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三种人乳头瘤病毒检测及分型检测方法的准确性评估:杂交捕获2代法、人乳头瘤病毒共识试剂盒法和核酸扩增检测法

[Evaluation of accuracy of three assays for human papillomavirus detection and typing: Hybrid Capture 2, HPV Consensus kit and Amplicor HPV].

作者信息

Hantz S, Caly H, Decroisette E, Dutrop A, Bakeland D, Pascal B, Darreye G, Dussartre C, Renaudie J, Rogez S, Aubard Y, Denis F, Alain S

机构信息

Laboratoire de bactériologie-virologie-hygiène, CHRU Dupuytren, 2, avenue Martin-Luther-King, 87042 Limoges cedex, France.

出版信息

Pathol Biol (Paris). 2008 Feb;56(1):29-35. doi: 10.1016/j.patbio.2007.09.006. Epub 2008 Jan 4.

Abstract

BACKGROUND

Detection of high-risk human papillomavirus has proved its usefulness in complement of abnormal cervical scrape result. The Hybrid Capture 2 (HC2, Digene) test has proven its efficiency. We have compared this test with HPV Consensus kit (HPVC, Argène) and Amplicor HPV test (AHPV, RocheDiagnostics) on a panel of 88 samples with low HC2 ratios or discordant results between HC2 and cervical scrape.

MATERIAL AND METHODS

Cervical samples were tested in parallel by the three methods using a nested amplification of L1 region as reference.

RESULTS

Eighty-six samples were suitable for analysis. Results of HC2 and AHPV tests were closely related. The use of a "generic" probe in the HPVC test was responsible for undetermined results, which were not clinically relevant.

CONCLUSION

Despite the low viral load of the samples chosen, the hybridization (HC2) and PCR (AHPV or HPVC) methods gave comparable results, with false positive and false negative results for all tests, but a 75% concordance and a high sensibility to detect HPV infection. However, a complementary study on a larger population with ASCUS diagnosis and biopsy under colposcopy would be necessary to valid these assays for a clinical indication.

摘要

背景

高危型人乳头瘤病毒检测已证明其在补充异常宫颈刮片结果方面的作用。杂交捕获2(HC2,Digene)检测已证明其有效性。我们在一组88份HC2比值低或HC2与宫颈刮片结果不一致的样本中,将该检测与HPV共识试剂盒(HPVC,Argène)和Amplicor HPV检测(AHPV,RocheDiagnostics)进行了比较。

材料与方法

采用L1区域巢式扩增作为参照,用这三种方法对宫颈样本进行平行检测。

结果

86份样本适合分析。HC2检测和AHPV检测的结果密切相关。HPVC检测中使用“通用”探针导致结果无法确定,而这些结果并无临床意义。

结论

尽管所选样本的病毒载量较低,但杂交(HC2)和聚合酶链反应(AHPV或HPVC)方法得出了可比结果;所有检测均有假阳性和假阴性结果,但一致性达75%,且检测HPV感染的灵敏度较高。然而,有必要对更多非典型鳞状细胞不能明确意义(ASCUS)诊断且在阴道镜检查下活检的人群进行补充研究,以验证这些检测方法的临床适用性。

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