Public health policy frequently exposes structural gaps in healthcare delivery. The CDC’s Advisory Committee on Immunization Practices (ACIP) recent mandate to expand post-vaccination antibody testing for Hepatitis B represents a critical inflection point. It signals a shift from an era of assumed immunity to an era of verified immunity—a transition that our current diagnostic infrastructure is ill-equipped to handle.

The Verification Mandate

Despite decades of widespread vaccination, Hepatitis B remains a persistent clinical blind spot. With an estimated 2.4 million Americans living with chronic HBV, and many undiagnosed, the ACIP’s updated guidance is a necessary move toward population-level risk management. However, moving from "assumption of protection" to "diagnostic verification" creates an immediate operational bottleneck. For clinical laboratories and health systems, this is not merely a clinical update; it is a scaling crisis. Incomplete vaccination records, waning immunity, and limited post-vaccination testing continue to complicate prevention efforts, especially in high-risk populations. The ACIP’s updated guidance underscores the need for verification rather than assumption of immunity.

Antibody testing is increasingly recognized as essential for clinical decision-making, guiding booster strategies, and reducing transmission risk. Implementing this guidance, however, reveals longstanding limitations in laboratory workflows.

The Labor-Operational Friction

The mandate for expanded testing arrives as the diagnostic sector faces a historic labor shortage. According to the American Society for Clinical Pathology, high vacancy rates for laboratory professionals have reached a tipping point.

Conventional HBV testing relies on single-analyte assays, requiring separate workflows, additional sample volumes, and significant hands-on time. In a healthcare system focused on "Value-Based Care," the traditional "one-test, one-vial" model is no longer economically or operationally sustainable. Without a shift in diagnostic methodology, well-intentioned policy will inevitably lead to diagnostic friction and delayed patient outcomes.

Targeted Proteomics: A Systemic Solution

Bridging this gap requires a departure from traditional immunodiagnostics toward Targeted Proteomics. By detecting multiple immune markers from a single, low-volume sample, laboratories can consolidate workflows and deliver broader clinical insights without increasing headcounts.

This approach supports a system-level testing model, enabling a single assay to inform multiple public health and clinical decisions. It aligns with key healthcare priorities, including early detection, integrated screening programs, and resource-efficient laboratory operations. From a market perspective, the ability to adapt to policy changes, scale efficiently, and support multiple analytes is increasingly viewed as a differentiator for laboratories and diagnostic platforms.

Case Study: ViraScreen-Core™ and the Future of Screening

The ViraScreen-Core™ assay best illustrates the application of Targeted Proteomics in infectious disease. By detecting antibodies for HBV, HIV-1, HIV-2, and HCV from a single sample, the platform transforms a routine screen into a comprehensive infectious disease profile.

Critically, the move toward non-invasive sampling (utilizing both serum and saliva) addresses the "equity gap" in public health. Non-invasive options reduce logistical complexity and improve compliance in pediatric and community health settings, where traditional phlebotomy acts as a barrier to entry.

The Institutional Path Forward

The ACIP guidance on Hepatitis B is a bellwether for the future of diagnostics. As public health mandates continue to evolve, the value of a diagnostic platform will be measured by its flexibility, scalability, and multi-analyticity.

The gap between policy expectations and diagnostic capacity can only be closed through innovation that prioritizes laboratory efficiency. Targeted proteomics offers that pathway, moving the industry toward a model where comprehensive insight is the standard, not the exception.

About the Author: Dr. Jamie Platt is CEO of Pictor and has more than 20 years of experience in genomics and molecular diagnostics. She has led the development and commercialization of high-complexity diagnostic tests globally and serves on the boards of DxTerity and bioAffinity Technologies. Jamie is a recognized voice in the diagnostics field, focused on advancing clinically meaningful, accessible testing that delivers real-world value for laboratories and health systems. Find her on LinkedIn.

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