The Rapid COVID-19 Antigen Test is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. Currently, individuals infected by SARS-CoV-2 are the main source of transmission; asymptomatic carriers are also known as a source of transmission. Based on the current epidemiological information, the incubation period can last from 1 to 14 days, where the average time before symptoms occur is about 5 days. Symptoms include fever or chills, cough, shortness of breath, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, runny nose, nausea or vomiting and diarrhea.
This test has not been reviewed by the FDA
Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.
Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory’s CLIA certificate of high-complexity testing.
This test is not for home-use or at-home specimen collection.
o Positive Percent Agreement (PPA): 95.7%
o Negative Percent Agreement (NPA): 99.6%
o Overall Percent Agreement (OPA): 98.9%
- Qualitative, visually read results in 15 minutes
- No instrument required
- Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
- Procedural internal control included
- Sterile Swabs, Extraction Buffer and Extraction Tubes included
- Clinical Evaluation
- Positive Percent Agreement (PPA): 95.7%
- Negative Percent Agreement (NPA): 99.6%
- Overall Percent Agreement (OPA): 98.9%
- Specimen: Nasopharyngeal (NP) Swab
- Time to Results: 15 minutes
- Shelf Life: 24 months from the date of manufacture
Rapid COVID-19 Antigen Test
Direct Nasopharyngeal Swab
What is antigen testing?
Antigen tests detect proteins specific to a virus that appears in infected individuals, which indicates active infection. Rapid antigen testing is beneficial because of their portability, ease-of-use, and swift time to result.
What is the extraction buffer?
The extraction buffer includes components to dissociate viral proteins from their surfaces to be used as a target for the test. The method of the extraction buffer is used to prepare the test sample by dissolving the virus shell, which also deactivates the virus.
Does the test kit include transport media?
The test kit includes an extraction buffer that is used to prepare the specimen for testing purposes. The extraction buffer IS NOT transport media and should not be used to preserve or transport specimens.
Can the test be used with alternative specimen types such as nasal swabs or any specimen contained in viral transport media?
The Rapid COVID-19 Antigen Test is for direct nasopharyngeal swab specimen only. The test can only be used with the swab provided in the kit.
Can I collect the specimen and test at a later time?
The specimen should be tested immediately after collection. The specimen can be retained up to 1 hour following collection if immediate testing of specimens is not possible. Dispose of the specimen and recollect if retained for more than 1 hour.
Can I freeze the device for long-term storage?
The device should never be frozen. If refrigerated, allow the test kit components to reach room temperature before use.