Thermo Fisher Scientific LBL-60110 Operating instructions

Brand: Thermo Fisher Scientific

Model: LBL-60110

Type: Operating instructions

Thermo Fisher Scientific LBL-60110, the Accula™ Flu A/Flu B Control Kit, is designed for quality control testing with the Accula™ Flu A/Flu B Test. It provides swabs coated with dried, inactivated influenza A or B virus, helping to verify test and operator performance. The kit includes positive and negative swabs for both influenza A and B, ensuring reliable results.

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.

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5 May 2022