1. Field evaluation of a prototype paper-based point-of-care fingerstick transaminase test
- Author
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Donn J Colby, Kathy Tietje, Patrick Beattie, Sariah Khormaee, Cori Anne Barfield, Nira R. Pollock, Kenneth R. Hawkins, Shailendra Kumar, Vo Minh Quang, Bernhard H. Weigl, Sarah McGray, Huyen Nguyen, Sidhartha Jain, Farzad Noubary, Matt Steele, Nguyen Van Vinh Chau, Jason P. Rolland, Whitaker College of Health Sciences and Technology, Harvard University--MIT Division of Health Sciences and Technology, and Khormaee, Sariah
- Subjects
Paper ,medicine.medical_specialty ,Fingerstick ,Intraclass correlation ,Point-of-Care Systems ,Microfluidics ,lcsh:Medicine ,02 engineering and technology ,Bioinformatics ,01 natural sciences ,Transaminase ,Liver Function Tests ,Humans ,Medicine ,Medical physics ,lcsh:Science ,Developing Countries ,Point of care ,Observer Variation ,Multidisciplinary ,Venipuncture ,biology ,medicine.diagnostic_test ,business.industry ,010401 analytical chemistry ,lcsh:R ,Alanine Transaminase ,021001 nanoscience & nanotechnology ,3. Good health ,0104 chemical sciences ,Test (assessment) ,Vietnam ,Alanine transaminase ,biology.protein ,lcsh:Q ,Chemical and Drug Induced Liver Injury ,Drug Monitoring ,0210 nano-technology ,business ,Liver function tests ,Blood Chemical Analysis ,Research Article - Abstract
Monitoring for drug-induced liver injury (DILI) via serial transaminase measurements in patients on potentially hepatotoxic medications (e.g., for HIV and tuberculosis) is routine in resource-rich nations, but often unavailable in resource-limited settings. Towards enabling universal access to affordable point-of-care (POC) screening for DILI, we have performed the first field evaluation of a paper-based, microfluidic fingerstick test for rapid, semi-quantitative, visual measurement of blood alanine aminotransferase (ALT). Our objectives were to assess operational feasibility, inter-operator variability, lot variability, device failure rate, and accuracy, to inform device modification for further field testing. The paper-based ALT test was performed at POC on fingerstick samples from 600 outpatients receiving HIV treatment in Vietnam. Results, read independently by two clinic nurses, were compared with gold-standard automated (Roche Cobas) results from venipuncture samples obtained in parallel. Two device lots were used sequentially. We demonstrated high inter-operator agreement, with 96.3% (95% C.I., 94.3–97.7%) agreement in placing visual results into clinically-defined “bins” (5x upper limit of normal), >90% agreement in validity determination, and intraclass correlation coefficient of 0.89 (95% C.I., 0.87–0.91). Lot variability was observed in % invalids due to hemolysis (21.1% for Lot 1, 1.6% for Lot 2) and correlated with lots of incorporated plasma separation membranes. Invalid rates, National Institutes of Health (U.S.) (PATH Center to Advance Point of Care Diagnostics for Global Health NIBIB U54-EB007949), National Institute of Neurological Disorders and Stroke (U.S.) (Grant 5F30NS06468)
- Published
- 2013