Evaluation of Six Commercial Mid- to High-Volume Antibody and Six Point-of-Care Lateral Flow Assays for Detection of SARS-CoV-2 Antibodies
- 22 September 2020
- journal article
- research article
- Published by American Society for Microbiology in Journal of Clinical Microbiology
- Vol. 58 (10)
- https://doi.org/10.1128/jcm.01361-20
Abstract
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.Keywords
This publication has 13 references indexed in Scilit:
- Laboratory Diagnosis of COVID-19: Current Issues and ChallengesJournal of Clinical Microbiology, 2020
- Rapid generation of neutralizing antibody responses in COVID-19 patientsPublished by Cold Spring Harbor Laboratory ,2020
- Evaluation of commercial and automated SARS-CoV-2 IgG and IgA ELISAs using coronavirus disease (COVID-19) patient samplesEurosurveillance, 2020
- Report from the American Society for Microbiology COVID-19 International Summit, 23 March 2020: Value of Diagnostic Testing for SARS–CoV-2/COVID-19mBio, 2020
- Serological Approaches for COVID-19: Epidemiologic Perspective on Surveillance and ControlFrontiers in Immunology, 2020
- SARS-CoV-2 serological analysis of COVID-19 hospitalized patients, pauci-symptomatic individuals and blood donorsPublished by Cold Spring Harbor Laboratory ,2020
- Developing antibody tests for SARS-CoV-2The Lancet, 2020
- Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus–Infected PneumoniaThe New England Journal of Medicine, 2020
- COVID-19: too little, too late?The Lancet, 2020
- A Novel Coronavirus Emerging in China - Key Questions for Impact AssessmentThe New England Journal of Medicine, 2020