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CROSSMARK_logo_3_Test 1/1

원저
Diagnostic Genetics
Vol. 11, No. 4: 290-296, October 2021 진단유전학
https://doi.org/10.47429/lmo.2021.11.4.290
https://crossmark-cdn.crossref.org/widget/v2.0/logos/CROSSMARK_Color_square.svg 2017-03-16

AccuPower® RV1 Real-Time RT-PCR 키트와


AccuPower® RV1 Multiplex 키트의 SARS-CoV-2 및
인플루엔자 바이러스 검출에 대한 평가
Evaluation of the AccuPower® RV1 Real-Time RT-PCR Kit and the AccuPower® RV1
Multiplex Kit for SARS-CoV-2 and Influenza Virus Detection
김만진1,2·박현웅3·전유라4·신호섭1·조성임1·김보람1·이지수1·박성섭1·성문우1
Man Jin Kim, M.D.1,2, Hyunwoong Park, M.D.3, You La Jeon, M.D.4, Ho Seob Shin, M.T.1, Sung Im Cho, M.T.1, Boram Kim, M.D.1,
Jee-Soo Lee, M.D.1, Sung Sup Park, M.D.1, Moon-Woo Seong, M.D.1
서울대학교병원 진단검사의학과1, 서울대학교병원 임상유전체의학과2, 서울대학교병원운영 서울특별시보라매병원 진단검사의학과3,
녹십자의료재단4
Departments of Laboratory Medicine1 and Genomic Medicine2, Seoul National University Hospital, Seoul; Department of Laboratory Medicine3,
Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul; Department of Laboratory Medicine4, Green Cross
Laboratories, Yongin, Korea

Background: The AccuPower® RV1 Real-Time RT-PCR Kit (Bioneer, Korea) and AccuPower® RV1 Multiplex Kit (Bioneer) are one-step real-time
reverse transcription PCR assays for detecting severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and influenza A and B.
Methods: We clinically evaluated the AccuPower® RV1 Real-Time RT-PCR Kit and AccuPower® RV1 Multiplex Kit by comparing their results for
1,098 clinical samples. The presence of SARS-CoV-2 was confirmed using the Allplex™ 2019-nCoV Assay (Seegene, Korea) and Standard M nCoV
Real-Time Detection Kit (SD Biosensor, Korea). Influenza viruses were detected using the Allplex™ Respiratory Panel 1 (Seegene).
Results: The comparative positive and negative agreement values of the AccuPower® RV1 Real-Time RT-PCR Kit for SARS-CoV-2 and influenza A
and B were 100%. The positive agreement of the AccuPower® RV1 Multiplex Kit was 100% for SARS-CoV-2 and 98.77% for influenza A and B. The
kappa values for SARS-CoV-2 and influenza A and B were > 0.99. SARS-CoV-2 was evaluated using both sputum and nasopharyngeal or oropharyn-
geal swabs. There was no difference in the detection rates for each type.
Conclusions: The findings confirm the clinically comparable performances of the AccuPower® RV1 Real-Time RT-PCR Kit and the AccuPower®
RV1 Multiplex Kit.
Key Words: SARS-CoV-2, Influenza virus, Multiplex real-time PCR, Clinical evaluation

INTRODUCTION

Corresponding author: Moon-Woo Seong, M.D., Ph.D. Coronavirus disease 2019 (COVID-19) was first detected in Wu-
https://orcid.org/0000-0003-2954-3677
Department of Laboratory Medicine, Seoul National University Hospital,
han, Hubei Province, China. The disease is caused by severe
Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, acute respiratory syndrome coronavirus-2 (SARS-CoV-2) [1, 2].
Seoul 03080, Korea
Tel: +82-2-2072-4180, Fax: +82-2-747-0359, E-mail: [email protected] To date, there have been over 100 million cases in the ongoing
SARS-CoV-2 pandemic, with over 2 million deaths globally, ac-
Received: June 5, 2021
Revision received: July 31, 2021 cording to the COVID-19 dashboard, Center for Systems Science
Accepted: August 9, 2021 and Engineering, Johns Hopkins University. We cannot accurately
This article is available from https://www.labmedonline.org diagnose patients with COVID-19 based on the observable symp-
2021, Laboratory Medicine Online toms alone because these are nonspecific, such as fever, cough,
This is an Open Access article distributed under the terms of the Creative Commons
Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) sputum production, and shortness of breath, and are shared by
which permits unrestricted non-commercial use, distribution, and reproduction in any
medium, provided the original work is properly cited. other respiratory infections [3]. Influenza virus is a common cause

290 www.labmedonline.org eISSN 2093-6338


김만진 외: Evaluation of the AccuPower® RV1 Kit

of respiratory infections. Influenza and SARS-CoV-2 infections Multiplex Kit (Bioneer). The samples were not frozen or thawed
present similar symptoms and modes of transmission, including more than once.
transmission through contact, droplets, and fomites [4].
Alveolar type II cells (AT2 pneumocytes), the primary site of in- 2. AccuPower® RV1 Real-Time RT-PCR Kit and
fluenza replication, especially influenza A, have been implicated AccuPower® RV1 Multiplex Kit
as targets for SARS-CoV-2 infection [5]. There is scant evidence re- The AccuPower® RV1 Kits can detect SARS-CoV-2, influenza A
garding the interaction between COVID-19 and influenza. One (Influenza A-H1, Influenza A-H3N2, and Influenza A-pdm09), and
case report described that symptoms worsened when patients influenza B with different Ct values. The test was performed us-
were co-infected with SARS-CoV-2 and influenza A [6]. Another ing an Exicycler™ 96 (Bioneer) for real-time PCR according to the
report described rapid respiratory deterioration in four patients manufacturer’s instructions. The results were interpreted auto-
infected with SARS-CoV-2 and influenza A or B [7]. Moreover, si- matically, and the analyzed data were presented using Bioneer’s
multaneous infection with SARS-CoV-2 and other respiratory software (ExiStation™ and ExiDiagnosis). A positive result entails
pathogens may influence the morbidity and prognosis in patients that the Ct value of the sample was below the cut-off Ct value. A
[8]. It is important to accurately detect SARS-CoV-2 and influenza negative result indicated the absence of infection confirmed by
viruses, including possible coinfections in the community [9]. amplification of the internal control.
Reverse-transcription PCR (RT-PCR) is highly sensitive and spe- BIONEER’s nucleic acid extraction eluted 400 µL of the clinical
cific and has become the standard test for detecting respiratory vi- sample in a final volume of 100 µL using an automated extraction
ruses, including SARS-CoV-2 [8]. This study aimed to evaluate a protocol on ExiStation™ and ExiPrep™ 48 Viral DNA/RNA Kit
multiplex PCR to detect SARS-CoV-2 and influenza A and B vi- (Bioneer). The ExiStation™ system consisted of ExiPrep™48Dx
ruses using the ExiStation™ system (Bioneer, Daejeon, Korea). (Bioneer) for RNA extraction and Exicycler™96 for real-time RT-
PCR.
MATERIALS AND METHODS We used 50 µL aliquots for the AccuPower® RV1 Real-Time RT-
PCR Kit analysis and 10 µL aliquots for the AccuPower® RV1 Mul-
1. Clinical specimens tiplex Kit analysis. The AccuPower® RV1 Real-Time RT-PCR Kit
This study was approved by the Institutional Review Board of was optimized for ExiStation™ and the AccuPower® RV1 Multi-
the Seoul National University Hospital. The study included 1,098 plex Kit was optimized for Exicycler™96. To determine clinical
clinical respiratory specimens obtained from the Seoul National sensitivity and specificity, we compared the results of Accu-
University Hospital, Seoul National University Boramae Medical Power® kits with those of the Allplex™ 2019-nCoV assay and the
Center, and Green Cross Laboratory. A total of 378 sputum sam- Standard M nCoV Real-Time Detection Kit for SARS-CoV-2 and
ples and 720 nasopharyngeal/oropharyngeal swabs were col- those of the Allplex™ Respiratory Panel 1 for influenza viruses.
lected from patients infected with SARS-CoV-2 or influenza. All
the sputum samples and 382 nasopharyngeal or oropharyngeal 3. Sequencing
swabs were analyzed for the presence of SARS-CoV-2. The re- The samples that exhibited discrepancies in their results were
maining 338 nasopharyngeal or oropharyngeal swabs were confirmed by sequencing. We extracted the total RNA from the
tested for influenza A and B. samples according to the manufacturer’s instructions using the
Clinical testing was performed using retrospective clinical sam- ExiStation™ and ExiPrep™ 48 Viral DNA/RNA Kit. We referred to
ples. We analyzed the samples using the Allplex™ 2019-nCoV As- the WHO protocol for the PCR conditions and primer sequences
say (Seegene, Seoul, Korea) and STANDARD M nCoV Real-Time used for amplification [9].Primer sequences for influenza were as
Detection kit (SD Biosensor, Suwon, Korea) for SARS-CoV-2, and follows: influenza type A M30F2/08: 5′-ATG AGY CTT YTA ACC
Allplex™ Respiratory Panel 1 (Seegene) for influenza viruses. All GAG GTC GAA ACG-3′ and influenza type A M264R3/08: 5′-TGG
®
specimens were stored at -70°C until testing with the AccuPower ACA AAN CGT CTA CGC TGC AG-3′ for the M gene; influenza
®
RV1 Real-Time RT-PCR Kit (Bioneer) and the AccuPower RV1 type B Victoria lineage Bvf224: 5′-ACA TAC CCT CGG CAA GAG

https://doi.org/10.47429/lmo.2021.11.4.290 www.labmedonline.org 291


김만진 외: Evaluation of the AccuPower® RV1 Kit

TTT C-3′; influenza type B Victoria lineage Bvr507: 5′-TGC TGT kits and the comparative methods. Clinical sensitivity, specificity,
TTT GTT GTC GTT TT-3′; influenza type B Yamagata lineage and kappa statistics were reported with 95% confidence intervals
BYf226: 5′-ACA CCT TCT GCG AAA GCT TCA-3′; and influenza (CIs).
type B Yamagata lineage BYf613: 5′-CAT AGA GGT TCT TCA
TTT GGG TT-3′ for the HA gene. Sequencing was performed us- RESULTS
ing an ABI 3730xl DNA Analyzer (Applied Biosystems, Foster
City, CA, USA). 1. Comparison of the AccuPower® Kits and the
confirmation results
4. Analytical sensitivity and specificity Out of the 760 samples analyzed for SARS-CoV-2, 384 (190 spu-
We determined the analytical sensitivity of SARS-CoV-2 using tum and 194 swab samples) were found to be positive, and 376
3-fold serially diluted virus samples. For sputum, 900, 300, 100, (188 sputum and 188 swab samples) were negative. Out of the
33.3, 11.1, and 3.7 copies/reaction, and for swabs, 300, 100, 33.3, samples tested for influenza, 81 were positive, and 95 were nega-
11.1, 3.7, and 1.23 copies/reaction, were tested in 72 replicates for tive (Table 1).
six concentrations. Similarly, influenza A and B were diluted For SARS-CoV-2, the evaluation was conducted at three institu-
3-fold from 600 copies/reaction to 0.27 copies/reaction and tested tions. The Green Cross Laboratory results were confirmed using
in 72 replicates for six concentrations. the Allplex™ 2019-nCoV Assay and Seoul National University
SARS-CoV-2 was obtained from SeraCare Life Sciences (Milford, Hospital and Boramae Medical Center results using the STAN-
MA, USA) and influenza viruses from Zeptometrix (Buffalo, NY, DARD M nCoV Real-Time Detection Kit. The SARS-CoV-2 results
USA). Protocols for analytical sensitivity followed the Clinical and analyzed with AccuPower® RV1 Kits were compared with the
Laboratory Standards Institute guideline EP17-A2 [10]. Analytical confirmed results from each institution (Table 2). Both the posi-
sensitivity was estimated via probit regression analysis using R tive and negative agreement between the results from Accu-
Studio (version 3.6.1). Power® RV1 kits and the confirmation results for SARS-CoV-2 was
The analytical specificities of the AccuPower® kits were tested 100%. The kappa values of the two methods were 1.0. Both the
using 40 different pathogens. DNA or RNA was extracted from positive and negative agreement values of influenza A and influ-
each reference panel and assayed using the same protocols used enza B between the results from AccuPower® RV1 Real-Time RT-
for clinical samples. PCR Kit and Allplex™ Respiratory Panel 1 were 100%. However,
the positive and negative agreement between influenza A and B
5. Statistical analysis between the results from AccuPower® RV1 Multiplex Kit and All-
We assessed significant differences between the two methods plex™ Respiratory Panel 1 was 98.77%. The kappa value was 0.99.
using 2 × 2 contingency tables and the VassarStats website (http:// The sequencing results for the discordant samples was positive.
vassarstats.net/) and performed agreement statistics (kappa cal- However, upon re-testing the samples with the comparative re-
culation) to compare the detection sensitivity of the AccuPower® agent (Allplex™ Respiratory Panel 1) and the AccuPower® RV1

Table 1. Comparison of the results of the AccuPower® RV1 Real-Time RT-PCR Kit and the confirmation tests for the detection of SARS-CoV-2 and
influenza viruses
Agreement
Virus Specimen type Positive Negative
% No. 95% CI % No. 95% CI
SARS-CoV-2 Sputum 100 190/190 98.02–100 100 188/188 98.00–100
Swab 100 194/194 98.06–100 100 188/188 98.00–100
Influenza A Swab 100 81/81 95.47–100 100 81/81 95.47–100
Influenza B Swab 100 81/81 95.47–100 100 95/95 96.11–100
Abbreviation: CI, confidence interval.

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김만진 외: Evaluation of the AccuPower® RV1 Kit

Table 2. Comparison of AccuPower® RV1 Real-Time RT-PCR Kit, AccuPower® RV1 Multiplex Kit and reference method
Agreement
Specimen No. AccuPower® RV1 Real-Time RT-PCR Kit No. AccuPower® RV1 Multiplex Kit
Virus
type
Sensitivity Specificity Kappa Sensitivity Specificity Kappa
Positive Negative Positive Negative
(95% CI) (95% CI) (95% CI) (95% CI) (95% CI) (95% CI)
SARS-CoV-2 Sputum 190/190 188/188 100 100 1 190/190 188/188 100 100 1
(98.02–100) (98.00–100) (0.99–1.00) (98.02–100) (98.00–100) (0.99–1.00)
Swab 194/194 188/188 100 100 1 194/194 188/188 100 100 1
(98.06–100) (98.00–100) (0.99–1.00) (98.06–100) (98.00–100) (0.99–1.00)
Influenza A Swab 80/81 81/81 100 100 1 80/81 81/81 98.77 100 0.99
(95.47–100) (95.47–100) (0.98–1.00) (93.33–99.78) (95.47–100) (0.97–1.00)
Influenza B Swab 81/81 95/95 100 100 1 80/81 95/95 98.77 100 0.99
(95.47–100) (96.11–100) (0.98–1.00) (93.33–99.78) (96.11–100) (0.99–1.00)
Abbreviation: CI, confidence interval.

Real-Time RT-PCR Kit, the Ct values were detected near the cut- samples and 44.67 copies/reaction (95% CI: 33.88–60.26) and
off in both kits. Therefore, the samples were low titer samples, 34.67 copies/reaction (95% CI: 26.30–44.67), respectively, with the
and the discrepancy was attributed to the difference in the mini- swab samples.
mum nucleic acid concentration needed for use in the two tests. We tested 40 different viruses and bacterial reference strains us-
ing the protocols used for the clinical samples to assess the cross-
2. Analytical sensitivity and specificity of the AccuPower ®
reactivity results and the detection specificity of the AccuPower®
RV1 Kits kits (Table 3). The test results were negative (34 species), except
®
The analytical sensitivities of the AccuPower RV1 Real-Time for the specific target (related SARS-CoV-2, Influenza A, and Influ-
RT-PCR Kit were 64.57 copies/reaction (95% CI: 42.66–97.72), enza B). No non-specific positive reactions were observed.
56.23 copies/reaction (95% CI: 37.15–87.10), 38.90 copies/reaction
(95% CI: 26.92–56.23), 37.15 copies/reaction (95% CI: 26.92–50.12), DISCUSSION
and 27.54 copies/reaction (95% CI: 19.05–39.81) for influenza A-
H1N1 seasonal, H1N1 pdm, H3N2, influenza B-Yamagata, and in- Data on SARS-CoV-2 and influenza virus co-infection are lim-
fluenza B-Victoria, respectively. The analytical sensitivities for the ited. Influenza infection was classified as one of the characteris-
E gene and the SARS-CoV-2-specific gene (RdRp gene and N tics of SARS-CoV-2 positive patients, and a small number of posi-
gene) were 107.15 copies/reaction (95% CI: 81.28–144.54) and tive cases were studied. However, many studies have reported a
109.65 copies/reaction (95% CI: 79.43–147.91), respectively, with correlation between the likelihood of co-infection and the sever-
the sputum samples and 42.66 copies/reaction (95% CI: 32.36– ity or mortality rate due to co-infection [11-13]. Therefore, co-in-
54.95) and 26.92 copies/reaction (95% CI: 19.50–36.31), respec- fection of SARS-CoV-2 and influenza viruses can pose serious
tively, with the swab samples. risks. We can prepare for potential pandemics due to such co-in-
®
The analytical sensitivities of the AccuPower RV1 Multiplex fections by routinely testing for respiratory viruses other than
Kits were 47.86 copies/reaction (95% CI: 34.67–66.07), 37.15 cop- SARS-CoV-2.
ies/reaction (95% CI: 26.30–52.48), 33.11 copies/reaction (95% CI: The AccuPower® RV1 Real-Time RT-PCR Kit contains dried pri-
22.91–46.77), 33.88 copies/reaction (95% CI: 25.12–45.71), and mary materials required for PCR in one tube optimized for the
26.92 copies/reaction (95% CI: 21.38–33.11) for influenza A-H1N1 ExiStation™ series. ExiStation™ can rapidly extract and analyze
seasonal, H1N1 pdm, H3N2, influenza B-Yamagata, and influenza nucleic acid using an exclusive software. This minimizes the
B-Victoria, respectively. The analytical sensitivities for the E gene hands-on time after sample processing and any human error that
and the SARS-CoV-2-specific gene (RdRp gene and N gene) were may occur during the preparation of the reaction mixture. The
117.48 copies/reaction (95% CI: 91.20–154.88) and 107.15 copies/ test was completed within 2 hours and 30 minutes. Additionally,
reaction (95% CI: 83.18–141.25), respectively, with the sputum the AccuPower ® RV1 Multiplex Kit is compatible with the

https://doi.org/10.47429/lmo.2021.11.4.290 www.labmedonline.org 293


김만진 외: Evaluation of the AccuPower® RV1 Kit

Table 3. Analytical specificities of the AccuPower® RV Real-Time RT-PCR Kit and the AccuPower® RV1 Multiplex Kit
No. Pathogen Strain Result
1 SARS-CoV-2 Seracare (0505-0159) Positive 1*
2 Human Influenza virus A H1N1 (seasonal) KBPV VR-33 Positive 2 † ,
3 Human Influenza virus A H3N2 (Wisconsin/67/05) Zeptometrix 0810252CFHI Positive 2
4 Human Influenza virus A H1N1 pdm virus (Michigan/45/15) Zeptometrix 0810538CFHI Positive 2
5 Human Influenza virus B (Yamagata/16/88) Zeptometrix 0810518CFHI Positive 3 ‡
6 Human Influenza virus B (Texas/6/11) Zeptometrix 0810242CFHI Positive 3
7 Human Coronavirus 229E KBPV VR-9 Negative
8 Human Coronavirus NL63 Zeptometrix 0810228CF Negative
9 Human Coronavirus OC43 Zeptometrix 0810024CF Negative
10 Human Coronavirus OC43 KBPV VR-8 Negative
11 Coronavirus HKU1 (synthetic RNA) ATCC 3262SD Negative
12 SARS-Coronavirus (Purified RNA of SARS-Coronavirus strain Frankfurt 1) EVAg 004N-02005 Negative
13 Parainfluenza virus 1 Zeptometrix 0810014CFHI Negative
14 Parainfluenza virus 2 Zeptometrix 0810015CFHI Negative
15 Parainfluenza virus 3 Zeptometrix 0810016CFHI Negative
16 Parainfluenza virus 4a Zeptometrix 0810060CFHI Negative
17 Parainfluenza virus 4b Zeptometrix 0810060BCFHI Negative
18 Human Respiratory syncytial virus A KBPV VR-41 Negative
19 Human Respiratory syncytial virus B KBPV VR-42 Negative
20 Human Rhinovirus 1 (type A) KBPV VR-81 Negative
21 Human Rhinovirus 7 (type A) KBPV VR-82 Negative
22 Human Rhinovirus 8 (type B) KBPV VR-79 Negative
23 Human Rhinovirus 42 (type B) KBPV VR-80 Negative
24 Human Metapneumovirus type 3 Type B1 Zeptometrix 0810156CFHI Negative
25 Human Metapneumovirus type 9 Type A1 Zeptometrix 0810160CFHI Negative
26 Human Parechovirus 1 Zeptometrix 0810145CF Negative
27 Human Parechovirus 2 Zeptometrix 0810146CF Negative
28 Human Parechovirus 3 Zeptometrix 0810147CF Negative
29 Human Adenovirus type 03 (type B) KBPV VR-62 Negative
30 Human Adenovirus type 02 (type C) KBPV VR-58 Negative
31 Human Bocavirus (synthetic DNA) ATCC 3251SD Negative
32 Enterovirus 70 KBPV VR-55 Negative
33 Coxsackievirus B5 KBPV VR-17 Negative
34 Echovirus 25 KBPV VR-24 Negative
35 MERS-CoV Seracare 0505-0002 Negative
36 Chlamydia pneumoniae ATCC 53592 Negative
37 Haemophilus influenzae ATCC 31441 Negative
38 Legionella pneumophila ATCC 33152 Negative
39 Streptococcus pneumoniae ATCC 49619 Negative
40 Bordetella pertussis ATCC 12742 Negative
*Detects only SARS-CoV-2; † Detects only Influenza A; ‡ Detects only Influenza B.
Abbreviations (strain): KBPV, Korea Bank for Pathogenic Viruses; EVAg, European Virus Archive-Global.

ABI7500 instrument (Applied Biosystems, Foster City, CA), CFX96 nasopharyngeal/oropharyngeal swabs. The LoD in sputum was
instrument (Bio-Rad, Hercules, CA), and the Exicycler™. approximately 100 copies/test, and that in the swabs was approxi-
We evaluated the cross-reactivity with 40 respiratory patho- mately 40 copies/test in both kits. The rate of positivity is higher
gens, including SARS-CoV-2, influenza A, and influenza B, and in sputum samples than that in the swabs and is less affected by
confirmed that there was no cross-reactivity to pathogens with the onset of symptoms or the time of collection [14]. However,
similar symptoms. sputum samples are usually viscous and contain many PCR and
We evaluated the limit of detection (LoD) in the sputum and extraction inhibitors; therefore, we recommend performing a pre-

294 www.labmedonline.org https://doi.org/10.47429/lmo.2021.11.4.290


김만진 외: Evaluation of the AccuPower® RV1 Kit

treatment process for nucleic acid extraction for real-time PCR. 는 98.77%였다. SARS-CoV-2와 인플루엔자 A, B에 대한 카파 값은
Homogenization of sputum with proteinase K, dithiothreitol, or 0.99를 넘었다. SARS-CoV-2는 객담과 비인두 및 구강인두 스왑 검
N-acetyl-L-cysteine (NALC) can increase the sensitivity of the test, 체를 이용하여 평가하였다. 검체 종류에 따른 검출률의 차이는 없
and hence, the rate of positivity [15, 16]. 었다.
We confirmed the clinical sensitivity and specificity by compar- 결론: AccuPower® RV1 Real-Time RT-PCR 키트와 AccuPower®
ing the confirmation results of the AccuPower® RV1 Real-Time RV1 Multiplex 키트는 임상적으로 사용되는 데 적합한 성능을 보
RT-PCR Kit and the AccuPower® RV1 Multiplex Kit using residual 여주었다.
clinical samples collected from three institutions. The sensitivity
and specificity were 100%, which is consistent with the confirma- Conflicts of Interest
tion results for both positive and negative samples of SARS-CoV-2.
One influenza A sample and some influenza B samples displayed None declared.
®
a discrepant result in the AccuPower RV1 Multiplex Kit. Sensitiv-
ity and specificity were 98.77%. The kappa values for all targets Acknowledgements
were ≥ 0.99 and were considered clinically valid when com-
pared with the results of the confirmation tests. This research was supported by a grant from the Korea Health
A limitation of our study is that we did not include asymptom- Technology R&D Project through the Korea Health Industry De-
atic, pre-symptomatic, and co-infection cases, as only residual velopment Institute (KHIDI), funded by the Ministry of Health &
samples were used. Further studies, including these cases, need Welfare, Republic of Korea (grant number: HI20C2038). Some
to be conducted. bioresources from the National Biobank of Korea and the Korea
®
In conclusion, the AccuPower RV1 Kits produced results com- Disease Control and Prevention Agency (grant number: 2020-
®
parable to the Allplex™ and Standard M Kit. The AccuPower 045) were used.
RV1 Kits showed a higher concordance with the results of the
comparative methods. Thus, the AccuPower® RV1 Kits are a valu- REFERENCES
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스는 Allplex™ Respiratory Panel 1 (Seegene)을 이용하여 재확인 31:395-403.
하였다. 6. Wu X, Cai Y, Huang X, Yu X, Zhao L, Wang F, et al. Co-infection with
결과: AccuPower® RV1 Real-Time RT-PCR 키트의 양성 및 음성일 SARS-CoV-2 and influenza A virus in patient with pneumonia, China.
치도는 100%였다. AccuPower RV1 Multiplex 키트의 양성일치도
®
Emerg Infect Dis 2020;26:1324-6.
는 SARS-CoV-2에 대해서는 100%였고 인플루엔자 A와 B에 대해서 7. Cuadrado-Payán E, Montagud-Marrahi E, Torres-Elorza M, Bodro M,

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김만진 외: Evaluation of the AccuPower® RV1 Kit

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