Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|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|
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|United States, North Carolina|
|Laboratory Corporation of America|
|Burlington, North Carolina, United States, 27215|
|United States, Tennessee|
|Molecular Pathology Laboratory Network, Inc|
|Maryville, Tennessee, United States, 37804|
|Study Director:||Jennifer L Reid, PhD||Gen-Probe, Incorporated|