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Evaluation of diagnostic accuracy of 10 serological assays for detection of SARS-CoV-2 antibodies.
Gutiérrez-Cobos, Ainhoa; Gómez de Frutos, Sara; Domingo García, Diego; Navarro Lara, Eva; Yarci Carrión, Ayla; Fontán García-Rodrigo, Leticia; Fraile Torres, Arturo Manuel; Cardeñoso Domingo, Laura.
Afiliación
  • Gutiérrez-Cobos A; Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28006, Madrid, Spain. ainhoagutierrezcobos@gmail.com.
  • Gómez de Frutos S; Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28006, Madrid, Spain.
  • Domingo García D; Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28006, Madrid, Spain.
  • Navarro Lara E; Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28006, Madrid, Spain.
  • Yarci Carrión A; Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28006, Madrid, Spain.
  • Fontán García-Rodrigo L; Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28006, Madrid, Spain.
  • Fraile Torres AM; Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28006, Madrid, Spain.
  • Cardeñoso Domingo L; Departament of Clinical Microbiology, La Princesa University Hospital, C/Diego de León 62, 28006, Madrid, Spain.
Eur J Clin Microbiol Infect Dis ; 40(5): 955-961, 2021 May.
Article en En | MEDLINE | ID: mdl-33236268
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Prueba Serológica para COVID-19 / SARS-CoV-2 / COVID-19 / Anticuerpos Antivirales Tipo de estudio: Diagnostic_studies / Evaluation_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Clin Microbiol Infect Dis Asunto de la revista: DOENCAS TRANSMISSIVEIS / MICROBIOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: España Pais de publicación: Alemania

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Prueba Serológica para COVID-19 / SARS-CoV-2 / COVID-19 / Anticuerpos Antivirales Tipo de estudio: Diagnostic_studies / Evaluation_studies Límite: Adult / Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Clin Microbiol Infect Dis Asunto de la revista: DOENCAS TRANSMISSIVEIS / MICROBIOLOGIA Año: 2021 Tipo del documento: Article País de afiliación: España Pais de publicación: Alemania