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.
Observational Model: Case Control, Time Perspective: Retrospective
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
Tadd S Lazarus, M.D.
United States: Institutional Review Board
|Hennepin County Medical Center||Minneapolis, Minnesota|
|Gen-Probe Incorporated||San Diego, California 92121|
|LabCorp Corporation of America||Burlington, North Carolina 27215|