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
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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DOI：
10.1128/jcm.43.6.2662-2667.2005
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发表时间：
2005-06-01
影响因子：
9.4
通讯作者：
Melchers, WJG
中科院分区：
文献类型：
--
作者：
van Ham, MAPC;Bakkers, JMJE;Melchers, WJG
某些高危（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感染的女性相比，持续HR HPV感染的女性发生高度宫颈病变的风险增加。因此，实施HPV检测到子宫颈普查计划可能会发现妇女在子宫颈癌的风险。有几种具有不同灵敏度和特异性的HPV检测方法可用。最近，一种新的基于PCR的技术，罗氏公司的AMPLYCOR HPV测试，被开发出来。该检测可同时识别13种HR HPV类型。本研究的目的是验证和比较使用AMPER COR HPV Test和INNO-LiPA HPV检测/基因分型检测试剂盒（SPF 10-利帕系统版本1）对573份宫颈刮片标本进行HPV检测。在9份标本中未检测到人类P-球蛋白，因此将其排除在比较之外。11份含有HPV 53型或66型的刮片标本也从比较中排除，因为这些（可能）HR HPV类型无法通过AMPDECOR HPV Test检测到。在5391553例病例中，通过INNO-LiPA HPV检测/基因分型试验证实了Roche AMRCOR HPV Test的HPV检测结果，显示绝对一致性为97.5%，Cohen kappa为0.9327，表明两种检测方法几乎完全相似。与INNO-LiPA HPV检测/基因分型检测试剂盒一样，AMINO COR HPV Test具有灵敏度、特异性、可行性和易于操作性。Roche AMDRCOR HPV Test具有广谱HR HPV检测的价值必须在前瞻性临床研究中确定。
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 P-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 5391553 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.