MTB-NTM Multiplex Real-Time PCR Kit

Product Overview


Tuberculosis remains one of the deadliest infectious diseases globally, with over 10 million new cases each year. Diagnosis is further complicated by non-tuberculous mycobacteria (NTM), which cause clinically similar pulmonary infections but require entirely different treatment strategies. Traditional smear microscopy and culture methods are time-consuming and cannot reliably differentiate MTBC from NTM, delaying critical treatment decisions and increasing the risk of disease spread.

The MTB-NTM Multiplex Real-Time PCR Kit from Genes2Me enables simultaneous, qualitative detection and differentiation of MTBC and NTM in a single assay. It works directly from a broad range of respiratory and extra-pulmonary samples, delivering rapid, accurate results that empower clinicians to initiate the right treatment without delay.

Targets:
Mycobacterium tuberculosis complex (MTBC) and Non-tuberculous Mycobacteria (NTM)
Technology:
TaqMan-based Multiplex Real-Time PCR
Detection:
Qualitative (Detected / Not Detected)
Sample Type:
Sputum, Tracheal Aspirate, Throat Swab, Nasopharyngeal / Oropharyngeal Swabs, BAL
Certification:
CE-IVD
MTC-Q

Genes2Me is a CE Marked molecular diagnostics company trusted by clinical laboratories across global markets. The MTB-NTM Multiplex Real-Time PCR Kit meets European conformity standards for in vitro diagnostic devices, validated to international benchmarks for accuracy, reliability, and safety.

How the Assay Works


The MTB-NTM kit uses TaqMan chemistry-based multiplex real-time PCR to simultaneously target and differentiate two mycobacterial groups. The mpb64 gene is targeted for MTBC detection in the Texas Red channel, while a conserved region of the 16S rRNA gene is targeted for NTM detection in the HEX channel. RNaseP serves as an internal control monitored in the Cy5 channel, validating extraction and amplification efficiency in every run. Positive and no-template controls are included to ensure assay reliability across all workflows.

Why Multiplex Testing Matters


MTBC and NTM infections present with near-identical symptoms, yet their treatment protocols differ significantly. Misidentification leads to inappropriate therapy, treatment delays, and continued disease transmission. A multiplex approach with three independent detection channels identifies both pathogen groups and validates the run simultaneously, reducing diagnostic turnaround from days to hours and ensuring clinicians have the information they need to act decisively.

Sample Type & Reporting Output


Sample Type:
Sputum, tracheal aspirate, throat swab, nasopharyngeal and oropharyngeal swabs, BAL, and other extra-pulmonary samples
Reporting Output:
Qualitative detection of MTBC and NTM (Detected / Not Detected)
Targets Detected:
MTBC (mpb64 gene) and NTM (16S rRNA gene)

Key Features & Benefits


Simultaneous detection of MTBC and NTM

A single multiplex assay differentiates Mycobacterium tuberculosis complex from non-tuberculous mycobacteria, eliminating the need for separate tests and accelerating clinical decision-making.

Three-channel multi-target detection

MTBC is monitored via Texas Red, NTM via HEX, and the RNaseP internal control via Cy5, enabling precise, independent identification of each target in every run.

TaqMan chemistry-based RT-PCR technology

Targets the mpb64 gene for MTBC and the 16S rRNA gene for NTM, ensuring highly specific identification and reliable differentiation from clinically similar pathogens.

Broad sample type compatibility

Accepts sputum, tracheal aspirate, throat swab, nasopharyngeal and oropharyngeal swabs, BAL, and other extra-pulmonary samples, offering flexibility across clinical collection protocols.

Positive and no-template controls included

Both controls are supplied in every kit, ensuring assay reliability and guarding against contamination or procedural errors.

Streamlined workflow with optimised reagents

Pre-formulated reagents and a simplified assay protocol reduce handling time, minimise procedural errors, and support consistent results across runs.

Applications


  • Clinical & Hospital Laboratories: Enables rapid, simultaneous detection and differentiation of MTBC and NTM from a wide range of respiratory samples, supporting accurate diagnosis and timely treatment initiation.
  • Paediatric & Neonatal Care: Supports early TB detection in children, where clinical presentation is often atypical and smear microscopy has lower sensitivity, reducing diagnostic delays in a vulnerable population.
  • Outbreak Surveillance: Rapid differentiation of TB from NTM supports targeted public health responses, preventing unnecessary isolation measures and ensuring appropriate infection control protocols.
  • Immunocompromised Patients: Essential for HIV-positive individuals, transplant recipients, and those on immunosuppressive therapy, where both MTBC and NTM infections carry a significantly elevated risk of severe outcomes.
  • Travel & Occupational Health: Reliable TB and NTM screening in occupational health programmes and travel medicine clinics, particularly for individuals with exposure to high-burden TB regions or healthcare settings.

Analytical Performance


  • Over 97% clinical sensitivity and 96% clinical specificity
  • Limit of detection: 120 copies/ml for MTBC and 112 copies/ml for NTM
  • Ct cut-off of 35 or below for positive detection across both targets
  • Three-channel detection (Texas Red, HEX, Cy5) enables independent, simultaneous monitoring of MTBC, NTM, and internal control
  • Positive and no-template controls included for full assay integrity validation

Ordering Information


Commercial Name Old Cat No. New Cat No. Pack Size
MTB-NTM Multiplex Real-Time PCR Kit G610015-1 50 Tests

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Since its inception in 2016, Genes2me has been constantly striving towards setting a benchmark in the diagnostics space by introducing premium quality (Made in India) diagnostic kits which are CE-IVD, ISO-13485:2016, and ISO 9001:2015 certified, assuring our clients of unparalleled quality and compliance with international standards.


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