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

Completed

• Conditions: Human Papilloma Virus Infection

• Registration Number: NCT01446198
• Lead Sponsor: Gen-Probe, Incorporated

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-04
• Study First Posted: 2011-10-05
• Study Start: 2012-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11816

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HPV Assay result Agreement between TIGRIS and PANTHER Systems	1 month	Percent Positive Agreement: The number of samples with a positive HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a positive HPV Assay result on TIGRIS, multiplied by 100; Percent Negative Agreement: The number of samples with a negative HPV Assay result on TIGRIS and PANTHER divided by the number of samples with a negative HPV Assay result on TIGRIS, multiplied by 100

Trial Locations

Locations (3)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

LabCorp Corporation of America; 🇺🇸 Burlington, North Carolina, United States

Gen-Probe Incorporated; 🇺🇸 San Diego, California, United States