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Clinical evaluation of the SD Biosensor SARS-CoV-2 saliva antigen rapid test with symptomatic and asymptomatic, non-hospitalized patients

Authors :
Igloi, Zsofia
Velzing, Jans
Huisman, Robin
Geurtsvankessel, Corine
Comvalius, Anoushka
Jpelaar, Jeroen I.
Van Beek, Janko
Ensing, Roel
Boelsums, Timo
Koopmans, Marion
Molenkamp, Richard
Igloi, Zsofia
Velzing, Jans
Huisman, Robin
Geurtsvankessel, Corine
Comvalius, Anoushka
Jpelaar, Jeroen I.
Van Beek, Janko
Ensing, Roel
Boelsums, Timo
Koopmans, Marion
Molenkamp, Richard
Source :
Igloi , Z , Velzing , J , Huisman , R , Geurtsvankessel , C , Comvalius , A , Jpelaar , J I , Van Beek , J , Ensing , R , Boelsums , T , Koopmans , M & Molenkamp , R 2021 , ' Clinical evaluation of the SD Biosensor SARS-CoV-2 saliva antigen rapid test with symptomatic and asymptomatic, non-hospitalized patients ' , PLoS ONE , vol. 16 , no. 12 December , e0260894 .
Publication Year :
2021

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 RTPCR, 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 <3 days post onset. When breaking down the data for symptomatic and asymptomatic individuals, sensitivity ranged from 69.2% to 50% respectively, however the total number of RT-PCR positive asymptomatic participants was very low (n = 5). Importantly, almost all culture positive samples were detected by the rapid test. 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, espe

Details

Database :
OAIster
Journal :
Igloi , Z , Velzing , J , Huisman , R , Geurtsvankessel , C , Comvalius , A , Jpelaar , J I , Van Beek , J , Ensing , R , Boelsums , T , Koopmans , M & Molenkamp , R 2021 , ' Clinical evaluation of the SD Biosensor SARS-CoV-2 saliva antigen rapid test with symptomatic and asymptomatic, non-hospitalized patients ' , PLoS ONE , vol. 16 , no. 12 December , e0260894 .
Notes :
application/pdf, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1313639759
Document Type :
Electronic Resource