Establishment And Validation Of The Hitachi 7170 Automatic Biochemical Analyzer System

Objective: Establish and avlidate the testing system of Hitachi 7170 automatic biochemical analyzer, Study the methods and meaning of. establishing and avlidating the testing system.Methods: Through the evaluating or avlidating of The precision and accuracy and sensitivity and range of linearity and range of reference, establish the new testing system composing of reagent and calibration made in china and Hitachi 7170 automatic biochemical analyzer made in japan;Appraise the new system by drawing spot on method evaluation decision chart according to the precision of new system and the bias between new system and Hitachi-Roche system; evaluate the whole testing system according to the precision of mteral quality control and the bias between data from our laboratory and average value from same group of EQA of national center for clinical laboratory ,by drawing spot on spot on method evaluation decision chart ;And confirm the rule of interal quality control according to the methods decision table of quality contral.Results: The methods capability of phosphorus is failure, The methods capability of glucose,urea,creatinine,albumin, cholesterol,calcium, magnesium are bad, The methods capability of total protein and AST are middle, The methods capability of uric acid,ALT,ALP,GGT,total bilirubin, direct bilirubin,triglyceride,HDL-c,LDL-c, ApoA,ApoB,LDH,CK,HBDH,AMY are choiceness.Conclusion: Validated by this testing, Most tests' methods capability of our Hitachi 7170 automatic biochemical testing system are choiceness. But some tests' methods capability are bad, and one tests' methods capability is failure yet; The reason of bad methods capability is multimode, Choose the reagent and calibration which fit our laboratory' instruments and other conditions are viable.Even though we use the original reagents and calibrations,Some tests' methods capability are bad yet; So the only way to improve the improve quality of measuring, to provide patients satisfying exact and reliable results is to perfect and administer every quality document that include avlidating the testing system.