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Venture Diagnostic Test offers Medomices COVID-19 -IgM/ IgG Rapid Anti-Body Test
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COVID-19 IgM/IgG
Rapid Antibody Test
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TESTS FOR LIFE
1. Certifications
2. Product Information & Advantages
3. Competitive Product Analysis
4. Overall Protocol
5. Requirements
6. Packaging
7. Summary & Contact
Content
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Product Information
& Advantages
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COVID-19 Antibody
IgM-IgG Combined Antibody Rapid Test
• Packing size: 20 tests/kit
• Specimen type: human serum, plasma, whole blood
sample (capillary or venous)
• Instrumentation: not required
• Detection time: 10-15 minutes
• Storage: Room temperature (2-30°C)
• Shelf Life:12 months
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SARS-COV-2 Serological Diagnostic Test
• Serological tests are to identify antibodies
(IgM, IgG) to SARS-Cov-2 from clinical
specimen.
• Typically, IgM antibodies appear within the
first few days of the onset of symptoms and
lasts for about one month. Detection of IgM
indicates recent exposure to infection.
• IgG antibodies appear one week after the
onset of symptoms and last longer. Detection
of IgG indicates virus exposure some time
ago.
MRM (24 Jan 2019)
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Test Design and Principle
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(1) Colloidal gold-labeled recombinant novel coronavirus antigen and quality control antibody
colloidal gold marker are sprayed on conjugation pads
(2) Test line M is fixed with monoclonal anti-human IgM antibody for detecting the novel
coronavirus IgM antibody. Test line G is fixed with monoclonal anti-human IgG antibody
for detecting the novel coronavirus IgG antibody. The quality control antibody is fixed on
the C line.
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COVID-19 Antibody
IgM-IgG Combined Antibody Rapid Test
• Our CE approved; rapid, point-of-care antibody detection test is one of
the world’s most sensitive tests for COVID-19.
• Detects both early (IgM) and late (IgG) marker antibodies in human finger
prick capillary blood, venous whole blood, serum, and plasma.
• Antibody tests have important public health and clinical uses for monitoring
and responding to the COVID-19 pandemic. It can be used for many
applications in Public Health Surveillance and patients’ health care.
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COVID-19 Antibody Applications:
Antibody testing for COVID-19 has many applications. Antibody testing
determines whether you had COVID-19 in the past and now have antibodies
against the virus. A test to diagnose COVID-19 determines if you currently have
the disease.
• Antibody tests are a great tool to track infection and provide infection time course information.
• Antibody tests are needed before medical procedure done in a hospital or clinic to verify
medical procedure related to COVID-19 infections.
• Antibody tests can be used for screening COVID-19 infection recovered plasma donation and
help treat others who have severe cases of COVID-19.
• Antibody tests can be used as a diagnostic tool to measure how effective your antibodies are in
blocking the virus to help protect you from another COVID-19 infection.
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COVID-19 Antibody
IgM-IgG Combined Antibody Rapid Test
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Combined Sensitivity of 100 %
Combined Specificity of 98.75 %
One of the World’s Most Sensitive Test
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Clinical Agreement Validation Study
IgM-IgG Combined Antibody Rapid Test
• Tests were validated against a panel of previously frozen
samples consisting of 26 SARS-CoV-2 antibody positive (both
IgM and IgG) and 80 antibody negative plasma samples.
• The antibody positive samples were collected from clinically-
confirmed COVID-19 infected patients and the presence of
anti-SARS-Cov-2 antibodies were confirmed with a
chemiluminescent IgM and IgG assay (magnetic particles).
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Clinical Agreement
Validation Study Results
• Within the 26 positive samples, 22
samples tested positive for both
IgM and IgG antibodies by
BioMedomics COVID-19 IgM-IgG
Rapid Test, 4 samples tested
positive for only IgG.
• All 80 negative specimens were
collected from healthy donors and
confirmed SARS-CoV-2 antibody
negative with both the COVID-19
IgM-IgG Rapid Test and the
chemiluminescent IgM and IgG
assay.
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Clinical Agreement
Validation Study Results
• The BioMedomics COVID-19 IgM-
IgG Rapid Test displayed a
combined sensitivity of 100%
(95% CI:86.77%-100%)
• The BioMedomics COVID-19 IgM-
IgG Rapid Test also displayed a
combined specificity of 98.75%
(95% CI:93.23%-99.97%)
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Competitive
Product Analysis
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COVID-19 Antibody
Comparison with Molecular Test
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Serological tests such as BioMedomics’ COVID-19 IgM/IgG-
Rapid Test allows fast screening and confirmation of infection at
scale when used in conjunction with molecular tests.
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COVID-19 Antibody
Sample Collection
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Sample Type Method Storage
Serum Capillary or venous
Short term: 2-8°C for 5 days
Long term: store at -20°C & avoid
repeated freeze/thaw cycles
Plasma Capillary or venous
Short term: 2-8°C for 5 days
Long term: store at -20°C & avoid
repeated freeze/thaw cycles
Whole blood Capillary or venous 2-8°C for 5 days
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COVID-19 Antibody
Instructions
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COVID-19 Antibody
Instructions for Vein Blood Test
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1. Collect blood/serum/plasma sample.
2. Add blood/serum/plasma sample to sample well.
3. Place 2 drops of buffer in sample well.
4. Read results after 10 minutes and no more than 15 minutes.
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COVID-19 Antibody
Results
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A total of three detection lines are possible, with the control
(C) line appearing when sample has been flowed through the
cassette.
1 | Negative Result: If only the quality control line (C)
appears and the detection lines G and M are not visible, then
no novel coronavirus antibody has been detected and the
result is negative.
2 | Positive Result, M only: If both the quality control line (C)
and the detection line M appears, then the novel coronavirus
IgM antibody has been detected and the result is positive for
the IgM antibody.
3 | Positive Result, G only: If both the quality control line (C)
and the detection line G appears, then the novel coronavirus
IgG antibody has been detected and the result is positive for
the IgG antibody.
4 | Positive Result, G and M: If the quality control line (C) and
both detection lines G and M appear, then the novel
coronavirus IgG and IgM antibodies have been detected and
the result is positive for both the IgG and IgM antibodies.
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Internal Quality Control Procedure
IgM-IgG Combined Antibody Rapid Test
• Each Test Cassette device has a built-in control.
• A red colored line in the detection window at the Control line can be considered
an internal positive procedural control.
• The Control line will appear if the test procedure has been correctly
performed.
• If the Control line does not appear, the test is invalid and a new test must be
performed.
• If the problem persists, please contact your local vendor or BioMedomics for
technical support.
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External Quality Control Procedure
IgM-IgG Combined Antibody Rapid Test
• Test performance can be evaluated using the COVID-19 External Control Kit available from
BioMedomics. Follow instructions included in the kit for preparation, use, storage, and
determination of appropriate values.
• Upon confirmation of the expected results, the test is ready to use with patient specimens.
• The COVID-19 External Control Kit includes positive external control. The positive control is
formulated by spiking humanized anti-SARS-Cov-2 antibodies in negative human serum. The
positive control may be reactive to the IgM line, IgG line or both.
• The COVID-19 External Control Kit includes negative human serum as a negative external
control. The negative control will yield an affirmative result (red line) for the control (C) line only,
when the test has been performed correctly and the test device is properly functioning.
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COVID-19 Antibody
Requirements
• Facility requirement: laboratory or healthcare facility
• Intended user: trained healthcare professionals
• Storage: reagent should be stored in the dark at room
temperature (2-30°C). Container should be protected from light
after being opened. Do not freeze.
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Packaging Specification
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Type of Packaging Type of Material
Outer Kit Box Cardboard
Outer Cassette Packaging Foil Pouch
Cassette Plastic
Buffer Bottle LDPE (Low Density Polyethylene)
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Labels
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Outer Carton Label Buffer Label Cassette Label
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COVID-19 IgM/IgG Rapid Antibody Test
Product Summary
• Rapid Point-of-Care Antibody Test
• Detects IgG and IgM antibodies in 10-15 minutes
• Simple to use. No instrumentation required.
• Faster & more affordable than PCR
• Intuitive visual representation
• Offer real time results
• Ships worldwide
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COVID-19 Antigen
SARS-CoV-2 Rapid Test
• Rapid Point-of-Care Antigen Test for Early Infection Detection
• Detects SARS-CoV-2 in less than 15 minutes
• Simple to use. No instrumentation required.
• Faster than PCR
• More Affordable than PCR
• Offer real time results
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OUR PARTNERS
• We have a global network of trusted
distributors at both the regional and
national level.
• Our products are sold in 40+ countries
including Mexico, UK, France, India,
Germany, Japan, China, Chile.
• We provide products to Hospitals,
Government Agencies, NGO’s,
Clinicians, Researchers and more.
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CONCLUSION
• High-Quality Manufacturing: BioMedomics
operates under an ISO-13485 certified quality
system with dual production capacity in both the
USA and China.
• Name Recognition with Established Customers:
BioMedomics has customers in over 40 countries
around the world, serving as a foundation for
current and future global sales and marketing
activities.
• Strategic Relationships with Key Opinion
Leaders: BioMedomics maintains strong
relationships with key opinion leaders around world
to offer support and understand clinical needs,
product design implementation, along with sales
and marketing strategies.
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CONTACTS
Distributor Interest & General Information:
info@biomedomics.com
Quotations & Orders:
sales@biomedomics.com
Customer Service:
custserv@biomedomics.com
Technical Support:
techsupport@biomedomics.com
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