{Reference Type}: Journal Article
{Title}: Effectiveness of a standardized quality control management procedure for COVID-19 RT-PCR testing: a large-scale diagnostic accuracy study in China.
{Author}: Liu M;Tian C;Chen Y;Zhu J;Zheng Y;Chen J;Li Z;Xu F;Wu L;Wang X;Xie L;Tan X;Cai Y;
{Journal}: Diagn Microbiol Infect Dis
{Volume}: 109
{Issue}: 2
{Year}: 2024 Jun 28
{Factor}: 2.983
{DOI}: 10.1016/j.diagmicrobio.2024.116287
{Abstract}: <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.