ABSTRACT
Objective To evaluate the performance of Beckman Coulter Enhanced troponin Ⅰ immunoassay system (including the limit of detection and total imprecision) and establish the 99th percentile of Enhanced troponin Ⅰ in apparently healthy Chinese people in Kunming and Wuhan.Methods Evaluated the limit of detection and total imprecision of Beckman Enhanced troponin Ⅰ according to protocols EP of Clinical Laboratory Standards Institute; chose apparently healthy people from Wuhan (average altitude of 27 m) which represents plain regions,and Kunming (average altitude of 1895 m) which represents plateau regions.760 subjects from Wuhan were selected,aging from 30 to 91,included 400 males and 360 females.A total of 192 subjects from Kunming were selected,aging from 30 and 77,60 patients,which included 60 male and 132 female cases.To calculate the 99th percentile of Enhanced troponin Ⅰ by region,age,and gender.Results The limit of detection of Beckman Enhanced troponin Ⅰ is 0.013 μg/L,the cTnI concentration is 0.025 μg/L at 10％ CV.The 99th percentile of Enhanced troponin Ⅰ of the total population in Wuhan is 0.036 μg/L,the 99th percentile of men and women are 0.038 μg/L and 0.035 μg/L respectively,the 99th percentile in the 30-69 years group and over 70 years group are 0.038 μg/L and 0.035 μg/L respectively.The 99th percentile of Enhanced troponin Ⅰ of the total population in Kunming is 0.040 μg/L.To keep the 2nd digit after decimal point for results from Wuhan and Kunming,the 99th percentile of Enhanced troponin Ⅰ of the apparently healthy Chinese in 0.04 μg/L,where the CV is 8.23％.The percentage of positive samples detected below the 99th percentile in the normal reference population in Wuhan is 94％.Conclusions The 99th percentile of Beckman Enhanced troponin Ⅰ of the Chinese apparently healthy people is 0.04 μg/L,where the total imprecision is 8.23％,and the detection performance reach the acceptable levels per the guideline.