Department of Laboratory Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea.
Department of Laboratory Medicine, University of Ulsan College of Medicine, Ulsan University Hospital, Ulsan, Korea.
Ann Lab Med. 2022 May 1;42(3):331-341. doi: 10.3343/alm.2022.42.3.331.
We established high-sensitivity cardiac troponin I (hsTnI) 99th percentile upper reference limits (URLs) for the Centaur XPT High-Sensitivity Troponin I assay (Centaur hsTnI; Siemens, Erlangen, Germany) and Atellica IM High-Sensitivity Troponin I assay (Atellica hsTnI; Siemens) and assessed the effect of outlier elimination.
The reference population comprised 380 men and 387 women, satisfying the strict systematic reference population criteria. After reference population verification by the N-terminal pro-B-type natriuretic peptide (NT-proBNP) assay, 99th percentile URLs for Centaur hsTnI and Atellica hsTnI were calculated before and after outlier elimination.
The 99th percentile URL for Centaur hsTnI was 60.4 (men, 74.7; women, 57.5) ng/L and that for Atellica hsTnI was 59.6 (men, 75.2; women, 55.1) ng/L. After the elimination of 61 (8.0%) outlier samples in Centaur hsTnI and 58 (7.6%) in Atellica hsTnI, the 99th percentile URLs were 13.5 ng/L (men, 15.3 ng/L; women, 11.9 ng/L) and 13.4 ng/L (men, 15.5 ng/L; women, 12.9 ng/L), respectively, significantly lower than those before outlier elimination. The CVs at the 99th percentile URLs were 5.2% and 3.5%, respectively. The measurable fractions among the reference population were 91.5% and 93.4%, respectively. Performance evaluation of Atellica B-type natriuretic peptide (BNP), Atellica NT-proBNP, Centaur hsTnI, and Atellica hsTnI showed outstanding results.
The Korean hsTnI 99th percentile URLs calculated in this study were significantly lower after outlier elimination than before. Centaur hsTnI and Atellica hsTnI meet the "Guideline acceptable" and "Level 3 (second generation, high sensitivity)" requirements, satisfying international standards.
我们为 Centaur XPT 高敏肌钙蛋白 I（hsTnI）检测试剂盒（Centaur hsTnI；西门子，德国埃朗根）和 Atellica IM 高敏肌钙蛋白 I 检测试剂盒（Atellica hsTnI；西门子）建立了高敏肌钙蛋白 I（hsTnI）99 百分位上限（URL）参考范围，并评估了剔除离群值的效果。
参考人群由 380 名男性和 387 名女性组成，满足严格的系统参考人群标准。在通过 N 端脑利钠肽前体（NT-proBNP）检测验证参考人群后，计算 Centaur hsTnI 和 Atellica hsTnI 剔除离群值前后的 99 百分位 URL。
Centaur hsTnI 的 99 百分位 URL 为 60.4（男性 74.7；女性 57.5）ng/L，Atellica hsTnI 的 99 百分位 URL 为 59.6（男性 75.2；女性 55.1）ng/L。剔除 Centaur hsTnI 中 61（8.0%）个离群值样本和 Atellica hsTnI 中 58（7.6%）个离群值样本后，99 百分位 URL 分别为 13.5 ng/L（男性 15.3 ng/L；女性 11.9 ng/L）和 13.4 ng/L（男性 15.5 ng/L；女性 12.9 ng/L），显著低于剔除离群值前的值。剔除离群值后 99 百分位 URL 的变异系数（CV）分别为 5.2%和 3.5%，参考人群的可测量分数分别为 91.5%和 93.4%。Atellica B 型利钠肽（BNP）、Atellica NT-proBNP、Centaur hsTnI 和 Atellica hsTnI 的性能评估结果优异。
剔除离群值后，本研究计算的韩国 hsTnI 99 百分位 URL 显著低于剔除离群值前的值。Centaur hsTnI 和 Atellica hsTnI 满足“指南可接受”和“级别 3（第二代，高敏）”要求，符合国际标准。
