WHO international standards are approved for use as standards during in-vitro diagnostics testing. In addition, NIBSC supplies 3 ranges of products which are CE marked to comply with the European In-Vitro Diagnostics Directive (IVDD).
The CE-marked range consist of serology and nucleic acid test run controls for use when testing blood for pathogenic viruses such as:
There are also standards for:
There are currently over 20 CE marked working standards available
The QCRU range consists of CE-marked quality control serum reagents for:
There are currently over 30 QCRU reagents available.
The Clinical Virology Network (CVN) range was developed with the assistance of the UK Clinical Virology Network. They consist of CE marked reference materials for use with Nucleic Acid Amplification Techniques for a range of clinically significant viruses. There are currently over 20 CVN reference materials available
All IFU’s are available in English. Translations into other languages are available where there is sufficient demand.Please refer to the current list of available IFU translations (PDF, 305KB)