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 1 single run1 with no additional processing, reagents or labor.
Clinical sensitivity for detection of ≥CIN3 was 93.5% in the NILM ≥30 years population, 91.4% in the ASC-US ≥21 years population, and 100% in the ASC-US 21-29 years 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


1HPV 16, 18 and 45 account for 77% of all HPV (+) invasive cancer and 94% of HPV (+) adenocarcinomas4


2HPV 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


3HPV 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

Consensus PCR

Consensus PCR uses common sequences to amplify all HPV types





The use of consensus PCR primers can lead to masking of HPV co-infections - failure to detect a less abundant type due to the presence of a high viral load of a co-infecting type6-10

GENE-SPECIFIC PCR
BD Onclarity™ HPV Assay

Gene-specific PCR uses unique sequences to amplify the different HPV types





Gene-specific PCR assays such as BD Onclarity™ HPV Assay amplify each genotype independently and can result in an increase in HPV detection where multiple infections are present7,8



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

Assays using the L1 target region may result in false negatives11,12

BD Onclarity™ HPV Assay uses E6/E7 targets, which are stably maintained13



60% of PCR-negative cancers had missing or mutated L1 regions12

When the HPV genome in integrated into the host genome it frequently results in the loss of viral DNA, especially the L1 gene11. Conversely, E6/E7 genes rarely undergo deletion.13

18% of L1 PCR-negative cancers were found to be positive with E6/E7 PCR11
Learn moreClinical 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 Onclarity™ 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.