Accurate Strep A Rapid Test strip Kits ( Control Line in Blue) convenient Throat Swab with CE
The Strep A Rapid Test Dipstick is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigens from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
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.
How to 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 160μL) 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.
【INTERPRETATION OF RESULTS】
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One blue line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that Strep A was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Strep A present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One blue line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that Strep A antigen is not present in the specimen, or is present below the detectable level of the test. The patient’s specimen should be cultured
to confirm the absence of Strep A infection. If clinical symptoms are not consistent with results, obtain another specimen for culture.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.