Test for professional use
Approval according to §1 sentence 1 Coronavirus Test Ordinance in Germany (BfArM VNr.: AT384/21)

Rapid test for the qualitative detection of SARS-CoV-2 nucleocapsid (N-protein) antigens in human throat or nasal swab specimens.

Product features

• BfArM No. AT 384/21
  
• CE1434 certified
• High sensitivity and specificity
• Short waiting time for the result
• Simple execution
• Approved for human throat or nose swabs
• Identification of an acute infection
• painless and very safe
• Results in 10 minutes
• Results are easy to read
• Storage at room temperature
• The SARS-CoV-2 Rapid Antigen Test is intended for use by trained
  clinical laboratory staff and those trained for point-of-care environments
  persons provided

Product content

• per box = 20 tests
• Foil pouches each with a test cassette and a desiccant
• Test buffer (each 0.5 ml)
• Instructions for use for the REDTEST PROFESSIONAL SARS-CoV-2 antigen rapid test (COVID-19 Ag)
• sample collection tube
• Dropper tip for the sample tube

Clinical evaluation

• Nasal Swab Samples:
  Relative Sensitivity: 98.13%
  Relative specificity: 100%
  Accuracy: 99.35%
• Throat swab samples:
  Relative Sensitivity: 93.64%
  Relative specificity: 100%
  Accuracy: 96.67%

Manufacturer

• Sigmad Sp. z oo
  Mickiewicza 59
  47-253 Cisek,
  Poland

Sales units

• Minimum order quantity: 1680 tests, 1 carton
• further quantities: a multiple of 1680
• REF CV19AGPL

Download the REDTEST manual in PDF format

*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.