Application of the Requirement of Biological Variation Determination in the Quality Management of Blood Cell Analyzer / 现代检验医学杂志

Objective To study application of the quality management of Blood Cell Analyzer according to the requirement of biological variation determination.Methods Collected the indoor imprecision value(CV％) from 8 items detected by blood cell analyzer during from April to Nov.of 2016,and the bias (Bias％) of 8 items of two EQA (external quality assessment) from the ministry of health in 2016.Then according to the 3 levels of the minium,appropriate and optimal quality specifications derived from the biological variability the rates of imprecision and bias were culculated.The pass rate of the imprecision and bias was calculated.By using mean bias and mean imprecision and biological variation 3 levels of total error (TEa) crite rion,and to calculate the corresponding σ and QGI value,so as to evaluate the performance of whole blood cell analyzer.Then improved the quality.Results For the imprecision value of 8 items,except the MCHC average value,all others were all 100 ％ meeting the appropriate level of quality requirements.For the bias value (Bias ％) from 8 items,except MCH,all others were over 80 ％ meeting the appropriate level of quality requirements.While for the calculated σ value,based on the best level of quality requirements,except the σ value of WBC was 4.6,the σ value of all other items were all＜3.Based on the appropriate level of quality requirements,except the σvalue of MCHC was 1.9,the value of σ of all other items were all＞ 3,and based on the minimal requirements,the σ value of all 8 items were all ＞3.After analysis,this blood cell analyzer,except that MCHC should use the minimal quality standard requirements,all other examination items could used the proper quality standard requirements,and the calculated QGI were all ＜0.8.Conclusion Based on the biological variation determination requirement and calculated σ and QGI value,this method could be used to more accurate quality evaluation of blood cell ana lyzer.Which is a higher levelof quality management,will be more conducive to quality improvement and better serve the clinical.

Investigations on the effect of measuring value transfer for human serum samples assigned by the reference laboratory network / 临床检验杂志

Objective To investigate the effect of measuring value transfer for human serum samples assigned by the reference laboratory network on improving the trueness of seven enzyme activities in clinical laboratories,such as ALT,AST,GGT,LDH,CK,AMY and ALP.Methods Depending on the medical imtitutions at all levels contacted by 5 reference laboratories in North China,South China,East China and Southwest China,the corresponding clinical laboratory measuring value transfer/traceability network was established.The frozen human serum samples with good interehangeability and standard material characteristics,including calibrator,sample 1 and sample 2,were provided by Beijing Aerospace General Hospital,and were assigned by 5 reference labotatories in four regiom.These samples were sent to 48 clinical laboratories.These clinical laboratories measured sample 1 and sample 2 according to their standard operating procedures,and then measured.the two samples again after adjusting their measurement system by using the supplied calibrator.The changes of trueness of detection results in these laboratories were evaluated according to the WS/T 403-2012 standard,and the changes of consistency for ALT and AST before and after measuring value tramfer were investigated.Results The results of AMY,ALP,GGT,CK and LDH calibrator,sample 1 and sample 2 assigned by the established network were 138.7 U/L,278.5 U/L and 68.3 U/L,265.3 U/L,94.5 U/L and 134.4 U/L,195.8 U/L,89.0 U/L and 158.9 U/L,393.7 U/L,260.0 U/L and 645.3 U/L,and 302.0 U/L,250.0 U/L and 452.7 U/L,respectively.The percentages of sample 1 and sample 2 which met the bias requirements of the WS/T 403-2012 standard before measuring value transfer for AMY,ALP and GGT were 65.9％ and 61.0％,76.6％ and 78.7％,and 66.7％ and 70.8％,respectively,while after measuring value transfer,they were 89.2％ and 83.8％,86.7％ and 80.0％,and 85.4％ and 91.7％,respectively.The percentages of sample 2 which met the bias requirements of the WS/T 403-2012 standard before measuring value transfer for CK and LDH were 64.6％ and 58.3％,respectively,while after measuring value trander,they were 93.5％ and 84.8％,respectively.The coefficients of variation (consistency) of sample 1 and sample 2 for ALT and AST before measuring value tramfer were 12.9％ and 11.3％,and 10.2％ and 8.9％,respectively,while after measuring value transfer,they were 9.3％ and 8.2％,and 5.6％ and 5.9％,respectively.Conclusion The calibration of routine measurement systems based on the measuring value transfer for human serum samples assigned by the reference laboratory network may improve the comparability of 7 enzyme actvities measurement results in chnical laboratories at all levels obviously,which deserves to be further spread.

Using the External Quality Assessment Return Target Value Obtained from Clinical Biochemical Analyzer to Evaluate the Accuracy After the Regression Calibration of Dry-type Biochemical Analyzer / 现代检验医学杂志

Objective Using Hitachi 7170 external quality assessment return target value to evaluate the accuracy of 10 items after Regression calibration of the Vistros 350 dry-type Biochemical Analyzer.Methods The same quality control samples were separately tested on two instruments,and results were reported to the clinical National Center for Clinical Laborato-ries.Substituted the external quality assessment return target value result from the National Center for Clinical Laboratories by using Vitros350 into regression calibration equation,then the getting data were compared with the external quality assess-ment return target value obtained from Hitachi 7170,and the deviation analysis was processed.The total error range from the America Clinical Laboratory Amended Bill was used as the standard.For the results within the reference range,error less than 1/2CLIA’88 total error,taken as the comparable judging standard,as it satisfied the requirement.For the results out off the reference range,error less than CLIA’88 total error,those still satisfied the requirement.For those items not meet the requirements,it must to do the regression calibration for Vitros350,using Hitachi 7170 as the standard instrument.Results The deviations of 7 items were all less than 1/2CLIA’88 allowed total error,with LDH was 0.16~-9.89,CK 2.92~6.25, ALT -4.64~-8.07,TBIL 0.08~2.67,TP -0.37~4.41,ALB 2.74~4.77 and URIC 1.04~3.0 respectively,and did not need re-calibration.For GLU and CREA,only one out of the reference range sample,the error range was >1/2CLIA’ 88,but

Animal biosafety isolation device and its evaluation / 中国比较医学杂志

This paper discusses the definition , classification, selection, monitoring and evaluation of animal biosafety isolation device .Evaluation order of animal biosafety isolation device follows animal survival needs -biosafety needs-animal welfare requirements .