人乳头瘤病毒疫苗临床血清学ELISA检测方法比对研究

Investigation of ELISA assays for HPV antibodies in different laboratories

目的为保证人乳头瘤病毒疫苗临床血清抗体检测的准确性和有效性,对ELISA检测方法进行了比对研究。方法采用编盲的200对血清,分别在两个不同实验室使用ELISA法进行HPV16、HPV18型抗体检测,并对结果进行统计学分析。结果两个实验室对免前、免后血清的16、18型抗体检测结果,阴阳性符合率均大于93%,统计学分析显示两个实验室的检测结果差异无统计学意义。免后血清HPV16型抗体几何平均效价比值为1.10,HPV18型比值为1.17,均在预先设定的范围内。结论该方法在两个不同实验室的检测结果一致性良好,可用于HPV疫苗临床血清学样本的检测。

Objective To ensure the investigation for accurance and efficency of measurement HPV-16 and HPV-18 antibodies in different laboratories , so as to support the application of this method for clinical samples evaluation . Methods The study was performed in detection of HPV-16 and HPV-18 antibody titers by testing the panel of 200 paired samples （ pre-and post-vaccination ） both at NIFDC and Rixensart .Results The agreement of negative and positive concordance at both laboratories is ≥90%.There is no significant difference proved by Bartlett ’ s and Levene ’ s statistic tests.The GMC ratio of post-vaccination samples between two laboratories is 1.10 and 1.17 for HPV-16 and HPV-18 type, respectively.The overall comparative data between both laboratories are very good and meet the acceptance criteria . Conclusion The results showed that the acceptance criteria are fully met at two laboratories and the antibodies testing method could be used in detection of samples from clinical trials .