iHealth will issue a report to your email after the COVID test is completed. Please be cautious of the following situations: Below is a list of iHealths authorized distributors (in alphabetical order): If you want to verify whether a seller not on the list is authorized to distribute iHealth tests, please contact us at legal@ihealthlabs.com. The iHealth COVID-19 Antigen Rapid Test is an antigen test. Food and Drug Administration. Will the test work if I don't have symptoms? If you do not have COVID-19 symptoms, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests. This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and. Even better, we now have access to at-home Covid tests so, if youre well-stocked, we dont even have to leave the house to take a test. Please obtain a new test kit and perform a new test. This test is not yet approved or cleared by the United States FDA. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc. Model: ICO-3000/ICO-3001/ICO-3002 For use with anterior nasal swab specimens Use the Test Card within 1 hour after opening the foil pouch. Choosing a selection results in a full page refresh. CDC Updates and Shortens Recommended Isolation and Quarantine Period for General Population. If you do not have COVID-19 symptoms or have been having symptoms for more than 7 days, you will need to perform two tests over two or three days with at least 24 hours and no more than 48 hours between tests. FDA can issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. The iHealth COVID-19 Antigen Rapid Test is able to detect small parts of the SARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions. For example, the antiviral treatment Paxlovid can be given in an outpatient setting and is effective at reducing hospitalization and death in people with COVID-19. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc. Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril. This is not a PCR test and not valid for travel. The test strip will have a control line, and if a second line appears (also known as a test line), no matter how faint, it should be read as a positive result. "- Satish Misra, MD, "I would recommend the companion app, named Gluco-Smart, to people with diabetes as a standalone glucose logbook app. "For the Stats Guy: iHealth Core. Her professional interests include preventive cardiology, medical journalism, and health policy. It has come to our attention that there is some false information regarding the price of iHealth Covid-19 Antigen Rapid Test (the "Kit") in the U.S. market. When Do Spring Candles Come Out At Bath & Body Works? Steps you should take to protect others include: When you receive a positive COVID-19 test result, it's extremely important to inform your contacts so they can test and isolate as needed. You won't need to collect a sample from deep in your nasal cavity to get accurate results. If you leave the iHealth COVID-19 Antigen Rapid Test app during test without exiting it, you may be able to return to the same screen. A POSITIVE result must show BOTH a C line and a T line. Can I re-use the swab? Once the Test Card is removed from the pouch, perform the test as soon as possible. From there, it takes a little over an hour to get your results, which will appear on your phone when theyre ready. The CDC currently recommends several Steps to help prevent the spread of COVID-19 if you are sick, detailed guidance could be found at: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html. If only the C line shows up, the test is negative. The app is nice because it also tracks your testing history and offers the ability to share your results with other people. As you can see in this photo, if a test line is present at all, whether its dark, light, or visible without a control line, its considered a positive reading. No. For the latest on COVID-19, visit ourcoronavirus news page. 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 increased risk of spread of COVID-19 within the community, or other unintended adverse events. Does a strong, dark line on a COVID-19 rapid test mean you're more infectious than a faint . Another typeof test is an antibody test. Dense with data, plus a few other accessories, the app can track BP and blood oxygen, too. The iHealth Test app allows the administrator of a small group to monitor and track the group members test results when needed at school, work or event. The test will take around 30 minutes, and youll know its complete when a green light appears next to done on the top right of the unit. What should I do if I have COVID-19 symptoms BUT my test result is negative? Remove the cl ea rov on the orange cap. Yes. After adding the sample to the sample port, do NOT confirm your result before your 15-minute timer is up. If you experience concerning symptoms such as shortness of breath, chest pain, and blue or gray skin or lips, you should seek medical care immediately. How far do I need to insert the Nasal Swab? False negatives can happen due to improper specimen collection, which is why it's important to perform the test exactly as instructed by the kit. If your test result is positive with the iHealth COVID-19 Antigen Rapid Test, you should self-isolate and seek follow-up care with your healthcare provider as additional testing may be necessary. After previously focusing on making medical devices like forehead thermometers, iHealth is now a major supplier of at-home tests to the federal government. Detect, Inc. is recalling the products out of an abundance of caution. How Accurate Are Rapid COVID Tests? What Research Shows - Healthline This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. As of Jan 11, 2023, the shelf life of iHealth tests is extended to 15 months. After the minute has passed, remove the swab and place the dropper top on top of the tube. With children, the maximum depth of insertion into the nostril may be less than of an inch, and you may need to have a second person to hold the childs head while swabbing. What to Do If You Get a Positive At-Home COVID-19 Test Result TAX ID (EIN): 80-06641524. Molecular tests (also known as PCR tests) detect genetic material from the virus. When COVID-19 is present in the body, your nasal secretions can also contain the SARS-CoV-2 virus (the virus that causes COVID-19). "- David Ahn, MD. Who is considered high risk for severe disease? Centers for Disease Control and Prevention. Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms. A positive at-home COVID-19 test doesn't necessarily require hospitalization or in-person treatment. Can You Still Use a COVID-19 At-Home Test If Its Expired? There are different kinds of tests for COVID-19. The test can be completed in the comfort of your own home without the need to ship your sample to a lab. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected in between May and October 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. We, iHealth Labs Inc, hereby clarify that we and our authorized distributors are the only organizations in the U.S. that may legally sell and distribute the Kit under FDA EUA. Covid testing has come a long way since 2020. The process for taking the test is the same as most of the others, a nasal swab, test tube, and dropper, but when the 15 minute waiting period is over, instead of reading the results yourself, youll scan the test and the app will read it fo you. Unlike a lot of other at-home Covid tests, this one has a fold-over card thats used for testing. Testing for asymptomatic individuals should be performed at least twice over three days, with at least twenty-four hours and no more than 48 hours between tests. The iHealth COVID-19 Antigen Rapid Test has been designed to minimize the likelihood of false positive test results. Each iHealth COVID-19 Antigen Rapid Test kit includes 2 tests. It works similarly to most others on this list. People in nursing homes or long-term care facilities, People of all ages with underlying medical conditions, particularly if they are not well controlled, Immunosuppressed following solid organ transplant, Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies, Cerebrovascular disease (affecting blood vessels to the brain), Immunocompromised (weakened immune system) from blood or bone marrow transplants, immune deficiencies, HIV, use of corticosteroids, use of other immune weakening medications. There are two types of Covid-19 diagnostic tests that are FDA-approved for home testing: Rapid antigen tests and molecular tests. Please note that you may not have sufficient liquid remaining to perform the test and may need to obtain a new test kit. Then, you'll set (dont push) the testing vile into the test unit and let it sit there while you use the test swab to collect your sample in each nostril. UPC Code: 8563620058902. When Should You Get Tested After a COVID-19 Exposure? Why and how to report your Covid-19 self-test result | CNN The BinaxNOW COVID-19 test is an FDA-authorized COVID-19 test kit under a EUA that can detect whether you have the virus. However, we recommend keeping the app on the screen until you get your result to avoid any possibility of interrupting the test. If the test is positive, a green light will appear next to positive on the testing unit, rather than next to negative like you see in this photo. With the Ellume Covid-19 Home Test, you dont have to worry about reading your own results, because theres an app that will do it for you thanks to Bluetooth technology.