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About the patented RVF® Technology

What is COVID-19?

The first cluster of pneumonia cases due to the respiratory illness (COVID-19) caused by the novel SARS-CoV-2 virus was reported in Wuhan, China, in December of 2019. Since then, COVID-19 has been declared a global pandemic, affected more than 2 million people, and caused more than 160 thousand deaths worldwide.
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Invented to detect total antibodies to SARS-CoV-2 and support healthcare providers

SARS-CoV-2 belongs to the Betacoronavirus genus that also includes SARS-CoV and MERS-CoV coronaviruses that caused 2003 and 2012 outbreaks, respectively. How SARS-CoV-2 was transmitted to humans is still unknown, however, some studies suggest that the virus came from bats and was possibly passed to humans through an intermediary host.
The effect of this novel coronavirus on the human body is not well-understood, but SARS-CoV-2 is known to target the angiotensin-converting enzyme 2 (ACE2) on the surface of the cells that subsequently triggers the import of the viral particles. Upon successful invasion, the virus hijacks the cell maintenance machinery and produces more copies of itself. When the newly created SARS-CoV-2 particles are released, they are free to infect neighboring cells throughout the body. ACE2 presented on the surface of lung alveolar cells is the primary target, however, the effect of SARS-CoV-2 on other organs, such as intestine, heart, brain, and kidneys, is still under investigation.

REVEALCOVID-19™ Total Antibody Test

REVEALCOVID-19™ Total Antibody Test detects total antibodies to SARS-CoV-2 present in the human serum, plasma or whole blood samples. Testing should be carried out in certified laboratories or authorized point-of-care sites and performed by the healthcare workers.

REVEALCOVID-19™ Total Antibody Test
IS:
  • Inexpensive, portable device
  • Fast (~3 min) and easy test
DOES NOT REQUIRE
  • Specialized equipment, additional reagents and skillful workers
  • Sophisticated sample preparation
ALLOWS
  • Widespread testing (including asymptomatic patients)
USEFUL IN
  • Follow-up screening
  • Vaccine development

How REVEALCOVID-19™ Total Antibody Test Works?

Packaging Inserts

USA Packaging Insert CE Packaging Insert

Disclaimer

  • This test has not been FDA cleared or approved.
  • This product has not been authorized by FDA under an EUA for use by authorized laboratories.
  • This product is not for self-testing.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
  • Follow-up testing with molecular diagnostics should be considered to rule out infection in these individuals.
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • Test is not intended for the screening of donated blood

“Antibody test results are important in detecting infections with few or no symptoms”

Center of Disease Control (CDC)

The most effective way to prevent infections and save lives is breaking the chains of transmission, and to do that, you must test and isolate. You cannot fight a fire blindfolded, and we cannot stop this pandemic if we don’t know who is infected. … We have a simple message for all countries: test, test, test, test…

World Health Organization director-general Dr. Tedros Adhanom Ghebreyesu

“We know that not everyone infected with COVID-19 has symptoms, so the antibody test is the only way of determining who was exposed and who is now immune. This is a vital tool, particularly when it comes to identifying those with immunity within the health system. Having this test may also help with treatment”

Global News, Canada

“Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of COVID-19 cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness”.

Food & Drug Administration

“The sooner you know if someone’s positive or negative, then the more infection control and outbreak control you can put in place”.

Dr. Anna Banerji. An associate professor at the Dalla Lana School of Public Health at the University of Toronto

“Canada's Chief Public Health Officer of Canada is in close contact with provincial and territorial Chief Medical Officers of Health to ensure that any cases of COVID-19 occurring in Canada continue to be rapidly identified and managed in order to protect the health of Canadians"

Government of Canada

“COVID-19 is a rapidly evolving global health crisis, and we have been working around the clock with provinces and territories to make sure everyone has what they need to continue to detect and interrupt the chain of transmission. Early diagnosis is a critical component, so we are taking extraordinary measures to help make that happen as quickly as possible.”

The Honourable Patty Hajdu, Minister of Health of Canada

"Urgent need for a truly point-of-care rapid test to detect the presence of antibody against coronavirus 2019 (COVID-19)"

Dr. Deborah Birx, the response coordinator for the White House Coronavirus Task Force
 

Useful Links – for up-to-date COVID-19 information

FAQ

1Fact Sheets for Healthcare Providers and Recipients
[PDF] REVEALCOVID-19™ Fact Sheet for Healthcare Providers
[PDF] REVEALCOVID-19™ Fact Sheet for Recipients
2Is REVEALCOVID-19™ Total Antibody Test FDA-approved or cleared?
No, this test is not yet been approved or cleared by the United States FDA. However, REVEALCOVID-19™ Total Antibody Test has been submitted to the FDA and is currently under review for authorization under EUA and is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19.
3What is an EUA?
The Emergency Use Authorization (EUA) is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19. An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective. The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
4Has REVEALCOVID-19™ Total Antibody Test been appropriately validated?
Yes, the test has been validated in accordance with FDA recommendations. The test has been assessed for the following: Limit of Detection, Cross-reactivity with other diseases, Potential Interferences caused by the common therapeutic drugs and abnormal blood chemistry, Clinical Agreement (PPA and NPA).
5Can REVEALCOVID-19™ Total Antibody Test be used as a "sole basis" for diagnosis or exclusion of SARS-CoV-2, virus that causes COVID-19 disease?
No, this test cannot be used to infer the infection status and follow-up testing with a molecular diagnostic should be considered to confirm or rule out infection.
6What does it mean if I have a positive test result?
If you have a positive test result, it is likely that you have or previously had COVID-19 and that you have developed an antibody response to the virus. Your healthcare provider will work with you to determine how best to care for you based on the test results along with other factors of your medical history, symptoms, possible exposures, and geographic location of places you have recently traveled to.
7What does it mean if I have a negative test result?
A negative test result means that the antibodies to the virus that causes COVID-19 were not found in your sample. However, it is also possible that a negative result can be incorrect (false negative) in some people with COVID-19. A negative result may occur if you are tested early in your illness and your body hasn’t had time to produce antibodies to infection. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled to) when deciding how to care for you.
8Can you comment on the price, anticipated quarterly sell-through, and gross profit for this test?
Unit pricing is available through our sales organization. As for sales and gross profit, as is customary, we don’t comment on sales and gross profit by individual product lines.
9Will Rapid Vertical Flow® (RVF) technology platform be feasible to develop other COVID-19 in vitro medical devices, such as antigen test?
MedMira’s RVF® technology platform is very robust and can be transformed to target other SARS-CoV-2-specific analytes (i.e. substance(s) that can be detected using the device). MedMira’s REVEALCOVID-19™ Total Antibody Test is designed to detect total antibodies to SARS-CoV-2 in human specimens. Our product development team continues evaluating other potential SARS-CoV-2-specific analytes to develop new rapid in vitro medical devices, including viral antigen test.
10Most rapid test companies launch separate IgM and IgG tests. Why MedMira’s REVEALCOVID-19™ Total Antibody Test was designed to detect total antibodies?
Limited information is currently available to completely characterize COVID-19 disease. Based on what is known about the virus that causes COVID-19 (i.e. SARS-CoV- 2), signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. According to the preliminary data, the median incubation period is approximately 5 days, but may range anywhere from 2 to 14 days. Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection. Limited scientific evidence is available to definitively tell how long or what class of antibodies to SARS-CoV-2 will remain present in the body after infection. Detection of total antibodies to SARS-CoV-2 may reduce the number of false negative samples identified by the class-specific tests.

Contact us now

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The following options can help direct your inquiries to the right MedMira team

For US and US territories inquires please send your request to:
us@revealcovid19.com
For CE territories inquires please send your request to:
ce@revealcovid19.com
For Canada inquires please send your request to:
canada@revealcovid19.com