全自动化学发光免疫分析仪在梅毒螺旋体抗体检测中的临床应用

目的探讨CHEMCLIN(600型全自动化学发光免疫分析仪(下称CLIA法)在梅毒螺旋体抗体检测中的临床应用价值。方法通过测定CLIA法在梅毒螺旋体抗体检测中的精密度、携带污染现象、灵敏度、干扰试验及对比试验。并进行统计分析1484份临床血清标本用CLIA法、甲苯胺红不加热血清试验(TRUST)和梅毒螺旋体明胶凝集试验(TPPA)三种方法的平行检测的结果。结果 CHEMCLIN(600型系统对高、中、低度3个浓度梅毒螺旋体抗体阳性标本检测的重复性结果显示,其批内、批间的变异系数均低于10%。通过比较强阳性混合血清混合前后及阴性混合血清,系统吸样针无携带污染,差异无显著性(P0.05)。用CLIA法和TPPA法同时检测弱阳性标本,CLIA法1∶16稀释检测结果为阴性,TPPA法1∶4稀释检测为阴性。三酰甘油浓度高达20.0mmol/L、血红蛋白浓度高达30.0g/L、胆红素高达95mol/L时对测定结果的发光值影响度3.5%,且前后判断结果不变。比较CLIA法与进口仪器I2000两种方法 ,差异无统计学意义P0.05。TPPA法与CLIA法两种方法检测结果比较,差异也无显著性(P0.05)。CLIA的敏感度为98.4%,特异度为99.8%。结论 CHEMCLIN(600型全自动化学发光免疫分析仪系统作为国内新开发的梅毒血清学特异性抗体检测方法 ,其检测精密度较好,无携带污染现象,检测灵敏度高于TPPA法,抗干扰能力强。其敏感性和特异性都很高,自动化程度高,值得在临床推广应用。

A Full-automatic Chemiluminescence Immunoassay Instrument Applied for Detection of Treponema Pallidum Antibody in Clinic

Objective To discuss its' practical application of a full-automatic chemiluminescence immunoassay instrument-CHEMCLIN 600 system(CLIA)applied for detection of the treponema pallidum antibody in clinic.Methods Analyze the precision,sensitivity,interferences,carryover and comparative test by detecting the treponema pallidum antibody thickness on the CHEMCLIN 600 system.Statistic al analyzed data of 1 484 clinical spcimens which are separately detected by three ways-CLIA,Toluidine red unheated serum regain test(TRUST),and Treponema pallidum particle agglutination test(TPPA).Results The repeatability of the intra-and inter-assay tests shows the coefficients of variation(CV)are <10% through detecting three levels of high,middle and low dose on the system.The carryover of the system needles can't be found through comparing the negative mixture serum results leading and following the positive mixture serum(P>0.05).The treponema pallidum antibody can't be detected by the CLIA in its 1∶16 dilutions and TPPA in its 1∶4 dilutions through examining the same weak positive specimen separately.There is only affect <3.5%,and the final judgments can't be changed when the concentration of TG in serum under 20.0 mmol/L,concentration of hemoglobin under 30.0 g/L and concentration of total biliubin under 95 mol/L.There is no significant difference(P>0.05),comparing CLIA and imported machine-I 2000 or TPPA and CLIA through detecting 1 484 clinical specimens.The sensitivity is 98.4% and specificity is 99.8% of CLIA.Conclusion The system is a new domestic method to detect the treponema pallidum specific antibody.It is reliable,sensitive,and faster method for the treponema pallidum antibody analysis.It is easy to operate with combining advantage of full automation.It's worth promoting in clinic.