Focus on patients most at risk
The unique risk stratification design of the BD Onclarity™ HPV Assay allows you to focus on patients with
Detects 14 hrHPV types & reports up to 10 results*1
*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
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 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
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
- 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.
- BD Onclarity™ HPV Assay European Product information, 8089899(14). Updated November 2020.
- Wright TC et al. Am J Clin Pathol. 2014;142(1):43-50
- Bottari F et al. J Clin Microbiol. 2015;53:2109-2114.
- de Sanjose S et al. Lancet Oncol. 2010;11(11):1048-1056.
- Stoler MH et al. Gynecol Oncol. 2018;149(3):498-505.
- van Doorn J et al. J Clin Microbiol. 2006;44(9):3292-3298.
- van Alewijk D et al. J Clin Microbiol. 2013;51(4):1171-1178.
- Struyf F et al. Clin Vaccin Immunol. 2015;22(2):235-244.
- Mori S et al. Cancer Sci. 2011;102(6):1223-1227.
- Cornall AM et al. J Virol Methods. 2015;214:10-14.
- Lagheden C et al. Br J Cancer. 2018;118(10):1377-1381.
- Arroyo Mühr LS et al. J Gen Virol. 2020;101(3):265-270.
- Vaughan LM and Malinowski DP. Rev Bras Ginecol Obstet. 2019;41(5):357-359.
About 6 in every 10 women who undergo colposcopy have abnormal cells in their cervix - known as cervical intra-epithelial neoplasia (CIN).
A biopsy can help determine the risk that these cells bear to become cancerous, according to the type of result:11
≥CIN2, also called high-grade CIN, collectively refers to CIN2 or CIN3.