title: A paper-based multiplexed transaminase test for low-cost, point-of-care liver function testing.
abstract: In developed nations, monitoring for drug-induced liver injury through serial measurements of serum transaminases [aspartate aminotransferase (AST) and alanine aminotransferase (ALT)] in at-risk individuals is the standard of care. Despite the need, monitoring for drug-related hepatotoxicity in resource-limited settings is often limited by expense and logistics, even for patients at highest risk. This article describes the development and clinical testing of a paper-based, multiplexed microfluidic assay designed for rapid, semiquantitative measurement of AST and ALT in a fingerstick specimen. Using 223 clinical specimens obtained by venipuncture and 10 fingerstick specimens from healthy volunteers, we have shown that our assay can, in 15 min, provide visual measurements of AST and ALT in whole blood or serum, which allow the user to place those values into one of three readout "bins" [<3× upper limit of normal (ULN), 3 to 5× ULN, and >5× ULN, corresponding to tuberculosis/HIV treatment guidelines] with >90% accuracy. These data suggest that the ultimate point-of-care fingerstick device will have high impact on patient care in low-resource settings.
authors.affiliation: Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA. npollock@bidmc.harvard.edu
authors.forename: Nira R
authors.initials: NR
authors.lastname: Pollock
authors.forename: Jason P
authors.initials: JP
authors.lastname: Rolland
authors.forename: Shailendra
authors.initials: S
authors.lastname: Kumar
authors.forename: Patrick D
authors.initials: PD
authors.lastname: Beattie
authors.forename: Sidhartha
authors.initials: S
authors.lastname: Jain
authors.forename: Farzad
authors.initials: F
authors.lastname: Noubary
authors.forename: Vicki L
authors.initials: VL
authors.lastname: Wong
authors.forename: Rebecca A
authors.initials: RA
authors.lastname: Pohlmann
authors.forename: Una S
authors.initials: US
authors.lastname: Ryan
authors.forename: George M
authors.initials: GM
authors.lastname: Whitesides
mesh_terms: D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D003365:Costs and Cost Analysis; D006801:Humans; D008111:Liver Function Tests / Q000191:economics* / Q000295:instrumentation / Q000379:methods*; D010209:Paper; D018962:Phlebotomy; D019095:Point-of-Care Systems / Q000191:economics*; D012015:Reference Standards; D015203:Reproducibility of Results; D013696:Temperature; D013997:Time Factors; D000637:Transaminases / Q000097:blood* / Q000191:economics*
chemical_list: D000637:Transaminases; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase