WRAIR Diagnostics and Countermeasures Branch Contributions to the COVID-19 Pandemic Response


Globally, the diagnosis of SARS-CoV-2 infection has relied extensively on molecular testing to identify cases, guide isolation and contact tracing, and rationalize infection control measures during the COVID-19 pandemic. The WRAIR Diagnostics and Countermeasures Branch (DCB) plays a critical role in developing, evaluating, and deploying diagnostic technologies to detect and monitor SARS-CoV-2 infections in DoD personnel, their dependents, and U.S. populations.
Within the first year of the pandemic, DCB validated and deployed a laboratory developed assay to confirm the presence of actively replicating virus in SARS-CoV-2 infected personnel. 

This test facilitates medical decision making, specifically return to duty status of military personnel. DCB also validated the performance characteristics of a laboratory-developed test for the quantification of SARS-CoV-2 viral load in infected personnel. Both of these tests were deployed on a commercial high-throughput platform for rapid turn-around of test results.

Results from these tests provide critical data for monitoring SARS-CoV-2 infection, helping to support patient medical management in clinical settings. The use of these laboratory developed tests in U.S. Army clinical diagnostic algorithms decrease Warfighter time away from their units, permitting more rapid re-integration or elimination of COVID-19 isolation and quarantine

While diagnostic testing is critical for detection of SARS-CoV-2 infection, the emergence of novel SARS-CoV-2 variants of concern underscores the need for next-generation vaccines and therapeutics that confer protection against COVID-19. DCB expedited the development and deployment of novel diagnostic assays to quantify SARS-CoV-2 virus in support of vaccine development efforts. Use of SARS-CoV-2 immunoassays to assess immune responses to vaccine candidates in development is critical for down selection of the most effective candidates.

WRAIR efforts to fight this global public health threat involved the development and evaluation of a SARS-CoV-2 Spike trimer ferritin nanoparticle (SpFN) vaccine adjuvanted with Army Liposomal Formulation QS-21 (ALFQ). DCB collaborated with WRAIR’s Emerging Infectious Diseases Branch (EIDB) and a commercial entity, Meso Scale Diagnostics, Inc, to develop a serological approach to evaluate immune responses to COVID vaccine countermeasures against the latest variants of concern in human, nonhuman primate and small animal models.

In addition to supporting WRAIR’s vaccine development, this testing capability has also been leveraged to determine the effectiveness of vaccination with other available COVID-19 vaccines in a population of active-duty U.S. Military personnel. Specifically, DCB tests are being used to assess SARS-CoV-2 vaccine protection against both clinical and subclinical SARS-CoV-2 infection; assess the kinetics and durability of the immune response to SARS-CoV-2 vaccines; and to characterize “breakthrough” infections. This data is critical to understanding the social and epidemiologic factors that may be related to new SARS-CoV-2 infections within vaccinated U.S. Military personnel. In addition, these quantitative tests developed, validated, and deployed by DCB to evaluate experimental SARS-CoV-2 vaccines may be rapidly pivoted for other militarily relevant projects.

In collaboration with commercial partners, DCB also developed a systems approach to pooled SARS-CoV-2 testing that entails the combination of independent specimens into a single sample for testing. The DCB-led study specifically established protocols and defined test characteristics for pooled sample testing of SARS-CoV-2 specimens from symptomatic and asymptomatic U.S. Military personnel for surveillance purposes. Results from DCB’s efforts, which combined five specimens into one test sample (5:1 pooling), maintained high agreement with individual specimen testing while offering substantial high throughput test benefits. These efforts, which were initiated early in the pandemic, expedited, and expanded COVID-19 surveillance testing for the U.S. Military and conserved critically constrained reagents and consumable supplies.

Diagnostic subject matter experts at WRAIR were detailed to DoD and White House Diagnostic Task Forces to facilitate expansion of diagnostic testing capacity for DoD and U.S. populations. These efforts expanded U.S. diagnostic capacity by three- to four-fold throughout the early stages of the pandemic. DCB advisors also served on Operation Warp Speed and U.S. Government Operation working groups for the development of SARS-CoV-2 vaccine and therapeutic countermeasures which helped develop effective tools for virus prevention and intervention.

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Written by: Dr. Sheila Peel and Janice M. Darden
Contributing author: Jamie Livengood