The National Blood Service (England) approach to evaluation of kits for detecting infectious agents.

Blood services test their donations for a range of infectious agents before release for transfusion. To ensure that the assays used have appropriate sensitivity, subtype detection range, and specificity, and meet operational requirements (timeliness, automation, and process control), some form of selection is needed. The approach of the English National Blood Service (NBS) to the evaluation of commercial kits to assess their suitability is presented.