Influenza A+B Self-Test for Home Use

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Product Description:

Test yourself for influenza A and influenza B at home in peace and quiet with our fast, CE-marked self-test. With a simple swab from the front of the nose (nasal swab), you get a reliable result in 10 minutes indicating whether your symptoms such as fever, chills, muscle aches, or cough are caused by influenza viruses. Sent in a completely neutral and discreetly packaged envelope directly to your mailbox.

 

How to perform the test in short

  1. Sampling: Gently insert the included sterile swab about 2 cm into one nostril. Slowly rotate the swab 5–10 times against the nasal wall. Repeat the same procedure in the other nostril using the same swab.
  2. Preparation: Place the swab into the extraction tube with buffer liquid. Press the swab head against the inside of the tube and rotate for 10–15 seconds. Remove the swab while squeezing the liquid out by pressing the sides of the tube together. Attach the dropper tip.
  3. Reading: Turn the tube upside down and add 3 drops to the specimen well (S) on the test cassette. Read the result at 10 minutes. (Do not interpret the result after 20 minutes have passed).

 

Result interpretation & Important advice

  • Positive for Influenza A (Line at C and A): Antigens for influenza A have been detected in the sample.
  • Positive for Influenza B (Line at C and B): Antigens for influenza B have been detected in the sample.
  • Positive for both A and B (Lines at C, A, and B): Antigens for both influenza A and B have been detected.
  • Important advice: Stay home, rest, and avoid contact with others to prevent spreading infection. Stay well hydrated. Contact healthcare if you belong to a high-risk group, experience severe breathing difficulties, or have a persistent high fever.
  • Negative result (Only line at C): No antigens for influenza A or B were detected. If your symptoms persist or worsen, you should still consult a healthcare provider.

 

Specifications & Product Information

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

  • Product name: Influenza A+B Rapid Test (REF: IIN-N502H)
  • Risk class (IVDR): Class C
  • Intended purpose: Rapid test for the qualitative detection of influenza A and B antigens in nasal swab specimens
  • Results within: 10 minutes (do not interpret after 20 minutes)
  • Sample type: Nasal swab (anterior nares, approx. 2 cm deep)
  • Performance characteristics:
    • Influenza A: Sensitivity 90.7 % | Specificity 99.5 % | Overall accuracy 97.7 %
    • Influenza B: Sensitivity 91.1 % | Specificity 100.0 % | Overall accuracy 98.5 %
  • 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



Item ID:
IIN-N502H-01

Documents:
attachment Package leaflet (PDF)

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