ANTIGEN TESTS SANSURE IVDst CE, pack of 25 pcs

COVID-19 ANTIGEN TEST WITH POSSIBILITY OF SAMPLING FROM THE FRONT OF THE NOSE OR NASOPHARYNX WITH RESULT WITHIN 15 MINUTES

Fast and gentle 2-in-1 colloidal gold antigen test for high quality detection of SARS-CoV-2 nucleocapsid protein (N-protein) antigen. These antigen tests are designed for testing persons with suspected COVID-19 by the anterior nasal swab method (Ministry of Health exemption for self-testing) or nasopharyngeal swab method (for trained healthcare personnel only) with results within 15 minutes. 

Sensitivity 98.4 %, specificity 98.1 % and overall agreement 98.23 %.

The overall sensitivity and specificity results compared to the PCR method of these high quality SANSURE antigen tests were performed on 1,132 samples (491 positive samples and 641 negative samples)

The test is intended for self-testing by the general public.

These tests have been authorised by the Ministry of Health according to Article 4(8) of Government Decree No. 56/2015 Coll. for self-testing from 1 May 2021, MZDR 15854/2021-2/OLZP. These tests are duly registered by the State Institute for Drug Control (SÚKL) for self-testing (IVDst) under the decision registration number 01033322. 

Our antigen tests were included in the testing conducted by the Institute of Organic Chemistry and Biochemistry of the Czech Academy of Sciences and performed very well. The full report of this testing can be found here.

The package contains 25 test cassettes, prefilled tubes with buffer, caps for the tubes, sampling sticks and instructions for use in Czech language.