Standardization of cardiac troponin I assays: round Robin of ten candidate reference materials.
Standardization of cardiac troponin I assays: round Robin of ten candidate reference materials.
复制标题
心肌肌钙蛋白 I 测定的标准化：十种候选参考材料的循环。
DOI：
10.1093/clinchem/47.3.431
复制
发表时间：
2001
影响因子：
9.3
通讯作者：
S. Kahn
中科院分区：
文献类型：
--
作者：
R. Christenson;S. Duh;F. Apple;G. Bodor;D. Bunk;J. Dalluge;M. Panteghini;J. Potter;Michael J. Welch;A. Wu;S. Kahn
背景
不同检测中的心肌肌钙蛋白 I (cTnI) 结果相差 100 倍。作为标准化的一步，我们使用 13 个 cTnI 测量系统检查了 10 种候选参考物质 (cRM) 在稀释研究中的性能。
方法
10 个 cTnI cRM 的解决方案（每个均由 NIST 表征）已运送给 13 个 cTnI 测量系统的制造商。制造商使用各自的稀释剂来制备 cTnI 浓度为 1、10、25 和 50 微克/升的每种 cRM。为了对 cRM 进行排名，在使用 10 microg/L cTnI 溶液标准化后，评估每个 cTnI 测量值与预期响应的偏差。以五种格式检查标准化偏差。测量的 cTnI 与预期值的线性回归分析参数也用于对 cRM 的性能进行排名。
结果
表现出最佳总体排名的三个 cRM 是肌钙蛋白 C、I 和 T 的复合物。这三个 cRM 值的矩阵不同；一种是直接由供应商提交的冻干形式重构的；一种以液体形式提交，在 NIST 冻干，随后重新配制；第三种以从供应商处收到的液体形式进行评估。表现出第四佳性能的 cRM 是肌钙蛋白 C 和 I 的二元复合物，以冻干形式提供，并在分配前重构。
结论
在 13 个 cTnI 分析系统中表现出最佳性能特征的 cRM 将纳入 AACC cTnI 标准化委员会的后续活动中。
BACKGROUND
Cardiac troponin I (cTnI) results vary 100-fold among assays. As a step toward standardization, we examined the performance of 10 candidate reference materials (cRMs) in dilution studies with 13 cTnI measurement systems.
METHODS
Solutions of 10 cTnI cRMs, each characterized by NIST, were shipped to the manufacturers of 13 cTnI measurement systems. Manufacturers used their respective diluents to prepare each cRM in cTnI concentrations of 1, 10, 25, and 50 microg/L. For the purpose of ranking the cRMs, the deviation of each cTnI measurement from the expected response was assessed after normalization with the 10 microg/L cTnI solution. Normalized deviations were examined in five formats. Parameters from linear regression analysis of the measured cTnI vs expected values were also used to rank performance of the cRMs.
RESULTS
The three cRMs demonstrating the best overall rankings were complexes of troponins C, I, and T. The matrices for these three cRMs values differed; one was reconstituted directly from the lyophilized form submitted by the supplier; one was submitted in liquid form, lyophilized at NIST, and subsequently reconstituted; and the third was evaluated in the liquid form received from the supplier. The cRM demonstrating the fourth best performance was a binary complex of troponins C and I supplied in lyophilized form and reconstituted before distribution.
CONCLUSIONS
The cRMs demonstrating the best performance characteristics in 13 cTnI analytical systems will be included in subsequent activities of the cTnI Standardization Committee of the AACC.