Performance Evaluation of the PowerChek SARS-CoV-2, Influenza A & B Multiplex Real-Time PCR Kit in Comparison with the BioFire Respiratory Panel
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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.
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.
참고문헌 (19)
- "COVID-19 weekly epidemiological update"[URL]
- Kim Young Jin, "Response of Clinical Laboratories to the Ongoing COVID-19 Pandemic", Annals of Laboratory Medicine, 41(6), pp.519~520 (2021), 대한진단검사의학회[DOI]
- Yeon Joo Lee, "Quality of Ribonucleic Acid Extraction for Real-Time Reverse Transcription-PCR (rRT-PCR) of SARS-CoV-2: Importance of Internal Control Monitoring", Annals of Laboratory Medicine, 40(6), pp.490~492 (2020), 대한진단검사의학회[DOI]
- Ki Ho Hong, "Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea", Annals of Laboratory Medicine, 40(5), pp.351~360 (2020), 대한진단검사의학회[DOI]
- 김영진, "COVID-19 Testing in South Korea: Current Status and the Need for Faster Diagnostics", Annals of Laboratory Medicine, 40(5), pp.349~350 (2020), 대한진단검사의학회[DOI]
- Huh Hee Jae, "Surveillance of Coronavirus Disease 2019 (COVID-19) Testing in Clinical Laboratories in Korea", Annals of Laboratory Medicine, 41(2), pp.225~229 (2021), 대한진단검사의학회[DOI]
- "Coronavirus disease 2019 (COVID-19) emergency use authorization information - in vitro diagnostic products" (2021)[URL]
- Zayet S, "Clinical features of COVID-19 and influenza : a comparative study on Nord Franche-Comte cluster", Microbes Infect, 22, pp.481~488 (2020)
- Cuadrado-Payán E, "SARS-CoV-2 and influenza virus co-infection", Lancet, 395, pp.e84~ (2020)
- Ding Q, "The clinical characteristics of pneumonia patients coinfected with 2019 novel coronavirus and influenza virus in Wuhan, China", J Med Virol, 92, pp.1549~1555 (2020)
- Kim D, "Rates of co-infection between SARS-CoV-2 and other respiratory pathogens", JAMA, 323, pp.2085~2086 (2020)
- Wu X, "Co-infection with SARS-CoV-2 and influenza A virus in patient with pneumonia, China", Emerg Infect Dis, 26, pp.1324~1326 (2020)
- Chung HY, "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, 2021, pp.10, 161~166
- Creager HM, "Clinical evaluation of the BioFire Respiratory Panel 2.1 and detection of SARS-CoV-2", J Clin Virol, 129, pp.104538~ (2020)
- Eckbo EJ, "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, 99, pp.115260~ (2021)
- Jarrett J, "Clinical performance of the GenMark Dx ePlex respiratory pathogen panels for upper and lower respiratory tract infections", J Clin Virol, 135, pp.104737~ (2021)
- Leung EC, "Evaluation of the Xpert Xpress SARS-CoV-2", Flu, J Clin Microbiol, pp.2021, 59[DOI]
- Mostafa HH, "Multi-center evaluation of the Cepheid Xpert Xpress SARS-CoV-2", Flu, J Clin Microbiol, pp.2021, 59[DOI]
- Visseaux B, "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, 58, pp.e00630-20~ (2020)