INDICAID P0038 COVID-19 Rapid Antigen At Home Test Instructions
- June 11, 2024
- INDICAID
Table of Contents
P0038 COVID-19 Rapid Antigen At Home Test
Product Information
The Rapid Antigen At-Home Test (P0038, P0039, P0040, P0041) is a
diagnostic test kit for the identification of SARS-CoV-2
nucleocapsid protein antigen. The test is intended for in vitro
diagnostic use only and for emergency use authorization (EUA) only.
The kit contains an individually wrapped sterile nasal swab, a
single-use buffer solution vial, an individually packaged
single-use test device, a quick reference guide, user instructions,
and a fact sheet for individuals. The product comes in a 2-test,
4-test, 12-test, or 24-test format. The number of items supplied in
the kit will vary depending on which kit was purchased.
Intended Use
The Rapid Antigen At-Home Test is intended 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 6 days of symptom onset. The test is also
authorized for non-prescription home use with self-collected
anterior nasal (nares) swab samples from individuals aged 14 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.
Usage Instructions
Before performing the test, wash your hands for at least 20
seconds and then dry your hands. Perform the test indoors, at room
temperature on a clean, flat surface. A timer is required to
perform the test and is not included in the test kit. Ensure you
have at least 25 minutes available to focus on performing the
test.
-
Open the buffer solution vial and place it on a clean, flat
surface. -
Open the test device package and remove the device.
-
Collect a nasal swab sample from the individual. For
self-collected samples, insert the swab into one nostril and rotate
it several times. Repeat the process with the same swab in the
other nostril. For adult-collected samples, insert the swab into
the anterior nares and rotate it several times. -
Insert the swab into the buffer solution vial, breaking the
swab at the score line. Mix the swab in the buffer solution by
rotating and pressing it against the side of the vial for at least
15 seconds. -
Remove the swab while squeezing the sides of the vial to
extract as much liquid as possible. Discard the swab and close the
vial with the cap. -
Apply three drops of the liquid from the buffer solution vial
onto the sample well of the test device. -
Set a timer for 15 minutes and wait for the test results to
appear. -
After 15 minutes, read the test results. A single line
indicates a negative result, while two lines indicate a positive
result.
Note that negative results should be treated as presumptive and
may be confirmed with a molecular assay, if necessary, for patient
management. 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.
Individuals who test negative and continue to experience COVID-19
like symptoms of fever, cough and/or shortness of breath may still
have SARSCoV-2 infection and should seek follow up care with their
healthcare provider. Individuals should provide all results
obtained with this product to their healthcare provider for public
health 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
(LVID) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.
USER INSTRUCTIONS
INDICAID® COVID-19
P0038, P0039, P0040, P0041
Rapid Antigen At-Home Test
FOR EMERGENCY USE AUTHORIZATION (EUA) ONLY. IN VITRO DIAGNOSTIC USE ONLY.
Read all instructions carefully before performing the test. Failure to follow
the instructions my result in inaccurate test results.
· 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.
· An anterior nasal swab sample can be self-collected by an individual age 14
years and older. Children age 2 to 13 years should be tested by an adult.
· 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.
§360bbb3(b)(1), unless the declaration is terminated, or authorization is
revoked sooner.
· For more information on EUAs visit: www.fda.gov/emergency-preparednessand-
response/mcm-legal-regulatoryand-policy-f ramework/emergency-useauthorization.
· For the most current information on COVID-19, please visit:
www.cdc.gov/COVID19.
KIT CONTENTS
1
2
INDICAID COVID-19 Rapid Antigen Test TEST DEVICE
3
4
1. Individually wrapped Sterile Nasal Swab 2. Single use Buffer Solution Vial 3. Individually packaged single-use Test Device
4. Quick Reference Guide (see reverse side)
5. User Instructions (this document) 6. Fact Sheet for Individuals
NOTE: This product comes in a 2-test, 4-test, 12-test, or 24-test format. The
number of items supplied in the kit will vary depending on which kit was
purchased.
A timer is required to perform the test and is not included in the test kit.
Do not begin if you do not have at least 25 minutes available to focus on
performing the test. Before you begin, wash your hands for at least 20 seconds
and then dry your hands. Perform the test indoors, at room temperature on a
clean, flat surface.
INTENDED USE
The INDICAID® COVID-19 Rapid Antigen At-Home Test is a lateral flow
immunoassay intended for the qualitative detection of SARS-CoV-2. This test is
authorized for non-prescription home use with self-collected direct anterior
Nasal (nares) swab samples from individuals 14 years or older with symptoms of
COVID-19 within the first 6 days of symptom onset.
This test is also intended 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 6 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 14 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 INDICAID® COVID-19 Rapid Antigen At-Home Test does not differentiate
between SARS-CoV and SARS-CoV-2 viruses.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen.
Antigen is generally detectable in anterior Nasal (nares) Swabs 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 and the
agent detected may not be the definite cause of disease. Individuals who test
positive with the INDICAID® COVID-19 Rapid Antigen At-Home Test should
selfisolate and seek follow-up care with their physician or healthcare
provider as additional testing may be necessary.
Negative results should be treated as presumptive and may be confirmed with a
molecular assay, if necessary, for patient management. 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. Negative results should be considered in the context of a patient’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
SARSCoV-2 infection, such as an individual with 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
COVID-19, such as in individuals without known exposures to COVID-19 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 SARSCoV-2
infection and should seek follow up care with their healthcare provider.
Individuals should provide all results obtained with this product to their
healthcare provider for public health 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 (LVID) Test Code Mapping for SARS-CoV-2
Tests provided by CDC.
The INDICAID® COVID-19 Rapid Antigen At-Home Test is intended for
nonprescription self-use and/or as applicable an adult lay user testing
another person 2 years of age or older. The INDICAID® COVID-19 Rapid Antigen
At-Home Test is only for use under the Food and Drug Administration’s
Emergency Use Authorization.
WARNINGS PRECAUTIONS AND SAFETY INFORMATION
· Leave test card sealed in its pouch until just before use. Once opened, the
test card should be used within 2 hours.
· Do not touch swab tip.
· To ensure correct results, you must follow the instructions for use.
· Use only the contents provided in the test kit.
· Test components are single use. Do not re-use.
· Do not use this test kit beyond its expiration date.
· Do not use if any of the test kit contents or packaging is damaged or open.
· Keep testing kit and kit components away from children and pets before and
after use. Avoid contact with your skin, eyes, nose, or mouth. Do not ingest
any kit components. The reagent solution contains harmful chemicals (see table
below). If contact to the body occurs, flush with copious amount of water. If
irritation persist, seek medical advice: https://www.poisonhelp.org or
1-800-222-1222.
· Do not use the test on children under 2 years of age.
· Children aged 2 to 13 years of age should be tested by an adult.
· Wear a safety mask or other face covering when collecting specimen from a
child or another individual.
· False negative test results may occur if a specimen is incorrectly collected
or handled.
· Keep foreign substances and household cleaning products away from the test
during the testing process. Contact with foreign substances and household
cleaning products (e.g., 1% bleach) may result in an incorrect test result.
HAZARDOUS INGREDIENTS
Reagent TritonTM X-100 ProClinTM 300
Concentration 0.1 % v/v1 0.045% v/v1
Link to the MSDS www.sigmaaldrich.com/US/en/sds/sial/x100 www.sigmaaldrich.com/US/en/sds/ sial/48914-u
1 Chemical agent is not considered hazardous at this concentration.
SERIAL TESTING INFORMATION AND LIMITATIONS
If you have symptoms of COVID-19 that started within the last 6 days, you can
use a single test.
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 test to perform this serial (repeat)
testing.
For serial testing, if your first test result is negative, you should test
again with a new test in 24 to 48 hours.
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.
If your first or second test is positive, then proteins from the virus that
causes COVID-19 have been found in your sample and you likely have COVID-19.
If both your first and second tests re negative, you may not have COVID-19,
however you should follow-up with your healthcare provider if you are at high
risk for COVID-19.
FREQUENTLY ASKED QUESTIONS Will this test hurt?
No. The Nasal Swab is not sharp and it should not hurt Sometimes the swab can
feel slightly uncomfortable. If you feel pain, please stop the test and seek
advice from a healthcare provider.
What is COVID-19?
COVID-19 is caused by the SARS-CoV-2 virus which is a new virus in humans
causing a contagious respiratory illness. COVID-19 can present with a mild to
severe illness, although some people infected with COVID-19 may have no
symptoms at all. Older adults and people of any age who have underlying
medical conditions have a higher risk of severe illness from COVID-19. Serious
outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus
can be spread to others not just while one is sick, but even before a person
shows signs or symptoms of being sick (e.g., fever, coughing, difficulty
breathing, etc.). A full list of symptoms of COVID-19 can be found at the
following link: www.cdc.gov/coronavirus/2019- ncov/symptoms-testing/
symptoms.html.
What is serial testing?
Serial testing is when one person tests themselves multiple times for COVID-19
on a routine basis, such as every day or every other day. By testing more
frequently, you may detect COVID-19 more quickly and reduce spread of
infection. 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.
Testing for asymptomatic individuals should be performed at least twice over
three days, with at lest 24 hours and no more than 48 hours between tests. You
may need to purchase additional tests to perform this serial (repeat) testing.
What are the known and potential risks and benefits of the test?
Potential risks include:
· Possible discomfort during sample collection.
· Possible incorrect results (see Warnings and Result Interpretation sections
for more information).
Benefits include:
· The results, along with other information, can help you and your healthcare
provider make informed recommendations about your care.
· The results of this test may help limit the potential spread of COVID-19 to
your family and others in your community.
What is the difference between an antigen and molecular test?
There are different kinds of tests for the virus that causes COVID-19.
Molecular tests detect genetic material from the virus. Antigen tests, such as
the INDICAID® COVID-19 Rapid Antigen AT-Home Test, detects proteins from the
virus. Antigen tests are very specific for the SARS-CoV-2 virus but are not as
sensitive as molecular tests. This means that positive result is highly
accurate, but negative result does not rule out infection. If your test result
is negative, you should discuss with your healthcare provider whether an
additional test is necessary and if you should continue isolating at home.
There is a higher chance of false negative results with antigen tests than
with laboratory-based molecular test. This means that there is a higher chance
this test will give you negative result when you have COVID-19 than a
molecular test would.
How accurate is this test?
The performance of the INDICAID® COVID-19 Rapid Antigen AT-Home Test was
established in a prospective study using an EUA authorized molecular test as a
comparator method (PPA 81.7% and NPA 99.4%). You can find further information
by visiting indicaidusa.com. The performance of this test is still being
studied in patients without signs and symptoms of respiratory infection and
for serial screening. Performance may differ in these populations.
What if I have a positive test result?
A positive result means that, it is very likely that you have COVID-19 because
proteins from the virus that causes COVID-19 were found in your sample. You
should self-isolate from others and contact healthcare provider for medical
advice about your positive result. Your healthcare provider will work with you
to determine how best to care for you based on your test result(s) medical
history, and symptoms.
What if I have a negative test result?
A negative test result indicates that antigens from the virus that causes
COVID-19 was not found in your sample. If you have symptoms, you likely do not
have COVID-19. If you do not have symptoms and you receive a second negative
result 24 to 48 hours after your first negative result, then you are likely
not infected with COVID-19. However, negative results do not rule out SARS-
CoV-2 infection. It is possible for this test to give a negative result that
is incorrect (false negative) in some people with COVID-19. This means you
could possibly still have COVID-19 even though the test is negative. For
example, you may get a false negative result if you did not perform the test
correctly or if the level of antigen from the virus causing COVID-19 was below
the test limits. The amount of antigen in a sample may decrease the longer you
have symptoms of infection. If you test negative and continue to experience
COVID-19 like symptoms of fever, cough and/or shortness of breath you should
seek follow up care with your healthcare provider. Your healthcare provider
will consider the test result together with all other aspects of your medical
history (such as symptoms, possible exposures, and geographical location of
places you have recently traveled) in deciding how to care for you.
It is important that you should work with your healthcare provider to help you
understand the next steps you should take.
What does Invalid test result mean?
If no control line shows up on the test, the result is invalid (even if any
test line shows up). An invalid result means the test was not able to tell if
you have COVID-19 or not. If the test is invalid, a new swab should be used to
collect a new nasal specimen and the test should be run again, using all new
test components.
STORAGE AND STABILITY
Store The INDICAID® COVID-19 Rapid Antigen At-Home Test between 2-30°C
(36-86°F) until use. Ensure all kit component are at room temperature before
use. Kit contents are stable until the expiration date printed on the outer
packaging. Do not use beyond the expiration date.
SUPPORT
For questions, or to report a problem, please call +1
877-934-9344, or email
care@indicaidusa.com or visit indicaidusa.com. Additional information is also
available for you and your healthcare provider at indicaidusa.com. This User
Instructions, Quick Reference Guide, Fact Sheet for Individuals, Fact Sheet
for Health Care Provider and Health Care Provider Instructions for Use are
also available at indicaidusa.com.
The INDICAID® COVID-19 Rapid Antigen At-Home Test Letter of Authorization,
authorized Fact Sheets and authorized labeling are available on the FDA
website and indicaidusa.com.
EXPLANATION OF SYMBOLS
In vitro diagnostic medical device
Keep away from moisture
Consult Instructions for use
Caution–consult accompanying documents
30ºC
Temperature limitation
2ºC
Keep away from sunlight
Do not reuse Catalog number Batch code Use by
Sufficient for use
Manufacturer
PHASE Scientific International Limited 32 & 33F, Gravity, 29 Hing Yip Street, Kwun Tong, Kowloon, Hong Kong
QUICK REFERENCE GUIDE
INDICAID® COVID-19 Rapid Antigen At-Home Test
P0038, P0039, P0040, P0041
30ºC 2ºC
Suitable for ages 2+ years Must be 14+ to use kit unsupervised
Performing Your Test
1
2
WHAT YOU NEED TO KNOW BEFORE YOU START
· This test aids in the clinical diagnosis of COVID-19, but it should not be
the only guide to manage illness. Please consult a healthcare professional if
your symptoms persist or worsen.
· This test kit is for testing for current infection only and cannot tell if
you have had a COVID-19 infection in the past.
· You must follow the test directions carefully to get an accurate result.
Read Lay user instructions carefully before starting the test.
· 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.
· Make sure you have enough time to complete the entire testing process. It
takes approximately 25 minutes to complete the process once you begin.
· This kit should not be used on children under 2. In children ages 2-13, the
nasal swab sample must be collected and tested by an adult (18+ years old).
· Always wear a protective mask or other face-covering when collecting Nasal
Swab samples from anyone, whether a child or an adult.
3
1
5 1st Nostril
20
SEC
Swabbing the nostrils is critical for obtaining an accurate result. If you do not swab your nose, the test will produce a false negative result.
½ ¾ in
2nd Nostril
INDICAID COVID-19 Rapid Antigen Test TEST DEVICE
20
mins
Note: Your test kit box may contain more than one test kit
x4
Same Swab
x4
Gather your supplies
· Check the expiration date on the outside of the product box.
· Remove 1 Swab, 1 Test Device pouch, and 1 Buffer Solution Vial.
· Make sure you have a timer (that can time 20 minutes). The test kit does not
come with one.
Wash your hands thoroughly for at least 20 seconds before and after testing.
Remove entire Buffer Solution Vial cap
· Twist off the entire cap (purple & white parts together) from the Buffer
Solution Vial.
· Place vial and cap on a flat surface.
Remove Nasal Swab from its pouch
· To keep the swab sterile, avoid touching the soft tip onto any surface. Only
remove the swab from its pouch once the test is ready to be performed.
Collect Nasal Swab sample from both nostrils using same swab
· Gently insert the swab tip into one nostril (no more than ½ to ¾ inch). You
do not need to go deep. Refer to diagram.
· Using firm pressure, slowly rotate the swab in a circular path against the
inside wall of the nostril. Make at least 4 big circles. Take approximately 15
seconds to collect the specimen. Be sure to collect any nasal drainage that
may be present on the swab.
· Repeat in the second nostril using the same swab.
· With children, the maximum depth of insertion into the nostril may be less
than ¾ of an inch, and you may need to have a second person hold the child’s
head while swabbing.
6
7
8
9
10
Interpreting Your Results
· 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.
· Read your results in a well-lit area.
· Look for lines next to the C’ (Control) and theT’ (Test) areas on the
Test Device. Use the table below to interpret what you see.
· Report your test results to your healthcare provider to receive appropriate
medical care.
· 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.
POSITIVE TEST RESULT
A positive test result means that the virus that causes COVID-19 was detected
in your sample and it is very likely you have COVID-19 and are contagious.
Please contact your doctor/primary care physician or your local health
authority immediately and adhere to the local guidelines regarding self-
isolation. There is a very small chance that this test can give a positive
result that is incorrect (a false positive). Your healthcare provider will
work with you to determine how best to care for you based on your test results
along with medical history and your symptoms.
C
C
or
T
T
If a Control (C) line and the Test (T) line are visible, the test is positive.
Any faint visible red test (T) line with the control line (C) should be read
as positive.
Look very closely! The color intensity in the “T” area can vary. Any faint
line right next to the “T” should be considered positive.
Take these next steps Please consult your healthcare provider to discuss your
positive test result. You should self-isolate at home per CDC recommendations
to stop spreading the virus to others.
NEGATIVE TEST RESULT
A negative test result indicates that antigens from the virus that causes
COVID-19 were not detected from the specimen. A negative result does not rule
out COVID-19. There is higher chance of false negative results with antigen
tests than with laboratory-based molecular tests. This means that there is
higher chance this test will give you a negative result when you have
COVID-19. If you test negative and continue to experience COVID-19 like
symptoms of fever, cough, and/or shortness of breath you should seek follow up
care with your health care provider.
If the Control (C) line is visible, but the Test (T) line is not visible, the
test is negative
C
T
Tilt
x20
T
3 drops
20
T
mins
Release sample into Buffer Solution Vial
· Immediately place the Nasal Swab into the Buffer Solution Vial. Tilt the
vial to make sure that the swab tip (soft end) is thoroughly soaked and
immersed in the Buffer Solution.
· Twist the swab back and forth 20 times in the Buffer Solution.
· Before taking out, press and roll the swab tip against the inner wall of the
vial to remove any excess solution.
· Properly dispose of the used swab in a trash receptacle.
Cap the vial and expose dropper tip
· Tightly cap the Buffer Solution Vial with the vial cap.
· Remove the purple part of the cap from the vial to expose the dropper tip.
· Avoid touching the dropper tip with your finger.
Add Buffer Solution to Test Device
· Open the Test Device pouch and place the Test Device on a flat surface.
· Locate the sample well (S) on the Test Device.
· Slowly squeeze 3 drops of the Buffer Solution into the sample well.
· False negative results may occur if less than 3 drops are applied to the
sample well.
Test samples immediately after collection, but no more than 5 minutes after specimen collection before placement into extraction buffer or up to 2 hours after placement into extraction buffer, if kept at room temperature.
Let Test Device sit for 20 minutes and Read test results
· Start a timer for 20 minutes. · Leave the Test Device on a table or
flat surface until the timer goes off. · Read your test results immediately
at 20 minutes.
Do NOT read the results before 20 minutes or if it has been longer than 25
minutes from when the vial solution has been added to the sample well, as the
test may have an inaccurate outcome.
Dispose of used test kit materials
· Dispose of all used test kit components and swab samples in a trash
receptacle.
· Do not flush or pour test liquids down the drain.
REV B DRAFT 4
PI-0001 | Rev B
Take these next steps
If you develop COVID-19 symptoms or your symptoms become severe, seek medical
attention immediately. If you have no symptoms OR if this is the first test in
a serial testing program, a second test must be done between 24 and 48 hours
after the first test.
INVALID TEST RESULT
No red-colored line next to the “C” means test is invalid. Re-test with new
swab and new test device.
C
C
or
T
T
If there is no red line next to the “C”, the result is invalid regardless of whether there is a red-colored line next to the “T”.
Take these next steps
Collect a new Nasal Swab sample and repeat the test with a new INDICAID®
COVID-19 Rapid Antigen At-Home Test. If you develop COVID-19 symptoms or your
symptoms become severe, seek medical attention immediately.
User Instructions and Fact Sheet for Individuals
Individually Wrapped Swabs (2 Each)
Buffer Solution Vial (2 Each)
Individually Wrapped Test Devices (2 Each)
COVID-19 RAPID ANTIGEN AT-HOME TEST
The INDICAID® COVID-19 Rapid Antigen At-Home Test is a lateral flow
immunoassay that uses antibodies to detect nucleocapsid protein from SARS-
CoV-2 in anterior nasal swabs
from those with symptoms of COVID-19 within the first 6 days of symptom onset
or those 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.
PPRROOTTEECCTToytohuerrsself
TEST WHEN…
COVID-19 symptoms Self-quarantine Travel decisions School/Work decisions
Protect others
REF P0038
IVD
RESULTS
C T
2 lines Positive Result
C T
1 line
Negative Result
Refer to detailed results explanation inside
IMPORTANT
2 One-time use only Read instructions inside before use
For use with and without symptoms
Contains 2 tests
2
Keep away f rom sunlight
Keep away f rom moisture
Use device with caution
Suitable for ages 2+ years. 2+ Must be 14+ to use kit
unsupervised
Store at 2°C 30°C (35.6°F 86°F)
PPRROOTTEECCTToytohuerrsself
OTC
Quick and Easy
T
CONTAINED IN THIS BOX
A timer is required but not provided.
SIMPLE TO USE Refer to detailed instructions inside
PB-0015 Rev. C
Lo t Exp
FDA EMERGENCY USE AUTHORIZATION
2
TESTS
COVID-19 RAPID ANTIGEN AT-HOME TEST
Quick · Easy · Results in 20 minutes
PPRROOTTEECCTToytohuerrsself
Manufacturer: PHASE SCIENTIFIC INTERNATIONAL LTD. 32 & 33/F, Gravity, 29 Hing Yip Street Kwun Tong, Kowloon, Hong Kong
indicaidusa.com
+1 877-934-9344
care@indicaidusa.com
· In the USA, this product has not been FDA cleared or approved; but has been
authorized by FDA under an 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.
· For Emergency Use Authorization (EUA) only · For in vitro diagnostic use ·
Must be 2+ years to use this kit · 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
test does NOT determine if you had COVID-19 in the past or if you have
immunity.
User Instructions and Fact Sheet for Individuals
Individually Wrapped Swabs (4 Each)
Buffer Solution Vial (4 Each)
Individually Wrapped Test Devices (4 Each)
COVID-19 RAPID ANTIGEN AT-HOME TEST
The INDICAID® COVID-19 Rapid Antigen At-Home Test is a lateral flow
immunoassay that uses antibodies to detect nucleocapsid protein from SARS-
CoV-2 in anterior nasal swabs
from those with symptoms of COVID-19 within the first 6 days of symptom onset
or those 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.
PPRROOTTEECCTToytohuerrsself
TEST WHEN…
COVID-19 symptoms Self-quarantine Travel decisions School/Work decisions
Protect others
REF P0039
IVD
RESULTS
C T
2 lines Positive Result
C T
1 line
Negative Result
Refer to detailed results explanation inside
IMPORTANT
2 One-time use only
Read instructions inside before use
For use with and without symptoms
Contains 4 tests
4
Keep away f rom sunlight
Keep away f rom moisture
Use device with caution
Suitable for ages 2+ years. 2+ Must be 14+ to use kit
unsupervised
Store at 2°C 30°C (35.6°F 86°F)
PPRROOTTEECCTToytohuerrsself
OTC
Quick and Easy
T
CONTAINED IN THIS BOX
A timer is required but not provided.
SIMPLE TO USE Refer to detailed instructions inside
PB-0016 Rev. B
Lo t Exp
FDA EMERGENCY USE AUTHORIZATION
4
TESTS
COVID-19 RAPID ANTIGEN AT-HOME TEST
Quick · Easy · Results in 20 minutes
PPRROOTTEECCTToytohuerrsself
Manufacturer: PHASE SCIENTIFIC INTERNATIONAL LTD. 32 & 33/F, Gravity, 29 Hing Yip Street Kwun Tong, Kowloon, Hong Kong
indicaidusa.com +1 877-934-9344
care@indicaidusa.com
· In the USA, this product has not been FDA cleared or approved; but has been
authorized by FDA under an 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.
· For Emergency Use Authorization (EUA) only · For in vitro diagnostic use ·
Must be 2+ years to use this kit · 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
test does NOT determine if you had COVID-19 in the past or if you have
immunity.
12
TESTS
PPRROOTTEECCTToytohuerrsself
EMERGENCY USE
AUTHORIZATION FDA
COVID-19 RAPID ANTIGEN AT-HOME TEST
Quick · Easy · Results in 20 minutes
Lo t Exp
T
COVID-19 RAPID ANTIGEN AT-HOME TEST
RESULTS
C T
2 lines Positive Result
C T
1 line
Negative Result
Refer to detailed results explanation inside
IMPORTANT
2 One-time use only Read instructions inside before use
For use with and without symptoms
Contains 12 tests
12
Keep away f rom sunlight
Keep away f rom moisture
REF P0040
IVD
PPRROOTTEECCTToytohuerrsself
Use device with caution Suitable for ages 2+ years. 2+ Must be 14+ to use kit
unsupervised Store at 2°C 30°C (35.6°F 86°F)
· In the USA, this product has not been FDA cleared or approved; but has been
authorized by FDA under an 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.
· For Emergency Use Authorization (EUA) only · For in vitro diagnostic use ·
Must be 2+ years to use this kit · 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
test does NOT determine if you had COVID-19 in the past or if you have
immunity.
CONTAINED IN THIS BOX A timer is required but not provided.
Individually Wrapped Test Devices (12 Each)
Buffer Solution Vial (12 Each)
Individually Wrapped Swabs (12 Each)
User Instructions and Fact Sheet for Individuals
indicaidusa.com +1 877-934-9344 care@indicaidusa.com
COVID-19 RAPID ANTIGEN AT-HOME TEST
TEST WHEN… COVID-19 symptoms Self-quarantine
Travel decisions School/Work decisions
Manufacturer: PHASE SCIENTIFIC INTERNATIONAL LTD. 32 & 33/F, Gravity, 29 Hing Yip Street Kwun Tong, Kowloon, Hong Kong
Protect others
PB-0017 Rev.B
12 TESTS PPRROOTTEECCTToytohuerrsself
The INDICAID® COVID-19 Rapid Antigen At-Home Test is a lateral flow
immunoassay that uses antibodies to detect nucleocapsid protein from SARS-
CoV-2 in anterior nasal swabs from those with symptoms of COVID-19 within the
first 6 days of symptom onset or those 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.
SIMPLE TO USE Refer to detailed instructions inside
Lo t Exp
T
24
TESTS
PPRROOTTEECCTToytohuerrsself
COVID-19 RAPID ANTIGEN AT-HOME TEST
Quick and Easy Results in 20 minutes
EMERGENCY USE
AUTHORIZATION FDA
COVID-19 RAPID ANTIGEN AT-HOME TEST
RESULTS
C T
2 lines
C T
1 line
Positive Result Negative Result
Refer to detailed results explanation inside
REF P0041
IVD
IMPORTANT
2 One-time use only Read instructions inside before use
For use with and without symptoms
Contains 12 tests
12
Keep away f rom sunlight
Keep away f rom moisture
PPRROOTTEECCTToytohuerrsself
Use device with caution Suitable for ages 2+ years.
2+
Must be 14+ to use kit unsupervised Store at 2°C 30°C (35.6°F 86°F)
CONTAINED IN THIS BOX A timer is required but not provided.
Individually Wrapped Buffer Solution Vial Individually Wrapped
Test Devices (24 Each)
(24 Each)
Swabs (24 Each)
User Instructions and Fact Sheet for Individuals
COVID-19 RAPID ANTIGEN AT-HOME TEST
TEST WHEN… COVID-19 symptoms Self-quarantine
Travel decisions School/Work decisions
Protect others
+1 877-934-9344
care@indicaidusa.com
· In the USA, this product has not been FDA cleared or approved; but has been
authorized by FDA under an 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.
· For Emergency Use Authorization (EUA) only · For in vitro diagnostic use ·
Must be 2+ years to use this kit · 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
test does NOT determine if you had COVID-19 in the past or if you have
immunity.
PB-0018 Rev. B
Manufacturer: PHASE SCIENTIFIC INTERNATIONAL LTD. 32 & 33/F, Gravity, 29 Hing Yip Street Kwun Tong, Kowloon, Hong Kong
indicaidusa.com
24
TESTS
PPRROOTTEECCTToytohuerrsself
The INDICAID® COVID-19 Rapid Antigen At-Home Test is a lateral flow
immunoassay that uses antibodies to detect nucleocapsid protein from SARS-
CoV-2 in anterior nasal swabs from those with symptoms of COVID-19 within the
first 6 days of symptom onset or those 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.
SIMPLE TO USE Refer to detailed instructions inside
References
- INDICAID 妥析快速測試 | 政府認可 獲多項國際認證及授權
- INDICAID® COVID-19 Rapid Antigen Tests (OTC)｜INDICAID
- MakeMyTestCount
- cdc.gov/coronavirus/2019-ncov/symptoms-testing/
- Coronavirus Disease 2019 (COVID-19) | CDC
- INDICAID 妥析快速測試 | 政府認可 獲多項國際認證及授權
- 800-222-1222" class="nturl" > Poison Control | Call Poison Help Centers Now 1-800-222-1222