EN
iHealth
COVID-19
Antigen Rapid Test
Instruction for use
Model: ICO-3000/ ICO-3001/ ICO-3002
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-ICO3000
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
1
Prepare Materials
You may have
Test Set 1
OR
Test Set 2
in the package. Please
follow proper steps based on the specific set you received.
Test Set 1:
Open the package, take out the COVID-19 Test
Card in Pouch, the Tube pre-filled with the extraction
solution and the Swab. When you are ready to proceed with
the test, open the foil pouch of the COVID-19 Test Card.
1 Swab
1 COVID-19 Test Card
in Pouch
1 Pre Filled Tube
Please go directly to
Step
2
Collect Sample.
Test Set 2:
Open the package, take out the COVID-19
Test Card in Pouch, empty Tube, sealed Solution and
the Swab. When you are ready to proceed with the
test, open the foil pouch of the COVID-19 Test Card.
1 Empty Tube and
1 Sealed Solution
1 Swab
1 COVID-19 Test Card
in Pouch
Please look carefully, there are
two Edges
on the empty
tube. Then squeeze the sealed solution completely
into the empty tube.
Edge
1
Edge
2
Please confirm the liquid level with or above Edge 2,
then go to
Step
2
Collect Sample.
Edge 1
Edge 2
Note:
It
is acceptable if the liquid level is above Edge 2. However,
pleas
e
do not
proceed with this test, if the liquid level is
below Edge 2, as this may result in false or invalid results.
2
Collect Sample
a. Remove the swab from its package, being careful
not to touch the tip of the swab. Please keep the
swab package for later use.
b. 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 nee
d
to have a second person to hold the child’s head while
swabbing.
c. 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.
3
Process Sample
a. Tap the tube vertically on the table and twist the
large orange cap to open the tube.
b. Insert the swab into the tube, touch the bottom of
the tube with the swab tip, and stir at least 15 times.
X
15
Stir
c. Squeeze the sides of the tube to express as much
liquid as possible from the swab, and then remove
the swab.
d. Screw back the large orange cap, put the swab
back into the package. Safely dispose of the swab
and the package.
Note:
If you don't squeeze the swab, there may not be
su
ffi
cient sample material to perform the test
properly (i.e., potentially resulting in a false negative
result).
4
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.
Note:
A false negative or invalid result may occur if too little
solution is added to the test card.
5
Wait 15 Minutes
Start the timer by clicking the “Start Timer” button on
the App, 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 15-min
timer has completed, as the T line may take as long as
15 minutes to appear.
6
Read Result
Results should not be read after 30 minutes (Result
shown at 2x magni
fi
cation).
Note:
A false negative or false positive result may occur if the
test result is read before 15 minutes or after 30 minutes.
Look carefully
Look carefully
for a C line here.
for a T line here
Note:
The T line can be extremely faint.
.
7
Test Result Explanation
Positive Result
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.
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
fi
rst test is negative, repeat the
test after 1-2 days and consult your healthcare
provider or local COVID-19 center.
Note: A negative result is presumptive and
con
fi
rmation 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
con
fi
rmatory 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 con
fi
rmatory 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.
8
Dispose the Test Kit
After test is completed, dispose the kit components
in trash.
9
Report Test Result
Report the result following the App instructions or
share your test result with your healthcare provider.
In the USA:
(1) 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.
(2) 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.
