Performance Evaluation Of The Mindray SAL 8000 Integrated Clinical Chemistry And Immunoassay Analyzer System

Background and objectiveBiochemical analyzer and immune analyzer are the most basic and necessary analytical instruments in clinical laboratory.With the development of economy and medicine,people have higher requirements to the efficiency and accuracy of the test results.The manufacturers are committed to research and produce a more automated,more reliable,safer and more practical in vitro diagnostic equipment.The integrated clinical chemistry and immunoassay analyzer comes into being.However,such equipment was mainly monopolized by foreign brands in the past.The price is generally expensive,limiting its promotion and application.In recent years,domestic enterprises of in vitro diagnostics have continued to strengthen their own research capabilities and production technology,and have made new progress in cascaded equipment.SAL 8000 integrated clinical chemistry and immunoassay analyzer system was launched by Mindray Bio-medical Electronics Co.,Ltd.,Shenzhen,China in 2014.It is the first biochemical and immune cascade equipment in China,filling the domestic blank.The analytical performance and market performance of such domestic equipment need to be proved because of its newly entering the market.Moreover,it is required by clinical laboratory standard management that any new detection system needs a comprehensive performance evaluation before its formal application.The purpose of this study is to evaluate the technical performance and clinical analytical performance of Mindray SAL 8000 integrated clinical chemistry and immunoassay analyzer system referring to the international and domestic professional standards and compare with foreign well-known brands,and to determine whether the optical devices,temperature control,precision,analytical measurement range,cleaning ability,accuracy,and so on meet the laboratory requirements,then,to propose suggestions to help companies improve their products,and to promote the development of industrial technology,enhance the confidence of potential users,expand domestic market share of equipment and reduce equipment purchase and testing costMethods1.Verifying the technical performance of BS-2000 biochemical module according to China medicine profession Standard-Automatic chemistry analyzer YY/T 0654-2008Including stray light,photometric linearity,photometric accuracy,photometric stability,photometric imprecision,temperature accuracy and fluctuation,sample carryover,accuracy and precision of sample/reagent dispensing and within-run imprecision.2.Verifying the technical performance of CL-2000i immune module according to China medicine profession Standard-Automatic luminescence immunoassy analyzer YY/T 1155-2009Including temperature accuracy and fluctuation,stability,within-run imprecision,linearity,sample carryover,accuracy and precision of sample/reagent dispensing..3.Evaluating the analytical performance of BS-2000 biochemical moduleReferring to the CLSI EP guidelines and combining with the characteristics of the analyzer,we evaluated the analytical performance of BS-2000 including precision,analytical measurement range of reagent,the ability against interference,dilution verification,carryover,methodological comparison.This part covered 25 items,namely ALT,AST,ALP,Y-GT,TBIL.,DBIL,TP,ALB,CREA,UA,UREA,Glu.,TC,TG,LDL-C,HDL-C,Ca,P,?-AMY,C3,IgG,FR-CRP,K,Na,Cl.4.Evaluating the analytical performance of CL-2000i immune moduleReferring to the CLSI EP guidelines and combining with the characteristics of the analyzer,we evaluated the analytical performance of CL-2000i including precision,analytical measurement range of reagent,dilution verification,methodological comparison.This part covered 12 items,namely HBsAg,Anti-HBs,HBeAg,Anti-HBe,Anti-HBc,AFP,CEA,CA125,CA19-9,TSH,FT4,FT3.5.Evaluating the carryover between BS-2000 biochemistry module and CL-2000i immune moduleTaking HBsAg as an example,high and low value samples were selected.First,the all samples were detected on biochemistry module in the largest sample volume.Then,the HBsAg concentration in the low value samples were determined on immune module,and the carryover rate was analyzed and discussed.Results1.The verification of the technical performance of BS-2000 biochemical moduleThe technical performance of biochemistry module including stray light,photometric linearity,Photometric accuracy,photometric stability,photometric imprecision,temperature accuracy and fluctuation,sample carryover,accuracy and precision of sample/reagent dispensing and within-run imprecision all met the professional standard and clinical requirement.2.The verification of the technical performance of CL-2000i immune moduleThe technical performance of immune module including temperature accuracy and fluctuation,stability,within-run imprecision,linearity,sample carryover,accuracy and precision of sample/reagent dispensing all met the professional standard and clinical requirement.3.The evaluation of the analytical performance of BS-2000 biochemical moduleThe intra-assay and total precisions were less than 1/4 and]/3CLIA'88 TEa(or TEa f'rom biologic variation)respectively for 25 analytes;The analytical measurement ranges were in line with the declared ranges of manufacturer.The correlation coefficients were>0.99 and the regression slope ranged from 0.97 to 1.03.Regression deviations at different concentration levels were within the requiring range of the goal;A significantly negative and positive interference by lipemia were observed for TBIL and P at low concentration,respectively.The ability against hemolysis.,icterus and lipemia was in accordance with the manufacturer's claims for other analytes;In except of UREA among 9 biochemical assays(ALT,AST,ALP,y-GT,CREA,UA,UREA,Glu,a-AMY),the biases were acceptable when the samples were subjected to a twenty-fold dilution by saline solution.The maximum dilution factor for UREA was 5;The carryover rates of..two salple needles were-0.02%and-0.01%,respectively,far less than 0.5%.Reagent needles,mixers and cuvettes showed no obvious carryover;BS-2000 was compared with the Cobas 8000 automatic biochemical analyzer with correlation coeffcients of regression equation more than 0.975.The slopes of regression equation were all between 0.9 and 1.1 except for HDL-C(Slope=0.89).The deviations at the first medical decision level(MDL)from ALT,?-GT and CREA,the deviations at all three MDLs from LDL-C were beyond the allowable range.Other assays met the requirements4.The evaluation of the analytical performance of CL-2000i immune moduleThe intra-assay and total CVs were less than 5%and 7%respectively for 12 analytes;The analytical measurement ranges were consistent with the declared ranges of manufacturer for 7 analytes(HBsAg,Anti-HBs,AFP,CEA,CA125,CA19-9?TSH).The correlation coefficients were>0.99 and the regression slope ranged from 0.97 to 1.03;The dilution recovery rates at the claimed dilution factors for HBsAg.Anti-HBs,AFP,CEA,CA19-9,TSH were within 75%to 125%except for greater biases from Anti-HBs and CA19-9;9 assays including HBsAg,Anti-HBs,AFP,CEA,CA125,CA19-9,TSH,FT4,FT3 were compared with Architect i2000sR and ADVIA Centaur chemiluminescence immunoassay analyzer,and the correlation coefficients were all greater than 0.975 except for Anti-HBs,meeting the clinical requirement.5.Carryover evaluation between BS-2000 biochemical module and CL-2000i immune moduleThe carryover rate between modules of SAL 8000 integrated clinical chemistry and immunoassay analyzer system was less than 0.1 ppm,no significant carryover.ConclusionThe technical performance and clinical analytical performance of the SAL 8000 integrated clinical chemistry and immunoassay analyzer system meet professional and clinical requirement generally and have good correlation with foreign detection system.Thus,it is suitable for the use in clinical laboratory.