This Diagotec rapid test by Vitamed is a pharmacy product designed for the qualitative detection of group A streptococcal antigens via a throat swab. Containing 1 pc, it works for self-testing as well as professional use, delivering results in 5 to 10 minutes. The single pack includes a test cassette, extraction buffer, disposable swab, waste bag, and instructions.
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Description
DIAGOTEC FASTEST Strep A Throat Swab Self-Test
The DIAGOTEC FASTEST Strep A Rapid Test is used for the qualitative detection of Group A Streptococcus antigens from a throat swab sample. According to the manufacturer's packaging, the product is intended for both self-testing and professional use.
Throat swab as sample material
The sample is collected using a throat swab. For reliable results, the collection and operating steps in the current instructions for use must be followed.
Results in 5–10 minutes
The test result is evaluated within 5–10 minutes. The result should no longer be interpreted after 10 minutes.
Interpretation of the result
The rapid test provides qualitative antigen detection of Group A Streptococcus. The result should be assessed in conjunction with symptoms, medical history, and, if applicable, further diagnostic findings.
Package contents
The single pack contains 1 test cassette, extraction buffer, a disposable throat swab, a waste bag, and instructions for use.
How to use
Preparation
Read the enclosed instructions for use carefully before performing the test. Wash your hands and check that all test components are complete and within their expiry date.
If the test kit was stored in a cool place, allow it to stand at room temperature for approximately 30 minutes before use. Do not open the sealed components until immediately before use. Take care not to touch the swab tip.
1. Sample collection
Take a throat swab using the enclosed swab according to the instructions for use. To do this, swab over the posterior pharyngeal area and around the tonsils, rotating the swab several times.
Avoid contact with the tongue, cheeks, teeth, and bleeding areas.
For children and adolescents under 15 years of age, sample collection and test procedure must be performed by a responsible adult.
2. Sample preparation
Insert the swab into the tube with the extraction buffer. Move it up and down at least ten times and then leave it in the liquid for one minute.
When removing the swab, press it against the inner wall of the tube to squeeze out as much liquid as possible. Then seal the tube tightly with the dropper cap.
3. Performing the test
Slowly add three drops of the prepared sample solution into the sample well marked "S" on the test cassette. Then start a timer.
Read the test result 5–10 minutes after adding the sample. After more than ten minutes, the result must no longer be evaluated.
Dispose of the used test materials in accordance with local regulations and wash your hands thoroughly afterwards.
Reading the test result
Positive result: A line appears at both the control line (C) and the test line (T). Even a faintly visible test line is considered a positive result. Have the findings clarified by a doctor.
Negative result: Only the control line (C) appears. Please note that a negative test result does not reliably rule out an infection with Group A Streptococcus. If symptoms persist, seek medical advice.
Invalid result: If no control line (C) appears, the test is invalid. Repeat the test with a new test kit, following the instructions for use.