OncoPredict HPV 定量分型 (QT) 分析法在自采样本上的临床准确性

IF 4 3区医学 Q2 VIROLOGY

Journal of Clinical Virology Pub Date : 2024-10-21 DOI:10.1016/j.jcv.2024.105737

Ardashel Latsuzbaia , Marianna Martinelli , Chiara Giubbi , Kate Cuschieri , Hana Elasifer , Anna D. Iacobone , Fabio Bottari , Andrea F. Piana , Roberto Pietri , Giancarlo Tisi , Franco Odicino , Clementina E. Cocuzza , Marc Arbyn , European VALHUDES working group

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引用次数: 0

摘要

背景VALHUDES计划旨在评估使用尿液和阴道自取样本检测宫颈癌前病变的HPV测定与宫颈临床医生采集样本相比的临床准确性。方法 490 名转诊至阴道镜检查的妇女分别使用 Colli-Pee 和 FLOQSwab 自取了尿液和阴道样本。随后进行阴道镜检查，用 Cervex-Brush 采集宫颈样本，如有临床指征则进行活检。结果当采用制造商的临界值时，OncoPredict HPV QT 检测尿液和阴道自取样本中 CIN2+ 的临床灵敏度与宫颈样本相似（比率分别为 0.99 [95 % CI 0.94-1.05] 和 1.00 [95 % CI 0.96-1.04]）。两种自检样本的<CIN2特异性均低于宫颈样本（尿液/宫颈比值=0.91 [95 % CI 0.84-0.98]；阴道/宫颈比值=0.90 [95 % CI 0.84-0.98]）。临界值优化提高了特异性，但并不影响灵敏度。与尿液或阴道自检样本相比，宫颈样本经细胞调整后的病毒载量中位值明显较高，一般来说，所有 12 种高风险 HPV 都是如此，尤其是 HPV16、18、31、33、35、45、51 和 58（p <0.05）。尿液样本和阴道样本的病毒载量中位数没有差异。结论经过截断点优化后，OncoPredict HPV QT 检测法在自取样本和宫颈样本中显示出相似的准确性。

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Clinical accuracy of OncoPredict HPV Quantitative Typing (QT) assay on self-samples

Background

The VALHUDES initiative was established to assess the clinical accuracy of HPV assays to detect cervical precancers using urine and vaginal self-samples compared to cervical clinician-collected samples. Here, the clinical performance of OncoPredict HPV Quantitative Typing (QT) assay (OncoPredict QT) was evaluated.

Methods

490 women referred to colposcopy self-collected a urine and a vaginal specimen using Colli-Pee and FLOQSwab, respectively. Subsequently, a colposcopy was performed, and a cervical sample was collected with Cervex-Brush, followed by biopsy if clinically indicated. Vaginal samples were transported dry and resuspended in 5 mL of eNAT medium, whilst cervical brushings were immediately transferred in 20 mL ThinPrep.

Results

The clinical sensitivity of OncoPredict HPV QT testing for CIN2+ in urine and vaginal self-samples was similar to cervical samples (ratios of 0.99 [95 % CI 0.94–1.05] and 1.00 [95 % CI 0.96–1.04]), respectively, when manufacturer's cut-offs were applied. The specificity for <CIN2 on both self-samples was lower than on cervical samples (urine/cervical ratio = 0.91 [95 % CI 0.84–0.98]; vaginal/cervical ratio = 0.90 [95 % CI 0.84–0.98]). Cut-off optimisation improved specificity without compromising sensitivity. Median viral load values adjusted for cellularity were significantly higher in cervical samples compared to urine or vaginal self-samples, in general for all 12 high-risk HPV and in particular for HPV16, 18, 31, 33, 35, 45, 51, 58 (p < 0.05). No difference was observed in median viral loads between urine and vaginal samples.

Conclusion

Following cut-off optimisation OncoPredict HPV QT assay demonstrated similar accuracy on self-collected versus cervical samples.

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来源期刊

Journal of Clinical Virology 医学-病毒学

CiteScore

22.70

自引率

1.10%

发文量

149

审稿时长

24 days

期刊介绍： The Journal of Clinical Virology, an esteemed international publication, serves as the official journal for both the Pan American Society for Clinical Virology and The European Society for Clinical Virology. Dedicated to advancing the understanding of human virology in clinical settings, the Journal of Clinical Virology focuses on disseminating research papers and reviews pertaining to the clinical aspects of virology. Its scope encompasses articles discussing diagnostic methodologies and virus-induced clinical conditions, with an emphasis on practicality and relevance to clinical practice. The journal publishes on topics that include: • new diagnostic technologies • nucleic acid amplification and serologic testing • targeted and metagenomic next-generation sequencing • emerging pandemic viral threats • respiratory viruses • transplant viruses • chronic viral infections • cancer-associated viruses • gastrointestinal viruses • central nervous system viruses • one health (excludes animal health)