RealTime High Risk HPV
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.
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 allow 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. The assay provides the necessary information for optimal patient stratification and allows for timely and cost effective HPV testing by consolidating the two diagnostic tools of screening and genotyping, thus saving time and money.
- 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
- Cellular internal control to monitor for inhibition and sample adequacy
- No cross-reactivity versus Low Risk HPV sequences
- Real-Time format
Design
Reliable Results Abbott RealTime High Risk HPV Intended UseThe 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.
| 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: | Specimens collected in PreservCyt Solution (Hologic, Inc.) | |
| 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 |
* Khan MJ et al., JNCI, 97, 2005, 1072 - 1079; Stoler M.H. et al., Am J Clin Path ol 2007; 127: 335 - 337; Wright et al., AJOG, Oct 2007, 346 - 355.
** 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 |
Order Information
| Product Name | Package Size | Vysis Order Number | Abbott Order Number |
| Abbott RealTime High Risk HPV Amplification Kit | 24 tests/pack X 4 packs = 96 tests/kit | 2N09-90 | 2N09-90 9
|
| Abbott RealTime High Risk HPV Control Kit | Negative Control: 12 vials / Positive Control: 12 vials | 2N09-80 | 2N09-80 9
|
| Abbott RealTime High Risk HPV Assay Application CD-ROM | 4N05 | 4N05 |
