Application of flow-through hybrization and gene chip on human papillomavious subtype detection in clinical / 中华检验医学杂志

ABSTRACT

Objectives To evaluate the application of flow-through hybrization and gene chip (HybriMax) on human papillomavious (HPV) subtype detection in clinical.Method 3 086 sexually active females from out-patient department were selected for HPV subtype analysis using HybriMax. Cervical tissue samples were taken under the colposcope from 463 females who had cervical lesion for pathological analysis. The predictive value of HybriMax in cervical abnormality was compared with pathological results, which were used as a golden standard. DNA sequence in HPV E6/E7 region was performed among 80 females with HPV 16 positive by HybriMax to determine the accuracy of HybriMax.Results All 21 different subtypes were found and total HPV positive rate was 63.1%(1 947/3 086). Among the 21 HPV subtypes, 5 of them had a infection rate over 5% and they were HPH16(15.9%, 490/3 086), 58(11.2%, 346/3 086), 52(8.5%、261/3 086)、33(6.3%、195/3 086)、53(6.2%、192/3 086)、6(5.6%、172/3 086), and CP8304(5.0%、155/3 086). The sensitivity for high degree squamous intraepithelial dysplasia(HSIL, CINⅡ+CINⅢ) by HybriMax was 95.49%(95%CI=95.44%～98.27%), while specificity was 34.85%(95% CI= 32.59%～37.57%)、Positive predictive value for HSIL was 37.13%(95%CI=30.79%～40.96%),while negative predictive vale was 95.04%(95%CI=89.24%～98.44%). Eighty sequence results in E6/E7 region completely matched to HybriMax results.Conclusion HybriMax has a high accurate rate in HPV subtype diction with good sensitivity and specificity for HSIL and above. It is an effective method to detect HPV subtype in clinical.