SKUP evaluation of FlowFlex SARS-CoV-2 Ag Rapid Test
SKUP has published a report describing the evaluation of FlowFlex SARS-CoV-2 Ag Rapid Test.
FlowFlex SARS-CoV-2 Ag Rapid Test is an in vitro diagnostic POC rapid test for detection of SARS-CoV-2 antigen in sample material from the nasal cavity (nasal) or using a deep nasal sample (nasopharynx). The evaluation is made on samples from the nasal specimens.
The test is intended for professionals use.
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 users in a dedicated COVID-19 center
The test was performed at two COVID-19 test centres, where a total of 564 close contacts to persons with confirmed SARS-CoV-2 infection, of whom 121 (21%) were tested positive for a comparison method. The results awere assessed according to pre-set quality goals (the results in relation to WHO recommendation for SARS-CoV-2 antigen tests).
- The WHO’s proposed minimum performance requirement of ≥80% sensitivity was not fulfilled
- The WHO’s proposed 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 evaluation report.