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Title: [HPV E6 and E7 mRNA combined with HPV 16 and 18 or 45 genotyping testing as a means of cervical cancer opportunistic screening].
Author: Wang JJ, Dong J, Deng ZX, Wang PF, Zhang XX, Du Y.
Journal: Zhonghua Fu Chan Ke Za Zhi; 2019 May 25; 54(5):301-306. PubMed ID: 31154710.
Abstract:
Objective: To evaluate Aptima HPV E6 and E7 mRNA assay (Aptima HPV) combined with Aptima HPV 16 and 18 or 45 (18/45) genotype assay (Aptima HPV-GT) as a means of cervical cancer opportunistic screening. Methods: From October 2016 to October 2017, a total of 23 258 women aged 25-65 years were enrolled in the physical examination center and gynecological clinic of Huzhou Maternity and Child Health Care Hospital. All the women had Aptima HPV tested, further Aptima HPV-GT testing for positive women and liquid-based thin layer cytology Thinprep cytologic test (TCT). Women with Aptima HPV (+) or ≥low-grade squamous intraepithelial lesion (LSIL) or obvious clinical symptoms (including vaginal bleeding after intercourse and watery, bloody vaginal discharge) were referred for colposcopy and further biopsy with or without endocervical curettage (ECC) if indicated. Expression of Aptima HPV, HPV 16 and HPV 18/45 with different cytological diagnostic groups and histological diagnosis groups were compared respectively. Sensitivity, specificity, positive predictive value and negative predictive value of Aptima HPV detection and TCT in identifying histological diagnosis of high-grade squamous intraepithelial lesion (HSIL) or worse (HSIL(+)) were compared. Results: (1) The positive rates of Aptima HPV, HPV 16 and HPV 18/45 were 14.00% (3 257/23 258), 1.85% (430/23 258) and 0.86% (199/23 258) respectively.The positive rates of Aptima HPV, HPV 16 and HPV 18/45 increased with cytology grading in squamous epithelium [negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASCUS), LSIL, atypical squamous cell cannot exclude HSIL (ASC-H), HSIL and squamous cell carcinoma (SCC), all P=0.000)]. According to histology results, the positive rates of Aptima HPV, HPV 16 and HPV 18/45 increased with histology grading in squamous epithelium (normal cervical tissue, LSIL, HSIL and SCC, all P=0.000). The positive rate of Aptima HPV was significantly higher in HSIL(+) group than that in the LSIL or better (LSIL(-)) group [98.11% (311/317) vs 12.84% (2 946/22 941), P=0.000]. The positive rate of Aptima HPV-GT was significantly higher in HSIL(+) group than that in LSIL(-) group [58.36% (185/317) vs 1.91% (439/22 941), P=0.000]. (2) Compared with cytology, Aptima HPV resulted in significant higher sensitivity (98.11% vs 59.62%, P=0.000) and negative predictive value (99.97% vs 99.42%, P=0.000), significant lower specificity (87.16% vs 95.37%, P=0.000) and positive predictive value (9.55% vs 15.10%, P=0.000) when identified HSIL(+). Conclusions: Women with Aptima HPV positive, especially those with Aptima HPV-GT positive, are more likely to have histological diagnosis of HSIL(+). Aptima HPV combined with Aptima HPV-GT is feasible as a means of cervical cancer opportunistic screening in tertiary hospitals. 目的： 探讨Aptima HPV检测（是基于HPV E6、E7 mRNA检测的方法）联合Aptima HPV 16型和HPV 18型和（或）45型（18/45型）分型（Aptima HPV-GT）检测作为子宫颈癌机会性筛查方法的可行性。 方法： 收集2016年10月—2017年10月在浙江省湖州市妇幼保健院体检或因妇科疾病就诊并自愿接受Aptima HPV检测（对其中HPV阳性妇女进一步行Aptima HPV-GT检测）和液基薄层细胞学检查（TCT）的妇女共23 258例，其年龄为（40±9）岁。对Aptima HPV检测阳性或TCT检查结果为低级别鳞状上皮内病变（LSIL）及以上病变或临床症状明显（如性交后出血、血性分泌物）的妇女行阴道镜检查，必要时在阴道镜定位下行子宫颈活检±子宫颈管搔刮（ECC）术。（1）分别比较不同细胞学诊断和组织学诊断妇女的Aptima HPV及Aptima HPV-GT检测结果。（2）以组织学诊断为"金标准"，比较Aptima HPV检测与TCT检查对组织学诊断≥高级别鳞状上皮内病变（HSIL；包括HSIL、原位腺癌、腺癌、鳞癌和腺鳞癌）的筛查价值。 结果： （1）23 258例妇女中，Aptima HPV、HPV 16型和HPV 18/45型阳性率分别为14.00%（3 257/23 258）、1.85%（430/23 258）和0.86%（199/23 258）。在细胞学诊断为未见上皮内病变或恶性病变（NILM）、未明确诊断意义的不典型鳞状上皮细胞（ASCUS）、LSIL、不能除外高度病变的不典型鳞状上皮细胞（ASC-H）、HSIL和鳞癌的妇女中，Aptima HPV、HPV 16型和HPV 18/45型阳性率均随着细胞学诊断的病变级别的增高而明显增高（P均=0.000）；在组织学诊断为正常子宫颈、LSIL、HSIL、鳞癌的妇女中，Aptima HPV、HPV 16型和HPV 18/45型阳性率也均随着组织学诊断的病变级别的增高而明显增高（P均=0.000）。在组织学诊断≥HSIL病变中，Aptima HPV检测阳性率为98.11%（311/317），明显高于组织学诊断≤LSIL者[包括正常子宫颈及LSIL，为12.84%（2 946/22 941）；P=0.000]；Aptima HPV-GT检测阳性率为58.36%（185/317），明显高于组织学诊断≤LSIL者[1.91%（439/22 941）；P=0.000]。（2）以组织学诊断为"金标准"，在筛查组织学诊断≥HSIL的病变时，Aptima HPV检测的敏感度（分别为98.11%、59.62%）和阴性预测值（分别为99.97%、99.42%）均显著高于细胞学TCT检查（P均=0.000），但其特异度（分别为87.16%、95.37%）和阳性预测值（分别为9.55%、15.10%）则显著低于细胞学TCT检查（P均=0.000）。 结论： Aptima HPV检测阳性特别是Aptima HPV-GT检测阳性的妇女发生组织学诊断≥HSIL病变的可能性大。在有条件的医院，Aptima HPV联合Aptima HPV-GT检测作为子宫颈癌机会性筛查方法是可行的。.

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