流式荧光杂交技术和导流杂交基因芯片技术在HPV分型检测中的应用评价

Evaluation of xMAP and HybriMax in the detection of human papillomavirous subtypes

目的对检测人乳头瘤病毒(human papillomavirus,HPV)感染分型的流式荧光杂交技术(flexible multi-analyte profiling,xMAP)和导流杂交基因芯片技术(flow-through hybridization and gene chip,HybriMax)进行评估。方法参照美国临床和实验室标准化协会(CLSI)EP12-A2文件推荐方法,通过比较2种检测试剂的C50值,判断其检测灵敏度差异;用xMAP技术检测751例宫颈病变妇女的宫颈脱落细胞标本,判断其临床符合率;用xMAP和HybriMax同时检测535份液基薄层细胞学检测(thinprep cytologic test,TCT)异常标本,比较两种方法检测高危亚型HPV(HR-HPV)结果的一致性。结果 xMAP技术检测HPV的C50小于HybriMax技术C50。HPV感染率随亚临床HPV感染(SPI)、子宫颈上皮内瘤变(CIN)Ⅰ、CINⅡ、CINⅢ的变化而升高,其差异有统计学意义(χ2=143.15,P<0.01)。两种试剂检测标本HR-HPV结果的kappa值为0.76;两者检出的13种HR-HPV的构成比差异无统计学意义(P均>0.05)。结论 xMAP技术和HybriMax技术检测HPV结果一致性较好,xMAP技术灵敏度更高,操作更快速方便,适用于HPV感染普查和宫颈疾病高危人群的监控。

Objective To evaluate the application of flexible multi-analyte profiling technology（ xMAP） and flow-through hybridization and gene chip（ HybriMax） in the detection of human papillomavirus（ HPV） subtypes. Methods According to the Clinical and Laboratory Standards Institute（ CLSI） EP12-A2 document,the C50values of xMAP and HybriMax were compared and their detection sensitivity was analyzed. Cervical exfoliated cell samples from 751 women with cervical lesions were detected by the xMAP method,and the obtained results were used to analyze the clinical coincidence. In addition,the HPV subtypes of 535 specimens with abnormal thinprep cytologic test（ TCT） results were determined by xMAP and HybriMax technology,respectively,and the consistency of high-risk types of HPV（ HR-HPV） was compared. Results The C50value for xMAP was less than that for HybriMax. The HPV infection rates increased with the advance of cervical lesions including subclinical HPV infections（ SPI）,cervical intraepithelial neoplasia（ CIN） Ⅰ, CIN Ⅱ and CIN Ⅲ（ χ2= 143. 15,P〈0. 01）. The Kappa value reflecting the consistency between xMAP and HybriMax was 0. 76. There was no any difference in the constituent ratio of 13 HR-HPV subtypes between xMAP and HybriMax（ P〉0. 05）. Conclusion There was a good consistency in the detection of HPV subtypes between xMAP and HybriMax. Moreover,the xMAP technology was more sensitivity and easy operation than the HybriMax,and was suited to screen and monitor the HPV infection of high risk population with cervical diseases.