Procop Gary W, Kadkhoda Kamran, Rhoads Daniel D, Gordon Steven G, Reddy Anita J
Pathology and Laboratory Medicine Institute, Cleveland Clinic, Cleveland, OH
Pathology and Laboratory Medicine Institute, Cleveland Clinic, Cleveland, OH.
Cleve Clin J Med. 2021 Mar 1. doi: 10.3949/ccjm.88a.ccc071.
The home test kits for detecting SARS-CoV-2 infection with Food and Drug Administration emergency use authorization primarily use either isothermal nucleic acid amplification or antigen detection, and each test has advantages and limitations in terms of sensitivity and specificity, cost, results reporting, and results turnaround time. In clinical studies, these tests provide accurate positive results in symptomatic individuals, although negative results are less accurate. There are also accuracy concerns for positive results in asymptomatic individuals. These factors have implications for their clinical interpretation and use.
获得美国食品药品监督管理局紧急使用授权的用于检测新型冠状病毒2感染的家用检测试剂盒主要采用等温核酸扩增或抗原检测方法,每种检测方法在灵敏度和特异性、成本、结果报告以及结果周转时间方面都有其优点和局限性。在临床研究中,这些检测方法能为有症状的个体提供准确的阳性结果,不过阴性结果的准确性较低。对于无症状个体的阳性结果也存在准确性方面的担忧。这些因素对其临床解读和应用都有影响。