Introduction:

Mycobacterial infections pose a major global public health challenge. Within the genus Mycobacteria, with over 200 different species, M. tuberculosis takes center stage as the main cause of tuberculosis. In addition, other species like M. avium complex (MAC) also contribute to diseases such as opportunistic infections in immunocompromised patients. The varying severity and clinical presentations of mycobacterial infections emphasize the need for tailored treatment strategies based on the specific mycobacterial species.

We are developing the LiquidArray® Mycobacteria direct assay as an innovative diagnostic test for the detection and differentiation of clinically significant mycobacterial species in sputum samples, such as those in the MAC, M. xenopi, M. kansasii as well as the M. tuberculosis complex.

Method:

The assay is powered by LiquidArray® technology, which utilizes multiplexed PCR to amplify target DNA sequences, capitalizing on the advanced capabilities of the FluoroCycler® XT for simultaneous detection across 5 fluorescence channels. The LiquidArray® technology uniquely integrates fluorescent probes that enable the detection of multiple targets in a single reaction to save time, resources and sample material. With the manual FluoroLyse® kit, as well as the automated GenoXtract® fleXT workflow for up to 96 samples, we ensure rapid DNA extraction during sample preparation.

Results:

The application of target-specific melting curve analysis enhances the assay's performance, distinguishing between closely related species. The LiquidArray® Mycobacteria direct can detect and distinguish between several different species from over 200 different mycobacteria in one reaction. In addition, all other mycobacteria species are detected at the Mycobacterium genus level. Including DNA isolation, reliable and automatically evaluated results are obtained within 3 hours.

Summary

The LiquidArray® Mycobacteria direct will be a powerful tool for the rapid identification of clinically relevant mycobacterial species directly from patient specimen paving the way for fast specific treatment and preventive measures.