This new 5-part series of educational guides from Randox Quality Control explains how to improve laboratory performance through quality control. It is easy for laboratories to get caught up in an abundance of QC statistics and forget the fundamental reason why QC exists in the first instance. QC is about detecting errors and ensuring that the results produced are accurate and reliable. With 70% of all medical decisions based on laboratory results, clinical lab specialists are not examining statistics, but real patients, real results and real lives. These five guides are individually titled as follows: Designing an appropriate QC procedure for your lab – An effective QC strategy is not as complicated as one might think. It is vitally important that each and every laboratory has a well-designed QC procedure in place. Troubleshooting QC errors – One analyte has been flagged as “out-of-control”, what is to be done next? How often is Right for QC? – It is widely accepted that laboratories should perform QC at least every day of patient testing. However, is this adequate for every assay and for every laboratory? Which QC is the Right QC? – When running internal QC, laboratories need to be assured of the accuracy of the results produced and, to ensure this, have confidence in the QC materials used. The role of EQA in QC – External Quality Assessment plays an essential role in assuring laboratory quality by facilitating inter-laboratory performance comparison and enabling assessment of the complete testing process.
These guides are available as PDF documents on:www.slideshare.net/Acusera
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The Labquality Days Congress will be held at the Messukeskus Expo and Convention Centre in Helsinki on 11th-12th of February 2016. Labquality Days is one of the largest annual congresses in Scandinavia focused on quality and laboratory medicine. The congress inspires clinical chemistry, laboratory medicine professionals, researchers, healthcare experts, users of point-of-care devices, medical staff working with quality issues, managers and higher level personnel administration of social- and or healthcare sectors. The 2016 congress themes are now announced: Point-of-Care Testing (POCT) and preanalytics. POCT has already a major role in healthcare workflow. Test sensitivity or specificity, price, speed and patient convenience are some heavily discussed topics in scientific meetings. In preanalytics, various disciplines such as microbiology, clinical chemistry and hematology have their own characteristic variables. Individual analyses have some unique factors that should also be taken into account in order to obtain reliable results. Labquality Days will bring together leading international speakers and opinion leaders. The programme consists of scientific lectures and panel discussions. During the congress participants have the opportunity to meet colleagues, share ideas and experience the vast clinical laboratory exhibition.
www.labqualitydays.com
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Researchers funded by the National Institutes of Health have discovered the cellular switch that boosts the activity of sperm cells so that they can travel to the egg. The finding may lead to new options for male contraception as well as treatments for infertility resulting from problems with sperm mobility.
Inside the male reproductive tract, mature sperm are capable of limited movement. This limited movement, however, is not enough to propel them toward the egg when they enter the female reproductive tract. To begin their journey, they must first be activated by the hormone progesterone, which is released by the egg.
The researchers report that the molecule to which progesterone must bind is the enzyme alpha/beta hydrolase domain containing protein 2 (ABHD2), found in the sperm cell’s outer membrane. The study was conducted by Melissa R. Miller and colleagues at the University of California, Berkley, the University of California, San Francisco, and Yale University School of Medicine in New Haven, Connecticut.
“This is an important advance in explaining how sperm become hypermotile in the female reproductive tract,” said Stuart Moss, Ph.D, director of the male reproductive health program at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, which funded the study.
“Developing new compounds that block ABHD2 ultimately may yield new contraceptive methods to prevent sperm from reaching the egg.”
Similarly, strategies to bypass or enhance the enzyme might provide therapies for treating infertility resulting from sperm that lack movement capability.
Before a sperm can transition to the hyper-active phase, calcium must pass through the cell’s outer membrane and enter the flagella, the tail-like appendage the cell uses to propel itself. The sperm protein known as CatSper joins with similar proteins in the flagella to allow the entry of calcium.
When the researchers undertook the current study, it was not known whether progesterone interacted directly with CatSper to trigger the calcium influx, or acted on some other molecule (which, in turn, acted on CatSper). Before treating sperm with progesterone, the researchers exposed them to a chemical that inhibits a particular class of enzymes that they believed could include the candidate molecule that acted on CatSper. The hunch proved correct: the treated cells remained inactive after progesterone exposure, indicating that CatSper was not directly involved.
Working with modified progesterone, the researchers eventually isolated ABHD2 from the sperm tails. When the researchers inactivated ABHD2, exposure to progesterone failed to activate the sperm cells, confirming that ABHD2 is the molecular target for progesterone.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Alex Travis, associate professor at the Baker Institute for Animal Health, co-authored the study that led to the development of a new stroke diagnosis tool.
Minutes count when treating stroke, but current diagnostics take as long as three hours, careful lab work and skilled technicians to arrive at a conclusive diagnosis. Scientists at Cornell’s Baker Institute for Animal Health have developed a device that helps diagnose stroke in less than 10 minutes using a drop of blood barely big enough to moisten your fingertip.
Having demonstrated proof of principle, the technology eventually could be expanded and used in point-of-care testing devices to diagnose other conditions in humans and animals, including traumatic brain injury (concussion), some forms of dementia, and even some types of cancer and heart disease.
The study’s lead author, Roy Cohen, a research scientist at the Baker Institute, says the technology represents the successful pairing of two big goals in medical diagnostics – small size and simplicity, a combination that means testing could be carried out at a patient’s bedside.
“Three-quarters of stroke patients suffer from ischemic stroke – a blockage of a blood vessel in the brain. In those cases, time is of the essence, because there is a good drug available, but for a successful outcome it has to be given within three or four hours after the onset of symptoms,” says Cohen. “By the time someone identifies the symptoms, gets to the hospital and sits in the emergency room, you don’t have much time to obtain the full benefit of this drug.” Enhancing the speed of diagnosis could save many people from suffering lasting effects of ischemic stroke, he says.
To diagnose stroke, a condition in which blood flow to an area of the brain is limited or cut off, the technology will one day detect several bloodborne biomarkers, molecules that appear in the blood when the stroke occurs. The technology uses enzymes attached to nanoparticles to detect the biomarker molecules and convert that detection into light.
To demonstrate the effectiveness of this new approach, the researchers focused on the biomarker neuron-specific enolase (NSE), a substance found in higher concentrations in the blood of victims of stroke and other conditions. By measuring the amount of light produced from various samples, Cohen and his colleagues can determine the concentration of NSE in the sample. At each step of the way, the signal from the NSE is amplified, so even minute quantities give off enough light for detection.
The idea to tether the enzymes, says co-author Alex Travis, associate professor of reproductive biology at the Baker Institute for Animal Health, came from the hardworking enzymes tethered to the shafts of sperm tails. These sperm enzymes efficiently turn sugars into energy that powers the flagellum and moves the sperm along. The fact that they’re attached to the sperm tail instead of floating around in solution enables the enzymes to efficiently pass the substrate along from point to point and get the most “bang for the buck” from a sugar molecule, according to Travis.
Going forward, Travis and his team will collaborate with a private company to develop the stroke-detecting technique for clinical testing and eventually make it available for use in hospitals. But he’s also excited to expand the system to diagnose other conditions.
“This system could be tailored to detect multiple biomarkers,” says Travis. “That’s the strength of the technique. You could assemble a microfluidic card based on this technology that could detect 10 biomarkers in different wells, and the readout would be the same for each one: light.” Using the same detection system for multiple different biomarkers would make for a simple system in a relatively small package, he says.
Cornell University
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Cancer is a result of normal cellular functions going wildly awry on a genetic level. That fact has been known for some time, but increasing evidence is showing that the human microbiome, the diverse population of microorganisms within every person, may play a key role in either setting the stage for cancer or even directly causing some forms of it. A new study from the Perelman School of Medicine at the University of Pennsylvania, led by Erle S. Robertson, PhD and James C. Alwine, PhD, has identified, for the first time, an association between two microbial signatures and triple negative breast cancer (TNBC), the most aggressive form of the disease.
‘Viruses and other microorganisms probably have much more to do with cancer, at least the propagation of cancer and promotion of it, than is really known,’ said Alwine, a professor of Cancer Biology and associate director for core services at the Abramson Cancer Center. Using a microarray technology called PathoChip containing 60,000 molecular probes to identify all known viruses and pathogenic bacteria, fungi, parasites, and other microorganisms, Robertson, a professor of Microbiology and his colleagues screened tissue samples from 100 TNBC patients.
They also examined 40 matched and non-matched controls (matched controls are non-tumour tissue from TNBC patients; non-matched controls are breast tissue from healthy patients).
The team found a distinct microbial signature distinguishing TNBC tissue from normal samples, which could be further delineated into two broad clusters, one predominantly viral and the other predominantly bacterial, with some fungi and parasites.
‘If we look at this closely, we may also find some smaller clusters within those major groups that could give us some insights to unique identifiers for individuals in these clusters,’ stated Robertson, who is also associate director for global cancer research and co-leader of the tumour virology program at the Abramson Cancer Center. He explains that the team found ‘about 30 organisms that provide a specific type of signature to give us clues for developing a diagnostic tool.’ Co-authors Sagarika Banerjee, PhD, and Kristen Peck, from the Robertson lab, screened the organisms, and Michael Feldman, MD, PhD, and Natalie Shi from the department of Pathology and Laboratory Medicine, performed the pathology examinations to identify the TNBC cases.
Among the most prevalent viruses detected were Herpesviruses, Parapoxviruses, Retroviruses, Hepadnaviruses, Polyomaviruses, and Papillomaviruses. Significant bacterial signatures included Arcanobacterium, Brevundimonas, Sphingobacteria, and Geobacillus, while fungal species Pleistophora and Piedra and parasitic organisms Foncecaea and Trichuris were among the prominent ones identified.
Alwine emphasizes that the detection of these and the other pathogens in TNBC tissues does not necessarily mean that they actually cause cancer. ‘There are a lot of different ways to look at this,’ he pointed out. ‘It’s possible that some of the organisms we’re looking at have a causative effect, but we don’t know that. We can’t say until it’s been thoroughly tested by many more experiments.’ One possibility is that the organisms could be adding something to the cellular microenvironment that helps damaged cells to become malignant or pushes them over the edge into cancer. Alternatively, certain organisms may simply find tumor tissue a favorable environment, without having any direct involvement at all with the cancer. ‘They might just be there because it’s a good place to hang out,’ Alwine said.
In either case, finding a distinct microbial signature associated with cancer raises the prospect of new diagnostic possibilities. ‘We’re looking at the signature as a potential for being able to diagnose cancer, possibly at an earlier stage,’ Alwine explained.
Penn Medicine
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Genetic errors identified in a new study led by Washington University School of Medicine in St. Louis may reduce risk of heart attacks and serve as a basis for developing new drugs designed to prevent heart disease.
To reduce risk of heart attack, the benefits of a healthy lifestyle are clear. But genetics can still stack the deck. Some people’s genes bestow a natural advantage — or disadvantage — in protecting against heart disease, the leading cause of death worldwide.
Now, a new study that included genetic data from more than 190,000 people has identified two genes that, when altered in specific ways, either promote or undermine cardiovascular health. The findings may help guide efforts to design new preventive drugs, similar to the way statins now are prescribed to lower “bad” cholesterol to reduce the risk of heart disease.
The research is from Washington University School of Medicine in St. Louis, the Broad Institute at Massachusetts Institute of Technology and Harvard.
“We identified genetic variation in several genes that associated with protection from coronary heart disease,” said first author Nathan O. Stitziel, MD, PhD, a Washington University cardiologist and assistant professor of medicine and genetics. “Our findings support the idea that therapies focused on a major pathway regulating triglycerides should help prevent the buildup of plaque in the heart’s coronary arteries and protect against heart attacks.”
To identify genes that might be relevant for drug discovery, the investigators plumbed DNA data from patients with coronary disease and from healthy controls. They searched across more than 220,000 genetic variants that altered proteins to identify those that appeared to influence heart disease risk. Errors in proteins can have major physiologic consequences.
As part of the study, the researchers confirmed past work identifying genes already shown to confer an advantage or a vulnerability in protecting against heart disease risk, and they implicated two new ones — ANGPTL4 and SVEP1. Rare errors in ANGPTL4 were associated with reduced risk of coronary artery disease. The reduction varied from 14 percent for a small error in the gene to cutting risk by about 50 percent when an entire copy of the gene was disabled. The other gene, SVEP1, showed the opposite correlation — a rare error increased risk of coronary artery disease by about 14 percent.
While ANGPTL4 has been the subject of much study, the other gene newly implicated in cardiovascular health is a bit of a mystery. In the new study, Stitziel and his colleagues showed that the error in SVEP1 also was linked to higher blood pressure in their study populations, but beyond that there are few clues to what it’s doing.
In contrast, ANGPTL4 has long been known to play a role in processing triglycerides, a type of fat that circulates in the bloodstream. Doctors measure levels of triglycerides as a marker of heart disease risk, though whether these fats play a role in causing plaque to build up in arteries historically has been a matter of debate. ANGPTL4’s role in processing triglycerides is part of a system called the lipoprotein lipase (LPL) pathway. Blocking ANGPTL4 actually opens up this pathway, allowing the body to process triglycerides from the diet and get them out of the bloodstream.
“The gene’s association with lower triglycerides has been known for a while,” said Stitziel, who also sees patients at Barnes-Jewish Hospital. “But for a long time it was not clear that high triglycerides were a cause of coronary disease rather than a marker of it. Now we know that errors in ANGPTL4 associate with both reduced triglycerides and lower risk of coronary disease. This is another piece of the puzzle that points to a causal role for triglycerides in coronary disease.”
Washington University School of Medicine in St. Louis
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There’s a typical ‘career’ for some allergic people, and it starts very early on the skin: babies develop atopic dermatitis, food allergies may follow, then comes asthma and later on hay fever. A group of scientists led by Ingo Marenholz and Young-Ae Lee at the Max Delbrück Center for Molecular Medicine in the Helmholtz Association (MDC), working with colleagues from several institutions, has now identified seven genetic risk loci for this course of disease. Two of these loci were previously unknown and mainly influence the connection between atopic dermatitis and asthma. According to the study, the regions that determine the risk for atopic dermatitis are mainly those that also determine the risk for the further development of the typical allergic career. This course of disease is also called the ‘atopic march.’ The scientists analysed data from nearly 20,000 people.
For their meta-analysis, the researchers concentrated on cases where atopic dermatitis preceded asthma. They included 12 studies with 2,428 patients and 17,034 healthy people. All of these studies were genome-wide association studies (GWAS) based on millions of genetic variants called Single Nucleotide Polymorphisms (SNPs).
It is the first GWAS for the atopic march and showed for the first time that there are specific genetic loci influencing the march’s unfortunate course. ‘Seen from a physician’s perspective, the prominent role of atopic dermatitis genes for later-onset of asthma is very interesting,“ says Young-Ae Lee.
Max Delbrück Center for Molecular Medicine
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29 September 2015, Darmstadt, Germany— Merck Millipore, the Life Science division of Merck, accepted a Silver Stevie® Award for its AFS® E Water Purification Systems at a banquet held on Friday, September 11 in San Francisco. The award was conferred by The American Business AwardsSM, the premier business awards program in the United States.
The AFS® E systems won the silver award in the ‘Health & Pharmaceuticals – Products & Services’ category in an event dedicated to outstanding new products and technology industries. Finalists were announced in May from over 3,300 entries submitted, and Gold, Silver and Bronze winners were judged and determined by more than 200 U.S. executives. Created in 2002 to recognize the achievements of organizations and professionals worldwide, the Stevie® Awards are organized in six separate programs, including The American Business AwardsSM.
Merck Millipore was represented at the awards dinner by Mohamed Bacchus, Regional Director of Sales West – Lab Water, and Joseph Plurad, North America Field Marketing Manager – Lab Water. ‘These AFS® E water purification systems incorporate our latest innovative technologies,’ said Joseph. ‘I’m proud to accept this award on behalf of all my colleagues worldwide who helped develop and support these new systems. By listening attentively to our clinical laboratory users, we were able to take their demands — as well as unmet needs — into account. The result is impressive, with systems offering our clinical lab customers the best advanced water purification technologies, as well as a unique user interface, serviceability, and sustainability.’
The AFS® 40E, 80E, 120E and 150E Water Purification Systems provide an economical and reliable high-performance solution for clinical analyzers with daily pure water needs up to 3000 liters. These systems integrate Merck Millipore’s state-of-the-art Elix® electrodeionization module, unique E.R.A.™ technology that decreases costs by automatically optimizing water recovery based on feed water quality, as well as 24/7 real-time monitoring and remote control.
Details about The American Business AwardsSM and the list of finalists in all categories are available at: www.stevieawards.com/aba
For more information on www.merckmillipore.com/labwater
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If you would like to speak to a media relations expert, please contact: Alexandra Langlois + 33 (0)6 76 54 41 28 – alexandra.langlois@external.merckgroup.com
About Merck Millipore Merck Millipore is the Life Science subsidiary of Merck, Darmstadt, Germany. As part of the global Life Science business of Merck, Merck Millipore offers a broad range of innovative performance products, services and business relationships that enable our customers’ success in research, development and production of biotech and pharmaceutical drug therapies. Through dedicated collaboration on new scientific and engineering insights, and as one of the top three R&D investors in the life science tools industry, the Life Science business of Merck serves as a strategic partner to customers and helps advance the promise of life science. Headquartered in Billerica, Massachusetts, the global business has around 10,000 employees, operations in 66 countries and 2014 revenues of €2.7 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada. For more information, please visit www.merckmillipore.com
About Merck Merck is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials – and generated sales of € 11.3 billion in 2014. Around 39,000 Merck employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials. For more information, please visit http://www.merckgroup.com/en/index.html
About the Stevie® Awards Stevie® Awards are conferred in six programs: the Asia-Pacific Stevie® Awards, the German Stevie® Awards, The American Business AwardsSM, The International Business Awards, the Stevie® Awards for Women in Business, and the Stevie® Awards for Sales & Customer Service. Stevie® Award competitions receive more than 10,000 entries each year from organizations in more than 60 nations. Honoring organizations of all types and sizes and the people behind them, the Stevies™ recognize outstanding performances in the workplace worldwide. Learn more about the Stevie® Awards at http://www.StevieAwards.com
Merck Millipore, the M mark, AFS, and Elix are registered trademarks of, and E.R.A is a trademark of Merck KGaA, Darmstadt, Germany. Any other trademarks are the property of their respective owners.
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According to the World Health Organization, in 2014, there was an estimated 9.6 million new cases of tuberculosis (TB). TB is one of the leading, potentially-fatal infectious diseases caused by a bacterium known as Mycobacterium tuberculosis (MTB) that commonly affects the lungs. In 2014, nearly 500,000 people developed resistance to the two most powerful, anti-TB drugs known as isoniazid (INH) and rifampicin (RIF). These drug therapies have been used for decades to treat TB, but resistance is becoming widespread from inappropriate or incorrect use. Today, molecular tests from Abbott are available to help doctors diagnose tuberculosis and to detect resistance to INH and RIF. The first test, Abbott’s Realtime MTB (CE-marked), is designed to qualitatively detect MTB in samples from individuals suspected of having tuberculosis. The second test, the RealTime MTB RIF/INH Resistance, was recently CE-marked and is designed to identify single resistance to INH or RIF as well as resistance to both drugs. At this year’s 46th Union World Conference on Lung Health (Cape Town, South Africa), Abbott hosted a satellite symposium titled “Advancing to the Next Level of Molecular Testing for Mycobacterium Tuberculosis (MTB)”.
www.abbottmolecular.com
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The researchers from University College London studied a group of genes that have previously been linked to an increased risk of disease in the arteries. They studied data from nearly 4,000 men and women from across Europe, comparing their genes, their artery thickness and their artery health.
The scientists, led by BHF Professor Steve Humphries, believe they have pinpointed the gene in the group that is associated with an increased risk of a heart attack or stroke in women, but not in men.
Called BCAR1, the gene they identified is involved in many processes in the body that are affected by the female sex hormone oestrogen. The researchers believe that a high risk version of the BCAR1 gene – the GG version – when combined with a woman’s naturally occurring high oestrogen levels, could lead to the increased risk of cardiovascular disease compared with the low risk version – the AA version. Men with the GG version of the BCAR1 gene do not seem to be affected.
Over the five-year study, women with the high risk BCAR1 gene – around a third of those studied – had an increased risk (6.1%) of having a heart attack, stroke or diseased blood vessels compared with those with the low risk version of the gene (2.5%).
Heart disease is the major cause of heart attack and someone has a heart attack in the UK every three minutes. Understanding what puts people at risk of heart attacks is an important part of finding ways to prevent them and potentially treat people with medication to lower their risk of having a heart attack.
British Heart Foundation
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