The donor line break cannula: effect on the donation process, blood component quality and transfusion microbiology testing of an important new blood bag safety feature.

Background: The use of blood packs with an integral sampling system can result in anti-coagulant from the main bag reaching the sample pouch via the donor line, causing delayed coagulation of blood samples. In NHS Blood and Transplant, this has prevented the use of serum, the preferred matrix for transfusion microbiology (TM) testing, which has led to an increased false positive rate with ethylenediaminetetraacetic acid (EDTA) plasma. There is also a remote possibility of false negative results owing to sample dilution.

Improvement in the performance of HIV screening kits.

The aim of this study was to assess the performance of HIV screening kits introduced over a 12-year period. HIV kits used by the National Blood Service (NBS) were assessed in the context of other HIV kits employed by diagnostic and reference laboratories. Thirty-three HIV screening kits were assessed and 13 had the potential to be used by the NBS.

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 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.

Evaluation of a combined HIV-1/2 and HTLV-I/II assay for screening blood donors.

A combined immunoassay for the simultaneous detection of antibodies to HIV-1/2 and HTLV-I/II (Bioelisa, Launch Diagnostics) has been evaluated to determine its suitability for routine use in blood screening. 84,222 donations were tested from 76,452 donors. One HIV- and 1 HTLV-1-positive donor were identified.