Q.How can I get this test reimbursed?
A. 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.
Q. How does the iHealth COVID-19/Flu A&B Rapid Test work?
A. 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.
Q. Will this test detect Covid-19 variants?
A. 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.
Q. Is the iHealth COVID-19/Flu A&B Rapid Test FDA approved or cleared?
A. 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).
Q. Do I need medical training to perform the iHealth COVID-19/Flu A&B Rapid Test?
A.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.
Q. What is the age range for the test?
A.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.
Q. Can the iHealth COVID-19/Flu A&B Rapid Test be used in children under two years old?
A. No. The test is not authorized for non-prescription home use for children under two years old.
Q.Do I need to perform two tests?
A.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.
Q. Will the test work if I don’t have any symptoms?
A.Do not use if you have had symptoms longer than 4 days or no symptoms at all.
Q. Should people who are vaccinated use this test?
A.Individuals can utilize this test as needed, regardless of vaccination status.
Q. Is a prescription required to perform this test?
A.The iHealth COVID-19/Flu A&B Rapid Test is authorized for non-prescription self-use.