Group A Streptococcal Antigen Rapid Test Uncut Sheet

Summary and Explanation

Beta-hemolytic Group A Streptococcus is a major cause of upper respiratory infection 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 used for the detection of the disease depend on the isolation and subsequent identification of the organism. These methods often require 24 - 48 hours to complete. Recent development of immunological techniques which can detect Group A Streptococcal antigen directly from throat swabs allow physicians to diagnose and administer therapy immediately.

Test Procedure

1.Open the foil pouch package and take out the test cassette.

2.Place the extraction tube on the workbench. The swab extractor bottle is pressed vertically downward to allow the solution to drip freely into the extractor tube without touching the edge of the tube. Add 6 drops (approximately 200ul) of Reagent A buffer to the extraction tube, then add 6 drops (approximately 200ul) of Reagent B buffer into the extraction tube, the color of the mixing solution in the tube change from blue to yellow.

3.Put the swab specimen into the extraction tube, rotate the swab for about 10 times, and press the swab head against the tube wall to release the antigen in the swab. Squeeze the swab over the head to remove the swab so as to remove as much liquid as possible from the swab. Dispose of swabs according to biohazard waste disposal method.

4.Install the dropper cap on the extraction tube and leave for 1 minute, then put three drops (approximately 100ul) into the specimen hole of the test card, start the timer.

5.Read the results at 15 minutes, and the results after 20 minutes are no longer valid.

Result Interpretation

Negative result: if there is only a quality control line C, the detection line is colorless, indicating that Strep A antigen has not been detected and the result is negative.

Positive result: if the quality control line C and the detection line appear, Strep A antigen has been detected and the result is positive for antigen;

Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line, and the test shall be conducted again.