Related Experiment Video
Updated: Jun 29, 2025
Author Spotlight: Advancing Pathogen Diagnostics with Standardized LAMP
Published on: September 8, 2023
Effectiveness of a standardized quality control management procedure for COVID-19 RT-PCR testing: a large-scale
Mengyu Liu1, Cuihong Tian2, Yequn Chen3
1Clinical Research Center, First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong 515041, PR China; Joint Laboratory of Shantou University Medical College and Guangdong Hybribio Biotech Ltd., Shantou University Medical College, Shantou, Guangdong 515041, PR China.
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.
