POINT OF CARE


HPA laboratory in Newcastle Upon Tyne into the detection of three respiratory viruses, influenza A and B viruses, common flu strains previously linked to some major epidemics, and Respiratory Syncytial Virus (RSV), a major cause of coughs and chest infections. During the initial stages of product


research and development, the HPA collected nasal secretions, nose/throat swabs and nasal aspirates from patients and used these samples to test the capability of the OJ-Bio biosensor against the current benchmark polymerase chain reaction (PCR) method as well as alongside another commercial PoC test. Assays were performed by mounting


SAW chips into specially designed fixtures connected to a control box. Clinical samples and controls were added to the chip surface followed by virus specific gold-conjugated secondary antibody for five minutes. The 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 influenza virus. The data obtained from the device confirmed the ability of the biosensor technology to provide accurate results in around 10 minutes, had good levels of diagnostic sensitivity for the three test viruses (total 93% when compared to the HPA lab-based PCR method, the ‘gold standard’ for respiratory testing) and did not give false positives, showing 100% specificity even when other viral analytes were present.


Next stages and potential impacts OJ Bio has now completed the prototype development of a handheld device incorporating a multi-channel biochip. Formal clinical trials using the device to detect the three respiratory viruses mentioned above are due to start in 2015. The platform technology developed by OJ Bio allows the detection of different protein biomarkers, meaning the potential application areas are very broad. Considerable work has already been


undertaken on the use of the specialist biochips for the detection of periodontal gum disease and another area of interest is the capability of the device to help in reducing problems associated with the overprescribing of antibiotics. Here, as well as providing a fast and accurate diagnosis for flu that could assist a


Considerable work has already been undertaken on the use of the specialist biochips for the detection of periodontal gum disease and another area of interest is the capability of the device to help in reducing problems associated with the overprescribing of antibiotics.


healthcare worker to demonstrate and explain why antibiotics may or may not be appropriate, the device can also be used to detect the presence of C-reactive protein. CRP is a recognised biomarker of inflammatory disease, which can be used to rule out serious bacterial infections. Although the CRP test is not new, its availability on a PoC diagnosis device, potentially for use by patients themselves as well as frontline healthcare staff, could provide a useful tool in the reduction of the inappropriate prescribing of antibiotics for flu-related conditions. In other areas of other infectious disease identification and control, OJ Bio is also working with researchers from University College London (UCL) on the development of a PoC device capable of detecting HIV marker proteins in human blood quickly and effectively. So far the technology has been proven to work using model HIV samples, where the inherent sensitivity to low levels of multiple markers has the potential for much earlier diagnosis of the disease. Eventually it is hoped that the technology will therefore empower patients to gain earlier access to antiretroviral treatment with better associated health outcomes. More broadly, effective PoC testing using portable devices could have potential applications in community screening programmes. However, at this stage it is thought unlikely that the technology would have sufficient sensitivity to detect infectious agents collected by swabs. In this way, there will always be a need for definitive, laboratory-based molecular testing methods capable of screening for all types of infectious agents.


However, in a complementary sense, the ability of PoC testing to deliver a fast and accurate result will have significant benefits in certain situations – and particularly in those situations where fast diagnosis is essential. For example,


The latest advances in biochip technology using sophisticated biocapture proteins demonstrate how reliable, high quality PoC testing is now becoming a reality.


APRIL 2015


if a patient presents with a suspected condition at a healthcare facility during ‘out of hours’ periods, the PoC test would enable an immediate diagnosis to be made, allowing clinical decisions to occur quickly with laboratory verification or confirmation testing being available later. The considerable potential of PoC testing to provide an effective solution to modern infectious disease diagnosis and control challenges has become widely recognised in recent years. As a result, it is now one of the fastest


growing fields of laboratory medicine and is becoming increasingly prominent on the international healthcare agenda. Of course the performance goals of


PoC testing to provide accurate and effective diagnosis are exactly the same as those of the traditional clinical laboratory. In this respect, the latest advances in biochip technology using sophisticated biocapture proteins demonstrate how reliable, high quality PoC testing is now becoming a reality.


About the author


Dr Dale Athey, BSc, MSc, MBA (Open), PhD, is CEO and founder of OJ-Bio Ltd, a joint venture between leading Japanese wireless communications company, Japan Radio Co., Ltd. (JRC) and UK nanobiotech company Orla Protein Technologies Ltd. Dale began his career as a clinical biochemist in the UK National Health Service, and gained then over 20 years industrial experience in both research and customer facing roles in the medical diagnostics industry, latterly with Chiron and Bayer Diagnostics. In 2002 Dale and Professor Jeremy Lakey co-founded the nano- biotechnology company Orla Protein Technologies Ltd, a spin-out from the University of Newcastle upon Tyne and in 2002, and Dale was instrumental in the founding of OJ-Bio in 2009. He has a masters degree in clinical biochemistry, a PhD in immunoassay from the University of Newcastle upon Tyne and a MBA from the Open University.


THE CLINICAL SERVICES JOURNAL 55


✚


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68