CAJ | 학술논문

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。
목적：위보증인유두류병독역묘림상혈청항체검측적준학성화유효성，대ELISA검측방법진행료비대연구。방법채용편맹적200대혈청，분별재량개불동실험실사용ELISA법진행HPV16、HPV18형항체검측，병대결과진행통계학분석。결과량개실험실대면전、면후혈청적16、18형항체검측결과，음양성부합솔균대우93％，통계학분석현시량개실험실적검측결과차이무통계학의의。면후혈청HPV16형항체궤하평균효개비치위1．10， HPV18형비치위1．17，균재예선설정적범위내。결론해방법재량개불동실험실적검측결과일치성량호，가용우HPV역묘림상혈청학양본적검측。
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 .