Could the Intra-Laboratory Inter-Identical-Instrument Bias Compromise the Interpretation of the Absolute High-Sensitive Troponin Delta Around the 99th Percentile Upper Reference Limit?

Abstract

Aim of the study: To measure high-sensitive troponin (Access hsTnI) interidentical- instrument bias (DxI800 Beckman Coulter) in order to understand if it can compromise the interpretation of absolute delta value for rapid algorithms 0/1-0/3 hours. Materials and methods: One hundred fifty-nine lithium/heparin plasma samples were processed sequentially on three DxI800 (DxI1, DxI2, DxI3). The results given by the three instruments were analyzed as followed: DxI1 vs. DxI2, DxI1 vs. DxI3, DxI2 vs. DxI3. Statistical analysis was done using the Passing-Bablok regression, Bland-Altman test, and Cohen’s Kappa statistic. Results: PB regression did not show any significant deviation from linearity and no proportional nor constant differences were observed among instruments. Moreover, the mean absolute bias, even though among the three instruments the lowest 95%CI lower limit was -3.75 and the highest 95%CI upper limit was 3.92 ng/L, was within the acceptance limits (all results

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实验室内相同仪器间的偏差是否会影响绝对高敏感肌钙蛋白δ在第99百分位上限附近的解释?

研究目的:测量高灵敏度肌钙蛋白(Access hsTnI)同质仪器偏差(DxI800 Beckman Coulter)，以了解它是否会影响快速算法0/1-0/3小时的绝对delta值的解释。材料与方法:在3台DxI800 (DxI1、DxI2、DxI3)上依次处理159份锂/肝素血浆样品。三种仪器给出的结果分析如下:DxI1与DxI2, DxI1与DxI3, DxI2与DxI3。统计分析采用Passing-Bablok回归、Bland-Altman检验和Cohen’s Kappa统计。结果:PB回归与线性关系无显著偏差，各仪器间无成比例或恒定差异。此外，尽管三种仪器的95%CI下限为-3.75,95%CI上限为3.92 ng/L，但平均绝对偏差仍在可接受范围内(所有结果均<参考变化值)。每一对乐器之间的一致性大多很强。结论:我们的数据表明，在评估一个绝对增量相对于另一个绝对增量的临床诊断准确性之前，需要考虑相同仪器间的偏差，以便确定实验室可以向临床医生保证的最小绝对增量。

本文章由计算机程序翻译，如有差异，请以英文原文为准。