FAQ - Getting started with the iHealth COVID-19 / Flu A&B (3-in-1) Rapid Test (ICF-3000)

Intended Use

The iHealth Flu A&B/COVID-19/RSV Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection.

Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV can be similar.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, RSV, or other pathogens.

Individuals who test negative and/or experience continued or worsening symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

Video Instructions

Scan the QR code to access the video tutorial.

BEFORE GETTING STARTED

1. Check the expiration date on the outside of the box. 
   Do not use beyond the expiration date. do not use if any of the test kit contents or packaging is damaged.

   

2. Wash your hands with soap and water for 20 seconds and dry them thoroughly before testing and use hand sanitizer. 
   
   NOTE: It is recommended that gloves be worn during testing. A face mask should be worn if swabbing others.

   

3. Clean the surface on which the test will be performed. Before testing, read instructions carefully. The test kit and specimen must be at room temperature (65-86 °F) for testing.

PREPARE THE MATERIALS

Material Provided

Materials required but not provided: A clock or timer; Recommended materials: Disposable gloves and mask, if swabbing others.

4. Arrange the materials on a clean, dry, flat surface. Your box may contain more than one test kit. Use only one of each of the materials provided for each test.  

   DO NOT open the individual pouches until instructed to do so.
   
    

5. Pick up the Test Tube and remove the sealing foil of the tube.
   
    
6. Push the extraction buffer tube into the perforated tube holder located on the front of the box, and insert the Test Tube in the front of box labeled "Insert tube here".
   
    

7. Remove the Test Card from its foil pouch. 

   

   DO NOT remove the Test Card until you are ready to begin the test.

PERFORMING THE TEST

8. Open the package from the swab's stick end and take out the swab by holding the stick.
    

   

   DO NOT touch the swab head (soft end).

    

9. Gently insert the swab 1/2 to 3/4 inch in to a nostril. For young children, swab should not be inserted more than 1/2 inch.

   

   DO NOT insert the swab any farther if you feel any resistance

   
   Using medium pressure, rub and rotate the swab against the inside walls of the nostril, making at least 5 circles.
   
   REPEAT IN THE OTHER NOSTRIL USING THE SAME SWAB.
   
   NOTE: If you are swabbing others, please wear a face mask. With children, you may not need to insert the swab as far into the nostril. For very young children, you may need another person to steady the child's head while swabbing.
   
   STOP: Did you swab BOTH nostrils? Inaccurate test results may occur if the nasal sample is not properly collected.
    

10. Place the swab into the extraction solution, making sure the swab head is completely immersed.

    
    Swirl the swab in the solution by rotating the swab forcefully against the side of the tube at least 10 times, keeping the swab tip submerged in the extraction solution the entire time.

    
    NOTE: Failure to rotate the swab 10 times may lead to false negative results.
    
     

11. Squeeze the tube 5 times with your fingers to ensure that the sample on the swab is fully mixed into the extraction solution. 
    
    Close the dropper cap that is attached to the tube. 
    
    
    
    NOTE: Failure to squeeze the tube may lead to false negative results.
     
12. Holding the dropper VERTICALLY over the sample well on the test card, squeeze out exactly 5 DROPS of the solution.

DO NOT squeeze more than 5 drops from the tube. 
Additional sample volume may yield inaccurate results.
 

13. Set a timer and read the test result at 15 minutes.
     

    

    DO NOT disturb the card during this time. 
    Inaccurate results can occur if the card is disturbed.

    

    DO NOT interpret test result before 15 minutes or after 30 minutes.
     

    

TEST RESULT INTERPRETATION

Test results are read and interpreted visually. Read result at 15 minutes with good lighting.

WARNING: DO NOT read the result before 15 minutes or after 30 minutes. Inaccurate test interpretations may occur.

INVALID RESULTS

If a control line is not visible at ‘C’ after 15 minutes, even if any 
other line is visible in the results window, THE TEST HAS FAILED 
and is considered invalid.

If the control line at ‘C’ is visible and you do not see a line at ‘A’, ‘B’, or ‘T’, 
it means the test is negative. To increase the chance that the negative 
result for COVID-19 is accurate, you should test again in 48 hours.

POSITIVE RESULTS

If the control line at ‘C’ is visible and any other single line or multiple lines on ‘A’, ‘B’, and/or ‘T’ appear, the test is positive.

Repeat Testing is needed to improve test accuracy for SARS-CoV-2 for all samples that are negative for SARS-CoV-2 on the first day of testing, even if they are positive for influenza A and/or B. Please follow the table below when interpreting test results. Serial (repeat) testing does not need to be performed if patients have a positive SARS-CoV-2 result on the first day of testing.

UNDERSTANDING YOUR RESULTS

INVALID RESULT:

This test did not work. The result should not be used. The test cannot determine if you have COVID-19, influenza A (Flu A), or influenza B (Flu B). The test needs to be repeated with a new kit and sample.

NEGATIVE RESULT:

The virus from COVID-19, Flu A, and/or Flu B were not detected in the sample. A negative result does not mean that you do not have COVID-19, Flu A, and/or Flu B infection. There is a higher chance of false negative results with antigen tests compared to laboratory-based molecular tests. If you tested negative and continue to experience COVID-19, Flu A, and/or Flu B-like symptoms, you should seek follow-up care with your healthcare provider.

All negative results should be treated as presumptive and confirmation with a molecular assay may be necessary if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.

POSITIVE RESULT:

Repeat testing does not need to be performed if individuals have a positive SARS-CoV-2 result at any time.

A positive test result means that the virus that causes COVID-19 or influenza infection was detected in your sample. It is very likely that you have the respective infection(s) and are contagious. Please contact your healthcare provider, or your local health authorities, and follow local guidelines for self-isolation. There is a small chance that this test or influenza infection can give you a positive result that is incorrect (a false positive).

Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of disease. If you tested positive with the iHealth COVID-19/Flu A&B Rapid Test, you should self isolate and seek follow-up care with your physician or healthcare provider as additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.

AFTER TEST IS COMPLETED, DISPOSE OF USED MATERIAL 
IN HOUSEHOLD TRASH AND WASH HANDS.

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.

Information Source: COVID-19:Flu A&B Test (ICF-3000) Quick Start Guide 20250728.pdf