Genomic sequencing has validated the variant in 30 states and is suspected to be present throughout the domestic US
HOLLYWOOD, FLORIDA, UNITED STATES, December 14, 2021 /EINPresswire.com/ — As of December 13, 2021, genomic sequencing has validated the variant in 30 states and is suspected throughout the domestic US. Due to epidemiological data indicating an increase in infections in South Africa, decreased vaccine efficacy, and potentially increased transmissibility compared to the Delta variant, the World Health Organization (WHO) and the European Center for Disease Prevention and Control classification as a Variant of Concern (VOC). In the United States, there is a nationwide mobilization of the US government and hospital networks in preparation for a potentially massive spike in hospitalizations during the upcoming holiday season.
Clear Health Pass Outlook on the Effectiveness of Vaccine and Anti-Viral?
According to researchers at the WHO, Omicron has 50 mutations, 30 of which are on the surface of the spike protein. These changes represent one of the most dramatic variant mutations to date. (For non-medical readers, proteins are made up of hundreds or thousands of smaller units called amino acids, attached in long chains. 20 different amino acids can be combined to make a protein.) The amino acid chain creates the Covid Protein “Spike” to bind to its host cell via angiotensin-converting enzyme 2 (ACE2). In March 2020, a study entitled "Structure of the SARS-CoV-2 spike receptor-binding domain bound to the ACE2 receptor" demonstrated that ACE2 was the dominant area for receptor binding of antibodies. (For non-medical readers, in this case, a receptor is a molecule in or on the surface of a cell membrane, which response precisely to a particular antibody or other substance.) However, in the case of Omicron, ten of those mutations are within the Spike Protein, which will most likely affect the receptor-binding area. Omicron’s binding area mutations a greater than 15% change in the surface area of the spike protein where monoclonal antibodies bind, given the 3-dimensional nature of the monoclonal antibody receptors, which bind together in a particular manner like a lock and fit into a key. Clear Health Pass's Science Team believes that the overall surface change will inhibit viral neutralization. In essence, the difference in binding receptors will not allow treatments or preventive measures that may severely limit the body’s immune response from a prior infection, monoclonal antibody therapeutics, anti-viral drugs, and potentially current vaccines may have lesser, limited, or potentially no effect on this type of variant.
Clear Health Pass Outlook on the Effectiveness of Current Rapid Antigen Molecular Tests?
Also, the Omicron B.1.1.529 variant may be able to avoid detection all together on several OTC – home and Clinical – Point of Care Test Kits, without a specific redesign of the testing kits to specifically seek biomarkers for this variant or a shared biomarker denoting a Covid infection. Such a test would yield a false negative, meaning that a test result incorrectly indicates a patient’s health status as Clear of Covid, when the patient has an active infection and can spread Omicron B.1.1.529 to others, states John Cataldi, CEO of Clear Health Pass. Dr. Richard Stripp, Chief Science Officer of Cordant Health Solutions, says, “antigen-based screening methods do have value as a front-line, rapid presumptive test that can provide preliminary results concerning Covid 19 infection. However, these tests are subject to both false positive and false negative results and are limited by the very nature of these tests. This may be due to low viral loads in a recently infected individual or a test that has been rendered less effective in detecting infection by new variants such as Omnicron. The worst-case scenario is an asymptomatic, false-negative result (i.e., the infected person but tests negative on a rapid antigen test). To date, at least 50% of new SARS-CoV-2 infections were estimated to have originated from exposure to individuals with infection but without symptoms. This person then becomes a dangerous carrier of the virus with the expected (and likely) dramatic increase in breakthrough infections… such a scenario may have frightening consequences. An effective, comprehensive testing approach would be a solution to reducing the potential for these “super-carriers” from spreading the disease. Such an approach as the Clear Health Pass, which utilizes a multi-variant testing platform, would limit misinterpretation common with currently employed rapid tests. Even a small percentage of false negatives resulting in asymptomatic carriers of the virus could be catastrophic.”
Do the PCR and antigen tests detect infections with the COVID-19 variant Omicron?
On December 6, the FDA listed the Impact of on regarding SARS-CoV-2 Viral Mutations. The FDA list will continue to be updated as additional tests are evaluated. “The Clear Health Pass approach has addressed this issue by specifically adding laboratory-based molecular testing as validation and confirmation of the initial results from tests in the field. Rapid turnaround, susceptible molecular laboratory-based testing (e.g., RT-LAMP, RT-PCR, and genomic testing) would identify false negative (false positive) and the variant present for positive individuals. Results from this multi-variant detection platform would allow for superior early infection identification and more rapid response, thus limiting potential exposures,” states Cataldi.
Clear Health Pass believes:
- Omicron overall surface change will reduce or potentially inhibit viral neutralization
2. Vaccines and boosters should be taken; however, they may be less effective against Omicron. Prior studies have shown that Vaccines may still help reduce long-term hospitalization and mortality.
3. Current Rapid Antigen Tests must use lab or specific testing protocols to reduce false negatives.
About Clear Health Pass™ (CHP):
Clear Health Pass ™ provides a next-generation Rapid Covid & Variant Saliva Test, the antigen of VOCs and Unknown variants. Clear Health Pass ™ is a Portfolio Partner of the Native American Venture Fund (NAVF). Clear Health Pass ™ is a Minority / Veteran Operated Organization in Partnership with Federally Recognized Native American Tribes 25 U.S.C. § 476. Clear Health Pass ™ is starting clinical trials pending pre-qual FDA submittal. For more information on Clear Health Pass ™, visit https://www.navf.net or Call NAVF’s Investor Desk at 212-634-4300 or email Investments@ClearHealthPass.com.
<
p class=”contact” dir=”auto” style=”margin: 1em 0″>John Cataldi
Clear Health Pass
+1 212-634-4300
investment@clearhealthpass.com
Visit us on social media:
Facebook
Twitter
LinkedIn
Other
