ALINITY M HR HPV ASSAY
Elevated confidence in every result
For in vitro diagnostic use. Rx only.
The end-to-end solution to help power HR HPV clinical testing with less testing burden
EXTENDED GENOTYPE REPORTING
Detects 14 high-risk HR HPV genotypes in one reaction. Separately reporting 16, 18, 45, and two other HR HPV genotype pools.
MULTI-PLEX ASSAY DESIGN
Delivers evidence-based risk stratification for the general and vaccinated population, enhancing patient management practices.
Built-in Cellular Control
Helps ensure sample integrity for accurate and reliable reporting of HR HPV test results.
Validated with Self-collected Samples
Clinically validated with simpli-COLLECT™ HPV Collection Kit and Evalyn® Brush, expanding access to care for more women.
Enables Workflow efficiency
Developed for easy integration with the Alinity m and Alinity mp systems.
Addresses evolving needs of clinicians and labs
FDA approved for primary screening, co-testing with cytology, and ASC-US.
More than 95% of invasive cervical cancers found are associated with 14 HR HPV genotypes1
Meeting the evolving clinical guidelines
The Alinity m HR HPV Assay meets current and evolving clinical guidelines allowing you to meet the needs of patients and clinicans today and in the future.
- Primary HR HPV testing is now the recommended approach for cervical cancer screening, as endorsed by the American Cancer Society and the U.S. Preventive Services Task Force. It also provides the necessary foundation for enabling HR HPV self‑collection.
- The ASCCP Enduring Consensus Cervical Cancer Screening and Management Guidelines conclude that HR HPV extended genotyping can guide clinical management in the setting of a positive HR HPV test result.
An integrated, end-to-end workflow requires less work
Supporting the fight against cervical cancer
Alinity m HR HPV testing solution, including the simpli-COLLECTTM HPV Collection Kit and Evalyn® Brush, supports the growing demand for patient-centric self-collection methods.
Survey of U.S. 24 to 63-year-olds6
85%
interested in using HR HPV self-sampling the next time they receive an HR HPV test mainly due to ease of use and improved privacy
>85%
feel confident to correctly self-collect HR HPV samples
Alinity m HR HPV Assay is compatible with various collection devices
Vaginal specimens
- simpli-COLLECT™ HPV Collection Kit
- Evalyn® Brush
Cervical specimens
- ThinPrep® PreservCyt® Solution
- SurePath™ Preservative Fluid
Intended use
Alinity m HR HPV is a qualitative in vitro test for the detection of Human Papillomavirus DNA. Cervical specimens should be collected by a health care professional using an endocervical collection brush/spatula placed in ThinPrep® PreservCyt® Solution or endocervical broom placed in SurePath™ Preservative Fluid.
Self-collected vaginal specimens, obtained in a healthcare setting, can be tested as an alternative specimen type when cervical sampling is either contraindicated or cervical specimens otherwise cannot be obtained.
This test identifies high-risk (HR) HPV types 16, 18, 45, while reporting the concurrent detection of the other HR genotypes (31/33/52/58) and (35/39/51/56/59/66/68).
Alinity m HR HPV is indicated for use in routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (adjunctive screening) with cytology, and HPV primary screening of women to assess the risk for cervical pre-cancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.
Warning
If a cervical specimen cannot be obtained, self-collected vaginal specimens should be obtained in a healthcare setting where specimens can be processed by trained personnel and transported to a testing laboratory under controlled conditions. Recommendations for clinical management after testing of either clinician-collected cervical specimens or self-collected vaginal specimens should follow professional guidelines and may differ for these two specimen types.
Alinity m HR HPV is NOT intended:
- for use in determining the need for treatment (ie, excisional or ablative treatment of the cervix) in the absence of high-grade cervical dysplasia. Patients who are HPV 16, 18, or 45 positive should be monitored carefully for the development of high-grade cervical dysplasia according to current practice guidelines.
- for women who have undergone hysterectomy with removal of the cervix.
- for use with samples other than those collected by a clinician using an endocervical brush/spatula placed in ThinPrep PreservCyt Solution or a cervical broom placed in SurePath Preservative Fluid.
- for use with self-collected vaginal specimens other than those collected with collection devices specifically FDA-approved or cleared for use with the Alinity m HR HPV assay.
HPV-negative cancers of the cervix do occur in rare circumstances.7,8 Also, no cancer screening test is 100% sensitive. Use of this device for primary cervical cancer screening should be undertaken after carefully considering the performance characteristics put forth in this label, as well as recommendations of professional guidelines.
The use of this test has not been evaluated for the management of women with prior ablative or excisional therapy, hysterectomy, who are pregnant or who have other risk factors (eg, HIV+, immunocompromised, history of sexually transmitted infections).
NEED HELP OPTIMIZING YOUR LAB’S WORKFLOW FROM SAMPLE TO RESULT?
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HVP clinician resources
Empower cervical cancer screening with Alinity m—extended HPV genotyping, self-collection, and reliable results for better patient care.
REFERENCES
- https://hpvcentre.net/datastatistics.php
- de Sanjose S, Serrano B, Tous S, et al. Burden of Human Papillomavirus (HPV)-Related Cancers Attributable to HPVs 6/11/16/18/31/33/45/52 and 58. JNCI Cancer Spectr. 2019 Jan 7;2(4):pky045
- Demarco M, Hyun N, Carter-Pokras O, et al. A study of type-specific HPV natural history and implications for contemporary cervical cancer screening programs. EClinicalMedicine. 2020 Apr 25:22:100293
- Valencak AO, Sterbenc A, Seme K, et al. Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings. J Clin Microbiol. 2019 Dec 23;58(1):e01120-19
- Perkins RB, Wentzensen N, Guido RS, et al. Cervical Cancer Screening: A Review. Perkins, et al. Cervical Cancer Screening. JAMA. 2023;330(6):547-558.
- Stella Roth., et al. Taking Health into Your Own Hands: Evaluating Patient and Provider Perspectives of Human Papillomavirus Self‑Sampling for Cervical Cancer Screenings and Opportunities for Education, Journal of Cancer Education, January 2025.