Do not insert the Swab any further if you experience sharp pain. A positive result on an at-home COVID-19 test is usually accurate, but false negatives can occur when a person has no COVID-19 symptoms or their infection happened recently. Add four drops of the sample to the test (the round dot with an S) and wait 15 minutes. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration justifying emergency of IVDs, unless it is terminated or authorization is revoked by FDA (after which the test may no longer be used). By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. NDC Code: 56362-0005-893. 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. If you test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath you should seek follow up care with your healthcare provider. The iHealth COVID-19 Antigen Rapid Test has been designed to minimize the likelihood of false positive test results. An in-home test designed to get results in 15 mins. Molecular tests (also known as PCR tests)detect genetic material from the virus. A false positive test means that the test shows a positive result when the person is not actually infected with COVID-19. Can You Use a Rapid At-Home COVID Test for BA.5? No. But an at-home test can give incorrect results too. What to Do If You Get a Positive At-Home COVID-19 Test Result. Why is the iHealth COVID-19 Test App asking me for my personal information? 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). 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. The test is a 15-minute self-test to detect whether or not an individual has the COVID-19. Results in 15 minutes. This article explains how at-home COVID-19 tests work, their accuracy, and what to do with a positive test result. No. Insert the swab with the sample into the bottom of the tube and stir it in the fluid 15 times. iHealth COVID-19 Antigen Rapid Test is the simplest way to detect SARS-CoV-2 nucleocapsid protein antigen. There are dozens of those PCR tests as well, with a longer delay until you receive results. All the components of iHealth COVID-19 Antigen Rapid Test Kit are not reusable and can only be used once. The iHealth COVID-19 Antigen Rapid Test has been designed to minimize the likelihood of false positive test results. The possibility of a false negative result should especially be considered if the patients 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. Sign up for our newsletter to get up-to-date information on healthcare! As of Jan 11, 2023, the shelf life of iHealth tests is extended to 15 months. Limited time offer: Get 20% off with code: TESTKIT20. Individuals can utilize this test, as needed, regardless of vaccination status. However, we do recommend you use the iHealth COVID-19 Antigen Rapid Test app as step-by-step instructional videos are available in the app for more intuitive understanding of how to perform the test correctly. The iHealth COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. In some cases, it has been observed that only one nostril has the detectable virus. The risk of getting a false positive result for COVID-19 is relatively low but false negatives are common. "For the Stats Guy: iHealth Core. Her professional interests include preventive cardiology, medical journalism, and health policy. As with any kind of medical testing, false negatives and false positives can happen. Possible discomfort or other complications that can happen during sample collection. Possible incorrect test result (see below for more information). So it can help to know more about what a positive test means and what to do next if you have a fever, cough, loss of smell, or other COVID-19 symptoms. There are no approved available alternative antigen tests. It is important that you work with your healthcare provider to help you understand the next steps you should take. Also, our manufacturer will NOT supply to any other organizations in the U.S. except for iHealth Labs Inc. Youll swirl the swab around and then dip a testing strip into the tube to test the sample. iHealth COVID-19 Antigen Rapid Test is the simplest way to detect SARS-CoV-2 nucleocapsid protein antigen. The self-administered test is recommended for individuals aged 15 years and older. Centers for Disease Control and Prevention. For additional recommendations regarding infection control, refer to CDCs 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). 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. If two lines appear on the test, then its positive. 1. Use of app is optional. Even a faint line indicates the presence of infection. Your healthcare provider will work with you to determine how best to care for you based on your test result(s) along with your medical history, and your symptoms. With the Access Bio CareStart Covid-19 Antigen Home Test, youll collect your nasal sample on a swab and mix it with the testing solution in the provided tube. The iHealth COVID-19 Antigen Rapid Test app saves your test results if you select and submit your results within the App. Potential benefits include: 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. 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. All the components of iHealth COVID-19 Antigen Rapid Test Kit are not reusable and can only be used once. 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. Only $8.99 per test. Then, after about 10 minutes you can use the app to take a photo of the test and it will let you know if its positive, negative, or invalid. No. In case of physical discomfort such as fever, sneezing, cough or fatigue, you can quickly detect SARS-CoV-2 nucleocapsid protein antigen by using iHealth COVID-19 Antigen Rapid Test. Additional testing with molecular COVID-19 test may be necessary, depending on your individual risk factors and test results. Squeeze the sides of the tube around the swab as you pull it out. IHealth COVID-19 Antigen Rapid Test [package insert on the internet]. What should I do if I have COVID-19 symptoms BUT my test result is negative? If youre asymptomatic, it is recommended that you perform the test at least twice over the course of three days for the most accurate results. Please consult with your health insurance to make sure if your test will be covered. 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. Any extended exposure of the test kit to temperatures beyond this range may affect quality of test results. If you are concerned about your COVID-19 infection status after testing or think you may need follow up testing, please contact your healthcare provider as well. 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. A positive result on the InteliSwab Covid-19 Rapid Antigen Home Test can potentially look a bit different than most other home tests, so its very important to read your results carefully. Biolabs International LLC / GriffMaier LLC, Paramount Sourcing LLC (exclusively partnered with Office Depot), Sunshine Paper LLC / Marketing Promotion Image Inc. It is overseen by an iHealth proctor who will instruct you to collect the sample and perform the test to guarantee COVID-19 testing authenticity. What Does a Positive Herpes IgM Test Result Mean? Centers for Disease Control and Prevention. FDA can issue an Emergency Use Authorization (EUA) when certain criteria are met, which includes that there are no adequate, approved, available alternatives. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. Choosing a selection results in a full page refresh. iHealth has completed testing on several heat inactivated variant strains and the iHealth COVID-19 Antigen Rapid Test was able to detect the mutations. Repeat testing is recommended after 48 hours if your test is negative. They suggest that you only need to insert the swab 1/2 an inch into the nose and even less for little kids to collect the sample, which also feels a little more doable than some of the others. Your healthcare provider may suggest you need another test to determine if you have contracted the virus causing COVID-19. Stay in contact with your healthcare provider and let them know if you are experiencing worsening symptoms or have any questions. If only the C line shows up, the test is negative. 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. 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. New variants have shown that anyone can be vulnerable to COVID-19 even if they are vaccinated or young. Her professional interests include preventive cardiology, medical journalism, and health policy. The iHealth COVID-19 Antigen Rapid Test can be used with or without any noticeable symptoms of COVID-19 (including a blocked or runny nose) 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. 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. Because antigen tests are less sensitive than other COVID-19 tests and false results may occur, repeated testing may identify individuals with COVID-19 more reliably than a single test. False positive results are much less common and can happen due to a problem with the test kit itself. Close the vile and push it down into the unit until you hear it click. In the unlikely event your nose starts bleeding, do not insert the Swab again. NDC Code: 56362-0005-893. There are different kinds of tests for COVID-19. 1 bestseller in health care thermometers. The iHealth COVID-19 Antigen Rapid Test app saves your test results if you select and submit your results within the App. As new research becomes available, well update this article. Learn more about CDC's COVID-19 testing requirement for international travel to the United States here. 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. 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. Is this iHealth COVID-19 Antigen Rapid Test Kit FDA approved or cleared? No, do not reuse any test components. 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. Additional testing with molecular COVID-19 test may be necessary, depending on your individual risk factors and test results. Next, place the dropper on the top of the tube and add three drops of the sample/solution to the square sample window on the test. With iHealth COVID-19 Antigen Rapid Test, you can test yourself after being out in public. Self-tests do not detect antibodies, and this test should not be performed to diagnose an active COVID-19 infection. According to the Department of Health & Human Services, beginning January 15, 2022, individuals with private health insurance coverage or covered by a group health plan who purchase an over-the-counter COVID-19 diagnostic test authorized, cleared, or approved by the U.S. Food and Drug Administration (FDA) will be able to have those test costs covered by their plan or insurance. A positive at-home COVID-19 test doesn't necessarily require hospitalization or in-person treatment. Available on the App Store and Google Play. Can the iHealth COVID-19 Antigen Rapid Test be used in children under two years old? Much like other at-home Covid tests, the Celltrion DiaTrust Covid-19 Ag Home Test uses a nasal swab to collect a sample for testing. Is a prescription required to perform this test? For a demonstration on how the test works, watch the instructional video. Going to a Super Bowl Party? 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. When you use the Lucira Check-It Covid-19 Test Kit, youll insert batteries into the test reader to ensure its ready to go (a green light will appear next to ready at the top). Most cases of COVID-19 do not. The iHealth COVID-19 Antigen Rapid Test Pro is a type of test called an antigen test. iHealth COVID-19 Antigen Rapid Test is compatible with most Bluetooth enabled smartphones. 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. 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. A positive test result for COVID-19 indicates that . 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. Do not insert the Swab any further if you experience sharp pain. Interpreting Results Positive Results Negative Results Note that the T line might be faint. Quidel QuickVue at-Home OTC COVID-19 Test Kit, On/Go 10-Minute Covid-19 Antigen Self-Test, a green light will appear next to positive, CLINITEST Rapid Covid-19 Antigen Self-Test, InteliSwab Covid-19 Rapid Antigen Home Test, Access Bio CareStart Covid-19 Antigen Home Test. Additional asymptomatic individuals and individuals beyond the seven days of symptom onset were tested, but excluded from the . 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. This test is approved by the Food and Drug Administration and is currently one of the more affordable options for at-home testing. 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. Please obtain a new test kit and perform a new test. Press the space key then arrow keys to make a selection. You may need to purchase additional tests to perform this serial (repeat) testing. Keep in mind that COVID-19 variants may have mutations that make them undetectable by the specific test. 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. Antigen tests are designed . The iHealth COVID-19 Antigen Rapid Test is an antigen test. 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). https://www.hhs.gov/about/news/2022/01/10/biden-harris-administration-requires-insurance-companies-group-health-plans-to-cover-cost-at-home-covid-19-tests-increasing-access-free-tests.html. ", "Experts recommend keeping a thermometer at home since the Centers for Disease Control and Prevention (CDC) lists fever as one COVID-19 symptom.