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Alinity m
HR HPV Assay

Elevated Confidence
in every result

For in-vitro diagnostic use

ALINITY m HR HPV ASSAY image
ALINITY m HR HPV ASSAY image
ALINITY m HR HPV ASSAY image

IS YOUR HPV WORKFLOW AUTOMATED AND READY TO MEET EVOLVING TESTING NEEDS?

THE COMPLETE HPV SOLUTION THAT SUPPORTS
YOUR LABORATORY’S TESTING NEEDS

Extended Genotype Reporting

Detects 14 high-risk HPV genotypes in one reaction. Separately reporting 16, 18, 45, and two other HR HPV genotype pools.

Multiplex assay design

Delivers evidence-based risk stratification for the general and vaccinated population, enhancing patient management practices.

Built-In cellular control

Ensures sample integrity for accurate and reliable reporting of HPV test results.

VALIDATED WITH SELF-COLLECTED SAMPLES

Clinically validated for self-collection devices*, expanding access to care for more women.

ENABLES WORKFLOW EFFICIENCY

Developed for easy integration with the Alinity m and Alinity mp systems—ideal for high-volume laboratories.

ADDRESSES EVOLVING NEEDS OF CLINICIANS AND LABS

CE-marked for primary screening, co-testing with cytology, and ASC-US.

*Validated with simpli-COLLECT™ HPV Collection Kit and Evalyn® Brush.

EXTENDED GENOTYPING TO PERSONALIZE CLINICAL MANAGEMENT FOR IMPROVED PATIENT CARE

OPTIMIZING YOUR LAB'S WORKFLOW FROM SAMPLE TO RESULT

†Upgrade kit (LN 09N65-007) is required for Alinity mp to process dry swabs using the simpli-COLLECT HPV Collection Kit.
*Specimens from Alinity m Cervi-Collect Specimen Collection Kit can be directly loaded on Alinity m.

Supporting the fight against cervical cancer

Alinity m HR HPV testing solution, including the
simpli-COLLECT™ HPV Collection Kit and Evalyn® Brush,
supports the growing demand for patient-centric self-collection methods.

Alinity m HR HPV Assay is compatible
with various collection devices

Vaginal Specimans

- simpli-COLLECT™ HPV Collection Kit

- Evalyn® Brush (Rovers Medical Device)

cervical specimans

- ThinPrep or SurePath

- Alinity m Cervi-Collect Specimen Collection Kit

Intended use

The Alinity m High Risk (HR) HPV assay is a qualitative in vitro test for use with the automated Alinity m System for the detection of DNA from 14 high-risk human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in clinical specimens. The assay specifically identifies HPV genotypes 16, 18, and 45 while reporting the concurrent detection of the other high-risk genotypes (31, 33, 52, 58) and (35, 39, 51, 56, 59, 66, 68) at clinically relevant infection levels. The Alinity m HR HPV assay is intended for the following uses:

  • To screen patients with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy.
  • To be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV genotype.
  • To be used as a first-line primary screening test to identify women at increased risk for the development of cervical cancer or the presence of high-grade disease.
  • To assess the presence or absence of HPV genotypes 16 and 18 to identify women at increased risk for the development of cervical cancer or the presence of high-grade disease with or without cervical cytology.

The results from the Alinity m HR HPV, together with the physician’s assessment of cytology, history, other risk factors, and professional guidelines, may be used to guide patient management.

Intended User: The intended users for Alinity m HR HPV AMP Kit are laboratory professionals.

The Alinity m HR HPV AMP Kit is CE-marked. Notified body number 2797.

 

 

NEED HELP OPTIMIZING YOUR LAB'S WORKFLOW FROM SAMPLE TO RESULT?

Talk to your Molecular sales representative to learn more.

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simpli-COLLECT™ HPV Patient Resources

View patient resources on how to use the simpli-COLLECT™ HPV Collection Kit.

Learn More

Alinity mp

See how this pre-analytical system can help you automate tedious tasks for your HPV workflow.

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Alinity m

Learn more about the Alinity m analyzer and how it can help transform your molecular lab to achieve measurably better healthcare performance.

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References

1. Alinity m HR HPV AMP Kit [package insert] 53-608488/R1. Des Plaines, IL: Abbott; 2024.

2. Human Papillomavirus Centre. Data statistics. Accessed January 22, 2025. https://hpvcentre.net/datastatistics.php

3. de Sanjose S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048-1056. doi:10.1016/S1470-2045(10)70230-8

4. Oštrbenk Valenčak A, Šterbenc A, Seme K, Poljak M. Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings. J Clin Microbiol. 2019;58(1):e01120-19. Published 2019 Dec 23. doi:10.1128/JCM.01120-19

5. Herrero R, González P, Markowitz LE. Present status of human papillomavirus vaccine development and implementation. Lancet Oncol. 2015;16(5):e206-e216. doi:10.1016/S1470-2045(14)70481-4

6. Meijer CJ, Berkhof J, Castle PE, et al. Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older. Int J Cancer. 2009;124(3):516-520. doi:10.1002/ijc.24010

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