I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
Different types of Coronavirus Tests
Molecular Test Antigen Test Antibody Test
Also known Diagnostic test, viral test, molecu- Rapid diagnostic test Serological test, serology blood
as: lar test, nucleic acid amplification (some molecular tests are also ra- test, serology test
test (NAAT), RT-PCR test, LAMP pid tests.)
test
Nasal or throat swab Finger stick or blood draw
Sample: Nasal or throat swab (most tests)
Salvia
15 minutes Same day (many locations)
Results: Same day (some locations)
or up to one week
Positive results are highly accura- Sometimes a second antibody test
Is another This test is typically highly accura- te. Negative results may need to is needed for accurate results.
test needed: te and usually does not need to be be confirmed with one more test.
repeated
Diagnoses active Coronavirus in- Shows if you have been infected
What it Diagnoses active Coronavirus in- fection by Coronavirus in the past.
shows: fection
An antigen is a molecule or struc- Antibodies are proteins that the
Definition: Molecular diagnostics is a collec- ture present on the outside of a body‘s white blood cells produce to
tion of techniques used to analyze pathogen. fight infection, which may remain
biological markers in the genome in the blood long after the infec-
and proteome - the individual‘s tion clears.
genetic code and how their cells
express their genes as protein - by
applying molecular biology to me-
dical testing.
 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
Benefits of Antigen Test

SARS-CoV-2 Antigen Rapid Test Kit Introduction

Benefits of Microprofit Antigen Test

• The test provides much faster results (In 15
• minutes)
The test than Molecular
provides Test.results than
much faster
Molecular test (15 minutes).

• • The
Thetest
testdetects
detects the virus directly
the virus atearly
directly at early stage
stage of the infection.
of the infection.
• The test is easy to use and can be used at
home (Colloidal Gold Method).
• The test is easy to use and can be used for hom
• (Colloidal Gold method).
The sensitivity of the Colloidal Gold Test
is close to 90%, specificity of test is close
to 100%.
• TheSensitivity
The sensitivity of Colloidal Gold test is clos
the Fluorescence
of the
90%, Specificity
toImmunoassay Testofist
test is close
over 90%, to 100%.
specifi- The
city of test is close to 100%.
Sensitivity of the Fluorescence Immunoassay
• test over 90%,ofSpecificity
Theisproduction this test isof testand
high is close
it to
can limit the spread of COVID-19 effec-
100%.
tively.
 SARS-CoV-2 Antigen Rapid Test Kit Test Pr
I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
Sampling Collection (Nasopharyngeal swab)

1. Tip the patient‘s head back and collect sample from

the nostril that has more mucus (head should be in-
clined from vertical for proper specimen collection).

2. Insert the swab through the nostril entry and then

slowly move along the bottom of the nasal cavity
(gently to avoid traumatic bleeding).

3. When the tip of the swab reaches the posterior wall

of the nasopharyngeal cavity, gently rotate it sever-
al times (collect as much secretion as possible).

4. To prevent reflex coughing, stop for one minute.

5. Slowly remove the swab.

6. Test the sample as soon as possible.

I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
COLLOIDAL GOLD TEST
 I N T E R N AT I O N A L

SARS-CoV-2 Antigen Rapid Test Kit Test Procedure - (Colloidal Gold)

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
COLLOIDAL GOLD TEST - Procedure

1. Add 300 μL 2. Squeeze the 3. Remove 4. Add 2 drops (about 50 μL)

sample treat- tube and rota- the swab and of sample to the sample hole,
ment solution te the swab 10 load the drop- then wait for 15 minutes for a
to the tube. * times. per lid. reaction (room temperature).

* If disposable plastic pipet is used to get the sample solution, repeat three times (100 μL each time) that in total 300 μL is
added to the tube.
 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
COLLOIDAL GOLD TEST - Procedure

COVID-19 COVID-19 COVID-19 COVID-19

C C C C
T T T T

S S S S

POSITIVE NEGATIVE INVALID

 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
COLLOIDAL GOLD TEST - Clinical Performance

The performance of the kit

has been verified by the Cen-
ters for Disease Control and
Prevention (CDC) in China
using 351 clinical samples
(with PCR results).

Method 2019-nCoV Nucleic Acid Test Kit Total

Results
SARS-CoV-2 Results Positive Negative
Spike Protein Test Kit
Clinical Sensitivity is 88% Positive 45 0 45
(Colloidal Gold Chroma-
Clinical Specificity is 100% tographic Immunoassay) Negative 6 300 306
Total Results 51 300 351

Clinical sensitivity = 45 / 51 =88,24% (95% CI: 76, 13% ~ 95,56%)

Clinical specificity = 300 / 300 = 100% (95% CI: 98,78% ~100%)
Accuracy: (45 + 300) / (45 + 0 + 6 + 300) * 100% = 98,29% (95% CI: 96,32% ~ 99,37%)
Pe: (45 * 51 + 45 * 300) / (351 * 351) = 0,128
Kappa: (Po - Pe) / (1 - Pe) = 0,9276
I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
FLUORESCENCE IMMUNOASSAY TEST
 SARS-CoV-2 Antigen Rapid Test Kit - (Fluorescence Immunoassay)
I N T E R N AT I O N A L

COVID-19
Test Procedure
SARS-CoV-2 Antigen Rapid Test Kit
FLUORESCENCE IMMUNOASSAY TEST - Procedure

1. Add 300 μL 2. Squeeze the 3. Remove 4. Add 3 drops (about 70 μL)

sample treat- tube and rota- the swab and of sample to the sample hole,
ment solution te the swab 10 load the drop- then wait for 15 minutes for a
to the tube. * times. per lid. reaction (room temperature).

* If disposable plastic pipet is used to get the sample solution, repeat three times (100 μL each time) that in total 300 μL is
added to the tube.
 SARS-CoV-2 Antigen Rapid Test Kit - (Fluorescence Immunoassay)
I N T E R N AT I O N A L

SARS-CoV-2
Test Antigen Rapid Test Kit - (Fluorescence Immunoassay)
Procedure
COVID-19 SARS-CoV-2 Antigen Rapid Test Kit - (Fluorescence Immunoassay)
Test Procedure
SARS-CoV-2
TestAntigen
ProcedureRapid Test Kit
FLUORESCENCE IMMUNOASSAY TEST - Procedure

1. Turn on the machine.

Press the [TEST] button on the screen

2. Insert the ID chip

Press [READ ID CARD] and [TEST] button on the screen

3. Take out the cassette and insert it into the analyzer

Press [TEST] and get the result.
Press [PRINT] and print out the result from inner printer.
 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
FLUORESCENCE IMMUNOASSAY TEST - Clinical Performance

The performance of the kit

has been verified by the Cen-
ters for Disease Control and
Prevention (CDC) in China
using 351 clinical samples
(with PCR results).

Method 2019-nCoV Nucleic Acid Test Kit Total

(RT-PCR) Results
SARS-CoV-2 Results Positive Negative
Spike Protein Test Kit
Clinical Sensitivity is 92% Positive 47 0 47
(Fluoescence
Clinical Specificity is 100% Immunoassay) Negative 4 300 304
Total Results 51 300 351

Clinical sensitivity = 47 / 51 =92,16% (95% CI: 81,12% ~ 97,82%)

Clinical specificity = 300 / 300 = 100% (95% CI: 98,78% ~100%)
Accuracy: (47 + 300) / (47 + 0 + 4 + 300) * 100% = 98,86% (95% CI: 97,11% ~ 99,69%)
Pe: (47 * 51 + 47 * 300) / (351 * 351) = 0,13
Kappa: (Po - Pe) / (1 - Pe) = 0,9526
 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
Comparison between
FLUORESCENCE IMMUNOASSAY TEST (with FIA Quantitative POCT Platform)
COLLOIDAL GOLD TEST

Distributor SVAN International Medical

Origin PRC
Product Name SARS-CoV-2 Spike Protein (Antigen) Test Kit
Assay FLUORESCENCE COLLOIDAL
IMMUNOASSAY GOLD ASSAY
Sample Type Nasal Swab / Viral Transport Media (VTM)
Sample Volume 50 / 70 μL
Reaction Time 15 minutes
Package 25 Tests / Box
Specificity 100%
Sensitivity Above 90% 80 - 90%
Number of Operator 1 1
How to Read Results Read from Fluorecare Reader Observe color with eyes
 I N T E R N AT I O N A L

COVID-19
S-CoV-2 Antigen Antigen
SARS-CoV-2 Rapid Test KitTest
Rapid - CEKit
Mark
- CEDeclaration of
Mark Declaration of
SARS-CoV-2
ormity，ISO13485 Antigen
Certificate
Conformity，ISO13485 Rapid Test Kit
Certificate
Declaration of Conformity, ISO13485 Certificate
 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2
SARS-CoV-2 Antigen
Antigen Rapid
Rapid TestTest
Kit - Kit
EC-REP
EC REP CERTIFICATE
CERTIFICATE
SARS-CoV-2 Antigen Rapid Test Kit
EC REP Certificate
 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
Component Information
Packing box
Instructions for use

Extraction Tube
100 μL Pipet
Sample Buffer

Test Kit
*Nasal swab

* Provide optional accessories: Nasal swab.

 I N T E R N AT I O N A L

SARS-CoV-2 Antigen Rapid Test Kit - Packaging Information

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
Shipping Information

25 tests/box, 40 boxes/carton
1000 tests/carton
25 tests / box
40 boxes / carton
1000 tests / carton
Material: corrugated paper
Material: corrugated paper
Size: 570x407x375mm
Size: 570 x 407 x 375 mm
375mm

Net Weight: 17,5 kg

Net weight: 17.5kg19 kg
Total Weight:

Total weight:19kg
 I N T E R N AT I O N A L

COVID-19
SARS-CoV-2 Antigen Rapid Test Kit
Contact

SVAN INTERNATIONAL IMPORT & EXPORT CO. LTD.

3rd Floor, Binjiang Building, No 80 Yangming North Road SVAN GERMANY
Shaoxing, Zhejiang, China Kirchhalde 21
office@svan-international.global 71083 Herrenberg
Tel: +86 (0) 575 8512 8529 Germany
Fax: +86 (0) 575 8513 5705 Tel: +49 (0) 171 521 9011
www.svan-international.global www.svan-medical-care.com