Diagnostic Accuracy of Rapid HPV Antigen Testing Versus PCR in Cervical Cancer Patient

Majead, Marrwa M.; Yousif, Maitham G.

doi:10.21608/ejmm.2025.384293.1638

Diagnostic Accuracy of Rapid HPV Antigen Testing Versus PCR in Cervical Cancer Patient

Document Type : New and original researches in the field of Microbiology.

Authors

Department of Biology, College of Science, University of Al-Qadisiyah, 58001, Iraq

10.21608/ejmm.2025.384293.1638

Abstract

Background: Human papillomavirus (HPV) is the most common sexually transmitted infection. Cervical cancer is primarily caused by high-risk HPV (hr-HPV). Objective: This study aims to evaluate the diagnostic performance of a rapid HPV antigen screening test as a potential tool for improving early detection and reducing the burden of cervical cancer. Methodology: The case-control study; biological samples, including cancerous tissues, wart samples, and control specimens, were collected for molecular analysis. Genomic DNA was extracted from the collected samples. The extracted DNA was subjected to Polymerase Chain Reaction (PCR) using specific primers designed to amplify target DNA sequences of HPV. Results: Overall, HPV genotype-specific assays identified HPV-16 in 23%, HPV-51 in 17%, and HPV-35 in 12% of samples whereas, 67% identified by the HPV rapid antigen test. The rapid HPV test showed perfect sensitivity (100%) across all PCR targets. However, specificity varied considerably, ranging from 37.7% (HPV-35) to 51.3% (MY09/11). Cohen’s kappa (κ) values further quantified agreement between the rapid test and PCR results, revealing moderate agreement for broad-spectrum MY09/11 detection (κ = 0.42, 95% CI: 0.25–0.42) but only slight-to-fair agreement for genotype-specific targets (HPV-16: κ = 0.26; HPV-51: κ = 0.18; HPV-35: κ = 0.12). The test exhibited perfect negative predictive value (NPV = 100%) across all targets however, was suboptimal, with only 52.5% of rapid test-positive samples confirmed as MY09/11 PCR-positive, decreasing to 17.5% for HPV-35. Conclusion: Although the test excels as a screening tool for excluding HPV, its limited specificity and PPV necessitate confirmatory PCR in clinical decision-making.