BACKGROUND Defining the 99th percentile upper reference limits (URL) of cardiac troponin I (cTnI) is critical because it is clinically important in determining myocardial injury, and is variable among reagents, age, sex, or races. The analytical performance of the new, high- sensitivity reagent Beckman Coulter Access hsTnI was evaluated, and its 99th percentile URL was determined in the Korean population. METHODS Analytical performances of Access hsTnI assay were evaluated including imprecision and limit of measurements. To define the reference limits, 600 healthy subjects were included with similar proportions of sex and age groups. RESULTS Beckman Coulter Access hsTnI assay presented a limit of blank, detection, and quantitation at 10% CV of 0.32 ng/L, 0.63 ng/L, and 6.1 ng/L, respectively, and 98.3% of the healthy population showed cTnI above the limit of detection. The 99th percentile URLs were 9.5 ng/L (90% CI 7.4-14.9), 7.8 ng/L (90% CI 5.5-19.2 ng/L), and 11.3 ng/L (90% CI 8.0-15.7 ng/L) in 600 healthy participants, 300 women and 300 men, respectively with imprecision less than 10% CV. The median values and 99th percentile URLs of hsTnI were higher in men and the age group ≥50 years than in women and the age group <50 years, respectively. CONCLUSIONS Access hsTnI assay met the performance criteria of the IFCC for high-sensitivity cTnI assays. Their 99th percentile URLs in the Korean population were lower than the manufacturer's claims. cTnI values were significantly different among different sex and age groups.

中文翻译：

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评估新的《贝克曼库尔特访问hsTnI》：根​​据韩国人口的年龄和性别，参考上限上限为99％。

背景技术定义心脏肌钙蛋白I（cTnI）的第99个百分位数上限是非常关键的，因为它在确定心肌损伤方面具有重要的临床意义，并且在试剂，年龄，性别或种族之间也各不相同。评估了新的高灵敏度试剂Beckman Coulter Access hsTnI的分析性能，并确定了其在韩国人群中的第99个百分位网址。方法评估Access hsTnI分析的分析性能，包括不精确性和测量范围。为了定义参考限值，纳入了600名健康受试者，其中性别和年龄组的比例相似。结果Beckman Coulter Access hsTnI分析在10％CV下的空白，检测和定量限分别为0.32 ng / L，0.63 ng / L和6.1 ng / L和98。3％的健康人群显示cTnI高于检测限。第99个百分点的URL为9.5 ng / L（90％CI 7.4-14.9），7.8 ng / L（90％CI 5.5-19.2 ng / L）和11.3 ng / L（90％CI 8.0-15.7 ng / L）在600名健康参与者中，不准确率低于10％的女性分别为300名女性和300名男性。hsTnI的中位数和第99个百分位URL在男性和≥50岁年龄组分别高于女性和小于50岁年龄组。结论Access hsTnI测定符合IFCC对高灵敏度cTnI测定的性能标准。他们在韩国人口中的第99个百分点网址低于制造商的要求。不同性别和年龄组的cTnI值差异显着。600名健康参与者，300名女性和300名男性的11.3 ng / L（90％CI 8.0-15.7 ng / L）的CV低于10％。hsTnI的中位数和第99个百分位URL在男性和≥50岁年龄组分别高于女性和小于50岁年龄组。结论Access hsTnI测定符合IFCC对高灵敏度cTnI测定的性能标准。他们在韩国人口中的第99个百分点网址低于制造商的要求。不同性别和年龄组的cTnI值差异显着。600名健康参与者，300名女性和300名男性的11.3 ng / L（90％CI 8.0-15.7 ng / L）的CV低于10％。hsTnI的中位数和第99个百分位URL在男性和≥50岁年龄组分别高于女性和小于50岁年龄组。结论Access hsTnI测定符合IFCC对高灵敏度cTnI测定的性能标准。他们在韩国人口中的第99个百分点网址低于制造商的要求。不同性别和年龄组的cTnI值差异显着。分别。结论Access hsTnI测定符合IFCC对高灵敏度cTnI测定的性能标准。他们在韩国人口中的第99个百分点网址低于制造商的要求。不同性别和年龄组的cTnI值差异显着。分别。结论Access hsTnI测定符合IFCC对高灵敏度cTnI测定的性能标准。他们在韩国人口中的第99个百分点网址低于制造商的要求。不同性别和年龄组的cTnI值差异显着。