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Posted on: May 16, 2022

Flowflex & iHealth COVID-19 Antigen Rapid Test Kits

Flowflex & iHealth COVID-19 Antigen Rapid Test Kits

 

            The iHeath COVID-19 and Flowflex Antigen Rapid Test Kits are authorized for non-prescription home use with self-collected anterior nasal swab sample with or without symptoms.  These Antigen Rapid Test Kits detect small parts of the SARS-CoV2 virus, known as nucleocapsid protein antigens, which is present in the acute phase of COVID-19 infection.  It is best to use these test kits when you have been exposed to the COVID-19 virus or have been in close contact with someone who is known to have COVID-19 disease (positive for COVID-19).

            COVID-19 is an acute respiratory infectious disease. It is passed on to others through the release of respiratory droplets when you sneeze, cough or speak with someone who is very close to you.  Many patients with COVID-19 develop fever and/ or symptoms of acute respiratory illness (e.g. cough, difficult or labored breathing), although some individuals experience only mild symptoms or no symptoms at all.  The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that symptoms include cough, fever, chills, headache, fatigue, nasal congestion, difficult or labored breathing, runny nose, sore throat or new loss of taste or smell. Based upon what is known about the Omicron Variants (BA:1, BA:2), signs and symptoms may appear within 2 or 3 days after being exposed to the virus or exposed to someone who has COVID-19. A person is considered contagious 1-2 days before the symptoms appear, 5 days after symptom onset and for an additional 5 days up until the 10th day for many.            

            Antigen tests are known to be less sensitive than molecular tests (PCR) which detect viral nucleic acids instead of protein antigens in the virus.  When an Antigen test is positive it is highly accurate and indicates you are positive for COVID-19.  No further testing is necessary.  As a result, you should isolate and stay home.  However, if the test result is negative it does not completely rule out COVID-19 infection, as antigen rapid tests are not sensitive enough to pick up low viral loads in the body.  The following is a summary on how to use the iHealth and Flowflex COVID-19 Antigen Rapid Test Kits when you have symptoms and no symptoms.  Carefully review each of the test kit instructions before conducting the test so that you handle the test correctly. 

 

Testing with Symptoms:

            Although the Antigen Rapid test kit instructions suggest that it can be used within the first 7 days of symptoms onset, testing after day 5 of illness will more likely be negative.  However, testing using a PCR test after this time frame will render an accurate result. This is because PCR tests are highly sensitive and can detect even low levels of virus in the body. Therefore, testing between 1 to 3 days after symptoms start is a good option.  Both Antigen Rapid Test Kits are designed to minimize the likelihood of false positive test results when used correctly.  A positive test result indicates that antigens from SAR-CoV-2 were detected and that the person is very likely to be infected with the virus and presumed to be contagious.  At this point no further testing is necessary so you should isolate and stay home.  If the test result is negative that means that antigens from the virus were not present – it may mean that the virus load in the body at the time of testing is too low to detect.  A repeat test should be done 24 hours later (1 day in between tests) to increase the chance of confirmation.   If the second test is negative, it DOES NOT rule out COVID-19.  A third Antigen Rapid test can be taken again, 24 hours after the second test.  However, if you had an exposure or close contact with someone known to have COVID-19 and you have COVID-19 symptoms a molecular test (PCR) to rule out COVID-19 infection should be taken.  While you have COVID-19 symptoms and are testing do not go to work or other places where others may get exposed to the virus until a negative result is recorded by a PCR test.   

 

Testing with No Symptoms:

            A person who does not exhibit symptoms but has been exposed to the virus or is considered a close contact to someone who has COVID-19 disease, iHealth COVID-19 and Flowflex Antigen Rapid Tests can be used to test for the virus in the body.  Repeat testing over two to three days should be performed with at least 24 hours in between tests.  As indicated above serial testing may decrease the risk of a false negative result.  The first test should be done two days (on day 3) after you have been exposed to the virus or have been a close contact to someone who is COVID-19 positive.  If the result is negative, a second test should be conducted 24 hours later (on day 4). Taking a test beyond day 5 after an exposure to the virus will reduce the likelihood of getting an accurate result.  A person conducting this kind of serial testing may require confirmation by taking a PCR test.  Especially if the close contact or exposure to a person with COVID-19 disease was definite and there is a good chance of COVID-19 infection.  It should be noted that 60% of the persons with COVID-19 have no symptoms.

 

Important:

 

The expiration dates on iHealth COVID-19 Antigen Rapid test kits have been extended by three months beyond the date listed on the package (see link).  The expiration dates on Flowflex COVID-19 Antigen Home Test kits have been extended beyond the date listed on the package as well (see link).

 

A negative Antigen test result should not be used on its own to determine if a patient can end Isolation.

 

The U.S. FDA has made these tests available under an emergency access mandate called an Emergency Use Authorization (EUA) only. This emergency use declares that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and /or diagnosis of the virus that causes COVID-19.  An EUA issued by the FDA needs to meet certain criteria, which includes that there are no adequate, approved, available alternative to diagnose COVID-19.  The EUA for these tests will be in effect until they get terminated or revoked (after which the test may no longer be used).

 

                                                                                                             

                                                                                                                                      Revised June 23, 2022


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