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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gen-Probe, Incorporated
ClinicalTrials.gov Identifier:
NCT01446198
First received: October 3, 2011
Last updated: June 29, 2012
Last verified: June 2012
History of Changes

October 3, 2011
June 29, 2012
March 2012
May 2012   (final data collection date for primary outcome measure)
HPV Assay result Agreement between TIGRIS and PANTHER Systems [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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
Same as current
Complete list of historical versions of study NCT01446198 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System
Clinical Evaluation of the APTIMA® HPV Assay Using 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.

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.
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

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.
Non-Probability Sample

Subjects with AHPV Assay positive results and subjects with AHPV negative results
Human Papilloma Virus Infection
Not Provided
AHPV positive and negative subjects
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11816
May 2012
May 2012   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01446198
AHPVPS-US11-003
No
Gen-Probe, Incorporated
Gen-Probe, Incorporated
Not Provided
Study Director: Tadd S Lazarus, M.D. Gen-Probe, Incorporated
Gen-Probe, Incorporated
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP