About: 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.   Goto Sponge  NotDistinct  Permalink

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  • 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.
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