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Diagnostic accuracy of two commercially available rapid assays for detection of IgG and IgM antibodies to SARS-CoV-2 compared to ELISA in a low-prevalence population.
Hackner, Klaus; Errhalt, Peter; Willheim, Martin; Schragel, Felix; Grasl, Maria-Anna; Lagumdzija, Jasmina; Riegler, Waltraud; Ecker, Michael; Wechdorn, Matthias; Thalhammer, Florian; Assadian, Ojan.
  • Hackner K; Department of Pneumology, University Hospital Krems, Karl Landsteiner University of Health Sciences, Krems, Austria.
  • Errhalt P; Department of Pneumology, University Hospital Krems, Karl Landsteiner University of Health Sciences, Krems, Austria.
  • Willheim M; Institute of Laboratory Medicine, University Hospital St. Poelten, Karl Landsteiner University of Health Sciences, St. Poelten, Austria.
  • Schragel F; Department of Pneumology, University Hospital Krems, Karl Landsteiner University of Health Sciences, Krems, Austria.
  • Grasl MA; Department of Pneumology, University Hospital Krems, Karl Landsteiner University of Health Sciences, Krems, Austria.
  • Lagumdzija J; Department of Pneumology, University Hospital Krems, Karl Landsteiner University of Health Sciences, Krems, Austria.
  • Riegler W; Department of Pneumology, University Hospital Krems, Karl Landsteiner University of Health Sciences, Krems, Austria.
  • Ecker M; Institute of Laboratory Medicine, University Hospital Krems, Karl Landsteiner University of Health Sciences, Krems, Austria.
  • Wechdorn M; Institute of Laboratory Medicine, University Hospital St. Poelten, Karl Landsteiner University of Health Sciences, St. Poelten, Austria.
  • Thalhammer F; Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
  • Assadian O; Department for Infection Control and Hospital Epidemiology, Medical University of Vienna, Vienna, Austria.
GMS Hyg Infect Control ; 15: Doc28, 2020.
Article in English | MEDLINE | ID: covidwho-937401
Semantic information from SemMedBD (by NLM)
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ABSTRACT

Background:

New commercially available point-of-care (POC) immunodiagnostic tests are appearing, which may yield rapid results for anti-SARS-CoV-2 antibodies. The aim of this study was to evaluate the diagnostic accuracy of rapid antibody detection tests compared to a validated laboratory-based enzyme-linked immunosorbent assay (ELISA) and to investigate infections amongst healthcare workers (HCWs) after unprotected close contact to COVID-19 patients.

Methods:

Blood serum and whole blood of 130 participants were tested with NADAL® COVID-19 IgG/IgM rapid test and mö-screen 2019-NCOV coronavirus test against a validated ELISA test. Infection status was evaluated using real-time polymerase-chain-reaction.

Results:

Acute COVID-19 infection was detected in 2.4% of exposed HCWs. Antibody tests showed an overall frequency of IgG and IgM in 5.3%, with 1.6% asymptomatic infections. The NADAL® test showed a sensitivity (IgM/IgG) of 100% (100%/100%), a specificity (IgM/IgG) of 98.8% (97.6%/100 %), a PPV of 76.9% (57.1%/100%), an NPV of 100% (100%/100%), and a diagnostic accuracy of 98.8% (97.7%/100%). The mö-screen test had a sensitivity (IgM/IgG) of 90.9% (80%/100%), a specificity (IgM/IgG) of 98.8% (97.6%/100%), a PPV of 76.9% (57.1%/100%), an NPV of 99.6% (99.2%/100%), and a diagnostic accuracy of 98.5% (96.9%/100%).

Conclusions:

The frequency of COVID-19 infections in HCWs after unprotected close contact is higher than in the general population of a low-prevalence country. Both POC tests were useful for detecting IgG, but did not perform well for IgM, mainly due to false positive results.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Language: English Journal: GMS Hyg Infect Control Year: 2020 Document Type: Article Affiliation country: Dgkh000363

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Language: English Journal: GMS Hyg Infect Control Year: 2020 Document Type: Article Affiliation country: Dgkh000363