Walter Reed Evaluation of FirstVue™ HBsAg Rapid Test | First Diagnostic™
Walter Reed Evaluation Identified FirstVue™ HBsAg Rapid Test as Preferred Among Tests Evaluated
FirstVue™ HBsAg Rapid Test demonstrated strong performance in a Walter Reed Army Institute of Research evaluation designed to assess rapid hepatitis B surface antigen testing for blood donor screening in military environments.
First Diagnostic™ Corporation is highlighting an important historical evaluation of the FirstVue™ HBsAg Rapid Test conducted by investigators associated with the Walter Reed Army Institute of Research (WRAIR) and U.S. military blood programs.
The laboratory evaluation, originally reported in 2008 and titled “Laboratory Evaluation of Hepatitis B Rapid Tests for Use in Screening Walking Blood Bank Donors,” examined rapid hepatitis B surface antigen tests for potential use in screening emergency blood donors in deployed military environments. The work was presented in connection with the Advanced Technology Applications for Combat Casualty Care meeting.
Among the six rapid HBsAg tests evaluated, the FirstVue™ HBsAg Rapid Test was identified as the preferred test based on the overall evaluation described in the original announcement.
Strong Performance Reported in the 2008 Evaluation
The evaluation compared selected rapid tests using blood and plasma specimens after an initial review of manufacturer claims and testing with HBsAg-positive samples.
According to the published 2008 announcement, the FirstVue™ HBsAg Rapid Test demonstrated:
- Reported sensitivity of 95.4%
- Reported specificity of 99.7%
- The highest reported sensitivity and specificity among the six rapid tests evaluated in that comparison
- Performance characteristics that resulted in FirstVue™ being identified as the preferred test in the evaluation
These figures should be understood specifically in the context of the 2008 study and the specimens, methodology, and conditions under which that evaluation was conducted. They should not be interpreted as current regulatory claims or universal performance specifications for products marketed today.
Subsequent U.S. military materials also discussed FirstVue in connection with rapid screening of blood donors in deployed environments, demonstrating the broader military interest at the time in rapid infectious-disease screening technologies for emergency blood collection.
Evaluating Rapid Hepatitis B Testing for Walking Blood Banks
The Walter Reed evaluation addressed a highly specialized military medical requirement: screening potential donors participating in walking blood banks.
In deployed or combat environments, emergency transfusion requirements can create circumstances in which rapidly identifying potential infectious-disease risks among prospective blood donors is especially important.
Traditional laboratory testing may not always provide the speed or operational flexibility required in austere environments. Rapid diagnostic technologies therefore represented an important area of investigation for military medicine.
The FirstVue™ HBsAg test was evaluated as a rapid method for detecting hepatitis B surface antigen (HBsAg), a recognized marker used in laboratory testing for hepatitis B virus infection.
The historical evaluation involved investigators and organizations associated with the:
- Walter Reed Army Institute of Research
- Walter Reed Army Institute of Research Division of Retrovirology
- U.S. Military HIV Research Program
- U.S. Army Blood Program
- Army Medical Department Center and School
- Walter Reed military research programs
- Robertson Blood Center
- American Red Cross
Published medical literature subsequently referenced the Walter Reed evaluation of hepatitis B rapid tests for walking blood bank donor screening.
Why Rapid HBsAg Testing Remains Important
Hepatitis B remains a major global health challenge.
According to the World Health Organization’s July 2026 hepatitis B fact sheet, an estimated 240 million people were living with chronic hepatitis B infection in 2024, with approximately 900,000 new infections annually. WHO estimates that hepatitis B resulted in approximately 1.1 million deaths in 2024, primarily from cirrhosis and hepatocellular carcinoma, or primary liver cancer.
Diagnosis is particularly important because hepatitis B cannot reliably be distinguished from other forms of viral hepatitis on clinical presentation alone. WHO states that laboratory confirmation is essential and specifically recognizes HBsAg testing as part of hepatitis B testing strategies.
These continuing global health needs reinforce the importance of developing diagnostic technologies capable of supporting accessible, reliable and efficient testing across diverse healthcare environments.
A History of Rapid Diagnostic Development
The Walter Reed evaluation represents an important milestone in the history of First Diagnostic’s involvement with rapid point-of-care diagnostic technologies.
Today, First Diagnostic™ Corporation focuses on developing and commercializing professional-use rapid diagnostic systems across areas including infectious disease, cardiology, oncology, drugs-of-abuse testing, and women’s health. The company’s platforms combine immunoassay technologies with point-of-care formats designed to support rapid clinical decision-making.
The historical FirstVue™ HBsAg evaluation illustrates a principle that continues to influence the company’s diagnostic-development strategy: a rapid test must deliver more than speed—it must be engineered around analytical performance, usability, reproducibility, and the clinical environment in which testing occurs.
Advancing Point-of-Care Diagnostics
Rapid diagnostic technology has evolved considerably since the original Walter Reed evaluation.
Advances in immunoassay chemistry, lateral-flow architectures, digital readers, analytical controls, manufacturing systems, and data interpretation are expanding the capabilities of point-of-care testing.
First Diagnostic™ continues to pursue diagnostic technologies intended to make clinically relevant testing more accessible across hospitals, laboratories, clinics, physician offices, urgent-care environments and other decentralized healthcare settings.
The company’s development philosophy remains centered on a straightforward objective:
Deliver actionable diagnostic information where and when healthcare professionals need it.
About First Diagnostic™ Corporation
First Diagnostic™ Corporation is a diagnostic medical-device company focused on rapid and point-of-care testing technologies.
The company develops and commercializes professional-use diagnostic platforms addressing important areas of healthcare, including infectious disease, cardiology, oncology, women’s health and drugs-of-abuse testing. First Diagnostic’s approach combines optimized immunoassay chemistry, rapid-test architectures and quality-system controls to support consistent analytical performance and practical point-of-care use.
For additional information about First Diagnostic™ Corporation, its technologies, distribution opportunities and diagnostic product programs, visit FirstDiagnostic.com.
Historical and Regulatory Notice
The Walter Reed evaluation discussed in this article was conducted and reported in 2008. References to test performance, military evaluation, product status, proposed regulatory submissions or commercial activities from the original announcement relate to that historical period.
The information presented here should not be interpreted as a current FDA clearance, FDA approval, Department of Defense endorsement, Walter Reed endorsement, recommendation for clinical use, or current product-performance claim.
Current availability, intended use, regulatory status and product specifications may vary by product and jurisdiction. Healthcare professionals and distributors should rely on the applicable current product labeling and regulatory authorization for the market in which a product is offered.
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Walter Reed Army Institute of Research investigators evaluated the FirstVue™ HBsAg Rapid Test for rapid hepatitis B surface antigen screening of walking blood bank donors. The 2008 evaluation identified FirstVue™ as the preferred test among six rapid HBsAg assays studied.
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FirstVue HBsAg, HBsAg Rapid Test, Hepatitis B Rapid Test, Walter Reed Army Institute of Research, WRAIR, First Diagnostic, Point-of-Care Diagnostics, Rapid Diagnostic Tests, Hepatitis B Screening, Blood Donor Screening, Lateral Flow Diagnostics
