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. 2022 Feb 22;8(2):e08998.
doi: 10.1016/j.heliyon.2022.e08998. eCollection 2022 Feb.

Evaluation of SARS-CoV-2 rapid antigen diagnostic tests for saliva samples

Marie Hagbom  1 , Noelia Carmona-Vicente  1 , Sumit Sharma  1 , Henrik Olsson  2 , Mikael Jämtberg  2 , Åsa Nilsdotter-Augustinsson  3 , Johanna Sjöwall  3 , Johan Nordgren  1
Affiliations

Evaluation of SARS-CoV-2 rapid antigen diagnostic tests for saliva samples

Marie Hagbom et al. Heliyon. .

Abstract

Using saliva samples would facilitate sample collection, diagnostic feasibility, and mass screening of SARS-CoV-2. We tested two rapid antigen (RAD) immunochromatographic tests designed for detection of SARS-CoV-2 in saliva: Rapid Response™ COVID-19 Antigen Rapid Test Cassette for oral fluids and DIAGNOS™ COVID-19 Antigen Saliva Test. Evaluation of detection limit was performed with purified SARS-CoV-2 nucleocapsid protein and live SARS-CoV-2 virus. Sensitivity and specificity were further evaluated with reverse transcription quantitative PCR (RT-qPCR) positive and negative saliva samples from hospitalized individuals with COVID-19 (n = 39) and healthcare workers (n = 20). DIAGNOS showed higher sensitivity than Rapid Response for both nucleocapsid protein and live virus. The limit of detection of the saliva test from DIAGNOS was further comparable with the Abbott Panbio™ COVID-19 Ag Rapid Test designed for nasopharyngeal samples. DIAGNOS and Rapid Response detected nine (50.0%) and seven (38.9%), respectively, of the 18 RT-qPCR positive saliva samples. All RT-qPCR negative saliva (n = 41) were negative with both tests. Only one of the RT-qPCR positive saliva samples contained infectious virus as determined by cell culture and was also positive using the saliva RADs. The results show that the DIAGNOS may be an important and easy-to-use saliva RAD complement to detect SARS-CoV-2 positive individuals, but validation with a larger sample set is warranted.

Keywords: Infectivity; Rapid antigen diagnostic test; SARS-CoV-2; Saliva.

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Conflict of interest statement

The authors declare the following conflict of interests: Henrik Olsson and Mikael Jämtberg are Co-chief executive officers at Noviral Sweden AB, which is a distributor of the Rapid Response™ COVID-19 Antigen Rapid Test Cassette and DIAGNOS™ COVID-19 Antigen Saliva Test.

Figures

Figure 1
Figure 1
Scatter dot blot indicating positivity (green dot) and negativity (red dot) of the rapid saliva antigen tests in association to RT-qPCR Ct-values for the envelope gene. Two saliva samples were positive only for the RdRp gene (triangle) and are marked with corresponding RdRp Ct-values. DIAGNOS™ detected nine and Rapid Response™ seven of the 18 RT-qPCR positive samples in the COVID-19 cohort (left panel). Using live SARS-CoV-2 titrated in 10-fold dilutions of saliva (right panel), DIAGNOS test exhibited higher sensitivity compared to the Rapid Response test. Green/red dot indicate weak positivity (+/-).
See this image and copyright information in PMC

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