免疫比浊法测定D-二聚体假阳性结果的甄别与处理方法

The Screening and Optimization Strategy of False Positive Results of D-dimer by Immunoturbidimetry

目的探讨免疫比浊法测定D-二聚体假阳性结果的甄别及处理方法。方法回顾性研究。收集本院2016年至2017年凝血五项中D-二聚体单纯性增高,且数值大于3 mg/L的患者302例为研究对象。其中妇科炎症患者71例,妇科良性肿瘤患者83例,妇科恶性肿瘤患者148例(卵巢癌52例,宫颈癌66例,内膜癌30例)。分别采用INNOVANCE试验在Sysmex cs-5100检测平台上测定纤维蛋白降解产物(FDP),D-二聚体及D-二聚体稀释试验,并通过VIDAS-30检测平台进行验证。结果302份标本中285份标本结果相符,符合率为94.4%,并呈正相关,此时判定D-二聚体检测值为真值。17份标本结果不符,不符合率为5.6%。表现为:D-二聚体结果阳性,FDP结果阴性,D-二聚体稀释试验结果随稀释倍数的增加而进行性下降且幅度很大,VIDAS试验验证为阴性。此时判定D-二聚体结果为假阳性。结论免疫比浊法测定D-二聚体时,可以通过D-二聚体,FDP及D-二聚体稀释试验联合检测来减少D-二聚体假阳性的出现,为临床提供准确的检测报告。

Objective To investigate the screening and optimization strategy of false positive results of D-dimer using immunoturbidimetry.Methods A retrospective study was conducted.A total of 302 patients with increased D-dimer(>3 mg/L)in the coagulation test in Beijing Obstetrics and Gynecology Hospital from 2016 to 2017 were enrolled in this study.Among them,71 patients with gynecological inflammation,83 patients with gynecological benign tumors,148 patients with gynecological malignant tumors(52 cases of ovarian cancer,66 cases of cervical cancer,30 cases of endometrial cancer).Fibrinogen degradation product(FDP),D-dimer and D-dimer dilution tests were determined by innovance assay on Sysmex cs-5100 platform,and verified by VIDAS-30 detection platform.Results 285 of 302 specimens showed consistencies in FDP and D-dimer tests with a positive correlation,with the coincidence rate 94.4%.These values of D-dimer were regarded as the ground truth values of D-dimer detection.17 specimens demonstrated inconsistent FDP and D-dimer values,presented as a positive D-dimer result along with negative results in FDP and VIDAS tests.These results were considered as the false positive.Conclusion When D-dimer is determined by immunoturbidimetry,researchers can reduce the occurrence of false-positive results by combing D-dimer,FDP and D-dimer dilution test,which could provide more accurate clinical reports of D-dimer.