PO.IM03.01 · 免疫学
先进的 OnePCR HPV 检测组套：覆盖完整高、中、低危基因型的快速 POCT 平台
Advanced OnePCR HPV panel: Fast POCT platform covering complete high, medium & low-risk genotypes
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
人乳头瘤病毒（HPV）因其与女性宫颈癌及男性口咽癌的密切关联，已成为全球重大公共卫生问题。HPV 相关病毒多达 200 余种，高危基因型的持续感染可驱动恶性转化。宫颈癌仍位居女性最常见癌症的第 4 位，2022 年新发病例约 660,000 例、死亡约 350,000 例，其中 94% 发生于中低收入国家。早期筛查、疫苗接种和及时治疗是减轻这一疾病负担的关键。创新诊断平台 Genes2Me 通过两套强大系统实现先进的 HPV 检测：OnePCR 系统——一款全自动的样本进、结果出（Sample-IN Result OUT）平台，将提取与实时 PCR 整合于单个试剂卡中。每份样本可检测多达 20 个靶标，无需任何移液步骤，约 100 分钟内即可提供结果。Rapi-Q 与 Rapi-X16 系统——一款半 POCT 高通量解决方案，可同时提取多达 16 份样本，并以 8 联管形式进行多重 PCR，为繁忙的实验室提供可扩展性与精确性。全面的 HPV 基因分型检测组套 Genes2Me HPV 检测采用带荧光探针的多重实时 PCR，实现精确的基因型区分。高危组套（Tube 1）：HPV16（HEX）、HPV18（FAM）、12 种合并的 HR 基因型（Texas Red）；beta-Actin 内参对照。低危及中危组套（Tube 2）：采用 FAM/HEX/Texas Red 检测 HPV6、11、44 等；Cy5 内参对照。扩展低/中危组套（Tube 3）：14 种基因型分为 FAM / HEX / Texas Red 组，配以 Cy5 内参对照。
查看英文原文 English abstract
Human Papillomavirus (HPV) is a major global health concern due to its strong association with cervical cancer in women and oropharyngeal cancer in men. With 200+ related viruses, persistent infection with high-risk genotypes can drive malignant transformation. Cervical cancer remains the 4th most common cancer in women, with around 660,000 new cases and 350,000 deaths in 2022 94% occurring in low- and middle-income countries. Early screening, vaccination, and timely treatment are key to reducing this burden.Innovative Diagnostic Platforms Genes2Me delivers advanced HPV detection through two powerful systems: OnePCR System - A fully automated Sample-IN Result OUT platform that integrates extraction and real-time PCR in one cartridge. It detects up to 20 targets per sample with zero pipetting steps and provides results in around 100 minutes. Rapi-Q and Rapi-X16 System - A semi-POCT high-throughput solution enabling extraction of up to 16 samples simultaneously and multiplex PCR in 8 tube format, offering scalability and precision for busy laboratories. Comprehensive HPV Genotyping Panels Genes2Me HPV assays use multiplex real-time PCR with fluorescent probes for accurate genotype differentiation. High-Risk Panel (Tube 1): HPV16 (HEX), HPV18 (FAM), 12 pooled HR genotypes (Texas Red); beta-Actin internal control. Low & Medium-Risk Panel (Tube 2): HPV6, 11, 44 and others using FAM/HEX/Texas Red; Cy5 internal control. Expanded Low/Medium Panel (Tube 3): 14 genotypes categorized into FAM / HEX / Texas Red groups with Cy5 internal control.
利益披露 Disclosure
B. S. Gurjar, None..
G. Tessarin, None..
N. Kumar, None..
N. Erande, None.