Product Manual

ManualsBrandsLifeSign ManualsFlu/Influenza A+B TestStatus Flu A & B Test Kit - 25 Tests

Table Of Contents

A PBM Group Company

71 Veronica Avenue,

Somerset, NJ 08873

800-526-2125, 732-246-3366

www.lifesignmed.com

Princeton BioMeditech Corporation

4242 U.S. Hwy 1, Monmouth Jct.

New Jersey 08852, U.S.A.

1-732-274–1000 www.pbmc.com

Manufactured for:

Manufactured by

Printed in U.S.A.

P-52718

484-12/23/10

Rapid Immunoassay for Direct Detection and

Diagnosis of Influenza Type A and Type B

For in vitro diagnostic use only

LifeSign LLC

Catalog No. 36022 22 Test Kit

Intended Use

Status Flu A & B is an in vitro rapid qualitative test that detects influenza type

A and type B nucleoproteins antigens directly from nasal swab,

nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens

obtained from patient with signs and symptoms of respiratory infection. It is

intended to aid in the rapid differential diagnosis of influenza A and B viral

infections.

Negative test results are presumptive and it is recommended these results

be confirmed by viral culture. Negative results do not preclude influenza

virus infection and should not be used as the sole basis for treatment or

other management decisions. The test is intended for professional and

laboratory use.

Performance characteristics for influenza were established during the

2007-2009 influenza seasons when influenza A viruses New Caledonia/20/99

(H1N1), Solomon Islands/3/2006 (H1N1), Brisbane/59/2007 (H1N1),

California/07/2009 (H1N1), A/Wisconsin/67/2005 (H3N2), A/Brisbane/10/2007

and influenza B viruses Ohio/01/2005, Florida/4/2006, Brisbane/60/2008

were the predominant influenza viruses in circulation according to the Flu

Activity & Surveillance report by CDC. Performance characteristics may

vary against other emerging influenza viruses.

If infection with a novel Influenza virus is suspected based on current clinical

and epidemiological screening criteria recommended by public health

authorities, specimens should be collected with appropriate infection control

precautions for novel virulent Influenza viruses and sent to state or local

health department for testing. Viral culture should not be attempted in these

cases unless a BSL 3+ facility is available to receive and culture specimens.

Summary and Explanation

Influenza is a highly contagious acute viral infection of the respiratory tract.

It is a communicable disease easily transmitted from person to person

through aerosol droplets excreted when sneezing and coughing. Common

symptoms include high fever, chills, headache, cough, sore throat and

malaise. The type A influenza virus is more prevalent and is the primary

pathogen associated with serious epidemics. The type B virus causes a

disease that is generally not as severe as that caused by the type A virus.

An accurate diagnosis of influenza based on clinical symptoms is difficult

because the initial symptoms of influenza are similar to those of numerous

other illnesses. Therefore, it can be confirmed only by laboratory diagnostic

testing.

Early differential diagnosis of influenza type A or type B can allow

for proper treatment with appropriate antiviral therapy while reducing the

incidence of inappropriate treatment with antibiotics. Early diagnosis and

treatment is of particular value in a clinical setting where accurate diagnosis

can assist the healthcare professional with management of influenza

patients who are at risk for complications.

Status Flu A & B is a rapid

immunoassay to be used as an aid for the differential diagnosis of influenza

type A and type B.

Principle of Procedure

Status Flu A & B utilizes the chemical extraction of viral antigens followed by

solid-phase immunoassay technology for the detection of extracted antigen,

influenza A and/or B. In the test procedure, a specimen is collected and

placed for one minute into the Extraction Well of the test device containing

extraction solution, during which time antigen is extracted from disrupted

virus particles. The test device is then raised, tapped and laid back down

onto a level surface to allow the solution in the Extraction Well to migrate

through the pads containing lyophilized detector antibodies conjugated to

gold dye and then through the test membrane. If influenza antigens are

present in the specimen, they will react with anti-influenza antibody coupled

to gold dye particles, migrate through the membrane as

antigen-antibody-dye complexes, bind to the immobilized anti-influenza

antibody on the membrane, and generate a colored line in the Test line

position (A and/or B). The rest of the sample and unbound/bound dye

complexes continue to migrate to the Control line position (C), where

antibody to the anti-influenza antibody is immobilized, and forms the Control

line. Formation of the Control line serves as an internal control to

demonstrate that lyophilized antibodies in the dye pad have been hydrated

and that sufficient sample has been applied to allow for migration to the Test

line and beyond. If the Control line does not appear within the designated

incubation time, the result is invalid and the test should be repeated.

Status Flu A & B has two Test lines, one for influenza A and one for influenza

B. The two Test lines allow for the separate and differential identification of

influenza A and/or B from the same specimen. If either Test line appears in

the test result window, together with the Control line, the test result is

positive for influenza.

Reagents and Materials Provided

Each Status Flu A & B kit contains enough reagents and materials for 22

tests. The following components are included in a kit.

• Status Flu A & B test devices (22): The test strip in each device contains

mouse monoclonal antibodies to nucleoprotein (NP) of influenza A and

influenza B. The device is individually pouched.

• Extraction Reagent in capsules (22): For use with swab samples, 300 µL

of Phosphate buffer with detergents and preservative.

• Sterile Swabs (22): For swab samples

• Positive Control Swab (1): Influenza A and B antigens (non-infective

recombinant nucleoprotein)

• Negative Control Swab (1): Inactivated Group B Streptococcus antigen

(non-infective)

• Package Insert /Instructions for use (1)

• Procedure Card (1)

Materials Required, But Not Provided

For Aspirate Samples only (available separately; Catalog No. : BSP-510AS)

• Extraction Reagent in a bottle (5 mL): Phosphate buffer with detergents

and 0.09% sodium azide

• Disposable Transfer Pipettes (44): Buffer and sample transfer

• Procedure card for aspirate samples

For All Sample types:

• Timer

• Latex gloves

Flu A

References

1. Shaw MW, Arden NH and Massab HF. New aspects of influenza viruses.

Clin. Microbiol. Rev. 5: 74-92 (1992)

2. WHO recommendations on the use of rapid testing for influenza

diagnosis, July 2005.

Symbols Key

P-52718

MT Promedt Consulting GmbH

Altenhofstrasse 80

66386 St. Ingbert

Germany

+49-68 94-58 10 20

EC REP

LOT

CONT

DEV

SWAB

CAP

POS

NEG

PRC

EC REP

MTD

INFLUENZA

IVD

REF

IFU

Contents

Test Device

Consult Instructions For Use

Manufactured For

Swabs - 22

Reagent Capsules - 22

Positive Control Swab - 1

Negative Control Swab - 1

Procedure Card - 1

Lot Number

Expiration Date

Store at 2-30˚C

Do Not Reuse

For in vitro Diagnostic Use

Catalog Number

Manufactured By

Instructions For Use

Contains sufficient for <n> tests

CE Mark

Authorized Representative

Influenza A & B Test

Summary of content (8 pages)

PAGE 1
References Symbols Key LOT Lot Number Expiration Date 1. Shaw MW, Arden NH and Massab HF. New aspects of influenza viruses. Clin. Microbiol. Rev. 5: 74-92 (1992) CONT DEV Store at 2-30˚C 2. WHO recommendations on the use of rapid testing for influenza diagnosis, July 2005.
PAGE 2
Precautions/Warnings · For in vitro diagnostic use only. · Do not use after the expiration date. · Use only the swabs provided for collecting swab samples. Other swabs may not work properly. · Two forms of Extraction Reagent are provided. Use Extraction Reagent in capsules to test swab samples, and Extraction Reagent in a bottle to test nasopharyngeal wash/aspirate samples. · Do not smoke, eat or drink in areas in which specimens or kit reagents are handled.
PAGE 3
Reproducibility The reproducibility study for Status Flu A & B test was conducted at two physicians’ offices and one laboratory using a panel of 90 coded specimens for each site. Testing was performed by two personnel for five days at each site. The panel consists of coded samples of high negative, low positive and moderate positive specimens for each of influenza A and B. For influenza A and B positive samples, A/PR/8/34 (H1N1) and B/Maryland/1/59 were used.
PAGE 4
Interpretation of Results Limitations Expected Values Positive: A reddish purple Control line (C position) and a reddish purple Test line (A or B position) indicate that Influenza A or B antigen has been detected. Lines at the A and C positions indicate the presence of Influenza type A viral antigen, and lines at the B and C positions indicate the presence of Influenza type B viral antigen in the specimen.
PAGE 5
Interpretation of Results Limitations Expected Values Positive: A reddish purple Control line (C position) and a reddish purple Test line (A or B position) indicate that Influenza A or B antigen has been detected. Lines at the A and C positions indicate the presence of Influenza type A viral antigen, and lines at the B and C positions indicate the presence of Influenza type B viral antigen in the specimen.
PAGE 6
Reproducibility The reproducibility study for Status Flu A & B test was conducted at two physicians’ offices and one laboratory using a panel of 90 coded specimens for each site. Testing was performed by two personnel for five days at each site. The panel consists of coded samples of high negative, low positive and moderate positive specimens for each of influenza A and B. For influenza A and B positive samples, A/PR/8/34 (H1N1) and B/Maryland/1/59 were used.
PAGE 7
Precautions/Warnings · For in vitro diagnostic use only. · Do not use after the expiration date. · Use only the swabs provided for collecting swab samples. Other swabs may not work properly. · Two forms of Extraction Reagent are provided. Use Extraction Reagent in capsules to test swab samples, and Extraction Reagent in a bottle to test nasopharyngeal wash/aspirate samples. · Do not smoke, eat or drink in areas in which specimens or kit reagents are handled.
PAGE 8
References Symbols Key LOT Lot Number Expiration Date 1. Shaw MW, Arden NH and Massab HF. New aspects of influenza viruses. Clin. Microbiol. Rev. 5: 74-92 (1992) CONT DEV Store at 2-30˚C 2. WHO recommendations on the use of rapid testing for influenza diagnosis, July 2005.