Department of Cytopathology, The Third Affiliated Hospital of Zhengzhou University, No. 7 Front Kangfu Street, Er'qi District, Zhengzhou 450052, China.
J Virol Methods. 2013 Feb;187(2):288-93. doi: 10.1016/j.jviromet.2012.11.024. Epub 2012 Nov 29.
Human papillomavirus (HPV) infection is the primary cause of cervical cancer. The Quantivirus(®) HPV E6/E7 RNA 3.0 assay (DiaCarta, CA, USA) detects E6/E7 mRNA of 13 high risk subtypes and 6 low risk subtypes. Cervical specimens collected in PreservCyt were processed for HPV detection. Cervical biopsies were taken only from those women with abnormal colposcopy. 200 out of 272 (73.5%) cases were mRNA positive. The percentage of HPV E6/E7 mRNA positive samples increases with the severity of the cytological diagnosis, but not in histological diagnosis. In 146 patients with both tests, the E6/E7 mRNA assay had significant higher positivity rate than the Hybrid Capture 2 assay (75.3% versus 62.3%). The HPV mRNA assay and the HC2 assay had the same sensitivity of high grade cervical intraepithelial neoplasia (CIN 2+), 82.4% (14/17) (95% confidence interval [CI], 64.3, 100). However, the specificity of CIN 2+ for the HPV mRNA assay was significantly lower than HC2 assay. Receiver operating characteristic curve analysis was used to compare the diagnostic performance of the E6/E7 mRNA and HC2. E6/E7 mRNA achieved 58.8% sensitivity with 74.1% specificity, HC2, achieved 47.1% sensitivity with 70.7% specificity. The overall performance of HPV E6/E7 mRNA assay for detecting CIN 2+ was lower than HC2. This study does not support the use of this assay in screening for cervical cancer prevention alone.
人乳头瘤病毒（HPV）感染是宫颈癌的主要病因。Quantivirus（®）HPV E6/E7 RNA 3.0 检测（DiaCarta，加利福尼亚州，美国）检测 13 种高危亚型和 6 种低危亚型的 E6/E7 mRNA。使用 PreservCyt 收集宫颈标本进行 HPV 检测。只有阴道镜检查异常的女性才进行宫颈活检。272 例中有 200 例（73.5%）mRNA 阳性。HPV E6/E7 mRNA 阳性样本的百分比随着细胞学诊断的严重程度而增加，但在组织学诊断中则不然。在 146 例同时进行两项检测的患者中，E6/E7 mRNA 检测的阳性率明显高于 Hybrid Capture 2 检测（75.3%比 62.3%）。HPV mRNA 检测和 HC2 检测对高级别宫颈上皮内瘤变（CIN 2+）的敏感性相同，为 82.4%（14/17）（95%置信区间 [CI]，64.3，100）。然而，HPV mRNA 检测对 CIN 2+的特异性明显低于 HC2 检测。使用受试者工作特征曲线分析比较 E6/E7 mRNA 和 HC2 的诊断性能。E6/E7 mRNA 的敏感性为 58.8%，特异性为 74.1%，HC2 的敏感性为 47.1%，特异性为 70.7%。HPV E6/E7 mRNA 检测用于检测 CIN 2+的总体性能低于 HC2。本研究不支持单独使用该检测进行宫颈癌筛查。
