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The BBL™ MGIT™ Mycobacteria Growth Indicator Tube supplemented with BACTEC™ MGIT™ Growth Supplement and BBL™ MGIT™ PANTA™ antibiotic mixture is intended for the detection and recovery of mycobacteria using the BACTEC™ MGIT™ 960 and BACTEC™ MGIT™ 320 Systems. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

From 1985 to 1992, the number of reported cases of infection with Mycobacterium tuberculosis (MTB) increased 18%. Tuberculosis still kills an estimated 3 million persons a year worldwide, making it the leading infectious disease cause of death.¹ Between 1981 and 1987, AIDS case surveillances indicated that 5.5% of the patients with AIDS had disseminated nontuberculous mycobacterial infections; e.g., MAC. By 1990, the increased cases of disseminated nontuberculous mycobacterial infections had resulted in a cumulative incidence of 7.6%.² In addition to the resurgence of MTB, multidrug-resistant MTB (MDR-TB) has become an increasing concern. Laboratory delays in the growth, identification and reporting of these MDR-TB cases contributed at least in part to the spread of the disease.³

The U.S. Centers for Disease Control and Prevention (CDC) have recommended that every effort must be made for laboratories to use the most rapid methods available for diagnostic mycobacteria testing. These recommendations include the use of both a liquid and a solid medium for mycobacterial culture.^3,4

The MGIT Mycobacteria Growth Indicator Tube contains 7 mL of modified Middlebrook 7H9 Broth base.^5,6 The complete medium, with OADC enrichment and PANTA antibiotic mixture, is one of the most commonly used liquid media for the cultivation of mycobacteria.

All types of clinical specimens, pulmonary as well as extrapulmonary (except blood and urine) can be processed for primary isolation in the MGIT tube using conventional methods.⁴ The processed specimen is inoculated into a MGIT tube, placed into the BACTEC™ MGIT™ instrument for continuous monitoring until positive or the end of the testing protocol.

Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and your laboratory's standard Quality Control procedures. It is recommended that the user refer to pertinent CLSI guidance and CLIA regulations for appropriate Quality Control practices.

Quality Control Certificates are provided on the BD website. Quality Control Certificates list test organisms, including ATCC™ cultures specified in the CLSI Approved Standard M22-A3, Quality Control for Commercially Prepared Microbiological Culture Media.¹²

NOTE: Middlebrook 7H9 Broth (supplemented) is exempt from User QC testing according to CLSI M22-A3.¹²

The BBL MGIT Mycobacteria Growth Indicator Tube contains: 110 μL of fluorescent indicator and 7 mL of broth. The indicator contains Tris 4, 7-diphenyl-1, 10-phenanthroline ruthenium chloride pentahydrate in a silicone rubber base. The tubes are flushed with 10% CO₂ and capped with polypropylene caps.

BACTEC MGIT Growth Supplement contains 15 mL Middlebrook OADC enrichment.

The BBL MGIT PANTA vial contains a lyophilized mixture of antimicrobial agents.

For in vitro Diagnostic Use.

This Product Contains Dry Natural Rubber.

Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"^7-10 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

Working with Mycobacterium tuberculosis grown in culture requires Biosafety Level 3 practices, containment equipment and facilities.⁴

Prior to use, each MGIT tube should be examined for evidence of contamination or damage. Discard any tubes if they appear unsuitable.

Dropped tubes should be examined carefully. If damage is seen, the tube should be discarded.

In the event of tube breakage: 1) Close the instrument drawers; 2) Turn off the instrument; 3) Vacate the area immediately; 4) Consult your facility/CDC guidelines. An inoculated leaking or broken vial may produce an aerosol of mycobacteria; appropriate handling should be observed.

Autoclave all inoculated MGIT tubes prior to disposal.