Streptococcus A Rapid Test – for At-Home Testing of Throat Infections (1 test/box)

The test is an in vitro diagnostic device intended for self-testing and can therefore be performed at home.

Streptococcus A infection can cause, among other conditions, inflammation of the throat and tonsils. According to the instructions for use, performing the test may be particularly appropriate in the presence of the following symptoms:

• sore throat,
• red, swollen tonsils,
• small red spots at the back of the roof of the mouth,
• swollen lymph nodes,
• fever,
• headache,
• nausea or vomiting – especially in children.

The test may provide rapid assistance in detecting the presence of Strep A antigen; however, the result should be interpreted together with the symptoms and, if necessary, additional medical examinations.

Product name: Streptococcus A Rapid Test

Sample: throat swab

Pack size: 1 test/box

Format: test cassette

Manufacturer: Hangzhou Alltest Biotech Co., Ltd., Ltd., 550 Yinhai Street, Hangzhou Economic and Technologic Development Area, 310018, Zhejiang, China; Phone: +86-571-56267891; info@alltests.com.cn

EC REP: MedNet GmbH, Hansestraße 91, 48165 Münster, Germany; +49 251 32266-0; info@medneteurope.com

Before testing, allow the test cassette and buffers to reach room temperature (15–30 °C).

1. Wash your hands thoroughly, then prepare the test components.

2. Remove the cap from the tube containing Buffer 2, then place the tube in the holder provided on the box.

3. Break the Buffer 1 container at its narrowest point, then pour the entire contents into the tube containing Buffer 2. The mixed solution must be used immediately.

4. Open the packaging of the sterile swab. Be careful not to touch the soft tip of the swab.

5. Sample collection: stand in front of a mirror, tilt your head slightly backwards and open your mouth wide. Use a tongue depressor or spoon to press down the tongue. Thoroughly rub the surface of one or both tonsils and the back wall of the throat with the sterile swab.

It is important not to touch the tongue, the inside of the cheeks or the teeth with the swab. Proper sample collection is particularly important for obtaining a reliable result.

6. Immediately after collecting the sample, place the swab into the tube containing the mixed buffer solution.

7. Rotate the swab approximately 15 times while pressing it against the inner wall of the tube, then leave it in the tube for 1 minute.

8. Remove the swab while pressing it against the wall of the tube to extract as much liquid as possible.

9. Attach the dropper tip to the tube. Remove the test cassette from the foil pouch and place it on a flat surface.

10. Add 3 drops of the solution to the sample well marked “S” on the test cassette.

11. Start the timer. Read the result after 5 minutes. The result must not be interpreted after 10 minutes.

If two lines appear, one in the C (control) region and one in the T (test) region, the result is positive. This means that the test detected Strep A antigen in the sample and a Group A Streptococcus infection may therefore be present.

The control line is blue, while the test line is red. The intensity of the T line may vary: even a faint test line is considered a positive result. In the event of a positive result, consult a doctor.

If only the C control line appears and there is no line in the T region, the result is negative. This means that the test did not detect Strep A antigen, or the amount present is below the detection limit of the test.

A negative result therefore does not completely rule out infection. If symptoms persist or there is still a suspicion of Streptococcus infection, the instructions for use recommend repeating the test after 1–2 days and consulting a doctor.

If the C control line does not appear, the test is invalid. In this case, the test must be repeated using a new test kit.

According to the manufacturer’s study, conducted on 304 throat swab samples and compared with a culture method, the test has the following performance characteristics:

Sensitivity: 95.1%

Specificity: 98.0%

Accuracy: 97.0%

The Streptococcus A Rapid Test provides a preliminary test result and does not replace a medical diagnosis. In the event of a positive result, it is recommended to consult a doctor. The test cannot distinguish between live and dead bacteria, so a positive result may also occur following a recent Streptococcus A infection.

The test must be stored at 2–30 °C, must not be frozen and must not be used after the expiry date. In children, the test must be performed by an adult.