Siemens Healthineers Starts Delivery of Test Kit for Coronavirus SARS-CoV-2, Now CE-IVD Registered
Siemens Healthineers registered its molecular Fast Track Diagnostics (FTD) SARS-CoV-2 Assay2 test kit for diagnostic use with the Luxembourg Ministry of Health. This registration of the kit, which was released for research use only (RUO) on April 2, 2020, allows for immediate rollout of the testing kit for diagnostic use in Europe.
- Test Kit Registered and Available for Diagnostic Use in EU
- CE labelling allows for molecular diagnostic test kit to be used in clinical practice
- Test has shown 100% (91.8-100, 95% CI) diagnostic sensitivity and 100% (93.8-100, 95% CI) diagnostic specificity