[+1] 800.221.6058 United States Directions For Use for the following: [+1] 360.260.2779 International Sudan III Stain INTENDED USE BIBLIOGRAPHY Sudan III Stain is used to detect fat in feces, urine and tissues. Patients 1. Balows, A., et al., 1991. Manual of Clinical Microbiology. ASM, demonstrating fat in stool (i.e., steatorrhea) may have a correlation to Washington, D.C., Fifth Ed. pancreatic diseases or other fat absorption diseases. 2. Clark, G., 1973. Staining Procedures. Biological Stain Commission. 3. Drummey, G.D.F., et al., 1961. “Microscopically Examination of the SUMMARY Stool for Steatorrhea,” Medical Intelligence”. Vol. 264, pp. 85-87. Intracellular protein-bound lipids are readily demonstrable by the use of 4. Gradwohl’s Clinical Laboratory Methods and Diagnosis, Eighth Sudan dyes when dissolved (or mixed) in a lipid solvent or wet Edition, 1980. specimen. When the specimen is mixed with the dye solvent (stain) the 5. Sonnenwirth, A., et al., 1980. Gradwohl’s Clinical Laboratory dye leaves the solvent for the intracellular (or extracellular) lipid, which Methods and Diagnosis, C.V. Mosby Co. takes on the color of the dye. The staining process is a physical 6. Van de Kamer, J.H., ten Bokkel Huinick, H., and Weyers, H.A., phenomenon that does not differentiate between the various types of 1949. “Rapid Method for Determination of Fat in Feces”. J. Biol. lipids. Sudan III and Sudan IV will stain neutral fats, while Sudan B will Chem., 177:347-355. identify phospholipids. CONTACT FOR IN VITRO DIAGNOSTIC USE ONLY Alpha-Tec Systems, Inc. offers a complete line of reagents, stains, and QC1™ Quality Control Slides for AFB, Parasitology, Bacteriology, and PRECAUTIONS Mycology processing, as well as O&P collection systems and For safety considerations, analysis of samples and cultures should be concentration devices for Parasitology. For Technical Assistance, email performed within a certified Class II biological safety cabinet (BSC). Any [email protected], and for Customer Service, email laboratory procedure involving infectious materials or cultures requires [email protected], or call either [+1] 800.221.6058 (USA) standard personal protective safety equipment, such as latex gloves and or [+1] 360.260.2779 between 8AM and 4PM Monday through Friday, laboratory coats (or disposable coats), and eye protection. Pacific Time. Decontamination can be accomplished with commercially available bleach solutions, diluted to an appropriate working concentration. WARRANTY Countertops, work surfaces and instruments can be wiped with the This product is warranted by Alpha-Tec Systems, Inc. to perform as bleach solution. ab supplies (pipettes, loops, microscope slide, etc.) described in the labeling and literature supplied. Alpha-Tec Systems, should be immersed in decontamination solution and then autoclaved. Inc. disclaims any implied warranty or merchantability or fitness for any other purpose, and in no event shall Alpha-Tec Systems, Inc. be liable STABILITY AND STORAGE for any consequential damages arising out of aforesaid express warranty. The stain solution is stable for 18 months following manufacturing. Refer to the listed expiration date on the stain reagent bottles. Store the stain TRADEMARKS solution at 15-30ºC (room temperature) away from direct light. QC1™ is a trademark of Alpha-Tec Systems, Inc., 1311 SE Cardinal Court, Suite 170, Vancouver, WA 98683 USA. USER QUALITY CONTROL Positive Control: Use a known source of neutral fats. PRODUCT CODES Out of Control Results: Recheck the positive control as a source of 0003537 Sudan III Stain, 25 ml neutral fat. Repeat the stain test. If the Positive Control fails, reorder a new lot of stain. SPECIMEN COLLECTION AND PROCESSING The most common specimens utilized for the Sudan III Stain are feces, urine or tissue. For patients suspected of steatorrhea, a fecal specimen is indicated. PROCEDURE Materials Provided: Sudan III Stain. Materials Not Provided: Applicator sticks, slides, coverslips, immersion oil, microscope. SPECIMEN PROCESSING 1. Place a small portion of the sample onto a clean glass slide. 2. Add a few drops of the Sudan III Stain to the sample and mix into the sample with an applicator stick. 3. Coverslip the stained specimen. If it becomes necessary to extend the viewing time, seal the coverslip to avoid evaporation of the dye. 4. View under a light microscope with low and high power. EXPECTED RESULTS Fat will stain orange to red. Cholesterol will stain less brilliant red. Cellular fatty acids will not stain. NOTE: Sudan III will give a darker orange-red or red color and is more stable in alcohol than Sudan IV. L003537.D // CC19-020, Effective Date: 16 May 2019 // ©2019 Alpha-Tec Systems, Inc. All rights reserved. 1 [+1] 800.221.6058 United States Directions For Use for the following: [+1] 360.260.2779 International Sudan III Stain L003537.D // CC19-020, Effective Date: 16 May 2019 // ©2019 Alpha-Tec Systems, Inc. All rights reserved. 2 .