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首页> 外文期刊>Journal of Clinical Microbiology >Comparison of Two Commercial Assays for Detection of Human Papillomavirus (HPV) in Cervical Scrape Specimens: Validation of the Roche AMPLICOR HPV Test as a Means To Screen for HPV Genotypes Associated with a Higher Risk of Cervical Disorders
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Comparison of Two Commercial Assays for Detection of Human Papillomavirus (HPV) in Cervical Scrape Specimens: Validation of the Roche AMPLICOR HPV Test as a Means To Screen for HPV Genotypes Associated with a Higher Risk of Cervical Disorders

机译：在宫颈刮擦标本中检测人类乳头瘤病毒（HPV）的两种商业化检测方法的比较：罗氏AMPLICOR HPV检测作为验证筛查与宫颈疾病高风险相关的HPV基因型的方法的验证

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Certain high-risk (HR) human papillomavirus (HPV) types are a necessary cause for the development of cervical disorders. Women with persistent HR HPV infections have an increased risk of developing high-grade cervical lesions, compared with those who have no or low-risk HPV infections. Therefore, implementation of HPV detection into cervical screening programs might identify women at risk of cervical cancer. Several HPV detection methods with different sensitivities and specificities are available. Recently, a new PCR-based technique, the Roche AMPLICOR HPV Test, was developed. This test recognizes a group of 13 HR HPV types simultaneously. This study was undertaken to validate and compare HPV detection in 573 cervical scrape specimens by the AMPLICOR HPV Test and the INNO-LiPA HPV detection/genotyping assay (SPF10-LiPA system version 1). Human β-globin was not detected in nine specimens, which were therefore excluded from the comparison. Eleven scrape specimens containing HPV type 53 or 66 were also excluded from the comparison because these (probably) HR HPV types cannot be detected by the AMPLICOR HPV Test. The results of HPV detection by the Roche AMPLICOR HPV Test were confirmed by INNO-LiPA HPV detection/genotyping assay in 539/553 cases, showing an absolute agreement of 97.5% with a Cohen's kappa of 0.9327, indicating almost complete similarity of the two tests. Like the INNO-LiPA HPV detection/genotyping assay, the AMPLICOR HPV Test was sensitive, specific, feasible, and easy to handle. The value of the Roche AMPLICOR HPV Test with a broad-spectrum HR HPV detection has to be determined in prospective clinical studies.
机译：某些高风险（HR）人乳头瘤病毒（HPV）类型是宫颈疾病发展的必要原因。与没有或低风险HPV感染的妇女相比，持续性HR HPV感染的妇女发生高级别宫颈病变的风险增加。因此，在宫颈癌筛查计划中实施HPV检测可能会发现有患宫颈癌风险的妇女。有几种具有不同敏感性和特异性的HPV检测方法。最近，开发了一种基于PCR的新技术，即Roche AMPLICOR HPV测试。该测试可同时识别13种HR HPV类型的组。这项研究旨在通过AMPLICOR HPV测试和INNO-LiPA HPV检测/基因分型分析（SPF 10 -LiPA系统版本1）验证和比较573例宫颈刮scrap样本中的HPV检测。在9个样本中未检测到人β珠蛋白，因此将它们从比较中排除。比较中还排除了11个含有HPV 53型或66型的刮擦样本，因为这些AMPHPOR HPV测试无法检测到这些（可能）HR HPV类型。罗氏AMPLICOR HPV检测法检测HPV的结果已通过INNO-LiPA HPV检测/基因分型测定法在539/553例病例中得到证实，显示97.5％的绝对一致性与0.9327的Cohenκ吻合，表明这两种检测法几乎完全相似。像INNO-LiPA HPV检测/基因分型测定法一样，AMPLICOR HPV检测也是灵敏，特异性，可行且易于操作的。必须在前瞻性临床研究中确定具有广谱HR HPV检测的Roche AMPLICOR HPV检测的价值。

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