In order to offer our customers the greatest possible security, we are also constantly developing our rapid antigen test. A new version of the Testsealab Antigen Rapid Test is now available on the European market. This was evaluated in a new clinical study and showed top performance in terms of sensitivity and specificity.
To determine the sensitivity, 125 PCR-positive test persons were examined, 97.6% of which were correctly identified 95% CI: (94.9% -100%). To determine the sensitivity, 250 PCR-negative test persons were examined, 98.4% of which were correctly recognized, 95% Cl: (96.9% -99.9%). The test thus achieves a convincing overall accuracy of 98.1%.
The test is already listed with the new performance data at the Federal Institute for Drugs and Medical Devices (BfArM) under the number AT082 / 20 and is therefore reimbursable.
BfArM: Antigen tests for direct pathogen detection of the coronavirus SARS-CoV-2