IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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Virus type Sample number Sample type PCR POC SAW RSV B 5 NPS 26.3 - + Negative 12 NT - + - RSV A 16 NS 28.1 - NT RSV B 17 NPA 26.68 - + Flu B 8 NPA - - - RSV A 10 NPA 21.03 + + RSV A 18 NS 21.22 + + Flu A 15 NPA - - - RSV B 19 NS 26.9 - + RSV B 20 NPS 22.55 - + Negative 6 NPA - - - RSV A 21 NPA 18.06 + + 100% 50% 91% Agreement with PCR Table I. Comparison of clinical sample testing with PCR, SAW biosensor, and commercial PoC test. The value in the PCR column relates to the Ct (number of amplifcation cycles required to detect virus). A value of Ct = 40 is deemed negative by PCR. We have managed to detect samples with Ct values ranging between Ct = 18–37. comprise transmitting and receiving interdigital transducers and a biochemical reaction area. Te transducers are protected from liquids by a glass lid, epoxy walls and a membrane constructed using a photolithograpy technique. Tis architecture allows liquid samples to be applied directly onto the chip. Te sensor area is modifed with capture antibodies that are specifc to each target marker and are held in the correct orientation to react with disease antigens. When the target marker in solution binds to the immobilised capture antibody, the added mass of the binding causes a shift in the phase angle of the SAW as it passes across the chip surface and is translated into an electronic signal. Diferent capture coatings can be tested immediately on a working prototype measurement unit for the development of robust assays. Te data are transferred to a simple handheld device, such as a mobile phone, where the results are displayed. In this way, disposable SAW sensors can be inserted into an electric reader to detect multiple antigen-antibody reactions via changes in the phase/amplitude of the input/output signals. Tis will allow medical staf to perform rapid near- patient testing without the need for complex or cumbersome equipment. Te technology is ideal for remote disease monitoring, and has many applications in rural settings or situations where clinical readings are needed without patient transfer. It is equally well-suited for use in walk-in clinics and for consumer diagnostics applications. POC Diagnosis of Respiratory Viruses As part of the initial research into the development of accurate, rapid and low-cost POC testing for respiratory viruses, OJ Bio recently led a project in which a new SAW biosensor was developed and tested in collaboration with the Health Protection Agency (HPA) in Newcastle, UK. Te VIRASENS project, funded by the UK Technology Strategy Board, was undertaken to pioneer the combination of electronics and biotechnology as part of the development of a prototype POC diagnostic biosensor device for respiratory virus detection. Work was channeled into the detection of three respiratory viruses—respi- Medical Device Design Manufacturing IP Innovations Engineering Exceptional Results For over 15 years, Minnetronix has combined design and manufacturing, and our own innovative IP solutions, to help customers transform ideas into commercial success. Our teams expand the boundaries of device performance to create sophisticated medical devices that reliably meet regulatory and market needs. FDA Registered ISO 13485 Certified Visit us at www.minnetronix.com/ivdt Medical Device Innovation concept commercialization+ © 2013 Minnetronix. All rights reserved. I VD T EC H N O LO G Y | FALL 2 0 1 3 2 1 magenta cyan yellow black ES320497_IV1309_021.pgs 09.19.2013 01:50 UBM

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