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Agreement between commercially available ELISA and in-house Luminex SARS-CoV-2 antibody immunoassays.
Santano, Rebeca; Barrios, Diana; Crispi, Fàtima; Crovetto, Francesca; Vidal, Marta; Chi, Jordi; Izquierdo, Luis; Gratacós, Eduard; Moncunill, Gemma; Dobaño, Carlota.
  • Santano R; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain. rebeca.santano@isglobal.org.
  • Barrios D; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.
  • Crispi F; BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine, Hospital Sant Joan de Déu and Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBER-ER, Barcelona, Spain.
  • Crovetto F; BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine, Hospital Sant Joan de Déu and Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBER-ER, Barcelona, Spain.
  • Vidal M; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.
  • Chi J; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.
  • Izquierdo L; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.
  • Gratacós E; BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine, Hospital Sant Joan de Déu and Hospital Clínic, IDIBAPS, Universitat de Barcelona, CIBER-ER, Barcelona, Spain.
  • Moncunill G; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain.
  • Dobaño C; ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Catalonia, Spain. carlota.dobano@isglobal.org.
Sci Rep ; 11(1): 18984, 2021 09 23.
Article in English | MEDLINE | ID: covidwho-1437691
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ABSTRACT
Serological diagnostic of the severe respiratory distress syndrome coronavirus 2 (SARS-CoV-2) is a valuable tool for the determination of immunity and surveillance of exposure to the virus. In the context of an ongoing pandemic, it is essential to externally validate widely used tests to assure correct diagnostics and epidemiological estimations. We evaluated the performance of the COVID-19 ELISA IgG and the COVID-19 ELISA IgM/A (Vircell, S.L.) against a highly specific and sensitive in-house Luminex immunoassay in a set of samples from pregnant women and cord blood. The agreement between both assays was moderate to high for IgG but low for IgM/A. Considering seropositivity by either IgG and/or IgM/A, the technical performance of the ELISA was highly imbalanced, with 96% sensitivity at the expense of 22% specificity. As for the clinical performance, the negative predictive value reached 87% while the positive predictive value was 51%. Our results stress the need for highly specific and sensitive assays and external validation of diagnostic tests with different sets of samples to avoid the clinical, epidemiological and personal disturbances derived from serological misdiagnosis.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Enzyme-Linked Immunosorbent Assay / COVID-19 Serological Testing / SARS-CoV-2 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Female / Humans / Pregnancy Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-98296-y

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Enzyme-Linked Immunosorbent Assay / COVID-19 Serological Testing / SARS-CoV-2 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Female / Humans / Pregnancy Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-98296-y