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July 13, 2021
HANGZHOU ALLTEST BIOTECH CO.,LTD said that is recently received Europe CE OTC certificate for its COVID-19 Antigen Rapid Test (Nasal Swab) for self testing, and is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen from symptomatic individuals who are suspected of being infected with COVID-19.
The OTC COVID-19 Antigen Rapid Test (Nasal Swab) 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 874 oral fluid specimens. According to ALLTEST, the test results demonstrated 99.4% specificity and 95.4% sensitivity with an overall accuracy of 97.8%. The observed accuracy may vary depending on the prevalence of the virus in the population.
Prior to this, ALLTEST has already obtained CE OTC Certified in the product of COVID-19 antigen rapid test (Oral Fluid) for self-testing. The acquisition of the COVID-19 Antigen Rapid Test (Nasal Swab) access qualification signifies that this series of products for self-testing has been recognized once again.
ALLTEST provide a complete solution for COVID-19 diagnosis, which is providing multiple choices of reliable COVID-19 rapid tests (both Antigen and Antibody tests) in time. Located in Hangzhou Economic and Technologic Development Area, P.R China.