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Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.
- Source :
-
European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology [Eur J Clin Microbiol Infect Dis] 2021 May; Vol. 40 (5), pp. 955-961. Date of Electronic Publication: 2020 Nov 24. - Publication Year :
- 2021
-
Abstract
- Antibody detection is essential to establish exposure, infection, and immunity to SARS-CoV-2, as well as to perform epidemiological studies. The worldwide urge for new diagnostic tools to control the pandemic has led to a quick incorporation in clinical practice of the recently developed serological assays. However, as only few comparative studies have been published, there is a lack of data about the diagnostic accuracy of currently available assays. We evaluated the diagnostic accuracy to detect Ig G, Ig M+A, and/or IgA anti SARS-CoV-2 of 10 different assays: lateral flow card immunoassays, 4 enzyme-linked immunosorbent assay (ELISA), and 3 chemiluminescent particle immunoassays (CMIA). Using reverse transcriptase polymerase chain reaction (RT-PCR) for COVID-19 as gold standard, sensitivity, specificity, PPV, and NPV were determined. Each assay was tested in 2 groups, namely, positive control, formed by 50 sera from 50 patients with SARS-CoV-2 pneumonia with positive RT-PCR; and negative control, formed by 50 sera from 50 patients with respiratory infection non-COVID-19. Sensitivity range of the 10 assays evaluated for patients with positive COVID-19 RT-PCR was 40-77% (65-81% considering IgG plus IgM). Specificity ranged 83-100%. VPP and VPN were respectively 81-100% and 61.6-81%. Among the lateral flow immunoassays, the highest sensitivity and specificity results were found in Wondfo® SARS-CoV-2 Antibody Test. ELISA IgG and IgA from EUROIMMUN® were the most sensitive ELISA. However, poor results were obtained for isolated detection of IgG. We found similar sensitivity for IgG with SARS-CoV-2 for Architect by Abbott® and ELISA by Vircell®. Results obtained varied widely among the assays evaluated. Due to a better specificity, overall diagnostic accuracy of the assays evaluated was higher in case of positive result. On the other side, lack of antibody detection should be taken with care because of the low sensitivity described. Highest diagnostic accuracy was obtained with ELISA and CMIAs, but they last much longer.
- Subjects :
- Adult
Aged
COVID-19 blood
COVID-19 Nucleic Acid Testing standards
Female
Humans
Immunoassay methods
Immunoglobulin Isotypes blood
Immunoglobulin Isotypes immunology
Male
Middle Aged
SARS-CoV-2 immunology
Sensitivity and Specificity
Antibodies, Viral blood
COVID-19 diagnosis
COVID-19 Serological Testing methods
SARS-CoV-2 isolation & purification
Subjects
Details
- Language :
- English
- ISSN :
- 1435-4373
- Volume :
- 40
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology
- Publication Type :
- Academic Journal
- Accession number :
- 33236268
- Full Text :
- https://doi.org/10.1007/s10096-020-04092-3