RealTime High Risk HPV

CE Marked

For In Vitro Diagnostic Use

The Abbott RealTime High-Risk HPV detects 14 high-risk HPV genotypes with simultaneous identification of HPV 16 and HPV 18. 

icon-link.pngInstructions for UseView Ordering Information 
Description
 

The Abbott RealTime High Risk (HR) HPV assay is a qualitative in vitro polymerase chain reaction (PCR) assay that utilizes homogeneous target amplification and detection technology for the detection of high risk human papillomavirus (HPV) DNA in cervical cells collected in liquid cytology media. The Abbott RealTime HR HPV assay is intended to detect 14 high risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 and to partially genotype 16, 18 from other 12 high risk genotypes.

  • Detection of single and mixed infections
  • Solutions for low, medium, and high throughput laboratories up to 96 tests per run
  • Automation with m2000 System family

The Abbott RealTime High-Risk HPV assay is designed for the detection of high-risk HPV genotypes in cervical specimens from women with precancerous lesions of the cervix uteri (≥ CIN2) and cervical cancer to provide clinically meaningful results in cervical cancer screening.

Risk stratification with HPV 16 and HPV 18 chart

Clinically Validated According to International Consensus Guidelines

RealTime HPV Clinical Validation

 
Design
 

Assay Design
Abbott RealTime High-Risk HPV assay design

 
Specifications
 
 
 
Abbott RealTime High Risk hpv
Instrumentation Extraction: m2000sp, m24; Amplification and Detection: m2000rt
Kit Configuration 4 x 24 tests/kits
Technology Multiplex real-time PCR
Assay Performance Clinical Sensitivity and Specificity in Referral Population: High Risk HPV Detection
Clinical Sensitivity: 97.5%**; Clinical Specificity: 99.4%**
HPV High Risk Detection 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
HPV Genotyping HPV 16, HPV 18
Sample Type PreservCyt Solution (Hologic, Inc.)
SurePath Preservative Fluid (TriPath Imaging)
Abbott Cervi-Collect Specimen Collection Kit
Input Volume 400 ul
Internal Control An endogenous human beta globin sequence in detected as sample validity control for cell adequacy, sample extraction and amplification efficiency
External Controls Negative control; Positive control
Reported Results

Qualitative detection of 14 High Risk HPV types, typing of HPV 16 and/or HPV 18, single and mixed infections

** Package Insert

Ordering Info

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. The website that you have requested also may not be optimised for your screen size.

Do you wish to continue and exit this website?

Yes No

You are about to enter an Abbott country or region specific website.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

Do you wish to continue and enter this website?

Yes No

You are about to enter an Abbott country or region specific website.

Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions.

Do you wish to continue and enter this website?

Yes No