Department of Clinical Pathology, The University Hospital of North Norway, Tromsø, Norway.
PLoS One. 2010 Sep 13;5(9):e12724. doi: 10.1371/journal.pone.0012724.
Human papillomavirus (HPV) testing is included in the cervical cancer screening program in the triage of women with equivocal (ASC-US) or low-grade (LSIL) cytological lesions. These women have an increased risk for developing high grade dysplasia and cancer (CIN2+) compared to women with normal cytology. However, in order to avoid unnecessary follow-up, as well as overtreatment, a high positive predictive value (PPV) of the triage test is important.
METHODOLOGY/PRINCIPAL FINDINGS: The HPV test PreTect HPV-Proofer, detecting E6/E7 mRNA from the HPV types 16, 18, 31, 33 and 45, is used as triage test together with repeat cytology. PPV data for HPV E6/E7 mRNA testing during the period from January 2006 up to June 2009 are reported. In total, 406 of 2099 women (19.3%) had a positive HPV test result. Of the women with a positive test result and with a histological diagnosis (n = 347), 243 women had histological high-grade dysplasia or cancer (CIN2+), giving a PPV of 70.0% (95% confidence interval [CI], 65.2%-74.8%). For HPV 16 or HPV 33 positive women above 40 years of age, the PPV was 83.7% (95% CI, 73.3%-94.0%) and 84.6% (95% CI, 65.0%-100.0%) respectively. The PPV of test positive women with HSIL cytology was 94.2% (95% CI, 88.7%-99.7%).
When the result in triage is HPV mRNA positive, our data suggest direct treatment for women above 40 years of age or for women with a concurrent cytological HSIL diagnosis, contributing to better clinical safety for these women. In addition, by decreasing the time to treatment, thereby reducing the number of recalls, the patient management algorithm will be considerably improved, in turn reducing follow-up costs as well as unnecessary psychological stress among patients.
人乳头瘤病毒（HPV）检测已被纳入宫颈癌筛查项目中，用于对意义不明确的非典型鳞状细胞（ASC-US）或低度鳞状上皮内病变（LSIL）细胞学检查结果的女性进行分流。与细胞学正常的女性相比，这些女性发生高级别上皮内瘤变和癌症（CIN2+）的风险增加。然而，为了避免不必要的随访和过度治疗，分流检测的高阳性预测值（PPV）非常重要。
方法/主要发现：PreTect HPV-Proofer HPV 检测试剂盒用于检测 HPV 16、18、31、33 和 45 型的 E6/E7 mRNA，可作为 HPV 检测阳性时的分流检测手段，同时联合重复细胞学检查。本文报告了 2006 年 1 月至 2009 年 6 月期间 HPV E6/E7 mRNA 检测的 PPV 数据。在总共 2099 名女性中，有 406 名（19.3%）HPV 检测结果阳性。在 HPV 检测阳性且有组织学诊断的女性中（n=347），有 243 名女性有高级别上皮内瘤变或癌症（CIN2+），其 PPV 为 70.0%（95%CI，65.2%-74.8%）。对于 40 岁以上 HPV 16 或 HPV 33 阳性的女性，其 PPV 分别为 83.7%（95%CI，73.3%-94.0%）和 84.6%（95%CI，65.0%-100.0%）。细胞学检查为高度鳞状上皮内病变的 HPV 检测阳性女性的 PPV 为 94.2%（95%CI，88.7%-99.7%）。
当分流检测结果为 HPV mRNA 阳性时，我们的数据提示对 40 岁以上的女性或同时伴有细胞学高度鳞状上皮内病变的女性直接进行治疗，这将有助于提高这些女性的临床安全性。此外，通过缩短治疗时间，减少召回次数，患者管理算法将得到显著改善，从而降低随访成本和患者的心理压力。
