VEUPLEX™ TBI Assay

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veuplex™ tbi assay the veuplex™ tbi assay is an in vitro diagnostic solution designed to quantitatively detect traumatic brain injury (tbi) or concussion through a blood test. the system measures two specific biomarkers that leak into the bloodstream following brain injury: gfap (glial fibrillary acidic protein) and uch l1 (ubiquitin c terminal hydrolase l1). this test uses magnetic particle immunoassay technology and is processed with the veudx analyzer, providing a more accurate, rapid, and cost effective alternative to conventional methods such as ct scans or the glasgow coma scale for monitoring patients after head trauma.

Highlights & Key Features
Key Features:
  • Dual Biomarker Detection: Measures GFAP and UCH-L1 simultaneously for superior clinical sensitivity compared to single-marker assays.
  • Rapid Turnaround: Provides quantitative results within 40–50 minutes.
  • Minimal Sample Volume: Requires only 50 µL of serum.
  • Fully Automated: Single-use test cartridges processed automatically by the VEUDx Analyzer with just a few touches.
  • Regulatory Certified: CE IVDD certified (assay kit) and CE IVDR approved (analyzer).
VEUPLEX™ TBI Assay

The VEUPLEX™ TBI assay is an in vitro diagnostic solution designed to quantitatively detect Traumatic Brain Injury (TBI) or concussion through a blood test. The system measures two specific biomarkers that leak into the bloodstream following brain injury: GFAP (Glial Fibrillary Acidic Protein) and UCH-L1 (Ubiquitin C-terminal Hydrolase L1).

This test uses magnetic particle immunoassay technology and is processed with the VEUDx Analyzer, providing a more accurate, rapid, and cost-effective alternative to conventional methods such as CT scans or the Glasgow Coma Scale for monitoring patients after head trauma.

Advantages:
  • High Accuracy: Clinical studies show 94.62% sensitivity and 98.97% specificity.
  • Effective vs. CT Scans: Achieves a Negative Predictive Value (NPV) of 98.91% and 99.15% sensitivity compared to CT results, helping predict the absence of intracranial injury.
  • Overcomes Conventional Limitations: Offers a solution to the high cost, radiation risk, and time requirements of CT scans, as well as the subjectivity of GCS scoring.
  • Severity Differentiation: Can differentiate TBI severity (mild vs. moderate/severe) based on biomarker concentration.
Model

EZ-TBIV
Indication

Traumatic Brain Injury (concussion)
Multiple Detection

Quantitative detection using magnetic particles with varied lengths
Target Biomarkers

GFAP & UCH-L1
Sample Type

50 µL serum
Test Time (TAT)

40–50 minutes
Cut-off Values: GFAP

24 pg/mL, UCH-L1: 138 pg/mL
Sensitivity

94.62%
Negative Predictive Value (NPV)

98.97%
Packaging

60 Tests per Kit
Components

Test cartridge, diluent buffer

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