Sensitivity evaluation of 2019 novel coronavirus (SARS-CoV-2) RT-PCR detection kits and strategy to reduce false negative

PloS One
Yunying ZhouYunshan Wang

Abstract

The early detection and differential diagnosis of respiratory infections increase the chances for successful control of COVID-19 disease. The nucleic acid RT-PCR test is regarded as the current standard for molecular diagnosis. However, the maximal specificity confirmation target ORF1ab gene is considered to be less sensitive than other targets in clinical application. In addition, recent evidence indicated that the initial missed diagnosis of asymptomatic patients with SARS-CoV-2 and discharged patients with "re-examination positive" might be due to low viral load, and the ability of rapid mutation of SARS-CoV-2 also increases the rate of false-negative results. Moreover, the mixed sample nucleic acid detection is helpful in seeking out the early community transmission of SARS-CoV-2 rapidly, but the detection kit needs ultra-high detection sensitivity. Herein, the lowest detection concentration of different nucleic acid detection kits was evaluated and compared to provide direct evidence for the selection of kits for mixed sample detection or make recommendations for the selection of validation kit, which is of great significance for the prevention and control of the current epidemic and the discharge criteria of low viral loa...Continue Reading

References

Jan 25, 2020·The New England Journal of Medicine·Vincent J MunsterEmmie de Wit
Jan 25, 2020·The New England Journal of Medicine·Na ZhuUNKNOWN China Novel Coronavirus Investigating and Research Team
Jan 30, 2020·Euro Surveillance : Bulletin Européen Sur Les Maladies Transmissibles = European Communicable Disease Bulletin·Victor M CormanChristian Drosten
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Apr 24, 2020·Journal of Translational Medicine·Maria PachettiRudy Ippodrino

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Citations

Mar 15, 2021·Echocardiography·Dena E HayesMuhamed Saric
Jun 3, 2021·Biosensors·Niharika GuptaBansi D Malhotra
Jun 24, 2021·Journal of Applied Clinical Medical Physics·Ga Young KimSung Min Kim
Jul 26, 2021·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Paulo Alexandre da Costa FernandesManuel Rui Azevedo Alves
Jul 30, 2021·Expert Review of Molecular Diagnostics·Nidhi ChauhanUtkarsh Jain
Aug 12, 2021·Biotechnology and Applied Biochemistry·Fatin Syakirah HalimNurfareezah Fareezah Jaapar

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Methods Mentioned

BETA
PCR
nucleic acid extraction
bronchoalveolar lavage
nucleic acid tests

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