News
Lab collection site on time, on budget
Residents of Medicine Hat and area will soon have a new location for blood and other laboratory testing. As part of the expansion of lab services in Medicine Hat, Alberta Health Services (AHS) has selected a location in a retail service centre, at 46 Carry Drive SE, to be the new site for community lab collections.
"The project is currently on time and on budget and is scheduled to be completed sometime in the fall of 2016. Then it will be ready to be opened in the spring of 2017," said Mauro Chies, Vice President of Clinical Support Services for AHS.
In addition to a waiting room, reception area and washrooms, there are 12 phlebotomy stations for taking blood specimens that will be sent to the laboratory at the hospital for testing. The Carry Drive location will also do ECGs and provide Holters — to continuously monitor various electrical activity of the cardiovascular system for at least 24 hours, said Ward.
The plan is to continue using Medicine Hat Diagnostic Laboratory until its contract expires in March 2017 and the transition to AHS is complete. If a decision is made to switch to Carry Drive sooner there would be absolutely "no interruption of servic" to the general public.
Iron Horse Diagnostics, Inc. announces license agreement with global IVD powerhouse EUROIMMUN AG for first-to-market ALS diagnostic test
Iron Horse Dx announced that they have signed a nonexclusive license agreement with Euroimmun Medizinische Labordiagnostika AG (Lübeck, Germany) to launch the first biological diagnostic test for amyotrophic lateral sclerosis (ALS), more commonly known as Lou Gehrig’s disease.
Under the terms of agreement, Euroimmun AG, with distribution into over 130 countries, will have the nonexclusive rights to launch the ALS diagnostic assays as a CE marked product, while Iron Horse is launching the assay in the U.S. as a laboratory-developed test in CLIA-certified laboratories. Iron Horse is working in close collaboration with the ALS Association.
The ALS Test is based on over 20 years of research by Dr. Robert Bowser, President of Iron Horse Dx, and is shown to be 93% accurate (positive predictive value = 0.939 and negative predictive value = 0.917). According to Dr. Bowser, "We have come a long way in researching and understanding the complexities of ALS over the past few years. The ALS Test will benefit patients by aiding physicians to make a more rapid and definitive diagnosis, allowing more efficient clinical trials in particular in early phases of ALS, thereby shorting the time to finding a cure."
Holmes to remain at Theranos despite federal ban and gross negligence
Theranos announced that the worst possible outcome of its troubled dealings with federal regulators had come to pass: the Centers for Medicare & Medicaid Services (CMS) had issued sanctions that, among other things, would revoke the company’s license to operate its Newark, California, laboratory and bar its high-profile CEO and founder Elizabeth Holmes from owning, operating, or directing any lab for at least two years.
In updated statements and information posted on its website, Theranos seemed to provide a clear, if not bold answer: Holmes will stay on at Theranos, even if it means abandoning its Arizona lab (where 90% of the company’s tests are processed) and focusing on its machines instead. "The clinical lab is just one of Theranos’ many opportunities to provide access to high-integrity, affordable and actionable health care information, and the company will continue to carry out its mission under the leadership of its founder and CEO, Elizabeth Holmes," the company stated. If Theranos intends to keep the Arizona lab running, it must split from Holmes before the sanctions take effect September 5.
Related Article: Arizona man says bum Theranos blood tests led to heart attack, files lawsuit
Quality
Pre-analytical variation the leading cause of error in laboratory medicine
In a recent report, researchers from Johns Hopkins University School of Medicine made headlines when they estimated that medical error is the third leading cause of death in the United States.
While patient safety remains a struggle in many areas of healthcare, laboratory medicine has been a leader in reducing error, with an estimated total error rate of 0.33%, the lowest in diagnostic medicine. Major advancements in automation and analytical instrumentation have helped reduce laboratory-associated errors over the last decade, but with pre-analytical errors currently accounting for up to 75% of all mistakes, laboratory medicine professionals must keep expanding their focus to what is happening outside of the lab.
There are four general categories of pre-analytical variability, including:
- test ordering
- patient preparation
- specimen collection
- specimen processing, transportation and storage.
Read this article to understand each category and the sources of variation, potential solutions, in addition to appropriate QIs.
Clinical Chemistry
Genetics of type 2 diabetes revealed in unprecedented detail
Published in the journal Nature by an international team of more than 300 scientists led by the University of Oxford, the Broad Institute, and the University of Michigan, reveals the complexity of type 2 diabetes in more detail than previously appreciated and identified several promising targets for new treatments.
Using DNA sequencing in more than 120,000 people with diverse ancestral origins, some had their entire genome sequenced while others received focused genome coding for proteins known as exome. The researchers then compared the genetic changes between affected and healthy participants. The findings suggest that most of the genetic risk of type 2 diabetes can be attributed to common, shared genetic variants rather than many rare variants unique to individuals. The researchers also identified over a dozen genes in affected participants where changes in the DNA sequence altered the structure or composition of the proteins they encode, suggesting that those genes and proteins are directly involved in the development of the disease and providing important clues to the mechanism by which they confer risk.
Results indicate that any personalized approach to treatment and prevention of type 2 diabetes will need to be tailored on the basis of an individual’s broader genetic profile, as well as environmental factors.
Transfusion Medicine
Researchers find association between donor age, female sex and transfusion outcomes
A large Canadian study has shown a link between blood donor characteristics and transfusion recipients' outcomes. This is the first study to suggest that red blood cell transfusions from young donors and from female donors may be associated with poorer survival in recipients.
"[It] is important to remember that our study was observational in nature, which means it cannot be considered definitive evidence." said Dr. Dean Fergusson, a senior scientist and Director of the Clinical Epidemiology Program at The Ottawa Hospital.
The study, published in JAMA Internal Medicine, evaluated the impact of blood donor sex and age on recipient outcomes by linking 30,503 transfusion recipients with their respective blood donors (80,755 donors). The researchers found that recipients of female donor red blood cells were associated with an 8% increased risk of death (from any cause) per unit transfused compared with recipients of male donor red blood cells. For example, six units of red blood cells translates into an associated risk of death of 36% for recipients of all-female donor blood compared to 27% for recipients of all-male donor blood one year later. Recipients of blood from donors aged 17- 20 were associated with an 8% increased risk of death per unit transfused compared with recipients of red blood cells from donors aged 40-50.
Microbiology
Genes found in H. pylori that influence biofilm formation
Most bacteria cannot survive in the acidic environment of the human stomach, but Helicobacter pylori, a major cause of ulcers, thrives under such circumstances. New research has shown that one of that bacterium's regulatory proteins that helps it adapt to these stressful conditions also regulates the formation of biofilms. Biofilms, a group of bacteria that adhere together on a surface, are often much harder to kill than bacteria in their normal, disaggregated state, and can cause major medical problems. In the study, investigators created a series of H. pylori strains that contained combinations of mutations that encode three known important regulatory proteins, which they figured would be involved in adaptation to stressors.
In particular, two genes, ArsS and ArsR, were thought to work together to sense and respond to acid stress. To the investigators' surprise, strains that lacked a functional ArsS gene formed a thick biofilm-like ring on the growth flask at the liquid-air interface, and formed large clumps of bacteria in the liquid media. Subsequently, it was found that the biofilm was forming more quickly and to a greater degree in these ArsS-deficient strains, as compared to other mutants. "The research gives us the opportunity to start to explore role of biofilms in H. pylori biology," said Dr. Scott Merrell, Professor of Microbiology and Immunology at the Uniformed Services University.
Molecular Biology
For the first time, scientists to sequence genes in space
Given her background in researching some of the deadliest pathogens on Earth, including Ebola, colleagues of newly arrived astronaut Kate Rubins had expected her to want to do "crazy science fiction" on the International Space Station. Instead, Rubins pushed for carefully controlled experiments with a mix of a bacteria, a common virus and mouse cells, all already repeatedly sequenced and safe for testing in the space station's closed-loop environment. One of the first things the scientists need to prove is just how well the machine operates in microgravity (MinION sequencer). With most sequencers, scientists put in a sample and it runs for 24 to 48 hours, then stops. The station's sequencer displays its analysis as it works. It will be the first use of the machine in space, Sarah Wallace, a microbiologist at the National Aeronautics and Space Administration's Johnson Space Center in Houston, said in a news briefing on Wednesday.
Currently, samples from space must be frozen and flown back to Earth for analysis. In the future, Rubins would like to use the DNA sequencer to learn more about potential colonies of microbes that have taken up residence in the station's water system and elsewhere aboard the orbiting laboratory. The sequencer could be used to help diagnose illness in astronauts on the space station and understand whether any disease-causing microbes are susceptible to antibiotics, helping to conserve valuable medications that cannot be readily restocked. It could pave the way for its use in remote or resource-poor areas on Earth.
Research
Stem cell scientists discover genetic switch to increase supply of stem cells from cord blood
International stem cell scientists, co-led in Canada by Dr. John Dick and in the Netherlands by Dr. Gerald de Haan, have discovered the switch to harness the power of cord blood and potentially increase the supply of stem cells for cancer patients needing transplantation therapy to fight their disease.
The proof-of-concept findings, published online in Cell Stem Cell provide a viable new approach to making more stem cells from cord blood, which is available through public cord blood banking.
In the lab, analysing murine and human models of blood development, the teams discovered that microRNA (mirR-125a) is a genetic switch that is normally on in stem cells and controls self-renewal; this normally gets turned off in the progenitor cells. "Our discovery shows a method that could be harnessed over the long term into a clinical therapy and we could take advantage of cord blood being collected in various public banks that are now growing across the country… About 40,000 people receive stem cell transplants each year, but that represents only about one-third of the patients who require this therapy," says Dr. Dick. "That's why there is a big push in research to explore cord blood as a source because it is readily available and increases the opportunity to find tissue matches."
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