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June 8, 2021
HANGZHOU ALLTEST BIOTECH CO.,LTD said that is recently received Europe CE OTC certificate for its COVID-19 Antigen Rapid Test (oral fluid) for self testing, and is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens present in human oral fluid.
This test is designed for home use with self-collected oral fluid samples in individuals who are suspected of COVID-19. The strengths of OTC COVID-19 Antigen Rapid Test (saliva) are EASY (specimen collection), FAST (results in 15 minutes assay time), SIMPLE (operation, no equipment required), and HIGH ACCURACY.
The OTC COVID-19 Antigen Rapid Test (saliva) obtain a preliminary results only, the final confirmation should be based on clinical diagnostic results. Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
A clinical evalution was conducted comparing the results obtained the COVID-19 Antigen Rapid Test with RT-PCR test results. The clinical trial included 406 oral fluid specimens. According to ALLTEST, the test results demonstrated 99.3% specificity and 90.1% sensitivity with an overall accuracy of 97.0%. The observed accuracy may vary depending on the prevalence of the virus in the population.
ALLTEST provide a complete solution for COVID-19 diagnosis, which is providing multiple choices of reliable COVID-19 rapid tests (both Antigen and IgG/IgM antibody tests) in time. Located in Hangzhou Economic and Technologic Development Area, P.R China.