Development and Performance Evaluation of Plasma D-Dimer Latex for Immunoturbidimetric Enhancement
血浆中D-二聚体胶乳增强免疫比浊试剂的开发及性能评价

摘要

目的 依据胶乳增强免疫比浊法的基本原理，研究D-二聚体检测方法。方法 通过共价交联制备胶乳微球-抗体结合物，观察胶乳微球-抗体结合物和D-二聚体的凝集反应，确备D-二聚体的检测方法，并对该方法的准确度、精密度、线性和临床一致性进行评价。结果 重复测定2个浓度的质控品各20次，其批内、日间精密度变异系数（CV）＜5％；线性范围为0.2～20.0μg/mL，平均回收率为93.5％，与商品化试剂盒临床相关系数为0.995。结论 该研究制备了胶乳比浊法的D-二聚体检测方法，各项性能满足临床使用需求，可用于临床D-二聚体的检测。

Abstract

Objective: To study the D-dimer detection method based on the basic principle of latex enhanced immunoturbidimetric method.
Methods: Latex microsphere-antibody conjugate was prepared by covalent cross-linking, and the agglutination reaction between latex microsphere-antibody conjugate and D-dimer was observed. The D-dimer detection method was confirmed, and the accuracy, precision, linearity and clinical consistency of the method were evaluated.
Results: The variation coefficient (CV) of intra-batch and intra-day precision of the two quality control products was < 5%. The linear range was 0.2-20.0 μg/mL, the average recovery was 93.5%, and the clinical correlation coefficient with commercial kit was 0.995.
Conclusion  : This study prepared the latex turbidimetric method for the detection of D-dimer, the performance can meet the requirements of clinical use, can be used for clinical detection of D-dimer.