Effectiveness of a standardized quality control management procedure for COVID-19 RT-PCR testing : a large-scale diagnostic accuracy study in China
Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:109 |
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| Enthalten in: |
Diagnostic microbiology and infectious disease - 109(2024), 2 vom: 04. Apr., Seite 116287 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Liu, Mengyu [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 28.04.2024 Date Revised 28.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.diagmicrobio.2024.116287 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370638670 |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CONCLUSIONS: The RT-PCR with QCMP showed excellent accuracy in identifying true negative COVID-19 and relieved the labor and time spent on retesting | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Coronavirus disease 2019 (COVID-19) | |
| 650 | 4 | |a Diagnostic accuracy | |
| 650 | 4 | |a False negative | |
| 650 | 4 | |a False positive | |
| 650 | 4 | |a Quality control management procedures (QCMP) | |
| 650 | 4 | |a Reverse transcriptase-polymerase chain reaction (RT-PCR) | |
| 700 | 1 | |a Tian, Cuihong |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Yequn |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, Jinxiu |e verfasserin |4 aut | |
| 700 | 1 | |a Zheng, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Jianhua |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Zhen |e verfasserin |4 aut | |
| 700 | 1 | |a Xu, Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Liang |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Xingyu |e verfasserin |4 aut | |
| 700 | 1 | |a Xie, Longxu |e verfasserin |4 aut | |
| 700 | 1 | |a Tan, Xuerui |e verfasserin |4 aut | |
| 700 | 1 | |a Cai, Yingmu |e verfasserin |4 aut | |
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