Comparability analysis between dry chemistry analyzer and wet chemistry analyzer
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Objective To investigate the comparability of the results of 16 routine biochemical indexes detected by different biochemical analyzers.Methods With the Beckman DXC800 automatic biochemical analyzer as the reference system and the VITROS5600 automatic biochemical immune analyzer as the compared system according to the EP9-A2,guideline established by NCCLS.The 16 routine biochemical indexes were detected in serum of patients by the two instruments.The clinical acceptability of the VITROS5600 dry chemistry system was evaluated according to the judgment basis of 1/2allowable error of the external quality assessment in CLIA′88standard.Results The reference system and the compared system had better comparability.All tests showed good correlation between the two analytical systems.The biases of all tests were clinically acceptable,except for ALT,LDH,Crea,AST,Ca and TP.Conclusion The VITROS5600 dry chemical instrument could have good comparability with the Beckman DXC800 automatic biochemical analyzer.But the biases of ALT,AST,LDH,Ca and Crea and TP in the clinical comparison at multiple levels were not acceptable.It is necessary to establish the different reference ranges aiming at different methods.Keywords:
Comparability
Hematology analyzer
Reference values
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Compar asion of the test results of partial biochemical parameters by two types of chemical analyzer
Objective:To compare the test results of partial biochemical items verified by VITROS 250 dry chemical analyzer and HITACHI 7600-200 automatic biochemistry instrument.Methods:The parameters including ALT,AST,ALP,GGT,TP,ALB,TBIL and DBIL in fifty samples were analyzed and recorded with these two instruments.Results:There was no statistical significance of the results of AST,GGT,TP and TBIL detected by these two analytical methods(P0.05),and these results had preferable correlation.While there was statistical differences between the results of ALT,ALP,ALB and DBIL with these two analytical methods(P0.05).Conclusions:If there are two or more biochemical analyzers to detect the same testing items,it is necessary to compare and calibrate the different testing results regularly to insure the accuracy of testing results.
Statistical Analysis
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Objective To discuss the comparability of blood glucose(GLU) results detected by different detection systems.Methods According to NCCLS document EP9-A2,3 biochemical testing systems including system 2-3(Y1-Y2,comparative testing systems) and system 1(X,targeted testing system,which was composed of Hitachi 7600 biochemical analyzer P1,maker reagents,C.f.a.s.calibrator and BIO-RAD quality control material),were used to obtain the correlation coefficient and the linear regression equation.The value of GLU in the patient′ s serum was detected by the three systems.Then the coefficient and the equation were used to evaluate the system bias between the comparative testing systems and the targeted testing system.The comparability of different testing systems was judged by half of the CLIA′ 88 standard.Results The variance analysis showed the results between various detection systems had no significant difference(P0.05) and were significantly correlated(r20.95).The results showed good comparability.The deflection evaluation on detection results was clinically acceptable.Conclusion There is good comparability among the results of GLU detected by 3 different testing systems in our hospital.
Comparability
Coefficient of variation
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Objective To provide stable clinical diagnosis and treatment through testing ALT,AST,ALP,GGT and CK by different instruments,which were important disease diagnosis related inspection items,and guarantee the same laboratory testing results of consistency.Methods According to National Committee for Clinical Laboratory Standards(NCCLS) document EP9A2,the precision of Hitachi 7600 automatic biochemistry analyzer P1,P2 module,Hitachi 7080 automatic biochemistry analyzer and Beckman Coulter DxC600 automatic biochemistry analyzer was investigated firstly.Under satisfaction the precision requirement,P1 module was taken as comparison system,results of ALT,AST,ALP,GGT and CK for patients′ fresh serum were analyzed by other systems,the expected bias and the 95% confidence interval of expected bias at medical decision level was calculated and compared to 1/2 allow total error of clinical laboratory improvement amendment 88(CLIA88) to inspect comparability between different biochemistry analyzer.Results The CV of ALT,AST,ALP,GGT and CK projects tested by different analyzer were less than 1/3 CLIA88 allowed total error,and the precision conformed to the requirements.The correlation between Hitachi 7080 automatic biochemistry analyzer,Hitachi 7600 automatic biochemistry analyzer P2 module,Beckman Coulter DxC600 automatic biochemical analyzer test results and Hitachi 7600 automatic biochemistry analyzer P1 module was good.The differences of above projects at medical decision level were within acceptance.Conclusion The results of above projects measured in different biochemistry analyzers in the lab were basically the same,with no statistically significance of the difference.
Clinical biochemistry
Comparability
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Objective This trial was performed to evaluate the comparability of the test result and the acceptability of the result bias of different automated biochemical analyzer on reactive time.Methods According to the NCCLS Documents EP9-A,GLU and HDL-C were analyzed using both HITACHI7170A and OLYMPUS AU640.Results Comparing the two biochemical analyzer for GLU,the correlative coefficient was 0.995 4,the detection reach the end point,to HDL-C,neigther of the two analyzer reach the end point,the correlative coefficient was 0.981 0.Conclusion HITACHI 7070A and OLYMPUS AU640 had fairly good comparability in detection GLU and HDL-C,the result is reliatable.
Comparability
Coefficient of variation
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Objective To investigate the results comparability of AU5400 and AU2700 biochemical analysis system for the detection of serum lipids.Methods According to document EP9-A2 of Clinic and Laboratory Standard Institute(CLSI) and taking the half of the allowed total error of Clinical Laboratory Improvement Amendment 88(CLIA′88) as clinically acceptable criterion,the comparability of these two systems for the detection of serum lipids was evaluated.Results There was fine correlation between the detection results of these two systems(r0.975) and the bias was consistent with requirements of CLIA′88.Conclusion Comparative test and bias evaluation of the detected results of the same tests should be performed between different analytical systems,thus to ensure the comparability among test results.
Comparability
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Objective To investigate the comparability of the results of 10 serum biochemical parameters including alanine aminotransferase(ALT)and total protein(TP)with different biochemical detecting systems in the same laboratory through bias estimation and method comparison,so as to provide reliable experimental data for laboratory accreditation.Methods According to Clinical and Laboratory Standard Institute(CLSI)document EP9-A2,different biochemical detecting systems [with Vitros950 automatic dry chemical assay method as reference(X),Olympus AU640 and two Dimension Xpand-HM biochemical analyzer assays as laboratory methods(Y1-3)] were applied to measuring the levels of the above biochemical parameters for different concentrations of fresh sera,and then the coefficient correlation and linear regression equation were obtained and used to evaluate the system bias between laboratory method and comparison method.The different detecting systems' bias acceptability was judged at different medical decisive levels with the half of CLIA'88 standard as reference.Results The bias of all detecting results with 3 kinds of laboratory methods was clinically acceptable at different medical decisive levels except for that of ALT level with system Y1.Conclusion When the same item is determined with more than two detecting systems,it is necessary to perform method comparison and bias estimation for judging clinical acceptability in order to ensure the comparability of detecting results.
Alanine aminotransferase
Comparability
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Objective To explore a practical way for traceability and comparability of the value obtained from clinical biochemical examination in regional medical organizations by transferring the assigned value in fresh serum to daily serum calibrator.Methods Six local comprehensive hospitals with Grade III were chosen to analyze the effects of calibration by traceability and the comparability of examined results.The definite values of standard panel in matching analytical system were transferred to fresh sera for value assignment.Verified biochemical analyzers were used to examine the values of alaninetransaminase(ALT),total cholesterol(TC),urea and total bilirubin(TBil) in mixed fresh sera and intercomparison with target system was performed to analyze the effect of traceable calibration and the comparability among various analytical systems.Results Although all the applied instruments in the present study were in good conditions with high precision,the comparability of obtained results of ALT,TC,Urea and TBil between tested system and target system was low and the differences were significant(P0.01).After traceable precision transfer with fresh serum,the comparability increased and the differences of results were reduced(P0.05).Conclusion Traceable precision transfer by using fresh serum is a simple,practical,feasible way to realize the traceability and comparability of regional clinical biochemical examination.
Comparability
Traceability
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Objective To discuss the conventional biochemical detecting results between three different systems,and provide evidence for clinical laboratory recognition.Methods Referring to the clinical laboratory standardization commission(NCCLS) EP9-A document,and taking HITACHI 7600 automatic biochemistry analyzer,roche diagnostics,cfas calibration and control product Randox British system as the target systems,we compared the results of fresh specimens of patients in different experimental detection systems on biochemical test of 14 routine with the result of target detection systems.We also measured the relative bias between the experimental comparison testing system(Y) and target detection system(X),and the total error analysis(TEa) of 1/2 according to the revised regulations of clinical inspection department of America(CLIA88) was taken as the standard to judge the comparability of the detection results.Results Detected by the experiment test system one(Y1),the difference of results between serum samples TG and TC was significant(P0.05), 1/2 TEa,and the difference of results among BUN 2 mmol/L level,Cr 50 μmol/L level,Tb and DB was statistically significant(P0.05), 1/2 TEa.Plasma samples of ALT difference was statistically significant as well(P0.05), 1/2 TEa,and the rest results were in accordance with that in blood serum.The difference of results among TB,BC and LDH in experiment test system two(Y2) was significant(P0.05), 1/2 TEa,which had no connection with the type of the samples.Conclusion The results of conventional biochemical detection by different systems on some items have various degrees of deviation.Using different detection systems to detect the same item,we should undertake comparative and clinical acceptability analysis on different methods,and take ameliorative actions to those do not have comparability for the test results.
Comparability
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Objective:Comparing the glucose test results of Siemens Dimension Xpand automatic biochemical analyzer and domestic Dirui CS-600 automatic biochemical analyzer according to the NCCLS EP9-A file,to explore the comparability for blood glucose test of the two instruments.Methods:We took Diri CS-600 automatic biochemical analyzer as reference instrument,and Siemens Dimension Xpand automatic biochemical analyzer as a test one.Fresh serum selected were tested by the two types of instruments everyday,obtain the correlation coefficient and regression equation of Y=bx+a by the statistical software from the test results,with USA amendment clinical laboratory(CLLA,88) provisions of 1/2 EQA(external quality assessment) permissible error as the standard,to judge the comparability of test results of the two instruments.Results:Differences between the two instruments test of blood glucose was not statistically significant(r = 0.9997,P 0.975).Conclusion:Blood glucose test results of the two instruments have good comparability.
Comparability
Siemens
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Objective To assess the comparability of measurement results for plasma glucose from two automatic biochemical systems.Methods According to the requirements in American EP9-A2 file, plasma glucose concentrations in the same plasma samples were determined, using ROCHE P800 as a standard system and TOSIBA ACCTUE as the experimental one. The clinical acceptability of the two kinds of biochemical analyzers was judged based on the criteria for quality assessment among clinical laboratories in American amend legislation (CLIA'88)in which the required criteria is defined as one third of allowable error.Results The glucose results from two kinds of instruments showed a good correlation(r0.975); clinical acceptability of the instruments was in the acceptable range.Conclusion The detected glucose results of two instruments have good comparability.
Comparability
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