Performance Evaluation of the PowerChek SARS-CoV-2, Influenza A & B Multiplex Real-Time PCR Kit in Comparison with the BioFire Respiratory Panel

Overview

Journal Ann Lab Med

Specialty Pathology

Date 2022 Feb 18

PMID 35177568

Authors

Tae Yeul Kim

Ji-Youn Kim

Hyang Jin Shim

Sun Ae Yun

Ja-Hyun Jang

Hee Jae Huh

Jong-Won Kim

Nam Yong Lee

Affiliations

Soon will be listed here.

Abstract

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and influenza viruses may pose enormous challenges to our healthcare system. We evaluated the performance of the PowerChek SARS-CoV-2, Influenza A & B Multiplex Real-time PCR Kit (PowerChek; Kogene Biotech, Seoul, Korea) in comparison with the BioFire Respiratory Panels 2 and 2.1 (RP2 and RP2.1; bioMérieux, Marcy l'Étoile, France), using 147 nasopharyngeal swabs. The limit of detection (LOD) of the PowerChek assay was determined using SARS-CoV-2, influenza A, and B RNA standards. The LOD values of the PowerChek assay for SARS-CoV-2 and influenza A and B were 1.12, 1.24, and 0.61 copies/μL, respectively. The positive and negative percent agreements of the PowerChek assay compared with RP2 and RP2.1 were 97.5% (39/40) and 100% (107/107) for SARS-CoV-2; 100% (39/39) and 100% (108/108) for influenza A; and 100% (35/35) and 100% (112/112) for influenza B, respectively. The performance of the PowerChek assay was comparable to that of RP2 and RP2.1 for detecting SARS-CoV-2 and influenza A and B, suggesting its use in diagnosing SARS-CoV-2 and influenza infections.

Citing Articles

Optimization of extraction-free protocols for SARS-CoV-2 detection using a commercial rRT-PCR assay.

Kang M, Jeong E, Kim J, Yun S, Jang M, Jang J Sci Rep. 2023; 13(1):20364.

PMID: 37990045 PMC: 10663557. DOI: 10.1038/s41598-023-47645-0.

Evaluation of the Kaira COVID-19/Flu/RSV Detection Kit for detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus: A comparative study with the PowerChek SARS-CoV-2, influenza A&B, RSV Multiplex Real-time PCR Kit.

Kim T, Bae G, Kim J, Kang M, Jang J, Huh H PLoS One. 2022; 17(12):e0278530.

PMID: 36516190 PMC: 9750031. DOI: 10.1371/journal.pone.0278530.

False-positive Xpert Xpress SARS-CoV-2 assay in an emergency room and trauma center: A retrospective chart review study.

Kim H, Jeon S, Lee S, Ri H, Lee H, Hong J Saudi Med J. 2022; 43(8):965-970.

PMID: 35964955 PMC: 9749665. DOI: 10.15537/smj.2022.43.8.20220317.

Influenza A, Influenza B, and SARS-CoV-2 Similarities and Differences - A Focus on Diagnosis.

Havasi A, Visan S, Cainap C, Cainap S, Mihaila A, Pop L Front Microbiol. 2022; 13:908525.

PMID: 35794916 PMC: 9251468. DOI: 10.3389/fmicb.2022.908525.

References

Kim Y, Sung H, Ki C, Hur M . COVID-19 Testing in South Korea: Current Status and the Need for Faster Diagnostics. Ann Lab Med. 2020; 40(5):349-350. PMC: 7169622. DOI: 10.3343/alm.2020.40.5.349. View

Creager H, Cabrera B, Schnaubelt A, Cox J, Cushman-Vokoun A, Shakir S . Clinical evaluation of the BioFire® Respiratory Panel 2.1 and detection of SARS-CoV-2. J Clin Virol. 2020; 129:104538. PMC: 7336953. DOI: 10.1016/j.jcv.2020.104538. View

Huh H, Hong K, Kim T, Song S, Roh K, Lee H . Surveillance of Coronavirus Disease 2019 (COVID-19) Testing in Clinical Laboratories in Korea. Ann Lab Med. 2020; 41(2):225-229. PMC: 7591284. DOI: 10.3343/alm.2021.41.2.225. View

Kim D, Quinn J, Pinsky B, Shah N, Brown I . Rates of Co-infection Between SARS-CoV-2 and Other Respiratory Pathogens. JAMA. 2020; 323(20):2085-2086. PMC: 7160748. DOI: 10.1001/jama.2020.6266. View

Ding Q, Lu P, Fan Y, Xia Y, Liu M . The clinical characteristics of pneumonia patients coinfected with 2019 novel coronavirus and influenza virus in Wuhan, China. J Med Virol. 2020; 92(9):1549-1555. PMC: 7228290. DOI: 10.1002/jmv.25781. View

Cuadrado-Payan E, Montagud-Marrahi E, Torres-Elorza M, Bodro M, Blasco M, Poch E . SARS-CoV-2 and influenza virus co-infection. Lancet. 2020; 395(10236):e84. PMC: 7200126. DOI: 10.1016/S0140-6736(20)31052-7. View

Leung E, Chow V, Lee M, Tang K, Li D, Lai R . Evaluation of the Xpert Xpress SARS-CoV-2/Flu/RSV Assay for Simultaneous Detection of SARS-CoV-2, Influenza A and B Viruses, and Respiratory Syncytial Virus in Nasopharyngeal Specimens. J Clin Microbiol. 2021; 59(4). PMC: 8092745. DOI: 10.1128/JCM.02965-20. View

Jarrett J, Uhteg K, Forman M, Hanlon A, Vargas C, Carroll K . Clinical performance of the GenMark Dx ePlex respiratory pathogen panels for upper and lower respiratory tract infections. J Clin Virol. 2021; 135:104737. DOI: 10.1016/j.jcv.2021.104737. View

Kim Y, Sung H, Ki C, Hur M . Response of Clinical Laboratories to the Ongoing COVID-19 Pandemic. Ann Lab Med. 2021; 41(6):519-520. PMC: 8203429. DOI: 10.3343/alm.2021.41.6.519. View

10.

Mostafa H, Carroll K, Hicken R, Berry G, Manji R, Smith E . Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test. J Clin Microbiol. 2020; 59(3). PMC: 8106732. DOI: 10.1128/JCM.02955-20. View

11.

Zayet S, Kadiane-Oussou N, Lepiller Q, Zahra H, Royer P, Toko L . Clinical features of COVID-19 and influenza: a comparative study on Nord Franche-Comte cluster. Microbes Infect. 2020; 22(9):481-488. PMC: 7297177. DOI: 10.1016/j.micinf.2020.05.016. View

12.

Chung H, Jian M, Chang C, Lin J, Yeh K, Chen C . Novel dual multiplex real-time RT-PCR assays for the rapid detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus using the BD MAX open system. Emerg Microbes Infect. 2021; 10(1):161-166. PMC: 7832498. DOI: 10.1080/22221751.2021.1873073. View

13.

Hong K, Lee S, Kim T, Huh H, Lee J, Kim S . Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea. Ann Lab Med. 2020; 40(5):351-360. PMC: 7169629. DOI: 10.3343/alm.2020.40.5.351. View

14.

Lee Y, Lim Y, Hur K, Sung H, Kim M . Quality of Ribonucleic Acid Extraction for Real-Time Reverse Transcription-PCR (rRT-PCR) of SARS-CoV-2: Importance of Internal Control Monitoring. Ann Lab Med. 2020; 40(6):490-492. PMC: 7295956. DOI: 10.3343/alm.2020.40.6.490. View

15.

Wu X, Cai Y, Huang X, Yu X, Zhao L, Wang F . Co-infection with SARS-CoV-2 and Influenza A Virus in Patient with Pneumonia, China. Emerg Infect Dis. 2020; 26(6):1324-1326. PMC: 7258479. DOI: 10.3201/eid2606.200299. View

16.

Eckbo E, Locher K, Caza M, Li L, Lavergne V, Charles M . Evaluation of the BioFire® COVID-19 test and Respiratory Panel 2.1 for rapid identification of SARS-CoV-2 in nasopharyngeal swab samples. Diagn Microbiol Infect Dis. 2020; 99(3):115260. PMC: 7654322. DOI: 10.1016/j.diagmicrobio.2020.115260. View

17.

Visseaux B, Le Hingrat Q, Collin G, Bouzid D, Lebourgeois S, Le Pluart D . Evaluation of the QIAstat-Dx Respiratory SARS-CoV-2 Panel, the First Rapid Multiplex PCR Commercial Assay for SARS-CoV-2 Detection. J Clin Microbiol. 2020; 58(8). PMC: 7383528. DOI: 10.1128/JCM.00630-20. View