Siemens Healthineers has announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood, Siemens reported on Monday. 

“As a leader in laboratory diagnostics, Siemens Healthineers designed a high-quality, highly accurate antibody test with the capacity and reach necessary to help address a critical societal need,” said Deepak Nath, PhD, President, Laboratory Diagnostics, Siemens Healthineers.

Siemens noted that test data demonstrated 100 percent sensitivity and 99.8 percent specificity. The total antibody test will allow for identification of patients who have developed an adaptive immune response, which will indicate recent infection or prior exposure. 

Testing will begin immediately. Siemens has shipped more than one million tests to health systems and laboratories. A spike protein on the surface of the SARS-CoV-2 virus will enable the virus to penetrate and infect human cells found in multiple organs and blood vessels. 

The Siemens Healthineers Total Antibody COV2T will detect antibodies to the spike protein. The antibodies are believed to neutralize the SARS-CoV-2 virus and prevent infection. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein within their focus.

“The test targets both IgM and IgG antibodies, which allows for early identification of individuals infected with the virus who have developed an immune response, even if they were asymptomatic or never diagnosed with the disease,” Nath added. 

About Antibody Test Specificity

Tests with high level of specificity yield low false positive rates, which is highly desirable especially when prevalence of disease is low. For example, a test with 99.8 percent specificity, in populations with low disease prevalence (e.g., 5 percent), will yield a positive predictive value (PPV) of 96.5 percent. 

In other words, 96.5 people in 100 testing positive will truly have antibodies. This number only goes up as the disease prevalence increases; for example, in communities with 10 percent of disease prevalence, this test would yield a PPV of 98.3 percent, meaning that 98.3 people in 100 people with positive tests results have antibodies. High-quality antibody testing is vital to accurately assess the prevalence of disease, which varies across the U.S.

The U.S. Small Business Administration has launched the first online Veteran Entrepreneurial Training and Resource Network Streetwise MBA program to provide virtual training for veteran small business owners and their immediate families beginning in August 2020, the administration announced on Friday.

"We're pleased to have the opportunity to continue offering such an impactful program to our veteran small business owners and their families throughout the Northeast," said Larry Stubblefield, associate administrator for SBA's Office of Veterans Business Development. 

President Donald Trump donated $100 thousand from his salary to fund the initiative. SBA’s program will mark the second cohort of the Veteran Owned Small Business Growth Training Pilot Program, following the successful completion of the first cohort in Portsmouth, New Hampshire in March 2020.

The VETRN Streetwise MBA program will be powered by Interise. The program was created exclusively for veterans to provide them with the skills, resources, mentoring and networking necessary to grow their own small business. 

Since the launch, the demand for the VETRN program has increased. The upcoming training will be held virtually. The online program content is designed to help veteran entrepreneurs build operational capacity, increase revenues, manage cash flow and create sustainable jobs. 

VETRN has added classes on crisis management and training on how to work with lending institutions and other stakeholders when facing financial difficulties to address the COVID-19 pandemic.  

The VETRN program is open to veteran-owned businesses that have been in operation at least one year, and generate at least $75 thousand in annual revenues. Exceptions may be considered on a case by case basis.

"Now, more than ever, the SBA is dedicated to finding new and innovative ways to provide virtual support for our veteran-owned small businesses during these trying and unprecedented times," concluded Stubblefield. 

About the U.S. Small Business Administration

The U.S. Small Business Administration makes the American dream of business ownership a reality. As the only go-to resource and voice for small businesses backed by the strength of the federal government, the SBA empowers entrepreneurs and small business owners with the resources and support they need to start, grow or expand their businesses, or recover from a declared disaster. It delivers services through an extensive network of SBA field offices and partnerships with public and private organizations.

The U.S. Space Force plans to establish its headquarters at the Pentagon and phase out the U.S. Air Force Space Command HQ in Colorado Springs next year, SpaceNews reported Thursday.

The Space Force will initially deploy around 200 personnel at its HQ offices ahead of plans to expand its workforce to 16,000. Previously, the Trump administration directed space-related Department of Defense organizations to transition personnel to the new service branch over the next year.

Brig. Gen. DeAnna Burt, director of operations and communications for Space Force, told SpaceNews that the service also plans to establish the Office of the Chief of Space Operations in Washington, D.C.

“The discussion that we’re having right now is where does U.S. Space Command headquarters go?” she said. “The Space Force, the service headquarters, will be in D.C. with all the other service headquarters,”

Dan Brouillette, secretary of the Department of Energy (DOE), has said that the country needs to revive its nuclear-energy industry and increase investments in related research and development efforts.

Brouillette wrote in an opinion piece published Thursday on Defense One that the U.S. must establish nuclear power as a clean, reliable and safe energy source that can drive industrial leadership in areas such as uranium mining, fuel technology and reactor development.

He added that a robust nuclear strategy will help the country strengthen international policy relations through the export of nuclear technologies and fuel sources. Such strategies will also help prevent the proliferation of nuclear weapons and drive U.S. credibility in the global market, Brouilette noted.

“To get back on track, we must revive America’s nuclear energy industry and restore our competitive advantage,” he said. “Ensuring a viable American nuclear industry would further secure future supply chains.”

Previously, the National Nuclear Security Administration reported that the U.S. has sufficient unobligated uranium fuel to support U.S. Navy propulsion systems through the 2050s and tritium production through 2041, according to Brouillette.