The Strep A Rapid Test (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group A Streptococcus antigens in human throat swab specimens. This kit is intended for use as an aid in the diagnosis of Strep A infection.

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Introduction

Beta-hemolytic Group A Streptococcus is a major cause of upper respiratory infections such as tonsillitis, pharyngitis, and scarlet fever. Early diagnosis and treatment of Group A Streptococcal pharyngitis has been shown to reduce the severity of symptoms and further complications, such as rheumatic fever and glomerulonephritis. Conventional methods for detecting Strep A infection are dependent on isolation and subsequent identification of the organism, and often require 24- 48 hours. Recent development of immunological techniques to detect Group A Streptococcal antigen directly from throat swabs allow physicians to diagnose and administer therapy immediately.

Storage

 • Store at 2 ~ 30 º C in the sealed pouch for 24 months.
 • Keep away from direct sunlight, moisture and heat.
 • DO NOT FREEZE.

Direction of Use

Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
Prepare swab specimens:
1. Place a clean extraction tube in the designated area of the workstation. Add 4 drops of Reagent 1 to the extraction tube, then add 5 drops of Reagent 2. Mix the solution by gently swirling the extraction tube.
2. Immediately immerse the swab into the extraction tube. Use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expressed from the swab and can reabsorb.
3. Let stand for 1-2 minutes at room temperature, then squeeze the swab firmly against the tube to expel as much liquid as possible from the swab. Cap the extraction tube with the attached dropper tip. Discard the swab following guidelines for handling infectious agents.
Remove the test from its sealed pouch, and place it on a clean, level surface. Label the cassette with patient or control identification. For best results, the assay should be performed within one hour.
4. Add 2 drops of extracted solution from the extraction tube to the sample well on the test cassette.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the observation window.
As the test begins to work, color will migrate across the membrane.
5. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 15 minutes.

Interpretation of Results

POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.

Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Rapid Test Kits, Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.

Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.

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