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Virol J . Assessing the comparability of cycle threshold values derived from five external quality assessment rounds for omicron nucleic acid testi

tetano

Editor, Senior Moderator
Virol J


. 2023 Jun 8;20(1):119.
doi: 10.1186/s12985-023-02032-z. Assessing the comparability of cycle threshold values derived from five external quality assessment rounds for omicron nucleic acid testing

Gaowei Fan[SUP] #[/SUP][SUP] 1 2 [/SUP], Yali Jin[SUP] #[/SUP][SUP] 3 [/SUP], Qingtao Wang[SUP] 4 5 6 [/SUP], Yuhong Yue[SUP] 7 8 9 [/SUP]



Affiliations
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.

Keywords: Comparability; Cycle threshold; Omicron; Qualitative test; RT-PCR; SARS-CoV-2.

 
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