A measurement gap is slowing research, quality assurance, and recovery—here’s how to close it.

Spikeopathy is a clinician-popular umbrella term used to describe suspected spike-protein–mediated biological effects contributing to symptoms seen after SARS-CoV-2 infection (and in some contexts, after exposure to spike via other routes). The mainstream clinical umbrella is Post-COVID-19 condition / PASC (Long COVID), defined by the WHO as symptoms occurring usually 3 months from onset, lasting ≥2 months, not explained by an alternative diagnosis. World Health Organization+1

A core problem remains: patients, researchers, and biologics/blood stakeholders still lack widely deployed, DIRECT quantitative measurement tools for spike antigen burden in relevant human samples—especially in a way that can be integrated into research workflows and quality assurance systems.

Ekklesia Research Group’s quantitative spike assay (RUO) was built to address that measurement gap.

Why “measurement” matters in spikeopathy research

Long COVID/PASC is heterogeneous and multifactorial. Many mechanistic pathways are under investigation (immune dysregulation, viral persistence/reservoirs, endothelial injury, microclotting, autoimmunity, dysautonomia, reactivation of latent viruses, etc.). But across these hypotheses, one recurring research question is:

Is viral material (including spike) persisting, and does it correlate with symptoms, recovery trajectories, or product safety/QC outcomes?

Multiple peer-reviewed studies have reported circulating SARS-CoV-2 antigens (including spike) in subsets of participants months and even years after infection, as well as autopsy studies supporting ongoing inquiry into antigen persistence and its clinical relevance.

Bottom line: whether spike antigen persistence is causal, contributory, or simply a biomarker in specific phenotypes, you can’t responsibly answer these questions at scale without measurement.

What the literature says

1) Spike and other SARS-CoV-2 antigens have been detected post-acute in some cohorts

• A Clinical Infectious Diseases paper reported detection of SARS-CoV-2 spike predominantly in PASC patients up to 12 months after diagnosis (observational biomarker work). OUP Academic+1
• A Lancet Infectious Diseases correspondence and related publications describe post-acute antigenemia in a subset of participants and call for urgent research into mechanisms and implications. The Lancet+2PubMed Central+2
• A large multicohort analysis in Clinical Microbiology and Infection quantified S1, full-length spike, and nucleocapsid in samples collected out to ~14 months post-infection, reporting antigen positivity in a subset and describing symptom prevalence in the cohort. ScienceDirect
• NIH RECOVER seminars/public summaries highlight continuing investigation into persistent antigens and symptom correlation. Recover COVID Research+2Recover COVID Research+2

2) Viral persistence in tissues has been documented in post-mortem studies

A major Nature paper mapped SARS-CoV-2 distribution and reported evidence consistent with systemic infection and persistence for months in some cases. Nature+1

3) Not all data supports the same interpretation—and that’s exactly why measurement matters

Some studies/preprints report spike detection in subsets without evidence of a pathogenic role in post-COVID syndrome, underscoring the need for:

• standardized assays
• reproducible thresholds
• phenotype stratification
• longitudinal sampling
• transparent methods MedRxiv

If you want answers that survive scrutiny, you need tools that survive scrutiny.

The problem: routine labs don’t solve this

Long COVID is often diagnosed clinically after exclusion of other causes, and many routine lab panels are not diagnostic. This is widely acknowledged in both clinical and public-health coverage and is a major driver for biomarker research. Axios

The Solution

Quantitative Spike Protein Measurement (RUO)

What our RUO assay is designed to do

Ekklesia’s RUO spike assay is designed for quantitative measurement of spike-related targets in research workflows, enabling teams to:

• stratify cohorts (e.g., antigen-positive vs antigen-negative)
• track trajectories longitudinally
• correlate burden with symptoms, biomarkers, or product lots
• support contamination-screening questions in donor-derived materials (as appropriate to study design)

What it is not

This assay is labeled For Research Use Only and is not for diagnostic procedures. We do not market it as an IVD or a medical diagnostic test. RUO/IUO labeling and distribution expectations are described by FDA guidance and device labeling policies. U.S. Food and Drug Administration+1

Who this is for

1) Long COVID / PASC research teams & patient-funded studies

If you’re designing observational studies, biobanking protocols, or mechanistic investigations, measurement allows you to move from “theories” to testable, falsifiable hypotheses.

2) Biologics manufacturers & tissue/cell therapy stakeholders

If you maintain a quality system, you already understand: you can’t manage what you don’t measure. Quantitative assays can support research programs exploring contamination hypotheses, lot characterization, and risk assessment.

3) Blood banks, directed donation initiatives, and biorepositories

For organizations pursuing transparency, donor-lot characterization, or investigational screening programs, RUO testing can be integrated into research protocols where appropriate.

4) CROs and academic labs seeking differentiated capability

Offer sponsors something rare: a way to incorporate spike antigen measurement into a serious, publishable program.

Partnership paths

Research Partnership

We co-develop a study plan with your team (IRB pathways, sampling schedule, endpoints, and statistical plan), then operationalize testing. For serious groups: publish methods, reproducibility, and limitations transparently. Integrate our RUO assay into your menu so your sponsors can add it as a module.

Biologics / Repository Collaboration

Lot characterization and targeted research initiatives to answer specific contamination and safety questions. Establish quality assurance for every step in the production and handling of biologics.

Click the Link below to learn how to become a research partner:

References

• WHO. A clinical case definition of post COVID-19 condition by a Delphi consensus (Oct 6, 2021). World Health Organization+1
• Swank Z et al. Persistent circulating SARS-CoV-2 spike is associated with post-acute COVID-19 sequelae. Clinical Infectious Diseases. OUP Academic+1
• Peluso MJ et al. Plasma-based antigen persistence in the post-acute phase of COVID-19. Lancet Infectious Diseases (and related open-access versions). The Lancet+2PubMed Central+2
• Swank Z et al. Measurement of circulating viral antigens post-SARS-CoV-2 infection in a multicohort study. Clinical Microbiology and Infection (2024). ScienceDirect
• Stein SR et al. SARS-CoV-2 infection and persistence in the human body and brain at autopsy. Nature (2022). Nature+1
• NIH RECOVER summaries/seminar materials on persistent antigens and Long COVID symptom correlation. Recover COVID Research+2Recover COVID Research+2
• FDA. Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only (guidance). U.S. Food and Drug Administration+1
• FDA. In Vitro Diagnostic Device Labeling Requirements (RUO statement example). U.S. Food and Drug Administration
• Example of mixed interpretation evidence (preprint): Long-term serum spike protein persistence but no evidence for a role in pathogenesis of PCS (medRxiv, 2024). MedRxiv