Jerip Abigail Rembui, Noni Vaenessa, Anthony Vanessa Kiah, Bong Andy Cheong Shin, Adam Jaria, Tan Cheng Siang
Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Kota Samarahan, Sarawak, 94300, Malaysia.
Pink and Teal Empowher, Kota Padawan, Kuching, Sarawak, 93050, Malaysia.
BMC Infect Dis. 2025 Mar 3;25(1):304. doi: 10.1186/s12879-025-10714-y.
Cervical cancer, primarily caused by persistent high-risk human papillomavirus (hrHPV) infections, is a significant health burden, particularly in low-resource settings such as Sarawak, Malaysia. Effective prevention depends on effective vaccination and early hrHPV detection. This study compares the performance of the point-of-care test (POCT) SD Biosensor Standard™ M10 HPV and laboratory-based Seegene Anyplex™ II HPV HR assay, focusing on their ability to detect and genotype hrHPV in self-collected high vaginal swab samples.
A total of 151 archived self-sampled high vaginal swabs from the Sarawak Urban and Rural Action for Cervical Cancer Elimination Programme (Program SUARA) were analyzed. hrHPV detection and genotyping were performed using Anyplex, which identifies 14 hrHPV genotypes, and M10, which detects HPV16, HPV18, and other hrHPV categorized into six genogroups. Agreement between the assays was evaluated using Cohen's Kappa (κ), McNemar's test, and overall agreement percentages. Statistical significance was determined with p-values, and discordant results were further analyzed for potential diagnostic implications.
The overall agreement between M10 and Anyplex for hrHPV detection was 92.05% (κ = 0.84, 95% CI 0.75-0.93), indicating almost perfect agreement. M10 demonstrated comparable sensitivity for detecting HPV16, HPV18, and other hrHPV genotypes, achieving 96.91% agreement (κ = 0.89, 95%CI 0.73-1.00) in hrHPV classification when discordant results were excluded. Genogrouping also showed almost perfect agreement (κ = 0.91, 95% CI 0.82-0.98). McNemar's test indicated no significant difference in hrHPV detection rates (p > 0.05), affirming their comparable performance in detecting clinically significant hrHPV infections.
The SD Biosensor Standard™ M10 HPV POCT and the Seegene Anyplex™ II HPV HR assay demonstrated almost perfect agreement in hrHPV detection and classification, supporting their complementary roles in cervical cancer prevention. M10's rapid, field-deployable design makes it suitable for resource-limited settings, while Anyplex provides enhanced genotyping capability in laboratory environments, allowing informed vaccine strategy. Incorporating both assays into cervical cancer prevention programs can improve screening coverage and accessibility, particularly in underserved areas. These findings align with the World Health Organization's cervical cancer elimination goals, reinforcing the importance of adaptable diagnostic tools in diverse healthcare contexts.
宫颈癌主要由持续性高危型人乳头瘤病毒（hrHPV）感染引起，是一项重大的健康负担，在马来西亚砂拉越等资源匮乏地区尤为如此。有效的预防措施依赖于有效的疫苗接种和早期hrHPV检测。本研究比较了即时检测（POCT）SD Biosensor Standard™ M10 HPV和基于实验室的Seegene Anyplex™ II HPV HR检测法的性能，重点关注它们在自我采集的高阴道拭子样本中检测hrHPV并进行基因分型的能力。
对来自砂拉越宫颈癌消除城乡行动项目（SUARA项目）的151份存档的自我采集的高阴道拭子进行了分析。使用可识别14种hrHPV基因型的Anyplex和检测HPV16、HPV18及其他分为六个基因组的hrHPV的M10进行hrHPV检测和基因分型。使用科恩kappa（κ）系数检验法、麦克尼马尔检验法和总体一致率评估两种检测法之间的一致性。通过p值确定统计学显著性，并对不一致的结果进行进一步分析以探讨潜在的诊断意义。
M10和Anyplex在hrHPV检测方面的总体一致率为92.05%（κ = 0.84，95%置信区间0.75 - 0.93），表明几乎完全一致。M10在检测HPV16、HPV18和其他hrHPV基因型方面表现出相当的敏感性，在排除不一致结果后，hrHPV分类的一致率达到96.91%（κ = 0.89，95%置信区间0.73 - 1.00）。基因组分类也显示出几乎完全一致（κ = 0.91，95%置信区间0.82 - 0.98）。麦克尼马尔检验表明hrHPV检测率无显著差异（p > 0.05），证实了它们在检测临床上有意义的hrHPV感染方面具有相当的性能。
SD Biosensor Standard™ M10 HPV POCT和Seegene Anyplex™ II HPV HR检测法在hrHPV检测和分类方面显示出几乎完全一致，支持它们在宫颈癌预防中的互补作用。M10快速、可现场部署的设计使其适用于资源有限的环境，而Anyplex在实验室环境中提供了更强的基因分型能力，有助于制定明智的疫苗策略。将这两种检测法纳入宫颈癌预防项目可以提高筛查覆盖率和可及性，特别是在服务不足的地区。这些发现与世界卫生组织的宫颈癌消除目标一致，强化了在不同医疗环境中采用适应性诊断工具的重要性。
