The COVID-19 Antigen Rapid Test Kit is an immunochromatographic intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal swab and oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2. The COVID-19 Antigen Rapid Test Kit does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimen during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. For in vitro diagnostic use only. For professional use only.
A novel coronavirus (2019-nCoV) was identified in December 2019, which has resulted in hundreds of thousands of confirmed human infections worldwide. On February 11, 2020 the International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2.The symptoms of COVID-19 are similar to other viral respiratory diseases and include fever, cough, shortness of breath.
The COVID-19 Antigen Rapid Test Kit is designed to detect the presence or absence of SARS-CoV or SARS-CoV-2 nucleocapsid proteins by sandwich method. When specimen are processed and added to the sample well, the specimen is absorbed into the device by capillary action. If SARS-CoV or SARS-CoV-2 antigens present in the specimen, it will bind to the SARS-CoV-2 Antibody-labeled conjugated and flows across the coated nitrocellulose membrane in the test strip. When the SARS-CoV or SARS-CoV-2 antigens level in the specimen is at or above the detection limit of the test, the antigens bound to the SARS-CoV-2 antibody-labeled conjugate are captured by another SARS-CoV-2 antibody immobilized in the Test line (T) of the device, and this produces a colored test band that indicates a positive result. When the SARS-CoV or SARS-CoV-2 antigens level in the specimen does not exist or detection limit of the test, there is not a visible colored band in the Test line (T) of the device. This indicates a negative result.
1. For in vitro diagnostic professional use only
2. Do not use the kit beyond the expiration date
3. Do not mix kit parts with different batch numbers
4. Avoid microbial contamination of the reagents
5. Use the test as soon as possible after opening to protect it from moisture
6. The technical staff involved in collecting COVID-19 detection samples should have biosafety training (special training) and corresponding experimental skills
7. If the test result is positive, you must handle the test cassette correctly
MATERIALS PROVIDED (FOR 20 TEST / KIT)
20 x Test - each test is packed in an airtight aluminum bag and contains a pack of desiccant
20 x collection containers
20 x sterile swabs
20 x Buffer
1 x Instructions
THE PRODUCT IS REGITERED WITH THE NDO
THE PRODUCT IS REGISTERED AND APPROVED BY THE GERMAN FEDERAL INSTITUTE BfArM