胶体金法和免疫荧光法检测血浆肌钙蛋白I的比较

Comparison of colloidal gold assay and immun of luorescence assay in determination of serum cardiac troponin I

目的通过两种方法检测结果的比较,对胶体金法(Colloidal Gold Assay)检测血清心肌肌钙蛋白I(cTnI)进行方法学评价,并探讨其临床应用价值。方法应用胶体金法测定20名健康人和20例急性心肌梗死(AMI)患者的血清cTnI水平,并与免疫荧光法(IFA)检测结果相比较,系统研究胶体金法测定cTnI的敏感性、特异性、可用度。结果胶体金法(Y)与免疫荧光法(X)具有良好的相关性(Y=0.801 X-0.174,r=0.980),结果差异无统计学意义(P>0.05)。诊断敏感度、特异度、可用度分别为85.0%、95.0%、80.3%,阳性和阴性似然比分别为17.0%和15.8%,阳性预测值和阴性预测值分别为94.4%、86.4%。结论胶体金法操作简便、结果准确可靠、自动化程度高,且检测快速,具有较高的临床可用度;cTnI对诊断AMI有高度特异性和敏感性,且持续时间较长,适合在临床工作中推广应用。

Objective To conduct the methodological evaluation on the colloidal gold assay for detecting cardiac troponin I（cTnl） by the comparison of two detection methods and to investigate its clinical application value. Methods Serum cTnI level was determined by the colloidal gold assay in 20 healthy individuals and 20 patients with acute myocardial infarction（AM1） and the detection results were compared with the results detected by the immunofluoresccnce assay. The sensitivity, specificity and availability of the colloidal gold assay for detecting cTnl were systematically studied. Results The colloidal gold assay（Y） had good correlation with the immunofluorescence assay（X） （Y 0.801X- 0. 174, r = 0.980）. There was no statistical difference between two methods （ P〉0.05 ）. The sensitivity, specificity and availability were 85.0 %, 95.0 % and 80.3 % respectively. The positive likelihood ratio and the negative likelihood ratio were 17.0% and 15.8% respectively. The positive predictive value （PPV） and the negative predictive value （NPV） were 94.4% and 86.4% respectively. Conclusion The colloidal gold method is reliable,available,fairly rapid and easy to perform with high automation degree, cTnl has the high specificity and sensitivity for diagnosing AMI,and lasts for a long time. This method is suitable for routine determinations of serum cTnl levels in clinical laboratory.