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Sensitivity evaluation of 2019 novel coronavirus (SARS-CoV-2) RT-PCR detection kits and strategy to reduce false negative
Author(s) -
Zhou Yang,
Fengyan Pei,
Mingyu Ji,
Li Wang,
Huichan Zhao,
Huanjie Li,
Weihua Yang,
Qingxi Wang,
Qianqian Zhao,
Yunshan Wang
Publication year - 2020
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0241469
Subject(s) - asymptomatic , covid-19 , nucleic acid amplification tests , nucleic acid , nucleic acid test , medicine , viral load , real time polymerase chain reaction , coronavirus , virology , transmission (telecommunications) , immunology , virus , biology , disease , gene , computer science , infectious disease (medical specialty) , genetics , telecommunications , chlamydia trachomatis
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 load patients.

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