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. 2022 Jun:119:38-40.
doi: 10.1016/j.ijid.2022.03.037. Epub 2022 Mar 30.

Diagnostic accuracy of SARS-CoV-2 saliva antigen testing in a real-life clinical setting

Sabrina Jegerlehner  1 , Franziska Suter-Riniker  2 , Philipp Jent  3 , Pascal Bittel  2 , Michael Nagler  4
Affiliations

Diagnostic accuracy of SARS-CoV-2 saliva antigen testing in a real-life clinical setting

Sabrina Jegerlehner et al. Int J Infect Dis. 2022 Jun.

Abstract

Background: SARS-CoV-2 antigen tests with saliva facilitate examination in settings that lack trained personnel. However, little is known about the diagnostic accuracy in real-life clinical settings. Therefore, we studied the diagnostic accuracy of a saliva antigen test in diagnosing SARS-CoV-2 infection in a primary/secondary care testing facility.

Methods: Individuals who presented at a COVID-19 testing facility affiliated with a Swiss university hospital were prospectively recruited (n=377). Saliva specimen was obtained, and the PCL Inc. COVID19 Gold antigen test was conducted in parallel with 2 real-time polymerase chain reaction (RT-PCR) assays from a nasopharyngeal swab.

Results: RT-PCR results were positive in 53 individuals, corresponding to a prevalence of 14.1% (missing material in 1 individual). The PCL saliva antigen test was positive in 22 individuals (5.8%) and negative in 354 (93.9%). The sensitivity of the saliva antigen test was 30.2% (95% confidence interval 18.3, 44.3), both overall and in symptomatic individuals. The specificity was 98.1% (96.0, 99.3).

Conclusions: The diagnostic accuracy of a SARS-CoV-2 saliva antigen test in a primary/secondary care testing facility was remarkably lower than that reported in the manufacturer's specifications.

Keywords: COVID-19 diagnostic testing [Supplementary Concept]; Infections/*epidemiology/transmission; severe acute respiratory syndrome coronavirus 2 [Supplementary Concept].

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Conflict of interest statement

Competing interests MN received research support from Roche diagnostics outside of the present work. The other authors declare no conflict of interest.

Figures

Figure 1:
Figure 1
Diagnostic accuracy of a SARS-CoV-2 saliva antigen test in a real-life clinical setting. 377 individuals who presented at a COVID-19 testing facility affiliated with a university hospital were included. (A) Sensitivities and specificities are given according to RT-PCR, including 95% confidence intervals. (B) Sensitivities in relation to adapted CTs of RT-PCR. The manufacturer uses 40 cycles, and if a signal is detected within these 40 cycles, the sample is considered positive. CT, cycle threshold; RT-PCR, real-time polymerase chain reaction.
See this image and copyright information in PMC

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