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Area of Science:

  • Analytical Chemistry
  • Biomedical Engineering
  • Clinical Diagnostics

Background:

  • Dried blood spots (DBSs) offer patient convenience for therapeutic drug monitoring.
  • Hematocrit levels in DBSs can significantly impact drug concentration measurements.
  • Accurate hematocrit determination is crucial for reliable DBS-based drug monitoring.

Purpose of the Study:

  • To develop a rapid, non-destructive method for measuring hematocrit in DBSs.
  • To address technical limitations in DBS analysis caused by hematocrit variations.
  • To enable accurate drug concentration correction in DBS samples.

Main Methods:

  • A partial least squares algorithm was employed for near-infrared (NIR) spectroscopy quantification.
  • The method was developed and validated using 522 patient residual venous blood samples.
  • Hematocrit measurements were compared against a Sysmex XN hemocytometry analyzer.

Main Results:

  • The NIR method demonstrated <15% difference compared to hemocytometry.
  • Accuracy (≤9%) and precision (≤7%) met acceptance criteria (<15%).
  • The method showed robustness with high hemolysis, icterus, and lipemia (HIL) indices and stability up to 14 days.

Conclusions:

  • A validated, non-destructive NIR spectroscopy method for DBS hematocrit measurement was developed.
  • The method is accurate, reproducible, and fast (51-second analysis time).
  • This technique supports reliable therapeutic drug monitoring using DBS samples stored for up to two weeks.