Comparison of a laboratory-developed test targeting the envelope gene with three nucleic acid amplification tests for detection of SARS-CoV-2

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
Philip L BulterysBenjamin A Pinsky

Abstract

Numerous nucleic acid amplification tests, including real-time, reverse transcription PCR (rRT-PCR) and isothermal amplification methods, have been developed to detect SARS-CoV-2 RNA, including many that have received emergency use authorization (EUA). There is a need to assess their test performance relative to one another. The aim of this study was to compare the test performance of a high complexity laboratory-developed rRT-PCR EUA from Stanford Health Care (SHC) targeting the SARS-CoV-2 envelope (E) gene with other tests: the Atila isothermal amplification assay targeting the nucleocapsid (N) gene and open reading frame 1ab (ORF1ab), the Altona E and spike (S) multiplex, real-time RT-PCR, and the US Centers for Disease Control and Prevention (CDC) N1 and N2 rRT-PCRs. A diagnostic comparison study was performed by testing nasopharyngeal samples from persons under investigation for coronavirus disease 2019 (COVID-19). Assay performance was assessed by percent agreement and Cohen's kappa coefficient. Positive percent agreement with the SHC EUA reference assay was 82.8 % (95 % confidence interval (CI) 65.0 to 92.9) for Atila, 86.7 % (95 % CI 69.7 to 95.3) for the Altona E and S targets, and 86.7 % (95 % CI 69.7 to 95.3) and 90....Continue Reading

Citations

Sep 26, 2020·Journal of Clinical Laboratory Analysis·Yu LuHongli Yu
Jul 6, 2020·Emerging Infectious Diseases·Catherine A HoganBenjamin A Pinsky
Jul 18, 2020·Annals of Internal Medicine·Tho D PhamBenjamin A Pinsky
Jan 8, 2021·The Analyst·Maria Ana Cristina Huergo, Nguyen Thi Kim Thanh
Sep 7, 2020·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Jürgen RödelBettina Löffler
Feb 27, 2021·Frontiers in Bioengineering and Biotechnology·Zeina HabliMassoud L Khraiche
Mar 25, 2021·The Cochrane Database of Systematic Reviews·Jacqueline DinnesUNKNOWN Cochrane COVID-19 Diagnostic Test Accuracy Group
Apr 18, 2021·Diagnostic Microbiology and Infectious Disease·Lauren LawrenceCatherine A Hogan
May 14, 2021·Clinical Microbiology Reviews·Seyed Hamid Safiabadi TaliSana Jahanshahi-Anbuhi
May 19, 2021·International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases·Abeer N AlshukairiEsam I Azhar
May 19, 2021·Journal of Medical Virology·Sally A MahmoudWalid A Zaher
Jan 23, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Kimberly E HansonReem A Mustafa
Jul 17, 2021·Frontiers in Cellular and Infection Microbiology·Eduardo Juscamayta-LópezMaribel Huaringa
Jun 18, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Karen B JacobsonMarisa Holubar
Jun 24, 2021·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Kimberly E HansonReem A Mustafa
Oct 5, 2021·Clinical Chemistry·Hannah WangBenjamin A Pinsky

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Methods Mentioned

BETA
nucleic acid amplification
PCR
Assay
reverse

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