ABSTRACT
Objective To evaluate Sysmex XS-800i,XS-1000i and XE-2100D hematology analyzers when used to detect RBC count,hemoglobin (HGB),hematocrit (HCT),mean corpuscular volume (MCV),mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC).Methods XE-2100D hematology analyzer was calibrated after performance evaluation,and the three analyzers had the intra-day precisions measured with three levels of whole-blood quality control materials.Totally 50 whole-blood specimens were detected with the three analyzers respectively,and statistical analyses and clinically acceptable performance evaluation were carried out on RBC count and the obtained results.Results XE-2100D hematology analyzer met the clinical requirements,and the three analyzers all gained high precisions when used to measure the parameters of the whole-blood quality control materials.The correlation coefficients (r2) respectively between the three analyzers were all higher than 0.95 when used to test the 50 specimens.At all medical decision levels XS-800i and XS-1000i hematology analyzers both gained acceptable detection results except XS-800i hematology analyzer in case of 5.9×1012/L RBC count as well as 35％ or 50％ HCT.Conclusion Sysmex XS-800i,XS-1000i and XE-2100D hematology analyzers have high precisions and correlations when used to detect RBC count,HGB,HCT and MCV,and contrast test is suggested to be executed periodically to ensure the comparability of tbe result.
ABSTRACT
Objective According to the comparison and deviation assessment of the part item test results between the OLYMPUS AU640 and BECKMAN AU5821 automatic biochemical analyzer in the laboratory,explore whether the test results between the 2 biochemical analyzers is comparable or not.Methods Reference EPg-A2 file requirements of the American Clinical Laboratory Standardization Committee(NCCLS),test the fresh clinical mixed serum and quality control serum in the 2 equipments respectively,the OLYMPUS AU640 is the reference equipment,the BECKMAN AU5821 is alignment equipment,using regression analysis and paired t test to compare the test results and deviation assessment of the same item,the standard is 1/2 of the total error which the American clinical laboratory improvement amendment (CLIA' 88)allowed,evaluate test results whether is comparable or not.Results Most test results showed good consistency between the 2 biochemical analyzers.Conclusion Through the comparison and deviation assessment in the different biochemical analyzers,the correlation of the same test results can be validated,it is useful to evaluate and correct the equipment,and meet the needs of the clinical.
ABSTRACT
Objective To perform the comparison and deviation analysis on the detection results among 7 automatic biochemical analyzers in the Abbott pipeline ,and to investigate the comparability of the same item results detected by different biochemical anal‐ysis systems .Methods The sixth analyzer was used as a reference ,the remaining six analyzers as the inspection systems .When the precision reached the requirement ,different concentrations of fresh mixed serum samples were detected by different instruments . The detection results of various items were performed the comparison and deviation analysis .The systematic error of medical deci‐sion level was served as the standard of methodological comparison .The clinical acceptability of different detection systems was judged with 1/2CLIA′88 allowable total error range as the standard .Results The SE% of TP ,ALB ,ALT ,AST ,GGT ,TBIL , BUN ,Cr ,GLU ,UA ,K ,Na ,P ,TC and TG were in the allowable ranges regulated by 1/2CLIA′88 ,the test results were in the clini‐cally acceptable levels ;the SE% of Cl and Ca were in the outside of the allowable ranges ,the results had no comparability ,but the results could reach the comparability by calibrating the self‐built detection system .Conclusion Conducting the comparison and de‐viation analysis of the results detected by different biochemical analyzers in the pipeline system at regular intervals is conducive to ensure the constancy of detection systems in the same laboratory and the traceability of their results to provide more accurate and reliable results for clinic .