INNOVANCE试验和PLUS试验检测D-二聚体方法比较

Method comparison between INNOVANCE D-Dimer and PLUS D-Dimer

目的评估INNOVANCE试验检测D-二聚体（D-Dimer）的临床效能，为临床有效使用INNOVANCE试验提供依据。方法回顾性研究。402份柠檬酸钠抗凝血标本来自2011年7月至2012年2月北京协和医院门诊及住院患者，采血后2h内进行D-二聚体测定。分别采用INNOVANCE试验和PLUS试验在SysmexCA7000检测平台上测定D-二聚体，并通过VIDAS-30检测平台进行验证。并对4份D-二聚体不同程度升高的标本连续监测5d，观察2种试验测定结果的变化趋势。验证干扰物血红蛋白、胆红素及甘油三酯对INNOVANCE试验检测D-二聚体的抗干扰能力。结果402份标本通过INNOVANCE试验检测D-二聚体的结果为[2．15（0．33，8．63）]mg/LFEU，PLUS试验检测结果为[325．50（123．75，974．00）]μg/LDDU，2种试验的一致性较差（Z=-17．375，P=0．000）。PLUS试验检测D-二聚体的结果为（201-300）μg／LDDU和（301-400）μg/LDDU时，与INNOVANCE试验测定的正常结果和异常结果的符合率最差，仅为25％和15％；当PLUS试验检测D-二聚体的结果为（500-600）μg／LDDU时，符合率可达85％；当PLUS试验检测D-二聚体的结果〉700μg/LDDU时，符合率达到100％。经2种试验检测，共有47份标本检狈4结果不符，通过VIDAS试验验证，83．0％（39／47）为PLUS试验假阴性，4．3％（2／47）为INNOVANCE试验假阴性，12．7％（6／47）为PLUS试验假阳性。4份D-二聚体升高标本通过INNOVANCE试验和PLUS试验测定的结果变化趋势一致。INNOVANCE试验对游离胆红素、结合胆红素、血红蛋白、三酰甘油的抗干扰浓度分别达到217μmo/L、337μmol／L、41．04g／L、18．35mmol/L。结论INNOVANCE试验较PLUS试验排除D-二聚体假阴性的能力明显增强；INNOVANCE试验对黄疸、溶血和脂血的抗干扰能力较强。

Objective To evaluate the clinical performance of INNOVANCE D-Dimer, and provide information for clinical application. Methods 402 cases of sodium citrate anticoagulant blood were tested with INNOVANCE assay and PLUS assay on CA7000 analyzer to measure plasma D-Dimer levels. VIDAS-30 immunology analyzer was also used to validate the two assays. 4 patients with elevated D-Dimer were monitored continuously during 5 days using INNOVANCE assay and PLUS assay respectively, then the consistency of trend between 2 assays was analyzed. Plasma specimens added with hemoglobin, bilirubin and triglyceride were used to verify the anti-interference capability of INNOVANCE D-Dimer assay. Results In 402 specimens, the result ranges of INNOVANCE D-Dimer and PLUS D-Dimer were [2. 15 （0. 33,8.63） mg/L FEU and 1325.50 （ 123.75,974. 00） ] μg/L DDU, respectively. The consistency between two assays was poor （Z = - 17. 375, P =0.000）, especially the results in the range of PLUS D-Dimer （201 - 300） p.g/L DDU and （301 -400） μg/L DDU, the coincidence rates were only 25% and 15%, respectively; the coincidence rate was up to 85% during PLUS D-Direct （500 -600） p.g/L DDU; the coincidence rate was close to 100% when PLUS D-Dimer over 700 p,g/L DDU. Totally 47 of 402 eases wereunmatched between two assays. Verified by VIDAS 30, 83.0% （39/47） was false negative for PLUS assay, 4. 3% （2/47） was false negative for INNOVANCE assay, 12.7% （6/47） was false positive for PLUS assay. There were 5 false positives and 39 false negative for PLUS assay, totally 45 cases ; Two false negative for INNOVANCE assay. Four patients with elevated D-Dimer were monitored and the results showed similar trend between 2 assays. For INNOVANCE assay, the capaeity of anti-interference to free bilirubin, unconjugated bilirubin, hemoglobin, and triglyceride was up to 217 μmol/L, 337 μmol/L, 41.04 g/L, 18.35 mmol/L, respectively. Conclusions INNOVANCE assay can markedly reduce false negative results of D-Dimer compared with PLUS assay. INNOVANCE D-Dimer has good performance on anti-interference to jaundice, hemolysis and lipemia samples.