COVID-19 Rapid Antigen Test (Saliva/Nasal Swab Samples)

(A rapid test for detection of COVID-19 antigen)

Fast & Convenient
Point-of-Care Testing

INTENDED USE
COVID-19 Rapid Antigen Test (Saliva/Nasal Swab) is an immunochromatographic assay designed for the
qualitative detection of specific SARS-CoV-2 antigen in human saliva and anterior nasal swab specimen. It
is intended to be used for the detection of SARS-CoV-2 virus infection. The test is to be used by clinical
laboratories or healthcare workers for point-of-care testing. Home self-testing is subjected to local
legislation. The results obtained should not be the sole determinant for clinical decision.

PERFORMANCE CHARACTERISTICS
A total of 242 saliva/nasal swab samples were tested with COVID-19 Rapid Antigen Test. From these
samples, 57 specimens were confirmed positive by using FDA Emergency Use Authorized real-time RT-
PCR assay. The comparison results are summarized in table below:

PCR Test Total

COVID-19 Rapid Antigen Test Positive Negative Results
Positive 52 0 52
Negative 5 185 190
Total Result 57 185 242

Relative Sensitivity: 91.23% (80.65-96.60%)*

Relative Specificity: 100% (98.26-100%)*
Overall Agreement: 97.93% (95.1-99.25%)* *95% Confidence Interval

REAGENTS AND MATERIALS SUPPLIED MATERIALS REQUIRED BUT NOT

Single Test 2 Tests/ Kit 10 Tests/ Kit SUPPLIED
COVID-19 Rapid Antigen 1 pc 2 pcs 10 pcs 1. Clock or timer
Test cassette individually
sealed in foil pouch with
desiccant
Extraction buffer 1 pc 1 pc 1 pc STORAGE AND STABILITY
Extraction tube and dripper 1 set 2 sets 10 sets Store at 4-30ºC, do not freeze. Keep the
Paper rack 1 pc 1 pc 1 pc test device sealed until used. Keep away
Disposable swab 2 pcs 4 pcs 20 pcs
from direct sunlight, moisture and heat.

Waste bag 1 pc 2 pcs 10 pcs

Instruction for Use (product 1 pc 1 pc 1 pc

insert)

KIT COMPONENTS

Test cassette Extraction Extraction Paper rack Disposable swabs Waste bag IFU (instruction
(sealed in foil pouch) buffer tube and (in sterile packing) for use)
dripper
buffer
SAMPLE COLLECTION AND PREPARATION
Avoid ANY food, drinks, candy, smoking, mouthwash, or other materials in mouth for at least
30 minutes prior to collection.

 Remove one disposable


Place the extraction swab from the sterile
tube on a rack and packaging.
add 6 drops (~150
µl) of extraction Avoid touching any surface
buffer into the tube. or object. Do not touch the
fabric tip of the swab.

Swab 1  
Do not touch the tongue, teeth, gums, or any other surfaces
with the fabric tip of the swab. If it touches anything else, it
may spoil your sample.

Swab 1

Put Swab 1 into

extraction tube
containing buffer.
a) Swab the fabric tip on inside of your left cheek (between the
cheek and the gum) by rubbing up and down for at least 5 times.
b) Repeat step a) above on the right cheek using the same swab.
c) Using the same swab, swab the palate area for 5 times.

Swab 2:  

Do not insert the Swab 2

swab too deep Swab 1
inside the nose.

Remove another disposable swab from the sterile packaging. Avoid

touching any surface or object.
a) Insert only fabric tip of the swab gently into 1 nostril until you feel
a slight resistance (approximately 2 cm up your nose). Put Swab 2 into
b) Roll the swab around the inside of the nostril, making 5 complete the same
circles. extraction tube.
c) Repeat step b) above with the other nostril.

(This step can be a little uncomfortable, but it shouldn’t be painful).

  
Immerse the swab
heads in the extraction Squeeze liquid from both swabs
buffer completely; to keep the solution in the tube
vigorously mix at least as much as possible and then
10 times. discard the swabs.

 

Dispose the used swabs Cover the tube with dripper head
in the waste bag provided and mix the sample solution
and seal the zipper thoroughly.
completely.

Testing should be performed immediately after the specimen has been collected. Do not expose the
specimen at room temperature for prolonged period. Samples are stable up to 30 mins when kept in
the extraction buffer provided with the test kit.

ASSAY PROCEDURE

 

Gently tear open the pouch and remove the test Lay the cassette on a clean, flat work surface.
cassette Label the test cassette with sample name.

 

Read results within 10-15 minutes.

Add 2 drops (~50µl) of the sample solution to the Do not interpret results after 15
sample well. Make sure there is no air bubble. minutes. Not following this procedure
Sample will start wicking up the membrane. can lead to inaccurate results.
INTERPRETATION OF RESULTS

Positive for SARS-CoV-2 Two (2) coloured bands appear, one at the control line
(C) and one at the test line (T). Look closely on (T) line.
Any visible or faint line indicates positive for SARS-CoV-
2 infection.

What you need to do:

 Consult a healthcare professional immediately.
Additional molecular testing such as PCR test may
be required to confirm your result. Your healthcare
professional will determine the best way to care for
you, based on the test results along with medical
history and symptoms.
 You should self-isolate to prevent spreading the virus
to others.

Only one (1) coloured band at the control line (C) is

Negative visible. This indicates that SARS-CoV-2 virus antigen is
not detected. The result does not exclude COVID-19
infection (see the limitations section).

What you need to do:

 If you develop symptoms, please consult your
healthcare professional immediately. Additional
molecular testing such as PCR test may be required
to confirm your result. Your healthcare professional
will determine the best way to care for you, based on
the test results along with medical history and
symptoms.
 You must continue to practice social distancing,
regular handwashing and wear mask.

Invalid

Control line (C) is absent.

What you need to do:

 You should repeat the test by using a new test
cassette.

Once your test is complete, put all of the used test kit contents in a sealed bag and throw in your
general household waste. Wash your hands thoroughly for 20 seconds, using soap and warm
water, or use hand sanitizer.