Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Clin Biochem. 2011 Oct;44(14-15):1247-52. doi: 10.1016/j.clinbiochem.2011.07.005. Epub 2011 Jul 20.
Lp-PLA2 is a biomarker with promise for predicting cardiac risk. The lack of reproducible results has limited its use. In evaluating a new reagent kit, we investigated conditions for optimal reproducibility.
The Auto-PLAC reagents were evaluated on the Cobas instrument. Performance characteristics, stability, and population ranges were determined.
Analytical performance characteristics replicated manufacturer's claims. The stability profile of the analyte was unusual, with increasing results observed with storage at 4°C or -20°C. Only storage at -70°C gave acceptable stability. Population median values with properly preserved samples were much lower than the cut off previously validated for increased risk.
It is postulated that variability in specimen handling was a major contributor to the lack of traceability of the current reagents to the earlier clinical studies demonstrating its utility. We are now unsure how to identify reliable criteria for result interpretation.
脂蛋白相关磷脂酶 A2（Lp-PLA2）是一种有前途的预测心脏风险的生物标志物。但其结果缺乏重现性，限制了其应用。在评估新的试剂试剂盒时，我们研究了实现最佳重现性的条件。
在 Cobas 仪器上评估 Auto-PLAC 试剂。确定性能特征、稳定性和人群范围。
分析性能特征复制了制造商的声明。分析物的稳定性特征不同寻常，在 4°C 或-20°C 下储存时观察到结果增加，只有在-70°C 下储存才能获得可接受的稳定性。经过适当保存的样本的人群中位数值远低于以前验证的增加风险的截断值。
据推测，样本处理的差异是当前试剂与先前证明其效用的临床研究缺乏可追溯性的主要原因。我们现在不确定如何确定结果解释的可靠标准。
