比较 digene HC2 HPV DNA 检测法和 INNO-LiPA HPV 基因分型检测法在检测 HIV 阳性非洲女性高危型 HPV 感染和宫颈癌前病变中的分析性能和临床性能。
Comparison of analytical and clinical performances of the digene HC2 HPV DNA assay and the INNO-LiPA HPV genotyping assay for detecting high-risk HPV infection and cervical neoplasia among HIV-positive African women.
机构信息
*INSERM U1058 and Department of Biology and Pathology, Montpellier University Hospital (CHU), Montpellier, France; †Departments of Clinical Research and Non Communicable Diseases Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom; ‡Department of Anatomical Pathology, University of the Witwatersrand, Johannesburg, South Africa; §University Hospital and Centre of International Research for Health, University of Ouagadougou, Ouagadougou, Burkina Faso; and ‖Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa.
出版信息
J Acquir Immune Defic Syndr. 2015 Feb 1;68(2):162-8. doi: 10.1097/QAI.0000000000000428.
OBJECTIVES
To compare the Hybrid Capture 2 human papillomaviruses (HPV) DNA assay (HC2) and the INNO-LiPA HPV Genotyping Extra assay (INNO-LiPA) for cervical cancer screening in HIV-1-infected African women.
DESIGN
The tests were compared for agreement in detecting high-risk HPV (hr-HPV) and performance to detect squamous intraepithelial lesions (SIL), by cytology, and cervical intraepithelial neoplasia, by histology, in cervical samples from 1224 women in Burkina Faso (N = 604) and South Africa (N = 620).
RESULTS
When considering the 13 hr-HPV types detected by HC2, 634 (51.8%) and 849 (69.4%) samples were positive by HC2 and INNO-LiPA, respectively. Agreement between assays was 73.9% [adjusted kappa coefficient value, 0.44 (95% confidence interval: 0.43 to 0.53)]. Agreement improved with analysis restricted to women with high-grade cervical lesions [adjusted kappa coefficient value, 0.83 (95% confidence interval: 0.74 to 0.91)]. The prevalence of hr-HPV, as determined by HC2 and INNO-LiPA, was 34.5% and 54.5%, respectively, in samples with normal cytology, 48.0% and 68.0%, respectively, in samples with atypical squamous cells of undetermined significance, 51.8% and 75.2%, respectively, in samples with low-grade SIL, and 86.3% and 89.8%, respectively, in samples with high-grade SIL/atypical squamous cells that cannot exclude HSIL. Sensitivity, specificity, positive, and negative predictive values for the diagnosis of histological high-grade lesions (CIN2+) were 88.8%, 55.2%, 24.7% and 96.7%, and 92.5%, 35.1%, 19.1% and 96.6% for HC2 and INNO-LiPA, respectively.
CONCLUSIONS
HC2 has lower analytical sensitivity but higher specificity than INNO-LiPA for diagnosing high-grade lesions; the 2 tests presented a comparable clinical sensitivity. HC2 might be suitable for cervical cancer screening in HIV-1-infected African women, but its use in resource-limited settings merits to be further evaluated in comparison with other prevention strategies.
目的
比较杂交捕获 2 型人乳头瘤病毒（HPV）DNA 检测（HC2）和 INNO-LiPA HPV 基因分型检测（INNO-LiPA）在 HIV-1 感染的非洲妇女宫颈癌筛查中的应用。
设计
在布基纳法索（N=604）和南非（N=620）的 1224 名妇女的宫颈样本中，通过细胞学检测鳞状上皮内病变（SIL）和组织学检测宫颈上皮内瘤变（CIN），比较两种检测方法在检测高危型 HPV（hr-HPV）和检测性能方面的一致性。
结果
当考虑到 HC2 检测到的 13 种 hr-HPV 型别时，HC2 和 INNO-LiPA 分别有 634（51.8%）和 849（69.4%）例样本呈阳性。两种检测方法的一致性为 73.9%[调整后的 Kappa 系数值，0.44（95%置信区间：0.43 至 0.53）]。当分析仅限于高级别宫颈病变的妇女时，一致性得到改善[调整后的 Kappa 系数值，0.83（95%置信区间：0.74 至 0.91）]。HC2 和 INNO-LiPA 检测到的 hr-HPV 在细胞学正常的样本中的患病率分别为 34.5%和 54.5%，在非典型鳞状细胞不能明确意义的样本中的患病率分别为 48.0%和 68.0%，在低级别 SIL 样本中的患病率分别为 51.8%和 75.2%，在高级别 SIL/非典型鳞状细胞不能排除 HSIL 的样本中的患病率分别为 86.3%和 89.8%。HC2 和 INNO-LiPA 分别用于诊断组织学高级别病变（CIN2+）的诊断敏感度、特异度、阳性预测值和阴性预测值分别为 88.8%、55.2%、24.7%和 96.7%和 92.5%、35.1%、19.1%和 96.6%。
结论
HC2 对诊断高级别病变的分析灵敏度低于 INNO-LiPA，但特异性高于 INNO-LiPA；两种检测方法的临床灵敏度相当。HC2 可能适合用于 HIV-1 感染的非洲妇女的宫颈癌筛查，但在资源有限的情况下，其应用需要与其他预防策略进行进一步评估。
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