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GenoFlow HPV array test kit

Genotypes 33 HPV subtypes via flow-through hybridization assay from a single specimen. Fast and cost-effective, this is the first HPV test kit with universal probe. The kit obtains 100% proficiency in WHO HPV LabNet study

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:
  • Genotype 17 high-risk HPV subtypes
  • Genotype 16 low-risk HPV subtypes
  • 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

    FT-PRO flow-through hybridization system

    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 FT-PRO is compatible with GenoFlow array kits. 

    Capture-PRO image capture system

    This instrument captures images of DNA analysis from the DiagCor FT-PRO 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.

    FT-PRO Auto System

    FT-PRO 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.

    Workflow (GenoFlow)

What you get

In the box

PCR box
  • HPV primer mix
  • Positive control
  • DNase free water
  • Taq polymerase
 
Hybridization box
  • Hybridization solution
  • Blocking solution
  • Enzyme conjugate
  • A solution
  • Detection solution
  • B solution
  • Stop solution
  • Cassettes
  • Reading grid (optional) 
  • Instruction manual

Service and support
The DiagCor support team includes skilled technicians, engineers and scientists
  • Distributor and end-users receive direct training supported by video conferencing
  • Standard operation procedures explain test execution step-by-step 
  • 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
  • Correct application of the system, including how to deploy in public health programs for best ROI
  • Practical lab technician training    

 


Options

FT-PRO compatible (32-test capacity)

FT-PRO AUTO compatible


Equipment required
  • FT-PRO flow-through hybridization device
  •  FT-PRO AUTO flow-through hybridization device
  • Capture-PRO image capture system (optional)
  • High speed centrifuge
  • Vortex
  • Pipettes
  • Thermocycler
  • Water bath
  • Ice bucket 

Analytes
  • Based on epidemiology data, the panel covers 97.8% of all cervical HPV infections
  • 17 high-risk HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73 and 82
  • 16 low-risk HPV genotypes: 6, 11, 26, 40, 42, 43, 44, 54, 55, 57, 61, 70, 71, 72, 81 and 84
  • 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