In a CLIA laboratory setting, we evaluated SARS-CoV-2 IgG detection with four lateral flow immunoassays [LFIAs; two iterations from BTNX Inc. (n = 457), and one each from ACON Laboratories (n = 200); and SD BIOSENSOR (n = 155)]. In a cohort of primarily hospitalized, RT-PCR confirmed COVID-19 cases, sensitivity at ≥14 days from symptom onset was: BTNX kit 1, 95%; BTNX kit 2, 91%; ACON, 95%; and SD, 92%. All assays showed good concordance with the Abbott SARS-CoV-2 IgG assay at ≥14 days from symptom onset: BTNX kit 1, 99%; BTNX kit 2, 94%; ACON, 99%; and SD, 100%. Specificity, measured using specimens collected prior to SARS-CoV-2 circulation in the US and “cross-reactivity challenge” specimens, was 98% for BTNX kit 1 and ACON and 100% for BTNX kit 2 and SD. These results suggest that LFIAs may provide adequate results for rapid detection of SARS-CoV-2.

在CLIA实验室环境中，我们通过四种侧向流免疫测定法[LFIAs；评估了SARS-CoV-2 IgG]。BTNX Inc.进行了两次迭代（n = 457），ACON Laboratories进行了两次迭代（n = 200）；和SD BIOSENSOR（n = 155）]。在一组最初住院的RT-PCR确诊的COVID-19病例中，从症状发作开始≥14天的敏感性为：BTNX试剂盒1，95％；BTNX套件2，占91％；ACON，95％；和SD，占92％。症状发作后≥14天，所有测定均与Abbott SARS-CoV-2 IgG测定具有良好的一致性：BTNX试剂盒1，99％；BTNX套件2，94％；ACON，99％；和SD，100％。使用美国SARS-CoV-2流通前收集的标本和“交叉反应性挑战”标本测量的特异性，对于BTNX试剂盒1和ACON为98％，对于BTNX试剂盒2和SD为100％。