健康科学杂志

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Evaluation of a Self-testing Rapid Diagnostic Test Device for Detecting SARS-CoV-2 in Oral Fluid

Zhang Lei, Yang Feng and Zhu Junzhe

Testing continues to be one of the World Health Organization’s (WHO) key strategies to better understanding and monitoring the spread and trends of SAR-CoV-2 transmission. Mounting an effective respond to the virus requires timely detection of cases. In many countries around the world, antigen-based rapid diagnostic tests have been a turning point to getting test results quickly. Antigen rapid tests are a key for point-of-care COVID-19 testing due to faster test results, as well as the tests do not need to be run on existing laboratory infrastructure or require skilled healthcare workers to process the test kits. Faster test results help improve the timeliness of diagnosis and lead to better decision making for managing COVID-19. Self-testing further improves access to testing which can contribute to early detection of COVID-19 and the isolation of confirmed cases.

Objective: The aim of this evaluation report was to explore the reliability and performance of the All Test COVID-19 Antigen Rapid Test for Self-Testing (Oral Fluid) on clinical specimens collected for SARS-CoV-2 diagnosis and compared to a laboratory run RT-qPCR (real-time reverse transcription polymerase chain reaction) test.

Method: The method was to run the All Test Antigen Rapid Test device for detection of SARS-CoV-2 antigen in oral fluid and compare the results to the RT-PCR system whose samples were collected by nasopharyngeal swabs for validation of the performance. The test kits were evaluated according to the procedures described in the manufacturers’ instructions for use.

Results: Concordance for SARS-Cov-2 negative results was 100% between the All Test Antigen Rapid Test and RT-PCR. Concordance for SARS-CoV-2 positive results was also 100% in our series (Ct range from 31-35).

Conclusion: Rapid antigen rests are convenient and economical devices to aid in the rapid diagnosis of SARS-CoV-2 infections. Specimens should be positive by rapid antigen testing if viral burden corresponds to Cycle Threshold (Ct value) of around 33 or less by RT-PCR. This is very frequent with virus-producing patients. In this evaluation, the All Test Rapid antigen test devices provided the expected positive results, and all negative RT-PCR results were concordant.