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A paper-based multiplexed transaminase test for low-cost, point-of-care liver function testing
Nira R Pollock1, Jason P Rolland, Shailendra Kumar
1Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA. npollock@bidmc.harvard.edu
A new paper-based microfluidic assay enables rapid, visual measurement of liver enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT) from a fingerstick blood sample. This low-cost diagnostic tool can significantly improve drug-induced liver injury monitoring in resource-limited settings.
Area of Science:
- Biomedical Engineering
- Point-of-Care Diagnostics
- Hepatotoxicity Monitoring
Background:
- Standard drug-induced liver injury monitoring relies on serum transaminase (AST/ALT) measurements.
- Resource-limited settings face challenges in accessing timely hepatotoxicity monitoring due to cost and logistics.
- Effective monitoring is crucial for patients at high risk of liver injury from medications.
Purpose of the Study:
- To develop and clinically validate a paper-based, multiplexed microfluidic assay for rapid, semiquantitative AST and ALT measurement.
- To enable point-of-care testing using fingerstick blood specimens.
- To provide a cost-effective solution for drug-induced liver injury monitoring in low-resource environments.
Main Methods:
- Development of a paper-based microfluidic device for multiplexed enzyme detection.
- Clinical testing using 223 venipuncture specimens and 10 fingerstick specimens.
- Semiquantitative visual readout categorizing AST/ALT levels into predefined clinical "bins" (<3× ULN, 3–5× ULN, >5× ULN).
Main Results:
- The assay provides visual AST and ALT measurements within 15 minutes from whole blood or serum.
- Accurate categorization of enzyme levels into clinical "bins" with >90% accuracy was achieved.
- The assay demonstrated feasibility with both venipuncture and fingerstick specimens.
Conclusions:
- The developed paper-based microfluidic assay offers a rapid, accurate, and visually interpreted method for AST/ALT measurement.
- This technology has the potential to significantly improve patient care and drug safety in resource-limited settings.
- The point-of-care fingerstick device is poised to have a high impact on managing drug-induced liver injury globally.
