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

NCT01446198 | Completed

• 1 other identifier: AHPVPS-US11-003
• Study Type: observational
• Target: 11,816
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Human Papilloma Virus Infection

Keywords

HPV

Outcome Measures

Primary Outcomes (1)

• HPV Assay result Agreement between TIGRIS and PANTHER Systems

  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

  1 month

Study Arms (1)

AHPV positive and negative subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with AHPV Assay positive results and subjects with AHPV negative results

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Gen-Probe, Incorporated: lead

Study Sites (3)

Gen-Probe Incorporated

San Diego, California, 92121, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

LabCorp Corporation of America

Burlington, North Carolina, 27215, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic, In., Marlborough, MA) with commercially available collection device or cytobrush/spatula combination may be tested with the HPV Assay either pre- or post-Pap processing.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tadd S Lazarus, M.D.

  Gen-Probe, Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 5, 2011
• Study Start: March 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 3, 2012

Record last verified: 2012-06

Locations

US (3)