iHealth COVID-19 Antigen Rapid Test Instructions

: June 6, 2024
: iHealth

Table of Contents

iHealth COVID-19 Antigen Rapid Test
What are the symptoms of COVID-19?
What do I need to know about COVID-19 testing?
What does it mean if the specimen tests positive for the virus that
What does it mean if the specimen tests negative for the virus that
What do I need to know about Serial Testing in Asymptomatic Individuals?
What is a EUA?
What are the approved available alternatives?
Where can I go for updates and more information?
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

iHealth COVID-19 Antigen Rapid Test

This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the iHealth® COVID-19 Antigen Rapid Test. The iHealth® COVID-19 Antigen Rapid Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with self- collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

All individuals who use this assay are required to receive and should carefully review the iHealth® COVID-19 Antigen Rapid Test Instruction for Use before they use the test.

What are the symptoms of COVID-19?

Many patients with COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, dyspnea), although some individuals experience only mild symptoms or no symptoms at all. The current information available to characterize the spectrum of a clinical illness associated with COVID-19 suggests that symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat or new loss of taste or smell. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 5 days but may range 2-14 days. For further information on the symptoms of COVID-19 please see the link provided in the “Where can I go for updates and more information?” section. Public health officials have identified cases of COVID-19 throughout the world, including the United States. Please check the CDC COVID-19 webpage (see link provided in the “Where can I go for updates and more information?” section at the end of this document) or your local jurisdiction’s website for the most up-to-date information.

This Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with symptoms of COVID-19 within the first seven (7) days of symptom onset, or with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

What do I need to know about COVID-19 testing?

Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information?” section). The iHealth® COVID-19 Antigen Rapid Test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.

The iHealth® COVID-19 Antigen Rapid Test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.
The iHealth® COVID-19 Antigen Rapid Test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests

Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 control precautions is available at the CDC’s website (see links provided in the “Where can I go for updates and more information” section). Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of having COVID-19 as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information” section).

What does it mean if the specimen tests positive for the virus that

causes COVID-19?

A positive test result for COVID-19 indicates that antigens from SARS-CoV-2 were detected, and the patient is very likely to be infected with the virus and presumed to be contagious. 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. Patient management decisions should be made by a healthcare provider and follow current CDC guidelines. The iHealth® COVID-19 Antigen Rapid Test has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects. Test results are automatically reported through the
“iHealth COVID-19 Antigen Rapid Test” App to relevant public health authorities in accordance with local, state, and federal requirements. All healthcare providers must follow the standard testing and reporting guidelines according to their appropriate public health authorities.

What does it mean if the specimen tests negative for the virus that

causes COVID-19?

A negative test result for this test means that antigens from SARS-CoV-2 were not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Antigen tests are known to be less sensitive than molecular tests that detect viral nucleic acids. The amount of antigen in a sample may decrease as the duration of illness increases. In symptomatic patients, specimens collected after day 5 of illness may be more likely to be negative compared to an RT-PCR assay. Negative results 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. Risks to a patient of a false negative test result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in an increased risk of spread of COVID-19 within the community, or other unintended adverse events. 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) (see links provided in “Where can I go for updates and more information” section). The performance of this test was established based on the evaluation of a limited number of clinical specimens collected in November 2020.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.

What do I need to know about Serial Testing in Asymptomatic Individuals?

In asymptomatic individuals, serial testing may assist in identifying infected individuals and facilitate timely infection control practices. A negative test result does not rule out infection but repeat testing over two or three days may decrease the risk of false-negative results. Additional clinical studies are underway to assess the performance of rapid antigen tests when used with serial testing. An initial negative test result should be the first of a minimum of two tests. An asymptomatic individual undergoing serial testing with two or more negative results may require ongoing serial testing or confirmatory testing, depending on patient history and potential exposures. An asymptomatic individual undergoing serial testing with one or more positive results indicates that SARS-CoV-2 antigen is present, but does not rule out coinfection with other pathogens.
Additional confirmatory testing with a molecular test for negative results may be necessary if there is a high likelihood of SARS-CoV-2 infection, such as, an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection. For additional recommendations regarding confirmation of antigen test
results, please refer to the CDC’s Interim Guidance for Antigen Testing for SARS-CoV-2 (see links provided
in ”Where can I go for updates and more information?” section).

What is a EUA?

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue a EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in diagnosing COVID-19. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs unless it is terminated or the authorization is revoked (after which the test may no longer be used).

What are the approved available alternatives?

There are no approved available alternative antigen tests. Any tests that have received full marketing status (e.g., cleared, approved), as opposed to a EUA, by FDA can be found by searching the medical device databases here: https://www.fda.gov/medicaldevices/device-advice-comp rehensive-regulatory assistance/medical-device-databases. A cleared or approved test should be used instead of a test made available under a EUA, when appropriate and available. FDA has issued EUAs for other tests that can be found at: https://www.fda.gov /emergencypreparedness-and-respo nse/mcm-legal-regulatory and-policy- framework/emergency-use-authorization.