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APTIMA mRNA vs. DNA-Based HPV Assays: Analytical Performance Insights from a Resource-Limited South African Setting.
Varsetile Varster Nkwinika1,2, Kelvin Amoh Amissah1, Johnny Nare Rakgole1
1Department of Virological Pathology, Sefako Makgatho Health Sciences University, Medunsa, P.O. Box 60, Pretoria 0204, South Africa.
International Journal of Molecular Sciences
|August 14, 2025
Summary
This study compared HPV testing methods for cervical cancer screening in South Africa. mRNA testing may improve screening efficiency by detecting active infections, reducing the burden of transient HPV infections.
Area of Science:
- Molecular diagnostics
- Oncology
- Virology
Background:
- Cervical cancer is a significant health issue in sub-Saharan Africa, with limited screening access.
- Persistent high-risk human papillomavirus (HR-HPV) infection is the primary cause of cervical cancer.
- Accurate molecular diagnostics are crucial for effective cervical cancer prevention.
Purpose of the Study:
- To evaluate the analytical performance of an mRNA assay (APTIMA HPV) and two DNA assays (Abbott RealTime HPV, Seegene Allplex HPV) for HR-HPV detection.
- To compare the detection rates and agreement between mRNA and DNA-based HPV testing methods.
- To assess the potential of mRNA testing for improving cervical cancer screening efficiency in resource-limited settings.
Main Methods:
- Cross-sectional study of 527 cervical samples from South Africa.
- Analysis of 14 shared HR-HPV genotypes using APTIMA mRNA, Abbott DNA, and Seegene DNA assays.
- Comparison of detection rates, sensitivity, negative predictive value (NPV), accuracy (AUC), and inter-assay agreement (κ).
Main Results:
- Seegene DNA had the highest detection rate (53.7%), followed by Abbott DNA (48.2%) and APTIMA mRNA (45.2%).
- APTIMA mRNA showed strong agreement with Abbott DNA (87.9%, κ = 0.80) and the highest accuracy (AUC = 0.8804).
- Moderate agreement between APTIMA mRNA and Seegene DNA (83.4%, κ = 0.70) suggests target differences; DNA-positive/mRNA-negative cases may indicate transient infections.
Conclusions:
- mRNA testing may enhance cervical cancer screening efficiency by focusing on transcriptionally active HR-HPV infections, potentially reducing the burden of managing transient infections.
- Scalable and cost-effective HPV assays with strong clinical utility are vital for expanding access to cervical cancer prevention.
- Further research is needed to integrate mRNA testing into longitudinal cervical cancer screening strategies.
