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Abbott HPV study

Title Alinity m HR HPV Specimen Collection Study from Women Referred to Colposcopy
Therapeutic Area Cervical Cancer
Principal Investigator Hong Thao Thieu, MD
Min Age 25 Years
Gender Female
Contact Bipin Malla
More Information


This study is evaluating a newly developed test which will help in detecting a virus that causes cervical cancer for example- high risk human papillomavirus (HR HPV). This test is called Alinity m HR HPV

Study Details

Inclusion Criteria

  • Has had a colposcopy referral in which routine cervical cancer screening has included HR HPV testing (HPV primary screening, co-testing, or ASC-US cytology triage) performed within 12 weeks preceding the colposcopy visit.
  • Has an intact cervix.
  • Is willing and able to undergo colposcopy, biopsy, and endocervical curettage (ECC).

Exclusion Criteria

  • Is pregnant when presenting for colposcopy
  • Has any known medical condition that, in the opinion of the investigator, would result in increased risk of bleeding at biopsy
  • Had a complete or partial hysterectomy, either supracervical or involving removal of the cervix

Study Requirements

Study will collect sample by biopsy during routinely scheduled Colposcopy (procedure to examine cervix through an instrument called Colposcope) for routine screening for cervical cancer in women of 25 years of age & older. There will not be a separate visit required for study purpose. Collected sample will be sent to central lab for testing where participants will have an option to be notified of result. This is apart from samples taken & sent for routine clinical testing.