Establishment and evaluation on the clinical reportable rang of serum alanine aminotransferase / 国际检验医学杂志

ABSTRACT

Objective To explore the functional sensitivity ,maximum allowable dilution ,analytical measurement range and clin‐ical reportable rang of the serum alanine aminotransferase (ALT ) detected by Beckman Dxc800 automatic analyzer with the DiaSys diagnostic biochemistry reagent kits .Methods According to the EP6‐A document published in 2004 by American Clinical and La‐boratory Standards Institution (CLSI) ,these samples with equal interval ,proportional prepared with the low levels serum and the high levels serum and their concentration exceeding the range claimed by manufacture ,were detected twice each .The results were registered and analyzed by the SPSS19 .0 statistic software with polynomial regression analysis to determine the analytical measure ‐ment range .Five samples at the low concentration ,which were prepared previously ,were detected repeat at day interval .And the functional sensitivity was determined with combining the coefficient of variation and the average value .Three samples ,diluted to different dilution ratio with physiological saline ,were detected .The dilution recovery rate ,which was required in the range of 90%- 110% ,was calculated to establish the clinical reportable rang by combining the Functional Sensitivity .Results The analytical measurement range of the serum ALT detected by Beckman Dxc800 analyzer was 5 .50 - 847 .50 U /L ,the runctional sensitivity was 3 .698 U /L ,the maximum allowable dilution was 1 ∶ 8 and the clinical reportable rang was 3 .698 - 6 780 .0 U /L .Conclusion The analytical measurement range of the serum ALT detected by Beckman Dxc800 analyzer with the DiaSys diagnostic biochemistry rea‐gent kits ,was wider than that of being claimed by manufacture ,the clinical reportable rang could meet the need of clinic .