​The iStatis COVID-19 Antigen Test is a single-use, visually read, lateral-flow in vitro qualitative immunoassay intended for the detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal specimens collected from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptoms onset.

The iStatis COVID-19 Antigen Home Test is a single-use, visually read, lateral-flow in vitro qualitative immunoassay intended for the detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal specimens collected from individuals suspected of COVID-19 within the first seven days of symptoms onset.

The iStatis COVID-19 Antigen Self Test is intended to be used by individuals suspected of COVID-19 within the first seven days of symptoms onset.

Please read the Instructions for Use or Package Insert provided with your iStatis Test.

​There are different kinds of tests for the virus that causes COVID-19. Molecular tests detect genetic material from the virus. Antigen tests, such as the iStatis COVID-19 Antigen Home Test, detect proteins from the virus. Antigen tests are very specific for the SARS-CoV-2 virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. If your test result is negative, you should discuss with your healthcare provider whether an additional test is necessary and if you should continue isolating at home. There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19.

​Serial testing is when one person tests themselves multiple times for COVID-19 on a routine basis, such as every day or every other day. By testing more frequently, you may detect COVID-19 more quickly and reduce spread of infection. Serial testing (i.e. testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms. Testing for asymptomatic individuals should be performed at least twice over three days, with at least twenty-four hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.

A negative test result means that proteins from the virus that causes COVID-19 was not found in your sample. It is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means you could possibly still have COVID-19 even though the test is negative. The amount of antigen in a sample may decrease the longer you have symptoms of infection. In symptomatic people, specimens collected after you have had symptoms for more than five days may be more likely to be negative compared to a molecular assay. If you test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider.

​A reactive test result means proteins from the virus that causes COVID-19 were found in your sample. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive result). If you test positive with the iStatis COVID-19 Antigen Home Test you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary.

​An invalid test result means that the test was run incorrectly, or insufficient specimen was added. Invalid test results cannot be interpreted. Repeat the test with a fresh specimen using a new cartridge, kit components and support materials.