The Strep A Rapid Test (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group A Streptococcus antigens in human throat swab specimens. This kit is intended for use as an aid in the diagnosis of Strep A infection.
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 24- 48 hours. Recent development of immunological techniques to detect Group A Streptococcal antigen directly from throat swabs allow physicians to diagnose and administer therapy immediately.
• Rapid test cassette with desiccant.
• Sampling Swab
• Reagent 1
• Reagent 2
• Extraction Tube
• Package insert
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
Sample Collection&Storage
• Collect throat swab specimens by standard clinical methods. Swab the posterior pharynx, tonsil and other inflamed areas. Avoid touching the tongue, cheeks or teeth with the swab.
• It is recommended that swab specimens be processed as soon as possible after collection. If swabs are not processed immediately, they should be placed in a sterile, dry, tightly capped tube or bottle and refrigerated. Do not freeze. Swabs can be stored at room temperature (15-30°C) up to 4 hours, or refrigerated (2- 8°C) up to 24 hours. All specimens should be allowed to reach room temperature (15-30°C) before testing.
• If a liquid transport method is desired, use Modified Stuart's Transport Media and follow the manufacturer's instructions. Do not place the swab in any transport device containing medium. Transport medium interferes with the assay, and viability of the organisms is not required for the assay. Do not use transport media formulas that include charcoal or agar.
1) If a bacteria culture is desired, lightly roll the swab on a 5% sheep blood agar plate before using it in the test. The extraction reagents in the test will kill bacteria on the swabs and make them impossible to culture.
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Prepare swab specimens:
1) 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.
1) 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.
2) 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. Cap the extraction tube with the attached dropper tip. Discard the swab following guidelines for handling infectious agents.
2. 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.
3. Add 2 drops (approximately 120 µL) of extracted solution 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.
4. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 15 minutes.
About Us
Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.
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