Apr 27, 2020:
Avidium Labs and NXT Group Announce COVID-19 Rapid IgG/IgM Blood Test Kits With Results in Minutes Validated with U.S. Laboratories
New York, New York & Las Vegas, Nevada – Avidium Labs in partnership with NXT Group have introduced a rapid IgG/IgM antibody test kit for SARS-CoV-2 also known as COVID-19. The test kit has been validated at it’s international partner facility and with U.S. based laboratories in New York and California. Evan Louie, Chief Executive Officer of Avidium Labs, stated, “We are excited to announce the news to the American public and the world. We have taken additional measures to further validate our results in CLIA certified and full laboratories within the United States. Our team is diligently working on getting our tests to a wide range of healthcare providers such as physician offices, hospitals, and government agencies for rapid results. Avidium labs has already started shipping tens of thousands of their IgG/IgM kits in the United States. We have the capacity to manufacture over 150,000 of our kits per week and have started receiving orders for shipment.”
Avidium Labs has partnered with SUNY Downstate Health Science University – University Hospital of Brooklyn in collaboration with Mirimus laboratory. The validation was performed on moderate to severe hospitalized patients. The research team is under the directorship of Dr. Prem Premsrirut and includes Dr. Rachelle Mendoza, Dr. Allen Norin, and Dr. Jenny Libien working with our Chief Medical Officer Dr. Tom Le. The test kit utilizes a small blood sample that can instantaneously produce results in less than 10 minutes.
SUNY Downstate in New York is currently recognized in the national media as a COVID-19 only facility and has the highest rate of infection per zip code in the United States. New York is the global epicenter of the coronavirus outbreak with more than 200,000 confirmed cases and over 12,000 deaths. Avidium Lab’s results verified by the laboratories demonstrate a high efficacy in detecting IgG/IgM antibodies against SARS-CoV-2 in serum, plasma, or a whole blood samples.
Avidium Labs and NXT Group IgG/IgM test kits are a serology test that can identify the antibodies to the SARS-CoV-2 virus in the patient’s blood. This can help to understand if one has ever been exposed to the SARS-CoV-2 virus. If implemented on a large scale, this serology test would give us a better understanding of the prevalence and fatality rate of the disease.
The serology test can identify people whose bodies have some degree of immune response to the SARS-CoV-2 virus. It can potentially be used to track immunity to SARS-CoV-2. It demonstrates a high efficacy in detecting antibodies against SARS-CoV-2.
Our international partners conducted a comparative study of our rapid IgG/IgM antibody test kit for SARS-CoV-2 against other commercially available SARS-CoV-2 IgG/IgM detection test kits that show a positive coincidence rate of 97.92% and a negative coincidence rate of 100%.
NXT Group in partnership with Avidium Labs has already submitted an application with the Food and Drug Administration (FDA) for both notification and on the Emergency Use Authorization (EUA) track
About SUNY Downstate University:
SUNY Downstate Health Sciences University is the borough’s only academic medical center for health education, research, and patient care, and is a 342-bed facility serving the healthcare needs of New York City, and Brooklyn’s 2.6 million residents, University Hospital of Brooklyn (UHB) is Downstate’s teaching hospital, backed the by the expertise of an outstanding medical school and the research facilities of a world-class academic center. More than 800 physicians, representing 53 specialties and sub-specialties – many of the ranks as tops in their fields – comprise Downstate’ staff. A regional center for cardiac care, neonatal and high-risk infant services, pediatric dialysis, and transplantation. Downstate also houses a major learning center of children with physical ailments or neurological disorders. In addition to UHB, Downstate comprises of a College of Medicine, College of Nursing, School of Health Professions, a School of Graduate Studies, a School of Public Health, and a multifaceted biotechnology initiative, including the Downstate Biotechnology Incubator and BioBAT for early-stage and more mature companies, respectively. For more information, visit www.downstate.edu or follow us on Twitter at @sunydownstate.
About Mirimus, Inc.:
Mirimus, Inc. is a leading biotechnology company located in the Downstate Biotechnology Incubator, specializing in RNA interference and CRISPR/Cas9 gene editing technologies and therapeutic design. Their expertise in molecular and cell biology has enabled them to channel their expertise toward the humanitarian effort and fight against COVID-19. Already, they have initiated the generation of humanized ACE2 and CD147 animal models for COVID-19 research and will make them widely available to researchers.
About Avidium Labs:
The Avidium Labs is a privately held company comprised of healthcare professionals, technology leaders, and business executives from all over the globe bringing you healthcare solutions to enrich lives. We serve clinics, physicians, states, and medical practitioners. Our organization offers world class products, support, and supply chain.
The mission is simple, we serve our global communities with expertise, cutting-edge technologies, and unparalleled service. Avidium Labs’s capacity enables shipment worldwide. Collectively, we strive to mobilize our healthcare solutions to those in need to help curve the COVID-19 epidemic. For more information, please visit www.avidiumlabs.com or email us firstname.lastname@example.org
Avidium Labs Contact:
•This test has not been finally reviewed by the FDA.
•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 a molecular diagnostic 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.
•Not for the screening of donated blood.