The systematic monitoring of transfusion microbiology test kit performance.

The Transfusion Microbiology Test Systems Monitoring Group (TMTSMG) was established as a National Blood Service (NBS) working group to monitor the performance of the microbiology screening assays used within the NBS Testing Laboratories. The group's primary objective was to ensure that technical performance (especially sensitivity, specificity and wastage) remains consistent with that established during validation. This includes the identification and investigation of significant variation in performance and any untoward incidents. The group is also responsible for optimizing transfusion microbiology working practice across the NBS through nationally agreed standards and procedures. Over the past 9 years, a total of 44 assays from 15 suppliers have been monitored. Five assays have been withdrawn from use as a result of identified poor performance; two hepatitis B virus surface antigen assays owing to poor sensitivity, two syphilis agglutination assays with nonspecific (false) reactive rates sustained above contract limits and one human cytomegalovirus antibody assay that persistently failed the manufacturer's quality control criteria. This approach has enabled the differentiation of genuine kit performance issues from 'natural variation' in kit performance, and local instrumentation or training issues. The NBS has been able to address the issues with suppliers much earlier and resolve minor issues before they became major problems. In addition, a lot release system has been developed and implemented, comprising a formal, centralized initial scientific assessment of each new manufacturer's lot, followed by 'delivery acceptance' testing at each site. This system helps to ensure that the evaluated minimum sensitivity and specificity of the assays is maintained from 'lot to lot'.