Short Description:
- Easy handling, per rod in the anterior nasal region
- BfArM Test ID: AT282/21
- Sensitivity: 95.37%; Specificity: 99.13%.
- Very easy to use, by swab in the anterior nasal region (Anterior Nasal)
- Test officially approved and suitable for laymen by BfArM
- In single packs
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| Intended use:
The kit is for the in vitro qualitative 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:
- SARS-CoV-2 Antigen Test Cassette
- Extraction solution in tube
- Disposable Virus Specimen Collection Swabs
- Biohazard sample bags (for safe disposal via household waste)
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Features:
- Sensitivity = 95.37%
- Specificity = 99.13%
- Easy to use – Fast and reliable test results in only 15 minutes.
- BfArM listed AT282/21, special approval 5640-S-057/21
- Manufacturer: Beijing Hotgen Biotech Co., Ltd.
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Further notes:
- The Hoten Self-Test should be stored at 4 to maximum 30°C.
- Shelf life is 18 months (date of manufacture and expiry date are indicated on the label).
- After opening the foil pouch, the test should be used within 30 minutes at room temperature (temperature 10 – 30 °C, humidity ≤ 70%).
- 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, and its transport and storage. Any errors may cause inaccurate test results.
- People 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
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Unterlagen
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