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Brief Title: Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
Official Title: Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System in Women With ASC-US Pap Test Results and in Women 30 Years of Age or Older With Negative Pap Test Results Using ThinPrep Pap Test Specimens
Study ID: NCT01694875
Brief Summary: The objective of the clinical study is to evaluate the AHPV-GT Assay using the PANTHER System in cervical cancer screening. This objective will be accomplished in the ASC-US Study by evaluating the performance characteristics of the AHPV-GT Assay using the PANTHER System in a sample population of women with ASC-US Pap test results who were 21 years of age or older ("≥21 years of age") at the time of their Pap visit. For the Adjunct Study, this objective will be accomplished by evaluating the ability of the AHPV-GT Assay using the PANTHER System to identify women at increased risk of cervical disease in a sample population of women with negative (NILM)cytology results who were ≥30 years of age at the time of their Pap visit.
Detailed Description:
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Laboratory Corporation of America, Burlington, North Carolina, United States
Molecular Pathology Laboratory Network, Inc, Maryville, Tennessee, United States
Name: Jennifer L Reid, PhD
Affiliation: Gen-Probe, Incorporated
Role: STUDY_DIRECTOR