Blood products and related biologicals

Regulation of in vitro diagnostic devices

A single contaminated blood plasma donation can spread infections (HIV, hepatitis) throughout the world. On the basis of 81 million donations per year in 178 countries worldwide only around 60% would be subject to stringent safety requirements. Deficient regulatory systems or lack of appropriate tests still account for about 40% of donations globally. The safety of products manufactured from plasma is dependent on the measures taken to minimize the contamination of the starting material (donor selection, screening and testing).

National Medicinal Regulatory Agencies (MRA) are responsible for evaluation, control and approval of in vitro diagnostic devices (IVD). IVD for infectious markers are either used in blood screening, clinical diagnosis or plasma pool testing prior to entering the fractionation process. Beyond blood safety they are also crucial tools for blood typing and the control of anticoagulant therapy.

Evaluation and quality control of in vitro diagnostic devices (IVD) are essential for

WHO contributes to the provision of the tools needed in the implementation of the respective quality assurance and safety procedures and for the dissemination of the relevant technology and expertise worldwide.

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Triatomine. Santos L.C. LDP-IOC-Fiocruz
Triatomine. Santos L.C. LDP-IOC-Fiocruz