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Area of Science:

  • Biomedical Engineering
  • Clinical Chemistry
  • Data Science

Background:

  • At-home biospecimen self-collection offers convenience but faces challenges with sample instability during transit.
  • Degradation of blood samples during shipment leads to inaccurate and imprecise clinical test results.
  • Existing methods lack robust solutions for maintaining sample integrity outside of controlled laboratory settings.

Purpose of the Study:

  • To develop and validate a software-based approach to model and control sample instability in self-collected blood.
  • To enable accurate calibration of blood test results despite degradation during transport.
  • To expand the feasibility of remote blood testing for clinical diagnostics and public health initiatives.

Main Methods:

  • Trained a predictive model (Remote Control) using environmental sensor data from blood samples subjected to real-world transit conditions.
  • Validated the model's ability to calibrate test results, approximating the time-zero value.
  • Assessed performance across various conditions, including ambient transport for up to 9 days and different temperatures (3.4–47.4 °C).

Main Results:

  • The calibrated model achieved high agreement (98.1–100%) with CLIA Total Error (TEa) for lipid panels.
  • Demonstrated low bias (0.1–1.6%), acceptable coefficient of variation (2.2–4.9%), and high sigma metrics (3–8.8σ).
  • Performance generalized across diverse laboratories, equipment, patient demographics, and health statuses, including capillary blood samples.

Conclusions:

  • A software-based calibration method effectively mitigates sample instability, enabling reliable at-home blood testing.
  • This approach supports decentralized clinical trials, public health screening, and affordable at-home healthcare delivery.
  • Unprocessed whole blood can be transported for extended periods under ambient conditions with accurate results post-calibration.