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GenoFlow DR-MTB array test kit

Test detects and genotypes tuberculosis variants resistant to rifampicin (RIF) and isoniazid (INH) in liquefied, decontaminated human respiratory specimens. 

What is it?

High efficiency screening for drug-resistant tuberculosis
 
This PCR flow-through hybridization assay detects the presence of wild-type of mycobacterium tuberculosis (MTB).
 
It genotypes MTB variants that are resistant to first-line therapy using Rifampicin and Isoniazid. 
 
The fast, cost-effective test is applied to liquefied, decontaminated human respiratory specimens. 
 
This assay is used with FT-PRO flow-through hybridization system.
 
Each consumable assay kit is capable of 32 reactions.
 
The test features:
 
  • 3 control probes (KatG, InhA, and RpoB)
  • KatG, InhA and RpoB wild-type probes
  • 10 mutation probes
 
Used with a compatible instrument, the assay is currently the fastest, most cost-effective method of achieving mid-resolution identification of the target molecule.

Who is it for?

This kit is especially valuable to practitioners responsible for the health of populations at risk of tuberculosis. 
 
It’s useful for designing treatment regimes for patients diagnosed with tuberculosis. 

Why is it different?

This highly sensitive test is currently the most cost-effective solution for genotyping MTB resistant to first-line therapy with Rifampicin and Isoniazid. 
 
It’s fast and can deliver results three hours after extraction. Up to 16 samples can be tested simultaneously.
 
The test features sample quality control and is easy to apply.

Advantages

Flexible – Genotypes and detects wild-type tuberculosis microbacterium and drug-resistant variations
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.
 
This array test kit is capable of a total of 32 reactions. 
 
Up to 16 samples can be processed in a test run. The capacity of the test chamber is four cassettes, each of which has four wells. 
 
All 32 reactions can be consumed in two test runs.

  • 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.

    TB real time PCR kit

    This sensitive, highly specific kit works with various real time PCR machines to quickly detect Mycobacterium Tuberculosis (MTB) complex in clinical specimens. 

  • 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 kit
  • Master mix
  • DR-MTB primer mix
  • Positive control
  • DNase free water
  • Taq polymerase  
 
Hybridization kit
  • Cassettes
  • Hybridization solution
  • Blocking solution
  • Enzyme conjugate
  • A solution
  • Detection solution
  • Stop solution
  • Stringent wash solution
 

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

This test requires an FT-PRO flow-through hybridization instrument


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

Extraction kits
  • AMPLICOR Respiratory Specimen Preparation Kit (Roche Diagnostics GmbH, Mannheim, Germany) 
  • QIAamp DNA Mini Kit (QIAGEN, Valencia, CA)
  • Sputum should be decontaminated and digested with NALC/NaOH before extraction
 

Analytes
  • Internal amplification control (IAC)
  • 5 wild-type probes (RpoB WTc, RpoB WTe, RpoB WTf, KatG WT, InhA WT)
  • 10 mutation probes (RpoB MUTc1/c2, RpoB MUTc2, RpoB MUTe1, RpoB MUTe2, RpoB MUTe3, RpoB MUTf1,   RpoB MUTf2,   KatG MUT1, KatG MUT2,  InhA MUT1)
  • Hybridization Control (HC)
 

Specs
Catalogue number 92004
Configuration 32 reactions (PCR kit); 32 reactions (Hybridization kit)
Technology PCR and flow-through hybridization
Wild-type probes 5
Mutation probes 10
Result format 4x1 cassette
Sample types Sputum and culture
Internal controls Internal amplification control (IAC); Hybridization control (HC)
External controls Positive control; negative control
Simultaneous run Up to 16 reactions
Reported results Wild-type MTB, typing of MTB RpoB, KatG and InhA mutants