CLINITEST Rapid COVID-19 Antigen Test
SKUP has published a report describing the testing of the CLINITEST Rapid Covid-19 Antigen Test from Siemens Healthineers.
CLINITEST Rapid COVID-19 Antigen Test is a rapid test for the detection of SARS-CoV-2 antigen in samples from either the nasal cavity (vestibulum nasi) or from the nasopharynx.
The system is intended for 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 intended users in a dedicatede Covid-19 test center.
The evaluation was performed at a Covid-19 test center in Oslo where 672 close contacts to individuals who within 10 days were tested positive for SARS-CoV-2 participated. In the test, nasopharyngeal samples were used on the CLINITEST Rapid Covid-19 Antigen Test.
- The quality goal for diagnostic sensitivity was not fulfilled.
- The quality goal for diagnostic specificity was fulfilled.
- The quality goal for user-friendliness was fulfilled
On SKUP’s website www.skup.org you can find the evaluation report.
Here you will also find an overview of ongoing evaluations and published SKUP reports.