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      Point-of-care diagnostics – is this driven by supply or demand?

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      Journal: Expert Opinion on Medical Diagnostics
      Publisher: Informa Healthcare

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          Abstract

          The diagnostic point-of-care testing (POCT) market is about one-third of the in vitro diagnostic (IVD) testing market but, although there are many different POCT products, most are for pregnancy and monitoring of diabetes (∼ 70% of all POCT). Despite the small contribution outside these areas there is huge investment from both suppliers and users of POCT to establish new products and increase the infrastructure for their use. The review is focused on determining the balance between the different drivers of supply and demand and how they have impacted the conflicts seen in POCT evolution. The conflicts have been based on a mix of analytical, regulatory, political and commercial aspects and here the supply and demand drivers are examined separately to determine whether the conflicts are real or whether there are hidden synergies. The focus is on recent publications, with reference to some key historical articles, so that the full environment can be assessed. It is concluded that the synergies between supply and demand now overcome the conflicts where clinical and economic benefit can be demonstrated.

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          Economic costs of diabetes in the U.S. In 2007.

          (2008)
          The prevalence of diabetes continues to grow, with the number of people in the U.S. with diagnosed diabetes now reaching 17.5 million. The objectives of this study are to quantify the economic burden of diabetes caused by increased health resource use and lost productivity, and to provide a detailed breakdown of the costs attributed to diabetes. This study uses a prevalence-based approach that combines the demographics of the population in 2007 with diabetes prevalence rates and other epidemiological data, health care costs, and economic data into a Cost of Diabetes Model. Health resource use and associated medical costs are analyzed by age, sex, type of medical condition, and health resource category. Data sources include national surveys and claims databases, as well as a proprietary database that contains annual medical claims for 16.3 million people in 2006. The total estimated cost of diabetes in 2007 is $174 billion, including $116 billion in excess medical expenditures and $58 billion in reduced national productivity. Medical costs attributed to diabetes include $27 billion for care to directly treat diabetes, $58 billion to treat the portion of diabetes-related chronic complications that are attributed to diabetes, and $31 billon in excess general medical costs. The largest components of medical expenditures attributed to diabetes are hospital inpatient care (50% of total cost), diabetes medication and supplies (12%), retail prescriptions to treat complications of diabetes (11%), and physician office visits (9%). People with diagnosed diabetes incur average expenditures of $11,744 per year, of which $6,649 is attributed to diabetes. People with diagnosed diabetes, on average, have medical expenditures that are approximately 2.3 times higher than what expenditures would be in the absence of diabetes. For the cost categories analyzed, approximately $1 in $5 health care dollars in the U.S. is spent caring for someone with diagnosed diabetes, while approximately $1 in $10 health care dollars is attributed to diabetes. Indirect costs include increased absenteeism ($2.6 billion) and reduced productivity while at work ($20.0 billion) for the employed population, reduced productivity for those not in the labor force ($0.8 billion), unemployment from disease-related disability ($7.9 billion), and lost productive capacity due to early mortality ($26.9 billion). The actual national burden of diabetes is likely to exceed the $174 billion estimate because it omits the social cost of intangibles such as pain and suffering, care provided by nonpaid caregivers, excess medical costs associated with undiagnosed diabetes, and diabetes-attributed costs for health care expenditures categories omitted from this study. Omitted from this analysis are expenditure categories such as health care system administrative costs, over-the-counter medications, clinician training programs, and research and infrastructure development. The burden of diabetes is imposed on all sectors of society-higher insurance premiums paid by employees and employers, reduced earnings through productivity loss, and reduced overall quality of life for people with diabetes and their families and friends.
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            Simultaneous quantification of five bacterial and plant toxins from complex matrices using a multiplexed fluorescent magnetic suspension assay.

            Stefan Kaulfuss, Diana Pauly, Marc-André Guerville … (2009)
            Proteotoxins such as ricin, abrin, botulinum neurotoxins type A and B (BoNT/A, BoNT/B) and staphylococcal enterotoxin B (SEB) are regarded as potential biological warfare agents which could be used for bioterrorism attacks on the food chain. In this study we used a novel immunisation strategy to generate high-affinity monoclonal and polyclonal antibodies against native ricin, BoNT/A, and BoNT/B. The antibodies were used along with antibodies against SEB and abrin to establish a highly sensitive magnetic and fluorescent multiplex bead array with excellent sensitivities between 2 ng/L and 546 ng/L from a minimal sample volume of 50 microL. The assay was validated using 20 different related analytes and the assay precision was determined. Advancing the existing bead array technology, the novel magnetic and fluorescent microbeads proved amenable to enrichment procedures, by further increasing sensitivity to 0.3-85 ng/L, starting from a sample volume of 500 microL. Furthermore, the method was successfully applied for the simultaneous identification of the target toxins spiked into complex food matrices like milk, baby food and yoghurt. On the basis of our results, the assay appears to be a good tool for large-scale screening of samples from the food supply chain.
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              Improving healthcare accessibility through point-of-care technologies.

              L. Kricka, , Erin P. Price (2007)
              The NIH is committed to improving healthcare quality in the US and has set up initiatives to address problems such as the fragmented nature of healthcare provision. A hypothesis has been developed that testing closer to the point at which care is delivered may reduce fragmentation of care and improve outcomes. The National Institute of Biomedical Imaging and Bioengineering (NIBIB), the NIH's National Heart, Lung, and Blood Institute, and the National Science Foundation sponsored a workshop, "Improving Health Care Accessibility through Point-of-Care Technologies," in April 2006. The workshop assessed the clinical needs and opportunities for point-of-care (POC) technologies in primary care, the home, and emergency medical services and reviewed minimally invasive and noninvasive testing, including imaging, and conventional testing based on sensor and lab-on-a-chip technologies. Emerging needs of informatics and telehealth and healthcare systems engineering were considered in the POC testing context. Additionally, implications of evidence-based decision-making were reviewed, particularly as it related to the challenges in producing reliable evidence, undertaking regulation, implementing evidence responsibly, and integrating evidence into health policy. Many testing procedures were considered to be valuable in the clinical settings discussed. Technological solutions were proposed to meet these needs, as well as the practical requirements around clinical process change and regulation. From these considerations, a series of recommendations was formulated for development of POC technologies based on input from the symposium attendees. NIBIB has developed a funding initiative to establish a Point-of-Care Technologies Research Network that will work to bridge the technology/clinical gap and provide the partnerships necessary for the application of technologies to pressing clinical needs in POC testing.
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                Author and article information

                Journal
                Title: Expert Opinion on Medical Diagnostics
                Abbreviated Title: Expert Opinion on Medical Diagnostics
                Publisher: Informa Healthcare
                ISSN (Print): 1753-0059
                ISSN (Electronic): 1753-0067
                Publication date Created: April 22 2010
                Publication date Created: May 2010
                Publication date (Electronic): March 15 2010
                Publication date (Print): May 2010
                Volume: 4
                Issue: 3
                Pages: 189-200
                Article
                DOI: 10.1517/17530051003671556
                PubMed ID: 23488530
                SO-VID: 5f1412ad-a726-4342-a458-21499fd5fb48
                Copyright © © 2010
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