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English Lyfo Disk, Kwik-Stik, Kwik-Stik Plus Instructions For Use

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INSTRUCTIONS FOR USE

INTENDED USE
KWIK-STIK™, KWIK-STIK™ Plus and LYFO DISK™ microorganisms are intended to be used as controls to
verify the performance of assays, reagents or media that are intended to be used in microbial testing for the
detection and identification of a cultured microorganism isolate.

SUMMARY AND EXPLANATION


Microorganisms with known and predictable characteristics are used in quality control, education and
proficiency programs.

PRINCIPLE
KWIK-STIK, KWIK-STIK Plus and LYFO DISK microorganisms provide equivalent results to traditional
methods used in preparing, storing and maintaining reference stock culture collections. The microorganism
preparations are traceable to the American Type Culture Collection (ATCC®) or other authentic reference
culture collections.

COMPOSITION
KWIK-STIK, KWIK-STIK Plus and LYFO DISK pellets contain a pure population of microorganisms and
excipients for the purpose of structure and/or stability including gelatin, skim milk, ascorbic acid,
carbohydrate, and charcoal.

PRODUCT DESCRIPTION
A. KWIK-STIK: Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating
fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant
to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from
the reference culture and are guaranteed to recover when processed using the recommended media and
incubation requirements. Available in packs of 2 or 6.
B. KWIK-STIK Plus: Each KWIK-STIK Plus unit contains a lyophilized microorganism pellet, an ampoule of
hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a
desiccant to prevent adverse moisture accumulation. KWIK-STIK Plus microorganisms are 2 passages
from the reference culture and are guaranteed to recover when processed using the recommended
media and incubation requirements. Available in packs of 5.

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C. LYFO DISK: LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized
microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK
microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when
processed using the recommended media and incubation requirements.
These products have been registered as a medical device under Pakistan’s medical device rules.

WARNING AND PRECAUTIONS


• These products are for in-vitro diagnostic use.
• Not intended for human, animal or pet consumption.
• Refer to the Safety Data Sheet (SDS) for more detailed information. The SDS can be located on our
website at www.microbiologics.com or by contacting Technical Support at 320.229.7045 or U.S. Toll
Free 1.866.286.6691.
• The hydrating fluid in the KWIK-STIK and KWIK-STIK Plus may cause serious eye irritation. If in eyes,
rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do.
Continue rinsing. If irritation persists, get medical advice/attention.
• Wear protective gloves/protective clothing/eye protection/face protection. Wash hands thoroughly after
handling.
• These devices contain viable microorganisms that may produce disease. Proper techniques must be
employed to avoid exposure and contact with any microorganism growth.
• The microbiology laboratory must be equipped and have the facilities to receive, process, maintain, store
and dispose of biohazard material.
• Only trained laboratory personnel should use these devices.
• Agencies and statutes regulate the disposal of all biohazard materials. Each laboratory must be aware of
and comply with the proper disposal of biohazard materials.
• KWIK-STIK, KWIK-STIK Plus and LYFO DISK microorganisms are not made with natural rubber latex.

MATERIALS REQUIRED BUT NOT PROVIDED


• LYFO DISK microorganisms require sterile tubes and 0.5 ml of a sterile liquid such as Tryptic Soy Broth,
Brain Heart Infusion Broth, saline, or deionized water to hydrate the lyophilized preparation. Sterile
swabs or inoculating loops are needed to transfer the hydrated preparation to an agar plate.
• KWIK-STIK, KWIK-STIK Plus and LYFO DISK microorganisms require non-selective, nutritive or
enriched agar media and specific incubation times and conditions to optimize growth and
recovery.
The Technical Information Bulletin (TIB.081) Recommended Culture Methods lists the recommended
media and incubation requirements. This bulletin is available at www.microbiologics.com.

INSTRUCTIONS FOR USE


A. KWIK-STIK and KWIK-STIK Plus Microorganism Procedure
1. Allow the unopened KWIK-STIK pouch to equilibrate to room temperature. Tear open pouch at notch
and remove the KWIK-STIK unit.
2. Tear off Pull-Tab portion on the label and attach it to the primary culture plate or QC record. Do not
disassemble the device during hydration.
3. Over the edge of the work bench or counter, crack the ampoule at the top of the KWIK-STIK (just
below the fluid meniscus) to release the hydrating fluid.
4. Hold vertically and tap on a hard surface to facilitate flow of the fluid through the shaft into the bottom
of the unit where the pellet is contained.
PI.194.ENG Rev D English Page 2 of 6
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5. Using a pinching action on the bottom portion of the unit, crush the pellet in the fluid until the pellet
suspension is homogenous.
6. Immediately heavily saturate the swab with the hydrated material and transfer to the appropriate agar
medium, or use according to the laboratory’s SOP.
7. Inoculate the primary culture plate(s) by gently rolling the swab over one-third of the plate.
8. Using a sterile loop, streak to facilitate colony isolation.
9. Using proper biohazard disposal, discard the KWIK-STIK.
10. Immediately incubate the inverted inoculated primary culture plate(s) at temperature and conditions
appropriate to the microorganism. Culture method can be found on the product’s page at
www.microbiologics.com

B. LYFO DISK Microorganism Procedure


1. Remove the unopened LYFO DISK vial from 2°C to 8°C storage and allow to equilibrate to room
temperature.
2. Aseptically remove 1 pellet with sterile forceps from the vial. Do not remove desiccant.
3. Place the pellet in 0.5 ml of sterile fluid (water, saline, TSB, or BHIB). Immediately stopper and recap vial
and return to 2°C to 8°C storage.
4. Crush the pellet with a sterile swab until the suspension is homogenous. Immediately heavily saturate the
same swab with the hydrated material and transfer to agar medium.
5. Inoculate the primary culture plate(s) by gently rolling the swab over one-third of the plate.
6. Using a sterile loop, streak to facilitate colony isolation.
7. Using proper biohazard disposal, discard the remaining hydrated material.
8. Immediately incubate the inverted inoculated primary culture plate(s) at temperature and conditions
appropriate to the microorganism. Culture method can be found on the product’s page at
www.microbiologics.com

STORAGE AND EXPIRATION


Store LYFO DISK, KWIK-STIK and KWIK-STIK Plus microorganisms at 2°C to 8°C in the original, sealed vial or
pouch containing the desiccant. LYFO DISK, KWIK-STIK and KWIK-STIK Plus microorganisms should not be
used if:
• Stored improperly
• There is evidence of excessive exposure to heat or moisture
• The expiration date has passed

LIMITATIONS
This product may not be suitable for use with all kits and procedures.

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2018.JULY.30
KEY OF SYMBOLS
Authorized Representative in the European Consult Instructions for Use
Community

Batch Code (Lot) In Vitro Diagnostic Medical Device

Biological Risks Manufacturer

Catalog Number Temperature Limitation

Caution, Consult Accompanying Documents Use By

CE Mark

PRODUCT WARRANTY

These products are covered under warranty to meet the specifications and performance printed and illustrated in
product inserts, instructions and supportive literature. The warranty, expressed or implied, is limited when:
• the procedures employed in the laboratory are contrary to printed and illustrated directions and
instructions.
• the products are employed for applications other than the intended use cited in product inserts,
instructions and supportive literature.
• If the resuscitated culture is frozen, Microbiologics cannot guarantee the stated characteristics of the
product.

WEBSITE
Visit our website, www.microbiologics.com, for current technical information and product availability.

ACKNOWLEDGEMENTS
Microbiologics, Inc. MediMark® Europe
200 Cooper Avenue North 11, rue Emile Zola B.P. 2332
St. Cloud, MN 56303 USA 38033 Grenoble Cedex 2, France
Tel. 33 (0)4 76 86 43 22
Customer Service Fax. 33 (0)4 76 17 19 82
Tel. 320-253-1640 Email. info@medimark-europe.com
U.S. Toll Free. 800-599-BUGS (2847)
Email. info@microbiologics.com

Technical Support
Tel. 320-229-7045
U.S. Toll Free 866-286-6691
Email. techsupport@microbiologics.com
www.microbiologics.com

*Look for the ATCC Licensed Derivative® Emblem for products derived from ATCC® cultures. The ATCC Licensed Derivative Emblem, the ATCC
Licensed Derivative Work Mark, and the ATCC Catalog Marks are trademarks of ATCC. Microbiologics, Inc. is licensed to use these trademarks and to
sell products derived from ATCC® cultures.

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2018.JULY.30
ILLUSTRATED INSTRUCTIONS

Over the edge of the work bench or


counter, crack the ampoule at the top
of the KWIK-STK (just below the fluid
meniscus of the ampoule) found in
Allow the unopened KWIK-STIK the cap to release the hydrating fluid.
pouch to equilibrate to room Tear off pull-tab portion on the label
temperature. Tear open pouch at and attach it to the primary culture
notch and remove the KWIK-STIK plate or QC record. Do not
unit. disassemble the device during
hydration.

Using a pinching
Hold vertically and action on the
tap on a hard bottom portion
surface to facilitate
of the unit, crush
flow of the fluid
through the shaft the pellet in the
Immediately heavily saturate the
into the bottom of fluid until the
swab with the hydrated material
unit where the pellet
and transfer to the appropriate agar
pellet is contained. suspension is
medium, or use according to the
homogenous.
laboratory’s SOP.

Using proper
biohazard
disposal, discard
the KWIK-STIK

Immediately incubate the


inverted inoculated primary
culture plate(s) at temperature
and conditions appropriate to
Inoculate the primary culture plate(s) the microorganism.
Using a sterile loop, streak to facilitate
by gently rolling the swab over one- colony isolation. Culture method can be found on the
third of the plate. product's page at microbiologics.com

PI.194.ENG Rev D English Page 5 of 6


2018.JULY.30
ILLUSTRATED INSTRUCTIONS

Place the pellet in


Remove the unopened Aseptically 0.5 ml of sterile
LYFO DISK vial from remove 1 pellet fluid (water, saline,
2°C to 8°C storage and with sterile TSB, or BHIB).
allow to equilibrate to forceps from the Immediately stopper
room temperature. vial. Do not and recap vial and
remove return to 2°C to 8°C
desiccant. storage.

Inoculate the primary culture


plates(s) by gently rolling the swab Using a sterile loop, streak to
over one-third of the plate. facilitate colony isolation.

Immediately incubate the inverted


Crush the pellet with a sterile swab inoculated primary culture plate(s)
until the suspension is homogenous. at temperature and conditions
Using proper biohazard disposal appropriate to the microorganism.
Immediately heavily saturate the
discard the remaining hydrated
same swab with the hydrated material Culture method can be found on the
material.
and transfer to agar medium. product's page at microbiologics.com

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2018.JULY.30

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