The Onclarity HPV assay (Becton, Dickinson and Company, BD Life Sciences - Integrated Diagnostic Solutions, Sparks, MD) is safe and effective for use in human papillomavirus (HPV) testing, according to a recent study published in the American Journal of Obstetrics and Gynecology.
Takeaways
- The Onclarity HPV assay, as indicated in a recent study, demonstrates safety and efficacy in detecting high-grade cervical disease, presenting a promising option for cervical cancer screening.
- Comparisons with predicate assays reveal similar performance metrics, suggesting reliability and consistency in results between different testing methods.
- Utilization of the Onclarity assay potentially offers cost-saving benefits, particularly in light of its FDA approval for primary HPV screening.
- The study underscores the importance of standardized screening protocols and the need for comprehensive evaluation of HPV testing methods in diverse clinical settings.
- Positive agreement rates for HPV detection, particularly for HPV16 and HPV18, highlight the assay's effectiveness in identifying high-risk HPV genotypes associated with cervical cancer.
Of over 200 known HPV genotypes, approximately 40 infect the cervical mucosa and 13 to 14 are associated with high cervical precancer and cancer risks. High-grade cervical disease and cancer risks are increased by 1 year or longer of genotype-specific persistent HPV infection.
Different countries have varied approaches to cervical cancer screening, liquid-based cytology (LBC) media types, HPV test type, and national screening recommendations. Cervical precancer, such as cervical intraepithelial neoplasia grades 2 or greater (≥CIN2) and 3 or greater (≥CIN3), can be detected with increased sensitivity through HPV testing.
Co-testing is associated with increased cost without significant added insurance of increased protection vs HPV primary screening. However, the FDA has approved the Onclarity HPV assay for HPV primary screening.
While the Onclarity HPV assay has been indicated safe and effective, there is little data evaluating this index HPV assay’s use with PreservCyt Cyt (Hologic, Inc, San Diego, CA) LBC in the United States. Investigators conducted a retrospective evaluation using deidentified cervical specimens collected in PreservCyt.
Women aged 21 to 65 receiving cervical cytology alone or co-testing screening from August 2013 to October 2016 were included in the analysis. Testing with the index and predicate HPV assays was performed for deidentified PreservCyt specimens selected from residual PreservCyt specimens.
During routine clinical practice, historical, baseline, and follow-up data for HPV tests, cervical cytology, hysterectomies, and cervical biopsies were reported. Investigators reviewed all cervical pathology within 5 years of enrollment, but only counted the first worse diagnosis.
Patients with atypical squamous cells of undetermined significance or negative for intraepithelial lesion or malignancy (NILM) baseline cytology received cervical biopsy during follow-up. Patients with low-grade squamous intraepithelial lesion (LSIL) or greater at baseline were recommended cervical biopsy during follow-up.
A negative status was given to patients with no endocervical curettages (ECCs) or cervical biopsy during follow-up and those with an NILM cytology result and negative or unavailable HPV result. Patients with hysterectomy before enrollment or cervical cytology, HPV testing, or cervical biopsy within 300 days before enrollment were excluded from the analysis.
