Strep A (Strep Throat) Self-Test for Home Use

Test yourself for strep throat (Streptococcus A) at home in peace and quiet with our fast, CE-marked self-test. With a simple throat swab, you get a reliable indication in 5–10 minutes whether your sore throat is caused by Strep A bacteria. Sent in a completely neutral and discreetly packaged envelope directly to your mailbox.

How to perform the test in short

1. Sampling: Use the provided tongue depressor to hold down your tongue and gently rub the sterile swab against the back of the throat and tonsils.
2. Preparation: Mix buffer solutions 1 and 2 in the extraction tube. Place the swab in the tube and rotate it against the inside of the tube for 1 minute. Squeeze the liquid from the swab as you remove it and attach the dropper tip.
3. Reading: Add 3 drops to the test cassette and read the result after 5–10 minutes. (Do not interpret the result after 10 minutes have passed).

Result interpretation & Important advice

• Positive result (Two colored lines C and T): Antigens for Strep A have been detected in the sample. Important: A positive result indicates an ongoing strep throat infection caused by Group A Streptococcus. You should contact a doctor or healthcare center for evaluation and possible antibiotic treatment.
• Negative result (One colored line at C): No Strep A antigens were detected. If your sore throat is severe, worsens, or is accompanied by a high fever, you should still contact a healthcare provider as a sore throat can also be caused by viruses.
• Important limitations: The test only detects the presence of Group A Streptococcus antigens and cannot distinguish between an active infection and asymptomatic carriage.

Specifications & Product Information

CE-marked IVD product for self-testing by laypersons according to IVDR (EU) 2017/746

• Product name: Strep A Rapid Test (REF: ISTB-N502H)
• Risk class (IVDR): Class C
• Intended purpose: Rapid test for the qualitative detection of Group A Streptococcus antigens in throat swab specimens
• Results within: 5–10 minutes (do not interpret after 10 minutes)
• Sample type: Throat swab (specimen from throat/tonsils)
• Performance characteristics:
  • Diagnostic sensitivity: 95.1 % (up to 96.8 % in lay user study)
  • Diagnostic specificity: 98.0 % (up to 100.0 % in lay user study)
  • Overall agreement: 97.0 %
• CE marking & Notified body: CE 0123
• Legal manufacturer: Hangzhou AllTest Biotech Co., Ltd., #550 Yinhai Street, Hangzhou, China
• EU Authorized Representative: MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany