Lepu Medical SARS-CoV-2 User manual
SARS-CoV-2
Antigen Rapid Test Kits
(Colloidal Gold Immunochromatography)
for Self-testing
Marketing@lepu-medical.com
Non-invasive Simple to use No prescription needed
Rapid, get result in 15 minutes Stable, with high accuracy Inexpensive, cost-efficiency
Product Feature
S
buffer
Operation Card
Swab
This product is a rapid, lateral flow immunoassay intended for the qualitative detection of
SARS-CoV-2 nucleocapsid antigens from anterior nasal swabs that are self-collected by an individ-
ual aged 18 years or older or are collected by an adult from an individual younger than 18 years old.
This test is intended for use in individuals with symptoms or other epidemiological reasons to
suspect a COVID-19 infection. This product is intended to be used as an aid in the diagnosis of
SARS-CoV-2 infection.
X2
PositiveNegative
HomeTest
PositiveNegative
HomeTest
Positive
Negative
HomeTest
3 4
1 2
Operating Steps
Wash and dry hands. Then take out test card
from outer package.
Take out swab from stick-end, refer to standard anterior
nasal swab specimen collection to collect specimen:
5.Add 6 drops of the Sample Treatment Solution to well
A. Then rotate the swab for 2 rounds, each direction in
the buffer.
Fold the left side over, fit two sides together
completely, start timing.
7.Wait for the appearance of purple-red line. Test
results should be read within 15-20 minutes.
After test, put the test card, swab, and sample treatment
solution bottle into outer package and seal it tightly.
Dispose the bag in waste container according to local
laws and regulations.
Insert the swab head into well A from the bottom of
well B.
2.Place test card flat on table, remove cover-layer
of adhesive.
7 8
5 6
SARS-CoV-2
Antigen Rapid Test Kits for Self-testing
(Colloidal Gold Immunochromatography)
Positive Negative
HomeTest
PositiveNegative
HomeTest
Positive
Negative
HomeTest
Open swab package
at stick end
Note: Do not touch
the swab head.
Note: Sampling in both nasal
cavity sample is required.
OPEN
Swab left
nasal cavity
X5
2-3cm 2-3cm
Swab right
nasal cavity
X5
Keep the card
flat on table
Positive Negative
HomeTest
PositiveNegative
HomeTest
PositiveNegative
HomeTest
Note: False negative
results may occur if
the sample swab is not
turned before closing
the test card.
Note: Do not rotate the
swab while dropping
the sample
Rotate clockwise and
counterclockwise twice
Keep the card
flat on table
Keep the card
flat on table
Positive Negative
HomeTest
Note: False results can occur if the card is disturbed/moved.
Note: False results can occur if the test results are read before
15minutes or over 20 minutes.
15-20 min
Positive Negative
Keep the card
flat on table，
Do not move
the test card
Positive Negative
Positive Negative
0197
0197
0197
0197
0197
X
6
drops
Results reading
window
SARS-CoV-2
AntigenRapid Test Kits for Self-testing
(ColloidalGold Immunochromatography)
SARS-CoV-2
AntigenRapidTest Kits for Self-testing
(ColloidalGoldImmunochromatography)
SARS-CoV-2
AntigenRapidTest Kits for Self-testing
(ColloidalGoldImmunochromatography)
SARS-CoV-2
AntigenRapidTest Kits for Self-testing
(ColloidalGoldImmunochromatography)
SARS-CoV-2
AntigenRapidTestKitsfor Self-testing
(ColloidalGoldImmunochromatography)
SARS-CoV-2
AntigenRapidTest Kits for Self-testing
(ColloidalGoldImmunochromatography)
SARS-CoV-2
AntigenRapidTestKitsforSelf-testing
(ColloidalGoldImmunochromatography)
SARS-CoV-2
AntigenRapidTest Kits for Self-testing
(ColloidalGoldImmunochromat ography)
The nasal swab head should be entirely inserted into the nasal cavity until you feel resistance
(about 2-3cm), and gently rotated 5 times. When it was removed, specimen should be taken in
the same way in another nasal cavity to ensure the collection of enough specimens.
*The length of anterior nasal cavity of users may be different in different regions, 2~3cm is
only for reference. It is recommended for user to insert swab until feel resistance.
C
T
C
T
C
T
C
T
C
T
C
T
C
T
C
T
C
T
C
T
C
T
C
T
3
1 2
Operating Steps
Wash and dry hands. Then take out test card
from outer package.
Take out swab from stick-end, refer to standard
anterior nasal swab specimen collection to collect
specimen:
Wait for the appearance of purple-red line. Test
results should be read within 15-20 minutes.
After test, put the test card, swab, and sample
treatment solution bottle into outer package and seal
it tightly. Dispose the bag in waste container accord-
ing to local laws and regulations.
Place test card at on table, remove cover-lay-
er of adhesive.
7 8
Positive Negative
HomeTest
Positive Negative
HomeTest
Positive Negative
HomeTest
Open swab package
at stick end
Note: Do not touch the swab head.
OPEN
Swab left
nasal cavity
X5
2-3cm 2-3cm
Swab right
nasal cavity
X5
4Insert the swab head into well A from the bottom of
well B.
Keep the card
at on table
Positive Negative
HomeTest
PositiveNegative
HomeTest
PositiveNegative
HomeTest
Note: False results can occur if the card is disturbed/moved.
Note: False results can occur if the test results are read before
15minutes or over 20 minutes.
15-20 min
Keep the card
at on table,
Do not move
the test card
Positive Negative
Positive Negative
0197
0197
0197
0197
X2
Positive Negative
HomeTest
Positive Negative
HomeTest
Positive Negative
HomeTest
Add 6 drops of the Sample Treatment Solution to
well A. Then rotate the swab for 2 rounds, each
direction in the buer.
5
Note: False negative
results may occur if
the sample swab is
not turned before
closing the test card.
Note: Do not rotate
the swab while
dropping the sample
Rotate clockwise and
counterclockwise twice
Keep the card
at on table
X
6
drops
Results reading
window
SARS-CoV-2
Antigen Rapid Test Kits
for Self-testing
(Colloidal Gold Immunochromatography)
SARS-CoV-2
Antigen Rapid Test Kits
for Self-testing
(Colloidal Gold Immunochromatography)
SARS-CoV-2
Antigen Rapid Test Kits
for Self-testing
(Colloidal Gold Immunochromatography)
SARS-CoV-2
Antigen Rapid Test Kits
forSelf-testing
(ColloidalGold Immunochromatography)
SARS-CoV-2
Antigen Rapid Test Kits
for Self-testing
(Colloidal Gold Immunochromatography)
SARS-CoV-2
AntigenRapid TestKits
forSelf-testing
(ColloidalGoldImmunochromatography)
Positive Negative
C
T
C
T
C
T
Positive Negative
C
T
C
T
C
T
Fold the left side over, t two sides together
completely, start timing.
6
Keep the card
at on table
The nasal swab head should be entirely inserted into the nasal cavity until you feel resistance
(about 2-3cm), and gently rotated 5 times. When it was removed, specimen should be taken in
the same way in another nasal cavity to ensure the collection of enough specimens. The
length of anterior nasal cavity of users may be dierent in dierent regions, 2~3cm is only for
reference. It is recommended for user to insert swab until feel resistance.
Note: Sampling in both nasal cavity sample is required.
Interpretation of Test Results
The bottom line can be
very faint Any pink/purple
line visible here is positive.
Positive
Control Line
Test Line
C
T
Positive
Solid Line Faint Line
OR
C
Negative
Control Line
Test Line
C
T
Invalid Invalid Invalid Invalid
Control Line
Test Line
·Positive (+): A purple-red band appears in the Control Line (C) and Test Line (T).
·Negative (-): Only the Control Line (C) shows a purple-red band. No purple-red band appears
in the Test Line (T).
·Invalid: If “no purple-red band appears in Control Line (C)” and “a blue band appears in the
Control Line (C)”, it indicates that the operation process is incorrect or the test paper has been
damaged. In this case, please read the instruction manual carefully again and retest with a new
test paper. If the problem persists, please stop using this batch of products immediately and
contact your local supplier.
Product specifications
Airport HotelCorporation Mass Screening
Test Site
1 Test 5 Tests
10 Tests 25 Tests
HomeSelf-testing
4. Insert the swab head into well A from the bottom of well B.
5. Add 6 drops of the Sample Treatment Solution to well A. Then rotate the swab for 2 rounds, each direction
in the buffer.
6
7. Wait for the appearance of purple-red line. Test results should beread within 15-20 minutes.
8. After test, put the test card, swab, and sample treatment solution bottle into outer package and seal it tightly.
Dispose the bag in medical waste container according to local laws and regulations.
Keep the card flat on
table
PositiveNegative
H
o
me
Test
Posit
HomeTest
PositiveNegative
HomeTest
PositiveNegative
Ho
m
eTest
Rotate clockwise and counterclock
wise twice
X
drops
Positive Negative
Home Test
SARS-CoV-2
AntigenRapid TestKits forSelf-testing
(ColloidalGold Immunochromatography)
Note: False resultscan occurif the card is disturbed/moved.
Note: False resultscan occurif the test results are read before 15minutes or over 20 minutes.
Keep the card flat on table
Do not move the test card
Results reading
window
C
T
C
T
C
T
. Fold the left side over, fit two sides together completely, start timing.
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