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.