Rapid Strep A Antigen Test

SKU: GCSTR-501Ca

In Stock

Strep A

Rapid 5-Minute Results

High Accuracy- 96.5% sensitivity and 99.5% specificity

Simple Throat Swab Testing

CLIA license Required to purchase this product

$55.00

$2.20 USD per test (25 test per box)

Volume Discounts

10-20 boxes $49.50 per box ($1.98 per test)

21-39 boxes $47.45 per box ($1.91 per test)

40-49 boxes $46.75 per box ($1.87 per test)

50+ boxes Request Bulk Discount

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Prepare the test. Allow the test materials to reach room temperature before use. Place an empty extraction tube securely in the tube holder.
Add Reagent A. Hold the Reagent A bottle vertically over the extraction tube and add 4 full drops.
Add Reagent B. Hold the Reagent B bottle vertically over the same tube and add 4 full drops. Gently swirl the extraction tube to mix the solution.
Insert the throat swab. Immediately place the collected throat swab into the extraction tube. Roll the swab in a circular motion at least 10 times, pressing it against the bottom and sides of the tube while rolling.
Let the swab stand. Leave the swab in the extraction tube for 1 minute.
Remove the swab. Press the swab against the side of the tube and squeeze the bottom of the tube while withdrawing the swab to extract as much liquid as possible. Discard the swab.
Insert the test strip. Remove a test strip from its foil pouch without touching the bottom of the strip. Place the strip into the extraction tube with the arrows pointing downward.
Start the timer. Allow the test to develop for 5 minutes. Do not handle or move the strip until testing is complete.
Read the results at 5 minutes. Do not read before 5 minutes or after 10 minutes.
Positive: Both the Control (C) and Test (T) lines are visible.
Negative: The Control (C) line appears, but no Test (T) line appears.
Invalid: No Control (C) line appears. The test should be repeated with a new test.

Important: The manufacturer's IFU states that negative results are presumptive and should be confirmed by bacterial culture because a negative result does not rule out Group A Streptococcus infection. These simplified instructions should not replace the complete manufacturer's Instructions for Use

The Healgen® Rapid Strep A Antigen Test is a rapid chromatographic immunoassay designed for the qualitative detection of Group A Streptococcal (Strep A) antigen from human throat swab specimens. It is intended to aid healthcare professionals in the diagnosis of Group A Streptococcal infection, providing easy-to-read results in just 5 minutes.

Designed for convenient point-of-care testing, the Healgen Rapid Strep A Antigen Test combines a straightforward testing procedure with strong clinical performance. The test offers 96.5% sensitivity and 99.5% specificity, can be stored at room temperature, and has a 24-month shelf life from the date of manufacture.

The U.S. GCSTR-501Ca configuration is FDA 510(k) cleared and CLIA Waived, comes in a 25-test kit, and includes external positive and negative controls. The kit contains the necessary testing components, making it a practical solution for physician offices, urgent care centers, clinics, and other eligible point-of-care testing environments.

Key Product Features