Hursting M J, Slaughter T F, Stead A G, Szewczyk K M, Witt D J, Greenberg C S
Organon Teknika Corporation, Durham, NC, USA.
Arch Pathol Lab Med. 1998 Jan;122(1):31-6.
Immunoassays for prothrombin fragment 1.2 (F1.2) provide a specific measure of thrombin generation and offer potential value in detecting activation of the coagulation system and monitoring anticoagulant therapy. To standardize laboratory measurements of this analyte, it is important to define factors affecting interassay variability.
To determine the potential for standardization of F1.2 measurement by examining the effects of preanalytical variables and calibrator selection on F1.2 measurement.
Using three commercially available immunoassays, interassay and intra-assay correlations for F1.2 were determined using blood samples collected into heparin, citrate, and a solution of ethylenediaminetetraacetic acid, aprotinin, and D-phenylalanyl-L-prolyl-L-arginyl chloromethyl ketone. In a cohort of patients, interassay correlations for F1.2 were determined using blood collected from an arterial catheter. Dose-response curves were generated for each manufacturer-supplied calibrator set by substitution into each of the previously untested competing immunoassays.
F1.2 immunoassays with the same recommended specimen anticoagulant displayed stronger correlation than assays requiring different anticoagulants. Furthermore, a stronger interassay correlation was elicited by samples collected through an intra-arterial catheter as opposed to venipuncture. F1.2 calibrator sets differed quantitatively, with buffer-related matrix effects contributing to interassay variability.
Analytical standardization of F1.2 immunoassays is possible when a common anticoagulant, blood collection method, and calibrator set are used.
凝血酶原片段1.2（F1.2）免疫测定可提供凝血酶生成的特异性指标，并在检测凝血系统激活和监测抗凝治疗方面具有潜在价值。为了规范该分析物的实验室测量，确定影响批间差异的因素很重要。
通过检查分析前变量和校准品选择对F1.2测量的影响，确定F1.2测量标准化的可能性。
使用三种市售免疫测定方法，对采集到肝素、枸橼酸盐以及乙二胺四乙酸、抑肽酶和D-苯丙氨酰-L-脯氨酰-L-精氨酰氯甲基酮溶液中的血样进行F1.2的批间和批内相关性测定。在一组患者中，使用从动脉导管采集的血液确定F1.2的批间相关性。通过将每个制造商提供的校准品组代入每个先前未测试的竞争性免疫测定中来生成剂量反应曲线。
推荐使用相同抗凝剂的F1.2免疫测定显示出比需要不同抗凝剂的测定更强的相关性。此外，与静脉穿刺相比，通过动脉内导管采集的样本引起更强的批间相关性。F1.2校准品组在数量上有所不同，缓冲液相关的基质效应导致批间差异。
当使用通用抗凝剂、采血方法和校准品组时，F1.2免疫测定的分析标准化是可行的。
