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Multidrug-Resistant Tuberculosis (MDR-TB)
For the simultaneous detection and identification of 25 mutations associated with MDR-TB | 13 mutations associated with XDR-TB

Mycobacterium tuberculosis (MTB) | Multidrug-resistant (MDR) | Extensively drug-resistant TB (XDR TB) | MTB/MDRe Detection

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According to the CDC in 2020, MDR TB at initial diagnosis was reported for 56 cases, including 0.2% of cases among U.S.-born persons and 1.3% of cases among non-U.S.–born persons (TB by Multidrug Resistance (MDR): 1993–2020).

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This rate is slightly lower than the previous 5 years. Multidrug resistance is a concern both globally and in the US.

Product Information
  • Novaplex™ II MTB/MDR Detection

    Select the assays you are interested in and a Seegene representative will contact you to complete your order.
    Analytes
    • Mycobacterium tuberculosis (MTB)
    • RIF-R (18 mutations in rpoB)
    • INH-R (4 mutations in katG)
    • INH-R (3 mutations in inhA promoter)
  • Novaplex™ II MTB/XDR Detection

    Select the assays you are interested in and a Seegene representative will contact you to complete your order.
    Analytes
    • Mycobacterium tuberculosis (MTB)
    • Injectable drug-resistance (3 mutations in his promoter)
    • Injectable drug-resistance (2 mutations in res: 1401G & 1484T)
    • Injectable drug-resistance (1 mutation in res: 1402T)
  • Novaplex™ MTB/MDRe Detection

    Select the assays you are interested in and a Seegene representative will contact you to complete your order.
    Analytes
    • Mycobacterium tuberculosis (MTB)
    • RIF-R (18 mutations in rpoB)
    • INH-R (4 mutations in katG)
    • INH-R (3 mutations in inhA promoter)
Specimen

Sputum
Cultured cell
Fresh Tissue
Bronchial washing

Compatible instrumentation

Auto Extraction & PCR Setup
Seegene NIMBUS
Seegene STARlet

Real-time PCR
CFX96™ Real-time PCR Detection System (Bio-Rad)
CFX96™ Dx (Bio-Rad)
CFX96™ Touch (Bio-Rad)
CFX96™ Opus (Bio-Rad)

Seegene Viewer Software

  • Quick and easy data analysis and interpretation
  • Interface specialized for multiplex testing
Key Features
  • Simultaneous detection of Mycobacterium tuberculosis and over 30 mutations associated with drug-resistance TB
  • Short TAT (4 hours) from extraction to final results
  • Informative MTB result with Ct value and qualitative drug-resistance result in a single test
Understanding Multidrug Resistance Tuberculosis (TB)

Multidrug-resistant TB (MDR TB) is caused by an organism that is resistant to at least isoniazid and rifampin, the two first-line antibiotics. XDR TB is resistant to some first- and second-line antibiotics. These drugs are used to treat all persons with TB disease.1

Drug resistant TB is concerning especially with immunocompromised patients including those with HIV infection due to the higher risk of developing TB and death. Drug-resistant TB (DR TB) spreads the same way as drug-susceptible TB, through the air from one person to another. Bacteria are put into the air when a person with TB disease of the lungs or throat coughs, sneezes, speaks, or sings and nearby people breathe in these bacteria and become infected.

Culturing methods determining TB drug resistance have long turnaround time to results, up to 4 weeks. Novaplex MTB/MDR*, MTB/XDR* and MTB/MDRe Detection* offers rapid same day detection of resistance genes for first and second-line drugs.

The Novaplex™ II MTB/MDR* multiplex real-time PCR assay simultaneously detects Mycobacterium tuberculosis (MTB) and its resistance to first-line anti-tuberculosis drugs (7 Isoniazid (INH) and 18 Rifampicin (RIF)), based on melting temperature analysis.

The Novaplex™ II MTB/XDR* PCR assay simultaneously detects Mycobacterium tuberculosis (MTB) and its resistance to second-line anti-tuberculosis drugs (Fluoriquinolones and Injectable drugs) based on melting temperature analysis. It covers 7 Fluoriquinolones resistance-causing mutations [gyrA A90V(GTG), S91P(CCG), D94A(GCC), D94H(CAC). D94Y(TAC)], 6 injectable drug resistance-causing mutations [rrs 1401(G), 1402(T), eis promoter -37(T), -14(T), -10(A)], and internal Control (IC).

The Novaplex™ MTB/MDRe Detection* multiplex real-time PCR system for detection of Mycobacterium tuberculosis and its resistance to first-line anti-tuberculosis drugs (Isoniazid and Rifampicin). It covers 7 Isoniazid (INH) resistance-causing mutations [katG S315I(ATC), S315N(AAC), S315T(ACC), S315T(ACA), inhA promoter -15(T), -8(A), -8(C)], 18 Rifampicin (RIF) resistance-causing mutations [rpoB L511P(CCG), Q513K(AAA), Q513L(CTA), Q513P(CCA), 3 amino acid-deletion in 513~516, D516V(GTC), D516Y(TAC), S522L(TTG), S522Q(CAG), H526C(TGC), H526D(GAC), H526L(CTC), H526N(AAC), H526R(CGC), H526Y(TAC), S531L(TTG), S531W(TGG), L533P(CCG)], and Internal Control (IC).

*Novaplex™ Assays are For Research Use Only. Not for Use in Diagnostic Procedures.

1 Centers for Disease Control and Prevention (2023); Multidrug-Resistant Tuberculosis (MDR TB) Fact Sheet. Retrieved from https://www.cdc.gov/tb/publications/factsheets/drtb/mdrtb.htm
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