梅毒螺旋体抗体检测试剂盒临床考核数据分析.docVIP

梅毒螺旋体抗体检测试剂盒临床考核数据分析 李娜李宏峰赵红（天津市传染病医院检验科300192） 【中图分类号】R446.1 ［文献标识码】A【文章编号】1672-5085 （2012） 7-0217-02 【摘要】目的探讨国外梅毒螺旋体抗体检测试剂盒的质量及可能的用途。方法 用考核试剂、参比试剂及第三方试剂对木院常规体检标木及梅毒可疑感染者血样 共700份血清进行检测，并对检测数据进行统计分析。结果考核试剂：美国美 德声科学技术公司牛产的梅毒螺旋体抗体检测试剂盒Lab21,参比试剂：日木富 士瑞必欧株式会社牛产的梅毒螺旋体抗体诊断试剂盒进行对比研究，考核试剂和 参比试剂的阳性符合率98.71%,阴性符合率100.0%,总符合率99.57%。对考核 试剂和参比试剂检测结果不一致的一例样木使用上海科华牛物工程股份有限公 司牛产的梅毒螺旋体抗体诊断试剂盒进一步验证分析，结果表明，考核试剂的敏 感性为99.06%,特异性为100%o结论美国美德声科学技术公司生产生产的梅 毒螺旋体抗体检测试剂盒有较高的准确性。该试剂采用对患者血清中的梅毒螺旋 体抗体（IgG+IgM）的联合检测，可以提高梅毒的临床检出率，有助于疾病的诊 断与预防。 【关键词】梅毒螺旋体抗体 酶联免疫吸附试验（ELISA）临床考核 Syphilitic Spirochaeta antibody test kit clinical assessment data analysis 【Abstract 】 Objective: To study the quality and possible uses of abroad syphilitic Spirochaeta antibody test kit .Methods: Use the assessment reagents, reference reagents and third-party agents to detect 700 serum samples which are including our hospital routine physical samples and TP potentially infective specimens, and statistical analysis the test data. Results: The assessment reagents: TP antibody test kit product by USA Meidesheng. Referenee reagents: TP antibody test kit product by Japan Co., Ltd.. When the TP antibody test kit product by Japan Co., Ltd was used as a refere nee, the Meideshe ng test dem on strated 98.71% positive coin cide nee rate, 100.0% feminine coincide nee rate, 99.57% total coin cide nee rate. One incon siste nt cases use the third-party reage nt sample testi ng, the result show that the assessment reagents has 99.06% sensitivity, 100% specificity. Conclusion: The Meidesheng test kit has higher accuracy, compared with the domestic application of awide range of diag no Stic was no sign ifica nt differe nee, there is a good con siste ncy; Clin ical exami nation found that the reage nts combi ned detect the TP antibody （IgG+IgM） in the serum of the patients, that could improve the clinical detection rate, con tribute to diag nosis and preve ntion. 【Key words】TP antibody ELASA clinical assessment 梅毒（Syphilis）是由梅毒螺旋体（Tpallidum