SKUP evaluation of MF-68 SARS-CoV-2 Antigen Test
SKUP has published a report describing the evaluation of MF-68 SARS-CoV-2 Antigen Test.
MF-68 SARS-CoV-2 Antigen Test is an in vitro diagnostic rapid test for detection of SARS-CoV-2 antigen in nasal, nasopharyngeal and oropharyngeal swab specimens. The test is intended for professionals use.
The evaluation was made on nasal swab specimens.
The report provides an objective and supplier-independent information about the analytical quality and user-friendliness of the test when used under real life conditions by intended users in a dedicated COVID-19 test centre
A total of 321 persons with high probability of SARS-CoV-2 infection participated in the evaluation, of whom 211 (66 %) tested positive on the comparison method. The results are assessed according to pre-set quality goals (WHO recommendation for SARS-CoV-2 antigen tests).
- WHO’s recommended minimum performance requirement of ≥80% sensitivity was not fulfilled
- WHO’s recommended minimum performance requirement of ≥97% specificity was fulfilled
- The user-friendliness was rated as satisfactory.
On SKUP’s website www.skup.org you can find the SKUP evaluation report and a short summary of the evaluation.