iHealth COVID-19/Flu A&B Rapid Test

Reimbursement eligibility is based on the benefits provided by your specific healthcare plan. While most medical plans typically cover all essential inpatient and outpatient Covid-19 care, we advise consulting your healthcare provider to confirm the possibility of reimbursement, as each plan varies.

The iHealth COVID-19/Flu A&B Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.This test is authorized for non-prescription home use with self-collected anterior nares nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older.

iHealth has completed testing on several heat inactivated variant strains and the iHealth COVID-19/Flu A&B Rapid Test was able to detect the mutations. 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.

No. This test is not yet approved or cleared by the United States FDA. The FDA can issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The EUA for this test is supported by the Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying the emergency of IVDs, unless it is terminated or authorization is revoked by FDA (after which the test may no longer be used).

No, specialized medical training is not required to perform the iHealth COVID-19/Flu A&B Rapid Test. The instructions are included in the box and are all you need to take the test. Please read the instructions first. For this test to work properly, you must follow each step.

The test is authorized for individuals aged 14 years or older for self-collected samples and for individuals aged 2-13 years old for adult-collected samples.

No. The test is not authorized for non-prescription home use for children under two years old.

Repeat Testing is needed to improve test accuracy for SARS-CoV-2 for all samples that are negative for SARS-CoV-2 on the first day of testing, even if they are positive for influenza A and/or B. Serial(repeat) testing does not need to be performed if patients have a positive SARS-CoV-2 result on the first day of testing.

Do not use if you have had symptoms longer than 4 days or no symptoms at all. 

Individuals can utilize this test as needed, regardless of vaccination status.

The iHealth COVID-19/Flu A&B Rapid Test is authorized for non-prescription self-use.

Clinical studies have shown that antigen tests more accurately determine whether you are infected with the virus that causes COVID-19 when taken multiple times across several days. Repeat testing improves test accuracy. This serial testing approach is recommended to minimize the risk of incorrect results. For more information on the performance of the test and how the performance may apply to you, please refer to the performance data in the Healthcare Provider Instructions for Use (IFU).

If the control line at “C” is visible and you do not see a line at “A”, “B”, or “T”, it means the test is negative. To increase the chance that the negative result for COVID-19 is accurate, you should test again in 48 hours.

If the control line at “C” is visible and any other single line or multiple lines on “A”, “B”, and/or “T” appear, the test is positive.

Note: Any pink or purple line in the correct indicated locations, no matter how faint, should be considered an indication of a positive result.

If a control line is not visible at “C” after 15 minutes, even if any other line is visible in the results window, THE TEST HAS FAILED and is considered invalid.

STOP: If the test is invalid, repeat the test procedure using a new kit and sample.

A positive result indicates the presence of the respective viruses (SARS-CoV-2, influenza A, or influenza B). Individuals are advised to self-isolate and seek follow-up care with a healthcare provider.

If you test positive, you should self-isolate and contact your healthcare provider for medical advice.

Negative results should be considered presumptive and individuals with symptoms should seek follow-up care.
Negative results do not rule out infection and clinical correlation is necessary.

If you continue to experience symptoms despite a negative result, it's recommended to seek follow-up care with your healthcare provider. Additionally, if you're uncertain about the nature of your symptoms, considering other diseases that may present similarly, such as the common cold or other respiratory infections, can help guide further medical evaluation.

An invalid result means the test was not able to tell if you have COVID-19 and influenza infection or not. If the test is invalid, a new swab should be used to collect a new nasal specimen and you should test again with a new test. 

The test components are single-use and should not be re-used.

No, the nasal swab is not sharp and it should not hurt. Sometimes the swab can feel slightly uncomfortable or tickly. If you feel pain, please stop the test and seek advice from a healthcare provider.

The instructions recommend inserting the swab 1/2 to 3/4 inch into a nostril.

Swabbing both nostrils is part of the recommended sample collection process in order to receive accurate results.

Holding the dropper VERTICALLY over the sample well on the test card, squeeze out exactly 5 DROPS of the solution. Do not squeeze more than five drops from the tube. Additional sample volume may yield inaccurate results.

Once opened, the test device should be used immediately.

We recommend setting a timer and reading the test result at 15 minutes.DO NOT read the result before 15 minutes or after 30 minutes. Inaccurate test interpretations may occur.

If you do not follow the steps exactly as outlined in the instructions, there is a chance you may get an incorrect or invalid test result. If you think you’ve made a mistake, perform another test with a new kit, paying close attention to the process instructions.

Yes. Always follow up with your healthcare provider after performing an at-home test. They will be able to tell you more about what your results mean.

The swab is sterile and safe to use. Gently insert the swab 1/2 to 3/4 inch into a nostril. For young children, swab should not be inserted more than 1/2 inch. You may experience some discomfort when swabbing your nose, but this is to be expected. DO NOT insert the swab any farther if you feel any resistance. If you experience any discomfort or have an allergic reaction to the swab, immediately stop using the swab and contact your healthcare provider.

In the unlikely event your nose starts bleeding, do not insert the swab again. Apply pressure to your nose until the bleeding stops and consult a healthcare professional.

No. You will need to obtain a new test kit. The swab with extraction reagent cannot be used for sample collection. The extraction reagent contains harmful chemicals (refer to “Hazardous Ingredients for Reagent Solution” part of “Instructions for Use”).

The liquid should be wiped off your clothing or surface immediately. Please note that you may not have sufficient liquid remaining to perform the test and may need to obtain a new test kit.

No, do not reuse any test components. Please obtain a new test kit and perform a new test.

If you have questions and need further assistance please reach out to our customer support team at support@ihealthlabs.com or give us a call at 1-855-816-7705 Mon - Fri 8:30AM - 5:30PM PST.