The iHealth COVID-19 Antigen Rapid Test is able to detect small parts of theSARS-CoV-2 virus, known as N protein or antigens, in your nasal secretions. The test is a 15-minute self-test to detect whether or not an individual has the COVID-19. Independently-sealed packaging ensures safe and hygienic testing. Back to school, back to the office, or just back from travel or public gatherings, a rapid,15-minute, self-test is waiting at home for when you get back. You may need to purchase additional tests to perform this serial (repeat) testing. 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. Food and Drug Administration. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. At-home care should include lots of rest and plenty of fluids to prevent dehydration. New variants have shown that anyone can be vulnerable to COVID-19 even if they are vaccinated or young. All healthcare providers must follow the standard testing and reporting guidelines according to their appropriate public health authorities. What to Know About the COVID-19 Antibody Test. 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. 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. Apple iPhones: iPhone 7, iPhone 7 plus, iPhone 8 plus, iPhone 10, iPhone 11, iPhone 11 Pro, iPhone 12, iPhone 12 max, iPhone 12 pro max, iPhone SE, iPhone SE2, iPhone X, iPhone X, iPhone XR, iPhone XS, iPhone XS MAX, Android Phones: LG Stylo 5X, Moto G8 Power, Moto G7 Plus, Samsung Galaxy Note8, Samsung Galaxy Note9, Samsung Galaxy S10, Samsung Galaxy S20, Samsung Galaxy S6, Samsung Galaxy S8, Samsung Galaxy S9, Google Pixel 4a, Huawei P20. Once youve finished swabbing your nose, insert the swab all the way into the testing vile, until you feel it touch the bottom. However, its not as pricey as the Cue a starter kit, with a reusable hub and single Detect Covid test will set you back $55. CDC Updates and Shortens Recommended Isolation and Quarantine Period for General Population. In some cases when COVID-19 infection is unlikely, a confirmatory PCR test can be considered after a positive result on the antigen test. Monitor your symptoms. You won't need to collect a sample from deep in your nasal cavity to get accurate results. There are dozens of those PCR tests as well, with a longer delay until you receive results. Based on the results of a clinical study where the iHealth COVID-19 Antigen Rapid Test was compared to an FDA authorized molecular SARS-CoV-2 test, iHealth COVID-19 Antigen Rapid Test correctly identified 94.3% of positive specimens and 98.1% of negative specimens. Additional asymptomatic individuals and individuals beyond the seven days of symptom onset were tested, but excluded from the primary performance calculations because they were not included in the intended use. The sample lines darkness may vary, but even a faint line should be considered positive. Sunnyvale (CA): iHealth Labs, Inc.; She completed undergraduate studies at the University of Virginia with a B.S. 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. As you can see in this photo, youll read your results in a little window with a test strip with a control line and a sample line. Press the space key then arrow keys to make a selection. Given that the virus itself is so new and still has so many unknowns, its fair to wonder whether or not at-home Covid tests are reliable. Receipt showing the date of purchase and testing kit charges, Please note that you have to contact your insurance company for the detailed reimbursement policy. No, DO NOT use it on anyone under 2 years old. The iHealth COVID-19 Antigen Rapid Test has been designed to minimize the likelihood of false positive test results. COVID rapid tests can indicate if a person is infectious and contagious at the exact time of testing. Take these steps to avoid spreading the virus. You will need to retest with a new test kit. UPC Code: 8563620058902. If you get a positive result on any repeat test with an at-home COVID-19 antigen test, you most likely have COVID-19 and should follow the CDC guidance for people with COVID-19.. You may experience some discomfort when swabbing your nose, but this is to be expected. No. The iHealth COVID-19 Antigen Rapid Test is an antigen test. Use left/right arrows to navigate the slideshow or swipe left/right if using a mobile device. Use left/right arrows to navigate the slideshow or swipe left/right if using a mobile device, Feel Wireless Blood Pressure Monitor (BP5), Track Connected Blood Pressure Monitor (550BT), View Wireless Blood Pressure Wrist Monitor (BP7S), Sense Wireless Blood Pressure Wrist Monitor (BP7), Core Wireless Body Composition Scale (HS6), Wave Activity, Swim, and Sleep Tracker (AM4), Wireless Activity and Sleep Tracker (AM3), Apple iOS devices (requires iOS version 12.0 or higher), Android devices (requires operating system 6.0 or later), For a demonstration on how the test works, watch the instructional video, You have had no fever for at least 24 hours (that is one full day of no fever without the use of medicine that reduces fevers), Other symptoms of COVID-19 are improving (for example, when your cough or shortness of breath has improved) Note: Loss of taste and smell may persist for weeks or months after recovery and need not delay the end of isolation. This test is authorized for nonprescription home use with self-collected (unobserved) anterior nasal swab specimens from individuals aged 15 years and older or with adult-collected anterior nasal swab samples from individuals aged 2 years or older. Our nasal swab is soft, highly absorbent, and only needs to be inserted - inches so you can test yourself comfortably. What should I do if my test result is positive? 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 iHealth has been a leader in innovation for medical supply since 2010. iHealths award-winning vitals monitoring devices and consumer healthcare products help people of all ages take a more active role in managing their health. It works similarly to most others on this list. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc. What Does a Positive Herpes IgM Test Result Mean? 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. iHealth will issue a report to your email after the COVID test is completed. Antigen tests are designed . Choosing a selection results in a full page refresh. But in addition to nice looks, iHealth devices have also earned strong reviews from users who have touted their reliable performance and affordability. If you see any indication of a positive result even a super faint second line you should assume you have Covid and check in with your health care provider. The results, along with other information, can help your healthcare provider make informed recommendations about your care. The results of this test may help limit the spread of COVID-19 to your family and others in your community. While most people do not experience severe symptoms, some have mild symptoms initially that worsen several days later. Your date of birth and zip code, together with test results, are the information required as they are shared with the relevant health authorities to support monitoring of COVID-19 infection and test positivity rates across the country. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc. 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. Fully vaccinated and boosted people do not have to isolate after exposure, but the Centers for Disease Control and Prevention (CDC) recommends testing after day five and wearing a face mask around others for 10 days. Test can be done by inserting only 1/2 to 3/4 inch with a simple non-invasive nasal swab, easy to use and zero discomfort. It also presents precautions that are still necessary, even if you take frequent at-home tests. These decrease the accuracy of a test. You may also choose to perform two tests if you wish. The following people are considered high risk for severe disease: People may be at increased risk due to the following conditions: The Swab is sterile and safe to use. However, in the meantime, you should still isolate until the diagnosis is clarified. For a demonstration on how the test works, watch the instructional videohere. A positive at-home COVID-19 test result may appear to answer one concerning question ("Do I have the virus?") Centers for Disease Control and Prevention. Contact your healthcare provider for additional guidance. 1-855-816-7705 The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. While antigen tests deliver results in about 15 minutes, before the Omicron variant emerged they were only 58% accurate for people who didn't have symptoms, or 72% accurate for those who did,. COVID Test program. No, do not reuse any test components. Generate health pass and store your vaccine record in the app. Interpreting Results Positive Results Negative Results Note that the T line might be faint. 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. The risk of getting a false positive result for COVID-19 is relatively low but false negatives are common. Under the Coronavirus Aid, Relief, and Economic Security Act, every CLIA-certified COVID-19 testing site is required to report diagnostic and screening SARS-CoV-2 test results to the state or . 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. Placenta Previa Dos & Donts, & What To Expect When You Give Birth, What Parents Are Talking About Delivered Straight To Your Inbox, By subscribing to this BDG newsletter, you agree to our. 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. Do I have to wait for 15 minutes to read the result? An in-home test designed to get results in 15 mins. The test has a highly-absorbent swab that is individually sealed to help prevent contamination so you can view the results of your in-home test with confidence. Potential risks include: Possible discomfort or other complications that can happen during sample collection. Possible incorrect test result (see below for more information). The verified tests meet the CDC's requirements for international travel to the United States. Below is the full list of compatible smartphones. Dense with data, plus a few other accessories, the app can track BP and blood oxygen, too.

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