IVDT_In Vitro Diagnostics Technology

IVD Technology, Fall 2013

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POINT-OF-CARE DIAGNOSTICS SAW biosensor technology can provide accurate diagnostic results in minutes. ratory syncytial virus (RSV), infuenza A, and infuenza B—in clinical samples collected by the HPA laboratory in Newcastle-upon-Tyne. During the initial stages of product research and development, the HPA collected nasal secretions, nose/ throat swabs, and nasal aspirates from patients. Tese samples were used to test the capability of the OJ-Bio biosensor against the current benchmark polymerase chain reaction (PCR) method as well as another commercial POC test. Assays were performed by mounting SAW chips into specially designed fxtures connected to a control box. Clinical samples and controls were added to the chip surface followed by virus-specifc gold-conjugated secondary antibody for fve minutes. Te amount of virus binding to the chip surface was recorded in degrees of phase shift, with a reduction in the phase angle (i.e., a negative phase shift) indicating the presence of the infuenza virus. An example of the type of data obtained on the SAW device is shown in Figure 1 and Table 1. Te data show that the SAW biosensor technology can provide accurate results within minutes, has good levels of diagnostic sensitivity for the three test viruses (totalling 93% when compared with the HPA lab-based PCR method, which is considered the gold standard for respiratory testing), and does not produce any false positives, showing 100% specifcity even when other viral analytes were present. Tese results compare favourably with currently available rapid tests for fu and RSV diagnosis, which have demonstrated sensitivity between 4.4 and 70% and specifcity between 50.5 15 Phase Shift [degrees] 10 5 0 L63-AAU06 -5 L63-AAU07 Mean -10 -15 -20 -25 -ve control +ve control Sample 20 Sample 12 Sample 5 Sample 10 Sample 17 Sample 15 Sample 18 Sample 19 RSV sample type Figure 1. Phase shift for Ag and secondary Ab binding for various RSV clinical samples using 1202 crosslinked DSP chips (+/- 2SD). and 100%. Tey demonstrate that SAW technology can provide a sensitive POC test for infuenza and RSV diagnosis. Importantly, along with the POC potential, results from the SAW biosensor device can be displayed on a complementary (app-enabled) handheld reading device such as a mobile phone and can be wirelessly transmitted to a central resource. Next-Stage Developments Government funding for further development work has been secured from the UK Technology Strategy Board's Biomedical Catalyst programme. Te funding will enable the company to continue its work by developing the lab-based prototypes described above into a fully functional pilot device capable of carrying out large-scale clinical trials. Te next stage of manufacture will involve considerable innovation in design and production of the SAW biochip, including the design and frst testing of a new multiparameter chip, and the reader, where functions will be placed within a wireless-enabled handheld device. In addition, software designed for the PC interface on the current prototype will be developed for the handheld device. Te optimised assays that have been developed for fu types A and B and RSV on the existing prototypes will be optimised on the current platform for transfer to the new devices and biochips. 22 IVD TEC HNOLO G Y | FA L L 2013 magenta cyan yellow black ES320495_IV1309_022.pgs 09.19.2013 01:51 UBM

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