Mycobacteria are slow-growing microorganisms that require specific culture conditions for their recovery and detection. Culture remains an important microbiological method for the diagnosis of mycobacterial infections, including tuberculosis, particularly when combined with other diagnostic methods.

Mycobacterial Culture Bottle is an in vitro diagnostic culture system designed for the qualitative detection of mycobacteria in sputum specimens using compatible automated blood culture and microbial detection systems. The test is intended to support the diagnosis of diseases caused by mycobacteria, including tuberculosis.

The disposable culture bottle contains 10 mL of Middlebrook 7H9 broth, supplemented with bovine serum and cow heart infusion powder. An internal sensor detects carbon dioxide (CO₂) as an indicator of microbial growth. When mycobacterial metabolism produces CO₂, the colorimetric sensor changes from blue-green to yellow, allowing the automated system to monitor microbial growth.

The system is supplied with a lyophilized antimicrobial agent containing polymyxin B, amphotericin B, nalidixic acid, trimethoprim and azlocillin sodium. The antimicrobial formulation acts selectively against most respiratory tract bacteria, helping to limit bacterial overgrowth and facilitate the recovery of mycobacteria from respiratory specimens.

KEY FEATURES AND BENEFITS:

• Qualitative detection of mycobacteria from sputum specimens.
• Designed to support the microbiological diagnosis of mycobacterial infections, including tuberculosis.
• Contains 10 mL of Middlebrook 7H9 broth supplemented with bovine serum and cow heart infusion powder.
• Integrated CO₂ sensor enables automated monitoring of microbial growth through a colorimetric detection principle.
• Supplied with a selective antimicrobial agent containing polymyxin B, amphotericin B, nalidixic acid, trimethoprim and azlocillin sodium.
• The antimicrobial agent inhibits the growth of most respiratory tract bacteria, helping to reduce bacterial interference during mycobacterial culture.
• Compatible with selected automated blood culture and microbial detection systems.
• Designed for professional laboratory and in vitro diagnostic use.
• Single-use culture bottles.

SPECIMEN TYPE:

Sputum specimens.

The typical specimen volume is 0.5 mL. Sputum specimens should be processed using the NALC-NaOH method recommended for mycobacteriological testing. Processed specimens should be inoculated within 72 hours when stored at 2–8°C.

CULTURE AND DETECTION:

Following inoculation, the culture bottle is loaded into the automated system and remains in the instrument until a positive result is detected or the assay is terminated with a negative result after 42 days.

A positive result indicates detection of mycobacteria and should be followed by smear examination and acid-fast staining. Further species identification should be performed according to the laboratory's established procedures.