INDICAID Rapid Strep A Antigen Test

Accurate. Simple. Actionable.
A trusted frontline tool for detecting Group A Streptococcus infections at the point of care—delivering results in as little as 5 minutes to support confident, timely treatment decisions.

FDA 510(k) cleared
For in vitro diagnostic use
For prescription use only

About

Where accuracy meets patient care. A rapid antigen test designed to support providers in diagnosing Strep A infections quickly and effectively.

Features

Rapid results: Results in as little as 5 minutes
CLIA-waived: Simple, streamlined workflow for frontline use
Ready-to-use: No instrumentation for easy adoption
Quality: Internal control line and external controls included
Improved Patient Care: A faster diagnosis and more timely treatment streamlines the diagnostic process, making patient management more efficient and effective

Specifications

Contents	25 Test strips, 25 Sterile swabs, 25 Disposable extraction tubes, 1 Reagent A, 1 Reagent B, 1 Positive Control, 1 Negative Control, 1 Instructions for Use
Tests per kit	25
Specimen type	Throat swab
Tine to result	5 Minutes
Accuracy	Sensitivity 97.1%, Specificity 99.4%
FDA status	510(k) cleared

Intended Use

The Rapid Strep A Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of Streptococcus pyogenes antigen from throat swab specimens of symptomatic patients to aid in the diagnosis of Group A Streptococcus bacterial infection. All negative tests should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.