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 Dipstick 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 dipstick from the sealed foil pouch and use it as soon as possible. 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 240μL) 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 μL) 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. With arrows pointing down, place the dipstick into the tube of solution and then start the timer. If the procedure is followed correctly, the liquid should be at or just below the maximum line (MAX) on the test dipstick. See the illustration 4.
6. Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not interpret the result after 10 minutes. See illustration 5.

 

Cat. No.	Product Description	Specimen	Format	Kit Size	Cut-Off	Status
ISTB-501	Strep A Rapid Test Dipstick (Control Line in Blue)	Throat Swab	Dipstick	25 T	See Insert	CE