评估五个外部质量评估轮次中获得的奥密克戎核酸检测循环阈值的可比性。
Assessing the comparability of cycle threshold values derived from five external quality assessment rounds for omicron nucleic acid testing.
机构信息
Department of Clinical Laboratory, Beijing Chao-Yang Hospital, Capital Medical University, 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China.
Beijing Medical Laboratory Quality Control and Improvement Center, Beijing, China.
出版信息
Virol J. 2023 Jun 8;20(1):119. doi: 10.1186/s12985-023-02032-z.
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.
背景
目前有多种用于检测多种急性呼吸综合征冠状病毒 2 的开放式实时逆转录聚合酶链反应（RT-PCR）检测方法。本研究旨在确保奥密克戎核酸检测质量，并评估 RT-PCR 得出的循环阈值（Ct）值的可比性。
方法
2022 年 2 月至 2022 年 6 月期间组织了五轮奥密克戎病毒样颗粒的外部质量评估（EQA）。
结果
共收集了 1401 份定性 EQA 报告。总体阳性百分比符合率为 99.72%，阴性百分比符合率为 99.75%，总符合率为 99.73%。本研究观察到不同检测系统得出的 Ct 值存在显著差异。不同 RT-PCR 试剂盒和实验室之间的 PCR 效率存在很大的异质性。
结论
进行定性奥密克戎核酸检测的实验室之间具有很强的一致性。不应将定性 RT-PCR 检测的 Ct 值用于临床或流行病学决策，以避免对结果产生潜在的误解。
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