COVID-19 IgG / IgM Rapid Test
On March 16th, 2020 the U.S. government took steps towards Coronavirus Disease (COVID-19) testing by allowing developers of certain tests to distribute the products in the U.S. without the requirement for an FDA approval or Emergency Use Authorization (EUA).
On May 4th, 2020 the “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)” was published by the FDA. https://www.fda.gov/media/135659/download
Per FDA statement of 04/07/20, “serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection, like COVID-19. In other words, the test detects the body’s immune response to the infection caused by the virus rather than detecting the virus itself. In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. Serological tests can play a critical role in the fight against COVID-19 by helping healthcare professionals to identify individuals who have overcome an infection in the past and have developed an immune response. In the future, this may potentially be used to help determine, together with other clinical data, that such individuals are no longer susceptible to infection…” https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-serological-tests
IgM and IgG may be helpful biomarkers to make determinations of a patient’s immune status, whether or not they are contagious, recovering, etc. The presence of IgG could mean that the patient has mounted an immune response following exposure to SARS-CoV-2. These individuals may also have been asymptomatic and never tested, or may have had mild symptoms that passed.
This is not an at-home test.
We have partnered with a manufacturer of COVID-19 IgG/IgM Rapid Test Kits that are used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. These COVID-19 kits have been recently authorized by the FDA under an Emergency Use Authorization (EUA). Per the FDA, the intended use of the kits are to aid in identifying individuals with an adaptive immune response to SARS-CoV-2 (the virus that causes COVID-19) indicating recent or prior infection.Furthermore, our exclusive CLIA laboratory partner created a proprietary, FDA approved system that allows us to sell these tests to point-of-care facilities under a legal CLIA Umbrella. This compliant umbrella facilitates reporting requirements of test results to government agencies and allows us to provide unparalleled customer service and the ability to sell to urgent care facilities, pharmacies, independent medical practices, selected third party administrators with medical professionals, hospitals, nursing homes, in house clinics for employers and self-insured organizations, patient service centers and more. Per the FDA test use classification, other distributors are only able to offer these test kits to moderate-high complexity laboratories.
- Our Rapid Test Kits are not only authorized for use by the FDA under an Emergency Use Authorization (EUA),
- But validated by BOTH the World Health Organization (sensitivity & specificity)
- And the NCI (National Cancer Institute).
- Additionally, the kits have received the CE certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
- We are in constant communications with the FDA, HHS, CDC and CLIA in order to assure we are adhering to all guidelines. To us, it is very important to stay ahead of what is asked by the reporting agencies.
PERSONAL PROTECTIVE EQUIPMENT (PPE)
Since the outbreak of COVID-19, we have partnered directly with PPE manufacturers to help get frontline workers the protection they need. We know that obtaining PPE right now is difficult and we want to extend our resources to assist you.
We have access to:
- Surgical masks (3-ply)
- Face shields
- Bulk sanitizer
If you are an entity in need, and able to order in large quantities,
please contact us for more information.
For questions, or to place an order,
please fill out the below form.