For personal use in the anterior nasal swab

The COVID-19 rapid antigen test provides direct evidence of an acute infection with SARS-CoV-2 within 15-20 minutes within the first two weeks after the onset of symptoms.

Product features

• BfArM No. AT 1200/21
  
• CE1434 certified
• MHD 6/2023
• approved for the front nasal area
• Identification of an acute infection
• High accuracy, specificity and sensitivity
• painless and very safe
• Results in 15 minutes
• Results are easy to read
• Storage at room temperature
• Evaluated according to the guidelines of the RKI and the Paul Ehrlich Institute

Product content

• per package = 1 test
• 1 test card
  
• 1 dropper
• 1 extraction buffer (0.5 ml)
• 1 sterile disposable swab
• 1 sealable plastic bag
• Instructions for use and brief instructions

Clinical evaluation

• Sensitivity: 98.13%
• Specificity: 100.0%

Manufacturer

• Genrui Biotech Inc.
  4-10F, Building 3, Geya Technology Park,
  Guangming District, 518106 Shenzhen, China

EU representative

• Lotus NL BV
  Queen Julianaplein 10, 1st floor,
  2595 AA The Hague, The Netherlands
  Email: peter@lotusnl.com

Sales units

• Minimum order quantity: 5 pieces (tests)
• Additional quantities: 10 pieces, 25 pieces, 50 pieces, 100 pieces, 500 pieces (1 complete outer box)
• REF 52104097

Download PDF instructions for use of the Genrui antigen self-test

*NOTE: Negative results do not rule out SARS-CoV-2 infection, especially in people who have recently come into contact with the virus. Follow-up examinations using a recognized reference method (e.g. RT PCR) should be considered to rule out infection in these individuals. Positive results may be due to a previous or current infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E. Antibody test results should not be used as the sole basis for diagnosing or ruling out SARS-CoV-2 infection or for providing information about the status of the infection. As with all Pharmact products, the results obtained are in addition to other information available to healthcare professionals. Treatment of patients should be based on a combination of symptoms, clinical signs, medical history, other laboratory tests, and therapeutic responses.