Professional Documents
Culture Documents
COVID-19
Testing Solutions
Real Time Rapid
RT-PCR Testing
Rapid Rapid
AntiGen (Ag) AntiBody (Ab)
Real Time
RT-PCR
Real Time Reverse Transcription
Polymerase Chain Reaction
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RT-PCR
TestsMed
OVERVIEW
of the procedure
1 Sampling 2 RNA Extraction
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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
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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)
1 2 3
10 min
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Rapid AntiGen
TestsMed
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) 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
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
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Rapid AntiBody
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
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
COVID-19 antigen
COVID-19 antibody
Sensitivity (%)
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
Suggested COVID-19 test guideline for High risk group without symptoms
Ag
test
Pos Neg
PCR
test
Pos Neg
Ab
test
Yes No
Follow up monitoring
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