WHO (World Health Organization) Emergency Quality Assessment Mechanism for EVD (Ebola Virus Disease) IVDs (In Vitro Diagnostics): Public Report; Product: RealStar® Filovirus Screen RT-PCR Kit 1.0 (2019) | NLM

Disaster Information Management Research Center | NLM

WHO (World Health Organization) Emergency Quality Assessment Mechanism for EVD (Ebola Virus Disease) IVDs (In Vitro Diagnostics): Public Report; Product: RealStar® Filovirus Screen RT-PCR Kit 1.0 (2019)

01/01/2019 12:00 AM EST

Source: World Health Organization (WHO). Published: 1/2019. This 41-page document describes the 2019 updated emergency quality assessment mechanism for Ebola virus disease in vitro diagnostics for RealStar® Filovirus Screen RT-PCR Kit 1.0. This product is a manual in vitro diagnostic test, based on real-time PCR technology, for the qualitative detection and differentiation of Ebola- and Marburg virus- specific RNA in human EDTA plasma. (PDF)