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Diagnostic accuracy of SARS-CoV-2 saliva antigen testing in a real-life clinical setting
Sabrina Jegerlehner1, Franziska Suter-Riniker2, Philipp Jent3
1Department of Emergency Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.
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.
