Gonorrhea Self-Test for Home Use

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CE-märkt IVD-produkt för självtestning av lekmän enligt IVDR (EU) 2017/746

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Product Description:

Test yourself for gonorrhea at home in peace and quiet with our fast, CE-marked self-test. You easily take the sample via a urine sample (men) or with a swab from the cervix (women) and get a reliable result in just 10 minutes. Sent in a completely neutral and discreetly packaged envelope directly to your mailbox.

 

How to perform the test in short

  1. Sampling: The sample is taken with the included sterile swab from the urethra (men) or cervix (women).
  2. Preparation: The swab is treated in the included buffer solutions 1 and 2 according to the complete instructions for use.
  3. Reading: Add 3 drops to the test cassette and read the result after 10 minutes. (Do not interpret the result after 30 minutes have passed).

 

Result interpretation & Important advice

  • Positive result (Two colored lines C and T): Antigens for gonorrhea have been detected in the sample. Important: In the event of a positive result, you are urged by national infectious disease regulations to immediately contact a healthcare center for confirmatory testing, contact tracing, and treatment.
  • Negative result (One colored line at C): No antigens have been detected. If you have persistent or worsening symptoms, you should still consult a healthcare provider.
  • Important limitations: Blood on the swab can cause a false positive result. Cervical samples on women should not be taken during ongoing menstruation.

 

Specifications & Product Information

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

  • Product name: Gonorrhea Rapid Test (REF: IGO-N502H)
  • Risk class (IVDR): Class C
  • Intended purpose: Rapid test for the qualitative detection of Neisseria gonorrhoeae antigens
  • Results within: 10 minutes
  • Sample type: Urine sample from the urethra (men) or cervical sample from the cervix (women)
  • Performance characteristics:
    • Diagnostic sensitivity: 96.0%
    • Diagnostic specificity: 98.3%
    • Overall agreement: 97.3%
  • CE marking & Notified body: CE 3018
  • Legal manufacturer: Hangzhou AllTest Biotech Co., Ltd., #550 Yinhai Street, Hangzhou, China
  • EU Authorized Representative: MedNet EC-REP GmbH, Borkstrasse 10, 48163 Muenster, Germany
  • Included swab: Jiangsu Hanheng Medical Technology Co., Ltd. (CE 0197)

 

📄 Download and read the full instructions for use (PDF in Nordic languages)




Item ID:
IGO-N502H-01

Documents:
attachment Package leaflet

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