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BACTEC™ MGIT™ Barcoded 7mL Tube (100 tubes)
Cat. # Desc. Qty. Unit
245122 BACTEC™ MGIT™ Barcoded 7mL Tube (100 tubes) 100 SP
Intended Use:

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 System. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

Catalog # Description Quantity Unit
245122 BACTEC™ MGIT™ Barcoded 7mL Tube (100 tubes) 100 SP

BBL™ MGIT™
Mycobacteria Growth Indicator Tube 7mL
Supplemented With BACTEC™ MGIT™ Growth Supplement, BBL™ MGIT™ PANTA™ Antibiotic Mixture
Revision: 0607    Revision Date: 06/01/2007   

Intended Use: «

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 System. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).

Intended Use: » Intended Use:

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 System. Acceptable specimen types are digested and decontaminated clinical specimens (except urine), and sterile body fluids (except blood).


Product Summary: «

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™ 960 System for continuous monitoring until positive or the end of the testing protocol.

Product Summary: » Product Summary:

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™ 960 System for continuous monitoring until positive or the end of the testing protocol.


User Quality Control: « User Quality Control:

Upon receipt of a new shipment or lot number of MGIT tubes, it is suggested that suspensions of the ATCC control organisms shown in Table 1 be prepared in Middlebrook 7H9 Broth.

1. From solid media cultures less than 15 days old, prepare a suspension in Middlebrook 7H9 Broth.
2. Allow the suspension to sit for 20 min.
3. Transfer the supernatant to an empty, sterile tube and allow to sit for an additional 15 min.
4. Transfer the supernatant to another empty, sterile tube.
5. Adjust the suspension to a turbidity comparable to a McFarland No. 0.5 standard.
6. Dilute the control organism suspensions following the dilution scheme outlined in Table 1.
7. Inoculate the MGIT tubes following the "Inoculation of MGIT Tubes" procedure.

The MGIT tubes should be detected as instrument positive within the time frame shown in Table 1. If the MGIT Quality Control tubes do not give the expected results, do not use the remaining tubes until you have contacted Technical Services at (800) 638-8663 (United States only).

Table 1

Species ATCC™ Number Dilution of 0.5 McFarland Suspension in Saline Days to Instrument Positivity
M. tuberculosis 27294 1:500 6 – 10
M. kansasii 12478 1:50000 6 – 11
M. fortuitum 6841 1:5000 1 – 3

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 NCCLS guidance and CLIA regulations for appropriate Quality Control practices.


Reagents: « Reagents:

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.

  Approximate Formula* Per L of Purified Water:
  Modified Middlebrook 7H9 Broth base  5.9   g
  Casein peptone  1.25   g
 

BACTEC MGIT Growth Supplement contains 15 mL Middlebrook OADC enrichment.

  Approximate Formula* Per L of Purified Water:
  Bovine albumin  50.0   g
  Dextrose  20.0   g
  Polyoxyethylene stearate (POES)  1.1   g
  Catalase  0.03   g
  Oleic acid  0.1   g
 

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

  Approximate Formula* Per Vial Lyophilized PANTA:
  Polymyxin B  6,000   units
  Amphotericin B  600   μg
  Nalidixic acid  2,400   μg
  Trimethoprim  600   μg
  Azlocillin  600   μg
  *Adjusted and/or supplemented as required to meet performance criteria.

Warnings and Precautions: « Warnings and Precautions:

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.



Information shown on this page is a short summary extracted from the Package Insert, available as a PDF under the Related Documents section of this page.