(including rapid test cassette, sampling swab, reagent1, reagent2, extraction tube and package insert.)

INTENDED USE
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.

METHOD
The Strep A Rapid Test (Swab) detects Group A Streptococcus antigens through visual interpretation of color development on the internal strip. Anti-Strep A antibodies are immobilized on the test region of the membrane. During the test, the specimen reacts with polyclonal anti-Strep A antibodies conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient Strep A antigen in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that proper volume of specimen has been added and membrane wicking has occurred.

STORAGE
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.

DIRECTION OF USE
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 5 drops of Reagent 1 to the extraction tube, then add 4 drops of Reagent 2. Mix the solution by gently swirling the extraction tube.
2) 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.
3) 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 cassette with patient or control identification. For best results, the assay should be performed within one hour.
3. Add 2 drops of extracted solution from the extraction tube to the sample well on the test cassette.
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.
5. Results reading
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. 

ABOUT US

R&D TEAM

WORKSHOP

CERTIFICATES

EXHIBITION PERFORMANCE

TRANSPORTATION

1, Are you a manufacturer?
Yes, we are a manufacturer based in Foshan City, Guangdong province. We have different production lines, more than 5000 square meter facility.

2, Can you put our logo or text on the products or packages?
Yes, we can provide OEM goods.

3, Could you provide free samples for our testing before we place an order?
Sure, we'd like to offer free samples for you, but the freight cost should be paid by the buyer.

4, How to make payment?
T/T, D/P, L/C, Paypal, Western Union and Made in China are both acceptable.

5, Which seaport and airport are the nearest to your factory?
The near seaport is Guangzhou Nansha Seaport & Shenzhen Shekou Seaport. And Guangzhou, Shenzhen, & Hongkong Airports are both convenient.

6,  What is your best delivery time?
Depend on your order quantities. 3-20 working days after payment is received.