■ CLIA WAIVED for swab specimens

Includes Positive and Negative control swabs■

Innovative flip design with onboard sample extraction■

Differentiates between Influenza A and B■

■ Pre-measured developer solution capsulefor increased accuracy and ease of use

■ Flocked nasal swabs for improved patient comfort and superior specimen collection

FLU FEARS US. YOU WILL LOVE US!

Flu A&B

ORDERING INFORMATION

PRODUCT # OF TESTS ITEM #

Status Flu A & B 22 36022

Nasal Aspirate Kit 22 BSP-510AS

For more information or to place an order, contact:

A PBM Group Company85 Orchard Road • Skillman • New Jersey • 08558

800.526.2125 • 732.246.3366 • Fax: 732.246.0570 • www.lifesignmed.com

Proudly made in the USA

THEY CAN RUN BUT CANNOT HIDE

An in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens*

*nasal aspirate/wash specimens – non waived

Positive Percent Agreement(PPA)

89.2 %(95% CI: 83.0 - 93.4%)

86.4 %(95% CI: 80.1 - 90.9%)

Negative Percent Agreement(NPA)

99.4 %(95% CI: 97.7 - 99.8%)

99.0 %(95% CI: 97.1 - 99.7%)

Printed in USA. All rights reserved.481- 10/29/16

Interpretation of Results

InfluenzaDateID

CBA

CBA

CBA

CBA

CBA

CBA

CBA

CBA

C Line onlyNEGATIVE

No C LineINVALID

Any visible A and/or B Line(s) with C Line is POSITIVE.

Repeat with newsample and device.

A line:Influenza type A

B line:Influenza type B

A & B lines:Influenza type A & B

Proven Clinical Performance

Simple Procedure for Swab Specimens

**See Package Insert For Details

Extract Incubate Flip Read

BA C

Date______ID________

BA C

Date______ID________

CBA

CBA

CBA

Fill extraction wellwith reagent

Insert collection swaband incubate for

1 minute

Tip device Interpret resultsat 10 to 15 minutes

Status Flu A & B vs. PCR

W inesota/2010(H3N2v), H5NX and H7N9.

CPT CODE

INFLUENZA A 87804QW

INFLUENZA B 87804QW-59

Cardinal Health™ Strep A Rapid Test Fast results for early diagnosis

New Cassette Rapid Test

Cardinal Health—providing proven,cost-effective products and solutionsfor all your laboratory needs.

Point-of-Care Testing

Both Cardinal Health™ Strep A Rapid Tests are CLIA-waived rapid chromatographic

immunoassays for the qualitative detection of Strep A antigen from throat swab

specimens to aid in the diagnosis of Group A Streptococcal infection.

Ease of use• Positive results in 5 minutes

• Room temperature storage

Precision• Excellent performance

• Sensitivity 97%; specificity 95%*

*Average value

Ordering informationCat. No. Description Qty. Bx

B1077-30 Cardinal Health™ Strep A Dipstick Test 50/test

Our easy-to-use, all-in-one reagent capsule saves you time by eliminating the steps needed when using separate reagent bottles.

Ease of use• Positive results in 5 minutes

• Room temperature storage

• All in one reagent capsule

• Untrained user study produced >99% correct answers

Precision• Excellent performance

• Sensitivity 96%; specificity 99% - cassette

• Clinical Correlation study performed in both pediatric and adult populations

Ordering informationCat. No. Description Qty. Bx

B1077-40 Cardinal Health Strep A Cassette Rapid Test 25/test

1. Tear the tab off the Extraction Reagent Capsule.

2. Squeeze the entire contents of the Extraction Reagent Capsule to dispense all of the solution into the Extraction Well of the test device.

3. Place the specimen swab in the Extraction Well of the device.

Hold the device with one hand and hold the swab with the other hand. While pressing down on the swab, spin the swab in one direction approximately 5 times to mix the specimen.

4. Incubate 1-2 minutes with swab in well.

5. Hold the device with one hand and hold the swab with the other hand. While pressing down on swab, spin the swab again 5 times in one direction. Remove and discard the swab.

9. Read the test results after 5 minutes, but not after 10 minutes.

Test ProtocolTest Protocol

7. Let stand 1-2 seconds. Tap device on flat surface to ensure liquid flows into hole.

8. Immediately after tapping, slowly lay the device back down onto the flat surface.

Interpretation of ResultsInterpretation of Results

C Line only NEGATIVE (-)

Any visible T line is positive

2 Lines POSITIVE (+)

No C Line INVALID

Repeat with new sample and device

6. Raise device until upright.

Raiseslowly.

Value• Accuracy and simplicity reduce staff

hands-on time and activities

Value• Accuracy and simplicity reduce staff

hands-on time and activities

Procedure: Allow the canister of test dipsticks, reagents, and/or controls to reach room temperature 15º-86ºC (59º-86ºF) prior to testing. Read Procedure before running test. Refer to Directional insert for details.

*Note: The intensity of the red color in the test line region (T) will vary depending on the concentration of strep A present in the sample. Therefore, any shade of red in the test region (T) should be considered positive.

The Cardinal Health™ Strep A Rapid Test is a CLIA-waived rapid

chromatographic immunoassay for the qualitative detection of

Strep A antigen from throat swab specimens to aid in the diagnosis

of Group A Streptococcal infection.

Cardinal Health Laboratory Products Waukegan, Illinois

cardinalhealth.com

We are your lab partner.Expertise. Choice. Efficiency. Savings.

For more information or to order,contact your Cardinal Health sales representative,

call 800.964.5227 or visit cardinalhealth.com.

© 2016 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Lit. No. 2LAB16-546232 (07/2016)

2LAB16-546232 - Strep A Rapid Test brochure revision-wkg-v3 2-spreadLifeSign Status Flu clia waived flyer 07012017