Development and fit-for-purpose validation of a LC-MS/MS assay for fibrinogen peptide A quantitation in human plasma

被引：5
|
作者：
Lin, Mingxiang [1 ]
Lassman, Michael E. [1 ]
Weiner, Russell [1 ]
Laterza, Omar F. [1 ]
机构：
[1] Merck Res Labs, Clin Dev Lab, Rahway, NJ 07065 USA
来源：
BIOANALYSIS | 2014年 / 6卷 / 13期
关键词：
D O I：
10.4155/bio.14.148
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
Background: Fibrinopeptide A (FPA) is a plasma peptide, formed by the action of thrombin on fibrinogen during clog formation. FPA represents a direct indicator of thrombin activity and could potentially be used as a biomarker for anti-thrombotic therapy development. Results/Methodology: A LC-MS/MS assay with a high throughput solid phase extraction procedure was developed and validated to measure FPA in plasma. The lower limit-of-quantitation (LLOQ) of this assay was determined to be 0.16 nM. The inter- and intra-day%CV was <15%. Freeze-thaw stability of FPA was +/- 30% up to 3 cycles and linear response of FPA was observed for plasma dilution up to 16-fold. Conclusion: The assay was validated and the biological variability of FPA in plasma was established (1-30 nM).
引用
收藏
页码：1759 / 1766
页数：8
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