Bruhn H D, Conard J, Mannucci M, Monteagudo J, Pelzer H, Reverter J C, Samama M, Tripodi A, Wagner C
Medizinische Klinik, Kiel, FRG.
Thromb Haemost. 1992 Oct 5;68(4):413-7.
A multicenter study of a recently developed ELISA for the determination of prothrombin fragment F1+2 was performed in order to evaluate analytical and clinical aspects. Mean intra-assay and inter-assay reproducibility were found to be 11.0 and 12.6%, respectively. The measuring range covered by the calibration curve reaches from 0.04 to 10.0 nM/l F1+2. Testing 133 healthy subjects a reference range of 0.37 to 1.11 nM/l F1+2 (2.5-97.5 percentile) with a median of 0.66 nM/l F1+2 was calculated. Minor difficulties with blood sampling (venous occlusion for 2 min) did not affect F1+2 plasma concentrations. Significantly increased F1+2 levels were measured in patients with leukemia (p < 0.0001), severe liver disease (p < 0.005) and after myocardial infarction (p < 0.01). Elevated F1+2 concentration before the beginning of heparin therapy (1.25 nM/l) decreased to 0.77 nM/l (p < 0.0001) after 1 day of therapy. For patients in the stable phase of oral anticoagulant therapy decreasing F1+2 concentrations were measured with increasing INR. F1+2 levels were already significantly reduced in patients with INR < 2.0 (0.56 nM/l; p = 0.0005). Thus F1+2 determination may be helpful in identifying activation processes as well as in monitoring anticoagulant therapy.
为了评估分析和临床方面，开展了一项关于最近开发的用于测定凝血酶原片段F1+2的酶联免疫吸附测定（ELISA）的多中心研究。发现批内和批间的平均重现性分别为11.0%和12.6%。校准曲线覆盖的测量范围为0.04至10.0 nM/l F1+2。对133名健康受试者进行检测后，计算出F1+2的参考范围为0.37至1.11 nM/l（第2.5-97.5百分位数），中位数为0.66 nM/l F1+2。采血时的小困难（静脉闭塞2分钟）并未影响F1+2的血浆浓度。在白血病患者（p<0.0001）、严重肝病患者（p<0.005）和心肌梗死后患者（p<0.01）中，F1+2水平显著升高。肝素治疗开始前F1+2浓度升高（1.25 nM/l），治疗1天后降至0.77 nM/l（p<0.0001）。对于口服抗凝治疗稳定期的患者，随着国际标准化比值（INR）升高，F1+2浓度降低。在INR<2.0的患者中，F1+2水平已显著降低（0.56 nM/l；p=0.0005）。因此，F1+2的测定可能有助于识别激活过程以及监测抗凝治疗。
