%0 Journal Article
%T Effectiveness of a standardized quality control management procedure for COVID-19 RT-PCR testing: a large-scale diagnostic accuracy study in China.
%A Liu M
%A Tian C
%A Chen Y
%A Zhu J
%A Zheng Y
%A Chen J
%A Li Z
%A Xu F
%A Wu L
%A Wang X
%A Xie L
%A Tan X
%A Cai Y
%J Diagn Microbiol Infect Dis
%V 109
%N 2
%D 2024 Jun 28
%M 38574444
%F 2.983
%R 10.1016/j.diagmicrobio.2024.116287
%X <B>BACKGROUND: </B>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).<BR><B>METHODS: </B>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.<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>The RT-PCR with QCMP showed excellent accuracy in identifying true negative COVID-19 and relieved the labor and time spent on retesting.