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Performance of an Optimized Paper-Based Test for Rapid Visual Measurement of Alanine Aminotransferase (ALT) in Fingerstick and Venipuncture Samples
- Source :
- PLoS ONE, PLoS ONE, Vol 10, Iss 5, p e0128118 (2015)
- Publication Year :
- 2015
-
Abstract
- Background A paper-based, multiplexed, microfluidic assay has been developed to visually measure alanine aminotransferase (ALT) in a fingerstick sample, generating rapid, semi-quantitative results. Prior studies indicated a need for improved accuracy; the device was subsequently optimized using an FDA-approved automated platform (Abaxis Piccolo Xpress) as a comparator. Here, we evaluated the performance of the optimized paper test for measurement of ALT in fingerstick blood and serum, as compared to Abaxis and Roche/Hitachi platforms. To evaluate feasibility of remote results interpretation, we also compared reading cell phone camera images of completed tests to reading the device in real time. Methods 96 ambulatory patients with varied baseline ALT concentration underwent fingerstick testing using the paper device; cell phone images of completed devices were taken and texted to a blinded off-site reader. Venipuncture serum was obtained from 93/96 participants for routine clinical testing (Roche/Hitachi); subsequently, 88/93 serum samples were captured and applied to paper and Abaxis platforms. Paper test and reference standard results were compared by Bland-Altman analysis. Findings For serum, there was excellent agreement between paper test and Abaxis results, with negligible bias (+4.5 U/L). Abaxis results were systematically 8.6% lower than Roche/Hitachi results. ALT values in fingerstick samples tested on paper were systematically lower than values in paired serum tested on paper (bias -23.6 U/L) or Abaxis (bias -18.4 U/L); a correction factor was developed for the paper device to match fingerstick blood to serum. Visual reads of cell phone images closely matched reads made in real time (bias +5.5 U/L). Conclusions The paper ALT test is highly accurate for serum testing, matching the reference method against which it was optimized better than the reference methods matched each other. A systematic difference exists between ALT values in fingerstick and paired serum samples, and can be addressed by application of a correction factor to fingerstick values. Remote reading of this device is feasible.
- Subjects :
- Male
Systematic difference
medicine.medical_specialty
Fingerstick
lcsh:Medicine
Sensitivity and Specificity
Phlebotomy
medicine
Humans
Alanine aminotransferase
lcsh:Science
Reference standards
Multidisciplinary
Venipuncture
business.industry
lcsh:R
Alanine Transaminase
Paper based
Serum samples
Test (assessment)
Surgery
lcsh:Q
Female
Reagent Kits, Diagnostic
business
Blood Chemical Analysis
Biomedical engineering
Research Article
Subjects
Details
- ISSN :
- 19326203
- Volume :
- 10
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- PloS one
- Accession number :
- edsair.doi.dedup.....e48da1727a6a6305eef6207a69fa30ce