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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01446198

Enrollment

11816

Registered

2011-10-05

Start date

2012-03-31

Completion date

2012-05-31

Last updated

2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Papilloma Virus Infection

Keywords

HPV

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results