Department of Microbiology, University Hospital of Vigo, Vigo, Spain.
J Med Virol. 2013 Jun;85(6):1063-8. doi: 10.1002/jmv.23544.
High-risk human papillomavirus (HPV) DNA detection provides high sensitivity but low specificity for moderate-grade cervical intraepithelial neoplasia or worse histological identification. A prospective study evaluated mRNA testing efficacy for predicting this histological diagnosis in case of HPV 16 and/or 18 DNA detection. A total of 165 endocervical samples harboring HPV 16 and/or 18 DNA were tested with NucliSENS-EasyQ® HPV E6/E7-mRNA-assay (Biomerieux, Marcy l´Etoile, France). Women with cytological alterations were referred to colposcopy (n = 111). Moderate-grade cervical intraepithelial neoplasia or worse was diagnosed in 25.8% of women presenting atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesions and in 89.8% of women with high-grade squamous intraepithelial lesions. mRNA sensitivity was 81.3% and 84.1%, respectively. Specificity was 52.2%, and 80.0%, respectively. Negative predictive value (NPV) was 88.9% in undetermined or low-grade squamous lesions. Positive predictive value (PPV) was 97.4% in high-grade squamous lesions. mRNA reduced colposcopies by 44.3% in undetermined or low-grade squamous lesions. Direct treatment of mRNA-positive cases reduced 77.5% of colposcopies in high-grade squamous lesions. Women without cytological alterations were followed for 18 months (n = 35), and moderate-grade cervical intraepithelial neoplasia or worse was diagnosed in 34.3%; mRNA sensitivity and specificity were 83.3% and 86.9%, respectively. PPV and NPV were 76.9% and 90.9%, respectively for predicting moderate-grade cervical intraepithelial neoplasia or worse in 18 months. mRNA reduced the number of visits for follow-up in 62.2%. In conclusion, NucliSENS-EasyQ® HPV E6/E7-mRNA-assay (Biomerieux) can serve as a triage test in case of HPV 16 and/or 18 DNA detection.
高危型人乳头瘤病毒（HPV）DNA 检测对中度宫颈上皮内瘤变或更高级别组织学诊断具有高灵敏度，但特异性低。一项前瞻性研究评估了针对 HPV 16 和/或 18 DNA 检测的 mRNA 检测对预测这种组织学诊断的疗效。共检测了 165 例含有 HPV 16 和/或 18 DNA 的宫颈内样本，采用 NucliSENS-EasyQ® HPV E6/E7-mRNA 检测试剂盒（Biomerieux，法国马西埃洛特）。细胞学改变的女性行阴道镜检查（n=111）。非典型鳞状细胞意义不明确或低度鳞状上皮内病变患者中，25.8%诊断为中度宫颈上皮内瘤变或更高级别病变，高级别鳞状上皮内病变患者中 89.8%诊断为中度宫颈上皮内瘤变或更高级别病变。mRNA 的灵敏度分别为 81.3%和 84.1%。特异性分别为 52.2%和 80.0%。在非典型鳞状细胞意义不明确或低度鳞状上皮内病变中，阴性预测值（NPV）为 88.9%。在高级别鳞状上皮内病变中，阳性预测值（PPV）为 97.4%。在非典型鳞状细胞意义不明确或低度鳞状上皮内病变中，mRNA 减少了 44.3%的阴道镜检查。在高级别鳞状上皮内病变中，对 mRNA 阳性病例的直接治疗减少了 77.5%的阴道镜检查。无细胞学改变的女性随访 18 个月（n=35），34.3%诊断为中度宫颈上皮内瘤变或更高级别病变；mRNA 的灵敏度和特异性分别为 83.3%和 86.9%。在 18 个月时，预测中度宫颈上皮内瘤变或更高级别病变的 PPV 和 NPV 分别为 76.9%和 90.9%。mRNA 使随访就诊次数减少了 62.2%。总之，在 HPV 16 和/或 18 DNA 检测的情况下，NucliSENS-EasyQ® HPV E6/E7-mRNA 检测试剂盒（Biomerieux）可用作分流试验。
