Université de Lorraine, CNRS, LCPME, Nancy, France.
Laboratoire de Virologie, CHRU de Nancy Brabois, Vandoeuvre-lès-Nancy, France.
Clin Chem Lab Med. 2021 Jul 30;59(12):2003-2009. doi: 10.1515/cclm-2021-0569. Print 2021 Nov 25.
The detection of SARS-CoV-2 in infected people is a key tool to help in controlling COVID-19 pandemic. Like rapid antigenic tests, automated antigen tests, that present the advantage of a higher throughput flow, may be of interest. The LIAISON SARS-CoV-2 Ag test was evaluated for the quantification of SARS-CoV-2 nucleocapsid antigen in nasopharyngeal swabs by comparison to RT-PCR.
The study involved 378 nasopharyngeal samples (UTM and FLOQSwab™, Copan Diagnostics), including 46 swabs positive for SARS-CoV-2 by RT-PCR. These samples came from asymptomatic (n=99, 26.2%) or symptomatic people (n=279, 73.8%), at different times from symptom onset. The samples were analyzed on LIAISON XL.
The overall specificity was 99.4% (CI95% [98.6-100]). The negative predictive value reached 100% in asymptomatic people. Among the 46 positive samples, the overall sensitivity was 84.8% (CI95% [74.4-95.2]), reached 91.9% (CI95% [83.1-100]) in the first fourth days after symptoms onset and was 100% for Cq values ≤25. Antigen was not detected in samples with Cq values >25. Similar results were observed on nasopharyngeal swabs coming from patients infected with the 20I/501Y.V1 variant or the 20H/501Y.V2 variant.
According to technical performances, the LIAISON SARS-CoV-2 Ag test may be a useful tool for COVID-19 diagnosis, especially during the first four days of symptoms.
检测感染人群中的 SARS-CoV-2 是帮助控制 COVID-19 大流行的关键工具。与快速抗原检测相比，具有更高通量的自动化抗原检测可能更具优势。本研究通过与 RT-PCR 比较，评估了 LIAISON SARS-CoV-2 Ag 检测试剂盒用于检测鼻咽拭子中 SARS-CoV-2 核衣壳抗原的定量检测。
该研究共纳入 378 例鼻咽样本（UTM 和 FLOQSwab™，Copan Diagnostics），其中 46 例样本经 RT-PCR 检测为 SARS-CoV-2 阳性。这些样本来自无症状（n=99，26.2%）或有症状（n=279，73.8%）人群，在出现症状的不同时间采集。样本在 LIAISON XL 上进行分析。
总体特异性为 99.4%（95%CI [98.6-100]）。在无症状人群中，阴性预测值达到 100%。在 46 例阳性样本中，总体敏感性为 84.8%（95%CI [74.4-95.2]），在症状出现后第 1-4 天达到 91.9%（95%CI [83.1-100]），对于 Cq 值≤25 的样本敏感性为 100%。对于 Cq 值>25 的样本，未检测到抗原。在感染 20I/501Y.V1 变异株或 20H/501Y.V2 变异株的患者的鼻咽拭子中也观察到了类似的结果。
根据技术性能，LIAISON SARS-CoV-2 Ag 检测试剂盒可能是 COVID-19 诊断的有用工具，尤其是在症状出现的前四天。
