Army tests foreign manufactured COVID-19 antibody test kits
1 / 2 Show Caption + Hide Caption – Dr. Keersten Ricks, USA Medical Research Institute of Infectious Diseases, programs lateral flow reader software to scan a lateral flow test to determine if a sample was positive or negative for COVID-19 antibodies. (Photo Credit: John W. Braun Jr., USAMRIID Visual Information Office) VIEW ORIGINAL
Army tests foreign manufactured COVID-19 antibody test kits
2 / 2 Show Caption + Hide Caption – Lateral flow device cassette shows a sample that tested positive for COVID-19 antibodies. These devices could be used to identify suitable convalescent plasma donors to determine potential immune status based on prior exposure to the virus. (Photo Credit: John W. Braun Jr., USAMRIID Visual Information Office) VIEW ORIGINAL

When the coronavirus pandemic hit earlier this year, the U.S. Army moved into high gear to develop ways to keep Soldiers and the nation safe. Antibody tests, which detect antibodies in the blood of people with an active infection as well as people with few or no symptoms, were important to help understand how the virus was infecting people across the country. Before large scale monitoring of antibody tests could proceed, existing kits had to be tested for reliability and accuracy.

Four organizations in the Army Futures Command teamed up to purchase and test foreign manufactured antibody test kits to support the coronavirus pandemic. The team included the U.S. Army Combat Capabilities Development Command Armaments Center; CCDC Chemical Biological Center; Office of Secretary of Defense CCDC Global Technologies Office; and U.S. Army Medical Research Institute of Infectious Diseases. The team also consulted with the Defense Biological Products Assurance Office, Joint Program Executive Office for Chemical Biological Radiological Nuclear Defense .

The OSD Foreign Comparative Test Program, which is part of the CCDC GTO, provided funding to buy and test foreign manufactured antibody test kits and an electronic reader, which records and shares data electronically. The team’s goal was to provide a cost-effective way to inform the Department of Defense about foreign COVID-19 antibody test kits.

“This was a rapid, agile, short-term collaboration to solve an urgent problem. The partnerships between government, academia and industry led to a cost-effective solution for foreign serology assay testing,” said Janet Jensen, CCDC CBC researcher.

CCDC AC stood up an internal COVID-19 working group, which assessed a variety of technologies related to Personal Protective Equipment, sterilization, diagnostics and advanced manufacturing. The group, at the request of GTO and in cooperation with CBC, procured the test items for CCDC to evaluate. Numerous potential foreign antibody kits were identified, and the team narrowed down the candidates to vendors from China, Canada and South Korea, based on data and certification, supply chain availability and budget.

The GTO reached out to CCDC CBC to assess the marketplace information and develop the project goal, test plan and matrix, as well as an appropriate testing venue. CCDC CBC partnered with CCDC AC and USAMRIID, which is the only partner equipped to test human specimens.

The USAMRIID diagnostic division team procured the human serum specimens and tested the foreign antibody test kits for accuracy, precision and ticket-to-ticket variations. Test kits from each country were tested, and the team chose the test kits from Canada, which were tested again using 58 specimens – 34 negative and 24 positive. The USAMRIID team added value to the data collection by using antibody assays developed in-house in the testing process.

Antibody testing continues to be a priority not only to help understand how the virus spreads, but also as a way to identify convalescent plasma donors. Convalescent plasma, which is donated from people who were sick with the coronavirus, may help people who have the coronavirus recover more quickly.

It is still unclear if people who have contracted the virus will be immune from the disease in the future. It is also unclear how much antibody is needed to provide immunity or how long the protection may last. Large-scale monitoring of the COVID-19 antibody test kits could help answer these questions and help save lives.

The congressionally authorized OUSD FCT Program provides an opportunity for DOD engineers, scientists and program managers to receive funding through a competitive process. The funding can be used to acquire, test and evaluate items and technologies from the industry of allies and other friendly nations that may fill a capability gap and or satisfy an urgent need. The program, which is managed for the US Army, is located in CCDC’s Global Technology Office, encourages international cooperation and helps reduce the DOD's overall acquisition costs.

USAMRIID is a subordinate laboratory of the U.S. Army Medical Research and Development Command that has provided leading-edge medical capabilities to deter and defend against biological threats for more than 50 years.