Comparison of seven serum assays on fourautomatic analysers

[摘要] Serum enzyme assays used on four different analysers (Hitachi 737,Hitachi 705, Cobas-bio and RA-2X) were compared by determiningthe activity of seven different enzymes (AST, ALT, LD, ALP,GGT, CK and AMS). Performance checks (quality controlprocedure) and replications (the study of the total analyticimprecision and of its components) were conducted and the methodswere compared by linear regression analysis with statisticalinference on the curves following the protocols of the NationalCommittee for Clinical Laboratory Standards (NCCLS: PSEP-2, PSEP-3, PSEP-4). The correlation coefficients between themethods (r = 0.991-0.999), together with the other statisticalparameters, indicated that the methods are well correlated on all theinstruments. The total imprecision was good for all analytes, exceptALT. Among the instruments tested, the RA-2X gave morevariable results, although the total imprecision was acceptable.There was no relevant carry-over effect. The evaluation of performance claims indicated that the expected error did notsubstantially affect the results at the level of clinical decisions.

[学科分类] 分析化学