The unique design of the BD Onclarity™ HPV Assay gives you the detailed and accurate
results that you need to enhance your patient’s care experience.1-4
BD Onclarity™ HPV Assay
HPV test results that you can trust
Sensitivity, specificity, negative predictive value & positive predictive value
Sensitivity:
the ability of a screening test to correctly identify all people with the condition from a group of people who are known to have the condition, aka the ability to detect a true positive
Specificity:
the ability of a screening test to correctly identify all people without the condition from a group of people who are known to not have the condition, aka the ability to detect a true negative
False positive:
A positive test result for someone who does not have the condition
False negative:
A negative test result for someone who has the condition
Trevethan R. Front Public Health. 2017;5:307.
Choose a reliable PCR-based high-risk HPV DNA assay
BD Onclarity™ HPV Assay is a future-proof PCR-based high-risk HPV DNA assay that you can rely on.
HPV tests can either target viral DNA (HPV DNA assay) or mRNA (HPV RNA assay). Both methods are available for cervical cancer screening in the US, but high-risk HPV RNA assays carry design drawbacks that currently limit their use.2
mRNA HPV assays
Not currently approved by the FDA for HPV primary screening*4,5
Lack an internal cellularity control*, which provides reassurance against an improperly collected sample when there is no cytology result available5
Not proven to be safe for screening intervals longer than 5 years in primary screening, as opposed to high-risk HPV DNA assays that are recommended to be used at 5- to 10-year intervals by international guidelines6,7
Less sensitive on patient-collected samples than clinician-collected samples, as opposed to PCR-based high-risk HPV DNA assays that are similarly accurate for both patient- and clinician-collected samples7,8
Reduce unnecessary colposcopies
The BD Onclarity™ HPV assay is designed to reduce the risk of false-positive results due to lack of cross-reactivity with low-risk HPV types1
HPV assays can show cross-reactivity with other, low-risk HPV genotypes, meaning that the HPV assay would generate a positive result for a high-risk HPV genotype when actually a low-risk or non-oncogenic HPV genotype was detected.9
The BD Onclarity™ HPV Assay shows low cross-reactivity as compared to the digene® HC2 High-Risk HPV DNA Test.10
Fewer false-positives means that fewer patients may have to undergo unnecessary further testing and colposcopy
Minimize false-negatives
BD Onclarity™ HPV assay is designed to minimize false-negative results by:
Including an internal cellular control to provide confidence that sample collection was adequate and the entire assay process functioned properly.1
- In assays where there is no internal control the system would report a negative result rather than a test failure.2
Targeting the E6/E7 region of the HPV viral genome rather than the L1 region, which can be deleted during HPV DNA integration.11
Oncogenes E6 and E7 are required for cell transformation and these gene products are directly involved in causing cervical disease.11
The L1 region can undergo deletion when the HPV virus integrates into the human genome leading to false-negative results.11,12
Improve detection of multiple HPV infections
The BD OnclarityTM HPV Assay can detect clinical levels of any HPV type in the presence of up to one million copies of another competing type. In other words, it is designed not to miss the less abundant HPV type(s) in your patients.13
Consensus PCR
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 type.13
Gene-specific PCR BD OnclarityTM HPV Assay
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 present13
Consensus PCR uses common sequences to amplify all HPV types
Gene-specific PCR uses unique sequences to amplify the different HPV types
Focus on your patients who are most at risk
The BD Onclarity HPV assay is designed to provide you with the detailed results you need to better support patients with higher risk of disease7
Detects 14 high-risk HPV genotypes and reports up to 9 results1
- Individual results for HPV genotypes with highest-risk for disease: 16, 18, 45, 31, 51 and 52
- Strategic grouped results for lower risk HPV genotypes: 35/39/68, 33/58 and 56/59/66
*mRNA-based assays that have been validated for cervical cancer screening in the US.
ACOG, American College of Obstetricians and Gynecologists; DNA, deoxyribonucleic acid; FDA, Food and Drug Administration; HC2, Hybrid Capture 2; HPV, human papillomavirus; mRNA, messenger ribonucleic acid; PCR, polymerase chain reaction.
1. BD Onclarity™ HPV Assay US Package Insert [8089894].
2. Salazar K et al. J Am Soc Cytopath. 2019;8:284–92.
3. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
4. Perkins RB et al. J Low Genit Tract Dis. 2020;24(2):102–31.
5. Aptima™ HPV Assay US Package Insert.
6. WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention, second edition: use of mRNA tests for human papillomavirus (HPV). Last updated Dec 21, 2021. Accessed August 30, 2022.
7. Arbyn M et al. Lancet Oncol. 2022;23(7): 950–60.
8. Arbyn M et al. BMJ. 2018;363:k4823.
9. Preisler S et al. BMC Cancer. 2016;16:510.
10. Ejegod DM et al. Papillomavirus Res. 2016;2:31–7.
11. Vaughan LM and Malinowski DP. Rev Bras Ginecol Obstet. 2019;41(5):357–9.
12. Arroyo Mühr LS et al. J Gen Virol. 2020;101:265–70.
13. Wright TC et al. Am J Clin Pathol. 2014;142(1):43–50.
14. Bottari F et al. J Clin Microbiol. 2015;53:2109–14.