title: Product qualification: a barrier to point-of-care microfluidic-based diagnostics?
abstract: One of the most exciting applications of microfluidics-based diagnostics is its potential use in next generation point-of-care (POC) devices. Many prototypes are already in existence, but, as of yet, few have achieved commercialisation. In this article, we consider the issue surrounding product qualification as a potential barrier to market success. The study discusses, in the context of POC microfluidics-based diagnostics, what the generic issues are and potential solutions. Our findings underline the need for a community-based effort that is necessary to speed up the product qualification process.
authors: National Physical Laboratory, Teddington, Middlesex, United Kingdom. ratna.tantra@npl.co.uk
authors: Ratna
authors: R
authors: Tantra
authors: Henne
authors: H
authors: van Heeren
mesh_terms: D001943:Breast Neoplasms / Q000175:diagnosis; D005260:Female; D015658:HIV Infections / Q000175:diagnosis; D006801:Humans; D007251:Influenza, Human / Q000175:diagnosis; D008288:Malaria / Q000175:diagnosis; D046210:Microfluidic Analytical Techniques; D019095:Point-of-Care Systems