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Abstract Details

Validation of a Neurofilament Light Chain Assay on a Clinical Autoanalyzer
General Neurology
P5 - Poster Session 5 (11:45 AM-12:45 PM)
12-006

NfL has been demonstrated to become elevated in serum as a result of several neurodegenerative diseases including MS, Alzheimer’s disease, ALS, Parkinson’s disease, and Huntington disease.  Measurements of NfL could assist with monitoring disease treatment as well as recovery from traumatic brain injuries such as concussions.

This work details the exhaustive LDT assay validation performed at Labcorp for the measurement of NfL in serum and plasma using the Roche cobas® autoanalyzer platform. This assay does not currently have regulatory approval. 

To validate a neurofilament light chain (NfL) assay on a clinical autoanalyzer to enable clinical utility for a broad range of neurogenerative diseases and conditions.

Assay validation studies investigating instrument carryover, blood matrix interferences, alternate specimen types, matrix mixing, lower limit of quantitation, analytical measurement range, and accuracy.  Comparison to the predicate assay from Quanterix which has primarily been utilized to establish the clinical utility of NfL levels.  Additionally, robust reference interval studies were performed to establish and verify normal levels of NfL across several patient age groups.

Studies were also performed to determine stability of NfL for a range of specimen types, storage conditions, and operational settings.  The stability of assay materials (reagent, calibrators, and controls) was also demonstrated over time periods that would facilitate operational utility. 

Acceptable assay and sample performance including correlation to a predicate assays was demonstrated preserving the clinical utility of NfL measurements with this assay.
The NfL assay is currently available for measurement of patient samples at a Labcorp laboratory.
Authors/Disclosures
Bradley Collier, PhD (Labcorp)
PRESENTER
Dr. Collier has received personal compensation for serving as an employee of Labcorp. Dr. Collier has stock in Labcorp.
Ahmed Chenna, PhD (Monogram Biosciences Inc) Dr. Chenna has received personal compensation for serving as an employee of LabCorp-monogram Biosciences.
Whitney C. Brandon (Labcorp) Whitney C. Brandon has received personal compensation for serving as an employee of Labcorp.
Matthew R. Chappell (Labcorp) Matthew R. Chappell has received personal compensation for serving as an employee of Labcorp. Matthew R. Chappell has stock in Labcorp.
John Winslow, PhD (Monogram Biosciences Inc., Laboratory Corporation of America) Dr. Winslow has received personal compensation for serving as an employee of Monogram Biosciences/Labcorp. Dr. Winslow has stock in Labcorp. Dr. Winslow has received intellectual property interests from a discovery or technology relating to health care.
Christos John Petropoulos, PhD (Monogram Biosciences, LabCorp) Dr. Petropoulos has received personal compensation for serving as an employee of Monogram Biosciences-Labcorp. Dr. Petropoulos has received stock or an ownership interest from Laboratory Corporation of America Holdings. Dr. Petropoulos has received intellectual property interests from a discovery or technology relating to health care.
Andre Valcour (Labcorp) Dr. Valcour has nothing to disclose.
Joseph Volpe, PhD (Labcorp) Dr. Volpe has received personal compensation for serving as an employee of Labcorp.
Russell Grant, PhD (labcorp) Dr. Grant has received personal compensation for serving as an employee of Labcorp.