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BACTEC™ Lytic/10 Anaerobic/F culture vials (prereduced enriched Soybean-Casein Digest broth with CO₂) are for anaerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the qualitative culture and recovery of anaerobic microorganisms from blood.

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.

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, Quality Control for Commercially Prepared Microbiological Culture Media.⁵

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:

Clostridium perfringens ATCC 13124
Streptococcus pneumoniae ATCC 6305
Clostridium histolyticum ATCC 19401
Bacteroides fragilis* ATCC 25285
Escherichia coli ATCC 25922
Bacteroides vulgatus ATCC 8482
Staphylococcus aureus ATCC 25923

*CLSI 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 Lytic/10 Anaerobic/F culture vials contain the following active ingredients prior to processing:

All BACTEC media are dispensed with added CO₂. Anaerobic media are prereduced and dispensed with added CO₂ and N₂. Composition may have been adjusted to meet specific performance requirements.

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"^1-4 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 damage, contamination or deterioration. Vials displaying evidence of damage or contamination such as leakage, cloudiness, discoloration (darkening), bulging or depressed septum should not be used.

A contaminated vial could contain positive pressure. If a contaminated vial is used for direct draw, contaminated culture media could be refluxed into the patient's vein. Vial contamination may not be readily apparent. When using direct draw procedures, monitor the process closely to avoid refluxing materials into patient.

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 vial may leak or spill. 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™ brand tips.