Hesselink Albertus T, van den Brule Adriaan J C, Brink Antoinette A T P, Berkhof Johannes, van Kemenade Folkert J, Verheijen René H M, Snijders Peter J F
Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
Cancer. 2004 Feb 25;102(1):11-8. doi: 10.1002/cncr.11904.
The performance of two commercially available detection systems for high-risk HPV (hrHPV), Hybrid Capture 2 (HC2) and in situ hybridization (ISH), were compared on cervical scrapings.
Using general primer (GP)-mediated GP5+/6+-polymerase chain reaction (PCR)-enzyme immunoassay and reverse line blot genotyping, 76 liquid-based cervical samples were identified with > or = 1 of the 12 hrHPV types present in the probes of the HC2 and ISH assays. The positivity rate of the assays and the HC2 viral load were determined and related to cytologic findings (n = 76 samples) and histologic findings (n = 43 samples).
Overall, HC2 scored significantly more samples positive compared with ISH (P < 0.01). Seventy-four of 76 samples (97%) were positive according to HC2. Forty-six of 76 samples (61%) were positive according to ISH, including 80% and 70% of samples that were classified cytologically as moderate dysplasia and severe dysplasia, respectively. All women with underlying cervical intraepithelial neoplasia (CIN) lesions and 67% of women without CIN had positive HC2 samples. ISH scored 33%, 66%, 88%, and 73% of samples positive of women with no CIN, Grade 1 CIN (CIN 1), CIN 2, and CIN 3, respectively. The HC2 viral load was significantly higher in women who had a cytologic diagnosis of dysplasia (P < 0.01) and in women who had an underlying diagnosis of CIN (P < 0.01) compared with women who had neither. In addition, the viral load was significantly higher in ISH positive samples compared with ISH negative samples (P < 0.01).
An increased HC2 viral load was associated with an increased chance of underlying high-grade CIN disease in women who tested hrHPV GP5+/6+-PCR positive. Moreover, although positive ISH results were associated with an increased overall viral load in the sample, the analytic sensitivity of ISH was too low to detect all women with prevalent high-grade CIN.
比较了两种市售的高危型人乳头瘤病毒（hrHPV）检测系统，即杂交捕获2代（HC2）和原位杂交（ISH）在宫颈刮片中的性能。
采用通用引物（GP）介导的GP5+/6+-聚合酶链反应（PCR）-酶免疫测定法和反向线印迹基因分型法，对76份液基宫颈样本进行检测，这些样本中存在HC2和ISH检测探针中12种hrHPV类型中的1种或更多种。确定了检测方法的阳性率和HC2病毒载量，并将其与细胞学结果（n = 76个样本）和组织学结果（n = 43个样本）相关联。
总体而言，与ISH相比，HC2检测出阳性的样本显著更多（P < 0.01）。根据HC2检测，76个样本中有74个（97%）呈阳性。根据ISH检测，76个样本中有46个（61%）呈阳性，其中细胞学分类为中度发育异常和重度发育异常的样本分别占80%和70%。所有患有宫颈上皮内瘤变（CIN）的女性以及67%没有CIN的女性，其HC2样本呈阳性。ISH检测无CIN、1级CIN（CIN 1）、CIN 2和CIN 3的女性样本阳性率分别为33%、66%、88%和73%。与既无细胞学诊断发育异常也无CIN诊断的女性相比，细胞学诊断为发育异常的女性（P < 0.01）以及有CIN诊断的女性（P < 0.01）的HC2病毒载量显著更高。此外，ISH阳性样本的病毒载量显著高于ISH阴性样本（P < 0.01）。
在hrHPV GP5+/6+-PCR检测呈阳性的女性中，HC2病毒载量增加与潜在的高级别CIN疾病发生几率增加相关。此外，尽管ISH阳性结果与样本中总体病毒载量增加相关，但ISH的分析灵敏度过低，无法检测出所有患有常见高级别CIN的女性。
