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
30 people
diagnosed with TB every hour in Europe3
An estimated 30% of TB patients tested
for susceptibility had MDR-TB3
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
Improved patient
management
Improved
workflow
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
Detection
Sensitivity (95% CI)
Specificity (95% CI)
MTBC*
93%
99%
RIF resistance
94%
98%
INH resistance
82%
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.
BD Sputum Collection System
BD BBL™ Mycoprep, BD BBL™ Acid Fast
and Fluorescent Stains and BD BBL™
Prepared Media
BD MAX™ System fully
automated platform
BD BACTEC™
MGIT™ Systems
BD MGIT™ TBcID
Identification Test
SIRE and PZA fully
automated primary DSTwith BD BACTEC™ MGIT™ Systems
BD Epicenter™ Data
Management System with TB-eXIST Extended Individual Susceptibility Testing
The BD MAX™ MDR-TB Assay is fully integrated on the BD MAX™ System