Comparative analysis of SD biosensor standard M10 HPV and seegene anyplex II HPV HR for detecting high-risk human papillomavirus: a concordance study.

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.