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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. 

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.

Clinically Validated According to International Consensus Guidelines

Assay Design
InstrumentationExtraction: m2000sp, m24; Amplification and Detection: m2000rt
Kit Configuration4 x 24 tests/kits
TechnologyMultiplex real-time PCR
Assay PerformanceClinical Sensitivity and Specificity in Referral Population: High Risk HPV Detection
Clinical Sensitivity: 97.5%**; Clinical Specificity: 99.4%**
HPV High Risk Detection16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
HPV GenotypingHPV 16, HPV 18
Sample TypePreservCyt Solution (Hologic, Inc.)
SurePath Preservative Fluid (TriPath Imaging)
Abbott Cervi-Collect Specimen Collection Kit
Input Volume400 ul
Internal ControlAn endogenous human beta globin sequence in detected as sample validity control for cell adequacy, sample extraction and amplification efficiency
External ControlsNegative control; Positive control
Reported ResultsQualitative detection of 14 High Risk HPV types, typing of HPV 16 and/or HPV 18, single and mixed infections

** Package Insert