NIBSC - IVD standards

In vitro diagnostic standards

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).

CE-marked range

The CE-marked range consist of serology and nucleic acid test run controls for use when testing blood for pathogenic viruses such as:

HTLV-1
HIV
Hepatitis A/B/C

There are also standards for:

flow cytometry
anti-HLA serology
HLA genotyping

There are currently over 20 CE marked working standards available

Quality Control Reagent Unit (QCRU) range

The QCRU range consists of CE-marked quality control serum reagents for:

pathogenic blood viruses (HIV and Hepatitis A/B/C)
Cytomegalovirus (CMV)
Malaria
Syphilis
Rubella
Toxoplasma
Herpes simplex virus (HSV)
Varicella zoster virus (VZV).

There are currently over 30 QCRU reagents available.

Clinical Virology Network products

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

Instructions for Use (IFU) - Translations

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)