Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

Gen-Probe

Status: Completed

Conditions: Human Papilloma Virus Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01446198

AHPVPS-US11-003

Details and patient eligibility

About

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Full description

The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt® Solution with commercially available collection devices (broom-type device or cytobrush/spatula combination) may be tested with the APTIMA HPV Assay either pre- or post-Pap processing. The assay is used with the TIGRIS System and the PANTHER System.

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Enrollment: 11,816 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30)
• an aliquot is available and suitable for testing, and
• the sample was randomly selected for inclusion.

Exclusion criteria

• sample integrity was compromised (eg, stored under unacceptable conditions)

Trial design

11,816 participants in 1 patient group

AHPV positive and negative subjects