Mycobacteria Product Series

Mycobacteria are bacteria of the genus Mycobacterium comprising of over 190 species with a characteristic thick waxy wall, which helps them survive in stressful environments and, in cases of infection, evade the immune response and standard antibiotic therapy. Although many mycobacteria are generally harmless, there are notable pathogenic species, leading to diseases such as tuberculosis and leprosy. Additionally, nontuberculous mycobacterioses are an emerging group of diseases caused by nontuberculous mycobacteria (NTM).

Mycobacteria can be divided into three groups:

• Mycobacterium tuberculosis complex – causative pathogen of tuberculosis
• Nontuberculous mycobacteria (NTM) – generally harmless but occasionally cause disease
• Mycobacterium leprae – causative pathogen of leprosy

Treatment of mycobacterial diseases depends on the causative species and usually involves multidrug therapy, which lasts for a minimum of several months. Certain drug regimens have been affected by the rapid spread of drug resistance making it more difficult to contain the infection at patient and public health levels. Therefore, rapid identification of the causative pathogen and associated drug resistances is essential for appropriate therapy selection and successful treatment outcomes.

Identification of the correct mycobacteria species and any relevant drug resistances needs to be performed in specialist laboratories, since clinical diagnosis alone is not sufficient due to overlapping clinical symptoms of many mycobacterial diseases. As some species have extremely long reproductive cycles, traditional culturing methods can take weeks to obtain results. In contrast, molecular genetic assays offer a highly sensitive and reliable approach to support clinical observations and selection of appropriate treatment in a timely manner.

Bruker offers a broad and comprehensive range of molecular diagnostics for mycobacteria testing to enable mycobacteria laboratories support clinicians in delivering timely and best-informed treatment advice to their patients. Our molecular assays cover detection and differentiation of Mycobacterium tuberculosis complex as well as first-line and second-line drug resistances down to a specific mutation. Additionally, we provide molecular tests for differentiation of species and subspecies of clinically relevant NTM. Furthermore, we offer the only commercially available test for the detection of leprosy and relevant drug resistances.

Bruker’s molecular diagnostic assays for mycobacteria are based on two technologies, allowing laboratories to choose between the highly multiplexed FluoroType^®/ LiquidArray^® products with results at a glance, and our established DNA•STRIP solutions based on Line Probe Assays. The two platforms offer a highly flexible approach to suit the needs of laboratories of any size and budget.

Tuberculosis is caused by one of around a dozen mycobacteria species within Mycobacterium tuberculosis complex (MTBC), primarily M. tuberculosis. The different MTBC species may cause similar clinical symptoms but different courses of disease and sometimes requiring different treatment regimens.

Active tuberculosis requires multidrug therapy, of which isoniazid and rifampicin are core first-line components. Drug-resistant and multidrug-resistant tuberculosis need to be treated with a selection of second-line drugs, to which resistances are also emerging.

Bruker offers a comprehensive selection of molecular assays that can be applied in a reflex-testing approach to ensure rapid and reliable detection of tuberculosis and associated drug resistances, and help initiate timely and appropriate therapy.

Nontuberculous mycobacteria (NTM) infections typically are transient and harmless but occasionally establish life-threatening infection. Early detection of NTM and identification of the species help doctors make best-informed decisions in disease management. Furthermore, some of the more common species can be differentiated into subspecies, which differ in their intrinsic susceptibility to antibiotics.

Drug resistance is spreading for some of the more prevalent NTM species and requires rapid detection so that appropriate therapy can be initiated. Bruker offers several molecular assays to detect and differentiate the most prevalent and clinically relevant NTM species and subspecies, as well as determine their drug susceptibility status.

Starting from decontaminated patient samples or culture samples, DNA extraction can be performed manually in a few easy steps or automated using our dedicated extraction kits and instruments*. For the DNA•STRIP assays PCR amplification takes place in our dedicated PCR cyclers or a PCR cycler of your choice, and the PCR reactions are followed by hybridisation onto the provided membrane strips in a semi-automated or automated manner. LiquidArray^® assays run fully automated on the FluoroCycler^® XT with integrated FluoroSoftware^® XT-IVD software generating results at a glance.

* Please check with your local representative or the respective Instructions for Use of the required assay for available options.