Blood products and related biologicals

Infectious markers

Reliable in vitro diagnostic devices (IVD) for infectious markers such as hepatitis B and C as well as HIV which are used for screening of blood donations are the prerequisite for the manufacturing of safe blood and blood products. IVDs have reached a high quality and blood products have become much safer since the introduction of modern technologies in the recent years. However, more effort is still needed for the transfer of those technologies around the world to make safe blood common worldwide.

Regulatory authorities do need every possible support to get the technical know-how to build up the regulatory instruments needed for market authorization and production control of IVDs. Besides effective standards for Good Manufacturing Practices (GMP), quality assurance as well as vigilance systems as general tools, regulatory bodies need to build up specific quality criteria for

  • Licensing
  • Batch release control
  • Re-evaluation

of in vitro diagnostic devices that depend on the respective marker.

Those criteria should help to guarantee products of high quality as well as consistent production of IVD batches. High quality of IVDs first of all means to reach the highest possible sensitivity, i.e. recognition of positive samples which needs to be linked to the ability of the assays to make a clear distinction between positive and negative samples.

Many of the IVD assays base their distinction of positive and negative results upon mathematical calculations by using calibrators. Positive and negative controls are provided together with the assays to verify calibration and to control the homogeneity of performance. Those calibrators and controls are developed by manufacturers themselves or are referred to international reference materials.

WHO provides International Reference Materials which contribute to the global harmonization of blood donation and patient testing, to get reliable and constant results of IVDs and to allow the communication of results in a common language worldwide.

These preparations have been developed both for the standardization of nucleic acid amplification technologies and immunoassays.

Reference preparations are established for:

Hepatitis B markers:
Hepatitis C markers:
HIV markers:
HAV markers:
Parvovirus B19 markers:

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Other WHO International Reference Materials

The characteristics of all reference preparations as well as the information regarding establishment can be found in the WHO Reference Material section.

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