How do I implement an automated screen for high-titer ABO antibody as an inventory management tool for ABO plasma-incompatible platelets?

BACKGROUND: Plasma volume reduction (PVR) may reduce the risk of hemolysis associated with transfusion of plateletpheresis blood products (PLTs) containing ABO-incompatible plasma. But PVR may delay PLT issue. In collaboration with our blood donor center we evaluated an automated screen of PLT for high-titer ABO antibody and to apply PVR to high-titer PLTs. STUDY DESIGN AND METHODS: At the donor center, plasma from PLT donors was tested using an automated microplate system (PK7300, Beckman). PK settings were set for a detection cutoff equivalent to 1 in 256 using a manual tube method. The donors associated with high-titer PLTs were characterized by sex and age. In the transfusion service, the number of PVR procedures was evaluated before and after implementation of the high-titer screen. RESULTS: During validation, 157 of 1008 PLT units (15%) were positive by the automated method versus 121 (12%) by manual method. After implementation, 2112 of 15,240 PLT units were high-titer, with higher frequency in donations from females versus males (18% vs. 12%, p < 0.0001). The PLT PVR rate was reduced by 50%. CONCLUSION: Implementation of an automated method to screen PLTs for high-titer ABO antibody at the donor center improves the inventory management of PLTs containing ABO-incompatible plasma at the hospital transfusion service.

Frequency and specificity of the Trima Accel "verify WBCs" advisory: considerations for product management.

BACKGROUND: The Trima Accel displays a "verify WBCs" message if the plateletpheresis product (PLT) may not be leukoreduced (LR). Most blood banks require sensitive white blood cell (WBC) testing of these PLTs by flow or Nageotte. We evaluated how often these PLTs were non-LR by European or US Food and Drug Administration (FDA) criteria and whether sensitive WBC testing is necessary. STUDY DESIGN AND METHODS: Phase 1 reviewed the frequency of this message with various procedure types and the flow WBC results for PLTs with or without the message. Phase 2 assessed how many FDA LR failures were detectable by a hematology analyzer. In Phase 3, PLTs were managed by hematology analyzer results. RESULTS: In Phase 1, 3.8% of PLT-only and 11.1% of PLT-plasma collections had the "verify WBCs" message. Only 1% of "verify" PLTs contained more than 1 × 10(6) WBCs and only 0.5% were FDA LR failures. In Phase 2, 10 of 670 "verify" PLTs and one nonflagged PLT were FDA LR failures. Six of 11 LR failures had hematology analyzer WBC concentrations of 0.4 × 10(9) /L or higher. In Phase 3, "verify" PLTs were allowed in inventory if hematology analyzer WBC concentration was below 0.4 × 10(9) /L; inventory quality control showed no FDA LR failures by flow. Trima Version 6.0 software lowered the "verify" message frequency in PLT-plasma procedures but not in PLT-only procedures. CONCLUSION: Four percent of Trima PLT collections have the "verify WBCs" message but almost all of these are LR by European and FDA criteria. Fifty percent of FDA LR failures were detectable by a hematology analyzer. Sensitive WBC testing of all "verify WBCs" PLTs may not be necessary to satisfy LR quality assurance requirements.

Feasibility of routine individual donation testing for West Nile virus RNA during epidemic season using the investigational Roche cobas TaqScreen West Nile virus test and cobas s 201 system prototype.

BACKGROUND: Minipool (MP) screening for West Nile virus (WNV) RNA may fail to detect presumptive viremic donations (PVDs) detectable by individual donation screening (IDS). Most blood centers switch collection regions to IDS when PVD detection by MP screening reaches a certain frequency. Use of IDS for all donations during WNV season was assessed during a clinical trial of the Roche cobas TaqScreen WNV test. Also evaluated was whether PVD detection reliably identifies regions that should be targeted for IDS. STUDY DESIGN AND METHODS: Test results, deviation reports, and service records were reviewed for 13.5 weeks of IDS in 2006 and 11.5 weeks of IDS in 2007. Numbers of PVDs and clinical WNV cases were obtained from public health and AABB Web sites and regional donor centers. RESULTS: Approximately 1000 donations were tested per week divided in six test runs. Each run required 1.2 shifts of technologists plus volunteers. A total of 7.2 percent of samples were initially unreportable in 2006 and 4.8 percent in 2007. Of 26,952 donations screened by IDS, none were reactive for WNV. A comparison of PVD and clinical case reports indicates that PVD detection in areas with intermediate or high clinical case prevalence may not reach commonly used criteria for triggering testing to IDS. CONCLUSION: Seasonal IDS was feasible using the cobas TaqScreen WNV test on the s 201, although staffing was impacted and a relatively high number of samples required retesting because of error messages. Seasonal IDS utilizing this highly specific assay may be a reasonable alternative to IDS triggered by regional PVD detection.