Author:
Terada Norihiko,Akashi Yusaku,Takeuchi Yuto,Ueda Atsuo,Notake Shigeyuki,Nakamura Koji,Suzuki Hiromichi
Abstract
AbstractIntroductionRapid qualitative antigen testing has been widely used for the laboratory diagnosis of COVID-19 with nasopharyngeal samples. Saliva samples have been used as alternative samples, but the analytical performance of those samples for qualitative antigen testing has not been sufficiently evaluated.MethodsA prospective observational study evaluated the analytical performance of three In Vitro Diagnostics (IVD) approved COVID-19 rapid antigen detection kits for saliva between June 2022 and July 2022 in Japan using real-time reverse transcription polymerase chain reaction (RT-PCR) as a reference. A nasopharyngeal sample and a saliva sample were simultaneously obtained, and RT-PCR was performed.ResultsIn total, saliva samples and nasopharyngeal samples were collected from 471 participants (140 RT-PCR-positive saliva samples and 143 RT-PCR-positive nasopharyngeal samples) for the analysis. The median Ct values were 25.5 (interquartile range [IQR]: 21.9-28.8) for saliva samples and 17.1 (IQR: 15.5-18.7) for nasopharyngeal samples (p<0.001). Compared with saliva samples of RT-PCR, the sensitivity and specificity were 46.4% and 99.7% for ImunoAce SARS-CoV-2 Saliva, 59.3% and 99.1% for Espline SARS-CoV-2 N, and 61.4% and 98.8% for QuickChaser Auto SARS-CoV-2, respectively. The sensitivity is >90% for saliva samples with a moderate-to-high viral load (Ct<25), whereas the sensitivity is <70% for high-viral-load nasopharyngeal samples (Ct<20).ConclusionCOVID-19 rapid antigen detection kits with saliva showed high specificities, but the sensitivities varied among kits, and the analytical performance of saliva qualitative antigen detection kits was much worse than that of kits using nasopharyngeal samples.
Publisher
Cold Spring Harbor Laboratory
Reference26 articles.
1. Hanson KE , Caliendo AM , Arias CA , Hayden MK , Englund JA , Lee MJ , et al. The Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Molecular Diagnostic Testing. Clin Infect Dis 2021;ciab048. https://doi.org/10.1093/cid/ciab557.
2. Diagnostic performance and characteristics of anterior nasal collection for the SARS-CoV-2 antigen test: a prospective study;Sci Rep,2021
3. The Sensitivity and Costs of Testing for SARS-CoV-2 Infection With Saliva Versus Nasopharyngeal Swabs: A Systematic Review and Meta-analysis;Ann Intern Med,2021
4. World Health Organization. Antigen-detection in the diagnosis of SARS-CoV-2 infection. https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays. [Accessed 20 October 2022].
5. Rapid, point-of-care antigen tests for diagnosis of SARS-CoV-2 infection;Cochrane Database Syst Rev,2022