FAQs

Report adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088.

There are alternative tests that have received EUA authorization. Any tests that have received full marketing status (e.g., cleared, approved), as opposed to an EUA by the FDA can be found by searching the medical device databases here:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases

Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

The INDICAID^® COVID-19 Rapid Antigen Test has been validated clinically. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between February 2021 and March 2021. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

Results from antigen testing should not be used as the sole basis to diagnose or exclude COVID-19 infection. A negative antigen test should not be the sole basis used to determine if a patient can end isolation precautions. For additional recommendations regarding infection control, refer to CDC’s Discontinuation of Isolation for Persons with COVID-19 Not in Healthcare Settings (Interim Guidance).

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. Specimens collected after day 5 of illness may be more likely to be negative compared to a RT-PCR assay. Therefore, negative results from patients with symptom onset beyond 5 days should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.

When diagnostic testing is negative, the possibility of a false-negative result should be considered in the context of a patient’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false-negative result should especially be considered if the patient’s recent exposures or clinical presentation indicate that COVID-19 is likely, and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If COVID-19 is still suspected based on exposure history together with other clinical findings, re-testing or testing with molecular methods should be considered by healthcare providers in consultation with public health authorities.

There is a higher chance of false negative results with antigen tests than with laboratory-based molecular tests due to the sensitivity of the test technology. This means that there is a higher chance this test will give a false negative result in an individual with COVID-19 as compared to a molecular test, especially in samples with low viral load.

This test has been designed to minimize the likelihood of false-positive test results. However, positive results can be due to present infection with non-SARS-CoV-2 coronavirus strains that do not cause COVID-19, such as SARS-CoV.

A negative test result for this test means that nucleocapsid antigens from SARS-CoV-2 were not present in the specimen above the limit of detection.

All negative results should be treated as presumptive and confirmation with a molecular assay, may be necessary if there is high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

There is a higher chance of false negative results with antigen tests compared to laboratory-based tests such as PCR tests.

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 for COVID-19 indicates that nucleocapsid antigens from SARS-CoV-2 were detected, and the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Please contact the patient’s doctor/primary care physician (if applicable) and the local health authority immediately and instruct your patient to adhere to the local guidelines regarding self-isolation.

There is a very small chance that this test can give a positive result that is incorrect (false positive). Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available on the CDC website. When collecting and handling specimens from individuals suspected of being infected with COVID-19, appropriate personal protective equipment (PPE) should be used as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).

This test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets requirements to perform moderate complexity, high complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

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

Antigens are present in the SARS-CoV-2 virus, and can bind with specific antibodies. When a virus enters a human body and begins to multiply, the body begins to react to the viral antigen, possibly resulting in symptoms. The INDICAID™ COVID-19 Rapid Antigen Test detects antigen from SARS-CoV-2 virus and can be used for COVID-19 screening during active infection.

This test can be administered with no equipment or training needed, and results can be developed in as fast as 20 minutes. 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 INDICAID^® COVID-19 Rapid Antigen Test (CE-IVD) is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 antigen in direct nasal swab samples.