A-299 The Clinical Triaging Impact of New HPV Platforms. A Comparison of mRNA and DNA Based Platforms

Abstract Background Newly FDA-approved HPV genotyping platforms use different technologies (mRNA vs. DNA) and target various genotypes to provide screening for cervical cancer and ultimately guide reflex to colposcopy. Small differences in ordering patterns and test specificity can have a significant impact on patient referral patterns. mRNA-based platforms claim superior specificity to detect CIN2+ lesions, while DNA platforms are better suited to accurately discriminate between different genotypes. As genotyping information is getting included in screening and reflex guidelines, it is becoming more important to understand the differences between these platforms and how they influence triaging. Methods The authors evaluated 900 patient results initially triaged by Hologic Aptima and cytology at a single laboratory in Las Vegas. Additional HPV testing with genotyping was performed using BD Onclarity and Roche cobas platforms and resulted in 899 cases with valid results for all 3 platforms. Overall correlation and calculated ASCCP referral pattern differences were analyzed. The HPV results were evaluated using McNemar’s test on the 2x2 tables comparing platforms against each other. Results The positivity rate for High-Risk HPV (HR-HPV) was 9.2%, 10.3%, and 11.7% for Hologic, BD, and Roche, respectively. The results were significantly different between Roche and Hologic Aptima (r=0.0035). Both Roche and BD assays reported genotypes 16 and 18 on all 899 cases while Hologic genotyping was not ordered on 22 out of the 84 initially HR-HPV positive cases (26%). This resulted in missing 5 genotypes 16 or 18 cases as compared to Roche, and 4 cases as compared to BD Onclarity. In addition, the DNA tests identified 5 HPV genotype 45 cases and categorized them either separately as “HPV genotype 45” or as “other HR-HPV” types. 2 of those 5 HPV45 cases were categorized as HPV 18/45 correctly by Hologic but resulted in referral to colposcopy while using the DNA platforms did not result in colposcopy referrals. HR-HPV and genotyping identification results were not significantly different between Roche cobas and BD Onclarity. 8 patients (0.8% of all screened) were triaged differently not due to overall HR-HPV specificity but the lack of genotyping order or grouping of HPV genotype 45 with the other higher risk Genotype 18. Conclusion It has been extensively studied that all FDA-approved platforms have sufficient sensitivity and specificity to use them as screening tools for cervical cancer. The current study highlights that these assays are not identical and have different limitations and strengths. Further evaluation of follow-up data will be performed and reported as results become available.