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BACTEC™ Mycosis-IC/F culture vials are for aerobic blood cultures. Principal use is with the BACTEC fluorescent series instruments for the selective culture and recovery of yeasts and fungi 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.

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 show 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:

*CLSI Strain

It is recommended that each shipment of media be tested for performance through the use of a positive and negative vial test. The positive vial should be inoculated with 0.1 mL of a 0.5 McFarland Standard of either Candida albicans (ATCC 10231) or Candida (Torulopsis) glabrata. This vial and an uninoculated vial should be logged into the instrument and tested. The inoculated vial should be detected as positive by the instrument within 72 hours. The negative control vial should remain negative. This verifies that the media were not subject to adverse storage or shipping conditions prior to receipt in your laboratory. If either of these vials do not give the expected results, do not use the media until you have contacted Technical Services at 1-800-638-8663, or your BD representative.

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

The BACTEC Mycosis-IC/F culture vials contain the following reactive ingredients prior to processing:

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