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Rigshospitalet - en del af Københavns Universitetshospital
Udgivet

Comparison of 16 Serological SARS-CoV-2 Immunoassays in 16 Clinical Laboratories

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DOI

  1. Update from a twelve-year nationwide fungaemia surveillance: increasing intrinsic and acquired resistance causes concern

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. PREVALENCE OF HUMAN PAPILLOMAVIRUS IN SELF-TAKEN SAMPLES FROM SCREENING NON-ATTENDERS

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Comparative Evaluation of Inoculation of Urine Samples with the Copan WASP® and BD Kiestra™ InoqulA™ Instruments

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Unexpected Diagnosis of Cerebral Toxoplasmosis by 16S and D2 Large-Subunit Ribosomal DNA PCR and Sequencing

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Capsid-like particles decorated with the SARS-CoV-2 receptor-binding domain elicit strong virus neutralization activity

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Eleven genomic loci affect plasma levels of chronic inflammation marker soluble urokinase-type plasminogen activator receptor

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. The evolution of the neonatal QRS axis during the first four weeks of life

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Genetic insight into sick sinus syndrome

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are needed to support clinical diagnosis and epidemiological investigations. Recently, assays for large-scale detection of total antibodies (Ab), immunoglobulin G (IgG), and IgM against SARS-CoV-2 antigens have been developed, but there are limited data on the diagnostic accuracy of these assays. This study was a Danish national collaboration and evaluated 15 commercial and one in-house anti-SARS-CoV-2 assays in 16 laboratories. Sensitivity was evaluated using 150 samples from individuals with asymptomatic, mild, or moderate COVID-19, nonhospitalized or hospitalized, confirmed by nucleic acid amplification tests (NAAT); samples were collected 13 to 73 days either from symptom onset or from positive NAAT (patients without symptoms). Specificity and cross-reactivity were evaluated in samples collected prior to the SARS-CoV-2 epidemic from >586 blood donors and patients with autoimmune diseases, cytomegalovirus or Epstein-Barr virus infections, and acute viral infections. A specificity of ≥99% was achieved by all total-Ab and IgG assays except one, DiaSorin Liaison XL IgG (97.2%). Sensitivities in descending order were Wantai ELISA total Ab (96.7%), CUH-NOVO in-house ELISA total Ab (96.0%), Ortho Vitros total Ab (95.3%), YHLO iFlash IgG (94.0%), Ortho Vitros IgG (93.3%), Siemens Atellica total Ab (93.2%), Roche Elecsys total Ab (92.7%), Abbott Architect IgG (90.0%), Abbott Alinity IgG (median 88.0%), DiaSorin Liaison XL IgG (median 84.6%), Siemens Vista total Ab (81.0%), Euroimmun/ELISA IgG (78.0%), and Snibe Maglumi IgG (median 78.0%). However, confidence intervals overlapped for several assays. The IgM results were variable, with the Wantai IgM ELISA showing the highest sensitivity (82.7%) and specificity (99%). The rate of seropositivity increased with time from symptom onset and symptom severity.

OriginalsprogEngelsk
TidsskriftJournal of Clinical Microbiology
Vol/bind59
Udgave nummer5
ISSN0095-1137
DOI
StatusUdgivet - 20 apr. 2021

Bibliografisk note

Copyright © 2021 American Society for Microbiology.

ID: 62295306