Strep A .Antigen Rapid Test

INTENDED USE

The Strep A Antigen Rapid Test is arapid chromatographic immunoassay for the qualitative detection of Group A Streptococcal antigen in human throat swab specimen. This kit is intended for use as an aid in the diagnosis of Strep A infection.

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 2448 hours. Recent development of immunological techniques to detect Group A Streptococcal antigen directly from throat swabs allow physicians to diagnose and administer therapy immediately.

TEST PROCEDURE

Bring tests, specimens, reagents and/or controls to room temperature (1530°C) before use.

Prepare swab specimens:

• Place a clean extraction tube in the designated area of the workstation. Add 4 drops of reagent 1 to the extraction tube, then add 4 drops of reagent 2. Mix the solution by gently swirling the extraction tube.
• 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.
• 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. 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 device with patient or control identification. For best results, the assay should be performed within one hour.

Add 3 drops (approximately 75 µL) of extracted solution with disposable pipettes from the extraction tube to the sample well on the test device.

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.

Wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

NOTE:

1. The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.
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