Abbott RealTime High Risk HPV

Optimizing Performance with

a Clinically Validated Assay

Abbott RealTime High Risk HPV provides clinically proven and

validated results allowing for improved and efficient patient
management in cervical cancer screening

Leading Science

• HPV DNA detection of 14 high risk HPV genotypes, high probe specificity to
avoid cross-reactivity with low risk types – Clinically relevant results based on
international guidelines*

• Optimal balanced clinical sensitivity and specificity – Highly informative for the
risk of progression to cervical cancer

• Includes HPV 16 and 18 genotyping – Improves risk stratification and patient

management without reflex testing

• Multiple validated sample types including the Abbott collection kit and
liquid-based cytology media – Provides flexibility in testing
* Meijer CJLM et al., Int J. Cancer 2009; 124:516-520

Powerful menu consolidation.

The Abbott RealTime High Risk HPV assay is
part of the broad Abbott RealTime assay menu
on the mSystem Family platform.

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 Abbott RealTime High Risk HPV
The performance you need. Now.
Choose the Abbott RealTime High Risk HPV assay with clinically validated performance and
HPV 16 and 18 genotyping to optimize your cervical cancer screening program!

Product Design
Instrumentation Extraction: manual, m 24sp, m 2000sp
Amplification & Detection: m 2000rt
Technology Multiplex real-time PCR
Probe Design Single-stranded probes
Target Region Conserved L1 region
Genotype Detection 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
HPV Genotyping HPV 16, HPV 18
Clinical Sensitivity • Disease detection in referral population: 96.0 %
• High Risk HPV detection in referral population: 97.5 %
Clinical Specificity • Disease detection in referral population: 39.9 %
• High Risk HPV detection in referral population: 99.4 %
• General screening population with normal cytology (age ≥ 30 years): 95.9 %
Reported Results Qualitative detection of 14 high risk HPV types, three results per test reported corresponding
to HPV 16, HPV 18, and 12 other high risk HPV, single and mixed infections
Sample Types Specimens collected with
• Abbott Cervi-Collect Specimen Collection Kit
• ThinPrep PreservCyt Solution (Cytyc Corporation)
• SurePath Preservative Fluid (TriPath Imaging, Inc.), either original vial or cell pellet sample
Sample Input Volume 400 μl
Internal Control An endogenous human beta globin sequence is detected as sample validity control for
cell adequacy, sample extraction and amplification efficiency
External Controls Positive Control, Negative Control

Ordering Information

Product List Number Configuration

Abbott RealTime High Risk HPV Amplification Reagent Kit 2N09-90 96 tests (4 x 24)
Abbott RealTime High Risk HPV Control Kit 2N09-80 12 vials Positive Control
12 vials Negative Control
Abbott RealTime High Risk HPV m2000 System ROW 4N05 1 CD-ROM
Combined Application CD-ROM
Abbott mSample Preparation SystemDNA 6K12-24 192 HPV sample preparations (4 x 48)
Abbott Cervi-Collect Specimen Collection Kit 4N73-06 10 boxes, 50 kits per box

m2000rt, m2000sp, m24sp and Cervi-Collect are trademarks

of Abbott Laboratories in various jurisdictions. ThinPrep,

bott
PreservCyt, SurePath and TriPath Imaging are property of
Ab
Ask
their respective owners.
AM167EU2012_en – 09/2012

Abbott GmbH & Co. KG

Abbott Molecular
Max-Planck-Ring 2
65205 Wiesbaden, Germany
Tel. (+49) 61 22 58 0 Contact your Abbott Molecular representative today.
Fax (+49) 61 22 58 12 44
www.abbottmolecular.com www.AbbottMolecular.com

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