1. Clinical evaluation of the SD Biosensor SARS-CoV-2 saliva antigen rapid test with symptomatic and asymptomatic, non-hospitalized patients
- Author
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Zsofia Igloi, Jans Velzing, Robin Huisman, Corine Geurtsvankessel, Anoushka Comvalius, Jeroen IJpelaar, Janko van Beek, Roel Ensing, Timo Boelsums, Marion Koopmans, Richard Molenkamp, and Virology
- Subjects
Male ,RNA viruses ,Physiology ,Coronaviruses ,Epidemiology ,Artificial Gene Amplification and Extension ,Biosensing Techniques ,Polymerase Chain Reaction ,Biochemistry ,Nasopharynx ,Immune Physiology ,Medicine and Health Sciences ,Pathology and laboratory medicine ,Virus Testing ,Multidisciplinary ,Immune System Proteins ,Middle Aged ,Medical microbiology ,Viral Load ,Body Fluids ,Hospitalization ,Carrier State ,Viruses ,Medicine ,Female ,Anatomy ,SARS CoV 2 ,Pathogens ,Research Article ,Adult ,Adolescent ,SARS coronavirus ,Patients ,Science ,Immunology ,Research and Analysis Methods ,Sensitivity and Specificity ,Microbiology ,Antibodies ,COVID-19 Serological Testing ,Young Adult ,Diagnostic Medicine ,Virology ,Humans ,Saliva ,Molecular Biology Techniques ,Molecular Biology ,Aged ,Organisms ,Viral pathogens ,COVID-19 ,Biology and Life Sciences ,Proteins ,Reverse Transcriptase-Polymerase Chain Reaction ,Microbial pathogens ,Health Care ,Viral Transmission and Infection - Abstract
Background Performance of the SD Biosensor saliva antigen rapid test was evaluated at a large designated testing site in non-hospitalized patients, with or without symptoms. Method All eligible people over 18 years of age presenting for a booked appointment at the designated SARS-CoV-2 testing site were approached for inclusion and enrolled following verbal informed consent. One nasopharyngeal swab was taken to carry out the default antigen rapid test from which the results were reported back to the patient and one saliva sample was self-taken according to verbal instruction on site. This was used for the saliva antigen rapid test, the RT-PCR and for virus culture. Sensitivity of the saliva antigen rapid test was analyzed in two ways: i, compared to saliva RT-PCR; and ii, compared to virus culture of the saliva samples. Study participants were also asked to fill in a short questionnaire stating age, sex, date of symptom onset. Recommended time of ≥30mins since last meal, drink or cigarette if applicable was also recorded. The study was carried out in February-March 2021 for 4 weeks. Results We could include 789 people with complete records and results. Compared to saliva RT-PCR, overall sensitivity and specificity of the saliva antigen rapid test was 66.1% and 99.6% which increased to 88.6% with Ct ≤30 cutoff. Analysis by days post onset did not result in higher sensitivities because the large majority of people were in the very early phase of disease ie Conclusion Overall, the potential benefits of saliva antigen rapid test, could outweigh the lower sensitivity compared to nasopharyngeal antigen rapid test in a comprehensive testing strategy, especially for home/self-testing and in vulnerable populations like elderly, disabled or children where in intrusive testing is either not possible or causes unnecessary stress.
- Published
- 2021