Department of Infectious Diseases and Tropical Medicine, Clinic Favoriten, Vienna, Austria.
Institute of Laboratory Diagnostics, Clinic Favoriten, Vienna, Austria.
J Gen Intern Med. 2022 May;37(6):1494-1500. doi: 10.1007/s11606-022-07448-x. Epub 2022 Mar 17.
Point-of-care antigen tests (AgTs) for the detection of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) enable the rapid testing of infected individuals and are easy-to-use. However, there are few studies evaluating their clinical use.
The present study aimed to evaluate and compare the clinical performance characteristics of various commercial SARS-CoV-2 AgTs.
The sensitivity of five AgTs, comprising four rapid antigen tests (RAT; AMP Rapid Test SARS-CoV-2 Ag, NADAL COVID-19 Antigen Rapid Test, CLINITEST Rapid COVID-19 Antigen Test, and Roche SARS-CoV-2 Rapid Antigen Test) and one sandwich chemiluminescence immunoassay (CLIA; LIAISON SARS-CoV-2 Assay), were evaluated in 300 nasopharyngeal (NP) swabs. Reverse transcriptase (RT) polymerase chain reaction (PCR) was used as a reference method.
NP swabs were collected from patients admitted to hospital due to COVID-19.
Sensitivities of the AgTs ranged from 64.9 to 91.7% for samples with RT-PCR cycle threshold (Ct) values lower than 30 and were 100% for cycle threshold (Ct) values lower than 20. The highest sensitivity was observed for CLINITEST Rapid COVID-19 Antigen Test, and Roche SARS-CoV-2 rapid antigen test. Multivariate analysis using time from symptom onset and the Ct value for AgT sensitivity showed an inverse correlation. Further, the female sex was an independent factor of lower RAT sensitivity.
Antigen tests from NP swab samples show high sensitivity in patients with a Ct value < 20. The best clinical sensitivity can be obtained using AgTs within the first 6 days after symptom onset.
即时检测抗原试验（AgT）可用于检测严重急性呼吸综合征冠状病毒 2（SARS-CoV-2），便于对感染个体进行快速检测，并且易于使用。然而，目前评估其临床应用的研究较少。
本研究旨在评估和比较各种商业 SARS-CoV-2 AgT 的临床性能特征。
评估了 5 种 AgT 的敏感性，包括 4 种快速抗原检测（RAT；AMP 快速 SARS-CoV-2 Ag 检测、NADAL COVID-19 抗原快速检测、CLINITEST 快速 COVID-19 抗原检测和罗氏 SARS-CoV-2 快速抗原检测）和 1 种夹心化学发光免疫分析（CLIA；LIAISON SARS-CoV-2 检测），共 300 份鼻咽（NP）拭子。以逆转录（RT）聚合酶链反应（PCR）为参考方法。
从因 COVID-19 住院的患者中采集 NP 拭子。
对于 RT-PCR 循环阈值（Ct）值低于 30 的样本，AgT 的敏感性为 64.9%至 91.7%，对于 Ct 值低于 20 的样本，敏感性为 100%。CLINITEST 快速 COVID-19 抗原检测和罗氏 SARS-CoV-2 快速抗原检测的敏感性最高。使用 AgT 敏感性的症状出现时间和 Ct 值的多变量分析显示出反比关系。此外，女性是 RAT 敏感性较低的独立因素。
来自 NP 拭子样本的抗原检测在 Ct 值<20 的患者中显示出高敏感性。在症状出现后 6 天内使用 AgT 可获得最佳的临床敏感性。
