四种 SARS-CoV-2 抗原检测方法在住院患者中的比较评估。
Comparative evaluation of four SARS-CoV-2 antigen tests in hospitalized patients.
机构信息
Department of Internal Medicine II, Infectious Disease, Immunology, Rheumatology, Pneumology, Medical University of Innsbruck, Innsbruck, Austria.
Central Institute for Medical and Chemical Laboratory Diagnosis, Innsbruck University Hospital, Innsbruck, Austria.
出版信息
Int J Infect Dis. 2021 Apr;105:144-146. doi: 10.1016/j.ijid.2021.02.052. Epub 2021 Feb 17.
OBJECTIVES
Rapid identification of infected subjects is a cornerstone for controlling a pandemic like the current one with the SARS-CoV-2. Easy to handle antigen tests can provide timely results, which is of particular importance in a primary care setting. However, concerns exist regarding their sensitivity, which led us to evaluate four commercially available tests in patients hospitalized for COVID-19.
METHODS
We analyzed in parallel nasopharyngeal/oropharyngeal swabs from 154 consecutive patients admitted to our department with moderate to severe COVID-19, using quantitative RT-PCR (Cobas, Roche) and up to four antigen tests from different distributors. Antigen test results were linked to Ct (cycle threshold) values as markers for patients' infectivity.
RESULTS
We found that two out of four antigen tests correctly identified subjects with high viral loads (Ct≤25), and three out of four tests detected more than 80% of subjects with a Ct≤30, which is considered the threshold for infectivity. However, one test investigated had a poor clinical performance. When investigating subjects with Ct values >30, we found that the antigen test was still positive in up to 45% of those cases.
CONCLUSION
Most antigen tests had a sufficient sensitivity to identify symptomatic subjects infected with SARS-CoV-2 and with transmissible infection. On the other hand, antigen testing may not be suitable to identify loss of infectivity in COVID-19 subjects during follow-up. Newly introduced antigen tests need to be validated in a clinical or primary care setting to define their clinical usefulness.
目的
快速识别感染者是控制当前 SARS-CoV-2 大流行的关键。易于操作的抗原检测可以提供及时的结果，这在初级保健环境中尤为重要。然而，人们对其敏感性存在担忧，这促使我们在因 COVID-19 住院的患者中评估了四种市售的抗原检测。
方法
我们平行分析了 154 例连续入院的中重度 COVID-19 患者的鼻咽/口咽拭子，使用定量 RT-PCR（Cobas，罗氏）和来自不同分销商的四种抗原检测。抗原检测结果与 Ct（循环阈值）值相关联，作为患者传染性的标志物。
结果
我们发现四种抗原检测中有两种能够正确识别高病毒载量（Ct≤25）的患者，四种抗原检测中有三种能够检测出 80%以上 Ct≤30 的患者，这被认为是传染性的阈值。然而，有一种检测的临床性能较差。当研究 Ct 值>30 的患者时，我们发现抗原检测在多达 45%的情况下仍然呈阳性。
结论
大多数抗原检测具有足够的敏感性，可以识别出感染 SARS-CoV-2 且具有传染性的有症状患者。另一方面，抗原检测可能不适合在 COVID-19 患者的随访中识别其传染性的丧失。新引入的抗原检测需要在临床或初级保健环境中进行验证，以确定其临床用途。
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