FLC | Army assesses foreign-manufactured COVID-19 antibody test kits for US use

Army assesses foreign-manufactured COVID-19 antibody test kits for US use

October 14, 2020

Four organizations in the Army Futures Command have teamed up to purchase and test foreign-manufactured antibody test kits to support the coronavirus pandemic.

When the 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. Now foreign-manufactured antibody test kits are undergoing the same scrutiny.

The team included the U.S. Army Combat Capabilities Development Command (CCDC) Armaments Center; CCDC Chemical Biological Center (CBC); Office of Secretary of Defense (OSD) CCDC Global Technologies Office (GTO); and U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). The team also consulted with the Joint Program Executive Office for Chemical Biological Radiological Nuclear Defense and the Defense Biological Product Assurance Office.

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 of 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 antibody testing,” said Jim Jensen, CCDC CBC engineer.

CCDC Armaments Center stood up an internal COVID-19 working group, which procured the test items. Numerous potential foreign antibody kits were identified, and the team narrowed down the candidates to vendors from China, Canada and South Korea. The selections were based on data and certification, supply chain availability and budget. Test kits from each country were assessed, and the team chose the test kits from Canada to assess again using 58 specimens – 34 negative and 24 positive.

The GTO reached out to CCDC CBC to assess information from the three vendors and develop the project goal, test plan and matrix, as well as an appropriate testing venue. CCDC CBC partnered with USAMRIID, which is 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. The USAMRIID team added value to the data collection by using antibody assays developed in-house in the tests.

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, helps 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 OSD 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.