Division of Obstetrics and Gynecology, Department of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital Solna, Stockholm, Sweden.
Department of Medical Epidemiology and Biostatistics Karolinska Institutet, Stockholm, Sweden.
PLoS One. 2014 Feb 26;9(2):e90023. doi: 10.1371/journal.pone.0090023. eCollection 2014.
Expression of the viral E6/E7 oncogenes of high-risk human papillomaviruses (HR-HPV) is necessary for malignant conversion and maintenance in cervical tissue. In order to determine whether HR-HPV E6/E7 mRNA testing more effectively predicts precancerous lesions and invasive cervical cancer than HR-HPV DNA testing, we aimed to compare triage using HR-HPV E6/E7 mRNA testing by APTIMA HPV Assay (APTIMA) to HPV16 DNA testing, HPV16/18 DNA testing, and repeat cytology.
Liquid-based (PreservCyt) cell samples were obtained from HR-HPV-positive women diagnosed with atypical squamous cells of undetermined significance (ASCUS) and low-grade squamous intraepithelial lesions (LSIL) within the framework of the population-based cervical cancer screening program in Stockholm, Sweden. Samples were tested for HR-HPV E6/E7 mRNA by APTIMA (Gene-Probe Inc., San Diego, CA, USA). Women were followed up for 4 years after the index cytology via medical and laboratory records, and the Stockholm Oncology Center.
Nine of 25 (36%) women in the ASCUS group, and 64 of 180 (36%) women in the LSIL group developed cervical intraepithelial neoplasia (CIN) grade 2 or worse during 4 years of follow-up. 162 (74%) women were APTIMA-positive, and APTIMA had the highest sensitivity to predict CIN2 or worse and CIN3 or worse in the ASCUS (77.8% and 100%) and LSIL (78.1 and 75.8%) groups, although specificity was insufficient (<50%). HPV16 DNA testing and repeat cytology were more specific than APTIMA.
The results of this population-based study with comprehensive follow-up support the use of APTIMA as a triage test for women with ASCUS. More focused investigation is required for women with LSIL.
高危型人乳头瘤病毒（HR-HPV）的病毒 E6/E7 癌基因的表达对于宫颈组织的恶性转化和维持是必要的。为了确定 HR-HPV E6/E7mRNA 检测是否比 HR-HPV DNA 检测更有效地预测癌前病变和浸润性宫颈癌，我们旨在比较使用 APTIMA HPV 检测（APTIMA）进行 HR-HPV E6/E7mRNA 检测的分流与 HPV16 DNA 检测、HPV16/18 DNA 检测和重复细胞学检查。
在瑞典斯德哥尔摩的基于人群的宫颈癌筛查计划中，从诊断为非典型鳞状细胞意义不明确（ASCUS）和低级别鳞状上皮内病变（LSIL）的 HR-HPV 阳性女性中获得液基（PreservCyt）细胞样本。通过 APTIMA（基因探针公司，圣地亚哥，CA，美国）对 HR-HPV E6/E7mRNA 进行检测。通过医疗和实验室记录以及斯德哥尔摩肿瘤中心对女性进行了 4 年的指数细胞学检查随访。
在 ASCUS 组的 25 名女性中，有 9 名（36%）和在 LSIL 组的 180 名女性中，有 64 名（36%）在 4 年的随访期间发展为宫颈上皮内瘤变（CIN）2 级或更高级别。162 名女性（74%）为 APTIMA 阳性，APTIMA 对预测 ASCUS（77.8%和 100%）和 LSIL（78.1%和 75.8%）组的 CIN2 或更高级别和 CIN3 或更高级别具有最高的敏感性，尽管特异性不足（<50%）。HPV16 DNA 检测和重复细胞学检查比 APTIMA 更具特异性。
这项基于人群的研究结果支持使用 APTIMA 作为 ASCUS 女性的分流检测。对于 LSIL 女性需要更有针对性的调查。
