摘要
目的评价国内常用的4种梅毒酶联免疫吸附试验（ELISA）试剂的有效性,为临床选择梅毒诊断试剂提供依据。方法对180例临床血清分别进行快速血浆反应素环状卡片试验（RPR）、梅毒螺旋体颗粒凝集试验（TPPA）和4种试剂的ELISA（试剂分别为A、B、C、D）。以TPPA结果为参考对照,分别统计各ELISA试剂的敏感性、特异性、阳性预测值和阴性预测值。结果 180例血清标本中,RPR阳性58例,TPPA阳性84例,两者均阴性95例。TPPA检测阳性率为46.67%（84/180）,A试剂为44.44%（80/180）,B试剂为45.00%（81/180）,C试剂为45.00%（81/180）,D试剂为28.33%（51/180）。D试剂与TPPA及其他3种试剂的检测阳性率差异有统计学意义（P均〈0.01）。D试剂的敏感性最差（57.14%）,而其他几种ELISA试剂的敏感性较好（94.05%~95.24%）。4种ELISA试剂的特异性均较理想（96.88%~100.00%）。结论个别国产ELISA试剂的敏感性差,提示在选择这类试剂时,应以质控血清进行预试验,使用符合要求的试剂。
Objective To evaluate the performance of 4 home-made enzyme-linked immunosorbent assay（ELISA） kits for the diagnosis of syphilis,and provide the reference for choosing diagnosis reagent in clinic.Methods A total of 180 serum samples were detected by rapid plasma reagin（RPR） circle card test,Treponema pallidum particle agglutination（TPPA） assay and 4 ELISA kits（labeled A,B,C and D）.The sensitivity,specificity,positive predictive value and negative predictive value of 4 ELISA kits were calculated statistically with the results of TPPA as reference.Results Of 180 serum samples,58 were positive for RPR,84 were positive for TPPA,and 95 were negative for both RPR and TPPA.The positive rates were 46.67%（84/180） for TPPA,44.44%（80/180） for ELISA A kit,45.00%（81/180） for ELISA B kit,45.00%（81/180） for ELISA C kit and 28.33%（51/180） for ELISA D kit.There were significant differences between ELISA D kit and TPPA,as well as the other ELISA kits（P0.01）.The worst sensitivity was found in ELISA D kit（57.14%）,in comparison with that in the other ELISA kits（94.05%-95.24%）.The specificities of 4 ELISA kits were ideal（96.88%-100.00%）.Conclusions The sensitivity in certain home-made ELISA kit is not good.The pretest with quality control sera is necessary before the clinical application of the ELISA kit.
出处
《检验医学》
CAS
北大核心
2010年第10期787-789,共3页
Laboratory Medicine
关键词
酶联免疫吸附试验
梅毒
血清
Enzyme-linked immunosorbent assay
Syphilis
Serum
