PREPARE TEST CARD

CLOSE DEVICE

7. Read Results

Remove card from its pouch just before use and lay flat.

9. Ordering and Contact Information

Immediately peel off adhesive liner from the right edge of the test card. Close and securely seal the card. Gently snap off swab shaft, which is purposely scored. Avoid dislodging the swab from the well when doing so. Do not reopen.

COLLECT SPECIMEN—NASOPHARYNGEAL SWAB EndFragment

READ NOW RESULTS WITH ALERE READER

STANDARD URINE COLLECTION CONTAINERS

ALERE BINAXNOW® LEGIONELLA URINARY ANTIGEN CARD DEMO

In Read Now mode, set timer and wait 15 minutes.

In Walk-away mode, place card in Alere Reader which will automatically interpret test results at 15 minutes. Results are displayed on the screen, with a Positive or Negative result. If a test error occurs, “Invalid” displays. Repeat invalid tests with a new test device. Call Alere Technical Services if the problem persists.

WALK-AWAY RESULTS WITH ALERE READER

MATERIALS RECOMMENDED BUT NOT PROVIDED

COLLECT SAMPLE

Visual read interpretation

Alere BinaxNOW® Legionella Antigen Card (12 Test) 852-012 Alere BinaxNOW® Legionella Antigen Card (22 Test) 852-100 Alere BinaxNOW® Legionella Antigen Control Swabs (5-Pos/Neg Swabs/Kit) 852-010 Click here to learn how to use the Alere™ Reader.

Dip an Alere™ swab into the urine specimen to be tested, completely covering the swab head.

With the Device closed, look through window to interpret results. Read results immediately. Results read before or after 15 minutes may be inaccurate.

Set time and wait 15 minutes

For a NEGATIVE SAMPLE   • The BLUE Control Line in the BOTTOM THIRD of the window turns a pink to purple color.   No other line appears.

PREPARE REAGENT

www.alere.com

For more information on our products and services, please visit​

Hold Reagent A vial vertically, ½ to 1 inch above the card.

Read results visually or with the Alere Reader.

TEMPERATURE

FLU B

© 2019 Abbott. All rights reserved. Alere and BinaxNOW are trademarks of the Abbott group of companies. 120002663-02 09/18

For a FLU A POSITIVE SAMPLE    • The BLUE Control Line in the BOTTOM THIRD of the window turns a pink to purple color.   • A SECOND pink to purple Sample Line appears above it in the MIDDLE THIRD of the window.   Any shade of a pink to purple Sample Line indicates a positive result.

CONTROL

VISUAL INTERPRETATION

READ NOW MODE

A test is INVALID if the Control Line remains BLUE or is not present at all, whether a Sample Line(s) is present or not. Repeat Invalid tests with a new test device. Call Alere™ Technical Service if the Problem persists.

Allow reagents and cards to equilibrate to room temperature (59–86°F, 15-30°C) before testing. Bring patient urine and/or liquid urine control(s) to room temperature(59–86°F, 15-30°C).

FLU A

After 15 minutes, place developed card in Alere Reader for interpretation. Read time: ~15 seconds. Results are displayed on the screen, with a Positive or Negative result. Allow Alere Reader to interpret results.  If a test error occurs, “Invalid” displays. Repeat invalid tests with a new test device. Call Alere Technical Services if the problem persists.

For a FLU B POSITIVE SAMPLE   • The BLUE Control Line in the BOTTOM THIRD of the window turns a pink to purple color.   • A SECOND pink to purple Sample Line appears above it in the TOP THIRD of the window.   Any shade of a pink to purple Sample Line indicates a positive result.

ORDERING AND CONTACT INFORMATION

For a FLU A and FLU B POSITIVE SAMPLE   • The BLUE Control Line in the BOTTOM THIRD of the window turns a pink to purple color.   • A SECOND pink to purple Sample Line appears above it in the MIDDLE and TOP thirds of the window.   Any shade of a pink to purple Sample Line indicates positive results.

Do not remove card from pouch until the specimen has reached room temperature

ADD REAGENT

1. Materials

There are two holes on the inner right panel of the card, insert swab into the BOTTOM hole (swab well). Firmly push upwards so that the swab tip is fully visible in the top hole.

2. Temperature

Slowly add three (3) free falling drops of Reagent A to the BOTTOM hole.

3. Prepare test card

Visual read interpretation – Invalid

ALERE BINAXNOW® LEGIONELLA URINARY ANTIGEN CARD

4. Collect Sample

With the Device closed, look through window to interpret results. Read results immediately. Results read before or after 15 minutes may be inaccurate.

BLUE Control Line

REMOVE EXCESS

5. Insert Swab

No Control Line

If the swab drips, touch swab to side of urine container to remove excess liquid.

INTERPRET RESULTS AFTER 15 MINUTES

INSERT SWAB

Read results either visually through the window or with the Alere™ Reader. Results read beyond 15 minutes may be inaccurate. However, some positive patients may produce a visible specimen line in less than 15 minutes.

Welcome to the  Alere BinaxNOW® Legionella Urinary Antigen Card  Product Demo EndFragment

This is CLIA Waived for nasal swab and nasopharyngeal swab.

MATERIALS INCLUDED EndFragment

POSITIVE

The Alere BinaxNOW® Legionella Urinary Antigen Card test kits contain the following:

A positive specimen will give two pink-to-purple colored lines. This means that antigen was detected. Specimens with low levels of antigen may give a faint Sample Line. Any visible line is positive.

NEGATIVE

A negative specimen will give a single pink-to-purple colored Control Line in the top half of the window, indicating a presumptive negative result. This Control Line means that the detection part of the test was done correctly, but no L. pneumophila serogroup 1 antigen was detected.

If no lines are seen, or if just the Sample Line is seen, the assay is invalid. Invalid tests should be repeated. If the problem persists, contact Alere™ Technical Service.

READ RESULTS

Read results with the Alere™ Reader. Results may be read with either Read Now or Walk Away mode.

X

6. Use Reagent

TEST DEVICES

A membrane coated with rabbit antibody specific for Legionella pneumophila serogroup 1 antigen and with control antibody is combined with rabbit anti-Legionella pneumophila serogroup 1 antigen and antispecies conjugates in a hinged test card.

REAGENT A

Citrate / Phosphate with Tween® 20 and Azide.

Designed for use with Alere BinaxNOW® Legionella. Do not use other swabs.

SWABS

L. pneumophilia negative swab.

NEGATIVE CONTROL SWAB

POSITIVE CONTROL SWAB

Heat inactivated L. pneumophilia dried onto swab.

TIMER

Read results with the Alere™ Reader. Results may be read with either Read Now or Walk Away mode.

INDEX

59–86°F

15–30°C

(+)

or

Invalid result:

(-)