Sale price$143.01

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Description

  • 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
  • Room temperature storage
  • Sensitivity 96%; specificity 99% - cassette
  • Clinical Correlation study performed in both pediatric and adult populations

Product Specs

Item Number 1094652
Catalog Number B1077-40
UOM BX
Level 1 Family Description Lab-Waived Lab
Level 2 Category Description Lab-Rapids
Level 3 Group Description Other Visual Rapids
Level 4 Sub-Category Description Other Visual Rapids
Application Respiratory Test Kit
Brand Cardinal Health
Buy American Act (BAA) Compliant No
CLIA Classification CLIA Waived
CLIA Classified CLIA Waived
Contents 1 (25) Test Devices, (25) Throat Swabs, (25) Extraction Reagent Capsules, Positive Control, Negative Control, Instructions for Use, Procedure Card
Country of Origin TAA Compliant
Manufacturer Cardinal
Manufacturer # B1077-40
McKesson # 1094652
Number of Tests 25 Tests
Purchase Program Type Standard Purchase
Reading Type Visual Read
Sample Type Throat Swab Sample
Specialty Immunoassay
Test Format Dipstick Format
Test Kit Type Rapid
Test Method Chromatographic Immunoassay
Test Name Strep A Test
Test Type Infectious Disease Immunoassay
Time to Results 5 Minute Results
Trade Agreement Act (TAA) Compliant Yes
UNSPSC Code 41116205

Frequently asked questions

How quickly does this test provide results?

This test is designed for rapid diagnosis, delivering reliable results in just 5 minutes.

Is this kit suitable for both children and adults?

Yes, the Cardinal Health Strep A Test is validated for use with both pediatric and adult populations, making it a versatile choice for family practices, pediatric clinics, and urgent care centers.

Does this test require professional laboratory equipment?

No. Because the kit is CLIA-waived, it is specifically designed for ease of use in various healthcare environments and does not require complex laboratory equipment. It utilizes a simple dipstick-based visual read method.

How reliable is the accuracy of this test?

The test demonstrates high clinical performance with a sensitivity of 96% and a specificity of 99%, as validated through clinical correlation studies.

Are storage requirements complicated for this kit?

Not at all. The kit can be stored at standard room temperature, which simplifies inventory management and does not require specialized refrigeration.

Are control samples provided for quality assurance?

Yes, the kit includes both positive and negative control samples to ensure your testing process remains accurate and consistent.

What is included in the test kit?

Each kit is a complete diagnostic package containing everything needed for 25 tests, including:

  • 25 Test Devices
  • 25 Throat Swabs
  • 25 Extraction Reagent Capsules
  • Positive and Negative Controls
  • Instructions for Use and Procedure Card
Is this test compliant with federal requirements?

Yes, this product is TAA (Trade Agreement Act) compliant and meets the necessary standards for professional clinical use.

Does the test require a throat swab sample?

Yes, the kit is specifically designed for the qualitative detection of Strep A antigens collected via throat swab specimens.

Is the test easy to read for clinical staff?

Yes, it uses a visual read format via a dipstick/cassette system, which is designed for straightforward interpretation during rapid clinical screenings.