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TestsMed

COVID-19
Testing Solutions
Real Time Rapid
RT-PCR Testing
Rapid Rapid
AntiGen (Ag) AntiBody (Ab)

is your direct access to the biggest South Korean


manufacturers and distributors, specializing in all types of
COVID-19 testing solutions. Our mission is to assist you with
getting the highest quality products, in the most attractive
pricing by ensuring priority in the factories' allocations.
Please contact us at info@testsmed.com
RT-PCR
TestsMed

Real Time
RT-PCR
Real Time Reverse Transcription
Polymerase Chain Reaction

• The current Gold Standard in laboratory methods for detecting,


tracking and studying the COVID-19 coronavirus.
• Suitable for entities with access to laboratories infrastructure
(countries/ hospitals/ other big health organizations).
• Real time RT-PCR is a nuclear-derived method for detecting the
presence of specific genetic material in any pathogen, including
a virus.
• Based on device and test kits used results are obtained after 30
minutes to 3 hours from arrival of collection sample in the lab.
• Requires shipping and storage in a -20o Celsius

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RT-PCR
TestsMed

OVERVIEW
of the procedure
1 Sampling 2 RNA Extraction

3 RT - PCR 4 Result Analysis

The test includes 4 steps:


https://www.youtube.com/watch?v=ThG_02miq-4

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TestsMed RT-PCR

1 SAMPLING
A sample is collected from a person’s nose or throat.

Product
UTM (Universal Transport Medium) and Swab Kits which includes
2 swabs and a test tube with pink viral preservation liquid.

Price Range
$2-$4

Certifications

Capacity
Millions / week

Manufacturers
info@testsmed.com 4
RT-PCR
TestsMed
2 RNA Extraction
(Reactive Nuclear Acid) Extraction
Product
RNA Extraction
Reagent Kit
Proteinase K
Carrier molecule
Binding buffer
Washing buffer
Elution buffer

Price range
$5-$24
(Depending on device used and level of automation)

Certifications

Capacity
Millions / month
(our added value is expediting lead times)

Manufacturers
6
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RT-PCR
TestsMed
3 RT-PCR Kit
Product
RT PCR Reagents kit

Price range
$11-$20

Certifications

Capacity
Millions / month
(our added value is expediting lead times)

Manufacturers
7
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TestsMed

Rapid
Testing
Rapid Rapid
AntiGen (Ag) AntiBody (Ab)

A crucial part of the fight against the spread


of covid-19 is the rapid testing field,
which is used in combination with RT PCR
to provide a more comprehensive answer.

1 2 3

10 min

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Rapid AntiGen
TestsMed

Rapid AntiGen (AG)


• Each category of diagnostic test has its own unique role in the fight against this virus.
• PCR tests can be incredibly accurate, but running the tests and analyzing the results can
take time.
• One of the main advantages of an antigen test is the speed of the test, which can provide
results in minutes. However, antigen tests may not detect all active infections, as they do not
work the same way as a PCR test.
• Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests.
This means that positive results from antigen tests are highly accurate, but there is a higher
chance of false negatives, so negative results do not rule out infection.
• With this in mind, negative results from an antigen test may need to be confirmed with a
PCR test prior to making treatment decisions or to prevent the possible spread of the virus
due to a false negative.

Antigen tests are also important in the overall response against COVID-19 as they can help
better identify infection rates closer to real time.

Certifications

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Rapid AntiGen
TestsMed
Rapid Antigen tests are
performed in Point of Care
• Results in 10-20 minutes
• In some cases detection device needs to be purchased
together with test kits

Test procedure
3 simple steps
1 Insert sterille swab used to
collect the sample into the 2 While squeezing the
tube, pull the swab out 3 Assemble a nozzle and the
extraction tube, and then fill the
extraction tube and swirl 5 times sample well completely with the
sample mixture

5 times
Fill the
sample well
Result
completely

12 minutes

Price range
$6-$15
Certifications

Capacity
Millions / month

Manufacturers
4
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Rapid AntiGen
TestsMed

“Antigen tests will play a critical role in the fight against COVID-19 and we will
continue to offer support and expertise to help with the development of
accurate tests, and to review and monitor marketed tests to ensure accuracy,
while balancing the urgent need for these critical diagnostics.”*

*Source: Statement made on May 9th 2020, by Commissioner of Food and Drugs - Food
and Drug Administration Stephen M. Hahn M.D. and Director - CDRH Offices: Office of
the Center Director Dr. Jeffrey E. Shuren MD, JD

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Rapid AntiBody
TestsMed

Rapid AntiBody (AB)


• Allows detection of SARS-CoV-2 antibodies ( IgM and IgG), that are generated as part of
the human immune response to the virus.
• IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial
infection, although levels over the course of infection are not well characterized.
• IgG antibodies to SARS-CoV-2 become detectable later following infection.
• Positive results for both IgG and IgM could occur after infection and can be indicative of
acute or recent infection.

Rapid AntiBody (AB) is a Serology test which is suitable for the self diagnosis and point of
care market segments.

There is a critical, global need for serology tests that can complement the RT-PCT tests for
diagnosing COVID-19 infection.

Nearly all immune competent individuals will develop an immune response following
SARS-CoV-2 infection. Like infections with other pathogens, SARS-CoV-2 infection elicits
development of IgM and IgG antibodies, which are the most useful for assessing antibody
response as little is known about IgA response in the blood.

PCR tests are only positive during the brief window of acute infection, after which they
become negative.

Serology tests are not as effective as PCR in the early days since onset of symptoms, but
they are able to detect COVID-19 antibodies for a prolonged period after disease resolution,
which enables identification of prior infection. Knowledge of prior infection is
epidemiologically important and represents a significant unmet need in the management of
the COVID-19 pandemic.

1
SARS-CoV-2 is the strain of coronavirus that causes coronavirus disease 2019 (COVID-19)

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Rapid AntiBody
TestsMed

IgM IgM + IgG


Antibody
level

0 days 7 days 14 days 35 days

Days from
onset of symptoms

• Especially important for detecting previous infections in people who had few or no
symptoms.
• Fast and easy to use in Point-of-Care setting or in self diagnosis (similar to how diabetic
patients self test)
• Detect and differentiate IgM/IgG antibody specific to SARS-CoV-2
• Obtain the results as little as 10 minutes

info@testsmed.com
Rapid AntiBody

Rapid Antibody Tests


TestsMed
include 2 types of solutions
1 Point of care (POC)
3 simple steps
1 2 3
Result

12 min

Price range
$8-$20 for kits and
$2,000-$30,000 for the device

Certifications

Capacity
Millions / month

Manufacturers
5
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Rapid AntiBody
TestsMed

2 Self-diagnosis
(retail) solution
1 Add 10uL of the sample 2 Add 1 drop of Assay 3 Read the test results
(whole blood, serum, or Buffer. after 10 minutes.
plasma).

10 minutes

Price range
$6-$20

Certifications

Capacity
Millions / month

Manufacturers
5

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TestsMed

Virus, immune response, test windows


Patient begins to
recover
Onset of
Asymptomatic symptoms
stage

COVID-19 virus / antigen

IgM antibody

IgG antibody

-5 0 5 10 15 20 25 30
Days since the onset of symptoms of COVID-19 infection
Antigen test

Antibody test

Detection rate by days since the onset of symptoms

100 COVID-19 virus RNA

COVID-19 antigen

COVID-19 antibody
Sensitivity (%)

COVID-19 antigen + antibody

50

1 5 10 15 20 25
Days since the onset of symptoms of COVID-19 infection

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TestsMed
Detection rate by days
5.5 day
150
IgM
Positive rate (%)

IgG
100
PCR

50

0 Days after
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Symptom
onset

Detection rate 0-5.5 day 6-13 day › 14 day


PCR › 90% 80 ‹ 50%
IgG/IgM ~ 75% 75.6 ~ 93.1%

5.5 days after symptom onset,


Serology (IgM/IgG) test detection rate is better than PCR positive rate.

Combine of PCR (antigen) + IgM/IgG is best method.

Suggested COVID-19 test guideline for High risk group without symptoms
Ag
test

Pos Neg

PCR
test

Pos Neg

Ab
test

Yes No

Active COVID-19 Convalescence COVID-19 Not COVID-19

Follow up monitoring

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