bd onclarity hpv assay
onclarity hpv assay vial
onclarity hpv assay aliquot tube
BD Viper LT

BD Onclarity HPV Assay

The BD Onclarity HPV Assay detects 14 high-risk genotypes and provides additional individual results beyond 16 and 18 in a single sample-to-result run, positioning the laboratory to adapt to evolving screening guidelines and to provide timely, comprehensive data to clinicians.

The BD Onclarity HPV Assay, which is FDA approved for use with the BD SurePath collection vial1, offers genotyping for HPV primary screening, co-testing, and cytology primary with ASCUS reflex screening paradigms.

Stratify Risk & Guide Patient Management

Detects 14 high-risk genotypes, with individual results for genotypes 16, 18 & 45.

Support Workflow Flexibility

FDA approved for all 3 cervical cancer screening paradigms, including HPV primary screening.

Advance HPV Testing Accuracy

Targets the E6/E7 region and includes internal cellular control.


120 results/day with the BD Viper™ LT system, an integrated table top system3.

Individual genotype reporting for types 16, 18 and 45

Offers an important tool to help stratify risk and guide patient management.

Individual (31, 51, 52) or concurrent (33/58, 35/39/68 and 56/59/66) detection of remaining types

A positive or negative pooled result for these remaining high-risk genotypes (non-16, 18, 45).

Single run

Does not require additional processing, reagents or hands-on-time to get genotype results1.

Unique multiplexed design

Uses genotype-specific primers and probes to detect single and mixed genotype HPV infections1.

Internal cellular control

Ensures a sample is present, minimizing false-negative results1.

E6/E7 viral genome target

Targets the E6/E7 genomic region that, different from the L1 region targeted in other assays, is not deleted during HPV DNA integration; minimizing another source of false-negative results4.

No cross-reactivity with low-risk HPV types

Reduced risk of false-positive results due to lack of cross-reactivity with low-risk HPV types.1

Ready to use reagents

No refrigeration needed and no waiting time for the reagents to reach room temperature to begin testing.

Cervical cancer screening paradigms

There are three main cervical cancer screening paradigms used throughout the world today: HPV primary, co-testing and cytology primary with ASCUS reflex. The BD Onclarity HPV Assay is FDA approved for all three screening paradigms, providing you with the flexibility to adapt to evolving screening guidelines.

  • HPV primary screening
    • Use of this newest paradigm is growing and has the potential to become the preferred screening method in the future.
    • This paradigm involves an initial HPV test to stratify risk and inform patient management.
    • Genotyping results are provided for high-risk genotypes 16 and 18.
    • Recent studies have spurred discussions about the clinical utility of extended genotyping to inform patient management, as data is becoming available to demonstrate that individual genotypes have varying risks in the rate of progression to cervical cancer 5, 6, 7, 8.
  • Co-testing
    • This is the dominant screening model in the United States and is a paradigm that is being adopted by some countries outside of the United States.
    • In this paradigm, cytology and HPV tests are performed at the same time.
  • Cytology primary screening with ASCUS reflex
    • This is the original and the most widely utilized paradigm globally.
    • Patients are initially screened with a cytology test and, in the case of an ASCUS result, a reflex HPV test may be performed to inform patient management.


Catalog no. Description
441990 BD Onclarity™ HPV Assay Reagent Pack
444087 BD Viper™ PCR Extraction Reagent Troughs
444088 BD Onclarity™ HPV Control Set
444089 BD FOX PCR Extraction Tubes
443837 BD Onclarity™ HPV LBC Diluent Tubes

Catalog no. Description
441354 BD Onclarity™ Neutralization Pouch
441996 BD Viper™ LT Pipette Tips
443747 HPV Key Card
442957 BD Viper™ LT PCR Tube / Tray Kit
442967 BD Viper™ LT System PCR Accessory Kit
442393 BD Totalys™ Aliquot Tube
443275 Suction Cups

Related Videos

Related Products

  1. BD Onclarity HPV Assay US Package Insert (8089894).
  2. Stoler MH et al. Gynecol Oncol. 149 (2018) 498-505.
  3. Last user intervention at 9.5 hr. in high-throughput mode - Viper LT High-throughput Workflow Study” Nov 2014. Conducted at BD.
  4. Tjalma WA et al. Eur J Obstet Gynecol Reprod Biol. 2013;170(1):45-46.
  5. de Sanjose et al. Lancet Oncol. 2010;11:1048-1056.
  6. Wright Jr TC et al. Gynecol Oncol 2019;154 (2):360-367.
  7. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.
  8. Schiffman M et al. Int J Cancer, 2016 :139(11) :2606-2615.

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