MDR-TB Test Kit (Sanity 2.0) is a cartridge-based diagnostic kit designed to detect mutations associated with multidrug resistance in Mycobacterium tuberculosis (MTB) from sputum samples and MTB culture. These mutations include resistance to rifampin and isoniazid, which are key components of standard tuberculosis treatment.

The kit is intended for use with the Sanity 2.0 System, which is a fully automated system that simplifies the testing process. It combines nucleic acid extraction, real-time polymerase chain reaction (rt-PCR), and result interpretation into a single, streamlined operation. This integrated approach reduces the complexity of the procedure and minimizes the potential for errors, ensuring that the detection of drug-resistant TB is both accurate and efficient.

By automating these steps, the Sanity 2.0 System allows for a more rapid turnaround time, which is crucial for the timely identification and treatment of multidrug-resistant tuberculosis. MDR-TB Test Kit (Sanity 2.0) in combination with Sanity 2.0 System provides a reliable and user-friendly solution for laboratories and healthcare facilities looking to enhance their TB diagnostic capabilities.

Principle

MDR-TB Test Kit (Sanity 2.0) utilizes a method involving dual-labeled probes to detect specific mutations in the Mycobacterium tuberculosis (MTB) genome that are associated with resistance to key anti-tuberculosis drugs. The process involves:

1. Asymmetric PCR: The test begins with an asymmetric PCR that amplifies DNA fragments, resulting in an excess of single-stranded DNA, known as amplicons.

2. Dual-labeled Probes: These probes are designed to bind to the single-stranded amplicons. They have two different fluorescent dyes attached to them.

3. Melting Curve Analysis: After the probes bind to the DNA, the sample is heated. As the temperature increases, the DNA-probe complexes start to separate, or “melt.” This process is monitored by measuring the change in fluorescence intensity.

4. Melting Temperature (Tm): The temperature at which half of the DNA-probe complexes have melted is called the melting temperature (Tm). A perfect match between the probe and the target DNA sequence results in a higher Tm.

5. Mutation Detection: Any mismatch, such as a point mutation, insertion, or deletion, will lower the Tm compared to a perfect match. The extent of the decrease in Tm is related to the nature of the mutation, the number of bases involved in the insertion or deletion, and the location of the mutation.

6. Mutation Coverage: MDR-TB Test Kit (Sanity 2.0) specifically targets mutations in the rpoB gene (codons 507 to 533) to detect resistance to rifampicin, and mutations in the ahpC promoter region (positions -44 to -30 and -15 to -4), inhA promoter region (positions -17 to -8), and katG codon 315 to detect resistance to isoniazid.

This method allows for a precise and sensitive detection of mutations that confer drug resistance, which is crucial for guiding the appropriate treatment strategy for patients with multidrug-resistant tuberculosis.

Sample Type

Sputum

Mycobacterium tuberculosis culture

Compatible Kit

This kit should be used with MTB DNA Extraction Kit (Sanity 2.0) for nucleic acid extraction.

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