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Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen

Institute for Infection Medicine, Christian-Albrecht University and University Medical Center Schleswig-Holstein, Brunswiker Str. 4, 24105 Kiel, Germany
Labor Dr. Krause und Kollegen MVZ GmbH, Steenbeker Weg 23, 24106 Kiel, Germany
Author to whom correspondence should be addressed.
These first authors contributed equally.
Received: 30 November 2020 / Revised: 16 December 2020 / Accepted: 24 December 2020 / Published: 28 December 2020
(This article belongs to the Special Issue COVID-19: Focusing on Epidemiologic, Virologic, and Clinical Studies)
The rapid detection of infections caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is necessary in the ongoing pandemic. Antigen-specific point-of-care tests (POCT) may be useful for this purpose. Here, such a POCT (SARS-CoV-2 NADAL® COVID-19 Ag) was compared to a laboratory-developed triplex real-time polymerase chain reaction (RT-PCR) designed for the detection of viral nucleoprotein gene and two control targets. This RT-PCR served as a reference to investigate POCT sensitivity by re-testing upper respiratory tract (URT) samples (n = 124) exhibiting different SARS-CoV-2 loads in terms of RT-PCR threshold cycle (Ct) values. The optical intensities of the antigen bands were compared to the Ct values of the RT-PCR. The infectivity of various virus loads was estimated by inoculating Vero cells with URT samples (n = 64, Ct 17-34). POCT sensitivity varied from 100% (Ct < 25) to 73.1% (Ct ≤ 30); higher SARS-CoV-2 loads correlated with higher band intensities. All samples with a Ct > 30 were negative; among SARS-CoV-2 free samples (n = 10) no false-positives were detected. A head-to-head comparison with another POCT (Abbott, Panbio™ COVID-19 Ag Rapid Test) yielded similar results. Isolation of SARS-CoV-2 in cell-culture was successful up to a Ct value of 29. The POCT reliably detects high SARS-CoV-2 loads and rapidly identifies infectious individuals. View Full-Text
Keywords: COVID-19; diagnostic; PCR; antigen; POCT; comparison COVID-19; diagnostic; PCR; antigen; POCT; comparison
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MDPI and ACS Style

Strömer, A.; Rose, R.; Schäfer, M.; Schön, F.; Vollersen, A.; Lorentz, T.; Fickenscher, H.; Krumbholz, A. Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen. Microorganisms 2021, 9, 58.

AMA Style

Strömer A, Rose R, Schäfer M, Schön F, Vollersen A, Lorentz T, Fickenscher H, Krumbholz A. Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen. Microorganisms. 2021; 9(1):58.

Chicago/Turabian Style

Strömer, Annabelle, Ruben Rose, Miriam Schäfer, Frieda Schön, Anna Vollersen, Thomas Lorentz, Helmut Fickenscher, and Andi Krumbholz. 2021. "Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen" Microorganisms 9, no. 1: 58.

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