Background Identification of 14 high-risk human papillomavirus (HR-HPV) is immensely important in elucidating molecular epidemiology, patient monitoring and evidence-based treatment. There is paucity of such data from Chhattisgarh state of Central India. The present study has evaluated tagging oligonucleotide cleavage and extension-mediated Anyplex HR-HPV genotyping assay in identification of 14 HR-HPV genotypes attributable to premalignant and malignant cervical lesion in comparison to GP5+/6+ assay, cytology and colposcopy. Materials and Methods A total of 185 clinically suspected cases of premalignant and malignant cervical lesion were investigated by HR-HPV genotyping, GP5+/6+, cytology and colposcopy. Results Genotyping assay showed clinical sensitivity and specificity of 86.5% (confidence interval [CI]: 80.7-91.0) and 100% (CI: 86.3-100) respectively and found noninferior to GP5+/6+ assay (P > 0.05). HR-HPV prevalence was 76.3%, 88.4%, 94.8%, 100% and 100% among cervical intraepithelial neoplasia (CIN) Grade I-III, squamous cell carcinoma and adenocarcinoma cases, respectively. The four most common genotypes detected in CIN I-III were HPV 16 (63.9%), HPV 39 (15.0%), HPV 18 (6.0%) and HPV 33 (5.3%). In cervical cancer (CC) cases, HPV 16 (44.4%), HPV 39 (11.1%), dual infection of HPV 16, 18 (11.1%) and triple infection of HPV 16, 18, 33 (11.1%) were the four most identified genotypic aetiologies. A novel coinfection of HR-HPV 35, 39 were found in two and one cases of CIN I and II. Finding of HPV 39 as the second most prevalent genotype was unusual and underscores the importance of genotyping screening. Conclusion Anyplex HR-HPV assay is arguably the useful assay for better patient management and can be useful for HR-HPV screening by its unique individual genotype identification of all HR-HPV. Finding of HPV 16, 39, 18, 33 and coinfection of 16,18 and 16, 18, 33 in CIN and CC would help vaccine manufacturer to design specific future HPV polyvalent vaccine preparation to curb down the CC-associated mortality.

中文翻译：

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来自恰蒂斯加尔邦赖布尔的患有癌前和恶性宫颈病变的女性中高风险人乳头瘤病毒基因型 16 和 39 的优势：标记寡核苷酸切割和延伸介导的基因分型测定的临床评估。


背景 14 种高危人乳头瘤病毒 (HR-HPV) 的鉴定对于阐明分子流行病学、患者监测和循证治疗极为重要。印度中部恰蒂斯加尔邦的此类数据很少。本研究评估了标记寡核苷酸切割和延伸介导的 Anyplex HR-HPV 基因分型测定，与 GP5+/6+ 测定、细胞学和阴道镜检查相比，可鉴定可归因于癌前和恶性宫颈病变的 14 种 HR-HPV 基因型。材料与方法对185例临床疑似宫颈癌前病变和恶性宫颈病变病例进行HR-HPV基因分型、GP5+/6+、细胞学检查和阴道镜检查。结果 基因分型检测的临床敏感性和特异性分别为 86.5%（置信区间 [CI]：80.7-91.0）和 100%（CI：86.3-100），且不劣于 GP5+/6+ 检测（P > 0.05）。在宫颈上皮内瘤变（CIN）I-III级、鳞状细胞癌和腺癌病例中，HR-HPV患病率分别为76.3%、88.4%、94.8%、100%和100%。 CIN I-III 中检测到的四种最常见基因型是 HPV 16 (63.9%)、HPV 39 (15.0%)、HPV 18 (6.0%) 和 HPV 33 (5.3%)。在宫颈癌（CC）病例中，HPV 16（44.4％）、HPV 39（11.1％）、HPV 16、18双重感染（11.1％）和HPV 16、18、33三重感染（11.1％）是四种。大多数已确定的基因型病因。在两例和一例 CIN I 和 II 病例中发现了 HR-HPV 35、39 的新型双重感染。 HPV 39 被发现为第二流行的基因型是不寻常的，这强调了基因分型筛查的重要性。 结论 Anyplex HR-HPV 检测可以说是一种有助于更好地管理患者的有用检测，并且通过其对所有 HR-HPV 的独特个体基因型识别，可用于 HR-HPV 筛查。在 CIN 和 CC 中发现 HPV 16、39、18、33 以及 16,18 和 16、18、33 的合并感染将有助于疫苗制造商设计未来特定的 HPV 多价疫苗制剂，以抑制 CC 相关死亡率。