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Clinical performance evaluation of a SARS-CoV-2 Rapid Antibody Test for determining past exposure to SARS-CoV-2.
Findeisen, Peter; Stiegler, Hugo; Lopez-Calle, Eloisa; Schneider, Tanja; Urlaub, Eva; Hayer, Johannes; Zemmrich, Claudia.
  • Findeisen P; MVZ Labor Dr. Limbach & Kollegen GbR, Heidelberg, Germany.
  • Stiegler H; MVZLM - Medizinisches Versorgungszentrum für Labormedizin und Mikrobiologie Ruhr GmbH, Essen, Germany.
  • Lopez-Calle E; Roche Diagnostics GmbH, Mannheim, Germany.
  • Schneider T; Roche Diagnostics GmbH, Penzberg, Germany.
  • Urlaub E; Roche Diagnostics GmbH, Mannheim, Germany.
  • Hayer J; Roche Diagnostics GmbH, Mannheim, Germany.
  • Zemmrich C; Institute for Pharmacology and Preventive Medicine, Mahlow, Germany; Roche Diagnostics International Ltd. Rotkreuz, Switzerland. Electronic address: claudia.zemmrich@ippmed.de.
Int J Infect Dis ; 103: 636-641, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-938978
Preprint
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ABSTRACT

OBJECTIVES:

Due to the number of asymptomatic infections and limited access to high-performance antibody tests, the true prevalence and seropositivity of SARS-CoV-2 infection remains unknown. To fill this gap, the clinical performance of a point-of-care SARS-CoV-2 Rapid Antibody Assay, a chromatographic immunoassay for detecting IgM/IgG antibodies, in near patient settings was assessed.

METHODS:

Forty-two anti-SARS-Cov-2 positive (CoV+) and 92 anti-SARS-Cov-2 negative (CoV-) leftover samples from before December 2019 were assessed; the Elecsys® Anti-SARS-CoV-2 was used as the reference assay. Analytical specificity was tested using leftover samples collected before December 2019 from patients with common cold symptoms.

RESULTS:

The SARS-CoV-2 Rapid Antibody Test was 100.0% (95% CI 91.59-100.0) sensitive and 96.74% (95% CI 90.77-99.32) specific, with 0.00% assay failure rate. No cross-reactivity was observed against the common cold panel. Method comparison was additionally conducted by two external laboratories, using 100 CoV+ and 275 CoV- samples, also comparing whole blood versus plasma matrix. The comparison demonstrated 96.00% positive and 96.36% negative percent agreement for plasma with the Elecsys Anti-SARS-CoV-2 and 99.20% percent overall agreement between whole blood and EDTA plasma.

CONCLUSION:

The SARS-CoV-2 Rapid Antibody Test demonstrated similar performance to the manufacturer's data and a centralised automated immunoassay, with no cross-reactivity with common cold panels.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Int J Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: J.ijid.2020.11.164

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Full text: Available Collection: International databases Database: MEDLINE Main subject: SARS-CoV-2 / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Int J Infect Dis Journal subject: Communicable Diseases Year: 2021 Document Type: Article Affiliation country: J.ijid.2020.11.164