Article ; Online: Diagnostic performance of seven rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients.
2020 Volume 26, Issue 8, Page(s) 1082–1087
Abstract: Objectives: To evaluate the diagnostic performance of seven rapid IgG/IgM tests and the Euroimmun ... for all seven LFAs compared to 89.5% for the IgG ELISA. The results for IgM varied significantly, and including ... Sensitivity and time to seropositivity was evaluated in 167 samples from 94 patients with COVID-19 confirmed ...
| Abstract | Objectives: To evaluate the diagnostic performance of seven rapid IgG/IgM tests and the Euroimmun IgA/IgG ELISA for antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in COVID-19 patients. Methods: Specificity was evaluated in 103 samples collected before January 2020. Sensitivity and time to seropositivity was evaluated in 167 samples from 94 patients with COVID-19 confirmed with RT-PCR on nasopharyngeal swab. Results: Specificity (confidence interval) of lateral flow assays (LFAs) was ≥91.3% (84.0-95.5) for IgM, ≥90.3% (82.9-94.8) for IgG, and ≥85.4% (77.2-91.1) for the combination IgM OR IgG. Specificity of the ELISA was 96.1% (90.1-98.8) for IgG and only 73.8% (64.5-81.4) for IgA. Sensitivity 14-25 days after the onset of symptoms was between ≥92.1% (78.5-98.0) and 100% (95.7-100) for IgG LFA compared to 89.5% (75.3-96.4) for IgG ELISA. Positivity of IgM OR IgG for LFA resulted in a decrease in specificity compared to IgG alone without a gain in diagnostic performance, except for VivaDiag. The results for IgM varied significantly between the LFAs with an average overall agreement of only 70% compared to 89% for IgG. The average dynamic trend to seropositivity for IgM was not shorter than for IgG. At the time of hospital admission the sensitivity of LFA was <60%. Conclusions: Sensitivity for the detection of IgG antibodies 14-25 days after the onset of symptoms was ≥92.1% for all seven LFAs compared to 89.5% for the IgG ELISA. The results for IgM varied significantly, and including IgM antibodies in addition to IgG for the interpretation of LFAs did not improve the diagnostic performance. |
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| MeSH term(s) | Adult ; Aged ; Aged, 80 and over ; Antibodies, Viral/analysis ; Antigens, Viral/immunology ; Betacoronavirus/immunology ; COVID-19 ; Coronavirus Infections/diagnosis ; Coronavirus Infections/immunology ; Diagnostic Tests, Routine ; Female ; Humans ; Immunoglobulin A/metabolism ; Immunoglobulin G/metabolism ; Immunoglobulin M/metabolism ; Male ; Middle Aged ; Pandemics ; Pneumonia, Viral/diagnosis ; Pneumonia, Viral/immunology ; SARS-CoV-2 ; Sensitivity and Specificity ; Time Factors ; Young Adult |
| Chemical Substances | Antibodies, Viral ; Antigens, Viral ; Immunoglobulin A ; Immunoglobulin G ; Immunoglobulin M |
| Keywords | covid19 |
| Language | English |
| Publishing date | 2020-05-28 |
| Publishing country | England |
| Document type | Comparative Study ; Journal Article |
| ZDB-ID | 1328418-6 |
| ISSN | 1469-0691 ; 1470-9465 ; 1198-743X |
| ISSN (online) | 1469-0691 |
| ISSN | 1470-9465 ; 1198-743X |
| DOI | 10.1016/j.cmi.2020.05.023 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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