ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT 84108, USA.
Clin Biochem. 2013 Jan;46(1-2):119-22. doi: 10.1016/j.clinbiochem.2012.09.014. Epub 2012 Sep 23.
Galectin-3 is an emerging biomarker that is commonly increased in patients with heart failure and/or patients at risk for cardiovascular disease. We evaluated the Galectin-3 assay on the Abbott ARCHITECT i1000(SR) and ARCHITECT i2000(SR) at 2 testing sites.
Imprecision (%CV), interference, limits of blank (LoB), detection (LoD), and quantitation (LoQ), linearity, method comparison to an ELISA method, comparisons between plasma and serum, and reference intervals were evaluated. Imprecision was performed based on two runs of duplicate testing conducted daily. Verification of LoB, LoD, and LoQ was performed according to Clinical and Laboratory Standards Institute guidelines. Linearity was evaluated by making 5 dilutions of a high patient EDTA plasma pool with a low patient pool. Reference intervals were established using EDTA plasma collected from self-reported healthy volunteers. A second lot of reagent was used at one site for method comparison and imprecision studies.
Total CV's were ≤6.0%. A positive interference was observed for hemolyzed samples over 2.0 g/L hemolysate. The LoB ranged from 0.1 to 0.3 ng/mL, the LoD from 1.4 to 2.1 ng/mL and the LoQ from 3.0 to 3.3 ng/mL. Linearity studies had slopes and correlation coefficients equal to 1.0. Comparison of the i1000(SR) and i2000(SR) to the ELISA method demonstrated slopes of 1.0 to 1.2 and correlation coefficients of 0.93 to 0.97. The 97.5th percentile of the reference interval was 18.7 and 17.9 ng/mL for the i1000(SR) and i2000(SR), respectively.
The Abbott Galectin-3 assay demonstrated acceptable analytical performance on both the ARCHITECT i1000(SR) and ARCHITECT i2000(SR).
半乳糖凝集素-3 是一种新兴的生物标志物，通常在心力衰竭患者和/或心血管疾病风险患者中升高。我们在 2 个检测地点评估了 Abbott ARCHITECT i1000(SR) 和 ARCHITECT i2000(SR) 上的半乳糖凝集素-3 检测。
精密度（%CV）、干扰、空白限（LoB）、检测限（LoD）和定量限（LoQ）、线性、与 ELISA 方法的比较方法、血浆与血清的比较以及参考区间进行了评估。精密度是基于每天进行两次重复测试运行来进行的。根据临床和实验室标准协会的指南验证了 LoB、LoD 和 LoQ。线性通过对高患者 EDTA 血浆池和低患者池进行 5 次稀释来评估。参考区间是使用自我报告的健康志愿者的 EDTA 血浆建立的。在一个地点使用第二批试剂进行方法比较和精密度研究。
总 CV 不超过 6.0%。超过 2.0 g/L 溶血样本观察到阳性干扰。LoB 范围为 0.1 至 0.3 ng/mL，LoD 范围为 1.4 至 2.1 ng/mL，LoQ 范围为 3.0 至 3.3 ng/mL。线性研究的斜率和相关系数均等于 1.0。i1000(SR) 和 i2000(SR) 与 ELISA 方法的比较表明，斜率为 1.0 至 1.2，相关系数为 0.93 至 0.97。参考区间的第 97.5 个百分位数分别为 i1000(SR) 和 i2000(SR) 的 18.7 和 17.9 ng/mL。
Abbott 半乳糖凝集素-3 检测在 ARCHITECT i1000(SR) 和 ARCHITECT i2000(SR) 上均表现出可接受的分析性能。
