- 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
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.
- 5 test cassettes
- 5 disposable swabs
- 5 extraction reagents
- 5 disposable extraction tubes
- 1 package insert
- 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..
- 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.