Product Manual
Note: The line next to the “C” does not show that an adequate sample has been collected.
READING BEFORE 30 MINUTES MAY CAUSE A FALSE NEGATIVE RESULT.
DO NOT
pour out
the liquid
Hold tube
upright
INTERPRETING RESULTS:
INSTRUCTIONS FOR USE
You must follow the test directions carefully to get an accurate result. Call OraSure Technologies at 1-833-601-0127
or visit www.InteliSwab.com to obtain the complete instructions for use. FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY.
IMPORTANT: Swabbing the nostrils is critical for obtaining an accurate result.
If you do not swab your nose, the device will produce a false negative result.
HOW TO USE THE INTELISWAB
™
COVID-19 RAPID TEST
Read test results in a well-lit area.
Tear open the pouch containing
the test device and remove.
DO NOT touch the flat pad
with your fingers.
DO NOT eat or swallow
the preservative.
If the preservative is not
present, DO NOT use the test.
Hold the test stand on a flat surface and insert
the flat pad of the device into the tube. Stir
10 times to mix the sample with the liquid
in the tube. Make sure the flat pad is toward
the back of the tube so it contacts the liquid.
Swirling the device less than 10 times may
cause invalid results.
After mixing, leave the device in the tube. Make sure
the flat pad is touching the bottom of the tube and
the result window is facing you. Start your timer for
30 minutes. DO NOT remove the device from tube
while the test is running. A pink background will pass
through the result window as the test is working.
Read results between 30 and 40 minutes.
To obtain an accurate result, DO NOT read
before 30 minutes or after 40 minutes.
Reading before 30 minutes may cause
false negative results.
Insert flat pad of the device inside the nostril. Circle around the nostril 15 times while maintaining
contact with the inside wall of the nostril. SWAB BOTH NOSTRILS (Fig. 1 and Fig. 2).
If you are conducting the test on someone who requires assistance, proceed by swabbing the individual.
If you do not swab both nostrils 15 times each, you may get a false result.
Kit Contains: Two (2) pouches, each with
a device and a tube, Instructions for Use
(in English and Spanish), Positive Result
Reference Card and test stand.
Pick up one of the two-part pouches.
Tear open the pouch containing the tube and remove.
With the tube in an upright position, gently rock
the cap back and forth to remove it. DO NOT twist.
DO NOT pour out the liquid. DO NOT drink.
POSITIVE RESULT
INVALID RESULT
NOT SURE OF YOUR RESULT
If you do not know your result or you are unsure of your result, contact OraSure Technologies at 1-833-601-0127 or go to www.InteliSwab.com
DISPOSE
Remove the test device from the tube, put the cap back on the tube and throw away in normal trash. Keep the test stand and instructions
for completing additional tests provided in the kit. Once all devices have been used for testing, throw away all contents.
D Do NOT Reuse
NEGATIVE RESULT
The test is POSITIVE if:
there is a reddish-purple line next to the "T" and NO reddish-purple
line next to the "C"
there is a reddish-purple line next to the "T" and a reddish-purple
line next to the "C", even if the "C" line is faint
there is a faint reddish-purple line next to the "T" and a
reddish-purple line next to the "C"
You need to quarantine so you do not infect others.
You may need additional testing, depending on your personal
health history and other factors.
The test is not working and should be repeated if:
no lines are present
the line next to the “T” or the line next to
the “C” is not complete (all the way across
the window), or
a reddish-purple background makes it
impossible to read the test after 30 minutes
You will need to obtain another test.
As soon as possible . . .
Call your healthcare
provider to report your result.
If you have emergency warning signs such as
trouble breathing, persistent pain or pressure
in the chest, new confusion, inability to wake
or stay awake or bluish lips or face, call 911
or go to the closest Emergency Room.
The test did NOT work properly.
Contact OraSure Technologies, Inc.
at 1-833-601-0127
Next Steps . . .
Call your healthcare provider to report
your result.
If your result is negative but you have signs
and symptoms of COVID-19, contact your
healthcare provider for additional testing.
The test is NEGATIVE if:
there is a reddish-purple line next to the "C" and NO reddish-purple line next to the "T"
There must be a line next to the "C" to be able to interpret a negative result.
If your first test result is negative, you should test again in 24 to 36 hours.
If both your first and second tests are negative, you may not have COVID-19.
Refer to the Positive Result Reference Card provided for more examples
of positive test results. This card will help you see how faint the test line can appear.
LEARN MORE
TIMER
SET
TIMER
00:30
START
STOP
YOU WILL NEED A WAY
TO TIME THE TEST.
20
sec.
Wash your hands thoroughly with
soapand water for 20 seconds
before starting the test.
FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY
01-3378
234567
017-06
FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY
01-3378
234567
017-06
DEV SOL VIAL
01-3378
234567
017-06
Slide the tube into the test stand on a flat sturdy surface.
DONOT force from the front as splashing may occur. Tube
should rest at an angle on the bottom of the stand. If the
solutionspills, you will need a new test.
Blow your nose into a tissue. If assisting someone,
instructthem to blow their nose. DO NOT use tissue to
clear out nasal passage. Discard tissue and wash hands
thoroughly. Dry hands before starting the collection.
ENGLISH
10 times
C
T
01-3378
234567
017-06
30 minutes
30
Wait Read
40
30
C
T
01-3378
234567
017-06
Make sure the
tube and device
are at an angle
12
11
Fig. 1
15
times
15
times
AND
C
T
C
T
Fig. 2
109
THROW AWAY
preservative.
NOT needed for the test.
DO NOT EAT.
Flat pad
Result window
Test device
DO NOT EAT
NO ES PARA CONSUMIR
DO NOT EAT
NO ES PARA CON
NE PAS MANAGER
PACKAGED IN TYVEK
NE PAS MANAGE
PACKAGED IN TY
FOR USE UNDER EMERGENCY USE AUTHORIZATION (EUA) ONLY
C
T
C
T
C
T
87654321