Gold Standard Diagnostics' and DIAsource ImmunoAssays' 25

Gold Standard Diagnostics, Corp. (GSD, www.gsdx.us), a leading manufacturer and marketer of clinical laboratory instrumentation and assays for the in vitro diagnostics market, announced 510k FDA Clearance of its 25-OH Vitamin D, Total ELISA. The competitive assay strongly correlates with established LC/MS, EIA and Chemiluminescence methods, and offers high sensitivity and specificity over a wide dynamic range. The assay can be automated on a variety of instruments, providing a cost-effective Vitamin D testing option, even at lower volumes.

"As Vitamin D levels have become an important indicator of overall health, testing volume has risen but assay choices have remained limited. Especially for labs or physicians with smaller volumes, the prohibitive cost and volume requirements of a high-throughput system can make running Vitamin D in-house difficult to justify financially. GSD has created an ELISA that can be fully-automated and cost-effective even if a lab only runs a few samples a week," says Gerrit Mueller, Product Manager for Gold Standard Diagnostics.

DIAsource Collaboration

The Vitamin D assay was developed by Belgium-based DIAsource ImmunoAssays S.A. Gold Standard Diagnostics and DIAsource have enjoyed a successful relationship for many years. GSD is the exclusive distributor of the Vitamin D assay in the U.S. market. In turn, DIAsource also distributes the GSD ThunderBolt® automated instrument worldwide.

"This approval is a milestone for our company. It not only proves the quality of our assay but it also allows us via GSD to enter into the US market with this exciting product that has been highly appreciated by our customers and made the assay a huge success in Europe and Asia immediately after launching in 2012," says Dr. Jef Vangenechten, CEO of DIAsource.

Automation Options

The GSD Vitamin D assay features a unique pre-treatment step that allows for complete automation on virtually any open ELISA processor. Because of the simple pre-treatment step and automation capability, GSD's 25-OH Vitamin D provides fast and consistent results. All assay protocol steps are completed in a standard microtiter plate, without the need for labor-intensive, time-consuming and complicated pre-treatment done manually outside of the analyzer.

Clinical Significance of Vitamin D Testing

Vitamin D testing offers important information for general physicians and specialists alike. Long-established as an important factor for bone metabolism, new research indicates Vitamin D also plays an important role in immune function, cardiovascular disease, autoimmune conditions, diabetes, depression and cancer prevention. Many reports estimate that up to 75% of the U.S. population has a deficiency of 25-Hyrdoxyvitamin D.

For more information on GSD's Vitamin D assay visit our website: http://www.gsdx.us/

Simplify Your Laboratory Experience

Contact Gold Standard Diagnostics for more information:Email: info@gsdx.us | Phone: (530) 759-8000 | Web: http://www.gsdx.us/

About Gold Standard Diagnostics:

Gold Standard Diagnostics (GSD) provides comprehensive diagnostic solutions that improve lab efficiency and minimize overall costs. Through an extensive product menu, automated instrument platforms, and outstanding customer service, GSD solves real laboratory problems. The result is a seamless laboratory experience achieved through an integrated approach.

More information is available at http://www.gsdx.us/

About DIAsource ImmunoAssays S.A.

DIAsource ImmunoAssays ( www.diasource.be) develops, manufactures and markets clinical diagnostic assays and antibodies in the field of endocrinology and infectious diseases. DIAsource has specific development and manufacturing programs for Vitamin D, Renin, Calcitonin and other specialty markers. DIAsource provides selected instrumentation Elisa reader, washer and shaker, along with open and closed fully automated Elisa platforms helping customers to automate their tests.

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Low vitamin D again linked to mobility issues for older people

Vitamin D deficiency may increase a senior citizen's risk of physical limitations like walking up and down stairs, and being able to dress and undress, says a new study from The Netherlands.

Researchers from the VU University Medical Center reported that vitamin D deficiency doubled the risk of an increase in functional limitations.

"The results of the present study are in line with the results of most studies on vitamin D status and physical performance, in which low vitamin D status was associated with low physical performance and its decline in individuals aged 65 years and older," wrote the researchers in The Journal of Clinical Endocrinology & Metabolism.

"Because functional limitations are a predictor of adverse outcomes, further research is necessary to explore underlying mechanisms and the potential benefits of vitamin D supplements on functional status." The sunshine vitamin

Vitamin D refers to two biologically inactive precursors - D3, also known as cholecalciferol, and D2, also known as ergocalciferol.

Both D3 and D2 precursors are transformed in the liver and kidneys into 25- hydroxyvitamin D (25(OH)D), the non-active 'storage' form, and 1,25-dihydroxyvitamin D (1,25(OH)2D), the biologically active form that is tightly controlled by the body.

Vitamin D deficiency, which is defined as a status of less than 20 nanograms per milliliter (ng/mL) of 25-(OH)D, can cause a number of health issues, including rickets and other musculoskeletal diseases.

While previous studies have reported a link between vitamin D status and functional limitations, the data to date has been 'contradictory', wrote the authors, led by Evelien Sohl.

For the new study, Sohl and her co-workers analyzed data from 1,237 people aged 65 to 88, and 725 people aged 55 to 65. Functional limitations were classed as problems walking up and down stairs, problems dressing or undressing, difficulty getting into and out of a chair, difficulty cutting toenails, being unable to walk outside for five minutes without rest, and whether the subject could use transportation.

Long term effects

The results indicated that, for the older and younger groups, 56 and 30% of people, respectively, had at least one limitation. Vitamin D deficiency in the older group was related to significant increases in functional limitations after three years. For the younger group, vitamin D deficiency was linked to an increase in limitations after six years, they wrote.

"The mechanism of action in our study may be the positive influence of vitamin D on muscles, and a poor vitamin D status may cause functional limitations," they said. "However, the previously found associations may be caused by, for example, less sunshine exposure due to mobility limitations."

Sohl and her co-workers added that the vitamin may exert its effects via genomic and non-genomic pathways. Muscle cells have vitamin D receptors on their surface, and these can activate over 300 genes.

It has been known that vitamin D receptors exist on muscle cells. By binding to this receptor more than 300 genes can be activated.

"Although the current study is not designed to determine the direction of the relationship, the results of the longitudinal analyses, the known presence of vitamin D receptors on muscle cells, and the positive effects of vitamin D supplementation on muscle function at least suggest a potential positive effect of vitamin D on functional performance."

Source: The Journal of Clinical Endocrinology & Metabolism Published online ahead of print, doi: 10.1210/jc.2013-1698"Vitamin D Status Is Associated With Functional Limitations and Functional Decline in Older Individuals"Authors: E. Sohl, N. M. van Schoor, R. T. de Jongh, M. Visser, D. J. H. Deeg and P. Lips

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Vitamin D Crucial During Pregnancy to Avoid Autism Risks

A deficiency of vitamin D during pregnancy may increase the risks of giving birth to a baby with autism, researchers warn expecting mothers.

The findings come at a time when about one in every 88 children in the United States is affected by autism, a developmental disorder that leads to significant social, communication and behavioral changes.

Previous studies have found an association between autism and maternal vitamin D deficiency. Findings of the current study published in Research in Developmental Disabilities recently re-confirm the claims.

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Vitamin D is essential during pregnancy. A severe vitamin D deficiency can lead to infantile rickets, and sufficient intake can reduce childhood wheezing and type 1 diabetes in children.

For the current study, Eva Kocovskaa of the Institute of Health and Wellbeing, University of Glasgow in Yorkhill, UK, carefully analyzed previous studies. They found areas of brain and gene regulation affected by vitamin D deficiency during pregnancy, leading to the development of autism, website Foodconsumer reported.

"Vitamin D deficiency-either during pregnancy or early childhood-may be an environmental trigger for ASD in individuals genetically predisposed for the broad phenotype of autism. On the basis of the results of the present review, we argue for the recognition of this possibly important role of vitamin D in ASD, and for urgent research in the field," Foodconsumer quoted the authors as writing.

Following a diet rich with vitamin D - milk, juice, cereal, orange juice, yogurt and margarine can, to an extent, help in solving this problem. Foods like shiitake and button mushrooms, oily fish (tuna, mackerel, trout, herring, sardines, kipper, carp, anchovies and orange roughy), beef liver, cheese and egg yolks are some of the natural sources of vitamin D apart from sunshine.

Early diagnosis of autism offers better treatment, so efforts have been made from a long time to identify the risk factors and provide a method of early intervention. A study published in Journal of Neuroinflammation found an association between exposure to preservative propionic acid (PA) and autism.

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Vitamin d deficiency impacts on expression of toll

Vitamin d deficiency impacts on expression of toll-like receptor-2 and cytokine profile: a pilot study

Vitamin D is believed to play an important role outside the endocrine system in the regulation of the immune system, and in cellular proliferation and differentiation. The aim of the study was to investigate the impact of vitamin D levels on innate immunity.Methods: Participants for this prospective, longitudinal study were recruited amongst otherwise healthy staff of a large hospital in Victoria, Australia. Those fulfilling the inclusion criteria, including a vitamin D level of Additonally, PBMCs at each timepoint were stimulated with specific TLR ligands and resultant supernatants were assayed for the cytokines TNFalpha, IL-6, IFN-alpha and IP-10.Results: In participants whose vitamin D level was >100 nmol/L post supplementation (n=11), TLR2 expression on PBMCs increased significantly, with no change noted in TLR4 or CD86 expression. Stimulation of vitamin D deficient samples with TLR ligands produced a number of proinflammatory cytokines, which were significantly reduced upon vitamin D normalisation. In patients whose levels returned to a deficient level at 3 months despite ongoing low-level supplementation, an increase in the pro-inflamamtory state returned. This suggests that vitamin D may play an important role in ensuring an appropriate baseline pro-inflammatory state.Conclusions: This ex-vivo pilot study adds clinical evidence supporting a possibly important role for vitamin D in innate immunity. If confirmed, this unique clinical study has potentially significant implications for the treatment of a variety of inflammatory conditions, where achieving optimal vitamin D levels may help reduce inflammation.Author: Samar OjaimiNarelle A SkinnerBoyd JG StraussVijaya SundararajanIan WoolleyKumar VisvanathanCredits/Source: Journal of Translational Medicine 2013, 11:176 Published on: 2013-07-22

Copyright by the authors listed above - made available via BioMedCentral (Open Access). Please make sure to read ourdisclaimer prior to contacting 7thSpace Interactive. To contact our editors, visit our online helpdesk. If you wish submit your own press release, click here.

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Low Vitamin D Linked to Limited Function in Aging Adults

Low Vitamin D Linked to Limited Function in Aging Adults

(HealthDay News) - Among individuals aged 55-65 years, and ≥65 years, vitamin D deficiency is associated with the presence of functional limitations and functional decline, according to a study published online July 17 in the Journal of Clinical Endocrinology & Metabolism.

Evelien Sohl, of the VU University Amsterdam, and colleagues conducted a study using two independent cohorts from the Longitudinal Aging Study Amsterdam, an older cohort of 1,237 individuals aged 65-88 years and a younger cohort of 725 individuals aged 55-65 years. Questionnaires were used to assess the ability and the degree of difficulty in performing six functions of daily living. The association between vitamin D status and functional limitations was examined.

The researchers found that at least one functional limitation was present in 56% of participants in the older cohort and in 30% of participants in the younger cohort. The presence of functional limitation at baseline was more likely in those with vitamin D deficiency (defined as serum 25-hydroxyvitamin D [25(OH)D] of <20ng/mL) than in the reference group (serum 25[OH]D >30ng/mL) for the older cohort (odds ratio [OR], 1.7) and the younger cohort (OR, 2.2). Vitamin D deficiency was associated with an increase in limitations of function at three years in the older cohort (OR, 2) and at six years in the younger cohort (OR, 3.3).

"Seniors who have low levels of vitamin D are more likely to have mobility limitations and to see their physical functioning decline over time," Sohl said in a statement.

The study was partially funded by a grant from Merck.

AbstractFull Text (subscription or payment may be required)

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How Vitamin D Can Help You Avoid Injuries

By Published February 18, 2010 Updated February 19, 2010 at 10:44 am Latest Headlines

New studies find that Vitamin D may be more important than previously thought when it comes to the health of endurance athletes.

Written by: Nathan Koch

As an avid cyclist and runner, I am always looking for ways to improve performance while avoiding forced time off due to injury or illness. While attending the American College of Sports Medicine meeting in Seattle last year, I heard a lecture from a well-known researcher on the benefits of vitamin D supplementation, which included increased athletic performance. I even learned about a study in which Russian and German athletes used ultraviolet sunlamps to improve performance. Four Russian sprinters used UV light and another group didn't. The two groups trained identically for the 100-meter sprint. The control group lowered its time by 1.7 percent and the UV group improved 7.4 percent.

A more recent study from the University of Wyoming's family and consumer science department revealed a direct correlation between vertical leap height (think power) and vitamin D levels.

So, of course, at my next physical, I asked my physician to order a vitamin D blood test (serum 25[OH]D concentration) along with the other standard tests. As a healthy endurance athlete residing in sunny Arizona and training outside on a daily basis, I was shocked by my results, which were 25nmol/L. My physician said that if my levels were any lower I would qualify for aggressive treatment. For the record, maintaining blood concentrations above 80nmol/L is currently considered ideal by most of the literature, although more research is needed.

Vitamin D deficiency is a growing epidemic in the U.S. and throughout the world. The deficiency causes rickets in children, osteoporosis in adults and stress fractures in athletes and has been linked to cancer, cardiovascular disease, multiple sclerosis, rheumatoid arthritis, type-1 diabetes mellitus and even influenza.

Vitamin D (calciferol) is really a combination of cholecalciferol (vitamin D3) and ergocalciferol (D2). D3 is produced by the action of ultraviolet B light on the skin of humans and is found in oily fish. D2 is formed when ultraviolet light irradiates the fungal steroid ergosterol, and very little is found in our food. With few exceptions (see table 1) there is little or no vitamin D in the food people normally eat. In other words, vitamin D deficiency is less a nutritional issue and more an environmental deficit due to inadequate ultraviolet exposure. In the past, most experts thought we could get enough vitamin D from fortified milk, but today there is increasing agreement among researchers that this measure does not even come close to doing the job.

Vitamin D absorption from the sun also has limitations and is affected by latitude, season of the year, time of day, skin pigmentation, use of sun block, age and clothing. Optimal sun exposure typically occurs between 10 a.m. and 3 p.m. and at lower latitudes. Therefore, those of us who live in the northern half of the U.S. or anywhere in Canada or Europe are at risk of being deficient. Whereas our ancestors were exposed to the sun almost daily, today we allow less than 5 percent of our skin to be exposed to sunlight. We work, play and live under artificial light, and when we get the time to soak up some rays, we either block the beneficial rays with high-powered sunscreen or totally overexpose ourselves, turning ourselves into tomatoes.

In athletes, a vitamin D deficiency can cause the dreaded down time resulting from a cold, the flu, stress fractures and joint inflammation. In a 2006 Finnish study on military recruits, Ruohola, et al., concluded that a lower level of serum 25(OH)D concentration may be a predisposing factor for bone stress fractures. Another study, from the University of Wyoming, found that 40 percent of a group of distance runners in Baton Rouge, La., were vitamin D deficient. For those of you who haven't been to Baton Rouge, it is sunny and closer to ideal latitude for vitamin D absorption via skin than most other cities in the U.S. A recent and encouraging study by Lappe, et al., out of Creighton University, found a 21 percent lower incidence of stress fractures in female Naval recruits in a supplemented (vitamin D and calcium) group versus the control group.

So should we increase our sun exposure to guarantee vitamin D sufficiency and subsequently increase our risk of skin cancer? Or should we take supplements and hope that doing so is enough to prevent fractures and illness? As athletes, we know that life is a balancing act. Sometimes we can be extreme and have an all-or-nothing attitude, but this is one challenge that will take a comprehensive approach and require careful moderation.

My everything in moderation theory for optimizing vitamin D efficiency:

1. Monitor your serum 24(OH)D levels with help from your physician. Test in the summer and in the winter.

2. Increase dietary and supplemental vitamin D2 and D3. Again, consult your physician for the specific amount. Remember the recommended daily allowance is low (400 IU) and not up to current research standards. At least 1,000-2,000 IU vitamin D3 per day is considered the new minimum. Recent research demonstrates these levels are safe and effective.

3. Get direct sun exposure for 10 to 30 minutes a couple of times per week. Sensible sun exposure is the most natural and effective way to increase vitamin D levels.

4. If all the above fail, move closer to the equator, surf some waves, eat some fish and do some shots of cod liver oil.

Here's a list of Vitamin D-rich foods from the National Institutes of Health:

Cod liver oil, 1 tablespoon

Mushrooms, enriched with vitamin D, 3 ounces

Salmon, cooked, 3.5 ounces

Mackerel, cooked, 3.5 ounces

Sardines, canned in oil, drained, 1.75 ounces

Tuna, canned in oil, 3 ounces

Orange juice fortified with vitamin D, 1 cup (check product labels, as amount of added vitamin D varies)

Milk, nonfat, reduced fat, and whole, vitamin D-fortified, 1 cup

Yogurt, fortified with 20 percent of the daily value for vitamin D, 6 ounces (more heavily fortified yogurts provide more of the daily value)

Margarine, fortified, 1 tablespoon

Ready-to-eat cereal, fortified with 10 percent of the daily value for vitamin D, 0.75-1 cup (more heavily fortified cereals might provide more of the daily value)

Egg, 1 whole (vitamin D is found in yolk)

Liver, beef, cooked, 3.5 ounces

Swiss Cheese, 1 ounce

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Women Over 50 Should Not Mix Vitamin D and Calcium, New Recommendation

Healthy postmenopausal women who want to ensure healthy bones by taking 400 international units (IU) of vitamin D and up to 1,000 milligrams of calcium might not actually be doing anything to help prevent broken bones, but may instead increase the risk of kidney stones, the U.S. Preventive Services Task Force said Monday.

According to a statement published online Feb. 26 in the Annals of Internal Medicine, the authors said there is no evidence that the supplements at that dose could prevent bone fractures.

Using data from two reviews and a meta-analysis, Virginia A. Moye, M.D., M.P.H., and colleagues on behalf of the USPSTF in Rockville, Md., examined the effects of vitamin D supplementation, with or without calcium, on bone health outcomes in community-dwelling adults. Adverse effects of supplementation were also considered.

"We know that vitamin D and calcium are essential to bone health," says task force member Jessica Herzstein, a public-health specialist who is global medical director at Air Products in Allentown, Pa.

The study showed that low-dose supplements don't prevent fractures in healthy older women, the task force says. Research also suggests that about one in 273 women taking the supplements will develop kidney stones. It's a small risk but worth considering, Herzstein says.

The US Preventive Services Task Force ( USPSTF) found that, regarding premenopausal women and men, the current evidence was insufficient to support an evaluation of the benefits and harms of combined vitamin D and calcium supplementation on the primary prevention of fractures, according to the report.

For non-institutionalized postmenopausal women, insufficient evidence was available to examine the balance of benefits and harms for supplementation with >400 IU of vitamin D3 and >1,000 mg of calcium for primary prevention of fractures. For non-institutionalized postmenopausal women, the USPSTF recommends against daily supplementation with ≤400 IU of vitamin D3 and ≤1,000 mg of calcium.

More than half of U.S. women over age 60 now take the supplements at various doses, according to the task force. Across the age groups, 20 percent of American adults take vitamin D supplements and 17 percent take calcium supplements, according to the 2012 Consumer Survey on Dietary Supplements by the Council on Responsible Nutrition, a supplement industry trade group.

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Vitamin D

Low Vitamin D Levels Can Create Physical Limitations in Older Adults

In fact, according to a recent study, older people with vitamin deficiencies may even struggle with daily physical activities, such as dressing or climbing stairs.

Researchers studied more than 1,300 individuals, aged 55 to 88, in the Netherlands who were followed for a six year period. Each participant's vitamin D level was tracked throughout the period, as well as their daily routine and their ability to function while doing certain physical tasks.

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The study results showed that participants aged 65 to 88 with the lowest vitamin D levels were 1.7 times as likely to have at least one physical limitation as those with the highest vitamin D levels. And worse yet, participants aged 55 to 65 that had the lowest levels of vitamin D were twice as likely to have at least one physical limitation as those with the highest vitamin D levels.

In the oldest group of participants, approximately 70 percent of those with the lowest vitamin D levels had at least one physical limitation, while most of those with moderate or high vitamin D levels had no physical limitations.

The researchers also found that over time, those with vitamin D deficiencies were more likely to develop additional physical limitations. This often occurred over three years among those in the older age group and over six years for those in the younger age group.

"Seniors who have low levels of vitamin D are more likely to have mobility limitations and to see their physical functioning decline over time," study author Evelien Sohl, of VU University Medical Center in Amsterdam, said in a journal news release. "Older individuals with these limitations are more likely to be admitted to nursing homes and face a higher risk of mortality."

These findings seem to indicate that low levels of vitamin D in older individuals may contribute to the declining ability to live independently, according to Sohl.

While the study found an association between low vitamin D levels and limited mobility, researchers must conduct further studies in order to know if they can establish a cause-effect relationship.

More information regarding the study can be found in the Journal of Clinical Endocrinology & amp; Metabolism.

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