 11.97 16.02 6.00 7.11 9.75 • The industrial productivity consultants clearly demonstrated that
positive benefits can be obtained even with minor but realistic
changes to our processes.
AST and Expert system performance
• In our organisation, using the VITEK® 2 compact, workflow
AST and Expert results are shown in Tables 5, 6, 7 and 8.
benefits were accompanied by confidence in the quality of ID/
The % of overall correct AST expertized results between the two
AST results referred.
systems is not significantly different.
52
01-18 / 9308339/008/GB/A / This document is not legally binding. bioMérieux reserves the right to modify specifications without notice / BIOMERIEUX, the blue logo, Advanced Expert System, API, ETEST and VITEK are used, pending and/or registered trademarks belonging to bioMérieux or one of its
subsidiaries or one of its companies / The ATCC trademark and trade name and any and all ATCC catalog numbers are trademarks of the American Type Culture Collection / PHOENIX, BBL and Prompt are trademarks belonging to Becton, Dickinson and Company /CLSI is a trademark belonging to the
Clinical and Laboratory Standards Institute / MICROSCAN and WALKAWAY are trademarks belonging to Siemens Healthcare Diagnostics Inc. / SIRSCAN and SIR are trademarks belonging to INTELLIGENCE ARTIFICIELLE APPLICATIONS / Any other name or trademark is the property of its respective
owner. / bioMérieux S.A. RCS Lyon 673 620 399 / Printed in France / thera / RCS Lyon B 398 160 242
Other “Selection of
to find out more about available literature

Contact your local bioMérieux representative
Publications” available
www.biomerieux.com • www.biomerieux-diagnostics.com/vitek-2
bioMérieux S.A. • 69280 Marcy l’Étoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90

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VITEK 2 ®

• GP (Gram-positive) Multicenter Evaluation of the New VITEK® 2 Neisseria-Haemophilus Identification Card. 8

• NH (Neisseria and Haemophilus) ANAEROBES, CORYNEBACTERIUM, etc.

Performance of VITEK® 2 for Antimicrobial Susceptibility Testing of Staphylococcus spp. 23

Torres E., Pérez S., Villanueva R., Bou G.

Clinical and Financial Benefits of Rapid Bacterial Identification and Antimicrobial 42

VITEK® 2 – WORKFLOW ANALYSIS

Comparison of bioMerieux VITEK® 2 XL, BD Phoenix™, and Siemens MicroScan 45

Analysis of the Comparative Workflow and Accuracy of the VITEK® 2 Compact 47

Analysis of the Comparative Workflow and ID/AST Test Result Accuracy of 49

GRAM-NEGATIVE ORGANISMS GRAM-NEGATIVE ORGANISMS

JOURNAL OF CLINICAL MICROBIOLOGY JOURNAL OF CLINICAL MICROBIOLOGY

KEY POINTS KEY POINTS

HAEMOPHILUS, NEISSERIA AND OTHER FASTIDIOUS ORGANISMS ANAEROBES, CORYNEBACTERIUM, etc.

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Evaluation of VITEK® 2 and RapIDTM Yeast Plus Systems

GRAM-NEGATIVE ORGANISMS GRAM-NEGATIVE ORGANISMS

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Evaluation of VITEK® 2 for Antimicrobial Susceptibility

Evaluation of the New VITEK® 2 Extended -Spectrum

Beta-Lactamase (ESBL) Test for Rapid Detection of ESBL

RESULTS Performance of CLSI carbapenem, aztreonam, cefazolin, cefotaxime, OVERALL PERFORMANCE

GRAM-NEGATIVE ORGANISMS RESULTS OVERALL PERFORMANCE

of non-Enterobacteriaceae and 2 MEs); doripenem (1 ME); piperacillin-tazobactam (1 ME) (Table 2).

GRAM-POSITIVE ORGANISMS GRAM-POSITIVE ORGANISMS

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“Overall the VITEK® 2 AST-GP71 and GP72 performed comparably to BMD.

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Use of VITEK® 2 antimicrobial susceptibility profile

KEY POINTS KEY POINTS

Evaluation of the VITEK® 2 AST-ST01 Card for Streptococcus

of Oxacillin Resistance in Staphylococcus aureus.

ETEST: Overnight cultures isolates were adjusted to a 0.5 McFarland

Broth Microdilution (BMD): BMD was performed according to the

Analysis: Performance was established by comparing the VITEK® 2 and

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Multicenter Evaluation of the New VITEK® 2 Yeast

Susceptibility Test Using New CLSI Breakpoints

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KEY POINTS KEY POINTS

JOURNAL OF CLINICAL MICROBIOLOGY

Multicenter Comparison of the VITEK® 2 Antifungal

* Amphotericin not available in the US

“… the MICs of amphotericin B, flucytosine, voriconazole, and fluconazole can now be

White Paper, JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

KEY POINTS KEY POINTS

JOURNAL OF CLINICAL MICROBIOLOGY

Potential Impact of the VITEK® 2 System and

EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY AND INFECTIOUS DISEASES JOURNAL OF INFECTION