Comparison of consistency for different automated hematology analyzers
Qian Yu
Abstract
Qian Yu
Abstract
Objective To estimate the bias of WBC,RBC,HGB,HCT and PLT results measured by different automated hematology analyzers in the lab,ensure the consistency of the results and provide accurate and reliable test results for clinical.Methods According to Clinical and Laboratory Standards Institute(CLSI) document EP9A2,we first adjusted Sysmex XE-2100,XT-1800i and Beckman Coulter LH780 automated hematology analyzers with traceability calibrator,then evaluated precision with supporting quality control.Under satisfactory precision and calibration,the EDTA-K2 anticoagulated blood was measured by XE-2100(as comparison method),XT-1800i and LH780(as experiment method).Then we evaluated the bias of WBC,RBC,Hb,HCT and PLT tests results in different analyzers,calculated the expected bias and the 95% confidence interval of expected bias at medical decision levels and compared to 1/3 allowed total error of to inspect comparability between different analyzers.Results The CV of WBC,RBC,Hb,HCT and PLT tested by different analyzer were less than 1/3 CLIA88 allowed total error,and the precision conformed the requirements.The correlation of the test results between XT-1800i,LH780 and XE-2100 was good and the expected bias of all projects were acceptable.Conclusion The results of WBC,RBC,Hb,HCT and PLT measured by different analyzers have a good consistency,and the differences of them have no statistical significance.
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Objective To estimate the bias of WBC,RBC,HGB,HCT and PLT results measured by different automated hematology analyzers in the lab,ensure the consistency of the results and provide accurate and reliable test results for clinical.Methods According to Clinical and Laboratory Standards Institute(CLSI) document EP9A2,we first adjusted Sysmex XE-2100,XT-1800i and Beckman Coulter LH780 automated hematology analyzers with traceability calibrator,then evaluated precision with supporting quality control.Under satisfactory precision and calibration,the EDTA-K2 anticoagulated blood was measured by XE-2100(as comparison method),XT-1800i and LH780(as experiment method).Then we evaluated the bias of WBC,RBC,Hb,HCT and PLT tests results in different analyzers,calculated the expected bias and the 95% confidence interval of expected bias at medical decision levels and compared to 1/3 allowed total error of to inspect comparability between different analyzers.Results The CV of WBC,RBC,Hb,HCT and PLT tested by different analyzer were less than 1/3 CLIA88 allowed total error,and the precision conformed the requirements.The correlation of the test results between XT-1800i,LH780 and XE-2100 was good and the expected bias of all projects were acceptable.Conclusion The results of WBC,RBC,Hb,HCT and PLT measured by different analyzers have a good consistency,and the differences of them have no statistical significance.
Key concepts: Hematology analyzer, Consistency (knowledge bases), Medicine, Repeatability, Limits of agreement, Spectrum analyzer, Accuracy and precision, Traceability