Gogstad G O, Dale S, Brosstad F, Brandsnes O, Holtlund J, Mørk E, Gärtner E, Borch S M
Diagnostica R&D, Nycomed Pharma AS, Oslo, Norway.
Clin Chem. 1993 Oct;39(10):2070-6.
In this immunofiltration assay of D-dimer in plasma samples, the antigens are captured by a monoclonal antibody on a porous membrane, and labeled with the same antibody conjugated to gold colloids. The assay time is < 2 min, and a color of intensity proportional to the concentration of D-dimer is left on the membrane. The reference range (mean +/- 2 SD) was 0.336 +/- 0.133 mg/L (n = 69). Linearity was found up to 10 mg/L. Comparison with ELISA results (x) for 198 patients' samples demonstrated a linear regression equation of y = 0.99(+/- 0.05)x + 0.68(+/- 0.07) and a mean square error of 0.503. Comparison of visual reading of the color signal (y) vs reflectometric measurements (x) for 220 patients' samples demonstrated a linear regression equation of y = 2.5(+/- 0.06)x -0.22(+/- 0.04) and a mean square error of 0.095. Bilirubin, hemoglobin, fibrinogen, soluble fibrin, and fibrinogen degradation products and freezing/thawing of samples did not interfere. Some interference from rheumatoid factor, heparin, and the presence of cells or large lipid particles was seen. The variance (CV) was 8-12% within run, 10-18% between runs, and 13-20% between persons. The new assay constitutes a rapid and reliable analytical tool combining simplicity equivalent to that of latex tests with analytical information approaching that of ELISA.
在这项血浆样本中D - 二聚体的免疫过滤测定中，抗原被多孔膜上的单克隆抗体捕获，并用与金胶体偶联的相同抗体进行标记。测定时间<2分钟，膜上会留下与D - 二聚体浓度成正比的颜色强度。参考范围（均值±2标准差）为0.336±0.133mg/L（n = 69）。在高达10mg/L时呈线性。对198例患者样本的测定结果与ELISA结果（x）进行比较，得出线性回归方程为y = 0.99（±0.05）x + 0.68（±0.07），均方误差为0.503。对220例患者样本的颜色信号视觉读数（y）与反射光度测量值（x）进行比较，得出线性回归方程为y = 2.5（±0.06）x - 0.22（±0.04），均方误差为0.095。胆红素、血红蛋白、纤维蛋白原、可溶性纤维蛋白、纤维蛋白原降解产物以及样本的冻融均无干扰。观察到类风湿因子、肝素以及细胞或大脂质颗粒的存在会产生一些干扰。批内变异系数（CV）为8 - 12%，批间为10 - 18%，不同人员间为13 - 20%。这种新的测定方法是一种快速可靠的分析工具，兼具乳胶试验的简便性和接近ELISA的分析信息。
