The Mycobacteria Identification Kit (Sanity 2.0) is a cartridge-based test kit for the identification of 19 clinically relevant mycobacteria from sputum samples, including:

• M. tuberculosis complex
• M. chelonae
• M. scrofulaceum
• M. bovis
• M. smegmatis
• M. abscessus
• M. kansasii
• M. gordonae
• M. lentiflavum
• M. simiae
• M. nonchromogenicum
• M. terrae
• M. marinum/M. ulcerans
• M. fortuitum
• M. avium
• M. intracellulare
• M. xenopi
• M. malmoense
• M. szulgai

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.

Principle

Mycobacteria Identification Kit (Sanity 2.0) utilizes dual-labeled probes to detect excess single-stranded DNA amplicons produced through asymmetric PCR. This method involves melting curve analysis, which creates a plot of the negative derivative of fluorescence intensity against temperature. The specific melting temperature (Tm) obtained from this analysis provides sequence information. When a target of interest is present, a melting peak appears at a characteristic position, and the Tm value correlates with specific mycobacterial species.

Additionally, the test includes a fragment of the Arabidopsis thaliana sucrose-proton symporter 2 (SUC2) gene, which serves as an internal Positive Control (IPC). This control indicates whether PCR inhibition has occurred, ensuring the reliability of the test results.

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.

CE-IVD Marked