Dombrose F A, Barnes C C, Gaynor J J, Elston R C
Am J Clin Pathol. 1982 Jan;77(1):32-45. doi: 10.1093/ajcp/77.1.32.
Results are reported of a one-year study on the stability of a lyophilized normal human reference plasma, originally standardized for eight clotting factor activities against a freshly prepared pool of citrated, platelet-poor normal human plasma. The stability of any particular coagulant activity in this reagent was represented mathematically as a function of the observed clotting times obtained under specific assay conditions, where any observed change in the clotting times over the trial period was taken to reflect a change in the stability of the reference plasma. Taking into consideration estimates of variability contributed by different donors of factor-deficient substrata-plasma, different lots of substrate from the same donor, different technologists, and certain age-of-substrate lot trends, there was no statistically significant change in functional activity for Factors V and VII through XII in the reagent when it was stored unreconstituted below -25C. By less rigorous criteria, both clottable fibrinogen (Factor I) and the thrombin-forming potential of prothrombin (Factor II) also were stable during this same period. Based on these results, it was concluded that when suitably prepared, lyophilized human plasma can be used as a stable, secondary standard reference for the assay of coagulation factors.
报告了一项为期一年的关于冻干正常人参考血浆稳定性的研究结果。该血浆最初针对八种凝血因子活性进行标准化，对照新鲜制备的枸橼酸盐化、少血小板正常人血浆池。该试剂中任何特定凝血活性的稳定性在数学上表示为在特定测定条件下获得的观察到的凝血时间的函数，其中在试验期间观察到的凝血时间的任何变化都被视为反映参考血浆稳定性的变化。考虑到由不同的因子缺乏底物血浆供体、同一供体的不同批次底物、不同技术人员以及底物批次的某些年龄趋势所导致的变异性估计，当试剂在低于-25°C未复溶保存时，其中因子V和VII至XII的功能活性没有统计学上的显著变化。按照不太严格的标准，可凝固纤维蛋白原（因子I）和凝血酶原（因子II）形成凝血酶的潜力在同一时期也很稳定。基于这些结果，得出结论：适当制备的冻干人血浆可用作凝血因子测定的稳定二级标准参考物。
