National Shift Toward Spike Protein Screening: Why Nearly 20 States Are Expected to Advance Blood & Biologics Safety Legislation in 2026

A Research Use Only Briefing for Clinician-Researchers, Blood Banks, and Biologics Manufacturers

Executive Summary

Why this matters
Across the United States, nearly 20 states have introduced or advanced legislation focused on strengthening biologics safety—specifically through:

• Screening of blood and blood products for COVID-19 spike protein.
• Greater transparency in biologics manufacturing and labeling.
• Segregation or disclosure of donor materials by exposure status.
• State-sponsored research into novel contaminants such as mRNA residues, plasmid DNA, and spike protein.

What’s driving this momentum

• Documented persistence of spike protein months after infection or vaccination.
• Growing concern about pooled donor-derived products such as IVIG and plasma therapeutics.
• Medical freedom advocacy groups supporting patient autonomy and informed consent
• Calls from experts for stricter quality control and contaminant monitoring.

Why this matters for laboratories and manufacturers
Quantitative spike protein testing is rapidly moving from an optional research technique to an essential QA/QC standard—applicable to:

• Donor screening and pool analytics.
• Process validation and lot consistency.
• Compliance with emerging state-level standards for regenerative biologics.

Bottom line
The policy landscape is shifting. States are signaling a clear expectation: modernized safety methods capable of detecting and quantifying spike protein across biologics. Science—not ideology—must provide the tools.

A Quiet but Rapid Policy Shift

Between 2023 and 2025, legislators in a dozen U.S. states—spanning the political spectrum—introduced bills addressing post-COVID biologic safety. Despite differences in language, these initiatives converge on a shared concern: modern biologic therapies, blood supplies, and cell-derived products deserve a new level of analytical clarity.

This mirrors the 1980s blood safety reform—a patchwork of early state actions that ultimately standardized HIV screening nationwide. A comparable inflection point is now emerging around spike protein and related molecular contaminants.

Why States Are Acting

1. Evidence of Persistent Spike Protein
Multiple studies report circulating spike protein or fragments long after infection or vaccination, with links to vascular, immune, and inflammatory changes. For transfusion science, the question is straightforward:
If spike persists in donors, do donor-derived products carry measurable residuals—and how much?

2. The Analytical Gap in Blood Safety
Blood banks currently test rigorously for infectious viruses such as HIV, hepatitis, and West Nile—but no validated methods exist for spike protein, residual mRNA, or plasmid DNA. Legislators view this absence as a correctable scientific blind spot.

3. Pooled Products Magnify Donor Signals
High-volume biologics such as IVIG, plasma fractions, and exosome preparations combine material from thousands of donors. Even low prevalence could concentrate measurable spike burdens. Clinicians have noted post-infusion immune fluctuations and inconsistent responses—observations warranting deeper study, not dismissal.

4. Regenerative Medicine and Contaminant Sensitivity
Leaders in regenerative therapy have emphasized that cell-based systems are highly sensitive to molecular contaminants. Even trace quantities of spike protein, plasmid DNA, or other impurities can alter cell behavior, differentiation, and viability. This recognition is driving demand for advanced screening tools.

Legislative Pathways Emerging

State proposals vary but frequently include:

1. Blood donation transparency: disclosure of spike testing status; patient-directed donor selection.
2. Screening mandates: detection of spike protein, residual mRNA, and DNA impurities.
3. Labeling or segregation protocols: analogous to CMV-negative or irradiated product designations.
4. Research directives: studies on spike persistence, contaminant prevalence, and transfusion outcomes.
5. Manufacturing requirements: standardized contaminant assays for biologics.

Collectively, these initiatives signal an accelerating demand for measurable assurance—evidence-based safety rather than assumption.

Implications Across the Field

Clinicians: expect rising patient inquiries on biologic purity and spike burden. Prepare for quantitative spike assays to inform diagnostic and therapeutic decisions, particularly in long-COVID care.

Blood and Tissue Banks: begin internal validation and method development. Early adoption of spike quantitation enables proactive quality assurance and readiness for future requirements.

Biologics Manufacturers: integrate spike testing into lot release, establish contaminant baselines, and differentiate through “purity-verified” designations—an emerging marker of scientific integrity.

The Scientific Imperative

Policy can raise questions, but only measurement delivers clarity. Our validated research-use-only (RUO) spike assay offers:

• Reliable quantitation across products and donors.
• Lot-to-lot comparability and process validation.
• Population-level data on spike persistence and burden.

Such analytical tools define the next generation of biologics safety—empowering researchers, restoring confidence, and aligning regulation with molecular reality.

Call to Collaboration

Clinics, blood centers, and regenerative medicine laboratories are invited to join the Spike Clarity Research Network to:

• Quantify spike protein levels across donor populations.
• Evaluate biologic and blood product purity.
• Develop standardized screening datasets ahead of regulation.
• Shape the national framework for biologics safety.

The moment calls for leadership, collaboration, and data-driven transparency. Together, we can modernize safety, restore transparency, and build confidence in the next generation of blood and biologic therapeutics.

This is the moment to lead—not wait for legislators and regulators to mandate action...