Cardinal Health™ Strep A Infectious Disease Immunoassay Respiratory Test Kit is a CLIA-waived rapid chromatographic immunoassay designed for the qualitative detection of Group A Streptococcus (Strep A) antigen from throat swab specimens. This point-of-care kit delivers fast, reliable results right in the office or clinic.

Key Features

• Rapid results: Strep A results in approximately 5 minutes.
• CLIA-waived: Suitable for waived laboratory and point-of-care settings, following manufacturer instructions.
• Room temperature storage: Convenient storage with no refrigeration needed.
• Chromatographic immunoassay: Qualitative detection of Strep A antigen from throat swab samples.
• All-in-one kit: Includes devices, reagents, swabs, and controls for testing.

What’s Included in the Kit

• Test devices
• Throat swabs
• Extraction reagent capsules
• Positive control
• Negative control
• Instructions for use
• Procedure card

Intended Use

This Strep A rapid test kit is intended for the qualitative detection of Group A Streptococcus antigen from throat swab specimens. It is used to aid in the diagnosis of Strep A infection in patients with signs and symptoms of pharyngitis, in conjunction with clinical evaluation and other laboratory findings.

Sample Type

• Throat swab

Ordering Information (SKU Breakdown)

On mobile: swipe left/right to view full table.

Use & Storage

• Follow the included instructions for specimen collection, preparation, and test procedure.
• Store the kit at room temperature as indicated by the manufacturer.

Note: This product is intended for use by healthcare professionals trained in rapid antigen testing and interpretation of results.