Ihealth Covid-19 antigen rapid test User manual

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

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

1Prepare 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 Swab1 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 Swab1 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,

please do not proceed with this test, if the liquid level is

below Edge 2, as this may result in false or invalid results.

2Collect 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 need

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.

3Process 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.

X15

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

sufficient sample material to perform the test

properly (i.e., potentially resulting in a false negative

result).

4Add 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.

5Wait 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.

6Read 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.

Look carefully Look carefully

for a C line here. for a T line here

Note: The T line can be extremely faint.

7Test 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 first 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

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.

8Dispose the Test Kit

After test is completed, dispose the kit components

in trash.

9Report 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.