Several rapid antigen tests (RATs) for the detection of SARS-CoV-2 were evaluated recently. However, reliable performance data for laboratory-based, high-throughput antigen tests are lacking. Therefore and in response to a short-term shortage of PCR reagents, we evaluated DiaSorin's LIAISON SARS-CoV-2 antigen test in comparison to RT-qPCR, and concerning the application of screening non-COVID-19 patients on hospital admission. Applying the manufacturer-recommended cut-off of 200 arbitrary units (AU/mL) the specificity of the LIAISON Test was 100%, the overall analytical sensitivity 40.2%. Lowering the cut-off to 100 AU/mL increased the sensitivity to 49.7% and decreased the specificity to 98.3%. Confining the analysis to samples with an RT-qPCR result < 25 Ct resulted in a sensitivity of 91.2%. The quality of the LIAISON test is very similar to that of good RATs described in the literature with the advantage of high throughput and the disadvantage of relatively long analysis time. It passes the WHO quality criteria for rapid antigen tests and is characterized by particularly high specificity. The LIAISON test can therefore be used for the same applications as recommended for RATs by the WHO. Due to limited sensitivity, the LIAISON test should only be used for screening, if PCR-based assays are not available.

最近评估了几种用于检测SARS-CoV-2的快速抗原测试（RAT）。但是，缺乏基于实验室的高通量抗原测试的可靠性能数据。因此，针对短期缺少PCR试剂的问题，我们将DiaSorin的LIAISON SARS-CoV-2抗原测试与RT-qPCR进行了比较，并评估了筛查非COVID-19患者在住院时的应用。使用制造商建议的200个任意单位（AU / mL）的临界值，LIAISON测试的特异性为100％，总分析灵敏度为40.2％。将临界值降低至100 AU / mL，可将灵敏度提高至49.7％，将特异性降低至98.3％。将分析局限于RT-qPCR结果<25 Ct的样品时，灵敏度为91.2％。LIAISON测试的质量与文献中描述的良好RAT的质量非常相似，具有高通量的优势和相对较长的分析时间的劣势。它通过了WHO的快速抗原检测质量标准，并具有特别高的特异性。因此，LIAISON测试可用于与WHO推荐的RAT相同的应用。由于灵敏度有限，如果无法使用基于PCR的检测方法，则只能将LIAISON检测用于筛选。因此，LIAISON测试可用于与WHO推荐的RAT相同的应用。由于灵敏度有限，如果无法使用基于PCR的检测方法，则只能将LIAISON检测用于筛选。因此，LIAISON测试可用于与WHO推荐的RAT相同的应用。由于灵敏度有限，如果无法使用基于PCR的检测方法，则只能将LIAISON检测用于筛选。