SCF-ECCA-PV-BIO-0003
Post-Viral / Long COVID Encephalopathy Biomarker Panel
Viral Neuroimmune Connectomic Collapse Validation System
FDA-Aligned Endpoint Framework for Precision Acupuncture Planning
Regulatory note: Long COVID currently has no approved laboratory diagnostic test; diagnosis remains clinical, supported by history, examination, and directed testing to exclude or characterize other conditions. CDC states no lab test can definitively diagnose or rule out Long COVID. The panel below is therefore an endpoint-validation and predictive-forecasting framework, not a standalone diagnostic test.
I. SCF Biomarker Domains
Domain | Purpose |
Viral/Immune History | Confirms post-infectious context |
Neuroimmune Activation | Tracks cytokine-glial inflammatory drift |
Neuroaxonal/Glial Injury | Measures neuronal and astrocytic injury |
BBB/Endothelial Integrity | Assesses neurovascular dysfunction |
Autonomic Function | Quantifies dysautonomia/POTS-like physiology |
Mitochondrial/Bioenergetic Status | Measures ATP-redox collapse |
Coagulation/Endothelial Stress | Screens thromboinflammatory burden |
Connectomics | Measures brain-network synchronization |
Cognitive Function | Tracks brain fog and functional impairment |
Acupuncture Forecasting | Maps biomarker pattern to neurocircuit selection |
II. Viral / Immune Context Panel
Biomarker | FDA-Aligned Assay | Baseline | Mild Risk | Moderate Risk | Severe Risk |
SARS-CoV-2 PCR/NAAT | FDA-authorized NAAT | Negative | Prior positive history | Persistent/recurrent positivity | Active infection |
SARS-CoV-2 Nucleocapsid IgG | EUA/CLIA serology | Negative | Prior exposure | Strong positive | Interpret with clinical context |
SARS-CoV-2 Spike IgG | EUA/CLIA serology | Vaccine/infection dependent | Elevated | High | Not diagnostic alone |
EBV VCA IgM / EA-D | CLIA serology | Negative | Borderline | Positive | Strong positive |
CMV IgM / PCR | CLIA serology/PCR | Negative | Borderline | Positive | High viral load |
Endpoint: Post-Viral Immune Context Score (PVICS)
III. Neuroimmune Activation Panel
Biomarker | Assay | Baseline | Mild | Moderate | Severe |
IL-6 | Multiplex immunoassay | <2 pg/mL | 2–10 | 10–50 | >50 |
TNF-α | Multiplex immunoassay | <5 pg/mL | 5–15 | 15–30 | >30 |
IL-1β | Multiplex immunoassay | <1 pg/mL | 1–5 | 5–15 | >15 |
IL-8 | Multiplex immunoassay | Lab reference | >1 SD | >2 SD | >3 SD |
hsCRP | FDA-cleared immunoassay | <1 mg/L | 1–3 | 3–10 | >10 |
Endpoint: Neuroimmune Activation Score (NIAS)
IV. Neuroaxonal / Glial Injury Panel
Biomarker | FDA-Aligned Assay | Baseline | Mild | Moderate | Severe |
NfL | Simoa / CLIA LDT | <10 pg/mL | 10–20 | 20–50 | >50 |
GFAP | Simoa / immunoassay | <120 pg/mL | 120–250 | 250–500 | >500 |
UCH-L1 | FDA-cleared TBI-context assay / CLIA | <100 pg/mL | 100–200 | 200–400 | >400 |
Total Tau | Simoa / CLIA LDT | <2 pg/mL | 2–4 | 4–8 | >8 |
NSE | CLIA immunoassay | <12 ng/mL | 12–18 | 18–25 | >25 |
Regulatory note: GFAP and UCH-L1 have FDA-cleared use in specific mild TBI contexts, not as Long COVID diagnostics.
Endpoint: Neuroglial Injury Index (NGII)
V. BBB / Neurovascular Integrity Panel
Biomarker | Assay | Baseline | Mild | Moderate | Severe |
S100B | Immunoassay | <0.1 ng/mL | 0.1–0.2 | 0.2–0.5 | >0.5 |
MMP-9 | ELISA / CLIA LDT | <150 ng/mL | 150–250 | 250–400 | >400 |
VEGF | Immunoassay | Lab reference | >1 SD | >2 SD | >3 SD |
vWF Antigen | Coagulation immunoassay | Lab reference | Elevated | High | Very high |
Albumin Quotient | CSF/serum | <6.5 | 6.5–8 | 8–12 | >12 |
Endpoint: Neurovascular Permeability Index (NVPI)
VI. Autonomic Dysfunction Panel
Biomarker / Endpoint | Assay | Baseline | Mild | Moderate | Severe |
HRV SDNN | ECG/validated wearable | >100 ms | 80–100 | 50–80 | <50 |
RMSSD | ECG/validated wearable | >30 ms | 20–30 | 10–20 | <10 |
Orthostatic HR Rise | Active stand / tilt table | <20 bpm | 20–30 | 30–40 | >40 |
Orthostatic BP Drop | Tilt / active stand | None | Mild | Symptomatic | Syncope-risk |
COMPASS-31 | Validated questionnaire | <10 | 10–25 | 25–45 | >45 |
Endpoint: Post-Viral Autonomic Collapse Index (PV-ACI)
VII. Mitochondrial / Bioenergetic Panel
Biomarker | Assay | Baseline | Mild | Moderate | Severe |
Lactate | Clinical chemistry | 0.5–2.0 mmol/L | 2–3 | 3–5 | >5 |
Pyruvate | LC-MS/MS | Lab reference | Elevated | High | Very high |
Lactate/Pyruvate Ratio | LC-MS/MS | <20 | 20–30 | 30–40 | >40 |
Acylcarnitine Profile | LC-MS/MS | Normal | Mild shift | Moderate shift | Severe shift |
ATP Production Rate | Seahorse / RUO | Normal | ↓10% | ↓25% | ↓50% |
Endpoint: Post-Viral Bioenergetic Failure Index (PV-BFI)
VIII. Coagulation / Endothelial Stress Panel
Biomarker | Assay | Baseline | Mild | Moderate | Severe |
D-dimer | FDA-cleared coagulation assay | <0.5 µg/mL FEU | 0.5–1.0 | 1–2 | >2 |
Fibrinogen | Coagulation assay | 200–400 mg/dL | 400–500 | 500–700 | >700 |
vWF Antigen | Immunoassay | Lab reference | Elevated | High | Very high |
Platelet Count | CBC | 150–450k/µL | Borderline | Abnormal | Critical abnormal |
hs-Troponin / NT-proBNP | FDA-cleared assays | Normal | Mild elevation | Moderate | Severe |
Endpoint: Thromboendothelial Stress Index (TESI)
IX. Connectomic Function Panel
Biomarker / Endpoint | Assay | Baseline | Mild | Moderate | Severe |
EEG Delta Power | qEEG | Normal | +20% | +50% | +100% |
EEG Theta Excess | qEEG | Normal | Mild | Moderate | Severe |
Alpha Connectivity | qEEG | Normal | ↓10% | ↓25% | ↓50% |
rs-fMRI Connectivity | MRI | Normal | ↓10% | ↓25% | ↓50% |
DTI Fractional Anisotropy | MRI-DTI | Normal | ↓5% | ↓10% | ↓20% |
Endpoint: Post-Viral Connectomic Collapse Index (PV-CCI)
X. Cognitive / Functional Endpoint Panel
Endpoint | Baseline | Mild | Moderate | Severe |
MoCA | ≥26 | 22–25 | 16–21 | <16 |
Digit Symbol Substitution | Normal | ↓10% | ↓25% | ↓50% |
Trail Making Test B | <75 sec | 75–120 | 120–180 | >180 |
PROMIS Cognitive Function | Normal | Mild impairment | Moderate | Severe |
Fatigue Severity Scale | <3 | 3–4 | 4–5.5 | >5.5 |
PEM Severity Diary | None | Mild | Moderate | Severe |
Endpoint: Post-Viral Cognitive–Functional Performance Score (PV-CFPS)
XI. Acupuncture Response Forecast Panel
Biomarker Pattern | Predicted Dysfunction | Primary SCF Acupoint Network |
High IL-6 / TNF-α / hsCRP | Neuroimmune hyperactivation | ST36 + LI11 + LI4 |
Low HRV + orthostatic HR rise | Dysautonomia / POTS-like pattern | PC6 + HT7 + CV17 |
High GFAP / S100B | Glial-BBB stress | GV20 + Sishencong + ST36 |
High lactate/pyruvate ratio | Bioenergetic collapse | KI3 + SP6 + ST36 |
Reduced rs-fMRI/qEEG coherence | Brain fog/connectomic collapse | GV20 + GV24 + Sishencong |
GI symptoms + inflammatory markers | Gut–brain immune activation | ST25 + CV12 + BL20 |
Sleep disruption + limbic symptoms | Limbic-autonomic instability | HT7 + Yintang + LV3 |
Respiratory-autonomic symptoms | Pulmonary-vagal instability | LU7 + CV17 + BL13 |
XII. SCF Precision Forecasting Model
Risk Class | Criteria | Predicted Acupuncture Planning Implication |
Low-Risk Recovery | MoCA >24, HRV preserved, NfL <20, GFAP <250, mild qEEG change | Standard neuromodulation stack; monitor fatigue/PEM |
Intermediate Risk | MoCA 18–24, HRV SDNN 50–80, GFAP 250–500, moderate qEEG slowing | Extended protocol; autonomic pacing; avoid overstimulation |
High-Risk Progression | MoCA <18, HRV SDNN <50, GFAP >500, NfL >50, marked connectivity loss | Medical escalation; neuromodulation only adjunctive and low-intensity |
XIII. Composite SCF Post-Viral Encephalopathy Score
Domain | Weight |
Neuroimmune Activation | 15% |
Neuroaxonal/Glial Injury | 15% |
BBB/Endothelial Integrity | 10% |
Autonomic Dysfunction | 15% |
Bioenergetic Dysfunction | 15% |
Connectomics | 15% |
Cognition/Function | 10% |
Viral/Immune Context | 5% |
Score | Classification |
<20 | Stable / compensated |
20–40 | Mild post-viral connectomic dysfunction |
40–60 | Moderate neuroimmune-autonomic collapse |
60–80 | Severe post-viral encephalopathy pattern |
>80 | Critical multisystem collapse risk |
XIV. Primary FDA-Aligned Endpoint Set
Diagnostic-support endpoints: clinical history, directed exclusion testing, MoCA, orthostatic vitals, CBC/CMP/TSH/B12/inflammatory markers.
Predictive endpoints: HRV SDNN/RMSSD, qEEG slowing, GFAP/NfL exploratory trend, lactate/pyruvate ratio, D-dimer/vWF where clinically indicated.
Therapeutic response endpoints: improved MoCA/PROMIS cognition, improved HRV, reduced symptom burden, stabilized qEEG/rs-fMRI, reduced PEM frequency.
MASTER REGISTRY INDEX
- SCF-ECCA-PV-BIO-0003 — Post-Viral / Long COVID Encephalopathy Biomarker Panel
- SCF-ECCA-PV-ACU-0003 — Post-Viral / Long COVID Acupoint Neuro-Circuit Mapping Atlas
- SCF-ECCA-0001 — Encephalopathy Connectomic Collapse Atlas
- SCF-BIOMARKER-ENDPOINTS-0001 — SCF Biomarker Endpoint Validation Framework