Product qualification: A barrier to point-of-care microfluidic-based diagnostics?

Lab on a Chip

Volumn 13, Issue 12, 2013, Pages 2199-2201

  Tantra, Ratna ^a   Van Heeren, Henne ^b  

^a NATIONAL PHYSICAL LABORATORY   (United Kingdom)

^b EnablingMNT   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; COMMUNITY; DIAGNOSTIC EQUIPMENT; HOSPITAL INFORMATION SYSTEM; MICROFLUIDICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PRODUCT DEVELOPMENT;

EID: 84878061938     PISSN: 14730197     EISSN: 14730189     Source Type: Journal    
DOI: 10.1039/c3lc50246e     Document Type: Article

References (17)

1. C. P. Price, A. S. John and J. M. Hicks, Point-of-care Testing, 2nd edn, 2004, American Association for Clinical Chemistry
2. C. D. Chin V. Linder S. K. Sia Commercialization of microfluidic point-of-care diagnostic devices Lab Chip 2012 12 12 2118 2134
3. K. A. Erickson P. Wilding Evaluation of a Novel Point-of-Care System The I-Stat Portable Clinical Analyzer Clinical Chemistry 1993 39 2 283 287
4. A. Floris et al., A prefilled, ready-to-use electrophoresis based lab-on-a-chip device for monitoring lithium in blood Lab Chip 2010 10 14 1799 1806
5. N. N. Watkins et al., A microfabricated electrical differential counter for the selective enumeration of CD4+T lymphocytes Lab Chip 2011 11 8 1437 1447
6. W. Ji Yeong C. Jeong-Woo M. Junhong Micro-fluidic chip platform for the characterization of breast cancer cells using aptamer-assisted immunohistochemistry Biosens. Bioelectron. 2013 40 1 161 6
7. C. C. Stemple H.-J. Kwon J.-Y. Yoon Rapid and Sensitive Detection of Malaria Antigen in Human Blood With Lab-on-a-Chip IEEE Sens. J. 2012 12 9 2735 2736
8. K. G. Lee et al., Development of a Plastic-Based Microfluidic Immunosensor Chip for Detection of H1N1 Influenza Sensors 2012 12 8 10810 10819
9. H. Becker Hype, hope and hubris: the quest for the killer application in microfluidics Lab Chip 2009 9 15 2119 2122
10. W. Weiqiang M. H. Azarian M. Pecht Qualification for product development 2008 International Conference on Electronic Packaging Technology & High Density Packaging (ICEPT-HDP) 2008 12 12
11. J. C. Forest Impact of the implementation of the EU directive 98/79/EC on in vitro diagnostic medical devices and of the relevant ISO Standards on patient care Clinica Chimica Acta 2005 355 S15 S16
12. R. Gutowski EC Proposal for in vitro Diagnostic Medical Devices Directive Lancet 1992 339 8805 1360 1361
13. S. Gutman K. Richter New directions in the FDA regulation of in vitro diagnostic devices Laboratory Medicine 1999 30 12 782 784
14. S. Gutman K. Richter S. Alpert Update on FDA regulation of in vitro diagnostic devices JAMA, J. Am. Med. Assoc. 1998 280 2 190 192
15. H. van Heeren Standards for connecting microfluidic devices? Lab Chip 2012 12 6 1022 1025
16. H. M. Park S. M. Hong J. S. Lee Estimation of zeta potential of electroosmotic flow in a microchannel using a reduced-order model Biomed. Microdevices 2007 9 5 751 760
17. M. R. Bown J. M. MacInnes R. W. K. Allen Micro-PIV simulation and measurement in complex microchannel geometries Meas. Sci. Technol. 2005 16 3 619 626