AMPLICOR® Human Papillomavirus Test 

 
Registration Status

Canada-IVD
CE-IVD
Japan-IVD
Detects 13 high-risk human papillomavirus (HPV) genotypes
A polymerase chain reaction-based (PCR) qualitative test for the detection of 13 high-risk HPV genotypes most commonly associated with cervical pre-cancer.
Features and Benefits
  • 96-microwell plate format
  • Targets and amplifies HPV DNA from 13 high-risk genotypes
  • Reproducible results minimizes repeat testing and provides definitive answers
  • No indeterminate zones1
  • Requires a sample size of only 250 microliters, enabling adequate HPV diagnosis after completion of liquid cytology screening
  • Concurrent isolation and amplification of the ß-globin gene assesses cellular adequacy and inhibition for each specimen
  • Validated on common liquid based cytology media: PreservCyt® Solution and SurePath® Preservative Fluid
Intended Use
 
This test is a qualitative in vitro test for the detection of Human Papilloma Virus in clinical specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of high risk (HR) HPV DNA Genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 in cervical cells collected in liquid media.
Not available in the United States


1. Pg 14, The AMPLICOR Human Papilloma Virus (HPV) test, Package Insert, Roche Molecular Diagnostics, Sept 2008.
More Information
 
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