Objective: To evaluate the clinical application performance of a domestic D-dimer assay reagent (ADX D-dimer). Methods: A total of 546 residual sodium citrate anticoagulated plasma samples (530 of which were used for comparability validation and 16 for sample preparation of other validation components) were selected after the completion of clinical testing at Peking Union Medical College Hospital from Jun 2022 to May 2023. According to the American Clinical Laboratory Standards Institute (CLSI) guidelines, national health industry standards and relevant references, the performance of ADX D-dimer used in Sysmex CS 5100 fully automated coagulation analyzer which included accuracy, precision, linear range, carryover rate, interference resistance capability and reference interval were validated and the agreement compared with two mainstream imported detection reagents (reagent A: Vidas D-dimer reagent; reagent B: Innovance D-dimer detection reagent) was evaluated. The clinical diagnostic efficacy of the ADX D-dimer was evaluated using the ELISA D-dimer (reagent A) test results as criteria. Results: The linear correlation coefficient of the 6-point calibrated absorbance and target value was 0.998, the bias of accuracy met the requirements (-2.8%-8.4%), and the coefficient of variation (CV) of within-run and between-day precision of the two levels were 1.0%-2.7% and 2.7%-4.1%, respectively, which were less than the requirements of the manufacturer's statement and the national health industry standard. The linear range within 0.33-9.69 mg/L FEU was verified and the carryover rate was 0. There was no significant interference with the assay results at bilirubin F≤0.22 g/L, bilirubin C≤0.22 g/L, hemoglobin≤5.5 g/L and celiac≤2 800 FTU. The manufacturer's reference interval≤0.5 mg/L FEU was verified suitable for this laboratory. For 358 samples without suspicious heterophilic antibody whose D-dimer levels range from 0.06 to143.63 mg/L FEU, the correlation between ADX D-dimer and another two assay was good, with r values being 0.968 and 0.975, respectively, the percentage of deviation and relative deviation beyond the 95% confidence interval was 3.4%-4.5% and 5.3%-7.0%. The correlation between ADX D-dimer and ELISA D-dimer was better than that of reagent B in the concentration range of 0.06-1.00 mg/L FEU (r=0.858, 0.134). For 172 samples with heterophilic antibody, the correlation between ADX D-dimer and ELISA D-dimer was still good(r=0.827), with the percentage of deviation and relative deviation being 6.4% (11/172). The diagnostic efficacy was evaluated using 530 samples, and the sensitivity, specificity, positive predictive value, negative predictive value of ADX D-dimer was 97.4%, 77.6%, 91.9%, 91.9%. The area under the curve was 0.976 (95%CI: 0.964-0.987, P<0.001). Conclusion: The ADX D-dimer reagent has superior assay and diagnostic performance, and can meet the needs of clinical laboratories.
目的： 对一种国产D-二聚体检测试剂（ADX D-二聚体）的临床应用性能进行评价。 方法： 选取2022年6月至2023年5月北京协和医院就诊完成临床检测后的柠檬酸钠抗凝血浆标本546份（其中530份用于可比性验证，16份用于其他验证），根据美国临床和实验室标准协会（CLSI）指南、国家卫生行业标准和相关参考文献，分别对其在Sysmex CS 5100全自动凝血分析仪上的准确度、精密度、线性范围、携带污染率、抗干扰能力和参考区间进行验证，并与两种进口检测试剂（试剂A：Vidas D-dimer试剂；试剂B：Innovance D-二聚体检测试剂）的配套检测系统进行结果比对。以ELISA（试剂A）D-二聚体检测结果为金标准，对ADX D-二聚体检测试剂的临床诊断效能进行评估。 结果： 6点定标吸光度与靶值的线性相关系数为0.998，准确度偏倚为-2.8%~8.4%，满足≤10%的要求。两水平批内精密度和日间精密度变异系数（CV）分别为1.0%~2.7%和2.7%~4.1%，均小于厂家声明和国家卫生行业标准的要求。在0.33~9.69 mg/L［纤维蛋白原等量单位（FEU）］内线性范围验证通过；携带污染率为0；胆红素F≤0.22 g/L、胆红素C≤0.22 g/L、血红蛋白≤5.5 g/L和乳糜≤2 800 FTU时对检测结果无明显干扰。厂家声明的参考区间≤0.5 mg/L FEU验证通过，适用于本实验室。358份不含异嗜性抗体的样本，D-二聚体水平在0.06~143.63 mg/L FEU浓度范围，ADX D-二聚体检测试剂与试剂A和试剂B间检测结果的相关性好，r值分别为0.968、0.975，可比性偏差和百分偏差超出95%CI的结果比例分别为3.4%~4.5%和5.3%~7.0%。其中132份样本的D-二聚体水平在0.06~1.00 mg/L FEU浓度范围，ADX D-二聚体试剂与ELISA 法（试剂A）检测结果的相关性优于与试剂B检测结果的相关性（r=0.858、0.134）。172份疑似存在抗体干扰的样本，ADX D-二聚体试剂与ELISA 法（试剂A）检测结果的相关性仍较好（r=0.827），可比性偏差和百分偏差超出95%CI的结果比例为6.4%（11/172）。以530份样本的检测结果进行临床诊断效能评价，cut-off值为0.5 mg/L FEU时，ADX D-二聚体试剂的诊断灵敏度为97.4%，特异度为77.6%，阳性预测值为91.9%，阴性预测值为91.9%，曲线下面积为0.976（95%CI：0.964~0.987，P<0.001）。 结论： ADX D-二聚体试剂具有良好的检测性能，能够满足临床实验室的使用需求。.