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BD BACTEC Plus Aerobic/F and Plus Anaerobic/F media are used in a qualitative procedure for the aerobic and anaerobic culture and recovery of microorganisms (bacteria and yeast) from blood. The principal use of these media is with the BD BACTEC fluorescent series instruments.

The sample to be tested is inoculated into one or more vials which are inserted into the BACTEC fluorescent series instrument for incubation and periodic reading. Each vial contains a chemical sensor which can detect increases in CO₂ produced by the growth of microorganisms. The sensor is monitored by the instrument every ten minutes for an increase in its fluorescence, which is proportional to the amount of CO₂ present. A positive reading indicates the presumptive presence of viable microorganisms in the vial. Detection is limited to microorganisms that will grow in a particular type of medium.

Resins have been described for the treatment of blood specimens both prior to and after their inoculation into culture media. Resins have been incorporated into BACTEC culture media to enhance recovery of organisms without a need for special processing.^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 CLSI (formerly NCCLS) guidance and CLIA regulations for appropriate Quality Control practices.

DO NOT USE culture vials past their expiration date.

DO NOT USE culture vials that exhibit any cracks or defects; discard the vial in the appropriate manner.

Quality Control Certificates are provided with each carton of media. Quality Control Certificates list test organisms, including ATCC™ cultures specified in the CLSI Standard M22, Quality Control for Commercially Prepared Microbiological Culture Media. The range of time-to-detection in hours was ≤72 hours for each of the organisms listed on the Quality Control Certificate for this medium:

*CLSI recommended strain

For information on Quality Control for the BACTEC fluorescent series instrument, refer to the appropriate BACTEC Fluorescent Series Instrument User's Manual.

The BACTEC culture vials contain the following reactive ingredients prior to processing:

All BACTEC media are dispensed with added CO₂. Anaerobic media are prereduced and dispensed with CO₂ and N₂.

*The medium volume has been increased in the BACTEC Plus Aerobic/F from 25 mL to 30 mL.

The prepared culture vials are 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"^4-7 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.

Prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depressed septum, or leakage. DO NOT USE any vial showing evidence of contamination. A contaminated vial could contain positive pressure. If a contaminated vial is used for direct draw, gas or contaminated culture media could be refluxed into the patient's vein. Vial contamination may not be readily apparent. If a direct draw procedure is used, monitor the process closely to avoid refluxing materials into the patient.

Prior to use, the user should examine the vials for evidence of damage or deterioration. Vials displaying turbidity, contamination, or discoloration (darkening) should not be used. On rare occasions, the glass bottle neck may be cracked and the neck may break during removal of the flip-off cap or in handling. Also, on rare occasions a vial may not be sealed sufficiently. In both cases the contents of the vials may leak or spill, especially if the vial is inverted. If the vial has been inoculated, treat the leak or spill with caution, as pathogenic organisms/agents may be present. Before discarding, sterilize all inoculated vials by autoclaving.

Positive culture vials for subculturing or staining, etc.: before sampling it is necessary to release gas which often builds up due to microbial metabolism. Sampling should be performed in a biological safety cabinet if possible, and appropriate protective clothing, including gloves and masks, should be worn. See Procedure section for more information on subculturing.

To minimize the potential of leakage during inoculation of specimen into culture vials, use syringes with permanently attached needles or Luer-Lok™ tips.