评估具有更高生物素耐受性的更新型高敏肌钙蛋白 T 检测方法的性能。

Evaluating the performance of an updated high-sensitivity troponin T assay with increased tolerance to biotin.

机构信息

Institute for Laboratory Medicine, Medical Microbiology and Technical Hygiene, München Klinik, Munich, Germany.

Roche Diagnostics International Ltd., Rotkreuz, Switzerland.

出版信息

Clin Chem Lab Med. 2020 Oct 29;59(3):591-597. doi: 10.1515/cclm-2020-0104. Print 2021 Feb 23.

DOI:10.1515/cclm-2020-0104

PMID:33112775

Abstract

OBJECTIVES

Biotin >20 ng/mL may interfere with the Elecsys Troponin T-high sensitive assay (cTnT-hs; Roche Diagnostics International Ltd). We evaluated the performance of an updated assay, cTnT-hs*, which was designed to reduce biotin interference.

METHODS

cTnT-hs* assay performance was assessed using up to two applications (18 min/9 min) on three analyzers (cobas e 411/cobas e 601/cobas e 801). Biotin interference was determined by measuring recovery in an 11-sample series dilution with biotin ranging from 0-3600 ng/mL. Repeatability/reproducibility were evaluated in five serum sample pools (n=75 each). Method comparisons tested: cTnT-hs* vs. cTnT-hs (18 min/cobas e 601); cTnT-hs* assay 18 vs. 9 min (cobas e 601); cTnT-hs* (18 min) on cobas e 601 vs. cobas e 411 and cobas e 601 vs. cobas e 801. Concordance at the 99th percentile decision limit between cTnT-hs* and cTnT-hs (9 min/cobas e 601) was calculated using 300 lithium-heparin plasma samples and a 14 ng/L assay cutoff.

RESULTS

cTnT-hs* assay (18 min/cobas e 601) recovery was ≥96% for biotin ≤1250 ng/mL. Across all applications/analyzers, coefficients of variation for repeatability/reproducibility with the cTnT-hs* assay were <5% in most serum sample pools (mean cardiac troponin T: 8.528-9484 ng/L). High correlation (Pearson's r=1.000) was demonstrated for all method comparisons. Concordance at the 99th percentile decision limit was high between the cTnT-hs* and cTnT-hs assays.

CONCLUSIONS

The updated cTnT-hs* assay may provide greater tolerance to biotin interference, and shows good analytical and clinical agreement/concordance with the previous cTnT-hs assay.

摘要

目的

生物素>20ng/mL 可能会干扰 Elecsys 肌钙蛋白 T-高敏检测（cTnT-hs；罗氏诊断国际有限公司）。我们评估了一种新的检测方法 cTnT-hs*的性能，该方法旨在减少生物素干扰。

方法

使用三个分析仪（cobas e 411/cobas e 601/cobas e 801），通过对 11 个样本系列稀释（生物素浓度范围为 0-3600ng/mL），评估 cTnT-hs检测方法的性能。通过测定生物素浓度在 0-3600ng/mL 范围内的 11 个样本系列稀释的回收率来确定生物素干扰。在 5 个血清样本池中（每个样本池 75 份样本）评估重复性/再现性。比较的检测方法为：cTnT-hs与 cTnT-hs（18 分钟/ cobas e 601）；cTnT-hs检测方法 18 分钟与 9 分钟（cobas e 601）；cTnT-hs（18 分钟）在 cobas e 601 与 cobas e 411 和 cobas e 601 与 cobas e 801 之间的差异。使用 300 份锂肝素血浆样本和 14ng/L 的检测截点，计算 cTnT-hs*与 cTnT-hs（9 分钟/ cobas e 601）在第 99 百分位决定限值的一致性。

结果

在所有应用/分析仪中，cTnT-hs检测方法的重复性/再现性的变异系数在大多数血清样本池（平均心肌肌钙蛋白 T：8.528-9484ng/L）中<5%。在所有方法比较中均显示出高度相关性（Pearson's r=1.000）。cTnT-hs与 cTnT-hs 检测方法在第 99 百分位决定限值处的一致性较高。