Expand your lab’s potential
Assays

Expand your lab’s potential
for drug-resistant tuberculosis testing

The BD MAX™ MDR-TB assay is designed to detect Mycobacterium tuberculosis complex, as well as resistance to the common first-line drugs rifampicin and isoniazid in a single test

Improve patient
management
Choose
efficiency
Maximise
clinical impact
BD TB diagnostic
solutions

The European Tuberculosis Laboratory Initiative recommends molecular testing and early identification of MDR as standard for TB diagnostics1

  • Determination of antibiotic resistance is critical in managing the treatment pathway and potential isolation processes for confirmed TB positive patients
  • Testing only for RIF resistance can lead to improper treatment of patients with RIF-susceptible/INH-resistant TB resulting in high failure rates, relapse and development of MDR-TB2
  • Fast diagnosis can accelerate patient treatment and prevent disease transmission
  • BD MAX™ MDR-TB is a real-time PCR assay with a high level of sensitivity, detecting Mycobacterium tuberculosis complex (MTBC) as well as key mutations associated with RIF and INH resistance
Improved patient management
30 people
diagnosed with TB
every hour in Europe3
Improved patient management
An estimated 30%
of TB patients tested
for susceptibility had MDR-TB3
Improved patient management
Treatment success rates for TB and drug-resistant TB are still below regional and global targets3

BD MAX™ MDR-TB: an integrated molecular solution that delivers 4 clinical results in one test4

  • MTBC
  • Mutations in the rpoB gene associated with rifampicin resistance
  • Mutations in the katG gene and inhA promoter region associated with isoniazid resistance
  • Can be used with fresh and processed sputum samples, BD Sample Treatment Reagent designed to minimise bioburden for effective sample processing
  • Same day results possible with a turnaround time of less than 4 hours for 24 samples
30 people diagnosed with TB
Improved patient
management
30 people diagnosed with TB
Improved
workflow
30 people diagnosed with TB
Fast time to
result vs. culture

The BD MAX™ MDR-TB assay has high sensitivity and specificity for detection of MTB and RIF and INH drug resistance and may be an important tool for rapid detection of TB and MDR-TB globally5

  • The high sensitivity of BD MAX™ MDR-TB for TB detection and multi-drug resistance adds predictive value to the TB diagnostic process and clinical decision making
  • Specific assay results for katG and inhA promoter, the two most well-known gene mutations which cause isoniazid resistant TB further direct appropriate medication dosages and combinations for successful patient treatment planning

Clinical performance in several high-burden settings demonstrated4

DetectionSensitivity (95% CI)Specificity (95% CI)
MTBC*93%99%
RIF resistance94%98%
INH resistance82%100%
*fresh sputum sample

BD has a legacy of trust and leadership in efficient and accurate diagnostics including sample collection, TB detection and drug susceptibility and resistance testing.

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BD Sputum Collection System
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BD BBL™ Mycoprep, BD BBL™ Acid Fast
and Fluorescent Stains and BD BBL™
Prepared Media
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BD MAX™ System fully
automated platform
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BD BACTEC™
MGIT™ Systems
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BD MGIT™ TBcID
Identification Test
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SIRE and PZA fully
automated primary DSTwith BD BACTEC™ MGIT™ Systems
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BD Epicenter™ Data
Management System with TB-eXIST Extended Individual Susceptibility Testing
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The BD MAX™ MDR-TB Assay is fully integrated on the
BD MAX™ System

Discover BD’s full Respiratory Infections Portfolio