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. 2021 May;35(5):e23745.
doi: 10.1002/jcla.23745. Epub 2021 Mar 5.

Performance evaluation of a lateral flow assay for nasopharyngeal antigen detection for SARS-CoV-2 diagnosis

Marcela Peña-Rodríguez  1 , Oliver Viera-Segura  2 , Mariel García-Chagollán  3 , José Sergio Zepeda-Nuño  4 , José Francisco Muñoz-Valle  3 , Jesús Mora-Mora  2   5 , Gabriela Espinoza-De León  2 , Gustavo Bustillo-Armendáriz  6 , Fernanda García-Cedillo  6 , Natali Vega-Magaña  2   3
Affiliations

Performance evaluation of a lateral flow assay for nasopharyngeal antigen detection for SARS-CoV-2 diagnosis

Marcela Peña-Rodríguez et al. J Clin Lab Anal. 2021 May.

Abstract

Background: SARS-CoV-2 has become a global pandemic due to its capacity for rapid transmission. In this context, an early and rapid diagnosis of infected patients that do not require expensive equipment or highly trained personnel is crucial in order to reduce the contagious rate. The aim of this study was to evaluate a chromatographic immunoassay's performance for the rapid diagnosis of SARS-CoV-antigen.

Methods: A cross-sectional study included 369 adults from Western México with diagnosis or suspicion of SARS-CoV-2 infection. Two samples were collected; a naso-oropharyngeal was used for a molecular determination of SARS-CoV-2 RNA. The molecular analysis was carried out using DeCoV19 Kit Triplex (Genes2life S.A.P.I.) based on the CDC diagnostic panel for N1, N2, and N3 regions. The second sample was retrieved from a nasopharyngeal rub and used for the rapid diagnosis of SARS-CoV-2 antigen employing the commercial STANDARD™ Q COVID-19 Ag Test (SD BIOSENSOR).

Results: Overall, in 28.2% of the patients was detected the SARS-CoV-2 RNA, and 21.4% were positive for antigen detection. The rapid antigen test showed a sensitivity and specificity of 75.9% and 100%, respectively, with a positive predictive and negative values of 100% and 91%. Symptoms as anosmia presented a high OR for the positive diagnosis for both test, reverse transcription-polymerase chain reaction (RT-PCR), and the rapid antigen test of 8.86 (CI = 4.91-16) and 6.09 (CI = 3.42-10.85), respectively.

Conclusion: SD BIOSENSOR is a useful assay, but some caveats must be considered before the general implementation.

Keywords: COVID-19; SARS-CoV-2; rapid test.

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Conflict of interest statement

Bustillo‐Armendaríz Gustavo and García‐Cedillo Fernanda declared that the rapid antigen test was supplied by P.M.I 12.10, S.A.P.I. de C.V company.

Figures

FIGURE 1
FIGURE 1
Ct‐values are directly related to the antigen test results. The Ct‐values from positive patients to SARS‐CoV‐2 diagnosed by reverse transcription‐polymerase chain reaction (RT‐PCR) were significantly higher than the negatives. Moreover, we observed that the sensitivity decreased
FIGURE 2
FIGURE 2
Symptoms with risk factors associated with the SARS‐CoV‐2 positive diagnosis. (A) Represents the symptoms risk related to polymerase chain reaction (PCR) and (B) to the rapid antigen test. Both diagnostic tests showed a better performance when anosmia symptoms were present. Diarrhea was the least relevant symptom
See this image and copyright information in PMC

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