Ginsberg J S, Siragusa S, Douketis J, Johnston M, Moffat K, Stevens P, Brill-Edwards P, Panju A, Patel A
Department of Medicine, McMaster University, Hamilton, Canada.
Thromb Haemost. 1995 Sep;74(3):833-6.
The objective of this study was to determine the clinical utility of an enzyme immunoassay (EIA) for soluble fibrin in patients with clinically suspected deep vein thrombosis (DVT).
101 unselected patients with clinically suspected DVT underwent blood sampling for measurement of plasma levels of soluble fibrin, and objective testing for DVT. According to results of the objective tests, patients were classified as DVT-positive (n = 34) or DVT-negative (n = 67). Using different cut-points of soluble fibrin results, the sensitivities, specificities, positive and negative predictive values of the soluble fibrin assay were calculated. A soluble fibrin result of < or = 0.75 mg/ml showed a sensitivity and negative predictive value of 100%, and a specificity of 17.9% for DVT, a soluble fibrin result of < or = 1.40 mg/ml showed a sensitivity of 91.2% and a negative predictive value of 93.6%, and a specificity of 65.7% for DVT, whereas a soluble fibrin result of < or = 8.0 mg/ml showed a specificity and positive predictive value of 100% for DVT.
This study demonstrates that the soluble fibrin assay used in the study has potential clinical utility as a diagnostic test in patients with clinically suspected DVT and supports further evaluation of this assay.
本研究的目的是确定酶免疫测定法（EIA）检测可溶性纤维蛋白在临床疑似深静脉血栓形成（DVT）患者中的临床应用价值。
101例未经筛选的临床疑似DVT患者接受血液采样，以测定血浆中可溶性纤维蛋白水平，并对DVT进行客观检测。根据客观检测结果，患者被分为DVT阳性（n = 34）或DVT阴性（n = 67）。使用可溶性纤维蛋白结果的不同切点，计算可溶性纤维蛋白测定的敏感性、特异性、阳性和阴性预测值。可溶性纤维蛋白结果≤0.75 mg/ml时，对DVT的敏感性和阴性预测值为100%，特异性为17.9%；可溶性纤维蛋白结果≤1.40 mg/ml时，对DVT的敏感性为91.2%，阴性预测值为93.6%，特异性为65.7%；而可溶性纤维蛋白结果≤8.0 mg/ml时，对DVT的特异性和阳性预测值为100%。
本研究表明，该研究中使用的可溶性纤维蛋白测定法在临床疑似DVT患者中作为诊断试验具有潜在的临床应用价值，并支持对该测定法进行进一步评估。
