Evaluation of six commercial mid to high volume antibody and six point of care lateral flow assays for detection of SARS-CoV-2 antibodies

Link to article at PubMed

Charlton CL, et al. J Clin Microbiol 2020.


Background: COVID serological tests are essential to determine the overall seroprevalence of a population, and to facilitate exposure estimates within that population.Methods: We performed a head-to-head assessment of enzyme immunoassays (EIA) and point of care lateral flow assays (POCT) to detect SARS-CoV-2 antibodies. Demographics, symptoms, co-morbidities, treatment, and mortality of patients whose sera was used were also reviewed.Results: Six EIAs (Abbott, Affinity, BioRad, DiaSorin, Euroimmun, and Roche), and six POCTs (BTNX, Biolidics, Deep Blue, Genrui, Getein BioTech, and Innovita) were evaluated for the detection of SARS-CoV-2 antibodies in known COVID-19 infected individuals. Sensitivity of EIAs ranged from 50-100%, with only four assays having overall sensitivities >95% after 21 days post symptom onset. Notably, cross-reactivity with other respiratory viruses (PIV-4 (n=5), hMPV (n=3), rhinovirus/enterovirus (n=1), CoV-229E (n=2), CoV-NL63 (n=2), and CoV-OC43 (n=2) was observed; however, overall specificity for EIAs was good (92-100%; where all but one assay had specificity above 95%). POCTs were 0-100% sensitive >21 days post onset, with specificity ranging from 96-100%. However, many POCTs had faint banding and were often difficult to interpret.Conclusions: Serology assays can detect SARS-CoV-2 antibodies as early as 10 days post onset. Serology assays vary in their sensitivity based on the marker (IgA/M vs. IgG vs. total) and by manufacturer; however, overall only 4 EIA and 4 POCT assays had sensitivities >95% >21 days post symptom onset. Cross-reactivity with other seasonal coronaviruses is of concern. The use of serology assays should not be used for the diagnosis of acute infection, but rather for use in carefully designed serosurveys to facilitate understanding of seroprevalence in a population and to identify previous exposure to SARS-CoV-2.

PMID:32665420 | DOI:10.1128/JCM.01361-20

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