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03399nam a2200553Ia 4500 |
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10.1016-j.plabm.2021.e00230 |
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220427s2021 CNT 000 0 und d |
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|a 23525517 (ISSN)
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|a Performance of an automated chemiluminescent immunoassay for SARS-COV-2 IgM and head-to-head comparison of Abbott and Roche COVID-19 antibody assays
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|b Elsevier B.V.
|c 2021
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|z View Fulltext in Publisher
|u https://doi.org/10.1016/j.plabm.2021.e00230
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|a Introduction: We evaluated the performance of the new Abbott SARS-CoV-2 IgM assay on the Architect immunoassay analyser and compared it to the Architect IgG/Roche Cobas total antibody assays in both SARS-CoV-2 RT-PCR positive cases and healthy controls. Method: 200 healthy control samples and 48 individuals with other antibody-positive disorders (18 hepatitis/18 dengue/11 ANA/1 dsDNA) served to assess for potential 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 of the Architect IgM assay were assessed. Concordance between the 3 assays were also analysed. Results: There was no cross-reactivity with controls and other antibody positive samples. The Architect IgM assay was 100% specific (95% CI 98.5 to 100) and sensitivity was 77.8% (95% CI 60.8 to 89.9) ≥14 days post-first positive RT-PCR (POS). Sensitivity of the combined Architect IgM and IgG results (30.8%) was significantly better than the Cobas total antibodies (15.4%) in early disease (p = 0.04). While the Architect IgM assay had moderate agreement with the Cobas total antibody result (Cohen's kappa 0.72), a combined Architect IgM and IgG result had better agreement (Cohen's kappa 0.83). Conclusion: The Architect IgM assay has good specificity and no cross-reactivity with other antibody positive cases. A combined Architect IgM and IgG result has better sensitivity than the individual assays for early COVID-19. The Architect IgM assay is not comparable to the Cobas total antibody assay, but the Architect IgM and IgG combined result has good agreement with the Cobas assay. © 2021 The Authors
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|a adult
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|a aged
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|a Antibodies
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|a antibody detection
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|a Article
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|a Assay evaluation
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|a automation
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|a chemiluminescence immunoassay
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|a clinical article
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|a controlled study
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|a coronavirus disease 2019
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|a COVID 19 antibody assay
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|a cross reaction
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|a diagnostic accuracy
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|a diagnostic test accuracy study
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|a double stranded DNA
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|a female
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|a human
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|a IgM
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|a immunoassay
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|a immunoglobulin G
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|a immunoglobulin M
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|a intermethod comparison
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|a male
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|a nonhuman
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|a reverse transcription polymerase chain reaction
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|a SARS-CoV-2
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|a sensitivity and specificity
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|a seroconversion
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|a Severe acute respiratory syndrome coronavirus 2
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|a virus detection
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|a CS, L.
|e author
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|a SK, P.
|e author
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|a SP, H.
|e author
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|a TC, A.
|e author
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|a YL, L.
|e author
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|t Practical Laboratory Medicine
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