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首页> 外文期刊>Annales de biologie clinique >Analytical performances of Hemoclot Protein C Reagent on ACL TOP analyzer
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Analytical performances of Hemoclot Protein C Reagent on ACL TOP analyzer

机译：血红蛋白C试剂在ACL TOP分析仪上的分析性能

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摘要

Our study aimed to evaluate and validate according to standard NF EN ISO 15189 the original protocol ajustement of Hemoclot Protein C (PC) (Hyphen BioMed), clotting-based assay of PC on ACL TOP analyzer (Werfen/Instrumentation Laboratory). We evaluated the performance in terms of imprecision and we validate additional parameters in range B required by the SH GTA 04 (COFRAC): repeatability, reproducibility, detection and quantification limits, limits of linearity, stability, inter-samples and inter-reagents contamination, inaccuracy, evaluation of interferences (hemolysis, bilirubinemia and chyles). A comparison with Hemoclot PC on STA Compact analyzer (Stago) was performed. Coefficients of variation were lower than 5 %. Detection and quantification limits were respectively 8.3 % and 9.3 %. Superior limit of linearity was 140 %. The test didn't diplay any inter-samples and inter-reagents contamination. Reagent after reconstitution was stable 6 hours on ACL TOP. No interferences were observed for hemoglobin lower than 500 mg/dL, for bilirubin lower than and for chyles lower than 300 mg/dL. Comparison with Hemoclot PC on STA analyzer (Stago) was satisfactory. Hemoclot PC adjusted on ACL TOP analyzer showed satisfactory analytical perfoiuiances with criteria chosen in our study. These data allow a better knowledge of the performances of this test and were useful to make a validation file in range B as recommended by SH GTA 04.
机译：我们的研究旨在根据标准NF EN ISO 15189评估和验证血凝蛋白C（PC）（Hyphen BioMed）的原始方案调整，即在ACL TOP分析仪（Werfen /仪器实验室）上基于凝结的PC测定。我们根据不精确度评估了性能，并验证了SH GTA 04（COFRAC）要求的B范围内的其他参数：可重复性，可重复性，检测和定量限，线性限度，稳定性，样品间和试剂间污染，不准确，评估干扰（溶血，胆红素血症和乳糜）。与STA Compact分析仪（Stago）上的Hemoclot PC进行了比较。变异系数低于5％。检测限和定量限分别为8.3％和9.3％。线性的上限为140％。该测试未消除任何样品间和试剂间污染。重建后的试剂在ACL TOP上稳定6小时。对于低于500 mg / dL的血红蛋白，低于300 mg / dL的胆红素和低于300 mg / dL的乳糜，均未观察到干扰。与STA分析仪（Stago）上的Hemoclot PC的比较令人满意。在ACL TOP分析仪上调整的Hemoclot PC表现出令人满意的分析性能，符合我们研究中选择的标准。这些数据使您可以更好地了解此测试的性能，并有助于按照SH GTA 04的建议在范围B中制作验证文件。

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