LOS ANGELES, Oct. 20, 2020 /PRNewswire/ -- The Doc, LLC. (the "Company") today announced the development of a new rapid detection serological antibody test kit for SARS-CoV-2, the virus that causes COVID-19. With results in minutes using only a drop of blood, the Company's IgM/IgG antibody test has been submitted for Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). The Company has already conducted several rounds of clinical trials with patients in Los Angeles, using antibody testing as an accurate and reliable diagnostic tool.
The new test, developed and manufactured in partnership with Teco Diagnostics and Scanwell Health, is designed to be the easiest and fastest solution to conduct private screenings in workplaces, schools and medical offices across the globe. The entire process from blood collection to result can be completed in under 15 minutes. During that time, a visual indicator will appear, similar to an at-home pregnancy test. A licensed professional will be able to advise patients on treatment and isolation immediately after an infection is determined. Rapid antibody detection combined with periodic monitoring can help support decisions to facilitate a return to everyday life, both safely and effectively.
At this critical moment in the global COVID-19 pandemic, rapid antigen testing will help reduce long wait times for PCR testing and also serve as an additional safeguard against false negatives. The detection of IgM antibodies can indicate an active infection within 5-7 days of exposure, while the presence of IgG antibodies signals a later stage of infection and potential immunity. While nearly all patients infected with SARS-CoV-2 will develop a detectable antibody response, existing PCR tests generally only read positive if a person is currently infected and the virus is still present.
Further, it is possible that asymptomatic individuals can produce a negative PCR test and a positive IgM test1, likely caused by a low viral load or an inadequate sample collection. Antibody testing is essential to helping identify individuals who have developed an adaptive immune response to the virus, even if they have never shown or are no longer showing symptoms.
The Company's SARS-CoV-2 (IgM/IgG) antibody test is packaged for individual single-use with all necessary materials provided and no additional equipment needed. The Company has over one million tests currently in production with capacity to scale up to market demand and will be distributed by ETIGroup Med, LLC.
1Long, Q., Liu, B., Deng, H. et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med (2020)
SOURCE The Doc LLC