tetano
Editor, Senior Moderator
Diagn Microbiol Infect Dis
. 2024 Mar 28;109(2):116287.
doi: 10.1016/j.diagmicrobio.2024.116287. Online ahead of print. Effectiveness of a standardized quality control management procedure for COVID-19 RT-PCR testing: a large-scale diagnostic accuracy study in China
Mengyu Liu[SUP] 1 [/SUP], Cuihong Tian[SUP] 2 [/SUP], Yequn Chen[SUP] 3 [/SUP], Jinxiu Zhu[SUP] 4 [/SUP], Yan Zheng[SUP] 5 [/SUP], Jianhua Chen[SUP] 6 [/SUP], Zhen Li[SUP] 7 [/SUP], Feng Xu[SUP] 7 [/SUP], Liang Wu[SUP] 8 [/SUP], Xingyu Wang[SUP] 9 [/SUP], Longxu Xie[SUP] 10 [/SUP], Xuerui Tan[SUP] 11 [/SUP], Yingmu Cai[SUP] 12 [/SUP]
Affiliations
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.
Keywords: Coronavirus disease 2019 (COVID-19); Diagnostic accuracy; False negative; False positive; Quality control management procedures (QCMP); Reverse transcriptase-polymerase chain reaction (RT-PCR).
. 2024 Mar 28;109(2):116287.
doi: 10.1016/j.diagmicrobio.2024.116287. Online ahead of print. Effectiveness of a standardized quality control management procedure for COVID-19 RT-PCR testing: a large-scale diagnostic accuracy study in China
Mengyu Liu[SUP] 1 [/SUP], Cuihong Tian[SUP] 2 [/SUP], Yequn Chen[SUP] 3 [/SUP], Jinxiu Zhu[SUP] 4 [/SUP], Yan Zheng[SUP] 5 [/SUP], Jianhua Chen[SUP] 6 [/SUP], Zhen Li[SUP] 7 [/SUP], Feng Xu[SUP] 7 [/SUP], Liang Wu[SUP] 8 [/SUP], Xingyu Wang[SUP] 9 [/SUP], Longxu Xie[SUP] 10 [/SUP], Xuerui Tan[SUP] 11 [/SUP], Yingmu Cai[SUP] 12 [/SUP]
Affiliations
- PMID: 38574444
- DOI: 10.1016/j.diagmicrobio.2024.116287
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.
Keywords: Coronavirus disease 2019 (COVID-19); Diagnostic accuracy; False negative; False positive; Quality control management procedures (QCMP); Reverse transcriptase-polymerase chain reaction (RT-PCR).