Unique Capabilities Come Together to Assist Hospitals with Equipment
As the U.S. and the world take on the challenge of combating the novel coronavirus, General Atomics (GA) and its affiliates are leveraging their expertise in manufacturing and innovation to meet the urgent needs of our communities. At GA facilities in San Diego and across the country, test kit development, 3D printing of Personal Protective Equipment (PPE) and ventilator component manufacturing are underway to assist in the fight against COVID-19 at a local, state and national level.
GA, Diazyme is offering a COVID-19 Antibody test from blood draws (serum or plasma). Under the FDA’s policy for Public Health Emergency for COVID-19, Diazyme utilized the notification process as outlined in Section IVD of the policy and is now listed on the FDA’s FAQ site dedicated to serological (Antibody) testing. The Diazyme’s sensitive test is run on a fully-automated Diazyme DZ-Lite 3000 chemiluminescence analyzer. Diazyme is already working with multiple clinical laboratories around the country, including the UCSD Medical Center to perform these serological tests. Serological tests are not for sole diagnosis of the COVID-19 disease but are valuable in understanding community spread of the disease.
Diazyme has also notified the FDA of a rapid COVID-19 Antibody test. This point-of-care test requires only a single drop of blood and provides results within 10-15 minutes. Rapid tests tend to be less sensitive than the lab run tests but are easy to use and can be performed at the point-of-care (doctor’s office, community clinics) and is useful in identifying people who may have been exposed to COVID-19, as well as those who have already recovered, but were unaware that they had been infected.
More information about Diazyme’s tests including regulatory statutory statements can be found at http://www.diazyme.com/dz-lite-sars-cov-2
GA, Electromagnetic Systems (GA-EMS) group is pursuing component manufacturing and integration services to help scale up production of ventilators. With extensive manufacturing facilities located across the U.S., GA-EMS provides a convenient, US-sourced option to help companies rapidly increase their production capacity to meet the high demand for critical medical equipment. GA-EMS has also tested their first generation mechanized bag valve mask. The system would fit into a backpack and could replace human interaction with the bag enabling more controlled and repeatable tides for infants, children and adults.
GA-EMS, GA-Energy group, and GA-ASI adapted their prototyping and production capacities to produce 3D-printed face shields to meet local demand for PPE. Since late March, the joint team has manufactured and shipped over 5,000 face shields in the greater San Diego area and across the nation.
GA-EMS is accelerating the development schedule of its MATCHBOX™ Point-of-Care molecular diagnostic platform responding to the growing need for COVID-19 testing. MATCHBOX is expected to have the capability to test and diagnose for a wide range of known respiratory infections, including COVID-19, within 30-60 minutes using a single patient sample using a portable point-of-care instrument.
“The health, safety and well-being of our employees and our communities at large is a top priority for GA,” said Neal Blue, GA Chairman and CEO. “GA has been delivering solutions in support of public health for decades, and with so many in need during this unprecedented time, we have concentrated our collective efforts to address the current pandemic. I salute colleagues as they continue to innovate and look for creative solutions to the current crisis.”