(P-BB-55) Lower Cost of Monitoring Leukocyte Reduction QC of Platelets With No Sampling

Background/Case Studies: Final FDA guidance for quality control (QC) monitoring of the leukocyte reduction process for platelets collected by automated methods (2012) recommended using a statistically valid plan that would achieve at least 95% confidence that more than 95% of the components would meet their recommended results1. A statistically valid sampling plan would need to identify representative platelet collections for each leukoreduction method (each filter type or each type of apheresis collection device). The guidance went on to say that a two-stage sampling approach based on the hypergeometric distribution could be used for monthly QC.

FDA guidance also requires measuring the actual platelet yield after each collection2. A hematology cell counter received 510(k) approval on May 23, 2022 for QC release testing of components including residual WBC count (rWBC) of leukoreduced platelets. This cell counter now provides an automated method of simultaneously testing every platelet collection for platelet yield and rWBC. It is now possible for sites collecting less than or equal to 2,500 platelets per month with one device type to test all collections and therefore meet or exceed FDA quality recommendations for leukoreduction at lower reagent costs as compared to sites using two-stage sampling allowing one failure, and licensed flowcytometry reagents (the predicate method). Similarly, cell counter users can test less than or equal 2,000 platelets per month and have lower reagent costs than sites using two-stage sampling allowing one failure and fluorescent image analysis reagents (FIA).

Study

Design/Methods: Reagent cost per rWBC with the cell counter is the estimated cost of a platelet count in blood bank mode divided by two tests (platelet count and rWBC).
Reagent cost for flowcytometry approved reagents is the estimated kit cost divided by 50 tests
Reagent cost for FIA is the estimated kit cost divided by 50 tests.

Results/Findings: Collections by
site and by Sample size Reagent Cost of Reagent Cost of Reagent Cost of
instrument 1 failure allowed rWBC / cell counter rWBC / flowcytometry rWBC / FIA
100 65 $ 50.00 $ 975.00 $ 780.00
1000 90 $ 500.00 $ 1,350.00 $ 1,080.00
1500 91 $ 750.00 $ 1,365.00 $ 1,092.00
2000 92 $ 1,000.00 $ 1,380.00 $ 1,104.00
2500 92 $ 1,250.00 $ 1,380.00 $ 1,104.00

Conclusions: The approved cell counter for QC release ensures that all leukoreduced platelets collected by automated methods meet the expected QC recommendations before product labeling, and at a lower cost of reagents as compared to sites using two-stage sampling allowing one failure and flowcytometry for up to 2,500; or 2,000 collections per month for those using FIA.

Importance of research: The abstract illustrates how a cell counter recently approved for leukoreduction QC can reduce reagent cost and improve product quality by obtaining a residual WBC count simultaneously with a platelet count for all collections from automated methods