Research Article
Volume 16 Issue 8 - 2020
Sensitivity Evaluation of 2019 Novel Coronavirus (SARS-CoV-2) RT-PCR Detection Kits and Strategy to Reduce False Negative
Yunying Zhou1,2,3, Fengyan Pei1,2, Li Wang4, Huailong Zhao5, Huanjie Li1, Mingyu Ji1,2, Weihua Yang1,2, Qingxi Wang1,2, Qianqian Zhao1,2* and Yunshan Wang1,2,3*
1Medical Research and Laboratory Diagnostic Center, Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, China
2Microbiology Department, Jinan Central Hospital Affiliated to Shandong first medical university, Jinan, China
3Research Center of Basic Medicine, Jinan Central Hospital Affiliated to Shandong First Medical University, Jinan, China
4Jinan Infectious Disease Hospital, Shandong University, Jinan, Shandong, China
5Jinan Center for Disease Control and Prevention, China
*Corresponding Author: Qianqian Zhao and Yunshan Wang, Medical Research and Laboratory Diagnostic Center, Jinan Central Hospital Affiliated to Shandong University, Jinan, Shandong, China.
Received: May 29, 2020; Published: July 23, 2020


An ongoing outbreak of pneumonia associated with SARS-CoV-2 has now been confirmed globally. In absence of effective vaccines, infection prevention and control through diagnostic testing and quarantine is critical. Early detection and differential diagnosis of respiratory infections increases the chances for successful control of COVID-19 disease. The nucleic acid RT-PCR test is regarded as the current standard for molecular diagnosis with high sensitivity. However, the highest specificity confirmation target ORF1ab gene is considered to be less sensitive than other targets in clinical application. In addition, a large amount of recent evidence indicates that the initial missed diagnosis of asymptomatic patients with SARS-CoV-2 and discharged patients with “re-examination positive” may be due to low viral load, and the ability of rapid mutation of SARS-CoV-2 also increases the rate of false negative results. We aimed to evaluate the sensitivity of different nucleic acid detection kits so as to make recommendations for the selection of validation kit, and amplify the suspicious result to be report-able positive by means of continuous amplification, which is of great significance for the prevention and control of the current epidemic and the discharge criteria of low viral load patients.

Keywords: SARS-CoV-2; False Negative; Sensitivity; Low Viral Load; RT-PCR


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Citation: Qianqian Zhao and Yunshan Wang., et al. “Sensitivity Evaluation of 2019 Novel Coronavirus (SARS-CoV-2) RT-PCR Detection Kits and Strategy to Reduce False Negative”. EC Microbiology 16.8 (2020): 53-63.

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