☆ 4.6 Article

Diagnostic Performance of Six Rapid Antigen Tests for SARS-CoV-2

MICROBIOLOGY SPECTRUM (2022)

Journal

MICROBIOLOGY SPECTRUM

Volume 10, Issue 2, Pages -

Publisher

AMER SOC MICROBIOLOGY

DOI: 10.1128/spectrum.02351-21

Keywords

SARS-CoV-2; rapid antigen test; diagnosis

Funding

Agencia de Gestio d'Ajuts Universitaris i de Recerca (AGAUR)-Departament d'Empresa i Coneixement
Generalitat de Catalunya [2017 SGR 794]

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Abstract

In this study, the diagnostic performance of six different commercial rapid antigen tests was evaluated. The sensitivity of the tests ranged from 65% to 79%, while the specificity was 100% for all of them. The Siemens test showed the highest sensitivity for patients with high viral loads, while the Vircell test performed better than the rest for samples with high C-T values.

Microbiological diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been a challenge. Although real-time reverse transcription PCR (RT-PCR) represents the gold standard method, strategies that allow rapid and simple diagnosis are necessary for the early identification of cases. In this study, we evaluated the diagnostic performance of six different commercial rapid antigen tests (Coronavirus antigen [Ag] rapid test cassette [Healgen Scientific, Houston, TX, USA], COVID-19 Ag FIA [Vircell, SD Biosensor Inc., Gyeonggi-do, Republic of Korea], Clinitest rapid COVID-19 antigen test [Siemens, Healthineers, Erlangen, Germany], SARS-CoV-2 rapid antigen test [SD Biosensor; Roche Diagnostics, Basel, Switzerland], Panbio COVID-19 Ag rapid test device [Abbott, Chicago, IL, USA], and SARS-CoV-2 test [MonLab, Barcelona, Spain]) in 130 nasopharyngeal swab samples tested previously by RT-PCR. The overall sensitivity of the rapid tests ranged from 65% to 79%, and the specificity was 100% for all of them. The sensitivity was higher for those samples with RT-PCR cycle threshold (C-T) values below 25 and those from patients presenting within the first week of symptoms. The Siemens test showed the highest sensitivity for patients with high viral loads while the Vircell test performed better than the rest for C-T values of >= 25. IMPORTANCE The rapid detection of people infected with SARS-CoV-2 is essential for a correct and effective control of the disease it causes. This process must be sensitive, fast, and simple, and it must be possible to carry out in any type of health center. Rapid antigen tests are the answer to this need. Knowing its ability to detect the virus in different stages of the disease is essential for a correct diagnosis, which is why this study has been carried out to evaluate the sensitivity and specificity of 6 different antigens tests in nasopharyngeal smear samples.

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Sensitivity of rapid antigen tests against SARS-CoV-2 Omicron and Delta variants

Anuradha Rao, Adrianna Westbrook, Leda Bassit, Richard Parsons, Eric Fitts, Morgan Greenleaf, Kaleb McLendon, Julie A. Sullivan, William O'Sick, Tyler Baugh, Heather B. Bowers, Filipp Frank, Ethan Wang, Mimi Le, Jennifer Frediani, Pavitra Roychoudhury, Alexander L. Greninger, Robert Jerris, Nira R. Pollock, Eric A. Ortlund, John D. Roback, Wilbur A. Lam, Anne Piantadosi

Summary: This study compared the performance of 10 commercially available RATs against the Delta and Omicron SARS-CoV-2 variants. The RATs exhibited lower sensitivity for Omicron samples when using PCR cycle threshold as the comparator, but exhibited similar sensitivity when using quantitative antigen concentration as the comparator. Additionally, Omicron samples had lower ratios of antigen to RNA, which may explain the lower sensitivity of RATs for that variant.

JOURNAL OF CLINICAL MICROBIOLOGY (2023)