Jungbauer Carsten, Hupf Julian, Giannitsis Evangelos, Frick Johann, Slagman Anna, Ehret Christoph, Herbert Nicolas, Jung Christine, Zerback Rainer, Bertsch Thomas, Christ Michael
Clin Lab. 2017 Apr 1;63(4):633-645. doi: 10.7754/Clin.Lab.2016.160814.
The point-of-care test Roche CARDIAC POC Troponin T (PoC TnT) is an improved assay which has been developed for the Roche cobas h 232 system.
We performed a multicentre evaluation (four sites) to assess the analytical performance of the PoC TnT assay and to compare it with the central laboratory Elecsys® troponin T high sensitive (lab cTnT-hs) assay.
The relative mean differences found in method comparisons of PoC TnT vs. lab cTnT-hs ranged from -4.1% to +6.8%. Additionally, there was good concordance between PoC TnT and lab cTnT-hs for the number of samples with troponin T values below the measuring range of 40 ng/L. Lot-to-lot differences of PoC TnT ranged from -8.6% to +4.6%. Within-series coefficients of variation (CV) resulting from 81 ten-fold measurements with patient samples were 9.3%, 11.8%, and 12.9% in the low (40 to < 200 ng/L), medium (200 to < 600 ng/L), and high (600 to 2000 ng/L) measuring range, respectively. Using the system quality control, the mean CV for between-day imprecision was 11.3%. No interference was observed by triglycerides (up to 11.4 mmol/L), bilirubin (up to 376 µmol/L), hemoglobin (up to 0.12 mmol/L), biotin (up to 30 µg/L), rheumatoid factor (up to 200 IU/mL), or with 52 standard or cardiovascular drugs at therapeutic concentrations. There was no influence on the results by varying hematocrit values in a range from 25% to 53%. However, interferences with human anti-mouse antibodies were found. No significant influence on the results was found with PoC TnT by using sample volumes between 135 to 165 µL. High troponin T concentrations up to 500 µg/L did not lead to false low results, indicating no high-concentration hook effect. No cross-reactivity was found between the PoC TnT assay and human skeletal troponin T up to 1000 µg/L (< 0.05%). Diagnostic sensitivity and specificity data of a subpopulation (23 patients) of this study are in agreement with results of another large pre-hospital study.
The PoC TnT assay showed good analytical performance with excellent concordance with the calibration and reference laboratory method. It should therefore be suitable for its intended use in point-of-care settings.
即时检验罗氏心肌肌钙蛋白T检测（PoC TnT）是一种为罗氏cobas h 232系统开发的改进检测方法。
我们进行了一项多中心评估（四个地点），以评估PoC TnT检测的分析性能，并将其与中心实验室的电化学发光法高敏肌钙蛋白T检测（实验室cTnT-hs）进行比较。
PoC TnT与实验室cTnT-hs方法比较中发现的相对平均差异范围为-4.1%至+6.8%。此外，对于肌钙蛋白T值低于40 ng/L测量范围的样本数量，PoC TnT与实验室cTnT-hs之间具有良好的一致性。PoC TnT的批次间差异范围为-8.6%至+4.6%。对患者样本进行81次十倍稀释测量得出的低（40至<200 ng/L）、中（200至<600 ng/L）、高（600至2000 ng/L）测量范围内的系列内变异系数（CV）分别为9.3%、11.8%和12.9%。使用系统质量控制，日间不精密度的平均CV为11.3%。甘油三酯（高达11.4 mmol/L）、胆红素（高达376 µmol/L）、血红蛋白（高达0.12 mmol/L）、生物素（高达30 µg/L）、类风湿因子（高达200 IU/mL）或52种治疗浓度的标准或心血管药物均未观察到干扰。血细胞比容值在25%至53%范围内变化对结果无影响。然而，发现了人抗鼠抗体的干扰。使用135至165 µL的样本体积，PoC TnT对结果无显著影响。高达500 µg/L的高肌钙蛋白T浓度未导致假低结果，表明无高浓度钩状效应。PoC TnT检测与高达1000 µg/L（<0.05%）的人骨骼肌肌钙蛋白T之间未发现交叉反应。本研究亚组（23例患者）的诊断敏感性和特异性数据与另一项大型院前研究结果一致。
PoC TnT检测显示出良好的分析性能，与校准和参考实验室方法具有出色的一致性。因此，它应适用于其在即时检验环境中的预期用途。
