基于基因芯片技术的人乳头瘤病毒分型检测方法及应用评价

The Use of Human Papillomavirus Genotying Kit Based on Gene Chip Technology for Detecting and Typing of Human Papillomavirus

目的评价基因芯片法人乳头瘤病毒分型检测试剂盒(HPG)的临床应用价值。方法采集慢性宫颈炎或不规则阴道流血女性的宫颈上皮脱落细胞151例,应用HPG检测方法、第二代杂交捕获技术(HC2)检测方法以及DNA直接测序法进行检测,通过对HPG与HC2、DNA直接测序结果的平行对照,对HPG检测方法进行评价。结果 HPG检测方法和HC2检测方法的总一致率为87.42%(kappa=0.75,P<0.05),以DNA直接测序结果为金标准,HPG检测方法对高危险HPV的灵敏度和特异度分别是100%、96.49%,HPG方法和DNA直接测序方法的一致率为98.70%(kappa=0.97,P<0.05)。通过HPG检测结果发现,多重HPV感染率为23.84%,HPV阳性感染率较高的HPV亚型依次为HPV 16(13.25%)、58(11.92%)、52(11.92%)、31(6.62%)、39(5.96%)、33(5.96%)。结论 HPG检测法和HC2检测法以及DNA直接测序法有着良好的一致率,HPG检测法可以实现HPV准确分型检测,适用于临床检测工作的需要。

Objective To evaluate a new human papillomavirus （HPV） genotyping technique based on gene chip technology （HPG） for HPV genotyping and its clinical efficacy. Methods HPV genotyping （HPG） test, hybrid capture II（HC2） test and DNA sequencing assay were performed in 151 patients aged 20-75 years with diagnosis of chronic cervicitis or abnormal vaginal bleeding. The cervical specimens were collected from cervical epithelium. All the cervical samples were analyzed by the HPG test, HC2 test and DNA sequencing. The clinical efficacy of the HPG test was analyzed. Results The consistent rate between HPG test and HC2 test was 87.42% （kappa=0. 75, P〈0.05）. When DNA sequencing assay was regarding as the final test result, the sensitivity and specificity of HPG test for high risk HPV were 100% and 96.49%, respectively. The consistent rate between HPG test and direct DNA sequencing was 98. 70% （kappa=0. 97, P〈0. 05）. The most common six HPV genotypes detected by HPG test were HPV 16 （13. 25%）, 58 （11. 92%）, 52 （11. 92%）, 31 （6. 62%） 39 （5. 96%）, 33 （5.96%） in descending order of frequency. The incidence of multiple-types infection detected by HPG test was 23.84%. Conclusion HPG test is a rapid and accurate test for HPV genotyping which could detect 29 types of HPV infection at one time. It is suitable for cervical HPV infection screening in clinic.