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Thermo Fisher Scientific Accula Flu A/Flu B Test Control Kit Operating instructions

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Accula™ Flu A/Flu B Control Kit
Catalog NumberFAB1100CW-C
Pub.No. LBL-60110 Rev. A
Intended use
The Accula™ Flu A/Flu B Control Kit is intended for in vitro
diagnostic use in quality control testing with the Accula™
Flu A/Flu B Test.
Product description
The Accula™ Flu A/Flu B Control Kit provides swabs coated with
dried, inactivated influenza A or influenza B virus. The level of
influenza A or influenza B virus applied to the swab is sucient to
provide a positive result when used with the Accula™ FluA/FluB
Test. The Accula™ Flu A Positive/Flu B Negative Swab acts as a
negative control for influenza B; the Accula™ Flu B Positive/Flu
A Negative Swab serves as a negative control for influenza A.
When used for quality control with the Accula™ Flu A/Flu B Test,
these controls are useful as an aid in verifying test and operator
performance.
Materials provided
Each Accula™ Flu A/Flu B Control Kit contains the following:
• Accula™ Flu A Positive/Flu B Negative Swab (yellow shaft,
3 swabs)—Contains inactivated influenza A virus dried onto a
swab.
• Accula™ Flu B Positive/Flu A Negative Swab (blue shaft,
3 swabs)—Contains inactivated influenza B virus dried onto a
swab.
• Electronic documentation instructions
Storage
• Accula™ Flu A/Flu B Control Kit must be stored at
15°C to 30°C (59°F to86°F).
• Swabs should be kept in the sealed pouch until testing.
Materials provided separately
• Accula™ Dock
– Catalog No. D2000
– Catalog No. D2002 (Contact your sales representative
for information on ordering this item)
• Accula™ Flu A/Flu B Test—Catalog No. FAB1100CW
Warnings and precautions
• For in vitro diagnostic use.
• Federal law restricts sale of this product to or on the order of
a licensed practitioner.
• To be used in conjunction with the Accula™ Flu A/Flu B Test
and the Accula™ Dock.
• Do not use the controls past their expiration date.
• Inactivated influenza A and influenza B viruses are used to
make the control swabs. However, control swabs and used
cassettes should be handled as though they could transmit
disease. Observe established precautions against microbial
hazards during use and disposal.
• Wear protective clothing such as laboratory coats,
disposable gloves, and eye protection when handling
samples.
• Do not use any damaged kit contents.
• Do not touch the heads of the control swabs. Cross-
contamination may occur due to the high sensitivity of the
test.
• Follow proper infection control guidelines for handling all
specimens, control swabs, and related items. Properly
dispose of all contaminated waste according to federal,
state, and local requirements.
• Not for patient use.
• Swabs stored in the foil pouch at 15°C to 30°C (59°F to 86°F)
are stable until the expiration date printed on the pouch.
Instructions for use
Process the Accula™ Flu A/Flu B Control Kit swabs as you would a
patient sample in accordance with the procedure for the Accula™
Flu A/Flu B Test. Read the instructions for use provided with the
Accula™ Flu A/Flu B Test before using the Accula™ Flu A/Flu B
Control Kit.
Expected results
The following results are expected when using the control swabs
with the Accula™ Flu A/Flu B Test:
• Accula™ Flu A Positive/Flu B Negative Swab should yield a
positive result for Flu A and a negative result for FluB.
• Accula™ Flu B Positive/Flu A Negative Swab should yield a
positive result for Flu B. and a negative result for FluA.
Disposing of material
Discard hazardous or biologically contaminated materials
according to your institution's practices. Discard all materials in a
safe and acceptable manner that is in compliance with all country,
state, and local requirements.
INSTRUCTIONS FOR USE
For In Vitro Diagnostic Use.
Technical support
If external QC testing fails, repeat the test using new control
swabs, reagents, and test cassettes, or contact Technical Support
before continuing with further samples.
Email: techsupport@thermofisher.com
Telephone: 1-800-955-6288, option 2
For the latest service and support information at all locations, or
to obtain Certificates of Analysis or Safety Data Sheets (SDSs;
also known as MSDSs), go to thermofisher.com/support.
Symbols
DO NOT REUSE MANUFACTURER
POSITIVE
CONTROL READ SAFETY
DATA SHEET
USE BY
UPPER AND
LOWER
TEMPERATURE
LIMIT
IN VITRO
DIAGNOSTIC
MEDICAL DEVICE
CONSULT
INSTRUCTIONS
FOR USE
CATALOG
NUMBER
NEGATIVE
CONTROL BATCH CODE PATIENT NUMBER
CAUTION:
FEDERAL LAW
RESTRICTS THIS
DEVICE TO SALE
BY OR ON ORDER
OF A PHYSICIAN
Mesa Biotech, Inc. | 6190 Cornerstone Court East, Suite 220 | San Diego, CA 92121 USA
The information in this guide is subject to change without notice.
DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT,
PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.
Revision history: Pub. No.LBL-60110
Revision Date Description
A 5 May 2022
• Supersedes LBL-60016.
• Initial document release with new publication number, using the latest Thermo Fisher
Scientific template, with associated logos, trademarks, and format.
Important Licensing Information: These products may be covered by one or more Limited Use Label Licenses. By use of these products, you accept the terms and conditions of all
applicable Limited Use Label Licenses.
©2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
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