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.
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.
摘要：
背景：该研究旨在构建标准化的质量控制管理程序（QCMP），并获得其在COVID-19逆转录酶聚合酶链反应（RT-PCR）质量控制中的准确性。
方法：考虑到不使用QCMP作为金标准的初始RT-PCR结果，一项大规模的诊断准确性研究，包括中国三个COVID-19RT-PCR检测地点的4,385,925名参与者，佛山(作为试点)，广州和沈阳（作为验证地点），于2021年5月21日至2022年12月15日进行。
结果：在试点测试中，使用QCMP的RT-PCR具有99.18％的高准确度和100％的特异性，100%阳性预测值(PPV)，和99.17%的阴性预测值(NPV)。复检率从1.98%降至1.16%。其准确性随后在广州和沈阳得到一致验证。
结论：使用QCMP的RT-PCR在鉴定真阴性COVID-19方面显示出极好的准确性，并减轻了劳力和重检时间。
方法：考虑到不使用QCMP作为金标准的初始RT-PCR结果，一项大规模的诊断准确性研究，包括中国三个COVID-19RT-PCR检测地点的4,385,925名参与者，佛山(作为试点)，广州和沈阳（作为验证地点），于2021年5月21日至2022年12月15日进行。
结果：在试点测试中，使用QCMP的RT-PCR具有99.18％的高准确度和100％的特异性，100%阳性预测值(PPV)，和99.17%的阴性预测值(NPV)。复检率从1.98%降至1.16%。其准确性随后在广州和沈阳得到一致验证。
结论：使用QCMP的RT-PCR在鉴定真阴性COVID-19方面显示出极好的准确性，并减轻了劳力和重检时间。
