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.
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。