A rapid test for the qualitative detection of SARS-CoV-19 Nucleocapsid Protein antigens present in nasal swab specimen. For self-testing in vitro diagnostic use.
The SARS-CoV-19 Antigen Rapid Test (Nasal Swab) is a single-use test kit intended to detect the SARS-CoV-19 that causes COVID-19 with self-collected nasal swab specimen from symptomatic individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset.
Results are for the detection of SARS-CoV-19 Nucleocapsid protein Antigens. An antigen is generally detectable in upper respiratory specimens 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. Positive results are indicative of the presence of SARS-CoV-19. Individuals who test positive should self-isolate and seek additional care from their healthcare provider. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection. Individuals who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider. The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is intended to be used by laypersons as a self-test for home and workplace (in offices, for sporting events, airports, schools, etc.).
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are found in a few cases.
The SARS-CoV-19 Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-19 nucleocapsid protein antigens in human swab specimens.
Storage and Stability:
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30 °C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use it beyond the expiration date.
- Test cassette
- Package inserts
- Sterile swab
- Extraction buffer
- Biosafety bag
Materials required but not Specifications:
- Timing device
- How does the SARS-CoV-19 Antigen Rapid Test work?
The test is for the qualitative detection of SARS-CoV-19 antigens in self-collected swab specimens. A positive result indicates SARS-CoV-19 antigens present in the specimen.
- When should the test be used?
The SARS-CoV-2 antigen can be detected in acute respiratory tract infection, it is recommended to run the test when symptoms include sudden onset of at least one or more of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia.
- Can the result be incorrect?
The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if inadequate sampling volume or the SARS-CoV-2 Antigen Rapid Test gets wet before test performing, or if the number of extraction buffer drops are less than 3 or more than 4. Besides, due to immunological principles involved, there exist the chances of false results in rare cases. A consultation with the doctor is always recommended for such tests based on immunological principles.
- How to interpret the test if the color and the intensity of the lines are different?
The color and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and clearly visible. The test should be considered as positive whatever the color intensity of the test line is.
- What do I have to do if the result is negative?
A negative result means that you are negative or that the viral load is too low to be recognized by the test. However, it is possible for this test to give a negative result that is incorrect (a false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. If you experience symptoms such as headaches, migraines, fever, loss of sense of smell and taste, contact the nearest medical facility using the rules of your local authority. In addition, you can repeat the test with a new test kit. In case of suspicion, repeat the test after 1-2 days, as the coronavirus cannot be precisely detected in all phases of infection. Distance and hygiene rules must still be observed. Even with a negative test result, distance and hygiene rules must be observed, migration/traveling, attending events, etc. should follow your local COVID guidelines/requirements.
- What do I have to do if the result is positive?
A positive result means the presence of SARS-CoV-19 antigens. A positive result means it is very likely you have COVID-19. Immediately go into self-isolation in accordance with the local guidelines and immediately contact your general practitioner/doctor or the local health department in accordance with the instructions of your local authorities. Your test result will be checked by a PCR confirmation test and you will be explained the next steps.
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