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The National Institute for Biological Standards and Control

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  • NIBSC develops new-CE marked virus triplex for NAT PCR blood testing – HBC, HCV, HIV

NIBSC develops new CE-marked virus triplex for NAT PCR blood testing – HBC, HCV, HIV

NIBSC are pleased to announce the availability of a very low positive triplex reagent (NIBSC Code 14/198) for NAT assays containing hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus-1 (HIV-1).

This product is CE marked for use as an IVD in Europe. In all other territories it is the sole responsibility of the recipient to ascertain whether it can be used as an IVD. The reagent is supplied in bar coded blood tubes which are suitable for loading directly onto blood analysers. 

Triplex 14/198 is for blood screening laboratories to use in the internal laboratory quality control of NAT assays against HBV, HCV and HIV-1. The reagent is intended to be included in each run as part of a continuing quality control programme to monitor the performance of the assay. This reagent is not intended for any calibration purposes. 

 
 
 
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