Poljak Mario, Kovanda Anja, Kocjan Bostjan J, Seme Katja, Jancar Nina, Vrtacnik-Bokal Eda
Institute of Microbiology and Immunology, Faculty of Medicine, Zaloska 4, 1000 Ljubljana, Slovenia.
Acta Dermatovenerol Alp Pannonica Adriat. 2009 Sep;18(3):94-103.
The Abbott RealTime High Risk HPV test (RealTime) is a novel assay designed to detect 14 high-risk human papillomavirus genotypes (hr-HPV) and concurrently distinguish HPV-16 and HPV-18 from other hr-HPV within a single test.
To evaluate analytical specificity and clinical sensitivity for cervical carcinoma and cervical intraepithelial neoplasia grade 3 (CIN3) of the RealTime test in comparison with the Digene Hybrid Capture II Test (hc2).
Analytical specificity of the RealTime assay was evaluated on 37 samples with previously determined hc2 false-positive results due to cross-reactivity of the hc2 high-risk probe cocktail with untargeted low-risk HPV genotypes. All 37 samples were negative for 14 hr-HPV using the RealTime test. Clinical sensitivity of RealTime was evaluated in comparison to hc2 on 95 and 267 archived routine cervical specimens collected from women with histologically confirmed cervical carcinoma and CIN3 lesions, respectively. Archived specimens were selected for the present study after linkage with the Slovenian national registry of CIN3 and cervical cancer to obtain histology data.
Concordant results between RealTime and hc2 were obtained in 90/95 cervical cancer samples (94.7% agreement) and in 250/267 CIN3 samples (93.6% agreement). Clinical sensitivity of RealTime and hc2 for cervical cancer in the total study cohort was 88.4% (95% confidence interval (CI): 80.3-93.6%) and 87.3% (95% CI: 79.0-92.8%), respectively, and analytical sensitivity for samples containing at least one targeted hr-HPV was 98.8% (95% CI: 93.0-100.0%) and 95.3% (95% CI: 88.2-98.5%), respectively. Clinical sensitivity of RealTime and hc2 for CIN3 lesions of the total study cohort was 91.8% (95% CI: 87.8-94.5%) and 89.1% (95% CI: 84.8-92.3%), respectively, and analytical sensitivity for samples containing at least one targeted hr-HPV was 96.4% (95% CI: 93.3-98.2%) and 92.5% (95% CI: 88.5-95.2%), respectively.
The RealTime test showed excellent analytical specificity and no cross-reactivity with low risk HPV genotypes that tested positive with hc2. Clinical sensitivity of the RealTime assay using archived routine cervical specimens was comparable to hc2. The RealTime test is an important new method applicable to cervical carcinoma screening and management of cervical precancerous lesions.
雅培实时高危型人乳头瘤病毒检测（实时检测）是一种新型检测方法，旨在检测14种高危型人乳头瘤病毒基因型（hr-HPV），并能在一次检测中同时将HPV-16和HPV-18与其他hr-HPV区分开来。
与Digene杂交捕获二代检测（hc2）相比，评估实时检测对宫颈癌和宫颈上皮内瘤变3级（CIN3）的分析特异性和临床敏感性。
实时检测的分析特异性通过对37份样本进行评估，这些样本因hc2高危型探针混合物与非靶向低危型HPV基因型发生交叉反应，先前hc2检测结果为假阳性。使用实时检测对所有37份样本进行检测，结果显示14种hr-HPV均为阴性。实时检测的临床敏感性通过与hc2对比进行评估，分别对95份和267份存档的常规宫颈标本进行检测，这些标本分别来自组织学确诊为宫颈癌和CIN3病变的女性。在与斯洛文尼亚CIN3和宫颈癌国家登记处建立联系以获取组织学数据后，选择存档标本用于本研究。
实时检测与hc2在90/95份宫颈癌样本中结果一致（一致性为94.7%），在250/267份CIN3样本中结果一致（一致性为93.6%）。在整个研究队列中，实时检测和hc2对宫颈癌的临床敏感性分别为88.4%（95%置信区间（CI）：80.3 - 93.6%）和87.3%（95%CI：79.0 - 92.8%），对至少含有一种靶向hr-HPV的样本的分析敏感性分别为98.8%（95%CI：93.0 - 100.0%）和95.3%（95%CI：88.2 - 98.5%）。在整个研究队列中，实时检测和hc2对CIN3病变的临床敏感性分别为91.8%（95%CI：87.8 - 94.5%）和89.1%（95%CI：84.8 - 92.3%），对至少含有一种靶向hr-HPV的样本的分析敏感性分别为96.4%（95%CI：93.3 - 98.2%）和92.5%（95%CI：88.5 - 95.2%）。
实时检测显示出优异的分析特异性，且与hc2检测呈阳性的低危型HPV基因型无交叉反应。使用存档常规宫颈标本时，实时检测的临床敏感性与hc2相当。实时检测是一种适用于宫颈癌筛查和宫颈癌前病变管理的重要新方法。
