What is it?
The first HPV test kit with universal probe
This flow-through hybridization assay kit can genotype 33 HPV (human papillomavirus) subtypes from a liquid-based cytology cervical specimen.
Featuring universal probe, this kit will identify the presence of HPV molecules other kits might miss. This is valuable because in the future new variations of the virus will be identified as malign. Patients tested with this kit can then be identified and retested if necessary.
Depending on the instrument used, each consumable assay kit can screen approximately 32 patients.
Used with a compatible instrument, this assay is currently the fastest, most cost-effective method of achieving mid-resolution identification of the target molecule. For fast, accurate, cost-effective screening for HPV to identify high-risk cervical cancer in patients. This is the first HPV test kit with universal probe. Genotypes 33 HPV subtypes via flow-through hybridization assay from a single specimen.
Who is it for?
This kit is especially valuable to practitioners responsible for the health of women between the ages of 21 and 65.
It’s also useful for labs conducting research into cervical cancer and HPV.
Why is it different?
Uniquely, this HPV test avoids the dangers associated with only testing for HPV types 16 and 18.
One simple test delivers 3 results:
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Genotype 17 high-risk HPV subtypes
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Genotype 16 low-risk HPV subtypes
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Detects rare HPV subtypes
Universal probe captures rare subtypes
This is currently the only HPV test kit with universal probe.
Advantages
Complete – Identifies 97.8% of all HPV types, so patients with persistent infections can be identified when new high-risk subtypes are discovered
Fast – Delivers results in approximately 3 hours
Easy – Requires almost no training. Results can be accurately interpreted at a glance
Cost effective – Lowest overall cost in market, and handles small batches
Need to know
This is a consumable assay kit, developed, supplied and supported by DiagCor. It requires a compatible instrument and a meticulous MDx workflow.
- Works with
This state-of-the-art instrument performs fast, accurate DNA hybridization to identify the presence of a target molecule in a flexible sample size. Benefits include high efficiency, accurate results and low cost. The FTPRO is compatible with GenoFlow array kits.
CapturePRO image capture system
This instrument captures images of DNA analysis from the DiagCor FTPRO flow-through system and converts them into data. Images are transferred to a server for storage, analysis and reporting. This is a cost-effective way of managing and archiving large volumes of data from DNA-based testing and screening.
FTPRO Auto System is an automatic flow-through hybridization device. This platform adopts the patented flow-through hybridization technology in addition to its automatic operation. Its sophisticated design drastically improves the quality of testing and diagnostic experience.
- Workflow
A key component in medium resolution DNA analysis, this flow-through hybridization device considerably speeds specimen throughput.
What you get
In the box
PCR box
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HPV primer mix
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Positive control
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DNase free water
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Taq polymerase
Hybridization box
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Hybridization solution
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Blocking solution
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Enzyme conjugate
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A solution
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Detection solution
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B solution
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Stop solution
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Cassettes
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Reading grid (optional)
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Instruction manual
Service and support
The DiagCor support team includes skilled technicians, engineers and scientists
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Distributor and end-users receive direct training supported by video conferencing
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Standard operation procedures explain test execution step-by-step
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Experienced technicians will familiarize users with procedures by guiding them through a series of trial tests
DiagCor provides extensive training to end users and distributors that covers
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Correct application of the system, including how to deploy in public health programs for best ROI
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Practical lab technician training
Options
FTPRO compatible (32-test capacity)
FTPRO Auto compatible
Equipment required
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FTPRO flow-through hybridization device
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FTPRO Auto flow-through hybridization device
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CapturePRO image capture system (optional)
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High speed centrifuge
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Vortex
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Pipettes
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Thermocycler
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Water bath
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Ice bucket
Analytes
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Based on epidemiology data, the panel covers 97.8% of all cervical HPV infections
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17 high-risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82
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16 low-risk HPV genotypes: 6, 11, 26, 40, 42, 43, 44, 54, 55, 57, 61, 70, 71, 72, 81 and 84
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Universal probe for detection of 33 HPV genotypes and out-of-panel HPV genotypes
Specs
Catalogue number |
92007 |
Configuration |
32 reactions (PCR kit); 32 reactions (Hybridization kit) |
Technology |
PCR and flow-through hybridization |
High-risk HPV genotyped |
16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66/68, 73, 82 |
Low-risk HPV genotyped |
6, 11, 40/61, 42, 43/44, 54/55, 70, 57/71, 72, 81, 84/26 |
Result format |
4x1 cassette |
Sample types |
Liquid-based cytology specimen, eg. ThinPrep® (Hologic) or SUREPATH™ (BD) specimens Cervical brush / swab |
Input volume |
1mL |
Internal controls |
Amplification control (AC); Hybridization control (HC) |
External controls |
Positive control; negative control |
Simultaneous run |
Up to 16 reactions (FT-PRO Version) |
Reported results |
Typing of 33 HPV subtypes; single and multiple infections |