Evaluation of Sample Pooling Strategies for Point-of-Care HPV DNA Testing Using the STANDARD™ M10 Platform

Area of Science:

• Molecular diagnostics
• Public health
• Gynecologic oncology

Background:

• Human papillomavirus (HPV) DNA testing is crucial for cervical cancer prevention.
• Resource-limited settings face challenges with HPV testing logistics and cost.
• Sample pooling offers potential efficiency gains, but its feasibility on point-of-care platforms needs evaluation.

Purpose of the Study:

• To assess the analytical performance and feasibility of sample pooling for high-risk HPV (hrHPV) detection.
• To evaluate the STANDARD™ M10 HPV point-of-care assay with pooled samples.
• To determine the reliability of pooled testing in resource-limited settings.

Main Methods:

• Utilized archived vaginal swab samples from a rural screening program.
• Assessed pooling strategies of 2-in-1, 4-in-1, and 8-in-1 using a Dorfman two-stage testing approach.
• Analyzed qualitative agreement, sensitivity, Ct shifts, and concordance with individual testing.

Main Results:

• All hrHPV-positive samples were consistently detected in pooled formats, achieving 100% sensitivity.
• Perfect agreement (κ=1.0) was observed between pooled and individual testing.
• Modest cycle threshold shifts occurred with pooling, without compromising detection of low viral loads.

Conclusions:

• Sample pooling for hrHPV DNA testing on the STANDARD™ M10 platform is analytically reliable and operationally feasible.
• Pooled testing can enhance throughput and reduce resource consumption.
• This strategy supports same-day screen-and-treat workflows in remote and underserved areas.