Alinity m HR HPV is a qualitative in vitro test for the detection of Human Papillomavirus DNA in cervical specimens 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. 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
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 highgrade 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.

HPV-negative cancers of the cervix do occur in rare circumstances. 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 the 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).