Greene Dina N, Holmes Daniel T, Liang Joy, Kwong Shiu-Land, Lorey Thomas S, Petrie Matthew S
Kaiser Permanente, TPMG Northern California Regional Laboratory, Berkeley, CA, USA.
University of British Columbia, Department of Pathology and Laboratory Medicine, Vancouver, BC, Canada.
Clin Biochem. 2015 Mar;48(4-5):268-74. doi: 10.1016/j.clinbiochem.2014.11.009. Epub 2014 Nov 20.
Beckman Coulter has recently introduced a new troponin assay manufactured for the Access2 and DxI platforms, releasing it under the name AccuTnI+3. Clinical laboratories are required to validate method performance before testing and reporting patient results.
Beckman Coulter Access 2 instruments (n=42) across Kaiser Permanente Northern California were evaluated for their performance characteristics using the AccuTnI+3 reagent. Precision, linearity, and patient sample comparisons were performed on each instrument. Limit of the blank (LOB), limit of detection (LOD), limit of quantitation (LOQ), serum plasma comparisons, and specimen stability were evaluated using a single instrument.
The assay was linear from 0-100,000ng/L. The LOB, LOD and LOQ were determined to be 5, 8 and 20ng/L, respectively. Interday precision on the low QC (mean concentration 41ng/L) ranged from 3.0% to 14.2%. The bias observed between the former assay (AccuTnI) and the AccuTnI+3 was comparable to the inter-instrument bias for either assay. Non-uniform distribution was observed in the precision and inter-instrument/inter-assay comparisons among the instruments evaluated.
The AccuTnI and AccuTnI+3 troponin assays are equivalent across the analytical measuring range. There was no significant difference at the medical decision point. No changes in patient results are anticipated. However, the assay-independent inter-instrument bias observed is an important consideration for harmonization efforts.
贝克曼库尔特公司最近推出了一种为Access2和DxI平台制造的新型肌钙蛋白检测方法，以AccuTnI+3的名称发布。临床实验室在检测和报告患者结果之前需要验证方法性能。
使用AccuTnI+3试剂对北加利福尼亚州凯撒医疗集团的42台贝克曼库尔特Access 2仪器的性能特征进行了评估。对每台仪器进行了精密度、线性和患者样本比较。使用一台仪器评估了空白限（LOB）、检测限（LOD）、定量限（LOQ）、血清与血浆比较以及样本稳定性。
该检测方法在0-100,000ng/L范围内呈线性。确定LOB、LOD和LOQ分别为5、8和20ng/L。低质量控制品（平均浓度41ng/L）的日间精密度范围为3.0%至14.2%。前一种检测方法（AccuTnI）与AccuTnI+3之间观察到的偏差与两种检测方法中仪器间的偏差相当。在所评估的仪器之间的精密度以及仪器间/检测方法间比较中观察到分布不均匀。
AccuTnI和AccuTnI+3肌钙蛋白检测方法在分析测量范围内相当。在医学决策点上没有显著差异。预计患者结果不会有变化。然而，观察到的与检测方法无关的仪器间偏差是协调工作的一个重要考虑因素。
