CTK’s OnSite® COVID-19 Ag Rapid Test is on the EU Common List and EU Mutual Recognition List! Our test meets the requirements for both Nasal and Nasopharyngeal specimens for individuals suspected of COVID-19 within the first seven days of the onset of symptoms.
The EU Common List requires that rapid antigen tests meet a minimum performance of ≥ 90% sensitivity and ≥ 97% specificity, are validated by at least one EU Member state, and have CE mark. The EU Mutual Recognition List is based on meeting the EU Common List requirements plus having three or more EU member states use the rapid antigen test.
CTK is the only company to demonstrate data for samples from patients who were asymptomatic and/or showed mild symptoms for EU Common List consideration.
Being on both of these lists is a significant accomplishment and demonstrates CTK’s commitment to developing quality diagnostics tests.
CTK has submitted for WHO EUL Assessment and is awaiting approval of CE certificate for Self-Testing.
To visit our page on the EU Common list, click here