The sensitivity and specificity of Abbott Panbio™ COVID 19 Ag Rapid test in the context of four SARS-CoV-2 variants

Miroslav Fajfr; Laith Rashad Hassan Muhammad Moolla; Joudi Barout; Saaz Sahani; Rudolf Kukla; Eva Cermakova; Radek Sleha; Pavel Bostik

doi:10.1016/j.heliyon.2023.e23475

The sensitivity and specificity of Abbott Panbio™ COVID 19 Ag Rapid test in the context of four SARS-CoV-2 variants

Heliyon. 2023 Dec 9;10(1):e23475. doi: 10.1016/j.heliyon.2023.e23475. eCollection 2024 Jan 15.

Authors

Miroslav Fajfr^{1

2}, Laith Rashad Hassan Muhammad Moolla², Joudi Barout², Saaz Sahani², Rudolf Kukla^{1

2}, Eva Cermakova², Radek Sleha^{2

3}, Pavel Bostik^{1

2}

Affiliations

¹ Institute of Clinical Microbiology, University Hospital in Hradec Kralove, Czech Republic.
² Charles University, Faculty of Medicine in Hradec Kralove, Hradec Kralove, Czech Republic.
³ Faculty of Military Health Sciences, University of Defence, Hradec Kralove, Czech Republic.

Abstract

Rapid antigen tests for the detection of SARS-CoV-2 are commonly used for the diagnosis of Covid-19. Previously published data showed a wide range of sensitivity and specificity of RATs, but these studies were performed on relatively small numbers of samples and using only limited numbers of virus variants. The aim of the study was to evaluate the main parameters of a commonly used RAT for 4 different virus variants in comparison with PCR.

Material and methods: A set of 2874 samples obtained from Covid-19 patients were examined both by PCR and RAT. Two commercial PCR kits (Generi Biotech, Diana Biotechnologies) and one RAT - Abbott Panbio™ COVID 19 Ag Rapid - were compared for their sensitivity and specificity in samples positive for one of the four different SARS-CoV-2 variants - B.1.258 (n = 496), Alpha (n = 645), Delta/Delta+ (n = 687), and Omicron (n = 1046).

Results: The sensitivity of Panbio™ COVID19 Ag Rapid test varied from 80.0 % in Omicron to 88.92 % in Alpha variants. The specificities of the RAT for all variants reached above 93 %. Statistically significant differences were found between the results from RAT assay in select virus variants. In addition, significantly higher sensitivity (p < 0.05) was detected in samples with higher viral loads than in those with lower.

Conclusion: Despite the different sensitivity and specificity of Panbio™ COVID19 Ag Rapid test (Abbott ®) for different SARS-CoV-2 variants, this test sensitivity was proven to be always above the 80 % suggested by WHO, which makes it suitable for common use, regardless of the virus variability.

Keywords: PCR ct value; Rapid antigen test; SARS CoV-2 variant; Sensitivity; Specificity.