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SABOURAUD DEXTROSE (SABDEX) MEDIA, USP

Cat. no. W70 SabDex Agar, USP, 15x100mm Plate, 26ml 10 plates/bag
Cat. no. H39 SabDex Agar, USP, 15x150mm Plate, 70ml 10 plates/bag
Cat. no. Q31 SabDex Agar, USP, 20x125mm Tube, 18ml Deep 20 tubes/box
Cat. no. Q83 SabDex Agar, USP, 20x150mm Tube, 20ml Deep 100 tubes/box
Cat. no. U227 SabDex Agar, USP, 16oz Glass Bottle, 200ml 12 bottles/box
Cat. no. U270 SabDex Agar, USP, 500ml Polypropylene Bottle, 200ml 10 bottles/box
Cat. no. U352 SabDex Agar, USP, 16oz Glass Bottle, 400ml 12 bottles/box
Cat. no. U353 SabDex Agar, USP, 500ml Polycarbonate Bottle, 500ml 10 bottles/box
Cat. no. W82 SabDex Agar Blue, USP, 15x100mm Plate, 26ml 10 plates/bag
Cat. no. W1770 SabDex Agar, Irradiated, USP, 15x100mm Plate, 18ml, Triple Bagged* 10 plates/bag
Cat. no. U73 SabDex Broth, USP, 125ml Polycarbonate Bottle with Septum Cap, 100ml 16 bottles/box
* A third/fourth sterile sample bag is included for packaging after the sample is collected.

INTENDED USE

Hardy Diagnostics Sabouraud Dextrose Agar and Sabouraud Dextrose Broth are recommended for the isolation, cultivation, and maintenance of non-pathogenic and pathogenic species of fungi and yeasts, and meet the harmonized USP/EP/JP standards for the microbial examination of non sterile products.

This product is not intended to be used for the diagnosis of human disease.

SUMMARY

Sabouraud Dextrose Agar was formulated by Sabouraud in 1892 for culturing dermatophytes.(3) The pH is adjusted to approximately 5.6 in order to enhance the growth of fungi, especially dermatophytes, and to slightly inhibit bacterial growth.(1) This medium is recommended for mold and yeast counts by the U.S. Pharmacopeia, Standard Methods for the Examination of Water and Wastewater, the Association of Official Analytical Chemists, and the Compendium of Methods for the Microbiological Examination of Foods.(2,4-6) Sabouraud Dextrose Broth is a modification of the original formulation made without agar. It is recommended by the U.S. Pharmacopeia for sterility testing of pharmaceutical products.(5,6)

Sabouraud Dextrose Medium contains digests of animal tissues (peptones) and casein which provide a nutritious source of amino acids and nitrogenous compounds for the growth of fungi and yeasts. Dextrose is added as the energy and carbon source.

Cat. no. W1770 is triple bagged and sterilized by irradiation to promote a higher sterility assurance level. A fourth sterile sample bag is included for packaging after the sample is collected.

FORMULA

Ingredients per liter of deionized water:*

Sabouraud Dextrose Agar:
Dextrose 40.0gm
Pancreatic Digest of Casein 5.0gm
Peptic Digest of Animal Tissue 5.0gm
Agar 15.0gm

Final pH 5.6 +/- 0.2 at 25°C.

In addition,

Sabouraud Dextrose Broth is the same formulation as above, without agar added.

Final pH 5.6 +/- 0.2 at 25°C.

* Adjusted and/or supplemented as required to meet performance criteria.

STORAGE AND SHELF LIFE

Storage: Upon receipt store plated products (Cat. no. W70, W1770, H39, and W82) at 2-8°C away from direct light. SabDex media tubed and bottled products (Cat no. Q83, Q31, U73, U227, U270, U352, and U353) should be stored at 2-30°C away from direct light.

Media should not be used if there are any signs of deterioration (shrinking, cracking, or discoloration), contamination, or if the expiration date has passed. Product is light and temperature sensitive; protect from light, excessive heat, moisture, and freezing.

PRECAUTIONS

Cat. no. W70

Cat. nos. H39, Q31, Q83, U227, U270, U352, U353, W82, W1770, U73

PROCEDURE

Specimen Collection: Consult listed references for information on specimen collection, processing and inoculation. (2,4-6)

For re-melting solid tube and bottle media: Autoclave containers with slightly loose caps at 121ºC for 1-3 minutes or until melted. Do not heat media longer than 3 hours at 45-50ºC. Alternatively, solid agar in capped containers can be racked and placed in a covered, boiling water bath (100ºC) before use. There should be enough water in the water bath to reach the top of the media line. A covered water bath will maintain consistent temperature of the media until melted. Cool media to 45-50ºC and aseptically dispense into sterile containers. Note: Sterile solidified media can be re-melted only once. In addition, the use of microwaves to melt media is not advised.

Examine SabDex Broth for growth by comparing turbidity to an uninoculated control. Subculture onto an appropriate agar medium when growth is observed.

Sedimentation (Settling) Plate Method: Place the plate on a clean piece of paper and expose the agar by removing the lid. Do not invert the lid while removed to avoid exposure to falling sediment. Expose the agar for 15 minutes or longer, depending upon established procedures, and replace the lid. Incubate according to laboratory protocol.

INTERPRETATION OF RESULTS

Identification of fungi is performed by observing various aspects of colony morphology, characteristic microscopic structures, rate of growth, media which supports the organism's growth, and source of specimen. Yeasts are identified by various biochemical tests. Consult the listed references for information regarding the identification and further testing of fungi and yeast cultures.(2,4-6)

After incubation, the colonies are counted, and the results are expressed as the number of colonies per square foot per minute. For Cat. no. W1770, the petri plate area is approximately 100cm2, the number of counted colonies can be divided by 100 to provide the estimated number of colonies per square centimeter.

LIMITATIONS

MATERIALS REQUIRED BUT NOT PROVIDED

Standard microbiological supplies and equipment such as loops, slides, colony counters, microscopes, MycoSeals™ (Cat. no. SS9225), incinerators, and incubators, etc., as well as serological and biochemical reagents, are not provided.

QUALITY CONTROL

Test Organisms** Inoculation Method* Incubation Results
Time Temperature Atmosphere
Candida albicans
ATCC® 10231
J 24-48hr 20-25°C Aerobic Growth
Aspergillus brasiliensis
ATCC® 16404
J 1-5 days 20-25°C Aerobic Growth

Tested in accordance with USP <61> and <62>.(5,6)

** Consult appropriate regulatory agency for user QC requirements.

User Quality Control

PHYSICAL APPEARANCE

Sabouraud Dextrose Media should appear translucent, and light amber in color.

SabDex Agar

Uninoculated plate of Sabouraud Dextrose Agar.

REFERENCES

1. Ajello, et al. 1963. CDC Laboratory Manual for Medical Mycology, PHS Publication No. 994. U.S. Gov't Printing Office, Washington, D.C.

2. U.S. Food and Drug Administration. Bacteriological Analytical Manual. AOAC, Arlington, VA. www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/default.htm =

3. Sabouraud, R. 1892. Ann. Dermatol. Syphil.;3:1061.

4. APHA Technical Committee on Microbiological Methods for Foods. 2001. Compendium of Methods for the Microbiological Examination of Foods, 4th ed. APHA, Washington, D.C.

5. The Official Compendia of Standards. USP General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. USP-NF. United States Pharmacopeial Convention Inc., Rockville, MD.

6. The Official Compendia of Standards. USP General Chapter <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. USP-NF. United States Pharmacopeial Convention Inc., Rockville, MD.

ATCC is a registered trademark of the American Type Culture Collection.

101416gr