Assessing the comparability of cycle threshold values derived from five external quality assessment rounds for omicron nucleic acid testing

Abstract Background A variety of open-system real-time reverse transcriptase polymerase chain reaction (RT-PCR) assays for several acute respiratory syndrome coronavirus 2 are currently in use. This study aimed to ensure the quality of omicron nucleic acid testing and to assess the comparability of...

Full description

Bibliographic Details
Main Authors: Gaowei Fan, Yali Jin, Qingtao Wang, Yuhong Yue
Format: Article
Language:English
Published: BMC 2023-06-01
Series:Virology Journal
Subjects:
Online Access:https://doi.org/10.1186/s12985-023-02032-z
Description
Summary:Abstract Background A variety of open-system real-time reverse transcriptase polymerase chain reaction (RT-PCR) assays for several acute respiratory syndrome coronavirus 2 are currently in use. This study aimed to ensure the quality of omicron nucleic acid testing and to assess the comparability of cycle threshold (Ct) values derived from RT-PCR. Methods Five external quality assessment (EQA) rounds using the omicron virus-like particles were organized between February 2022 and June 2022. Results A total of 1401 qualitative EQA reports have been collected. The overall positive percentage agreement was 99.72%, the negative percentage agreement was 99.75%, and the percent agreement was 99.73%. This study observed a significant variance in Ct values derived from different test systems. There was a wide heterogeneity in PCR efficiency among different RT-PCR kits and inter-laboratories. Conclusion There was strong concordance among laboratories performing qualitative omicron nucleic acid testing. Ct values from qualitative RT-PCR tests should not be used for clinical or epidemiological decision-making to avoid the potential for misinterpretation of the results.
ISSN:1743-422X