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

•All three RADTs Sofia, Standard Q and Panbio™ were specific and adequately sensitive.•RADTs were less sensitive than RT-PCR.•RADTs were about as sensitive as virus culture.•RADTs are fast and easy so can perform well in diagnostics in selected settings. The COVID-19 pandemic has led to high demand...

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Bibliographic Details
Published in:Journal of clinical virology 2021-04, Vol.137, p.104785-104785, Article 104785
Main Authors: Jääskeläinen, A.E., Ahava, M.J., Jokela, P., Szirovicza, L., Pohjala, S., Vapalahti, O., Lappalainen, M., Hepojoki, J., Kurkela, S.
Format: Article
Language:English
Subjects:
Antigen detection
Antigens, Viral - analysis
COVID-19
COVID-19 - diagnosis
COVID-19 - immunology
COVID-19 - virology
COVID-19 Nucleic Acid Testing - methods
COVID-19 Serological Testing - methods
COVID-19 Testing - methods
Humans
Nasopharynx - virology
RADT
Rapid testing
Retrospective Studies
SARS-CoV-2
SARS-CoV-2 - immunology
SARS-CoV-2 - isolation & purification
Sensitivity and Specificity
Short Communication
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Summary:•All three RADTs Sofia, Standard Q and Panbio™ were specific and adequately sensitive.•RADTs were less sensitive than RT-PCR.•RADTs were about as sensitive as virus culture.•RADTs are fast and easy so can perform well in diagnostics in selected settings. 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. 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. 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
ISSN:1386-6532
1873-5967
1873-5967
DOI:10.1016/j.jcv.2021.104785