Clinical Evaluation of the APTIMA® HPV 16 18/45 Genotype Assay on the PANTHER® System

Gen-Probe

Status: Completed

Conditions: Human Papillomavirus Infection

Treatments: Device: APTIMA HPV Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT01694875

HPVGPS-US12-001

Details and patient eligibility

About

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.

Enrollment: 2,200 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects who were previously enrolled into the prospective, multicenter US clinical study for the APTIMA HPV Assay on the TIGRIS System (protocol 2007HPVASCUS30) will be eligible for inclusion in the study of the AHPV-GT Assay using the PANTHER System described in this protocol. All evaluable ASC-US Study subjects ≥21 years of age will be eligible for inclusion.

Evaluable Adjunct Study subjects ≥30 years of age will be eligible if the following criteria are met:

• the subject attended the colposcopy visit, or
• the subject did not attend the colposcopy visit but the referral Pap sample had a positive APTIMA HPV Assay result in the APTIMA HPV Assay TIGRIS System study (protocol 2007HPVASCUS30) or in the APTIMA HPV Assay PANTHER System study (protocol AHPVPS-US11-003).

Exclusion criteria

Eligible subjects will be excluded if they do not have an evaluable sample. This may be due to insufficient volume or because the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).

Trial design

2,200 participants in 1 patient group

No Treatment

Treatment:

Device: APTIMA HPV Assay