The BD
Onclarity™ HPV
Assay:
Clinically validated to simultaneously detect 14 high-risk HPV genotypes, allowing you to focus on patients with higher risk1
BD Onclarity™ HPV Assay
Extend the Power of HPV Testing
A 3-well, multiplexed design with
genotype specific primers and probes1
(instead of consensus primers) provides
excellent detection of single and
mixed HPV infections.2
Simultaneous HPV detection and
extended genotyping on-demand
in one single run1 with no additional
processing, reagents or labor.
Clinical sensitivity for detection of ≥CIN3
was 93.5% in the NILM ≥30-year
population, 91.4% in the ASC-US ≥21-year population, and 100% in the ASC-US
21-29-year unvaccinated population.1
Focus on patients most at risk
The unique risk stratification design of the BD Onclarity™ HPV Assay allows you to focus on patients with higher risks3
Detects 14 hrHPV types & reports up to 10 results*1
- HPV 16, 18 and 45 account for 77% of all HPV (+) invasive cancer and 94% of HPV (+) adenocarcinomas4
- HPV 31 poses the highest ≥CIN2 and ≥CIN3 risk after HPV 165, HPV 33/58 and 52 pose the next highest risk of ≥CIN2 after HPV 16,18 and 315, HPV 33 and 58 are detected in a group1
- HPV 51, 35/39/68 and 56/59/66 have a reduced risk for ≥CIN3 compared to the top 7 hrHPV types: HPV 16, 18, 31, 33/58, 45 and 525 HPV 35/39/68 and 56/59/66 are detected in groups1
*Positive/Negative for high-risk HPV plus 9 results for single or pooled HPV genotypes
Improve detection of multiple HPV infections
The BD Onclarity™ HPV Assay can detect clinical levels of any HPV type in the presence of up to one million copies of another competing type1
Reduce the risk of false negatives
The E6/E7-based PCR design of the BD Onclarity™ HPV Assay significantly reduces the risk of false negative results due to gene deletion after HPV integration11
Learn more – Clinical performance of BD Onclarity™ HPV Assay
CIN, cervical intraepithelial neoplasia; CIN1, cervical intraepithelial neoplasia grade 1; CIN2, cervical intraepithelial neoplasia grade 2; CIN3, cervical intraepithelial neoplasia grade 3; DNA, deoxyribonucleic acid; HPV, human papillomavirus; hrHPV, high-risk human papillomavirus; IC, Internal control; PCR, polymerase chain reaction.
1. BD OnclarityTM HPV Assay European Product information, 8089899(14). Updated November 2020. 2. Wright TC et al. Am J Clin Pathol. 2014;142(1):43-50. 3. Bottari F et al. J Clin Microbiol. 2015;53:2109-2114. 4. de Sanjose S et al. Lancet Oncol. 2010;11(11):1048-1056. 5. Stoler MH et al. Gynecol Oncol. 2018;149(3):498-505. 6. van Doorn J et al. J Clin Microbiol. 2006;44(9):3292-3298. 7. van Alewijk D et al. J Clin Microbiol. 2013;51(4):1171-1178. 8. Struyf F et al. Clin Vaccin Immunol. 2015;22(2):235-244. 9. Mori S et al. Cancer Sci. 2011;102(6):1223-1227. 10. Cornall AM et al. J Virol Methods. 2015;214:10-14. 11. Lagheden C et al. Br J Cancer. 2018;118(10):1377-1381. 12. Arroyo Mühr LS et al. J Gen Virol. 2020;101(3):265-270. 13. Vaughan LM and Malinowski DP. Rev Bras Ginecol Obstet. 2019;41(5):357-359.