Department of Laboratory Medicine, Ilsan Paik Hospital, Inje University College of Medicine, Republic of Korea.
Department of Laboratory Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Republic of Korea.
Clin Biochem. 2020 May;79:48-53. doi: 10.1016/j.clinbiochem.2020.02.005. Epub 2020 Feb 12.
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.
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.
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.
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.
定义心脏肌钙蛋白 I（cTnI）的第 99 个百分位上限（URL）至关重要，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、性别或种族之间存在差异。评估了新型高敏试剂贝克曼库尔特 Access hsTnI 的分析性能，并在韩国人群中确定了其 99 个百分位 URL。
评估 Access hsTnI 测定的分析性能，包括不精密度和测量限。为了确定参考范围，纳入了 600 名健康受试者，其性别和年龄组的比例相似。
贝克曼库尔特 Access hsTnI 检测的检测限分别为空白、检测和定量限的 10% CV 为 0.32ng/L、0.63ng/L 和 6.1ng/L，98.3%的健康人群的 cTnI 均高于检测限。600 名健康参与者（300 名女性和 300 名男性）的第 99 个百分位 URL 分别为 9.5ng/L（90%CI 7.4-14.9）、7.8ng/L（90%CI 5.5-19.2ng/L）和 11.3ng/L（90%CI 8.0-15.7ng/L），不精密度小于 10%CV。hsTnI 的中位数和 99 个百分位 URL 在男性和≥50 岁年龄组中高于女性和<50 岁年龄组。
Access hsTnI 测定符合 IFCC 对高敏 cTnI 测定的性能标准。其在韩国人群中的第 99 个百分位 URL 低于制造商的声明。cTnI 值在不同性别和年龄组之间存在显著差异。
