The application of different linear evaluation method for clinical chemistry measurement / 国际检验医学杂志

ABSTRACT

Objective To explore the application of different linear evaluation methods for clinical chemistry measurement .Meth‐ods The analytical measurement ranges of clinical common items ,including alanine aminotransferase(ALT) ,creatine kinase(CK) , glucose(Glu) ,urea(Urea) and uric acid(UA) were established by using visual method ,modified Doumas method ,and according to′Guide to linearity evaluation of clinical chemistry analyzers′(health profession standard method) and Clinical and Laboratory Stand‐ards Institute(CLSI) EP6‐A document(EP6‐A method) .Results The visual method shown that the expected values and the meas‐ured values of these inspection items were probably in a straight line .The modified Doumas method shown that nonlinearity be‐tween expected values and measured values of CK was found ,but linearity was evaluated when discarding the last two points ;and the rest of inspection items all had linearity .The health profession standard method indicated that nonlinearities between expected values and measured values of CK and Urea were found ,but could not determine whether the nonlinearities of the two items were clinically acceptable ;and the rest of inspection items all had linearity .The EP6‐A method shown that linearities were directly found between expected values and measured values of ALT ,Glu and UA ,while CK and Urea had clinical acceptable linearities and linear‐ities were evaluated when discarding the maximum values .Conclusion The linearity evaluation is integrated with clinical objectives through EP6‐A document .Through setting methodology allowable deviation ,the EP6‐A method could expand the scope of accredi‐tion of linearity within the clinical acceptable range ,which has higher clinical practicability .