Diagnostic performance of 7 rapid IgG/IgM antibody tests and the Euroimmun IgA/IgG ELISA in COVID-19 patients
| Autor: | Van Elslande, Jan, Houben, Els, Depypere, Melissa, Brackenier, Anouk, Desmet, Stefanie, André, Emmanuel, Van Ranst, Marc, Lagrou, Katrien, Vermeersch, Pieter |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Time Factors Pneumonia Viral Lateral flow assay Antibodies Viral Sensitivity and Specificity Article Betacoronavirus Young Adult PCR polymerase chain reaction Diagnosis Humans FDA Food and Drug Administation ELISA Enzyme-Linked Immunosorbent Assay Antigens Viral Pandemics IVD In Vitro Diagnostics Aged Immunoassay Aged 80 and over SARS-CoV-2 Diagnostic Tests Routine COVID-19 LFA Lateral Flow Assay Middle Aged CE ConformitéEuropéenne Immunoglobulin A CI confidence interval SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2 Immunoglobulin M Point-of-Care Testing Seroconversion COVID-19 Coronavirus Disease 2019 Immunoglobulin G ELISA Female Coronavirus Infections LR+ Positive Likelihood Ratio |
| Zdroj: | Clinical Microbiology and Infection |
| ISSN: | 1469-0691 1198-743X |
| Popis: | 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.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.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 was60%.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. |
| Databáze: | OpenAIRE |
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