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Objective To investigate the necessity of dilution in samples with high concentrations of D-Dimer and optimum dilution multiple.Methods Quality control products and calibration were detected by using Sysmex CS5100 for precision evaluation,including within-batch and between-run precision.Calibration were detected for validation of linear range and clinical reportable.Samples with D-Dimer5 mg/L and FDP>20 μg/mL were also serially diluted and detected to calculated recovery rate.Results Within-batch and between-run coefficients of variation were both less than 3%.Within the scope of 0.207-5.170 mg/L,the linear distribution was fine.The clinical reportable range was 0.207-165.440 mg/L.For samples with D-Dimer5 mg/L and FDP>20 μg/mL,there was obvious antigen excess phenomenon,and gradient dilution was required.Conclusion For samples with D-Dimer>5 mg/L and FDP>20 μg/mL,dilution should be performed to ensure the accuracy of detected results.
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Objective To evaluate the detection performance of the cobas8000 c702 fully automatic biochemical analyzer for de‐tecting the second generation Roche urine trace albumin (ALBU2) .Methods (1) The precise evaluation :with the allowable error stipulated by CLIA 88 as the basis ,the requirements were the repeat precision <1/4TEa ,and intermediate precision <1/3TEa;(2) the linear range and the evaluation of the reportable range :the EP6‐A scheme was adopted ,and extend to calculate the average re‐covery rate of dilution ,the clinical reportable range was evaluated by the average dilution recovery of 90% -110% ;(3) the carry o‐ver pollution assessment :the carry over pollution of serum albumin on urine trace albumin detection was evaluated by the judgment standard of carry over pollution rate of 0 .5% ;(4)the methodological comparative analysis :with SIEMENS BN Ⅱas the reference system ,the Roche Cobas 8000 C702 and the BN2 results were performed the correlation contrastive analysis .Results The repeat precision :low concentration CV=1 .98% .high concentration CV=1 .64% ;intermediate precision :low concentration CV=4 .35% , high concentration CV=1 .20% ;the linear range verification :the measurement range 5 .6-413 .55 mg/L ;clinical reportable range :in the maximum diluted multiples of 30 times ,the clinical reportable range was 5 .6-12 406 .5 mg/L ;the carry over pollution rate :serum albumin (42 .6 g/L) on urine trace albumin(6 .9 mg/L) ,the carry over pollution rate was 0 .28% ;the indoor comparison :in the concentration within 200 mg/L ,the regression line was Y=0 .896 X+5 .049 ,the correlation coefficient r2 =0 .994 4 ,the system shift was passed at the medical decision level .When the specimen concentration within 201-413 .55 mg/L ,the regression line was Y=0 .848X-10 .44 ,the correlation coefficient r2 =0 .917 ,the system shift was not passed at the medical decision level .Conclusion The detection of the Roche ALBU2 in the Cobas 8000 C702 platform can meet the clinical needs ,the comparison among different instruments has difference in different concentration ranges ,therefore the independent reference ranges should be established ac‐cording to the each instrument system .
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Objective To estimate the assay performance of two different kind of reagent with different concentration of NADH.Methods Verificated function index of these two reagents,such as accuracy,sensitiveness,blank space and so on, and determined the molar extinction coefficient of NADH using hexokinase method and calculated the NADH density in two kind of AST reagents.Then estimated the effect of concentation of NADH on the analysis performance.Results NADH concentration was 0.21 mmol/L,and the sample detection limit of the linear was 1 629 U/L.NADH concentration was 0.13 mmol/L,and the sample detection limit of the linear was 1 263 U/L.So the gap between the two reagent’s detection linear was visible.But there were no significant changes in other performance indicators such as detection sensitivity,reagent blank,precision.Conclusion The NADH concentration in the reagent of AST had greatimpact on the detecting linear range, so should pay attention to the potential change of linear range in the daily work.
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Abstact:Objective To evaluate the method change from JSCC to IFCC for ALT,AST,GGT and LDH Detection.Methods The accuracy,precision,linearity and reportable range of the new detection method for ALT,AST,GGT and LDH,and the comparison analysis on the two different reagents were evaluated.Results All the accuracy bias of the testing items were within the required 1/2TEa,and all the within-run precision and between run precision were within the required 1/4TEa and 1/3TEa respectively.The linear verification results got the regression equation of the theoretical and measured valuesY =aX+b,in which a was within the range of 0.97~1.03,b was within an acceptable range.The reportable range verification re-sults showed that after the samples being diluted by different proportions,the measured/expected values were all between 90% and 110%,indicating that within a certain range of sample dilution the test esults were reliable.The comparison results showed the R 2 closed to 1.Conclusion The evaluation of the method change for ALT,AST,GGT and LDH detection met the basic requirements of the experiments in clinical diagnosis.
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Objective To verify the performance of Hitachi 7600 automatic biochemical analyzer .Methods According to labora‐tory accreditation criteria and the performance verification documents of American CLIA′88 ,the precision ,accuracy ,reference inter‐val ,linear range and clinical reportable range were verified for the tests of 19 conventional biochemical indicators performed on Hita‐chi 7600 biochemical analyzer most often .Results The precision ,accuracy ,reference interval ,linear range and clinical reportable range were all acceptable .Conclusion Hitachi 7600 automatic biochemical analyzer could fully meet the reqirements in clinical ap‐plication .
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Objective To detect the prolactin (PRL)analytical performance verification by BECKMAN DxI 800 automated chemiluminescence analyzer.Methods According to the American Society for Clinical Laboratory Standards (NCCLS)doc-uments,selected the patient’s serum and EQA control materials,the precision,accuracy and linearity of the BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting PRL were detected.Results The CV values of intra-and in-ter-precision were less than manufacturer’s declaration,and within the allowable range.The validation results of linear range showed that,a value of 1.0114,r value of 0.9974,both within the requirements of the instrument,and has excellent lineari-ty;the relative bias between the measured results and the EQA control samples at five levels was -1.18%~-7.78%,both within the scope of the EQA measurement.Conclusion The BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting PRL in precision,accuracy,linearity and other performance indicators were within the requirements of the instrument,tomeet the requirements,can be used in clinical testing.
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Objective To evaluate the performance of electrolyte module in OLYMPUS AU5421 Automatic Biochemical Analy-zer in K+ ,Na+ ,Cl- detection .Methods Electrolyte module in OLYMPUS AU5421 Automatic Biochemical Analyzer was employed to detect K+ ,Na+ ,Cl- ,and their precision ,accuracy ,linearity range ,cross-contamination and the test results of instruments were compared .The linear regression equation and regression coefficients were calculated according to the methods of Clinical and Labo-ratory Standards Institute(CLSI) EP6-A ,EP9-A2 documents .Results The within-run precisions of K + ,Na+ ,Cl- were 0 .328% , 0 .306% ,0 .343% ,respectively ,and their between-run precisions were 0 .780% ,1 .012% ,0 .985% ,respectively .Their regression coefficients of linear equation were all greater than 0 .999 ,and their cross-contamination rate were 1 .066% ,0 .812% and 0 .858% , respectively .Conclusion Electrolyte module in OLYMPUS AU5421 Automatic Biochemical Analyzer modules has advantages of good precision ,accuracy ,linear range ,and low cross-contamination rate .
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Objective To verify the analytical performance of the Roche cobas 8000 automatic biochemical analyzer.Methods The intra-batch and inter-batch precisions,accuracy,linearity and reference interval were validated according to the Clinical and La-boratory Standards Institute (CLSI)documents (EP5-A2,EP15-A2,EP6-A;C28-A2 ).Results The intra-batch precision was 0.5%-2.3% and the inter-batch precision was 0.8%-3.11%,which were all less than 1/4 Tea(CLIA'88).The detection results of various items had better correlation with the target values(r2 >0.99);the linear range of various detected items were in line with the linear range provided by the specification;the quotative biological reference range conformed to the group of this laboratory services.Conclusion The various performance indexes of the Roche cobas 8000 automatic biochemical analyzer conform to the qual-ity requirements and this analyzer can be used in clinical biochemical detection work..
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Objective:To evaluate the performance of Sysmex company's new product Sysmex XN-9000 automatic blood fluid analyzer and confirm the test results. Methods: According to the American association of clinical laboratory standardization guidelines EP15-A2, the EP6-A2 requirements for Sysmex XN-9000 blood analyzer for precision, carry pollution rate, linear range and accuracy verification, to Backman LH750 comparison results for evaluating the basis, the results and the performance of manufacturer's statement or recognized quality standards. Results:XN-9000 blood analyzer determination of white blood cell (WBC), red blood cell (RBC), hemoglobin (HGB), RBC deposited (HCT) and platelet (PLT) the main parameters in the batch coefficient of variation (CV%) of 0.11%~0.11%, between the group of CV% of 0.12%~0.12%, linear correlation r is 0.99991~0.99999, carry pollution rate was 0.00%~0.38%, the correlation analysis of each index r>0.999, the indicators accuracy verification bias of 0.67~0.67. Conclusion: XN-9000 instrument for determination of main parameters of precision, accuracy, linear, carrying pollution rate and other major evaluation indexes meet the requirements, test results can be used for clinical diagnosis and treatment of related diseases and curative effect judgment.
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Objective Use real-time fluorescence quantitative polymerase chain reaction(PCR)to determine HBV DNA,then calculate the linear range and the minimum detection limit,which are the main performance indicators in the laboratory verification. Methods According to the related documents,by serial dilution of high concentration samples,samples of serial concentrations were obtained which were out of the linear range mentioned in the instructions,then verifid the new linear range.By serial dilution of low concentration,samples were obtained,the concentrations of which were lower than the minimum detection limit of provide by the manufacturer,then the new minimum detection limit was verified.Results The linear range of HBV DNA detection was 8.58× 102 -8.41×107 IU/mL,and the minimum detection limit of HBV DNA detection was 4.07 ×102 IU/mL.Conclusion The linear range and the minimum detection limit of Real-time fluorescence quantitative PCR assessed reaches the expected requirement,and the method and validation scheme are simple and feasible.
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Objective To certify the linear range of WBC measured by CD3700.Methods Use the white stratum of blood after centrifugation.Then,the high value specimens were diluted with saline to get a series of samples with different concentrations.Every specimen was measured twice in order to keep the sequence of specimens randomly.The perform outlier test,polynomial regression analysis,and the random error estimation were carried out.Results There was no outlier in the results.It was demonstrated by polynomial regression to be linear from(0～219)?109 L-1.The random error was within the allowable limit of 1/4CLIA'88(3.75%).Conclusion The linear range of WBC measured by CD3700 is just like that of the manufacturer claims.