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Strep A Rapid Test
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SUMMARY 
Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigens that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis. Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess. Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer. 
The Strep A Rapid Test Cassette is a rapid test to qualitatively detect the presence of Strep A antigens in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigens in a throat swab specimen. 

DIRECTIONS FOR USE 
Allow the test, reagents, throat swab specimen, and/or controls to reach room temperature (15-30 ℃) prior to testing. 
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch. 
2. Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approximately 240 ul) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in color. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops (approximately 160 ul) to the tube. Extraction Reagent 2 is colorless. Mix the solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to Extraction Reagent 1 changes the color of the solution from red to yellow. See illustration 1. 
3. Immediately add the swab into the extraction tube, agitate the swab vigorously 15 times, Leave the swab in the extraction test tube for 1 minute. See illustration 2 
4. Press the swab against the side of the tube and squeeze the bottom of the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab. See illustration 3 
5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. 

6. Add three drops of the solution (approx.100ul) to the sample well and then start the timer. Read the result at 5 minutes. Do not interpret the result after 10 minutes. See illustration 4 and illustration5.