Blood products and In vitro diagnostics
Since the middle of the 20th century, medical science has found ways to prepare therapeutic products derived from human blood and plasma for the treatment of many life threatening diseases, as well as for complex surgical procedures. Processing blood into various types of medicines or products is a highly specialized process because blood products and biological technologies are inherently variable due to the nature of the source materials as well as the methods to test them. Only blood products of demonstrated quality, safety and efficacy should be used, which is the overall responsibility of the National Regulatory Authorities (NRA) worldwide.
Some NRAs are also responsible for evaluation, control and approval of certain in vitro diagnostic devices (IVD). WHO provides WHO biological reference materials for applications in the standardization of materials and approaches used in medical diagnostics such as:
- diagnosing disease
- monitoring therapy
- blood safety, and
- public health applications (e.g. monitoring immune status, screening for disease or susceptibility) or otherwise characterizing biological material from individuals.
The current focus of WHO's work in this area is for IVDs that are either used in blood screening, clinical diagnosis or plasma pool testing prior to entering the blood fractionation process.