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Evaluation of the clinical performance of single-, dual-, and triple-target SARS-CoV-2 RT-qPCR methods.
Hu, Xiaomei; Zhu, Lingxiang; Luo, Yijun; Zhao, Qinfei; Tan, Chianru; Chen, Xiao; Zhang, Huijuan; Hu, Xiaojun; Lu, Linping; Xiao, Yongwei; Huang, Shao; He, Yingke; Sim, Jacqueline Xiu Ling; Su, Shisheng; Wang, Fang; Peng, Yanke; Wang, Jigang; Guo, Yong; Zhong, Tianyu.
  • Hu X; Laboratory Medicine, First Affiliated Hospital of Gannan Medical University, Ganzhou 341000, China.
  • Zhu L; National Research Institute for Family Planning, Beijing 100081, China.
  • Luo Y; Clinical Laboratory, Fifth People's Hospital of Ganzhou, Ganzhou 341000, China.
  • Zhao Q; Laboratory Medicine, First Affiliated Hospital of Gannan Medical University, Ganzhou 341000, China.
  • Tan C; Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing 100084, China.
  • Chen X; School of Medicine & Holistic Integrative Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, China.
  • Zhang H; Laboratory Medicine, First Affiliated Hospital of Gannan Medical University, Ganzhou 341000, China.
  • Hu X; Ganzhou Center for Disease Control and Prevention, Ganzhou 341000, China.
  • Lu L; TargetingOne Corporation, Beijing 100190, China.
  • Xiao Y; Key Laboratory of Prevention and Treatment of Cardiovascular and Cerebrovascular Diseases, Ministry of Education, Gannan Medical University, Ganzhou 341000, China.
  • Huang S; Jiangxi Shiningmed Medical Technology Ltd, Ganzhou 341000, China.
  • He Y; Division of Anaesthesiology, Singapore General Hospital, Outram Road, 169608, Singapore.
  • Sim JXL; Division of Anaesthesiology, Singapore General Hospital, Outram Road, 169608, Singapore.
  • Su S; Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing 100084, China.
  • Wang F; Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing 100084, China.
  • Peng Y; Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing 100084, China.
  • Wang J; Key Laboratory of Prevention and Treatment of Cardiovascular and Cerebrovascular Diseases, Ministry of Education, Gannan Medical University, Ganzhou 341000, China; Artemisinin Research Center, Institute of Chinese Materia Medical, China Academy of Chinese Medical Sciences, Beijing 100700, China. Ele
  • Guo Y; Department of Biomedical Engineering, School of Medicine, Tsinghua University, Beijing 100084, China. Electronic address: yongguo@tsinghua.edu.cn.
  • Zhong T; Laboratory Medicine, First Affiliated Hospital of Gannan Medical University, Ganzhou 341000, China; Key Laboratory of Prevention and Treatment of Cardiovascular and Cerebrovascular Diseases, Ministry of Education, Gannan Medical University, Ganzhou 341000, China. Electronic address: zhongtianyu@gum.
Clin Chim Acta ; 511: 143-148, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-844315
ABSTRACT

BACKGROUND:

The coronavirus disease 2019 (COVID-19) has become a pandemic. Reverse transcription quantitative PCR (RT-qPCR) has played a vital role in the diagnosis of COVID-19, but the rates of false negatives is not ideal in dealing with this highly infectious virus. It is thus necessary to systematically evaluate the clinical performance of the single-, dual-, triple-target detection kits to guide the clinical diagnosis of this disease.

METHODS:

A series of reference materials calibrated by droplet digital PCR (ddPCR) and 57 clinical samples were used to evaluate the clinical performance of six single-, dual-, triple-target SARS-CoV-2 nucleic acid detection kits based on RT-qPCR.

RESULTS:

The dual-target kits, kit B and kit C had the highest and the lowest detection sensitivity, which was 125 copies/mL and 4000 copies/mL, respectively. Among the 57 clinical samples from patients with COVID-19, 47 were tested positive by the kit B, while 35, 29, 28, 30, and 29 were found positive by the kits A, C, D, E, and F, respectively. The number of targets in a detection kit is not a key factor affecting sensitivity, while the amount of sample loading may influence the performance of a detection kit.

CONCLUSIONS:

This study provides a guide when choosing or developing a nucleic acid detection kit for the diagnosis of COVID-19. Also, the absolute-quantification feature and high-sensitivity performance of ddPCR, suggesting that it can be used to review clinically suspected samples.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Reverse Transcriptase Polymerase Chain Reaction / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Clin Chim Acta Year: 2020 Document Type: Article Affiliation country: J.cca.2020.10.008

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Reverse Transcriptase Polymerase Chain Reaction / SARS-CoV-2 / COVID-19 Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged / Young adult Language: English Journal: Clin Chim Acta Year: 2020 Document Type: Article Affiliation country: J.cca.2020.10.008