HPV E1 qPCR, a Low-Cost Alternative Assay to Roche Diagnostic Linear Array is Effective in Identifying Women at Risk...

Area of Science:

• Oncology
• Virology
• Genetics

Background:

• Cervical cancer screening relies on detecting high-risk human papillomavirus (HR-HPV) genotypes.
• Existing genotyping tests vary in cost and complexity.
• A simple, cost-effective assay is needed for widespread HR-HPV detection.

Purpose of the Study:

• To evaluate the agreement between the Roche Diagnostics Linear Array (RDLA) and a quantitative polymerase chain reaction (qPCR)-based E1 assay for HR-HPV detection.
• To compare the accuracy of both assays in detecting cervical intraepithelial neoplasia grade 2 or worse (CIN 2+).

Main Methods:

• The study included 257 African American and 266 Caucasian American women with CIN ≤1 or CIN 2+.
• HPV testing was performed using both RDLA and E1 assays.
• Agreement was assessed using Gwet's AC1 statistic, and predictive values (PPV, NPV) were calculated.

Main Results:

• The E1 assay demonstrated substantial agreement with the RDLA assay for detecting any HR-HPV genotype.
• Agreement was higher in women with CIN 2+ compared to those with CIN ≤1.
• Concordance was generally higher in Caucasian Americans than African Americans, with similar PPV and NPV for detecting CIN lesions.

Conclusions:

• The HPV E1 assay is a cost-effective tool for cervical cancer screening.
• The assay is applicable to both vaccinated and unvaccinated populations.
• The E1 assay shows significant potential for HR-HPV detection and CIN lesion diagnosis.