Annika Petersson1, Kim Ekblom2,3. 1. Clinical Chemistry and Transfusion Medicine, Växjö Central Hospital, Växjö, Sweden. 2. Department of Research and Development, Region Kronoberg, Växjö, Sweden. 3. Department of Medical Biosciences, Clinical Chemistry, Umeå University, Umeå, Sweden.
Abstract
BACKGROUND: Quality control of residual white blood cells (WBCs) and red blood cells (RBCs) in leukoreduced plasma is mandatory. Although technological advances have been made, analysis of quality controls using routine hematology analyzers has not generally been introduced. The aim of this study was to evaluate if the routine hematology analyzer Sysmex XN-10, (Sysmex Nordic ApS) could be used for quality control of residual WBCs and RBCs in leukoreduced plasma. STUDY DESIGN AND METHODS: Linearity, accuracy, and precision were established for two Sysmex XN-10 analyzers using spiked donor plasma. ADAM rWBC (NanoEnTek) and manual counting in the Bürker chamber (NanoEnTek) were reference methods for WBCs and RBCs, respectively. Twenty-five consecutive leukoreduced donor plasma samples were also tested. RESULTS: For WBCs, the linearity criteria were met for the ADAM rWBC, but not for the Sysmex XN-10 instruments. Precision on both Sysmex XN-10 instruments was accurate only at 6 cells/μL, and accuracy was consistently acceptable only at 5 to 6 cells/μL. The precision and accuracy of the ADAM rWBC were acceptable at 2 to 6 cells/μL. For RBCs, both Sysmex XN-10 instruments and manual counting in the Bürker chamber were linear and fulfilled the precision criteria. Accuracy was acceptable for both Sysmex instruments at 6 to 12 × 109 WBCs/L but fluctuated within the study's measuring range for the Bürker chamber. No false-positive results were seen in the 25 consecutive donor plasma samples tested. CONCLUSION: For quality control purposes of leukoreduced plasma, the Sysmex XN-10 analyzer is suitable for the enumeration of residual RBCs but not of residual WBCs.
BACKGROUND: Quality control of residual white blood cells (WBCs) and red blood cells (RBCs) in leukoreduced plasma is mandatory. Although technological advances have been made, analysis of quality controls using routine hematology analyzers has not generally been introduced. The aim of this study was to evaluate if the routine hematology analyzer Sysmex XN-10, (Sysmex Nordic ApS) could be used for quality control of residual WBCs and RBCs in leukoreduced plasma. STUDY DESIGN AND METHODS: Linearity, accuracy, and precision were established for two Sysmex XN-10 analyzers using spiked donor plasma. ADAM rWBC (NanoEnTek) and manual counting in the Bürker chamber (NanoEnTek) were reference methods for WBCs and RBCs, respectively. Twenty-five consecutive leukoreduced donor plasma samples were also tested. RESULTS: For WBCs, the linearity criteria were met for the ADAM rWBC, but not for the Sysmex XN-10 instruments. Precision on both Sysmex XN-10 instruments was accurate only at 6 cells/μL, and accuracy was consistently acceptable only at 5 to 6 cells/μL. The precision and accuracy of the ADAM rWBC were acceptable at 2 to 6 cells/μL. For RBCs, both Sysmex XN-10 instruments and manual counting in the Bürker chamber were linear and fulfilled the precision criteria. Accuracy was acceptable for both Sysmex instruments at 6 to 12 × 109 WBCs/L but fluctuated within the study's measuring range for the Bürker chamber. No false-positive results were seen in the 25 consecutive donor plasma samples tested. CONCLUSION: For quality control purposes of leukoreduced plasma, the Sysmex XN-10 analyzer is suitable for the enumeration of residual RBCs but not of residual WBCs.
Authors: Chloe Cavagnetto; Richard Alejo Blanco; Hollie McKenna; Laura Willmott; Elif Aydogdu; Nicola Akinyemi; Helena Standring; Simon Procter; Johan W Lagerberg; Elin Johansson; Harry Croxon; Dirk de Korte; Stephen F Garner; Atsushi Shirakami; Jarob Saker; Joachim Linssen; Rebecca Cardigan Journal: Transfusion Date: 2020-11-17 Impact factor: 3.157