Background/Case Studies: In 2023, our blood center piloted and replaced the PocHi-100 Automated Hematology Analyzer (Sysmex) with the XW-100 Automated Hematology Analyzer (Sysmex) to measure pre-plateletpheresis platelet counts. The PocH-100i is a commonly used moderate complexity CLIA test system. It can report 17 complete blood count (CBC) parameters, with the ability to hide parameters. As such, we had programmed our PocH-100i machines to only report platelet counts. The XW-100 is the first CLIA-waived automated CBC analyzer that was cleared by the FDA on 11/16/2018. The machine suppresses results that are questionable and recommends further testing. A significant difference between the PocH-100i and XW-100 is that the XW-100 does not allow hiding of reported parameters, meaning that all 12 CBC parameters are reported. As part of our new standard operating procedure (SOP), we had to determine how to address suppressed results. We decided to proceed with collections of donors with suppressed white blood cell counts (WBC) with the plan of running a CBC on the retention tube using the Sysmex XE2100D in our hematology lab. If white cell counts were within normal range (3-12 x 103/µL), the platelet product could be released. If counts were outside this range, the medical director would be contacted to determine action. We also planned to collect this data to determine if we could forgo running of the retention tube in the future. The aim of this abstract is to share our experience with the use of the XW-100 to measure pre-procedure platelet counts.
Study
Design/Methods: We performed prospective data collection on platelet collections in which the XW-100 suppressed WBC results. We collected information on the donor demographics, XW-100 results, and Sysmex XE2100D CBC results.
Results/Findings: Within a two-week period, we have had 36 cases in which WBC results have been suppressed by the XW-100. WBC count results from the retention tube show that white cell counts were within normal range in 34 of the 36 samples run (94%). The Sysmex XE2100D values ranged from 2.81-9.44 x 103/µL with a median value of 5.09 x 103/µL. The two out of range WBC results were 2.81 and 2.96, and both products were released into inventory with medical director approval. Of note, 5 of the 36 samples also had suppressed hemoglobin and hematocrit results. We use the HemoCue as the test of record and thus had decided to proceed with platelet collections if RBC parameters were suppressed. As expected, the hematology lab results demonstrated normal hemoglobin and hematocrit values on all 36 samples. Of note, none of the products had a WBC QC needed flag added by apheresis cell separator which is expected if the product has high WBC count. Conclusions: We intend to continue platelet collections on donors that have suppressed WBC (and/or Hemoglobin) results on XW-100 platform and release products without further testing by modifying our procedure.
Importance of research: The XW-100 is the first CLIA-waived hematology analyzer. The CLIA complexity of this instrument has many advantages of the PocH-100i, which is used in many blood centers to determine pre-plateletpheresis platelet counts. Not many blood centers have switched to the XW-100 and we wanted to share our experience with the challenges we have faced with the different reporting of CBC values.
