NewScen HIV(1+2) and HCV rapid test kit has successfully passed the performance evaluation from three reputable European professional laboratories: Institute of Tropical Medicine (Belgium)、Sanquin Diagnostic services( the Netherlands) and the German Red Cross(Germany) –Baden-Württemberg-Hessen gGmbH (DRK), by Qarad b.v.b.a( Europe Clinic Coordination Body ).
This performance evaluation is in accordance with CTS, which is a common technical specifications of Directive 98/79/EC on In Vitro Diagnostic Medical Device (IVDD), Annex II: List A, It has finished tests of 20 serum panel with 2650 samples, and the result shows that its sensitivity and specificity has met the requirements of CE certification ,and especially for the analytical sensitivity is superior to the CE marked products on the market.
On account of its high sensitivity ,it is expected to be widely used in the diagnosis of AIDS and Hepatitis C.
