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Evaluating 3D printing to solve the sample-to-device interface for LRS and POC diagnostics: example of an interlock meter-mix device for metering and lysing clinical urine samples

Jue, Erik and Schoepp, Nathan G. and Witters, Daan and Ismagilov, Rustem F. (2016) Evaluating 3D printing to solve the sample-to-device interface for LRS and POC diagnostics: example of an interlock meter-mix device for metering and lysing clinical urine samples. Lab on a Chip, 16 (10). pp. 1852-1860. ISSN 1473-0197. http://resolver.caltech.edu/CaltechAUTHORS:20160502-101837713

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Abstract

This paper evaluates the potential of 3D printing, a semi-automated additive prototyping technology, as a means to design and prototype a sample-to-device interface, amenable to diagnostics in limited-resource settings, where speed, accuracy and user-friendly design are critical components. As a test case, we built and validated an interlock meter-mix device for accurately metering and lysing human urine samples for use in downstream nucleic acid amplification. Two plungers and a multivalve generated and controlled fluid flow through the device and demonstrate the utility of 3D printing to create leak-free seals. Device operation consists of three simple steps that must be performed sequentially, eliminating manual pipetting and vortexing to provide rapid (5 to 10 s) and accurate metering and mixing. Bretherton's prediction was applied, using the bond number to guide a design that prevents potentially biohazardous samples from leaking from the device. We employed multi-material 3D printing technology, which allows composites with rigid and elastomeric properties to be printed as a single part. To validate the meter-mix device with a clinically relevant sample, we used urine spiked with inactivated Chlamydia trachomatis and Neisseria gonorrhoeae. A downstream nucleic acid amplification by quantitative PCR (qPCR) confirmed there was no statistically significant difference between samples metered and mixed using the standard protocol and those prepared with the meter-mix device, showing the 3D-printed device could accurately meter, mix and dispense a human urine sample without loss of nucleic acids. Although there are some limitations to 3D printing capabilities (e.g. dimension limitations related to support material used in the printing process), the advantages of customizability, modularity and rapid prototyping illustrate the utility of 3D printing for developing sample-to-device interfaces for diagnostics.


Item Type:Article
Related URLs:
URLURL TypeDescription
http://dx.doi.org/10.1039/C6LC00292GDOIArticle
http://pubs.rsc.org/en/Content/ArticleLanding/2016/LC/C6LC00292GPublisherArticle
http://www.rsc.org/suppdata/c6/lc/c6lc00292g/c6lc00292g1.mp4PublisherSupplementary Movie
ORCID:
AuthorORCID
Ismagilov, Rustem F.0000-0002-3680-4399
Additional Information:© 2016 The Royal Society of Chemistry. This article is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported Licence. Received 01 Mar 2016, Accepted 18 Apr 2016. First published online 28 Apr 2016. This article is part of themed collection: 3D Printing and Open access articles from Lab on a Chip. This research was supported by DARPA Cooperative Agreement HR0011-11-2-0006. The content of this article does not necessarily reflect the position or the policy of the Government, and no official endorsement should be inferred. This material is also based upon work supported by National Science Foundation Graduate Research Fellowships DGE-1144469 (to E. J.). R. F. I. holds an Innovation in Regulatory Science Award from BWF. We thank Natasha Shelby for contributions to writing and editing this manuscript.
Funders:
Funding AgencyGrant Number
Defense Advanced Research Projects Agency (DARPA)HR0011-11-2-0006
NSF Graduate Research FellowshipDGE-1144469
Burroughs Wellcome FundUNSPECIFIED
Record Number:CaltechAUTHORS:20160502-101837713
Persistent URL:http://resolver.caltech.edu/CaltechAUTHORS:20160502-101837713
Official Citation:Evaluating 3D printing to solve the sample-to-device interface for LRS and POC diagnostics: example of an interlock meter-mix device for metering and lysing clinical urine samples Erik Jue, Nathan G. Schoepp, Daan Witters and Rustem F. Ismagilov Lab Chip, 2016, 16, 1852-1860 DOI: 10.1039/C6LC00292G
Usage Policy:No commercial reproduction, distribution, display or performance rights in this work are provided.
ID Code:66582
Collection:CaltechAUTHORS
Deposited By: Ruth Sustaita
Deposited On:02 May 2016 19:20
Last Modified:02 Jun 2016 22:13

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