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RealTime High Risk HPV

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View Ordering Information
Product Name Quantity Order # Additional Information
Abbott RealTime High Risk HPV Amplification Kit 24 tests/pack X 4 packs = 96 tests/kit 2N09-90
Abbott RealTime High Risk HPV Control Kit Negative Control: 12 vials / Positive Control: 12 vials 2N09-80
Abbott RealTime High Risk HPV Assay Application CD-ROM 4N05

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.

One Assay - Three Results:
Women infected with HPV 16 and / or HPV 18 have an increased risk of progression to dysplasia and cervical cancer compared to women infected with other high risk HPV genotypes. Detection of the 14 high risk HPV genotypes and genotyping of HPV 16 and HPV 18 allows for improved risk assessment and patient management. The Abbott RealTime High Risk HPV assay enables the laboratory to be ONE STEP AHEAD by detecting the 14 High Risk HPV genotypes and identifying HPV genotypes 16 and 18 with one single assay consolidating the two diagnostic tools of screening and genotyping. The assay provides the necessary information for patient stratification and is designed for more timely and cost effective HPV testing.

  • Detection of single and mixed infections
  • Solutions for low, medium to high throughput laboratories up to 96 tests per run
  • Two external controls per run (up to 96 batch size)
  • Automation with m2000 System Family

Results You Can TrustHigh Risk HPV

  • Cellular internal control to monitor for inhibition and sample adequacy
  • No cross-reactivity with low risk HPV sequences
  • Real-time PCR format


 

Reliable Results Abbott RealTime High Risk HPV Intended Use
The Abbott RealTime High Risk HPV is a qualitative in vitro test for the detection of DNA from 14 High Risk human papillomavirus (HPV) genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68 in clinical specimens.

Product Design
Instrumentation Extraction: m2000sp, m24; Amplification and Detection: m2000rt
Kit Configuration 4 x 24 tests/kit
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 is 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

Dyes Probe Labels
 Type Specific Probes
1 VIC HPV 16
2 NED HPV 18
3 FAM HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
4 Quasar Internal Control (human beta globin)
5 ROX Passive Reference
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