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 nose 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 infection with SARS-CoV-2, particularly in people who have recently been exposed to the virus. Follow-up testing using a recognized reference method (eg, RT PCR) should be considered to rule out infection in these individuals. Positive results may be due to past or current infection with non-SARS-CoV-2 strains of coronavirus, 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 informing infection status. As with all Pharmact products, the results obtained are a supplement to other information available to healthcare professionals. Management of patients should be based on a combination of symptoms, clinical signs, medical history, other laboratory tests, and therapeutic response.