22-23 October 1999. To outline the value of evaluation of test kits with continued assessment of performance in achieving safety in blood transfusion. The pristine performance of screening tests is the key to assuring that transmission of HIV and other blood-borne infection does not occur. The Blood Service must be sure that tests operate at maximum sensitivity without compromise to specificity which will result in unnecessary wastage of blood. Sensitivity to low affinity, low levels of antibody seen during seroconversion is also of great importance and the window period must also be assessed.
Some large centres conduct large evaluation studies which can be built upon.
These parameters may be assessed as a baseline evaluation. However other considerations must be taken into account. These include the quality in production of the kits, the ability of the technical staff to implement the use of the kit, quality assurance available and assessment of variation in use. It is essential that blood service staff are aware of evaluation and how to assess the data in order to be sure that the assays are operating to the levels they expect. However, this must be a continuing process to assure the safety of the blood supply.