---
title: "Validated NF-L Measurement for Neurodegeneration Trials: A CLIA/GCLP Assay Package from SBH Sciences"
description: Explore how exosomes are transforming precision biomarker research, enabling earlier detection, deeper disease insights, and more targeted therapeutic strategies.
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![Validated NF-L Measurement for Neurodegeneration Trials: A CLIA/GCLP Assay Package from SBH Sciences](https://sbhsciences.com/hubfs/ChatGPT%20Image%20May%2019%2c%202026%2c%2011_28_21%20AM.png)

# *May 19, 2026 |* Validated NF-L Measurement for Neurodegeneration Trials: A CLIA/GCLP Assay Package from SBH Sciences

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Neurofilament light chain (NF-L) is a neuronal cytoskeletal protein released into biofluids upon axonal injury and neurodegeneration. Elevated plasma and cerebrospinal fluid NF-L levels have been reported across a broad range of neurological conditions, including amyotrophic lateral sclerosis, multiple sclerosis, Alzheimer's disease, and traumatic brain injury. Elevated plasma NF-L is a sensitive, quantitative indicator of ongoing neurodegeneration — rising before symptom onset, tracking disease progression, and responding to effective treatment. This translates into a powerful, non-invasive tool that can:

▸ Enrich and stratify trial populations by neurological damage burden at screening

▸ Serve as a pharmacodynamic endpoint to demonstrate target engagement

▸ Provide objective evidence of disease modification or slowing of neurodegeneration

▸ Support regulatory submissions as an exploratory, secondary, or co-primary endpoint

**Established across the major neurodegenerative indications**

Alzheimer's disease · MSA · ALS · Multiple sclerosis · Huntington's disease · Traumatic brain injury

NF-L has been accepted by the FDA and EMA as an exploratory biomarker in multiple IND and regulatory packages, and is increasingly featured as a secondary endpoint in Phase II/III neurology trials. By choosing a CLIA-certified, Good Clinical Laboratory Practice (GCLP)-compliant NF-L service, sponsors gain a defensible, audit-ready data package with the analytical rigor required for regulatory scrutiny.

# The SBH Sciences NF-L Analytical Validation Program

All analytical validation described in this report — including **every ELLA™ Simple Plex run, precision study, interference testing, stability testing, and carryover assessment** — was performed by **SBH Sciences in its CLIA-certified laboratory** operating under GCLP guidelines, in collaboration with Neurodex.

This validation establishes SBH Sciences as a fully qualified provider of high-integrity NF-L biomarker data for clinical trial applications, using the ELLA™ Simple Plex immunoassay platform (Bio-Techne).

SBH Sciences provides sponsors with:

### Regulatory readiness

✓ CLIA-certified laboratory operations   
✓ GCLP-compliant SOPs, documentation, and QA oversight   
✓ Full audit trail and chain of custody   
✓ Complete method validation package generated from SBH-run studies   
✓ Suitable for FDA and EMA submissions

### Turnaround and logistics

✓ EDTA plasma compatibility   
✓ LIMS-based sample tracking and storage   
✓ Batch reporting with QC flagging   
✓ Secure electronic data transfer (SFTP / EDC integration)

# Validation at a Glance

The SBH Sciences validation program demonstrates that the ELLA NF-L assay meets all analytical performance criteria required for clinical biomarker deployment. All results below are derived from **seven independent SBH Sciences analytical runs**.

![](https://sbhsciences.com/hs-fs/hubfs/undefined.png?width=936&height=936&name=undefined.png)

# 1. Assay Platform and Validation Design

## 1.1 ELLA™ Simple Plex technology

The ELLA™ Simple Plex platform (Bio-Techne) uses single-use microfluidic cartridges containing antibody-coated nanoreactors. This closed-system architecture eliminates cross-contamination, minimizes operator variability, and enables high-sensitivity chemiluminescent detection.

For NF-L, the assay spans approximately **2–2,000 pg/mL**, covering both healthy baseline levels (~5–20 pg/mL) and advanced neurodegenerative disease ranges (\>1,000 pg/mL).

## 1.2 SBH Sciences validation design

All validation studies were executed by SBH Sciences across seven independent analytical runs in single-plate format.

Three human EDTA plasma donors with endogenous NF-L levels (~7–18 pg/mL) were used throughout. Three spike concentrations were applied:

- Low: 6 pg/mL (near LLOQ)
- Mid: 54 pg/mL
- High: 486 pg/mL

These cover \>95% of clinically relevant NF-L concentrations.

Run Structure:

- Run 1: Linearity (8-point dilution), selectivity, intra-run precision
- Runs 2–7: Precision across standards and plasma samples
- Runs 2–3: Interference testing (hemolysis, lipids, icterus, biotin)
- Run 4: Stability (4°C storage + freeze-thaw cycling)
- Run 7: Carryover and sensitivity assessment

# 2. Analytical Performance Results

## 2.1 Linearity

SBH Sciences demonstrated exceptional linearity across the full analytical range (2–1458 pg/mL), with log-log regression yielding **R² ≥ 0.9999**.

Recovery remained within 80–120% across mid-to-high concentrations, with expected deviation near the LLOQ reflecting standard immunoassay behavior.

![graph 1](https://sbhsciences.com/hs-fs/hubfs/graph%201.png?width=1280&height=750&name=graph%201.png)

**Interpretation:** The assay provides reliable proportional quantification across the entire clinically relevant range for neurodegenerative disease trials.

## 2.2 Specificity

No cross-reactivity was observed with:

- Neurofilament medium (NFM)
- Neurofilament heavy (NFH)
- Peripherin

All tested conditions remained below LLOQ, confirming high analytical specificity for NF-L in complex plasma matrices.

## 2.3 Intra-run precision

Across all SBH Sciences runs (n=21 total measurements per level):

- %CV ≤ 12% at all concentrations
- High concentration precision: ≤ 5.2% CV
- Low concentration (near LLOQ): 4.0–12.0% CV

All results met the ≤15% acceptance criterion.

![graph 2](https://sbhsciences.com/hs-fs/hubfs/graph%202.png?width=1280&height=750&name=graph%202.png)

**Interpretation:** The assay supports reliable detection of 20–30% longitudinal changes in NF-L in clinical studies.

## 2.4 Matrix spike recovery

Across three independent plasma donors:

- Recovery range: ~85–115%
- Consistent performance across low, mid, and high spike levels
- No donor-dependent bias observed  
  ![graph 3](https://sbhsciences.com/hs-fs/hubfs/graph%203.png?width=1280&height=750&name=graph%203.png)

**Interpretation:** Robust performance across heterogeneous clinical trial populations.

## 2.5 Interference testing

SBH Sciences evaluated hemoglobin, lipids, bilirubin, and biotin.

- Hemoglobin: interference only at severe hemolysis levels
- Lipids: no measurable effect
- Bilirubin: negative bias only at clinically severe jaundice levels
- Biotin: no interference observed

![graph. 4](https://sbhsciences.com/hs-fs/hubfs/graph.%204.png?width=1280&height=750&name=graph.%204.png)

**Conclusion:** Standard GCLP pre-analytical controls are sufficient to mitigate interference risk.

## 2.6 Sample stability

NF-L demonstrated strong stability under real-world trial conditions:

- 4°C stability: up to 32 hours
- Freeze-thaw stability: up to 3 cycles
- Recovery: 87–119% across all conditions  
  ![graph 4](https://sbhsciences.com/hs-fs/hubfs/graph%204.png?width=1280&height=350&name=graph%204.png)

**Interpretation:** Fully compatible with multi-site sample shipping and centralized biobanking workflows.

## 2.7 Carryover

Carryover was minimal:

- Observed bias: 5.6%
- Acceptance threshold: \<10%

**Interpretation:** The ELLA cartridge system effectively eliminates carryover risk in routine use.

## 2.8 Sensitivity

All blank samples were below LLOQ (~2 pg/mL), confirming:

- No background signal
- Full suitability for low-level NF-L detection in healthy controls

# 3. Clinical Validation in Neurological Disease

All clinical samples were measured using SBH Sciences’ validated ELLA NF-L protocol.

## 3.1 ALS

- Controls (n=123): median 16.0 pg/mL
- ALS (n=114): median 51.2 pg/mL
- Fold change: 3.2×
- p \< 0.0001   
  ![graph 5](https://sbhsciences.com/hs-fs/hubfs/graph%205.png?width=438&height=375&name=graph%205.png)

**Interpretation:** Strong separation consistent with published ALS NF-L distributions and suitable for stratification and pharmacodynamic monitoring.

## 3.2 Alzheimer’s disease

- Controls (n=187): median 18.9 pg/mL
- AD (n=67): median 44.9 pg/mL
- Fold change: 2.4×
- p \< 0.0001

![graph 6](https://sbhsciences.com/hs-fs/hubfs/graph%206.png?width=396&height=287&name=graph%206.png)

**Interpretation:** Robust elevation consistent with neuroaxonal injury and suitable as a longitudinal pharmacodynamic biomarker.

## 3.3 Cross-indication relevance

Across both ALS and AD datasets, SBH Sciences demonstrated:

- Consistent analytical performance across disease contexts
- Full sample coverage within validated assay range
- Strong statistical separation between patients and controls

![graph 7](https://sbhsciences.com/hs-fs/hubfs/graph%207.png?width=1280&height=350&name=graph%207.png)

This confirms NF-L’s utility as a broadly deployable neurodegeneration biomarker in clinical trials.

# 4. Fit for Clinical Trials: Practical Implications

 

**1. Sensitive enough for longitudinal change detection?**   
Yes — CV ≤12% supports detection of ~20–30% change.   
**2. Robust across patient heterogeneity?**   
Yes — validated across multiple plasma donors.   
**3. Compatible with global trials?**   
Yes — stable under shipping and freeze-thaw conditions.   
**4. Interference risk manageable?**   
Yes — standard clinical lab controls are sufficient.   
**5. Regulatory readiness?**   
Yes — all validation conducted under CLIA/GCLP by SBH Sciences with full audit-ready documentation.

# SBH Sciences NF-L Clinical Biomarker Service

The ELLA NF-L assay is fully validated and operational within **SBH Sciences** as a GCLP-compliant biomarker service and CLIA-certified through our subsidiary **SBH Diagnostics.**

SBH Sciences provides:

- Full analytical validation package
- Clinical trial sample testing
- Biomarker strategy support
- Data interpretation and regulatory documentation support

 

The service is immediately available for Phase I–III neurodegenerative disease trials.

**Ready to add NF-L to your biomarker strategy? Contact SBH Sciences to learn more.**

[**mstewart@sbhscience.com**](mailto:mstewart@sbhscience.com)**|** [**www.sbhsciences.com**](https://www.sbhsciences.com/)

 

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