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评估Xpert HPV检测法在摩洛哥检测HPV阳性病例中的表现。

Evaluating the performance of the Xpert HPV assay in detecting HPV positive cases in Morocco.

作者信息

Yerim Said Ali, Khazraji Youssef Chami, Bekkali Rachid, Bennai Maria, Bahra Nassiba, Chaoui Imane, Chellat Fatima Zahra, Gaizi Zineb, Tachfouti Nabil, Benabdellah Anas, Belkadi Bouchra, Attaleb Mohammed, Berraho Mohamed Amine, El Mzibri Mohammed

机构信息

Biology and Medical Research Unit, Centre National de L'Energie, des Sciences et Techniques Nucléaires (CNESTEN), Rabat, Morocco; Microbiology and Molecular Biology Laboratory, Faculty of Sciences, Mohammed V University, in Rabat, Morocco.

Fondation Lalla Salma- Prévention et Traitement des Cancers, Rabat, Morocco.

出版信息

Tumour Virus Res. 2025 Apr 17;19:200318. doi: 10.1016/j.tvr.2025.200318.

DOI:10.1016/j.tvr.2025.200318
PMID:40246229
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12032899/
Abstract

Recently, the World Health Organization recommended integrating HPV testing into cervical cancer screening programs globally. This study aimed to compare the GeneXpert assay with PCR-sequencing for HPV detection and genotyping to assess the feasibility of incorporating HPV molecular testing into cervical cancer screening. A total of 1000 women aged 30 or 40 from rural and urban areas across four regions in Morocco with high sexually transmitted infection prevalence were recruited. After excluding 21 invalid tests, DNA testing on the remaining 979 samples showed an HPV prevalence of 4.0 % (39/979) by PCR and 5.0 % (49/979) by Xpert, with an overall prevalence of 5.7 % (56/979) when combining both techniques. The concordance rate between the tests was 97.5 %. Notably, the Xpert HPV assay was highly efficient in detecting HPV, with nearly all identified HPVs being high-risk oncogenic types, predominantly HPV16, 18, 31, 35, and 45. The Xpert HPV assay has demonstrated excellent analytical performance, making it a reliable option for HPV detection in vaginal and cervical swabs. Its integration into primary cervical cancer screening programs could significantly enhance the early detection of HPV-positive cases, thereby strengthening the screening framework and potentially reducing both the incidence and mortality of cervical cancer. Future studies should focus on confirming these results and exploring the utility of this method in conjunction with other diagnostic tools such as visual inspection with acetic acid (VIA) for a comprehensive assessment of its effectiveness in real-world settings.

摘要

最近,世界卫生组织建议在全球范围内将人乳头瘤病毒(HPV)检测纳入宫颈癌筛查项目。本研究旨在比较GeneXpert检测法与聚合酶链反应测序法(PCR测序)在HPV检测和基因分型方面的效果,以评估将HPV分子检测纳入宫颈癌筛查的可行性。在摩洛哥四个性传播感染率较高地区的城乡,共招募了1000名年龄在30岁或40岁的女性。排除21份无效检测后,对其余979份样本进行DNA检测,结果显示PCR检测的HPV感染率为4.0%(39/979),GeneXpert检测的感染率为5.0%(49/979),两种技术联合检测的总体感染率为5.7%(56/979)。两种检测方法的一致性率为97.5%。值得注意的是,GeneXpert HPV检测法在检测HPV方面效率很高,几乎所有检测出的HPV都是高危致癌类型,主要是HPV16、18、31、35和45。GeneXpert HPV检测法已显示出出色的分析性能,使其成为阴道和宫颈拭子中HPV检测的可靠选择。将其纳入原发性宫颈癌筛查项目可显著提高HPV阳性病例的早期检测率,从而加强筛查框架,并有可能降低宫颈癌的发病率和死亡率。未来的研究应着重于证实这些结果,并探索该方法与其他诊断工具(如醋酸目视检查法(VIA))联合使用的效用,以便在实际环境中对其有效性进行全面评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fde4/12032899/6afe466508a9/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fde4/12032899/b49dabe41e00/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fde4/12032899/6afe466508a9/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fde4/12032899/b49dabe41e00/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fde4/12032899/6afe466508a9/gr2.jpg

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本文引用的文献

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Evaluating operational parameters of the careHPV, GeneXpert, AmpFire, and MA-6000 HPV systems for cervical precancer screening: Experience from Battor, Ghana.评估CareHPV、GeneXpert、AmpFire和MA - 6000型人乳头瘤病毒(HPV)检测系统用于宫颈癌前病变筛查的操作参数:来自加纳巴托尔的经验
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Comparison of the Clinical Accuracy of Xpert HPV Assay on Vaginal Self-Samples and Cervical Clinician-Taken Samples within the VALHUDES Framework.
VALHUDES 框架内 Xpert HPV 检测试剂盒对阴道自采样和宫颈临床医生采样的临床准确性比较。
J Mol Diagn. 2023 Sep;25(9):702-708. doi: 10.1016/j.jmoldx.2023.06.004. Epub 2023 Jun 22.
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Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation.AmpFire®多重人乳头瘤病毒检测法与Xpert®人乳头瘤病毒检测法在检测感染人类免疫缺陷病毒女性的人乳头瘤病毒及宫颈疾病中的比较:一项实用性性能评估
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Human Papillomaviruses-Related Cancers: An Update on the Presence and Prevention Strategies in the Middle East and North African Regions.人乳头瘤病毒相关癌症:中东和北非地区的现状及预防策略更新
Pathogens. 2022 Nov 19;11(11):1380. doi: 10.3390/pathogens11111380.
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Agreement between Xpert and AmpFire tests for high-risk human papillomavirus among HIV-positive women in Rwanda.卢旺达HIV阳性女性中Xpert检测与AmpFire检测对高危型人乳头瘤病毒检测结果的一致性
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The Prevalence, Genotype Distribution and Risk Factors of Human Papillomavirus in Tunisia: A National-Based Study.突尼斯基于国家的人乳头瘤病毒流行率、基因型分布和危险因素研究。
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