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ScreenFire HPV RS测定斑马生物圆形格式的分析性能及其对大规模人口HPV查的潜力

Jun Wang^1,2, Godwin Imade³, Alani S Akanmu⁴

¹Department of Preventive Medicine, Division of Cancer Epidemiology and Prevention, Feinberg School of Medicine, Northwestern University, 680 N Lake Shore Dr, Suite 1400, Chicago, IL, 60611, USA. j-wang4@northwestern.edu.

Infectious agents and cancer

|November 29, 2024

概括

对于ScreenFire HPV风险分层 (RS) 试验的新型无污染Zebra BioDome格式显示了与标准格式的高度一致. 这项创新非常适合在低资源环境中进行大规模的宫癌查.

科学领域:

分子诊断学分子诊断学
传染病研究传染病研究.
公共卫生公共卫生

背景情况:

高通量,成本效益的人类乳头瘤病毒 (HPV) 测试对于资源较低的环境至关重要.
通过ScreenFire HPV风险分层 (RS) 测试,在4个瘤风险组中确定了13种高风险的HPV类型.
基于PCR的传统测试容易受到实验室污染,阻碍了可扩展性.

研究的目的:

为了评估 ScreenFire HPV RS 测试的创新,无污染的 Zebra BioDome 格式的分析性能.
为了将斑马生物圈格式与测试的标准格式进行比较.

主要方法:

使用Biorad CFX-96实时PCR仪器进行分析性能评估.
使用整体协议率和未加权的kappa值,比较Zebra BioDome和标准格式.

主要成果:

在两种格式之间,高风险HPV (hrHPV) 检测的总体一致性高达96.0% (kappa = 0.94).
对于HPV16和四个hrHPV基因型风险组的协议率超过了97.5%.

结论:

屏幕Fire HPV RS测定斑马生物圆形格式显示与标准格式高度一致.
没有污染的功能和易于使用使得Zebra BioDome格式适合大规模的HPV查.
这种分析的进步可以有助于减少全球宫癌负担.

关键词:

艾提拉·斯凯恩费尔HPV风险分层 (RS) 测定高风险的人类乳头瘤病毒 (HPV)异热放大器的同热放大方式斑马生物DomeHPV测定测试方法

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