Effectiveness of a standardized quality control management procedure for COVID-19 RT-PCR testing: A large-scale diagnostic accuracy study in China

Authors

Mengyu Liu
Cuihong Tian, Edith Cowan UniversityFollow
Yequn Chen
Jinxiu Zhu
Yan Zheng
Jianhua Chen
Zhen Li
Feng Xu
Liang Wu
Xingyu Wang
Longxu Xie
Xuerui Tan
Yingmu Cai

Document Type

Journal Article

Publication Title

Diagnostic Microbiology and Infectious Disease

Volume

109

Issue

2

PubMed ID

38574444

Publisher

Elsevier

School

Centre for Precision Health

RAS ID

69840

Funders

Special Major Application Research Project for COVID-19 Prevention and Control in Universities / Department of Education of Guangdong / Provincial Program of Innovation and Strengthening School, Guangdong, China / Special Project for COVID-19 Prevention and Treatment of Shantou Science and Technology Bureau, Guangdong, China

Comments

Liu, M., Tian, C., Chen, Y., Zhu, J., Zheng, Y., Chen, J., . . . Cai, Y. (2024). Effectiveness of a standardized quality control management procedure for COVID-19 RT-PCR testing: A large-scale diagnostic accuracy study in China. Diagnostic Microbiology and Infectious Disease, 109(2), article 116287. https://doi.org/10.1016/j.diagmicrobio.2024.116287

Abstract

Background: The study aimed to construct a standardized quality control management procedure (QCMP) and access its accuracy in the quality control of COVID-19 reverse transcriptase-polymerase chain reaction (RT-PCR). Methods: Considering the initial RT-PCR results without applying QCMP as the gold standard, a large-scale diagnostic accuracy study including 4,385,925 participants at three COVID-19 RT-PCR testing sites in China, Foshan (as a pilot test), Guangzhou and Shenyang (as validation sites), was conducted from May 21, 2021, to December 15, 2022. Results: In the pilot test, the RT-PCR with QCMP had a high accuracy of 99.18% with 100% specificity, 100% positive predictive value (PPV), and 99.17% negative predictive value (NPV). The rate of retesting was reduced from 1.98% to 1.16%. Its accuracy was then consistently validated in Guangzhou and Shenyang. Conclusions: The RT-PCR with QCMP showed excellent accuracy in identifying true negative COVID-19 and relieved the labor and time spent on retesting.

DOI

10.1016/j.diagmicrobio.2024.116287

Creative Commons License

This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License