TB-Q Comprehensive Real Time PCR Kit for Tuberculosis - Genes2Me

Product Overview

Tuberculosis (TB) is a highly infectious bacterial disease caused by Mycobacterium tuberculosis (MTB), primarily affecting the lungs but also capable of affecting the brain, kidneys, spine, and other organs. Despite being preventable and treatable, TB remains one of the leading infectious causes of mortality worldwide. The emergence of multidrug-resistant tuberculosis (MDR-TB), particularly resistance to Rifampicin and Isoniazid, has further intensified the need for rapid and accurate molecular diagnostics.

The TB-Q Comprehensive Real-Time PCR Kit from Genes2Me is a highly sensitive and specific diagnostic assay designed for the qualitative detection of MTB along with simultaneous identification of Rifampicin and Isoniazid resistance-associated mutations directly from clinical samples. The assay enables early detection of drug-resistant TB, supporting faster therapeutic decisions, improved patient outcomes, and effective infection control strategies.

Targets:

Mycobacterium tuberculosis (mpt64 & IS6110), Rifampicin Resistance (Rif-1, Rif-2, Rif-3, Rif-4), Isoniazid Resistance (katG, inhA)

Technology:

Real-Time PCR (TaqMan)

Detection:

Qualitative Detection of MTB and Drug-Resistant Tuberculosis (Detected / Not Detected)

Sample Type:

Pulmonary sputum or Bronchoalveolar lavage (BAL) & culture specimens

Certification:

CE-IVD

How the Assay Works

The TB-Q Comprehensive kit uses a two-tube multiplex real-time PCR workflow for the simultaneous qualitative detection of Mycobacterium tuberculosis complex (MTBC) DNA and Multi- Drug Resistance from clinical specimens. The assay detects katG mutation, Rif-2 mutation, Rif-3 mutation, and MTB targets mpt64 & IS6110 with the detection of Rif-1 mutation, Rif-4 mutation, and INH-inhA mutation.

The assay is based on the negative diagnostic principle for resistance interpretation, where absence of amplification in one or more drug-resistance target regions indicates resistance-associated mutations. Built-in internal, positive, and negative controls ensure reliable assay performance, minimize false results, and validate sample integrity and PCR efficiency in every run.

Why Molecular Testing Matters for Tuberculosis

Smear microscopy and culture used in conventional TB diagnosis are often limited by lower sensitivity or prolonged turnaround times. Molecular detection enables rapid identification of MTB and associated drug resistance mutations directly from clinical samples with high sensitivity and specificity. Early identification of Rifampicin and Isoniazid resistance is especially critical for timely initiation of appropriate MDR-TB treatment regimens.

The TB-Q Comprehensive assay supports accurate differentiation between drug-sensitive and drug-resistant TB, enabling clinicians and public health programs to make faster and more informed decisions.

Key Features & Benefits

Comprehensive MTB & Drug Resistance Detection

Simultaneously detects Mycobacterium tuberculosis (MTB) along with Rifampicin and Isoniazid resistance-associated targets in a single workflow.

Advanced 2-Tube Multiplex RT-PCR Design

Optimized 2-tube reaction format allows simultaneous analysis of multiple MTB and resistance markers including katG, inhA, and rpoB targets with high analytical accuracy.

High Sensitivity & Specificity

Delivers 98% clinical sensitivity and 98% clinical specificity with reliable detection up to Ct ≤ 35, ensuring accurate results even in low bacterial load samples.

Built-In Internal & Positive Controls

Integrated RNase P internal control along with positive and negative controls validate sample quality, extraction efficiency, and PCR performance for dependable reporting.

Rapid & Reliable MDR-TB Detection

Provides faster detection of drug-resistant TB compared to conventional culture-based methods, supporting early treatment decisions and improved patient management.

Applications

Clinical & Hospital Laboratories: Rapid identification of tuberculosis infections for timely patient diagnosis and treatment initiation.
Reference & Public Health Laboratories: Supports large-scale TB surveillance and molecular screening programs.
Infection Control Programs: Enables faster confirmation of active TB cases to support isolation measures and outbreak containment.
Respiratory Disease Differential Diagnosis: Assists clinicians in differentiating TB from other respiratory infections presenting with similar pulmonary symptoms.

Analytical Performance

Clinical sensitivity of 98% with clinical specificity of 98%
Limit of Detection (LOD) of 150 copies/mL
Ct cut-off value ≤ 35
Coefficient of variation below 4%
No interference observed with human genomic DNA, tobacco/nicotine, and Rifampicin compounds
No cross-reactivity observed with HIV, Influenza A, or Influenza B
12-month shelf life under recommended storage conditions

Commercial Name	Old Cat No.	New Cat No.	Pack Size
TB-Q Comprehensive Real Time PCR Kit	G2M803121	G610034	50 Tests

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.

TB-Q Comprehensive Real Time PCR Kit

Product Overview

How the Assay Works

Why Molecular Testing Matters for Tuberculosis

Sample Type & Reporting Output