FREQUENTLY ASKED QUESTIONS
Q: WHAT ARE THE KNOWN POTENTIAL RISKS AND BENEFITS OF THIS TEST?
A: Potential risks include:
- Possible discomfort during sample collection.
- Possible incorrect test results (see Warnings and Result Interpretation sections for more information).
- Potential benefits include:
- The results, along with other information, can help you and your healthcare provider make informed recommendations about your care.
- The results of this test may help limit the spread of Flu, COVID-19, and RSV to the family of the tested individual and others in your community.
Q: WHAT IS THE DIFFERENCE BETWEEN AN ANTIGEN AND MOLECULAR TEST?
A: There are different kinds of tests for the viruses that cause Flu, COVID-19, and RSV. Molecular tests detect genetic material from the virus. Antigen tests, such as the iHealth Flu A&B/COVID-19/RSV Rapid Test, detect proteins from the virus. Due to the lower sensitivity of antigen tests, there is a higher chance this test will give you a false negative result when you have Flu, COVID-19, and RSV than a molecular test would.
Q: WHAT ARE THE SYMPTOMS OF RSV IN CHILDREN?
A: Most infants are unable to communicate some of the typical signs and symptoms of infection, and some of these may be different from symptoms in older children and adults, and may be subtle such as: irritability, decreased activity, breathing difficulties (apnea episodes), eating or drinking less. For individuals aged 2 years or older, symptoms may include fever, chills, cough, sneezing, wheezing, fatigue, decrease in appetite. unusual tiredness, congestion or runny nose, nausea, vomiting, or diarrhea. Many infants will not have a fever with RSV infection
Q: WHAT ARE SIGNS AND SYMPTOMS OF SEVERE DISEASE?
A: These symptoms usually appear in stages and not all at once. Short and shallow breathing, flaring of the nostrils of straining (retractions) of the chest or stomach while breathing, or turning blue around the ips and fingertips advance disease are some of the signs of possible severe viral infection (bronchiolitis, pneumonia and possible progression to respiratory failure). If you or your child currently have signs and symptoms of severe disease do not use this test. Delayed or avoided medical care to infants or patients having these conditions might get much sicker quickly or even die.
Q: WHEN TO SEEK EMERGENCY CARE?
A: Respiratory infections (especially RSV) can be serious for infants, some young children, and adults who are older or have certain risk factors. Persons with risk factors for severe disease from respiratory pathogens (eg. infants and young children, elderly individuals, chronic lung or heart disease, compromised immune system, diabetes, and other conditions), should contact a healthcare provider. Users should also contact a healthcare provider if symptoms persist (not improving) or worsen (specially for infants and young children, independently of (positive or negative) test results, or if you have any concerns.
Q: WHAT TO DO IF YOUR INFANT HAS RECEIVED A MONOCLONAL ANTIBODY?
A: Test results may be affected if your infant has received monoclonal antibodies. Talk to your health care professional to help interpreting your test results
Q: WHAT DOES A POSITIVE RESULT MEAN?
A: A positive test result means that any one or multiple of the viruses detected by this test were also detected in your sample. It is very likely that you have the respective RSV, COVID-19, or influenza infection(s) and are contagious. You should self-isolate following local guidelines. Please contact your physician or healthcare provider to discuss your test results and follow-up care, în rare instances, individuals may also have co-infections with other bacteria or viruses that this test is not designed to detect. This means that the virus detected by this test may not be the definitive or the only cause of your disease. There is a very small chance that this test can give you a positive result that is incorrect (a false positive)
Q: WHAT DOES A NEGATIVE RESULT MEAN?
A: A negative test result means that RSV, COVID-1 F A and/or Flu viruses were not detected in the sample A negative result is presumptive because despite a negative result you may still have RSV, COVID-TRFMA and/or FUN infections. This is because the amount of virus in your sample may be too low for the test to detect it, which is called a false negative result. False negative results can occur if you read your test result before the 15 minutes have passed or when your sample has only a low amount of virus in it. A low amount of virus can occur if you take your sample at a time when your symptoms just started appearing, or when you already started to feel better at the end of your infection. If an adult or child tested negative and continues to experience RSV, COVID-19, Flu A, and/or Flu B-like symptoms, you should therefore seek follow-up care with a healthcare provider who will determine the best course of action. The healthcare provider can also determine if confirmation of your test result with a molecular assay is necessary.
Q: WHAT SHOULD I DO IF I RECEIVE A POSITIVE TEST RESULT FOR RSV?
A: Because there is no specific treatment for RSV, the CDC recommends managing symptoms with over-the-counter medications. Most RSV infections are resolved within 1-2 weeks. For adults and children, especially infants aged 6-23 months, immediately talk to your healthcare provider for emergency care if you are having difficulty breathing, not drinking enough fluids, or experiencing worsening conditions.
Q: HOW ACCURATE IS THIS TEST?
A: The iHealth Flu A&B/COVID-19/RSV Rapid Test was compared to highly sensitive PCR tests. Antigen tests, such as the iHealth Flu A&B/COVID-19/RSV Rapid Test detect proteins from the virus, while a molecular test (e.g., PCR) detects the virus's genetic material and is generally more sensitive. For more information on the performance of the test and how it may apply to you, please refer to the performance data in the Instructions for Use (IFU) available at https://support.iHealthlabs.com/4-in-1-IFU
Q: WHAT DOES AN INVALID TEST RESULT MEAN?
A: An invalid result means the test was not able to tell if you have influenza, COVID-19, and RSV 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.
IMPORTANT: Do not use this test as the only guide to manage your illness. Consult your healthcare provider if your symptoms persist or become more severe. Individuals should provide all results obtained with this product to their healthcare provider.
iHealth Customer Service
iHealth Customer Service Can be reached via phone at 1-855-816-7705 (Monday-Friday 8:30am to 5:30 PM PT) or via email at support@ihealthlabs.com. Self Help can be obtained 24 hours at the Help Center.