(Box) CLIA Waived Rapid Strep A Antigen Test, 25Test/Kit

The Strep A Rapid Test is a 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. Materials Provided

Strep A Rapid Test Strips/Cassettes

Sterile swabs 

Extraction tubes and dropper tips Reagent A Reagent B 

Negative control (when applicable) 

Positive control (when applicable)

Workstation CLIA WAIVED FDA 510(k)

The CPT code for a visually read strep A test is 

87880, which is defined as "Infectious agent antigen detection by immunoassay with direct optical observation; Streptococcus, group A". For Medicare patients, the -QW modifier must be added to the code to indicate it is a CLIA-waived test, making the complete code 87880-QW. 

Instructions for use:

CLIA Waiver

Selling Sheet

IFU