iHealth ICO-3000 COVID-19 Antigen Rapid Test Instructions

: June 6, 2024
: iHealth

Table of Contents

iHealth ICO-3000 COVID-19 Antigen Rapid Test
Instruction for use
Step by Step Instructions
WARNINGS AND PRECAUTIONS
STORAGE AND OPERATION CONDITIONS
Contents
FAQ’S
VIDEO
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

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iHealth ICO-3000 COVID-19 Antigen Rapid Test

iHealth ICO-3000 COVID-19 Antigen Rapid Test featured

iHealth ICO-3000 COVID-19 Antigen Rapid Test

COVID-19 Antigen Rapid Test

Instruction for use

Model: IC0-3000
This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA). Please read all the information in this instruction for use before performing the test.
For use with anterior nasal swab specimens.
For In Vitro Diagnostic (IVD) Use Only.

Download App & Open App

Scan the QR code to download the “iHealth COVID-19 Antigen Rapid Test” App through your smartphone (iOS12.0+, Android 6.0+).

For a full list of compatible smartphones visit:
https://ihealthlabs.com/pages/support-1(O3000

Register and Log into The App, Watch Video in App
Each step has a corresponding instructional video in the App. Watch the video and perform the test according to the instructions.

Step by Step Instructions

Prepare Materials

Open the package, take out the COVID-19 Test Card in Pouch, the Tube filled with the extraction buffer and the Swab. When you are ready to proceed with the test, open the foil pouch of the COVID-19Test Card.

Package

Collect Sample

Remove the swab from its package, being careful not to touch the tip of the swab. Please keep the swab package for later use.
Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril.

Note: With children, the maximum depth of insertion into the nostril may be less than 3/4 of an inch, and you may need to have a second person to hold the child’s head while swabbing.
Firmly and slowly brush against insides of nostril in a circular motion against the nasal wall at least 5 times. Take at least 15 seconds to collect the specimen and be sure to collect any nasal drainage on the swab. Using the same swab, repeat the same sample collection procedure for the other nostril. Be sure to brush BOTH nostrils with the SAME SWAB.
Note: Failure to swab properly may cause false negative results.

Process Sample

Tap the tube vertically on the table and twist the large orange cap to open the tube.
Insert the swab into the tube, touch the bottom of the tube with the swab tip, and stir at least 15 times.
Squeeze the sides of the tube to express as much liquid as possible from the swab, and then remove the swab.
Note:
If you don’t squeeze the swab, there may not be sufficient sample material to perform the test properly (i.e., potentially resulting in a false-negative result).
Screw back the large orange cap, put the swab back into the package. Safely dispose of the swab and the package.

Add Sample

Twist to open the small white cap of the tube. Add 3 drops of sample to the Sample Port of the COVID-19 Test Card. Screw back the small white cap.
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Note: A false negative or invalid result may occur if too little solution is added to the test card.

Wait 15 Minutes
Start the timer by clicking the “Start Timer” button, immediately after adding sample to the Sample Port. The result will be ready in 15 minutes.

Note: Do NOT interpret your test result until after your 5-min timer has completed, as the T line may take as long as 15 minutes to appear.

Read Result
Results should not be read after 30 minutes (Result shown at 2x magnification).
Note: A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes.

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Note: The T line can be extremely faint.

Test Result Explanation
Positive Result

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A POSITIVE result must show BOTH a C line and a T line. A positive result means that viral antigens from COVID-19 were detected and the individual is positive for COVID-19.
Below are photos of actual positive tests. Please note that the T line may be faint.

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Persons who test positive should self-isolate and seek follow up care with their physician or healthcare provider as additional testing and public health reporting may be necessary.

Negative Result

A NEGATIVE result will show ONLY a C line. A negative result means that viral antigens from COVID-19 were not detected and that the individual is presumed negative for COVID-19.

Please note that negative results do not rule out COVID-19.
In case of negative test result: Continue to follow all social distancing recommendations and take protective measures. If suspicions of infection persist and/or your first test is negative, repeat the test after 1-2 days and consult your healthcare provider or local COVI D-19 center.
Note: A negative result is presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed. Individuals without symptoms that test negative should be tested again with at least 24 hours and no more than 48 hours between tests. Additional confirmatory testing with a molecular test for negative results may be necessary after second negative result for asymptomatic patients, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with as close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS-CoV-2 or residing in communities with low prevalence of infection.

Invalid Result

If there is NO LINE, or if there is ONLY a T line, the test is INVALID. Invalid result means that the test did not function correctly. You will need to retest with a new test kit. If upon retesting, the test result is still invalid, contact your doctor or local COVID-19 center. An invalid result does not indicate if the individual did or did not have COVID-19 and should be repeated.

Dispose the Test Kit
After test is completed, dispose the kit components in trash.

Report Test Result
Report the result following the App instructions or share your test result with your healthcare provider.

In the USA:

This test is intended to be used as an aid to the clinical diagnosis of a current COVID-19 infection, Do not use this test as the only guide to manage your illness.
In USA – This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other virus or pathogens. 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. § 360bbb-3(b)(1 ), unless the declaration is terminated, or authorization is revoked sooner.

iHealth
COVID-19 Antigen Rapid Test Instructions for Use
Model: ICO-3000

This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA).
Please read this instruction for use before using the test. For use with anterior nasal swab specimens.
For In Vitro Diagnostic (IVD) Use Only.

INTENDED USE
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.

This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset. This test is also authorized for non-prescription home use with adult- collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first seven (7) days of symptom onset.

This test is also authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older, with or without symptoms 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.

The iHealth® COVID-19 Antigen Rapid Test does not differentiate between SARS- CoV and SARS-CoV-2.
Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive with the iHealth® COVID-19 Antigen Rapid Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary.

Negative results are presumptive, 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. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such as in an individual with as a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures to SARS- CoV-2 or residing in communities with low prevalence of infection.

Individuals who test negative and continue to experience COVID-19 like symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2 infection and should seek follow up care with their physician or healthcare provider.

Individuals should provide all results obtained with this product to their healthcare provider for public health reporting or by following the mobile application instructions for self-reporting. All healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.

The iHealth® COVID-19 Antigen Rapid Test is authorized for non-prescription self-use and/or, as applicable for an adult lay user testing another person aged 2 years or older. The iHealth® COVID-19 Antigen Rapid Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.

WARNINGS AND PRECAUTIONS

Testing for asymptomatic individuals should be performed at least twice over three days, with at least 24 hours and no more than 48 hours between tests. You may need to purchase additional tests to perform this serial (repeat) testing.
There is a higher chance of false-negative results with home-use tests than with laboratory-based molecular tests. This means that there is a higher chance this test will give you a negative result when you have COVID-19.
Serial testing (i.e., testing every day or every other day) is more likely to detect COVID-19, especially when you do not have any symptoms.
This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
This test is intended for diagnosis of coronavirus infection by detecting COVID-19 antigen but should not be used as a sole criterion for the determination of SARS-CoV-2 infection. Other laboratory tests and clinical information (signs and symptoms) should be used and considered for diagnosis.
Do not use on anyone under 2 years old.
Children aged 2-14 years should be tested by an adult.
Do not use on anyone who is prone to nosebleeds or has had facial or head injury/surgery in the last 6 months.
Do not use any test component after the expiration date which is printed on the outer packaging.
Do not use the COVID-19Test Card if the pouch is damaged or if the seal is broken.
Do not reuse any test component.
To obtain accurate results, the test must be performed as indicated in the application (iHealth COVID-19 Antigen Rapid Test) and/or Instructions for Use.
Once the COVID-19 Test Card is removed from the pouch, perform the test as soon as possible. Use the COVID-19 Test Card within 1 hour after opening the foil pouch.
Inadequate or inappropriate sample collection may yield false test results.
Do not touch the tip of the swab before and after collecting the sample from the nostrils.
Insert the swab into the tube right after taking the sample.
Test samples immediately after collection, but no more than 4 hours after specimen collection before placement into extraction buffer or up to 2 hours after placement into extraction buffer, if kept at room temperature. Be sure to read test result after 15 minutes. Do not read results after 30 minutes.
Be sure to read test result within 15-30 minutes.
Do not ingest extraction liquid.
Keep test kit and components out of the reach of children and pets before and after use.
Avoid contact with skin and eyes.
The reagent in the extraction liquid contains ProClin® 300 which may cause an allergic skin reaction in some people. If the solution makes contact with the skin or eye, wash/flush with copious amounts of water. If skin irritation or rash occurs get medical advice/attention.

STORAGE AND OPERATION CONDITIONS

Store iHealth® COVID-19 Antigen Rapid Test in a dry place between 36-86 °F (2-30 °C). Ensure all test components are at room temperature 65-86 °F (18-30 °() before use. It is stable before the expiration date marked on the packaging.

HAZARDOUS INGREDIENTS FOR REAGENT SOLUTION
The Extraction Reagent contains potentially harmful chemicals (see table below). If the solution contacts the skin or eye, flush with copious amounts of water.
If irritation persists, seek medical advice: https://www.poison.org/contact- us or 1-800-222-1222

If you have symptoms of COVID-19, you can use a single test.
If you do not have symptoms of COVID-19, you will need at least two tests per person. You may need to purchase additional tests to perform serial (repeat) testing.
This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test.
This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
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. § 360bbb-3(b)(1 ), unless the declaration is terminated or authorization is revoked sooner.

The iHealth COVID-19 Antigen Rapid Test is intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal (nares) swab samples.

If you have symptoms of COVID-19, you can use a single test.
If you do not have symptoms of COVID-19, you will need at least two tests per person. You may need to purchase additional tests to perform serial (repeat) testing.
This test is more likely to give you a false negative result when you have COVID-19 than a lab-based molecular test.
This product has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA). This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
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. § 360bbb-3(b)(1 ), unless the declaration is terminated or authorization is revoked sooner.

FAQ’S

How do I know if the test is working?

The test is working if the color of the sample area on the test card changes from purple to yellow.

How do I know that I am not contaminating the swab tip with my fingers?

Please follow the instructions carefully. The swab tip should not be touched by your fingers or any other surface.

What if I don’t see a color change?

If you don’t see a color change, it means that there is no antigen in your sample. Please try again with a new swab and a new COVID-19 Test Card.

How do I know when to stop swabbing?

The test card has been pre-loaded with enough buffer to cover approximately 10mm of the swab tip. If you are swabbing for longer than 10mm, please discard the sample and start over with a new swab and a new COVID-19 Test Card.

Can I use more than one COVID-19 Test Card for my sample?

No, each COVID-19 Test Card can only be used once. Please discard your first test card and use a new one for your second attempt. If you still do not see a color change after two attempts, please visit www.ihealthlabs.com/pages/
support-1(O3000 or call our customer service team at 1(800) 829-9696 for further assistance.

What if I accidentally touch my nose or mouth while collecting my sample?

If you accidentally touch your nose or mouth while collecting your sample, please discard the sample and start over with a new swab and a new COVID-19 Test Card.

What if I accidentally touch my nose or mouth while collecting my sample?

If you accidentally touch your nose or mouth while collecting your sample, please discard the sample and start over with a new swab and a new COVID-19 Test Card.

How does the iHealth® COVID-19 Antigen Rapid Test work?

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). 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.

What are the differences between a COVID-19 antigen, molecular and antibody test?

There are different kinds of tests for COVID-19. Molecular tests (also known as PCR tests) detect genetic material from the virus. Antigen tests detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. This means that a positive result is highly accurate, but a negative result does not rule out infection. Another type of test is an antibody test. A COVID-19 antibody test detects antibodies that have been made by your immune system in response to a previous COVID-19 infection or vaccination. Antibody tests are not suitable to diagnose an active COVID-19 infection.

Will the test work if I don’t have symptoms?

Yes. 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.

Should people who are vaccinated use this test?

Individuals can utilize this test, as needed, regardless of vaccination status.

What is the age range for the test?

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.