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Bio-Bag™ Type A is a transparent, individual, disposable environmental chamber that contains a gas generator consisting of one tablet of potassium borohydride and sodium bicarbonate and an ampule of hydrochloric acid, a catalyst cup containing palladium catalyst, and an indicator containing an ampule of resazurin. When the Bio-Bag containing all three components has been properly heat-sealed and the generator activated, an anaerobic environment will be created. An oxygen reduction indicator, resazurin, monitors the oxygen level.

Bio-Bag Type A is designed to provide an anaerobic environment suitable for the isolation of obligate or facultative anaerobic bacteria, while permitting visualization without disrupting the gaseous atmosphere. It is sized to hold either a standard 100 mm BBL™ Petri dish, or anaerobic MIC microdilution tray.

Recognition of anaerobic organisms as causative agents of disease has become important to microbiologists and clinicians. New techniques in isolation, identification, and susceptibility testing have provided a better understanding of these fastidious organisms. Proper collection of specimens to prevent contamination by normal flora, to provide adequate material for testing, as well as appropriate transport of specimens to the laboratory, are critical in isolation and subsequent study of pathogens.^1-4

By definition, anaerobic organisms require reduced levels or the absence of oxygen.¹ Some organisms can tolerate a short exposure to oxygen and are designated as aerotolerant.^1,3 The Bio-Bag Type A system, when directions are followed, provides a rapid reduction of atmospheric oxygen. Studies have shown levels of O₂ to be less than 1% at 1 h through 72 h.⁵ Carbon dioxide is produced to enhance the growth of certain organisms.

Transparency of the Bio-Bag envelope allows macroscopic observation of each culture without disturbing the anaerobic atmosphere. Protection from exposure to oxygen is assured for the more fastidious organisms. As some anaerobic organisms exhibit colonies in 24 h, identification and antimicrobial susceptibility procedures can be initiated as soon as visible growth is observed.

Because of the individuality of this system, specimens can be set up as they arrive in the laboratory.

A stock culture of Bacteroides fragilis subsp. fragilis, or other anaerobic organism, should be tested in the Bio-Bag Type A system periodically to assure adequate conditions for recovery and characteristic morphology.

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.

Each Bio-Bag Type A system consists of:

1 Gas Impermeable Environment Chamber
1 Gas Generator (containing one tablet of potassium borohydride and sodium bicarbonate and a 0.5 mL ampule of 1.8N hydrochloric acid)
1 Catalyst Container
1 Anaerobic Indicator (containing a 0.5 mL ampule of 0.001% resazurin)

For in vitro Diagnostic Use.

Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard Precautions"^6-9 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

WARNING: Hydrogen is generated. This gas is flammable and may be explosive. Avoid exposure to sparks or flame.

Do not use generator if it appears damaged or previously activated.

Do not allow generator to come in contact with water prior to use. Store in tightly closed bag with desiccant to assure integrity of the generator tablet.

Do not activate generator until Bio-Bag has been properly sealed.

Repeat procedure if indicator change is not observed 2 h after generation process.