SARS-COV-2 ANTIGEN RAPID TEST KITS FOR SELF-TESTING - PERIOS MEDICAL DEVICES
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SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) Marketing@lepu-medical.com
SARS-CoV-2
Antigen Rapid Test Kits for Self-testing
(Colloidal Gold Immunochromatography)
Operating Steps
1 Wash and dry hands. Then take out test card 2 2.Place test card flat on table, remove cover-layer
from outer package. of adhesive.
0197
Home Test
Negative
Positive Negative
Positive
Home Test
Negative
Positive
Test
Home
SARS-CoV-2
Antigen Rapid Test Kits for Self-testing
(Colloidal Gold Immunochromatography)
3 Take out swab from stick-end, refer to standard anterior 4 Insert the swab head into well A from the bottom of
nasal swab specimen collection to collect specimen: well B.
OPEN
2-3cm 2-3cm
X 5 X5 Home Test
Negative
Positive Negative
Home Test
Positive
Negative
Positive
Test
Home
Open swab package
at stick end Swab left Swab right
nasal cavity nasal cavity
Note: Do not touch Note: Sampling in both nasal
the swab head. cavity sample is required.
Keep the card
The nasal swab head should be entirely inserted into the nasal cavity until you feel resistance
flat on table
(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.
Swab
5 5.Add 6 drops of the Sample Treatment Solution to well 6 Fold the left side over, fit two sides together
A. Then rotate the swab for 2 rounds, each direction in completely, start timing.
the buffer.
Keep the card
Home Test
Negative
Positive Test
Negative
Positive
Home
flat on table C
T
Negative
Positive
C
Test
Home
Note: False negative
C T e
Negativ
T
results may occur if Keep the card
Positive
X6 the sample swab is not
drops for Self-testi
ng
flat on table
turned before closing
phy)
-CoV-2
Test Kitsromatogra
SARSRapidImmunoch
Antigen Gold
the test card. (Colloidal
Home
Test
X2
Note: Do not rotate the
Rotate clockwise and swab while dropping
counterclockwise twice the sample
7 7.Wait for the appearance of purple-red line. Test 8 After test, put the test card, swab, and sample treatment
results should be read within 15-20 minutes. solution bottle into outer package and seal it tightly.
Results reading Dispose the bag in waste container according to local
buffer
window laws and regulations.
C
T
C
T
C C
Keep the card
T T
Positive Negative
SARS-C
C C SARS-CoV-2
Antigen
RapidoV-2
(Colloidal
Antigen Rapid Test Kits for Self-testing
Gold Test
T T
(Colloidal Gold Immunochromatography)
Kits
Immunochro
for 0197
Self-testin
flat on table，
matography
Positive Negative g
)
C
T
C C
0197
0197
0197
Do not move
T T
Positive Negative
SARS-CoV-2 15-20 min
Antigen Rapid Test Kits for Self-testing
Antigen Rapid Test Kits for Self-testing
Antigen Rapid Test Kits for Self-testing
the test card
(Colloidal Gold Immunochromatography)
(Colloidal Gold Immunochromatography)
(Colloidal Gold Immunochromatography)
Antigen Rapid Test Kits for Self-testing
(Colloidal Gold Immunochromatography)
SARS-CoV-2
SARS-CoV-2
SARS-CoV-2
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.
Operation Card
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.
Product Feature
Non-invasive Simple to use No prescription needed
S
Rapid, get result in 15 minutes Stable, with high accuracy Inexpensive, cost-efficiency
Clinical performance
The clinical performance study for SARS-CoV-2 Antigen Rapid Test Kit was conducted in Germany. A
total of 222 clinical samples were used to perform the test. The positive and negative samples were
all confirmed by PCR. The diagnostic sensitivity and diagnostic specificity of the product was 95.9%
(90.8-98.2%) and 100% (96.3-100.0%) respectively.
Results with correlation to Ct value of the positive samples were shown in the table below
Ct Value Diagnostic sensitivity 95%CI
≤ 30 96.2 % 88.3-98.7%
≤ 32 96.0 % 90.0-98.4%
≤ 34 95.5% 90.0-98.1%
≤ 36 95.9 % 90.8- 98.2%
Operating Steps
1 Wash and dry hands. Then take out test card 2 Place test card flat on table, remove cover-lay-
from outer package. er of adhesive.
Negative
Positive
Negative
Positive
Home Test
Home Test
Negative
Positive
Test
Home
3 Take out swab from stick-end, refer to standard 4 Insert the swab head into well A from the bottom of
anterior nasal swab specimen collection to collect well B.
specimen:
OPEN
2-3cm 2-3cm
X 5 X 5 Home Test
Positive
Negative
Home Test
Positive
Negative
Positive
Negative
Test
Home
Open swab package Swab left Swab right
at stick end nasal cavity nasal cavity
Note: Do not touch the swab head. Note: Sampling in both nasal cavity sample is required.
The nasal swab head should be entirely inserted into the nasal cavity until you feel resistance Keep the card
(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 flat on table
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.
5 Add 6 drops of the Sample Treatment Solution to 6 Fold the left side over, fit two sides together
well A. Then rotate the swab for 2 rounds, each completely, start timing.
direction in the buffer.
Keep the card
Home Test
Positive
Negative
Home Test
Positive
Negative
flat on table C
Negative
T
Positive
Home
Test
C
Note: False negative
C T e
ativ
Neg
T
Keep the card
itive
results may occur if
Pos
X6 the sample swab is flat on table
drops not turned before
closing the test card.
X2
Note: Do not rotate
Rotate clockwise and the swab while
counterclockwise twice dropping the sample
7 Wait for the appearance of purple-red line. Test 8 After test, put the test card, swab, and sample
results should be read within 15-20 minutes. treatment solution bottle into outer package and seal
Results reading it tightly. Dispose the bag in waste container accord-
window ing to local laws and regulations.
C
T
Keep the card
Positive Negative
SA
An RS
C C tig -C
llo en Ra oV
SARS-CoV-2 (Co
Antigen Rapid Test Kits
for Self-testing
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flat on table,
ch
rom for
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Positive Negative ph sting
y)
0197
0197
0197
Do not move
Positive Negative
SARS-CoV-2 15-20 min
for Self-testing
for Self-testing
for Self-testing
the test card Antigen Rapid Test Kits
(Colloidal Gold Immunochromatography)
(Colloidal Gold Immunochromatography)
(Colloidal Gold Immunochromatography)
for Self-testing
(Colloidal Gold Immunochromatography)
Antigen Rapid Test Kits
Antigen Rapid Test Kits
Antigen Rapid Test Kits
SARS-CoV-2
SARS-CoV-2
SARS-CoV-2
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.
Interpretation of Test Results
·Positive (+): A purple-red band appears in the Control Line (C) and Test Line (T).
Solid Line Faint Line
C Control Line
The bottom line can be
T Test Line
OR very faint Any pink/purple
line visible here is positive.
Positive Positive
·Negative (-): Only the Control Line (C) shows a purple-red band. No purple-red band appears
in the Test Line (T).
C Control Line
Test Line
Negative
·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.
C Control Line
T Test Line
Invalid Invalid Invalid Invalid
Product specifications
1 Test 5 Tests
4. Insert the swab head into
gative
Positive Ne
st
HomeTe
Keep the card flat
table
5. Add 6 drops of the Samp
in the buffer.
tositive Negativ
e
sP
HomeTe sitive Negative
Po
HomeTest
dr
Rotate clockwise and counte
wise twice
6. Fold the left side over, fit
C
T
C
C T e
ativ
Neg
T
itive
Pos
Self y) -testing
V-2Kits foratog
-CoTest raph
SARSRapidImm
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Anti l Gold
(Colloida
e Test
Hom
10 Tests 25 Tests 7. Wait for the appearance o
Results readin
window
Keep the card flat on t
Do not move the test car
Note: False results can occu
Note: False results can occu
8. After test, put the test card
Dispose the bag in medical w
Self-testing Home Test Site Airport Hotel Corporation Mass Screening0123 MDD 93/42/EEC 4. Insert the swab head into well A from the bottom of well B.
Manufacturer 1: Zhejiang Gongdong Medical Technology Co., Ltd.Beicheng Industrial Area 318020
0197 EN Huangyan China
Positive Negative
gative
Positive Ne gative
Positive Ne
st
HomeTe
HomeTest
0197 MDD 93/42/EEC Positive
Negative
SARS-CoV-2
Antigen Rapid Test Kits for Self-testing
(Colloidal Gold Immunochromatography)
Manufacturer 2: Jiangsu Changfeng Medical Industry Co., Ltd. Touqiao Town,Guangling District
Test
Home
SARS-CoV-2 Antigen Rapid Test Kits for Self-testing Yangzhou 225109 Jiangsu China
0197
0197
Positive Nega
(Colloidal Gold Immunochromatography) 0197 MDD 93/42/EEC
Antigen Rapid Test Kits for Self-testing
Antigen Rapid Test Kits for Self-testing
(Colloidal Gold Immunochromatography)
(Colloidal Gold Immunochromatography)
Manufacturer 3: Shenzhen KangDaAn Biological Technology Co., Ltd.Liuxiandong industrial zone,Xili
For In Vitro Diagnostic Use Only street Nanshan district,Shenzhen 518055 Guangdong China
SARS-CoV-2
SARS-CoV-2
Swab Left Nasal Cavity Swab Right Nasal Cavity
[Packing Specifications] 0413 MDD 93/42/EEC
Manufacturer 4: Medico Technology Co., Ltd.Zhangbei Industrial Park, Longcheng Street, Longgang Specimen preservation: After the specimen are collected, please test immediately after sampling. Do not
1 test/kit, 5 tests/kit, 10 tests/kit, 25 tests/kit, 50 tests/kit
district, Shenzhen, 518100 Guangdong, China complete the test over 1 hour. Keep the card flat on
No. Catalogue number Spec. table
0197 MDD 93/42/EEC
1 CG3601 1 test/kit 【Test Method】
2 CG3605 5 tests/kit
Manufacturer 5: Goodwood Medical Care Ltd. 1-2 Floor, 3-919, Yongzheng Street, Jinzhou District, 【Interpretation of Test
3 CG3610 10 tests/kit Dalian 116100 Liaoning, China Please read the instruction for use completely before performing any test, and use the reagents and specimens
· Positive (+): A purple-red band a
4 CG3625 25 tests/kit after returning to room temperature. 5. Add 6 drops of the Sample Treatment Solution to well A. Then rotate the swab for 2 rounds, each direction
5 50 tests/kit Spec. Test card Instruction manual Operation card Sample treatment solution Swabs
CG3650 in the buffer.
1 test / kit 1 test 1 1 300μl×1 1 piece Solid Line
1. Wash and dry hands. Then take out test card from outer package. Keep the card flat on
【Produktname】 5 tests / kit 5 tests 1 1 300 μl×5 5 pieces
10 tests / kit 10 tests 1 1 300 μl×10 10 pieces table C Control Line
SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography) 25 tests / kit 25 tests 1 1 300 μl×25 25 pieces sP
HomeTe
ve
tositive Negati
HomeTest
Po
e
sitvie Negativ
50 tests / kit 50 tests 1 1 300 μl×50 50 pieces 0197
Home
Test
Positive
Negative
T Test Line
OR
【Intended Use】 Note: False negative results may occur
Test card consists of paper shell, test strip, sample well and adhesive tape. The test strip, sample well and
This product is a rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 adhesive tape are attached on the paper shell. if the sample swab is not turned before Positive
nucleocapsid antigens from anterior nasal swabs that are self-collected by an individual aged 18 years or The test strip consists of gold marked pad (coated with gold-marked SARS-CoV-2 N protein mouse anti X6 closing the test card.
A positive test result means that yo
older or are collected by an adult from an individual younger than 18 years old. This test is intended for human monoclonal antibody), sample pad, NC membrane (paired SARS-CoV-2 N protein mouse anti SARS-CoV-2 drops your health care provider of the
use in individuals with symptoms or other epidemiological reasons to suspect a COVID-19 infection. human monoclonal antibody coated on the test line (T) and goat anti-mouse IgG polyclonal antibody coated Antigen Rapid Test Kits for Self-testing diagnosis of COVID-19 and dete
This product is intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. on the quality control line (C)) and absorbing paper. (Colloidal Gold Immunochromatography) X2 Note: Do not rotate the swab while medical history, symptoms and ot
Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen is The main compositions of sample treatment solution include tris, tritonX-100, sodium caseinate. Rotate clockwise and counterclock-
generally detectable in anterior nasal swab specimens during the acute phase of infection. Positive results wise twice dropping the sample ·Negative (-): Only the Control Li
indicate the presence of viral antigens, but the clinical correlation with past medical history and other 【General description】
diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial The SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochromatography)
infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. C Control Line
contains 3 core elements for operation: 6. Fold the left side over, fit two sides together completely, start timing.
Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, ·Test card: Test card which is book-shaped hinged test cardboard containing the test strip (for single use)
for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and Test Line
·Sample Treatment Solution: Bottle containing sample treatment solution (for single use)
should not be used as the sole basis for treatment or patient management decisions including infection ·Nasal Swabs: Sterile swab (for single use) 2. Place test card flat on table, remove cover-layer of adhesive.
Negative
control decisions. Negative results should be considered in the context of a patient’s recent exposures,
history and the presence of clinical signs and symptoms consistent with COVID-19. C
T
A negative test result means that p
Individuals who test negative and continue to experience COVID-like symptoms should seek follow up Positive
Negative
Positive
gative
Ne
C
sample.
HomeTest
st
HomeTe
care from their healthcare provider. Negative
C T
ativ
e
Neg
Negative results are presumptive a
Positive
T
itive
Home
Test
Pos
Keep the card flat on
may be performed. Negative resu
【Introduction】 table
C -testing
history and the presence of clinica
Self y)
Coronavirus, as the broad family of viruses, is a single strand plus RNA virus with an envelope. The virus -Co V-2Kits foratograph
T RSRap
SAgen id Test
Imm
unoc
hrom
·Invalid: If “no purple-red band a
Antioidal
Gold
is known to cause major diseases such as cold, Middle East Respiratory Syndrome (MERS) and Severe (Coll
Hom
e Test
it indicates that the operation proc
Acute Respiratory Syndrome (SARS). The core protein of SARS-CoV-2 is N protein (Nucleocapsid), C C
instruction manual carefully again
which is a protein component inside the virus. It is relatively conservative among β-coronaviruses and is T T
batch of products immediately and
commonly used as a diagnostic tool for coronavirus. As the key receptor for SARS-CoV-2 to enter cells, Positive Negative 1 Sample Treatment Solution(buffer)
ACE2 is significant for the study of viral infection mechanisms.
C
【Principle】
SARS-CoV-2 3. Take out swab from stick-end, refer to standard anterior nasal swab specimen collection to collect specimen: 7. Wait for the appearance of purple-red line. Test results should be read within 15-20 minutes.
T
The current test kit is based on specific antibody-antigen reaction and immunoassay technique. The test Antigen Rapid Test Kits for Self-testing The nasal swab head should be entirely inserted into the nasal cavity until you feel resistance (about 2-3cm), and
(Colloidal Gold Immunochromatography)
strip consists of gold marked pad (coated with gold-marked SARS-CoV-2 N protein mouse anti human gently rotated 5 times. When it was removed, specimen should be taken in the same way in another nasal cavity
monoclonal antibody), sample pad, NC membrane (paired SARS-CoV-2 N protein mouse anti human Invalid Invalid
monoclonal antibody coated on the test line (T) and goat anti-mouse IgG polyclonal antibody coated on 1 Test Card 1 Swab
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
Results reading
the quality control line (C)) and absorbing paper. is recommended for user to insert swab until feel resistance. window 【Limitations of the test
During the test, the N protein in the specimen binds to the gold-marked SARS-CoV-2 N protein mouse 【Material required but not provided】 C
1. The test results of this product sh
T
anti human monoclonal antibody pre-coated on the gold marked pad, and the conjugate moves upward by physicians, and should not be u
Clock or timer or stopwatch, Waste container Keep the card flat on table，
under the capillary effect, and then is trapped by N protein mouse anti human monoclonal antibody C C
2. This product is only used to det
conjugate fixed in the Test Line (T). The higher the N protein content in the specimen, the more conjugates 【Storage Conditions and Validity Period】
OPEN
2-3cm 2-3cm Do not move the test card T
Positive
T
Negative 3. A negative test result may occu
are trapped, and the darker the color of the Test Line (T). If there is no SARS-CoV-2 in the specimen or 4. False negative results may occu
the virus content is below the detection limit, no color appears in the Test Line (T). A purple-red band will 1.The test kit should be stored in a dry and dark place with temperature of 4-30℃, valid for 18 months.
5. Invalid results may occur if ina
appear in the Control Line (C) regardless of whether there is a virus in the specimen. The purple-red band 2.The validity period of the test card is 1 hour after opening its inner package and it is suggested that the storage X 5 X 5 SARS-CoV-2
15-20 min may occur if excessive sample trea
that appears in the Control Line (C) is the criteria for determining whether there is enough specimen and temperature should be 4 ~ 30 ℃ and the humidity should not exceed 70%. Antigen Rapid Test Kits for Self-testing
(Colloidal Gold Immunochromatography) 6. False negative results may occu
whether the chromatography process is normal. 3.The sample treatment solution should be used immediately after opening.
7. False negative results may occu
See package label for date of manufacture and expiration.
8. False negative results are more
【Main Components】 【Specimen Requirements】 9. This test detects both viable (liv
Open swab package at virus (antigen) in the sample and
The product includes test cards, instruction for use, operation card, disposable sterile swabs and sample This test kit is suitable for testing human anterior nasal swab specimens: stick end Note: False results can occur if the card is disturbed/moved. sample.
treatment solution. Each reagent kit contains 1 novel coronavirus (SARS-CoV-2) antigen test card and 1 bag of Specimen collection: During the collection process, relevant personnel should be well protected to avoid direct
desiccant. Swab left nasal cavity Swab right nasal cavity Note: False results can occur if the test results are read before 15minutes or over 20 minutes. 10. The performance of the SARS
contact with the specimen. In case of accidental contact, timely disinfection should be carried out and necessary matography) was evaluated using
Disposable sterile swab information： measures should be taken. 8. After test, put the test card, swab, and sample treatment solution bottle into outer package and seal it tightly. procedures may alter the performa
Nasal Swab could be provided based on customer’s requirement. Anterior nasal swab specimen collection: During sampling, the nasal swab head should be entirely inserted into Dispose the bag in medical waste container according to local laws and regulations. 11. The presence of high concent
the nasal cavity until you feel resistance (about 2-3cm), and gently rotated 5 times. When it was removed, Note: Do not touch the swab Note: Sampling in both nasal cavity sample is
Name Application head. required. results.
specimen should be taken in the same way in the other nasal cavity to ensure the collection of enough
Disposable sterile swab information Nasal swab specimens.
12. Positive test results do not rule out co-infections with other pathogens. Phenylephrine 15% 【Explanation of Symbols】
13. Negative test results are not intended to rule in other non-SARS viral or bacterial infections. Oxazole (nasal spray) 15%
14. Negative results do not rule out COVID-19 infection and it may be necessary to obtain additional testing with Fluticasone 5%
Positive Negative
SAR
SARS-CoV-2
AntigS-C
oV-
(Collo en Rapi a molecular assay, if needed for patient management. Sodium chloride (containing preservatives) 10 mg/mL DO NOT USE IF CONSULT
2
2μg/mL
idal
Gold d Test
Antigen Rapid Test Kits for Self-testing
(Colloidal Gold Immunochromatography)
Immu Kits
nochr for Self-
0197
Beclomethasone PACKAGE IS DAMAGED INSTRUCTIONS FOR USE
omat
ograp testing
hy) 15. Positive test results do not differentiate between SARS-COV and SARS-CoV-2.
Budesonide 4ng/mL
0197
0197
0197
Mometasone 2ng/mL
【Internal Quality Control】
Positive Negative
Strepsils (flurbiprofen 8.75mg) 5%
USE-BY DATE
Antigen Rapid Test Kits for Self-testing
Antigen Rapid Test Kits for Self-testing
Antigen Rapid Test Kits for Self-testing
DO NOT REUSE
The product has a Test Line (T) and a Control Line (C) on the surface of the test card. Neither the Test Line (T)
(Colloidal Gold Immunochromatography)
(Colloidal Gold Immunochromatography)
(Colloidal Gold Immunochromatography)
Throat candy (Mint) 5%
nor the Control Line (C) is visible in the result window before applying a specimen. The control line is used for Naso GEL (NeilMed) 5%
SARS-CoV-2
SARS-CoV-2
SARS-CoV-2
procedural control and should always appear if the test procedure is performed properly and the test reagents of
the control line are working. 3. Clinical performance TEMPERATURE LIMIT DATE OF MANUFACTURER
The clinical performance study for SARS-CoV-2 Antigen Rapid Test Kit was conducted in Germany. A total
【Product Performance Index】
of 222 clinical samples were used to perform the test. The positive and negative samples were all confirmed by
1.Determination of the Limit of Detection PCR. The diagnostic sensitivity and diagnostic specificity of the product was 95.9% (90.8-98.2%) and 100%
【Interpretation of Test Results】 SARS-CoV-2 Antigen Rapid Test Kits limit of detection (LOD) was determined by evaluating different (96.3-100.0%) respectively. MANUFACTURER BATCH CODE
concentrations of inactivated new coronavirus culture medium. Negative natural nasal swab specimens were Results with correlation to Ct value of the positive samples were shown in the table below.
· Positive (+): A purple-red band appears in the Control Line (C) and Test Line (T).
e swab for 2 rounds, each direction eluted in 6 drops of sample treatment solution. 20 Swab eluates were combined and mixed thoroughly to create a
clinical matrix pool to be used as the diluent. Inactivated new coronavirus culture medium was diluted in this Ct Value Diagnostic sensitivity 95%CI
Solid Line Faint Line ≤ 30 96.2 % 88.3-98.7%
d flat on natural nasal swab matrix pool to generate virus dilutions for testing. KEEP AWAY FROM SUNLIGHT KEEP DRY
≤ 32 96.0 % 90.0-98.4%
C Control Line The testing was performed according to the test procedure, with the virus dilutions applied directly onto the Swab
≤ 34 95.5% 90.0-98.1%
The bottom line can be to prepare the contrived nasal swab samples. ≤ 36 95.9 % 90.8- 98.2%
T Test Line
OR very faint Any pink/purple The LOD was determined as the lowest virus concentration that was detected ≥ 95% of the time (i.e., concentra-
tion at which at least 19 out of 20 replicates tested positive). The SARS-CoV-2 Antigen Rapid Test Kits for IN VITRO DIAGNOSTIC
ive results may occur line visible here is positive. CE MARK
Self-testing (Colloidal Gold Immunochromatography) LOD in natural nasal swab matrix was confirmed 200 【Warnings and Precautions】 MEDICAL DEVICE
b is not turned before Positive Positive 0197
rd. TCID50/mL. 1. For in vitro diagnostic use only. The product can be used for self-testing.
A positive test result means that you may have Corona Virus Disease 2019 (COVID-19). It is important to inform 2. Analysis of specificity 2. Do not eat or smoke while handling specimens. AUTHORIZED
your health care provider of the results. Your healthcare provider will work with you to further confirm the 2.1 Cross-reaction: No cross-reactivity was seen with the following microorganisms when tested at the REPRESENTATIVE CATALOGUE NUMBER
diagnosis of COVID-19 and determine how best to care for you based on your test result(s) along with your concentration presented in the table below. 3. The temperature and humidity of the experimental environment should be avoided to be too high, the IN THE EUROPEAN
tate the swab while medical history, symptoms and other related medical tests. reaction temperature should be 15-30°C and the humidity should be below 70%. COMMUNITY
Potential Cross-Reactant Test Concentration
ple ·Negative (-): Only the Control Line (C) shows a purple-red band. No purple-red band appears in the Test Line (T). 4. The packaging bag contains desiccant, do not eat.
Human coronavirus OC43 10 5 TCID50/mL
Human coronavirus 229E 10 6 TCID50/mL 5. It is recommended to test in a well-lit environment.
Human coronavirus NL63 10 5 TCID50/mL
【Basic Information】
C Control Line 6. Before testing, please wash hands or wear clean gloves.
Human coronavirus HKU1 recombinant N protein 50μg/mL
7. Please do not use the test card with damaged card bag packaging, unclear marking or beyond the Beijing Lepu Medical Technology Co., Ltd.
adenovirus 10 6 TCID50/mL
Test Line Building 7-1, No.37 Chaoqian Road, Changping District, 102200 Beijing, China
Human metapneumovirus（hMPV） 10 6 TCID50/mL expiration date.
Tel: +86-10-80123964
MERS coronavirus recombinant N protein 50μg/mL 8. A test card should be used within 1 hour after it is taken out from the aluminum foil bag.
Negative Parainfluenza virus 1 7
10 TCID50/mL
Email: lepuservice@lepumedical.com
Parainfluenza virus 2 10 5 TCID50/mL 9. Users shall take samples according to the instruction manual. Inadequate or inappropriate sample Web: en.lepumedical.com
A negative test result means that proteins from SARS-CoV-2 which causes COVID-19 were not found in your Parainfluenza virus 3 10 6 TCID50/mL collection may yield error results and retesting with a new test may be required. Particular attention
sample. Lepu Medical (Europe) Cooperatief U.A.
Parainfluenza virus 4 10 7 TCID50/mL needs to be paid to appropriate sample collection technique.
Negative results are presumptive and confirmation with a molecular assay, if necessary, for patient management Influenza A 10 6 TCID50/mL Abe Lenstra Boulevard 36, 8448 JB, Heerenveen,The Netherlands
may be performed. Negative results should be considered in the context of an individual’s recent exposures, Influenza B 10 6 TCID50/mL 10. Remove the covering layer of double-sided adhesive to prevent liquid splashing before testing. Tel: +31-515-573399 Fax: +31-515-76002
history and the presence of clinical signs and symptoms consistent with COVID-19. Enterovirus（EV68） 10 7 TCID50/mL 11. Do not drop the dilution buffer into the wrong well.
·Invalid: If “no purple-red band appears in Control Line (C)” and “a blue band appears in the Control Line (C)”,
Respiratory syncytial virus 10 5 TCID50/mL
12. In the process of testing, the test card should be placed on a horizontal table, and it should not be 【Date of Approval and Revision of the Manual】
Rhinovirus 10 6 TCID50/mL
it indicates that the operation process is incorrect or the test paper has been damaged. In this case, please read the Measles virus 10 5 TCID50/mL
moved. Approved on 01th, June, 2021;
instruction manual carefully again and retest with a new test paper. If the problem persists, please stop using this Varicella zoster virus 10 5 TCID50/mL Version number: CE-EN-CG36-In-002 A
13. If the buffer solution makes contact with the skin or eye, wash/ flush with a large volume of water.
batch of products immediately and contact your local supplier. Haemophilus influenzae 107 CFU/mL
If skin irritation, rash or other abnormal reaction occurs, please get medical advice/attention.
Chlamydia pneumoniae 10 6 CFU/mL
Legionella pneumophila 107 CFU/mL 14. Avoid splashing or aerosol formation of specimen and buffer.
C Control Line
Mycobacterium tuberculosis 107 CFU/mL 15.All users have to read the instruction prior to performing a test.
ithin 15-20 minutes. Streptococcus pneumoniae 107 CFU/mL
T Test Line Streptococcus pyogenes 107 CFU/mL 16. Do not mix or interchange different specimens.
Bordetella pertussis 107 CFU/mL 17. Do not mix reagent of different lots or those for other products.
Invalid Invalid Invalid Invalid Mycoplasma pneumoniae 108 CFU/mL
18. To avoid contamination, do not touch the head of provided swab when
Candida albicans 107 CFU/mL
【Limitations of the testing method】 Staphylococcus epidermidis 107 CFU/mL opening the swab pouch.
Staphylococcus aureus 107 CFU/mL 19. To avoid cross-contamination, do not reuse the sterilized swabs for specimen collection.
1. The test results of this product should be combined with other clinical information and comprehensively judged Pneumocystis giraldii 10 6 CFU/mL
by physicians, and should not be used as the only criterion. Staphylococcus salivarius 107 CFU/mL
20. Do not dilute the collected swab with any solution except for the provided extraction buffer.
2. This product is only used to determine the novel coronavirus (SARS-CoV-2) antigen in the specimen. Combined human nasal Lotion / 21. Keep foreign substances away from the test during the testing process. Contact with foreign
3. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test. substances, specifically bleach, may result in an incorrect test result.
4. False negative results may occur if a specimen is improperly collected or handled. 2.2 Interfering substances: No interference was seen with the following substances when tested at the 22. Nasal swabs are not recommended for anyone who is prone to nosebleeds or has had facial or head
5. Invalid results may occur if inadequate sample treatment buffer is used (e.g., 6 drops). injury/surgery in the last 6 months.
6. False negative results may occur if specimen swabs are not twirled within the test card. Potential Interfering substances Test Concentration 23. Patients with severe allergic rhinitis may have false positive results.
7. False negative results may occur if swabs are stored in their paper sheath after specimen collection. Mucin 0.5%
Human whole blood 4% 24. For patients with severe dry nasal mucosa, the sample volume may be insufficient due to the serious
8. False negative results are more likely after seven days or more of symptoms.
9. This test detects both viable (live) and non-viable SARS-CoV-2. Test performance depends on the amount of
HAMA 60 ng/mL shortage of nasal secretions, resulting in inaccurate results.
Biotin 1.2μg/mL 25. Do not refrigerate or use after the expiration date (see packaging bag for expiration date).
virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same
Benzocaine 2 mg/mL
sample. Zanamivir 18μg/mL 26. Dispose of used specimens, test cards and other waste into waste container in accordance with
r over 20 minutes. 10. The performance of the SARS-CoV-2 Antigen Rapid Test Kits for Self-testing (Colloidal Gold Immunochro- Ribavirin 25μg/mL relevant local laws and regulations.
matography) was evaluated using the procedures provided in this product insert only. Modifications to these Lopinavir 20μg/L
to outer package and seal it tightly. procedures may alter the performance of the test. 27. It is suggested that the test should be performed in the company of people with normal vision for
Ritonavir 18μg/mL
ulations. 11. The presence of high concentration mupirocin may interfere with the product and may cause false positive Acetylsalicylic acid 2 mg/dL abnormal color vision users.
results. Ibuprofen 25 mg/dLYou can also read
