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. 2021 Apr:137:104785.
doi: 10.1016/j.jcv.2021.104785. Epub 2021 Mar 5.

Evaluation of three rapid lateral flow antigen detection tests for the diagnosis of SARS-CoV-2 infection

A E Jääskeläinen  1 , M J Ahava  2 , P Jokela  2 , L Szirovicza  3 , S Pohjala  4 , O Vapalahti  5 , M Lappalainen  2 , J Hepojoki  6 , S Kurkela  2
Affiliations

Evaluation of three rapid lateral flow antigen detection tests for the diagnosis of SARS-CoV-2 infection

A E Jääskeläinen et al. J Clin Virol. 2021 Apr.

Abstract

Introduction: The COVID-19 pandemic has led to high demand of diagnostic tools. Rapid antigen detection tests have been developed and many have received regulatory acceptance such as CE IVD or FDA markings. Their performance needs to be carefully assessed.

Materials and methods: 158 positive and 40 negative retrospective samples collected in saline and analyzed by a laboratory-developed RT-PCR test were used to evaluate Sofia (Quidel), Standard Q (SD Biosensor), and Panbio™ (Abbott) rapid antigen detection tests (RADTs). A subset of the specimens was subjected to virus culture.

Results: The specificity of all RADTs was 100 % and the sensitivity and percent agreement was 80 % and 85 % for Sofia, 81 % and 85 % for Standard Q, and 83 % and 86 % for Panbio™, respectively. All three RADTs evaluated in this study reached a more than 90 % sensitivity for samples with a high viral load as estimated from the low Ct (Cycle threshold) values in the reference RT-PCR. Virus culture was successful in 80 % of specimens with a Ct value <25.

Conclusions: As expected, the RADTs were less sensitive than RT-PCR. However, they benefit from the speed and ease of testing, and lower price as compared to RT-PCR. Repeated testing in appropriate settings may improve the overall performance.

Keywords: Antigen detection; COVID-19; RADT; Rapid testing; SARS-CoV-2.

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Conflict of interest statement

The authors report no declarations of interest.

Figures

Fig. 1
Fig. 1
Sensitivity of the RADTs in comparison to Ct values in RT-PCR. Samples include all the LDT RT-PCR positive nasopharyngeal samples from adult outpatients at HUSLAB in 1.-18. November 2020 that had enough sample volume left for three antigen tests. N = 96, however, in some cases, not all three RADTs were performed to all samples. Each dot indicates one samples. Ct <25: 75 samples; Ct 25-29.99: 16 samples; Ct ≥30: 5 samples.
See this image and copyright information in PMC

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