News

Autobio Announces CE-Mark for Rapid SARS-CoV-2 Self Test Kits

Source:Autobio DiagnosticsTime:2022.03.24

Autobio Diagnostics obtains a CE mark for its SARS-CoV-2 Self Test Kit today, paving the way for the sales of the test directly to European Market. The SARS-CoV-2 antigen rapid test for home use is available in packs of 1 test, 2 test, 5 tests, and 20 tests. The test is designed as a colloidal gold immunochromatography assay for qualitative identification of Covid-19 virus.

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Using anterior nasal swabs, the test provides results in 15 minutes without any instrumentation. Self-testing makes it more convenient for individuals above 2 years old to identify whether someone was infected by the virus and helps mitigate the spread of Covid-19 among European countries and communities.   

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Clinical assessment shows that Autobio SARS-CoV-2 Antigen Self Test has a sensitivity of 94.55% and a specificity of 100 %. Besides, the assay remains stable accuracy in sensitivity and specificity for detecting SARS-CoV-2 variants, including Alpha, Beta, Gamma, Delta and Omicron.

 

It only takes 4 steps to get a reliable result. Collect sample with a gentle anterior nasal swab, then swirl the swab in the Extraction Reagent. Drip four drops of samples into the cassette. Start the timer and read your result after 15 minutes.

 

With CE mark approval for the SARS-CoV-2 Self-Test, Autobio Diagnostics have been able to provide all kinds of COVID-19 testing products for both professional use and self-test use. As the first self-test kit with CE certification, more self-test product is in development and will be available soon. Stay tuned. Follow us at Facebook, Linkedin, Youtube and Twitter for latest updates of Autobio.

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