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


N/A
18 Years
N/A
Not Enrolling
Female
Human Papilloma Virus Infection

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Trial Information

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


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)

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Retrospective

Outcome Measure:

HPV Assay result Agreement between TIGRIS and PANTHER Systems

Outcome Description:

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

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Tadd S Lazarus, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gen-Probe, Incorporated

Authority:

United States: Institutional Review Board

Study ID:

AHPVPS-US11-003

NCT ID:

NCT01446198

Start Date:

March 2012

Completion Date:

May 2012

Related Keywords:

  • Human Papilloma Virus Infection
  • HPV
  • Papilloma
  • Virus Diseases
  • Warts
  • Papillomavirus Infections

Name

Location
Hennepin County Medical Center Minneapolis, Minnesota  
Gen-Probe Incorporated San Diego, California  92121
LabCorp Corporation of America Burlington, North Carolina  27215