AI Article Synopsis
- The study developed a standardized quality control management procedure (QCMP) to improve the accuracy of COVID-19 RT-PCR testing.
- The research involved over 4.3 million participants across three testing sites in China, comparing initial RT-PCR results as a gold standard.
- The results demonstrated that with QCMP, the accuracy of RT-PCR reached 99.18%, significantly reducing the retesting rate and validating its effectiveness at different locations.
Article 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.
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| http://dx.doi.org/10.1016/j.diagmicrobio.2024.116287 | DOI Listing |
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