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TB Assay key visual

IMDX MTB / NTM RTPCR Assay Streamline MTB & NTM testing for complex sample types (pulmonary & extrapulmonary) with IMDX MTB / NTM RTPCR assay

TB Assay image


IMDX MTB / NTM RTPCR assay is a Real-time Polymerase Chain Reaction (RTPCR) screening and diagnostic test, intended for the qualitative detection and differentiation of nucleic acids of Mycobacterium tuberculosis (MTB) & non-tuberculosis mycobacteria (NTM) in samples of human origin such as sputum and bronchoalveolar lavage (BAL) etc. The MTB complex specific primer and probe sets in the assay are designed for the detection of specific and conserved region in MTB and universal 16s rRNA gene of Mycobacterium species other than tuberculosis, along with RNaseP gene as the human endogenous/housekeeping Internal Control (IC) in a single tube assay.


Key offerings 

•    Designed on Taqman probe Real-time PCR technology 

•    Dual MTB targets for qualitative detection and screening, NTM screening with 16s rRNA as target

•    Platform agnostics assay, fully compatible with major open RTPCR instruments available

•    Unified workflow suitable for small to large reference labs

•    Housekeeping gene as internal control makes testing solution robust and ensures quality at every step required for quality testing




Features & Benefits 

Technology_RTPCR

Single Tube Multiplex Assay

IMDX MTB / NTM RTPCR assay is a single tube multiplex assay with FAM/Green channel that qualitatively detects two unique regions in MTB genome. And Joe/HEX/Yellow channel that qualitatively detects the 16s rRNA gene of non-tuberculosis mycobacteria species.

Inclusivity_RTPCR

Inclusivity


IMDX MTB / NTM RTPCR assay is supported by detailed bioinformatic analysis to predict ultra-conserved sites to design primer and probes which are devoid of any mutation to maintain high specificity. 

Endogenous gene_RTPCR

Endogenous/Housekeeping gene as Internal Control

Using endogenous/housekeeping genes as IC approach with IMDX MTB / NTM RTPCR assay, laboratories can ensure quality of complete value chain, starting from sample collection, sample transportation, sample storage, DNA extraction, reaction setup and amplification. CY5/Red channel detects endogenous/housekeeping control (IC).

High-throughput_RTPCR

High Throughput detection in core/reference labs for large scale testing

Core/reference labs are best suited for mass screening in population wherein >500 samples can be tested in MTB BSL lab using IMDX MTB / NTM RTPCR assay, with extractions automation workflow.

Technical information

Sensitivity

98.2%

Specificity

100%

Shelf Life

12 months

Manufacturing site

India

Clinical Use

TB Assay image

Mycobacterium tuberculosis (MTB) and non-tuberculous mycobacteria (NTM) pose significant challenges for clinical laboratories due to their complex nature and varying treatment outcomes. Molecular diagnostic tools, such as IMDX MTB / NTM RTPCR assay facilitate diagnosis of complex MTB and NTM infections by providing rapid and accurate results. This accuracy ensures that patients receive appropriate treatment based on the correct identification of the infectious agent. Detection of MTB followed by downstream testing for drug resistance guides clinicians in selecting appropriate anti-tuberculosis regimens, improving treatment outcomes, and preventing the spread of drug-resistant strains. 

NTM infections present other challenges in clinical diagnosis due to their similar clinical manifestations to MTB and other respiratory infections. IMDX MTB / NTM RTPCR assay assist in accurately differentiating NTM from MTB by targeting species-specific genetic markers. This differentiation is crucial for appropriate therapeutic decisions, as NTM infections often require different treatment regimens than MTB.