INDICAID 2120100 Quick Start Manual

QUICK START
® ®
GUIDE
INTENDED USE
INDICAID COVID-19 Rapid Antigen Test is an in vitro
®
diagnostic test for determining the presence of SARS-CoV-2
antigens in direct nasal swab samples.
CONTAINED IN THIS BOX
1 individually-wrapped 1 vial of buffer solution
test device
HOW TO USE
Follow these instructions closely to achieve the best results:
Remove the swab and test Tilt your head back. Gently insert
device from their packaging. the swab about 1 inch into one of
your nostrils. Twist for 5 seconds.
Repeat with your other nostril.
Remove the top half of the vial
cap to expose the dropper tip.
INTERPRETING YOUR RESULTS :
INDICATOR
A line appears in regions
C
(C) and (T)
T
A line appears in the
C
region (C)
T
No line appears in the
C
region (C)
T
NOTE: The indicator lines could be faint. Any line, even if faint, should be interpreted as a line.
Do not compare the color intensity of each indicator line to another.
IMPORTANT
• For in vitro diagnostic use
• User should not make any decision of medical relevance without first
consulting his/her health care provider
• All components in this test kit should remain sealed until ready for use
• The test must be performed between 18-25°C
• All components in this test kit are for one-time use only. Do not reuse
• Store at 2-30°C. Do not freeze. Avoid direct sunlight
• Do not swallow or inhale
• Avoid contact with your eyes. If contact occurs, flush with water immediately
and seek medical help
• Do not use the test kit after the expiration date
COVID-19 RAPID
ANTIGEN TEST
Ref # 2120100
PRINCIPLE
Antigen is generally detectable in upper respiratory tract during the
early phase of infection. Antigens are present on the SARS-CoV-2
virus, and can be used as markers for disease exposure.
1 individually wrapped swab 1 instruction sheet
The Buffer Solution Vial cap is
Close the entire vial cap tightly.
composed of two parts. Remove the
Immediately perform Steps 5-7.
entire cap. Stir the swab into the buffer
solution by twisting the swab back and
forth 20 times.
Ensure that the swab tip
is fully submerged
in the solution.
x 20
Leave for 20 minutes and read the
results. Do not read after 25 minutes.
Refer to "Interpreting Your
Results" section below.
20
mins
RESULT INTERPRETATION
Positive The presence of both the control line (C) and line (T)
indicates the presence of SARS-CoV-2 antigens. The result
suggests current COVID-19 infection.
Negative The presence of only the control line (C) and not the line (T)
indicates no detection of SARS-CoV-2 antigens.
Invalid If the control line (C) does not appear, the result is invalid,
regardless whether the line (T) is present. Repeat the test
with a new test device.
LIMITATIONS
• The test is designed for using nasal swab samples.
• Negative results do not rule out COVID-19 infection, especially if you
have been in contact with the virus. Follow-up molecular testing
should be considered to rule out infection.
• Positive results may be due to present infection with non
SARS-CoV-2 coronavirus strains, such as SARS-CoV.
• Results from antigen testing should not be used as the sole basis to
diagnose or exclude COVID-19 infection.
• If you have questions about your results, please contact Customer
Service at +852-3892-7200 or indicaid@phasesci.com.
F R EQ UE NT LY A SKED QU E STI ONS (FAQs )
I ACCIDENTALLY SPILLED THE TEST SOLUTION. IS IT HARMFUL?
If the test solutions have been spilled, flush abundantly with water upon disposal.
Avoid having the test solutions come into contact with your eyes, skin and mouth. If contact occurs with the eyes, flush with
water immediately and seek medical help. If contact occurs with your skin, wash the area with soap and rinse with water.
Do not ingest or inhale the test solutions. If accidental ingestion occurs, please seek medical help immediately.
HOW FAR SHOULD I INSERT THE SWAB INTO MY NOSTRILS?
Inserting the swab 1 inch into your nostril should be far enough to collect samples for this test. You can stop pushing the swab
when you feel a slight resistance and proceed to collecting your sample. Samples should be collected gently.
WHAT DO I DO WITH THE TEST UNIT AFTER READING THE RESULTS?
After recording your results, carefully wrap and seal all product components and dispose by throwing it into the garbage just
like any household trash. Wash your hands thoroughly after handling and disposing the components.
HOW DOES THE TEST WORK?
This test is designed to detect the presence of SARS-CoV-2 antigens from nasal swab samples. Antigens are present on the
SARS-CoV-2 virus, and can be used as markers for disease exposure.
WHAT IF I TESTED NEGATIVE?
Rapid antigen tests can only detect the presence of antigens at the time of the test. A false negative result may be produced
when the level of antigen in the sample is below the detection limit of the test, the sample is collected improperly, or when
the test was performed incorrectly. If you had contact with a known or suspected COVID-19 cases, as a best practice, performing
the test at least once every week is recommended.
WHAT IF I TESTED POSITIVE?
If you tested positive for COVID-19 antigens, we recommend contacting your local health authorities to organize a follow-up
molecular diagnostics test for diagnosis.
IC04PI2001 | PI-2120100QS | Rev A | For in vitro diagnostics |
Information subjected to change without notice | © 2020 PHASE Scientific Int'l Ltd, all rights reserved.
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