INDICAID COVID-19 Rapid Antigen PoC (Point-of-Care) Test

The INDICAID COVID-19 Rapid Antigen Test is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigens. Antigen tests are designed to detect proteins from the virus that causes COVID-19 through swab specimens taken from the patient’s nose.

This test can be administered with no equipment or training needed. The test has high sensitivity and can detect lower viral load samples against competitive products. This test has been granted Emergency Use Authorization (EUA) by the United States Food and Drug Administration.

The shelf-life of the INDICAID test is 15 Months from the date of manufacture. The expiration date is provided on the label of the outer box. This includes the 3 Month (90 Day) FDA extension.

Data from our US multi-center clinical study demonstrates similar performance for detection of the COVID-19 Omicron variant compared to the original COVID-19 strain.

The test is performed by a CLIA Certified Health Care Provider (HCP) using direct anterior nasal swab specimens from suspected COVID-19 individuals within the first five (5) days of symptom onset. Anterior nasal swab specimens may be collected by an HCP or self-collected by individuals 18 years of age or older, under the supervision of an HCP.

INDICAID’s intuitive design allows the collection of multiple samples within a very short timeframe, followed by bulk-testing of samples within only two hours.

The swab test method is utilized by the biomedical community for the collection of upper-respiratory specimens for molecular and rapid antigen testing. The CDC supports and promotes this testing method in light of the current COVID-19 pandemic climate for its practicality, simplicity, and efficiency of gathering much-needed data in bulk.

A negative test result means that proteins from the virus that causes COVID-19 were not found in your sample, all negative results are presumptive. However, it is possible for this test to give a negative result that is incorrect (false-negative) in some people with COVID-19. Your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you.

Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing.

A positive test result means that proteins from the virus that causes COVID-19 were found in your sample. This means that it is likely that you have COVID-19, even if you do not have any symptoms. There is also a very small chance that this test can give a positive result that is incorrect (a false-positive), particularly when used in a population without many cases of COVID-19. Your healthcare provider will discuss the next steps with you and how to best care for you based on your medical history and symptoms.

• This test does not differentiate between SARS-CoV and SARS-CoV-2 viruses, so you may receive a positive result but have a different coronavirus that does not cause COVID-19.

• It is possible to test a person too early or too late during COVID-19 to make an accurate diagnosis. The amount of antigen in a sample may decrease as the duration of illness increases. Negative results should be treated as presumptive, results from patients with symptom onset beyond 5 days may need to be confirmed with a molecular assay, if necessary, for patient management.

• Improper handling of the test kit not according to guidelines may yield imprecise test results.

• When an incorrect result is suspected, it is important that you engage with your healthcare provider to help you understand the situation and evaluate your next steps.

The INDICAID COVID-19 Rapid Antigen Test is for diagnosis only and is safe to use, with no long-term impact on human health.

Potential risks include:

Potential benefits include:

For detailed information see the “Warnings, Precautions, and Safety Information” section of the Instructions For Use (IFU).

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the 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. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.

If your antigen test result is negative, serial testing should be performed at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing. All negative results are presumptive.

Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have COVID-19 than a molecular test would.

Discuss with your healthcare provider whether a molecular test would help with your care, and when you should discontinue home isolation if necessary. If a molecular test is not available, the CDC recommends that you should stay home.

Refer to the CDC website for most updated guidelines: https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html

Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids. Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management. Results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19.