Institute for Laboratory Medicine, Medical Microbiology and Technical Hygiene, München Klinik, Munich, Germany.
Roche Diagnostics International Ltd., Rotkreuz, Switzerland.
Clin Chem Lab Med. 2020 Oct 29;59(3):591-597. doi: 10.1515/cclm-2020-0104. Print 2021 Feb 23.
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.
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.
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.
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.
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。
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。
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。
更新后的 cTnT-hs*检测方法可能对生物素干扰具有更高的耐受性，并且与之前的 cTnT-hs 检测方法具有良好的分析和临床一致性/一致性。
