Strep A Rapid Test

PocTell^® Strep A Rapid Test is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a color line in the test line region. The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred..

PocTell^® Strep A Rapid Test is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. During testing, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. The mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a color line in the test line region. The presence of this color line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred..

Bring the specimen and test components to room temperature Mix the specimen well prior to assay once thawed. Place the test device on a clean, flat surface.

1.Remove the test 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 reagent A bottle vertically and add 6 drops (approximately 240 µL) of reagent A to the extraction tube. Reagent A appears red. Immediately insert the swab, compress the bottom of the test tube, and rotate the swab 15 times. Let stand for 1 minute. Hold reagent B bottle vertically, add 4 drops of reagent B (approximately 160 µL) to the extraction tube, and let stand for 1 minute. Press the cotton swab onto the side of the extraction tube and remove it while squeezing the extraction tube. Leave as much liquid as possible in the extraction tube.

3.Place the reagent kit on a clean and flat surface. Install the tip of the dropper on the top of the extraction tube, and vertically add 3 drops (approximately 120 µL) of sample diluent without empty bubbles into the sampling hole (S) of the test. Start the timer.

4.Wait for the colored line(s) to appear. Read the result at 5 minutes. Do not read the result after 10 minutes.

5.Used throat swabs, samples, devices or devices should be treated as biological waste..

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