Departamente of Pathological Anatomy, Instituto Adolfo Lutz, São Paulo, SP, Brazil.
Rev Bras Ginecol Obstet. 2020 Jun;42(6):340-348. doi: 10.1055/s-0040-1712992. Epub 2020 Jun 30.
To evaluate the performance of the hybrid capture 2 (HC2) high-risk papillomavirus (hrHPV) assay and cytological test in women with previous abnormalities, to detect cervical intraepithelial neoplasia grade 2 or worse (≥ CIN 2).
A cytological test and HC2 (Qiagen, Gaithersburg, Maryland, EUA) for hrHPV were conducted in 359 liquid-based (Sure Path, Becton Dickinson, TriPath Imaging, Burlington, NC, USA) samples collected from women from the Vale do Ribeira Region, during July 2013 and September 2015 with previous cytology classified as atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesions (ASC-H), and atypical glandular cells (AGC). The histopathological examination was conducted in 179 women. The performance evaluations were calculated using the "exact" Clopper-Pearson 95% confidence interval (CI) test by MEDCALC (Medcalc Software Ltd, Ostend, Belgium).
The ≥ CIN 2 frequency was 11.7% (21/179). The HC2 for hrHPV and repeat cytology to detect ≥ CIN 2 obtained, respectively, a sensitivity of 90.5% (95%CI = 69.6-98.8) and 90.5%, (95%CI = 69.6-98.8), a specificity of 65.8% (95% CI = 57.9-73.2) and 43.7% (95%CI = 35.8-51.8), a positive predictive value of 26.0% (95% CI = 21.4-31.3) and 17.6%, (95%CI = 14.9-20.6), and a negative predictive value of 98.1% (95%CI = 93.3-99.5) and 97.2% (95% CI = 90.1-99.2).
Hybrid capture 2 for hrHPV improves the performance of the detection of ≥ CIN 2, without compromising sensitivity, and provides a greater safety margin to return to the triennial screening of women undergoing follow-up due to previous abnormalities, without underlying ≥ CIN 2.
评估杂交捕获 2（HC2）高危型人乳头瘤病毒（hrHPV）检测和细胞学检测在有异常病史的女性中的表现，以检测宫颈上皮内瘤变 2 级或更高级别（≥CIN 2）。
2013 年 7 月至 2015 年 9 月，对来自里贝拉谷地区的 359 名女性进行了液基细胞学检查（SurePath，Becton Dickinson，TriPath Imaging，北卡罗来纳州伯灵顿，美国）和 HC2（Qiagen，Gaithersburg，马里兰州，EUA）检测 hrHPV，此前的细胞学分类为非典型鳞状细胞不能明确意义（ASC-US）、低级别鳞状上皮内病变（LSIL）、非典型鳞状细胞、不能排除高级别鳞状上皮内病变（ASC-H）和非典型腺细胞（AGC）。对 179 名女性进行了组织病理学检查。使用 MEDCALC（Medcalc Software Ltd，奥斯坦德，比利时）的“精确”Clopper-Pearson 95%置信区间（CI）检验计算了性能评估。
≥CIN 2 的频率为 11.7%（21/179）。HC2 检测 hrHPV 和重复细胞学检测以检测≥CIN 2 的敏感性分别为 90.5%（95%CI=69.6-98.8）和 90.5%（95%CI=69.6-98.8），特异性分别为 65.8%（95%CI=57.9-73.2）和 43.7%（95%CI=35.8-51.8），阳性预测值分别为 26.0%（95%CI=21.4-31.3）和 17.6%（95%CI=14.9-20.6），阴性预测值分别为 98.1%（95%CI=93.3-99.5）和 97.2%（95%CI=90.1-99.2）。
HC2 检测 hrHPV 提高了检测≥CIN 2 的性能，而不降低敏感性，并为因异常病史而接受随访的女性提供了更大的安全边际，而无需进行潜在的≥CIN 2 检测。
