iCassette Diagnostic Kit for Mycobacterium Tuberculosis (MTB) Complex DNA and Rifampicin Resistance
The iCassette Diagnostic Kit for Mycobacterium Tuberculosis (MTB) Complex DNA and Rifampicin Resistance is a highly automated, in vitro diagnostic tool designed for the qualitative detection of MTB complex DNA and rifampicin resistance in sputum samples. Using real-time multiplex fluorescence PCR technology, this kit streamlines the extraction and amplification process, providing rapid and accurate results. It is an essential tool for diagnosing tuberculosis and identifying rifampicin-resistant strains, helping clinicians make informed treatment decisions.
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IFU
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Tuberculosis (TB), caused by the Mycobacterium tuberculosis (MTB) complex, remains a major global health concern, particularly due to the rise of drug-resistant strains. Rapid and accurate detection of MTB and its resistance to key drugs like rifampicin is critical for effective treatment and disease management.
The iCassette Diagnostic Kit for Mycobacterium Tuberculosis (MTB) Complex DNA and Rifampicin Resistance is a highly advanced tool designed for the in vitro qualitative detection of MTB complex nucleic acids in sputum samples. This kit also detects rifampicin resistance in MTB-positive samples, which is crucial for identifying drug-resistant TB cases and guiding appropriate treatment strategies.
Utilizing real-time multiplex fluorescence PCR technology, the kit automates the entire process of nucleic acid extraction and amplification, ensuring precision and minimizing the risk of contamination. By targeting the IS6110 gene fragment for MTB detection and the rifampicin resistance-determining region (RRDR) of the RpoB gene, the kit provides reliable results, helping healthcare providers make informed decisions in the diagnosis and treatment of tuberculosis.
The iCassette uses a magnetic bead transfer structure and process technology, as well as a material distributed mixing device structure. It is compatible with the Galaxy: Nano, Lite and Pro. The test can be performed on demand with no minimum batch size requirement, which is advantageous for clinics and hospitals that require rapid results. The fully automated sample magnetic beads extraction to qPCR process provides results in one and a half hours with minimal hands-on time, increasing laboratory efficiency and reducing patient waiting times.
The iCassette Diagnostic Kit for Mycobacterium Tuberculosis (MTB) Complex DNA and Rifampicin Resistance is suitable for sputum samples. It is stored at 2-8°C and includes internal process control to ensure the accuracy and reliability of each test performed.
This kit is an essential tool for laboratories and healthcare facilities focused on TB diagnosis, offering a fast, reliable, and automated solution to detect both Mycobacterium tuberculosis and its resistance to rifampicin, one of the most important drugs used in TB treatment.
The kit includes tests for Mycobacterium tuberculosis and rifampicin-resistant.
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