641. Evaluation of the FilmArray Pneumonia Panel and Potential Impact of 643.

643. Comparison of Multiplex Polymerase Chain Reaction (PCR) and Routine

Antimicrobial Use on Patients in a Trauma and Medical Intensive Care Unit Culture for the Detection of Respiratory Pathogens in Pneumonia Patients
Kathy Krupinski- Shaw, BSc1; Lauren Lopez, PharmD, BCPS, BCIDP2; Emad Abu Sitta, MD1; Nicole Hubbard, MD2; Geehan Suleyman, MD1; 1University of
Halle Orlinski, PharmD2; Patrick Ozbolt, MS, MT(ASCP)2; Toledo Medical Center, Toledo, Ohio; 2Promedica Toledo Hospital, Toledo, Ohio
Stella Antonara, PhD, D(ABMM)2; 1OhioHealth Laboratory Services, Columbus,
Session: 67. New Diagnostics
Ohio; 2OhioHealth, Columbus, Ohio
Thursday, October 3, 2019: 12:15 PM
Session: 67. New Diagnostics
Background.  The identification of causative pathogens in pneumonia can be
Thursday, October 3, 2019: 12:15 PM
challenging, and conventional culture methods can take up to 72 hours. However,
Background.  Organisms causing infections of the lower respiratory tract in rapid microbiologic tests identify organisms within hours. The Biofire®Filmarray
hospitalized patients can lead to high morbidity and mortality. Identification of the ((bioMérieux, North Carolina) Pneumonia Panel was recently approved by the FDA.
agents of pneumonia allows implementation of appropriate antimicrobial therapy The multiplex PCR system identifies 33 targets from sputum and bronchoalveolar
and fast and accurate results are essential for the application of the correct antimicro- (BAL) samples, which include 18 bacteria, 8 viruses, and 7 antibiotic resistance genes.
bial regimen. The purpose is to compare the panel to routine culture methods for the detection of
Methods.  For 6 months results of quantitative bronchioalveolar lavage (Q-BALs) respiratory pathogens in patients with pneumonia in a 794-bed teaching hospital in
respiratory cultures, ordered as a standard of care for patients in our intensive care northwest Ohio.
unit, were compared with the results obtained by a new multiplex molecular assay for Methods.  We retrospectively screened all hospitalized intensive care unit

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the detection of lower respiratory tract pathogens, the FilmArray pneumonia panel patients who met clinical and radiological criteria of pneumonia using electronic
(PP). The panel offers semi-quantitation of the bacterial targets that were compared medical records between November 2018 and February 2019. Adult patients who had
with the quantitative results of the Q-BALs. Additionally, a retrospective chart review respiratory cultures collected within 7  days were included. Repeat specimens were
was performed to examine whether there would be any difference in the timing of ap- excluded. Routine cultures were performed using the laboratory’s standard procedure,
propriate antimicrobial therapy if the results of the panel were to be available for those and Pneumonia Panel testing was performed according to manufacturer instructions.
patients. Appropriate antimicrobial therapy was determined according to the institu- Results.  Fifty-nine respiratory or 13 BAL and 46 sputum specimens were eval-
tion protocol for treatment of patients for ventilator-associated pneumonia based on uated. There was no discrepancy between culture and PCR in 63% (37/59) samples.
the results of the quantitative cultures One (8%) BAL and 10 (22%) sputum specimens had additional pathogens detected
Results.  Thirty-six unique patients Q-BALs were run and of those there was by PCR. There was a discrepancy between culture and PCR in four (31%) BAL and
82% agreement on the detected targets between cultures and PP. Six targets were not seven (15%) sputum samples. The largest discrepancy was noted amongst Serratia
detected by the panel (yeast, S. maltophilia, Streptococci, Salmonella spp.). M. catarrh- marcescens (4/59 or 7%) and Haemophilus influenzae (6/59 or 10%) species. Only
alis, S. agalactiae and 3 viral targets were detected only by the panel. There was 100% one sputum culture had Legionella detected by PCR. Additionally, 17 specimens had a
agreement between the panel detected resistance markers and the culture isolates sus- virus detected either alone or with another bacterial pathogen by PCR. For the resist-
ceptibilities. Of the 36 patients, 12 were excluded because their medical records were ance genes, KPC was detected by PCR but not by Modified Carbapenem Inactivation
not available for review. Of the 24 reviewed, 8 (33.3%) would have de-escalation in Method (mCIM) test. The mecA gene was detected in six of seven (86%) of methicil-
their antibiotics use at least 24h earlier due to the PP result. Eight (33.3%) would have lin-resistant Staphylococcus aureus (MRSA) isolates. CTX-M was detected in Serratia
no potential change in therapy and 8 (33.3%) could have inappropriate escalation or and Klebsiella pneunomiae in two samples; however, the organisms were not isolated
continuation due to reporting of potential pathogens by the PP but recorded as normal in culture.
flora by cultures. Conclusion.  The Pneumonia Panel can identify additional bacteria that did not
Conclusion.  The use of PP would lead to a reduction of unnecessary antimicro- grow in culture. This panel can rapidly identify pathogens and potentially reduce un-
bial therapy in 1/3 of the patients examined. However, quantification of organisms necessary antibiotic use.
otherwise reported as normal flora may lead to unnecessary treatment and requires Disclosures. All authors: No reported disclosures
education of staff to understand the results of the assay.
Disclosures. All authors: No reported disclosures.
644. Comparative Evaluation of ETEST® ERV bioMérieux with the CLSI Broth
Microdilution Method for Eravacycline MIC Determination
Veronique Sauvonnet1; Corey Fyfe, MS2; Diane Halimi1; Roland Martelin1;
642. Higher Diagnostic Accuracy with Ultrasensitive Detection of Helicobacter Gilles Zambardi1; 1Biomerieux, La Balme Les Grottes, Rhone-Alpes, France;
pylori Stool Antigen Using Single-Molecule Counting Technology 2
Tetraphase Pharmaceuticals, Watertown, Massachusetts
Phoebe Katzenbach, BS1; Gipshu Dave, MS1; Ali Mukherjee, PhD1;
Johanna Sandlund, MD1; Joel Estis, MS1; Niamh Nolan, MS1; Session: 67. New Diagnostics
Niaz Banaei, MD2; Brian Noland, PhD1; 1Singulex, Inc., Alameda, California; Thursday, October 3, 2019: 12:15 PM
2
Stanford University School of Medicine, Palo Alto, California Background.  Eravacycline (XERAVA™) is a novel, FDA and EMA-approved ful-
Session: 67. New Diagnostics ly-synthetic fluorocycline antibiotic developed by Tetraphase Pharmaceuticals Inc. for
Thursday, October 3, 2019: 12:15 PM the treatment of complicated intra-abdominal infections (cIAI) including those caused
by multidrug-resistant (MDR) pathogens that have been highlighted as urgent public
Background.  Current diagnostic methods for Helicobacter pylori infection in- health threats by the US CDC and the WHO.
clude fecal antigen tests, 13C-urea breath test, and gastric biopsy. The breath test is The new ETEST ERV strip (MIC range 0.002  – 32  µg/mL) has been developed
limited by poor specificity and the fecal antigen tests by poor sensitivity. We have by bioMérieux and calibrated vs. the broth microdilution reference method (BMD)
developed a prototype assay for detection of H. pylori antigen in human stool, pow- as described by the Clinical and Laboratory Standards Institute (CLSI) to determine
ered by ultrasensitive Single Molecule Counting technology, and compared the ana- the minimal inhibitory concentration (MIC) of eravacycline against Enterobacterales
lytical performance to a commercially available enzyme-linked immunoassay (EIA) and Enterococci. The aim of the study was to compare ETEST ERV to the CLSI BMD
antigen test. method on a panel of 166 strains comprising 131 Enterobacterales and 35 Enterococci.
Methods.  The Singulex Clarity H.  pylori antigen assay incubates diluted stool Methods.  Quality control was performed with the CLSI QC strains E.coli ATCC
with capture and fluorescent-labeled detection antibodies. After incubation and wash 25922 and E.faecalis ATCC 29212. The ETEST ERV strip was applied on a Mueller–
steps, fluorescent molecules are eluted and single-molecule fluorescence measured by Hinton agar plate previously seeded with a 0.5 McF bacterial suspension. After incu-
detected events (DE′). Analytical performance was compared with a commercial EIA bation for 16–20H at 35°C, the reading was performed using the bacteriostatic mode
(Premier Platinum HpSA® Plus, Meridian Bioscience, Inc.) using serial dilutions of i.e.,80% of growth. The FDA-approved breakpoints were applied (S≤0.5µg/mL for
H.  pylori control (~37,500–1.7  ng/mL) and high positive stool (signal to noise ratio Enterobacterales and S ≤0.064 µg/mL for Enterococci).
>2). Clinical performance was evaluated using two cohorts, one had 10 EIA-negative Results.  The MIC essential agreement was 99.4% at ±1 dilution for the whole
and 10 EIA-positive samples and the other 13 high positives (> 0.500 at 450/630) and 5 panel and the category agreement was 96.4% with 4.8% Major Errors (1 E.  coli, 2
low positives near the EIA cutoff (0.100–0.500 at 450/630). One sample was excluded K. pneumoniae, 1 K.aerogenes, 1 C. koseri, 1 E. faecalis), all at ±1 dilution around the
due to discordant EIA results, and three to reader flags. single breakpoint. No Very Major Error (VME) was observed.
Results.  The lower limit of detection of the Clarity H. pylori assay was 1.7 ng/mL Conclusion.  In this study, the new ETEST ERV strip has been found to be sub-
and the EIA 1,250 ng/mL (IFU: LOD 4.67 ng/mL). A high positive stool sample was de- stantially equivalent to the CLI reference method. MIC end-points appear easier to
tectable by the Clarity H. pylori assay diluted 1:10,000,000 and by the EIA 1:10,000. The read in comparison to the reference method. With a 15-dilution MIC range and sim-
Clarity H. pylori assay showed a 729-fold increase in lower limit of detection and 1,000- plicity of use, ETEST ERV could represent a valuable tool for MIC determination and
fold increase in endogenous antigen lower limit of detection compared with the EIA. an alternative to the BMD reference method. ETEST ERV will undergo clinical studies
Clarity signal ranged from 46–665 DE’ for EIA-negative samples and 487,484–576,747 to seek IVD FDA clearance and CE marking. For Research Use Only. The performance
DE’ for EIA-positive samples. characteristics of this product have not yet been established.
Conclusion.  The Singulex Clarity H. pylori antigen assay may have orders of mag- Disclosures. All authors: No reported disclosures.
nitude higher analytical sensitivity than the commercial EIA and demonstrated 100%
positive agreement and 100% negative agreement on detection of H. pylori antigen in
human stool samples. The ultrasensitive Clarity H. pylori assay has the potential for 645. Singulex Clarity Norovirus Assay (In Development) Provides Ultrasensitive
high sensitivity and specificity to improve current diagnostic options for H. pylori in- Detection of Norovirus Genogroups I and II
fection; however, additional multicenter studies are required. Gipshu Dave, MS1; Phoebe Katzenbach, BS1; Johanna Sandlund, MD1;
Disclosures. All authors: No reported disclosures. Joel Estis, MS1; Ali Mukherjee, PhD1; Niamh Nolan, MS1;

Poster Abstracts  •  OFID  2019:6 (Suppl 2) • S297