Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
Alinity m HR HPV Specimen Collection Study From Women Undergoing Routine Cervical Cancer Screening
A prospective multicenter interventional study will be conducted to enroll women undergoing routine cervical cancer screening to collect cervical liquid-based cytology (LBC) specimen(s). For all subjects, two cervical specimens will be collected, and one placed into Hologic ThinPrep Pap Test collection kit with PreservCyt Solution (also referred to as ThinPrep specimen) and the other into BD SurePath liquid-based Pap test (also referred to as SurePath specimen). Cytology and HR HPV results will be generated and utilized to determine need for subject referral to colposcopy. Collection of an endocervical curettage (ECC) specimen, and biopsy(ies) if applicable, from women who are referred to colposcopy as a follow up will be conducted according to a standardized protocol. Disease status for each subject will be determined based on cytology, HPV test results, and/or consensus histology review of cervical biopsy specimens.
Inclusion Criteria:
Women is eligible if she meets the following:
Exclusion Criteria:
A women is ineligible for the study if she meets any of the following criteria:
Phoenix, Arizona 85031, United States
South Miami, Florida 33143, United States
Winston-Salem, North Carolina 27103, United States
Worthington, Ohio 43085-2688, United States
Worthington, Ohio 43085, United States
Greer, South Carolina 29651, United States
Corpus Christi, Texas 78412, United States