Please use this identifier to cite or link to this item: https://doi.org/10.1016/j.plabm.2021.e00201
Title: Performance of two rapid point of care SARS-COV-2 antibody assays against laboratory-based automated chemiluminescent immunoassays for SARS-COV-2 IG-G, IG-M and total antibodies
Authors: Lau, C. S.
Hoo, S. P.
Liang, Y. L.
Phua, S. K.
Aw, T. C. 
Keywords: Antibodies
Assay evaluation
Point-of-care testing
SARS-CoV-2
Issue Date: 1-Mar-2021
Publisher: Elsevier B.V.
Citation: Lau, C. S., Hoo, S. P., Liang, Y. L., Phua, S. K., Aw, T. C. (2021-03-01). Performance of two rapid point of care SARS-COV-2 antibody assays against laboratory-based automated chemiluminescent immunoassays for SARS-COV-2 IG-G, IG-M and total antibodies. Practical Laboratory Medicine 24 : e00201. ScholarBank@NUS Repository. https://doi.org/10.1016/j.plabm.2021.e00201
Rights: Attribution 4.0 International
Abstract: Introduction: We evaluated two SARS-CoV-2 antibody point-of-care tests (POCTs) (Abbott Panbio COVID-19 IgG/IgM and Roche SARS-CoV-2 Rapid Antibody tests) and compared the results to their respective chemiluminescent immunoassays (CLIAs) (Abbott Architect IgM, Architect IgG, Roche Cobas total antibody assays). Method: 200 pre-pandemic sera and 48 samples positive for various conditions (18 viral hepatitis, 18 dengue, 11 ANA and 1 dsDNA) were used as controls and to assess for cross-reactivity. Anonymised residual leftover sera positive for SARS-CoV-2 on RT-PCR were recruited as cases (n ​= ​133). The sensitivity/specificity/cross-reactivity/positive predictive value (PPV)/negative predictive value (NPV) of the POCTs were assessed. Concordance between the POCTs and chemiluminescent immunoassays (CLIAs) were analysed. Results: Abbott/Roche POCT specificity was 98.7%/100% (95% CI 96.5–99.8/98.5–100) and sensitivity was 97.2%/97.2% (95% CI 85.5–99.9/85.5–99.9) in cases ≥14 days post-first positive RT-PCR (POS), PPV was 68.7%/100% (95% CI 41.3–87.2/94.7–100.0), and NPV was 97.4%/97.6% (95% CI 97.0–97.8/97.2–98.0). In cases ≥14 days POS, concordance of Abbott/Roche POCT and CLIAs was 97.2%/100% (35/36 and 36/36 results). The sensitivity of individual IgM-band results on both POCTs did not increase >95% even after 14 days POS (Abbott 2.78%, Roche 44.4%). Conclusion: Both POCTs have good specificity, little cross-reactivity with other antibodies, and sensitivity >95% when used in subjects ≥14 days POS. Analysis of individual POCT IgG/IgM-bands did not provide any additional information. POCTs can substitute for CLIAs in cases ≥14 days POS. In low prevalence areas, POCTs would be especially useful when combined with antigen testing in an orthogonal format to increase the PPV of COVID-19 results. © 2021 The Authors
Source Title: Practical Laboratory Medicine
URI: https://scholarbank.nus.edu.sg/handle/10635/232133
ISSN: 2352-5517
DOI: 10.1016/j.plabm.2021.e00201
Rights: Attribution 4.0 International
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