梅毒特异性抗体分离检测装置的性能验证和初步应用
Performance verification and preliminary application of a specific antibody separation and detection device for syphilis

目的 ·设计获得梅毒特异性抗体分离检测的免疫亲和层析装置，对其检测性能进行验证，并初步应用于临床。方法 ·通过亲和层析装置中包被梅毒螺旋体抗原的亲和填料，特异性吸附样品中可能存在的梅毒螺旋体特异性抗体（包括IgG和IgM型），经洗涤、洗脱、脱盐处理后，由羊抗人IgG、IgM金标层析试纸条检测可能存在的梅毒特异性IgG、IgM型抗体。对20例梅毒总抗体检测阴性标本、230例梅毒抗体阳性的临床标本进行检测，并对其中的40例标本进行免疫印迹检测法对比测定。结果 ·优化获得亲和层析装置标准化操作程序。该装置能有效实现梅毒特异性IgG、IgM型抗体的分离检测。20例梅毒总抗体检测阴性标本经该装置检测的结果均为阴性。230例梅毒抗体阳性的临床标本中，2例标本检测结果为TP-IgG、IgM型抗体均阴性，210例标本检测结果为TP-IgG型抗体阳性、TP-IgM型抗体性， 10例标本检测结果为TP-IgG型抗体阴性、TP-IgM型抗体阳性，8例标本检测结果为TP-IgG、IgM型抗体均阳性。40例标本检测结果与免疫印迹检测法结果进行比对，其中2例标本亲和层析装置检测结果为TP-IgG、IgM型抗体均阴性，免疫印迹检测法结果均为TP-IgG型抗体阳性、TP-IgM型抗体阴性，但2种方法检测结果的差异无统计学意义（P>0.05）。结论 ·设计获得的该亲和装置应用于临床样本中梅毒特异性IgM、IgG抗体的分离检测切实可行，对后续临床运用有重要价值。
： Objective · To design an immuno-affinity chromatography device for the separation and detection of syphilis specific antibody, then verify its performance of detection and clinical application. Methods · Affinity filler packed by Treponema pallidum (TP) antigen in affinity chromatography can specifically adsorb TP specific antibody (including IgG and IgM) in samples. After balance, elution and desalination, IgG or IgM gold labeled chromatography strip detects the possibly present syphilis specific IgG or IgM antibody. Twenty cases of syphilis antibody negative samples and 230 cases of syphilis antibody positive clinical specimens were detected by this chromatography device, and 40 cases were also detected by Western blotting. Results ·The standard operation procedure of the affinity chromatography device was optimized, which could effectively detect the specific IgG and IgM antibody of syphilis. The results of 20 syphilis antibody negative samples were all negative. In 230 syphilis antibody positive cases, the detection results were 2 cases with TP-IgG(-) and TP-IgM(-), 210 cases with TP-IgG(+) and TP-IgM(-),10 cases with TP-IgG(-) and TP-IgM(+), and 2 cases with TP-IgG(+) and TP-IgM(+). The detection results of 40 cases were compared with the results detected by Western blotting, among which 2 cases detected by affinity chromatography device were TP-IgG(-) and TP-IgM(-), while the results detected by Western blotting were TP-IgG(+) and TP-IgM(-). But the results of the two methods showed no statistically significant difference (P>0.05). Conclusion · The application of the device in separation and detection of IgG and IgM antibodies against TP pathogens is feasible, and it has important value for further application in clinical diagnosis