Product Manual

QUICK REFERENCE INSTRUCTIONS
CLINITEST®
RAPID COVID-19 ANTIGEN SELF-TEST
For Emergency Use Authorization (EUA) only.
diagnostic
use only.
STEP 3
Place the tube back into the tube holder. Keep the swab inside of the tube.
Start timer for 1 minute.
PLACE SWAB IN TUBE
PLACE TUBE IN TUBE HOLDER
OPEN TEST DEVICE
6 circles
REMOVE SWAB FROM TUBE
1 minute
INSERT TIP
Take a tube tip from the kit and push it into the top of the tube.
Make sure there is a tight fit.
ADD 4 DROPS
START TIMER
Hold the tube straight up and down above the test device and gently squeeze to
add 4 drops of solution into the sample well, labeled as “S” on the test device.
Adding more or less than 4 drops of solution into the sample well may result in
incorrect results.
15 minutes
STEP 5
PAGE 1
COVID - 19 NEGATIVE
INVALID
CLINITEST®
Rapid COVID-19 Antigen Test
INTRODUCTION
STEP 1.
STEP 4. STEP 5.
STEP 3.
Wash your hands with soap and water for 30 seconds or use hand sanitizer.
Make sure hands are dry before starting.
Check expiration date of the test kit before use. Expiration date is printed on the
box and each test pouch. Do not use if test is expired.
Do not start Step 1 until you are ready to begin the test.
TUBE
TEST DEVICE
POUCH
TIP
TUBE HOLDER
TEST DEVICE
POUCH
IMPORTANT
Read instructions carefully before starting the test.
-
-
Test setup is about 5 minutes. The result must be read at 15 minutes.
All test materials must be at room temperature before use.
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-
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You should wear a face mask if swabbing others.
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You must follow the test directions carefully to get an accurate result.
If you have any questions about using the test or reading the results please call
our customer care hotline.
Telephone: [phone]
E-Mail: [e-mail]
www.clinitest.siemens-healthineers.com/us
WASH HANDS
GATHER MATERIALS
OPEN SWAB
PLACE TUBE IN TUBE HOLDER
Find tube holder shown on the back of the box.
Push tube through outlined hole.
Open the swab pouch on the end opposite the swab tip by peeling back the pouch cover.
Hold the plastic stick end of the swab and remove from pouch. Be careful not to
touch the tip of the swab.
SWAB BOTH NOSTRILS
CLINITEST®
Rapid COVID-19 Antigen Test
NOTE: If you are swabbing others, please wear a face mask. With children, you may
not need to insert the swab as far into the nostril. For very young children, you may
need another person to steady the child's head while swabbing.
NOTE: Failure to swab properly may cause false negative results.
IF THE TEST IS INVALID
If at 15 minutes the line next to the “C” does not appear, even if any shade of
pink/red “T” line appears, the test result is invalid. If the test result is invalid,
a new swab should be collected, and the test should be performed again with
a new tube and test device.
IF THE TEST IS NEGATIVE
A negative test result means that protein from the virus that causes COVID-19
was not detected in your sample. If you took this test while you have symptoms,
a negative test result usually means that your current illness was not caused by
COVID-19. However, it is possible for this test to give a negative result that is
incorrect (a false negative) in some people with COVID-19. Negative results do
not rule out COVID-19. This means you could possibly still have COVID-19 even
though the test is negative. 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 with all other aspects of your history such as symptoms
and possible exposures to decide how to care for you.
For example, your healthcare provider may suggest you need another test to
determine if you have the virus causing COVID-19. It is important you work with
your healthcare provider to help you understand the next steps you should take.
If you DO NOT have COVID-19 symptoms and your result is negative, you should
test again with at least 24 hours and no more than 48 hours between tests. If
both your first an second test results are negative, you may not have COVID-19.
Remove the swab from your nostril. Immediately take the tube out of the
tube holder and insert swab tip into the liquid inside the tube. Mix vigorously
by rolling the swab tip at least 6 times on the bottom and sides of the tube.
STEP 2.
READ TEST RESULT
COVID -19 POSITIVE
STEP 6.
IF THE TEST IS POSITIVE
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 it is important to be
under the care of a healthcare provider. It is likely you will be asked to isolate
yourself at home to avoid spreading the virus to others. There is a very small
chance that this test can give a positive result that is incorrect (a false positive).
If you test positive with the CLINITEST Rapid COVID-19 Antigen Self-Test you
should self-isolate and seek follow-up care with your healthcare provider as
additional testing may be necessary. 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.
After 15 minutes find result window, labeled as “C” (for Control) and “T” (for Test)
on the test device. It is important to read your test result at 15-20 minutes.
False negative or false positive results can occur if test results are read before
15 minutes or after 30 minutes.
Below are examples for positive, negative and invalid test results. Used test
materials should be thrown away as household waste.
If the test device looks like the examples below, then protein from the virus that
causes COVID-19 was detected in the sample. The test is positive if there are
two pink/red lines present, one at the Control "C" line and one at the Test "T"
line. Look very closely for line next to "T". This line can be very faint. Any visible
pink/red "T" line is a positive result when the "C" line is also present.
If the test device looks like the example below then protein from the virus that
causes COVID-19 was not detected. You will only see one line next to “C” and
there will not be any line visible next to"T".
If the test device looks like the examples below then the test was not able to
give a result and you must repeat the test with a new swab, a new tube, and
a new test device. The test is INVALID if there is no line next to "C".
Carefully insert swab tip into one nostril about 1/2 to 3/4 of an inch deep.
Do not insert the swab any further if you feel any resistance. Rub the insides of
the nostril in a complete circle at least 5 times. Make sure that you are rubbing
the insides of the nostril. Take approximately 15 seconds to collect the specimen.
Be sure to collect any nasal drainage that may be present on the swab. Remove swab
from the nostril and repeat in your other nostril.
Open the test device pouch by tearing the area circled below.
Place the test device on a flat surface.
OPEN TUBE
Remove the seal from the tube. Avoid spilling the liquid.
Make sure the tube is standing up straight.
CLINITEST®
Rapid COVID-19 Antigen Test
Result
window
Sample
well
5 circles 5 circles
For Emergency Use Authorization (EUA) Only.
In vitro diagnostic use only.
In the USA, this product has not been FDA cleared or approved; but has been
authorized by FDA under an Emergency Use Authorization. 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 non-prescription home use with self-collected anterior nasal swab samples
from individuals aged 14 years or older, or adult-collected anterior nasal swab
samples from individuals aged 2 years or older with symptoms of COVID-19
within the first 7 days of symptom onset. Also for non-prescription home use
with self-collected anterior nasal swab samples from individuals aged 14 years
or older, or adult-collected anterior nasal 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.
PREP
Remove all contents in the box. Read instructions.
STERILE SWAB
TIMER
(not included)
After 1 minute take the tube out of the tube holder.
As you remove the swab from the tube, squeeze swab tip several times from
outside of the tube. Try to release as much liquid from the swab as possible.
Dispose the swab in the trash.
Start timer for 15 minutes.
Do not move the test device. Keep on a flat surface.