The Strep A Rapid Test Device is a rapid visual immunoassay for the qualitative and presumptive detection of group A streptococcus antigens from oropharyngeal swab specimens. The test is used to help quickly identify acute group A streptococcus infection. It targets Strep A's unique antigens, with a cross-reactivity rate under 0.1% and sensitivity over 97%.
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Product name |
Strep A Antigen Rapid Test Self-Test |
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Item type |
STP-S21 |
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Specimens |
Saliva |
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Shelf life |
2 years |
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Test Time |
Waiting about 15 minutes |
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Certificate |
CE, ISO:13485 |
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OEM |
Acceptable |
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Storage condition |
The kit should be stored at 2-30°C |
PRECAUTIONS
Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
Humidity and temperature can adversely affect results.
The used testing materials should be discarded in accordance with local, state and/or federal regulations.
STORAGE AND STABILITY
The Strep A Rapid Test Device should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use. Do not freeze.
Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.
PROCEDURE
Allow the test device, urine specimen, and/or controls to equilibrate to room temperature (15‐30℃) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 μL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S).
3. Wait for the red line(C) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.
FAQ
Q: What is the Strep A Antigen Rapid Self-Test (Colloidal Gold) used for?
A: It's for qualitative detection of Group A Streptococcus (Strep A) antigens in throat secretions to help identify Strep A-related pharyngitis/tonsillitis.
Q: What sampling method does this test use?
A: It uses a non-invasive throat swab-gently swab the back of the throat/tonsils as instructed, no pain or discomfort.
Q: What do the test lines (C and T) mean?
A: • C line (Control Line): Must appear to confirm the test is valid.
• T line (Test Line): Appears = negative (no Strep A detected); no appearance = positive.
Q: How should I store the unused test kit?
A: Store it at 2-30°C in a dry, dark place. Do not freeze or expose to direct sunlight, as this damages reagents.
Q: Is a positive result enough to confirm Strep A infection?
A: No. It's a preliminary screening tool. A positive result needs confirmation by a doctor with further professional tests (e.g., culture).
Q: How to dispose of used test components (swab, tube, etc.)?
A: Treat them as household biohazard waste-seal in a plastic bag and discard according to local waste management rules.
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