Short Description:

  • Easy handling, per rod in the anterior nasal region.
  • BfArM special approval: 5640-S-168/21
  • Sensitivity: 97,1o%; Specificity: 99,40%
  • Very easy to use by swab in the anterior nasal region (Anterior Nasal)
  • Officially approved, tested and evaluated test by BfArM for laymen
  • In packs of 5
Intended use:

The kit is intended for the qualitative in vitro determination of SARS-CoV-2 antigen in human anterior nasal specimens. A positive test result indicates that the specimens contain SARS-CoV-2 antigen. A negative test result does not rule out the possibility of infection.

This kit is intended for home use by lay persons outside the laboratory. This includes a person’s home or certain non-traditional locations such as offices, sporting events, airports, schools, etc.

Components:

  • 5 test cassettes
  • 5 disposable swabs
  • 5 extraction reagents
  • 5 disposable extraction tubes
  • 1 package insert
Properties:

  • Sensitivity = 97.10%
  • Specificity = 99.62
  • Easy to use – fast and reliable test results in only 15 minutes
  • BfArM special approval: 5640-S-104/21
  • Manufacturer: Hangzhou Clongene Biotech Co., Ltd..
Additional Notes:

  • The kit should be stored at 4 to 30 degrees max.
  • Shelf life is 12 months (manufacturing date and expiration date are indicated on the label)
  • After opening the foil pouch, the test should be used within one hour at room temperature.
  • Sensitivity of the test decreases after the first 5 days after the onset of symptoms
  • Test can only tell if antigen is present, not in what concentration
  • Test result depends on quality of specimen collection, processing, transport and storage. Any errors may cause inaccurate test results.
  • Persons under 18 years of age should be assisted by an adult
  • Intended for in vitro diagnostic use only

    This product has been approved for the detection of SARS-Cov-2 nucleocapsid protein only, not for other viruses or pathogens.

    Please be sure to follow the manufacturer’s information within the instructions for use and on the product packaging.