VereMTB™

The VereMTB™ is a nucleic acid-based, Lab-On-Chip (LOC) device which combines multiplex PCR and microarray hybridization assay to detect, differentiate and identify: 10 different mycobacterium strains with special emphasis on Mycobacterium tuberculosis Complex (MTBC) and its Resistance to Rifampicin and/or Isoniazid from Pulmonary Clinical Specimens or Cultivated Samples (MDR-TB)

Tuberculosis (TB) is a common, and in many cases lethal infectious diseases caused by various strains of mycobacterium, usually Mycobacterium tuberculosis complex. It is spread through the air when people who have an active MTB infection cough, sneeze, or otherwise transmit their saliva through the air. Most infections in humans result in an asymptomatic, latent infection, and about one in ten latent infections eventually progress to active disease, which, if left untreated, kills more than 50% of those infected.

Global prospects for TB control are challenged by the emergence of drug-resistant strains, especially those that are multi-drug resistant (MDR) and extensively drug resistant (XDR). Soon after anti-TB drugs became available in the 1940s came reports of drug resistance among patients undergoing treatment. The prevalence of TB resistance to a single drug was continuously on the rise in several parts of the world, and eventually in the early 1990s, multiple converging factors led to an explosive emergence of MDR-TB, defined as resistance to the two most effective first-line anti-TB agents, Isoniazid and Rifampicin. In 2010, there were an estimated 650 000 cases of MDR-TB.

The threat of tuberculosis has propelled the need of a new tuberculosis diagnostic test system that is able to do fast and reliable detection and identification of Mycobacterium tuberculosis complex, with the capability to differentiate it from clinically relevant non-tuberculous mycobacterium species as well as detecting drug resistance especially multidrug resistance.

To meet this need, Veredus offers a new solution: VereMTB™. This Lab-On-Chip application allows for rapid detection, differentiation and identification of Mycobacterium tuberculosis complex (MTBC) and its resistance to Rifampicin and Isoniazid as well as 9 clinically relevant non-MTBC species.

Product Description:

VereMTB™ is a fast, multiplexed PCR-microarray based test using the VerePLEX™ Biosystem Lab-on-Chip technology to identify 10 different mycobacterium strains with special emphasis on Mycobacterium tuberculosisComplex (MTBC) and its Resistance to Rifampicin and/or Isoniazid from Smear-Positive Pulmonary Clinical Specimens or Cultivated Samples (MDR-TB).

VereMTB™ enables a rapid result from smear-positive pulmonary patient specimen and from culture material (liquid or solid cultures).  Also for diagnosing patients after treatment failure and relapse, with unknown anamnesis and originating from high prevalence areas of MDR-TB as well as for diagnosing patients in high prevalence TB countries and high burden MDR-TB regions the use of VereMTB™is reasonable. Finally the test can also be applied for screening purposes to develop country-specific TB action plans.

For Research Use Only. Not for use in diagnostic procedures.

Multiple diagnostic tests on one chip

  • Mycobacterium tuberculosis complex
  • Rifampicin resistance
  • Isoniazid resistance
  • Mycobacterium avium
  • Mycobacterium intracellulare/ vulneris / chimaera / colombiense
  • Mycobacterium simiae / kansasii / scrofulaceum / gastri / mantenii
  • Mycobacterium abscessus / chelonae
  • Mycobacterium xenopi
  • Mycobacterium fortuitum

 

Specificity: 100% (MTBC), 89% (NTMS)

Reproducibility: 99% 

Analytical performances evaluated on extracted sputum and crude culture extracts

Limit of detection: 11-100 copies/reaction

Sample types: culture (solid & liquid), smear positive sputum

For Research Use Only. Not for use in diagnostic procedures.

Technology

  • VereMTB™ chip combines time tested technologies of PCR and Microarray into a single platform. This allows specific, rapid and simultaneous identification of different mycobacterium strains.

Mobile

  • The VerePLEX™ Biosystem is designed to be portable so that first responders can test at point of need.

Comprehensive

  • Tests for Mycobacterium tuberculosis complex, 9 other clinically relevant mycobacterium strains as well as resistance to Rifampicin and Isoniazid in a single assay

Easy to use

  • Open sample preparation protocol to accommodate different sample types
  • Easy workflow to fit into any existing laboratory setup
  • Software Diagnostic rules to eliminate any human subjectivity for microarray data analysis

 

  • Multiplex amplification reactions
  • Multiple probes per target ensures reliable detection of subtypes in every test
  • Small sample volume requirement
  • Fast and programmable temperature ramp rate
  • Scalable for high throughput
  • PCR yield is comparable to standard thermal cyclers
  • 40% faster than conventional thermal cyclers
  • Functional validation of PCR is provided by an internal positive control
  • Functional validation of hybridization for each assay is provided by an internal positive hybridization control
  • Short hands-on time required for fluidic operations

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