OXY-SWAB Following Recommended Guidelines.5,6

light pink to light rusty brown. This color variation does not affect the performance of the test.

SPECIMEN COLLECTION, STORAGE, TRANSPORT ® Specimens should be collected and handled OXY-SWAB following recommended guidelines.5,6

INTENDED USE Remel OXY-SWAB® is a reagent-impregnated swab MATERIALS REQUIRED BUT NOT SUPPLIED recommended for use as a rapid, qualitative test for (1) Loop sterilization device, (2) Inoculating loop, the detection of cytochrome oxidase activity in swabs, collection containers, (3) Incubators, microorganisms. alternative environmental systems, (4) Supplemental media, (5) Quality control organisms. SUMMARY AND EXPLANATION Oxidase-positive bacteria possess cytochrome PROCEDURE oxidase which is the last link in the chain of aerobic 1. Test isolate should be 18-24 hours old and respiration.1 This enzyme system is usually only grown on a medium that is nonselective and present in aerobic organisms. McLeod and Gordon nondifferential (e.g., blood agar, tryptic soy used the oxidase test to differentiate closely related agar, chocolate agar, etc.). 2 bacteria and aid in the identification of gonococci. In 2. Touch the OXY-SWAB® gently to a well-isolated 1947, Carpenter et al. described an improved oxidase colony. test using an oxalate salt of ρ-aminodimethylaniline.3 3. Press the inoculated area of the swab against PRINCIPLE the inside wall of the petri dish to diffuse the Cytochromes are iron-containing hemoproteins that inoculum into the swab fibers. This eliminates link with the aerobic respiratory chain by transferring the possibility of an inoculum that is too heavy hydrogen to oxygen, with the formation of water. In and accelerates the reaction. the oxidase test, reagent dyes substitute for oxygen as artificial electron acceptors. Hydrogen is 4. Observe for the development of a purple to transferred to ρ-phenylenediamine instead of oxygen. black color within 10 to 30 seconds. In a positive reaction, ρ-phenylenediamine is oxidized, producing a purple colored compound.4 INTERPRETATION Positive Test - Development of a purple to black REAGENTS color within 10 to 30 seconds Reactive ingredient: Negative Test -Delayed reactions or no color N,N-Dimethyl-ρ-phenylenediamine change

PRECAUTIONS QUALITY CONTROL This product is for In Vitro diagnostic use and should All lot numbers of OXY–SWAB® have been tested be used by properly trained individuals. Precautions using the following quality control organisms and should be taken against the dangers of have been found to be acceptable. Testing of control microbiological hazards by properly sterilizing organisms should be performed in accordance with specimens, containers, and media after use. established laboratory quality control procedures. If Directions should be read and followed carefully. aberrant quality control results are noted, patient results should not be reported. STORAGE This product is ready for use and no further CONTROL INCUBATION RESULTS preparation is necessary. Store product in its original Pseudomonas Ambient, up to 30 Positive container at 2-8°C in the dark. Do not freeze or over- aeruginosa seconds @ 25°C heat. Allow product to equilibrate to room ATCC® 27853 temperature (20-25°C) before use. Once opened, the foil package can be folded over and resealed Neisseria Ambient, up to 30 Positive before returning to storage at 2-8°C. gonorrhoeae seconds @ 25°C ATCC® 43069 PRODUCT DETERIORATION This product should not be used if (a) the expiration Escherichia coli Ambient, up to 30 Negative date has passed or (b) there are other signs of ATCC® 25922 seconds @ 25°C deterioration. Note: Color of swabs ranges from very

LIMITATIONS 6. Forbes, B.A., D.F. Sahm, and A.S. Weissfeld. 2007. th 1. Select colonies for testing which have not been Bailey and Scott’s Diagnostic Microbiology. 12 ed. grown on selective, differential, or glucose- Mosby Elsevier, St. Louis, MO. 7. Winn, W., S. Allen, J. William, E. Koneman, G. Procop, containing media. Selective and differential P. Schreckenberger, and G. Woods. 2006. Koneman’s agents and the end-products of glucose Color Atlas and Textbook of Diagnostic Microbiology. fermentation have been shown to inhibit oxidase 6th ed. Lippincott Williams and Wilkins, Baltimore, MD. 1 activity and cause false-negative results. 2. False-negative results may occur if mixed PACKAGING cultures contain the two genera, Neisseria and OXY-SWAB®: Pseudomonas. An inhibitory substance is REF R249348 (25 swabs/envelope) ...... 4/Pk produced by Pseudomonas spp. which interferes with the production of oxidase by 1 Symbol Legend Neisseria spp. 3. The oxidase test only occurs in the presence of REF Catalog Number atmospheric oxygen; oxygen must reach the 1 colonies for optimal results. IVD In Vitro Diagnostic Medical Device 4. Organisms which are weak-oxidase producers, such as Pasteurella spp., may appear negative LAB For Laboratory Use within the 10-30 second time limit. If such an organism is suspected, allow 60 seconds to Consult Instructions for Use (IFU) elapse before reporting as oxidase-negative.7 Temperature Limitation (Storage Temp.)

BIBLIOGRAPHY LOT Batch Code (Lot Number) 1. MacFaddin, J.F. 2000. Biochemical Tests for rd Identification of Medical Bacteria. 3 ed. Lippincott Use By (Expiration Date) Williams & Wilkins, Philadelphia, PA.

2. Gordon, J. and J.W. McLeod. 1928. J. Pathol. ® Bacteriol. 31:185-190. OXY-SWAB is a registered trademark of Remel Inc. ATCC® is a registered trademark of American Type Culture Collection. 3. Carpenter, C.M., L.G. Suhrland, and M. Morrison.

1947. Science, 105: 649. 4. W.H. Ewing. 1986. Edwards and Ewing’s Identification th of Enterobacteriaceae. 4 ed. Elsevier Science

Publishing Co., Inc., New York, N.Y.

5. Murray, P.R., E.J. Baron, J.H. Jorgensen, M.L. Landry, and M.A. Pfaller. 2007. Manual of Clinical Microbiology. 9th ed. ASM Press, Washington, D.C. IFU 49348, Revised July 26, 2010 Printed in U.S.A.

12076 Santa Fe Drive, Lenexa, KS 66215, USA General Information: (800) 255-6730 Website: www.remel.com Email: [email protected] Local/International Phone: (913) 888-0939 International Fax: (913) 895-4128