中国部分地区表面健康人群敏感型肌钙蛋白I第99百分位值的建立

Establishment of the 99th percentile of sensitive troponin I in apparently healthy Chinese people in Kunming and Wuhan

目的评价BeckmanCoulter敏感肌钙蛋白I检测系统的检测性能（包括检出限和总不精密度），并建立中国部分地区（武汉和昆明）表面健康人群敏感肌钙蛋白I的第99百分位值。方法参考美国临床实验室标准化研究所EP文件，评价BeckmanCoulter敏感肌钙蛋白I的检出限和总不精密度；选择中国代表平原地域的武汉地区（平均海拔27n1）和代表高原地域的昆明地区（平均海拔1895m）的表面健康人群，武汉个体共760位，年龄30～91岁（均值为50．4岁，标准差为13．1岁），男性400例（年龄均值为52．2岁，标准差为14．0岁），女性360例（年龄均值为48．3岁，标准差为11．7岁）。昆明地区192例，年龄30～77岁（年龄均值为39．4岁，标准差为8．2岁），其中男性60例（年龄均值为40．6岁，标准差为9．8岁），女性132例（年龄均值为38．9岁，标准差为7．3岁）。按地区、年龄、性别计算敏感肌钙蛋白I的第99百分位值。结果BeckmanCoulter敏感肌钙蛋白I的检出限为0．013μg／L，总不精密度10％对应的肌钙蛋白I浓度为0．025μg／L。武汉地区表面健康人群敏感肌钙蛋白第99百分位值为0．036μg／L，男性和女性第99百分位值分别为0．038μg／L和0．035μg／L，30—69岁人群和I〉70岁人群第99百分位值分别为0．038μg／L和0．035μg／L；昆明地区表面健康人群敏感肌钙蛋白I第99百分位值为0．040μg／L。武汉地区与昆明地区的第99百分位值无太大差异，如果检测数据保留2位小数则中国表面健康人群敏感肌钙蛋白I的第99百分位值可定为0．04μg／L，此处的总不精密度为8．23％。结论中国表面健康人群BeckmanCoulter敏感肌钙蛋白I的第99百分位值为0．04μg／L，此处的总不精密度为8．23％，检测性能达到“导则可接受”水平。

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 cTnl 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＂.