Hardy Diagnostics HUGO

LYFO DISK ® AND KWIK-STIK™ MICROORGANISMS BY MICROBIOLOGICS

Cat. no. ____L LYFO DISK ® Vials 6 LYFO DISK ® pellets/vial
Cat. no. ____K KWIK-STIK™ Canisters 6 KWIK STIK™ units/canister
Cat. no. ____P KWIK STIK™ DuoPak 2 KWIK STIK™ units/canister

SUMMARY AND PRINCIPLE

A reliable source of reference stock cultures for use in Microbiology Quality Assurance programs is essential. Microorganisms with known and predictable growth requirements, selective and differential properties, biochemical activity or phenotypic profiles, serological, assay responses, antimicrobial susceptibility characteristics, and assay values are used in Quality Control, education and proficiency programs.

Ultra-cold freezing and lyophilization are well-documented methods for preserving microorganisms. LYFO DISK ® and KWIK-STIK™ Microorganisms incorporate a lyophilization method, reported by Obara et al., which uses a suspending medium consisting of gelatin, skim milk, ascorbic acid, dextrose and charcoal. The gelatin serves as a carrier for the microorganism. Skim milk, ascorbic acid, and dextrose protect the microorganism by preserving the integrity of the cell wall during freeze-drying and storage. The charcoal is included to neutralize any toxic substances formed during the lyophilization process.

LYFO DISK ® and KWIK-STIK™ Microorganisms are derivatives and are traceable to authentic reference culture collections such as the American Type Culture Collection (ATCC ® ).

SPECIFICATIONS AND PERFORMANCE

The production and process design for these lyophilized microorganism preparations results in a pure population of an individual microorganism that is traceable to an authentic reference culture.

Quality Assurance documentation includes, but is not limited to, the product label and a Certificate of Analysis stating:

The Certificate of Analysis (attached to the Packing Slip) is included in each microorganism shipment.

PRODUCT DESCRIPTION

A. LYFO DISK ® Microorganisms

LYFO DISK ® Microorganisms are packaged in a resealable vial that contains six (6) lyophilized pellets of a single microorganism strain and a desiccator to prevent adverse moisture accumulation.

B. KWIK-STIK™ Microorganisms

Each KWIK-STIK™ unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccator to prevent adverse moisture accumulation. KWIK-STIK™ Microorganisms are available as

C. MICROORGANISM SETS

Microorganism Sets are combinations of LYFO DISK ® or KWIK-STIK™ Microorganisms that are used together for common applications.

STORAGE AND EXPIRATION

Store the LYFO DISK ® and KWIK-STIK™ Microorganisms at 2-8ºC. in the dark, in the original, sealed pouch or vial containing the desiccator. The lyophilized microorganism may be rendered nonviable by an abnormal accumulation of moisture in the pellet, or excessive heat, due to improper storage or handling.

The LYFO DISK ® and KWIK-STIK™ Microorganisms should not be used if:

PRECAUTIONS AND LIMITATIONS

These products are for laboratory use and are to be used only by adequately trained and qualified laboratory personnel. Observe approved biohazard precautions and aseptic techniques. All laboratory specimens should be considered infectious and handled according to "standard precautions." The "Guideline for Isolation Precautions" is available from The Centers for Disease Control and Prevention at www.cdc.gov/ncidod/dhqp/gl_isolation.html .

For additional information regarding specific precautions for the prevention of the transmission of all infectious agents from laboratory instruments and materials, and for recommendations for the management of exposure to infectious disease, refer to CLSI document M-29: Protection of Laboratory Workers from Occupationally Acquired Infections: Approved Guideline.

Sterilize all biohazard waste before disposal.

Refer to the keyword "Precautions," in the Hardy Diagnostics software program HUGO™, for more information regarding general precautions when using culture media.

Refer to the keyword "MSDS," in the Hardy Diagnostics software program HUGO™, for more information on handling potentially hazardous material.

IMPORTANT CONSIDERATIONS

Lyophilized microorganisms are no different than naturally occurring strains with regard to their requirements for nutrients, specific supplements, incubation temperatures, or environment demands.

INSTRUCTIONS FOR USE

LYFO DISK ® Microorganisms

Click For Illustrated Instructions

1. Remove the LYFO DISK ® vial from 2-8ºC. storage and allow the unopened vial to equilibrate to room temperature.

2. Using sterile forceps, aseptically remove one (1) gelatin pellet from the vial. Do not remove the desiccant. Place the pellet in 0.5ml of sterile Tryptic Soy Broth, Brain Heart Infusion Broth, saline, or deionized water. IMMEDIATELY stopper and recap vial and return to 2-8ºC. storage.

3. Emulsify and crush pellet with a sterile swab until the pellet particles are uniform in size and the suspension is homogenous in appearance. DO NOT INCUBATE.

4. IMMEDIATELY saturate the swab with the hydrated material and transfer the material to an appropriate, non-selective, nutrient or enriched agar medium. With pressure, rotate the swab, and inoculate a circular area (i.e. one inch or 25mm in diameter) of the agar medium. Using the same swab or a sterile loop, repeatedly (about 10 to 20 times) streak through the inoculated area and then continue to streak the remainder of the agar surface.

5. Release the hydrating fluid by breaking the ampoule using a pinching action at the middle of the ampoule in the cap of the device. Allow the hydrating fluid to flow through the swab shaft and INTO the bottom portion of the unit containing the gelatin pellet.

6. IMMEDIATELY incubate the inoculated media at temperature and atmospheric conditions that are appropriate for the microorganism.

7. Following incubation, select representative well-isolated colonies for indicated transfers.



KWIK-STIK™ Microorganisms

Click For Illustrated Instructions

1. Remove the KWIK-STIK™ unit from 2-8ºC. storage and allow the unopened pouch to equilibrate to room temperature.

2. Open the pouch and remove the KWIK-STIK™ unit.

3. Tear off the pull tab portion of the label from the KWIK-STIK™ device. The label can be attached to permanent QC Records or attached to the primary plate agar medium for identification.

4. Take note of the position of the gelatin pellet in the bottom part of the device and the reservoir of hydrating fluid in the top (cap) part of the device. DO NOT DISASSEMBLE THE DEVICE DURING HYDRATION.

5. Release the hydrating fluid by pinching the very top of the ampoule in the cap of the device. PINCH AMPOULE ONLY ONCE TO AVOID INJURY. Allow the hydrating fluid to flow through the swab shaft and into the bottom portion of the unit containing the gelatin pellet.

6. Holding the device vertically, with the cap up, and tapping the bottom of the device on the counter can further facilitate the flow of the fluid.

7. Using a pinching action on the bottom portion of the unit, crush and mix the pellet in the fluid until the pellet particles are uniform in size and the suspension is homogenous in appearance. DO NOT INCUBATE.

8. Now that the swab is saturated with the hydrated material, immediately transfer the material to an appropriate, non-selective, nutrient or enriched agar medium. With pressure, rotate the swab and inoculate a circular area (i.e. one inch or 25mm in diameter) of the agar medium. With a sterile loop, streak repeatedly through the inoculated area in order to obtain isolated colonies.

9. Discard the remaining hydrated material in accordance with the laboratory protocol for disposal of biohazardous materials.

10. IMMEDIATELY incubate the inoculated media at temperature and atmospheric conditions that are appropriate for the microorganism.

11. Following incubation, select representative well-isolated colonies for indicated transfers.

QUALITY CONTROL

This product is produced in compliance with the FDA: Quality System Regulation; 1996 (QSR). Quality Control functions include, but are not limited to, purity, growth characteristics, morphological features and biochemical activity. The decision to perform additional in-house Quality Control is the responsibility of each individual laboratory.

MATERIALS REQUIRED BUT NOT PROVIDED

The document "Growth Requirements" lists the recommended media and incubation requirements.

REFERENCES

1. Clinical Microbiology Procedure Handbook. Vol. I & II. 1st ed. 1992. ASM. Washington, D.C.

2. Compendium of Methods for the Microbiological Examination of Food.

3. FDA Bacteriological Analytical Manual.

4. Manual of Clinical Microbiology, 4th ed. 1985. ASM, Washington, D.C.

5. Journal of Clinical Microbiology. 1981. 14:61-66.

6. Manual of Quality Control Procedures for Microbiology Laboratories, 3rd ed., 1981. CDC, Atlanta, GA.

7. Methods for Dilution Antimicrobial Susceptibility Test for Bacteria that Grow Anaerobically. CLSI (formerly NCCLS).

8. Official Methods of Analysis of the Association of Official Analytical Chemists.

9. Performance Standards for Antimicrobial Disk Susceptibility Tests. CLSI (formerly NCCLS).

10. Quality Control for Commercially Prepared Microbiological Culture Media. CLSI (formerly NCCLS).

11. Reference Agar Dilution Procedure Antimicrobial Susceptibility Testing of Anaerobic Bacteria. CLSI (formerly NCCLS).

12. Standard Methods for the Examination of Dairy Products.

13. Standard Methods for the Examination of Water and Wastewater.

14. U.S. Pharmacopeia 24 and National Formulary 19.


This document is provided for general product information only. It does not replace the manufacturer's product insert. Always refer to the actual product insert for procedural use and for most recent product information.

ATCC is a registered trademark of the American Type Culture Collection.
LYFO DISK is a registered trademark of MicroBioLogics, Inc., St. Cloud, MN.
KWIK-STIK is a trademark of MicroBioLogics, Inc., St. Cloud, MN.

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