Creatinine assay interferences compromises MELD accuracy and may bias liver allocation

Area of Science:

• Hepatology
• Clinical Chemistry
• Medical Diagnostics

Background:

• The Model for End-Stage Liver Disease (MELD) score is crucial for liver transplant prioritization and mortality prediction.
• Serum creatinine, a MELD component, can be inaccurately measured due to bilirubin interference.
• Current methods lack standardization to correct for this analytical bias.

Purpose of the Study:

• To investigate the impact of bilirubin interference on MELD score accuracy.
• To develop and validate a model for correcting MELD score distortions caused by bilirubin.
• To assess the clinical relevance of corrected MELD scores on transplantation and mortality outcomes.

Main Methods:

• Developed a MELD correction model using controlled in vitro matrices.
• Validated the model against patient samples and large registry data.
• Applied the corrected model to assess shifts in MELD scores and associated outcomes.

Main Results:

• Bilirubin interference causes clinically significant MELD score distortions.
• A substantial proportion of patients experienced meaningful score shifts after correction.
• Corrected MELD scores altered transplantation probability and mortality estimates.

Conclusions:

• Analytical bias from bilirubin interference significantly impacts MELD scores and clinical decisions.
• A validated correction model demonstrates the potential for improved accuracy.
• Harmonized, interference-resistant creatinine assays are essential for equitable liver transplant allocation.