NADAL COVID-19 Ag Test
SKUP has published a report describing the evaluation of NADAL COVID-19 Ag Test.
NADAL COVID-19 Ag Test is an in vitro diagnostic POC rapid test for detection of SARS-CoV-2 Antigen in sample material from the nasal cavity (vestibulum nasi) or using a deep nasal sample (nasapharynx).
The instrument is intended for use by healthcare professionals.
The report provides a vendor-independent evaluation of the analysis quality and user-friendliness of the instrument when used under real life conditions by users in a COVID-19 test center.
The evaluation was carried out in dedicated COVID-19 test centres, with the participation of 679 persons exposed to individuals with confirmed SARS-CoV-2 infection, of whom 78 (11 %) tested positive on the comparison method.
- 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.