Human Papillomavirus Infection Clinical Trial
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
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.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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