免疫比浊法定量检测D-二聚体的实验程序优化及实际价值

Optimization of Test Protocols and Its Actual Application in the Detection of D-dimer by Immune Turbidimetry

目的优化实验程序以拓展免疫比浊法定量检测D-二聚体的检测范围.方法分别以未稀释样本及预稀释样本方式在CA1500全自动血凝仪上建立两套程序.应用D-二聚体标准品分别建立两套程序相应的定量标准曲线,一条为未稀释标准曲线,另一为预稀释标准曲线.在两条标准曲线模式下,分别对D-二聚体高值质控血浆和临床收集的43例D-二聚体异常升高血浆样本进行D-二聚体测定.结果未稀释标准曲线与预稀释标准曲线对应的D-二聚体检测线性范围分别是124～3 980μg/L和498～7 960μg/L.在未稀释标准曲线模式下,上述样本的D-二聚体均不能直接测出;而在预稀释标准曲线模式下,所有样本D-二聚体均可直接测出,其中D-二聚体高值质控血浆的D-二聚体测定结果为3 328±194μg/L,43例临床样本D-二聚体结果在1 386～6 185μg/L之间,平均为3 009±1 497μg/L.结论在应用免疫比浊法进行D-二聚体测定中,另外建立一套预稀释程序可以拓展免疫比浊法定量检测D-二聚体的检测范围,而且可以较好地解决D-二聚体异常升高样本不能直接测定的问题.

Objective To optimize the test protocols in the detection of D-dimer by immune turbidimetry,and to extend the detection ranges. Methods Two sets of test protocols were programmed on the automatic CA1500 coagulation analyzer, one used the undiluted samples,and the other utilizing diluted samples. Using the standard human plasma to create the double standard curves,one was the undiluted standard curve,and tiae other was the pre-dilution standard curve. Utilizing the double standard curve,the D-dimer levels of abnormal control plasma and 43 clinical samples were determined. Results The detection linear ranges of the undiluted standard curve and the pre-dilution standard curve were 124～3 980 μg/L and 498～7 960μg/L,respectively. Under the mode of the undiluted standard curve,the D-dimer in aforementioned samples could not be directly detected. However ,the D-dimer level of these samples could be directly determined under the predilution mode. The D-dimer levels of abnormal control plasma were 3 328± 194 μg/L,and the D-dimer levels in 43 clinical samples were 3 009±1 497 μg/L（range,1 386～6 185μg/L）. Conclusion In the detection of D-dimer by immune turbidimetry,a second pre-dilution test protocol helps extend the detection ranges and solve the problem that the D-dimer could not be detected in some abnormal clinical samples.