News
Province announces new super lab at U of A’s south campus
A parcel of provincial land near the University of Alberta’s south campus has been chosen as the site for a massive, high-tech medical testing lab scheduled to open in 2022, the provincial government announced on December 21st.
Health Minister Sarah Hoffman said the facility will become the new central hub for processing more than 80 per cent of the medical tests in the Edmonton region, while also serving as a training and research centre for innovations in diagnostics.
The lab will have the capacity to accommodate a greater volume of tests, while also providing the opportunity to introduce new high-tech, specialized diagnostics — such as genetic testing — that are currently outsourced. As well, dedicated research space will help academics develop their diagnostic innovations into marketable products that can put to use in the health system, Yiu said.
In addition to announcing plans for the lab facility, Hoffman also unveiled her government’s decision that management of all lab services in the province will be operated by a new subsidiary of AHS beginning next year. Calgary Laboratory Services is currently operated under such a model. However, provincewide, lab services are delivered by at least six different organizations, resulting in a fragmented system that is "needlessly complex," Hoffman said.
The decision ends a long period of uncertainty over lab services dating back to 2015, when AHS was set to sign a $3-billion deal to have a private company build a new lab facility and manage virtually all medical testing in the Edmonton region
Lab Tests Online Redesigns Website to Improve Patient Access to Crucial Information About Clinical Tests
Lab Tests Online, AACC's award-winning public resource on laboratory testing, is pleased to announce that it has launched a dynamic redesign of their website to better help patients, caregivers, and medical professionals understand the many lab tests that are an integral part of healthcare.
The launch of the new Lab Tests Online marks the first major redesign of the U.S. site since its initial debut in 2001. Between now and early 2018, the global Lab Tests Online sites for Brazil, China, Turkey, the U.K., Korea, Hungary, Italy, and Spain will also unveil new website designs. The redesign aims to enhance the user experience by adding new functionality and enabling users to access the site via mobile device. User-friendly tools like pull-down menus will remain, while new features have been added such as image galleries and an improved article layout. Following this redesign, the site will continue to evolve over the next few years with advanced features to optimize the user experience.
"Lab Tests Online is a vital resource for patients around the world and has served more than 300 million users globally since 2001," said AACC CEO Janet Kreizman. "Through this redesign, we now hope to make it even easier for patients to access easy-to-understand information on lab tests so that they can work with their healthcare providers to find the most effective treatments possible."
Clinical Chemistry
New Cholesterol Test May Allow Patients to Pass on Fasting, Study Suggests
In a direct comparison study, Johns Hopkins researchers have added to evidence that a newer method of calculating so-called "bad cholesterol" levels in the blood is more accurate than the older Friedewald method in people who did not fast before blood was drawn. The research results, published Jan. 2 in Circulation, suggest that routine fasting for cholesterol tests could be eliminated for most people, making such screening more convenient.
The newer method for calculating LDL was developed by Seth Martin, an assistant professor of medicine at the Johns Hopkins School of Medicine, and his colleagues in 2013. Other researchers in the United States and abroad have confirmed the method's greater accuracy, and it has been adopted by at least one major U.S. national diagnostic company.
"Although the new LDL calculation method is a bit more complex, the beauty is that it can be performed using information that is already collected in the blood sample for the standard lipid profile and automated in the lab's computer system to give a more accurate result," said Martin. "Since nonfasting samples are now accurate, it's more convenient for patients because they can come in at any time and don't need to return for a second appointment if they have eaten."
For the study, the researchers compared the accuracy of the new LDL calculation method with the Friedewald method, which was developed in the late 1970s when patients fasted or did not fast. The Friedewald method was shown by Martin and colleagues in 2013 to underestimate LDL cholesterol levels, particularly in people with high triglycerides—fatty acids that tend to be higher in people with obesity and diabetes and that increase after eating. The method, the researchers say, applies a one-size-fits-all factor to everyone and doesn't take into account variations among individuals.
The newer method uses a chart developed by Johns Hopkins physicians with 180 different factors to more accurately calculate LDL cholesterol and individualize a person's assessment. The new test doesn't take any longer to provide results to physicians and patients, and the cost is the same to administer.
Click on the article title above to learn more about the test.
Hematology
Lymphocytosis Can Be Anything – Lablogatory
Case Study
A 63 year old patient presented with a high white cell count of 108 K/uL and thrombocytopenia of 110 K/uL.
Peripheral smear examination revealed marked lymphocytosis with presence of numerous small to medium sized lymphoid cells with round to oval nuclei, clumped nuclear chromatin and variable amount of cytoplasm, some with cytoplasmic projections. As the features were consistent with a lymphoproliferative disorder peripheral blood was sent for flow cytometry.
Based on the morphology the differential diagnosis included B-cell lymphoproliferative disorders such as marginal zone lymphoma, hairy cell leukemia/variant, or less likely chronic lymphocytic leukemia and/or mantle cell lymphoma.
Flow cytometry revealed presence of clonal B-cells expressing CD19, CD20, Cd11c, CD103 and FMC-7. The cells were negative for CD5, CD10, and CD25.
The phenotype together with the morphology and CBC findings were diagnostic of hairy cell leukemia variant.
Discussion
Hairy cell leukemia variant ( HCL-v) is a B-cell lymphoproliferative disorder that resembles classic hairy cell leukemia but exhibits variant cytological and hematological features such as leukocytosis and also shows variant immunophenotype including absence of CD25, CD123 and/or annexin A1.
HCL-v is about one tenth as common as HCL (hairy cell leukemia) with an annual incidence of approximately 0.03 cases per 100,000 population. There is slight male preponderance. Patients with HCL-v typically present with leukocytosis with an average WBC of 30 K/ul and /or thrombocytopenia.
The 5 year survival rate is around 50-60%. Most patients require therapy which can range from splenectomy to combination chemotherapy with Rituximab.
Microbiology
Laboratory technique can detect Zika virus infection and make diagnostic tests more accessible
A new test for the Zika virus could help limit future outbreaks, especially in areas without access to sophisticated diagnostic methods.
The current gold standard diagnostic test identifies the presence of Zika virus RNA in blood or urine. To be sure of detecting infection, however, blood samples must be taken within seven days of the onset of symptoms or within 14 days for urine. There are also tests for antibodies against the virus in blood, but these tests can fail to distinguish Zika from closely-related flaviviruses like dengue.
A team of researchers from Singapore, Estonia and Russia made a synthetic version of NS3, a protein that helps the Zika virus replicate. They injected these proteins into rabbits to generate NS3 antigen-specific antibodies, which they then added to blood samples taken from 47 Zika patients at Tan Tock Hospital in Singapore.
The researchers used a flow cytometry technique called fluorescence-activated cell sorting (FACS) to measure the proportion of white blood cells containing Zika virus antigen in the patient samples. After tests on samples from healthy controls, the group set the threshold for Zika virus infection at 0.5 per cent.
Detection rates of less than 10 per cent, 10–40 per cent and more than 40 per cent were characterized respectively as low, medium and high.
All the samples from patients in the high detection group were taken between two and five days after the onset of symptoms, suggesting this may be the optimum window for the test. Further tests also showed the technique can differentiate between Zika virus and similar viruses.
"The current detection methods all have limitations," says Ng. "Using FACS to detect Zika virus NS3 antigen in the blood could offer a relatively efficient and fast complementary method. It can be done using fresh blood samples and requires minimal processing, and so could be especially useful in settings where there is no access to the equipment and trained technicians required by current molecular tests."
Molecular Genetics
New Genome Scores Predict Breast Cancer Odds for Any Woman
Angelina Jolie prompted droves of women to seek genetic testing after she revealed, in 2013, that a “faulty gene” called BRCA1 had given her an 87 percent chance of developing breast cancer. The subsequent surge in women asking for DNA tests was dubbed the "Angelina effect." Yet most never found out what they wanted to know. That’s because only 10 percent of women with a family history of breast cancer are ever found to have an inherited cancer gene. Now Myriad Genetics, the Utah firm that tested Jolie’s genes, says it has started offering a new type of DNA test that could eventually tell any woman her risk of breast cancer.
The new test works very differently from older ones. Instead of checking notorious genes like BRCA1 and BRCA2, another gene with variations tightly linked to breast cancer, it instead scavenges for small clues distributed throughout a woman’s genome. Adding these together creates what is called a "polygenic" risk score. In some cases, women are learning that their potential risk of breast cancer is 60 percent or more.
Scientists are calling polygenic risk scores a potential crystal ball. In addition to breast cancer, tests to predict who will get Alzheimer’s or suffer a heart attack are in development. Myriad is the first large company to market one, several doctors said.
The new predictions are the payoff of billions spent by the U.S. and other governments over the last decade on giant population studies that searched for the genetic causes of disease. By comparing people’s DNA, scientists began zeroing in on individual genetic letters—among the billions in a genome—that, statistically, appeared more often in those who got specific diseases like breast cancer.
"A poly-gene is a gene that acts in concert with other genes. It has a small effect, but when you put them all together, we found it did predict the risk of breast cancer," says Myriad’s chief scientist, Jerry S. Lanchbury.
In its new test, Myriad combines 86 DNA variants with a person’s history, including information on how old a woman was at puberty. The results can be as strongly indicative of breast cancer risk as a mutation in the BRCA gene, but those odds will apply to many more women.
Safety
Vacuum Sealing Reduces Nurses' Exposure to Formaldehyde
Histology technicians and anatomic pathology (AP) laboratories regularly handle dangerous chemicals such as formaldehyde. They understand the risks exposure brings and take precautions to minimize those risks. However, in operating suites worldwide, nurses assisting surgeons also are being exposed to this nasty chemical.
Nurses must place biopsies and other tissues into buckets of formaldehyde to preserve the tissue between the operating room (OR) and histology laboratory. Formaldehyde, along with toluene, and xylene, is used to process and preserve biopsy tissue, displace water, and to create glass slides. It is an important substance that has long been used to maintain the viability of tissue specimens. Thus, exposure to formaldehyde among nurses is well-documented.
According to a National Academy of Sciences report, formalin, a tissue preservative that is a form of formaldehyde, has been linked to:
- Myeloid leukemia
- Nasopharyngeal cancer
- Sinonasal cancer
However, as Dark Daily previously reported, "One alternative to storing specimens in buckets with formalin is to vacuum-seal specimens … [so] that both the quality management of the patient specimen and worker safety for handling the specimens are greatly improved."
Now, motivated by increasing formaldehyde regulations in Europe, as well as the need to increase awareness of exposure risks, the University of Turin (Unito), and other hospitals in Italy’s Piedmont region, conducted a cross-sectional study of 94 female nurses who were being potentially exposed to formaldehyde. The Unito study showed that nurses using an under-vacuum sealing (UVS) system in ORs are exposed to levels of formaldehyde 75% lower than those who did not use the system. This study differs from other similar tests because the level of exposure is not just potential, due to environmental contamination, but confirmed with analytic data from specific urine analyses.
Click on the article title to read more about the study.
Research
Flush with success: Philly duo invents biodegradable pregnancy test
The idea for a biodegradable pregnancy test came to Bethany Edwards and Anna Simpson in graduate school. The Temple University alums were looking for ways to make everyday health care products sustainable while working on their master’s degrees at PennDesign — and the at-home pregnancy test stood out. "It hadn’t been functionally updated in 40 years," said Edwards. "It was the same stiff plastic stick. What people were doing was adding expensive digital landfill-based components, but nobody was innovating on the sustainability side."
After graduation, Edwards and Simpson formed their Philadelphia-based company, Lia Diagnostics, in 2015 to research and develop their idea. The U.S. Food and Drug Administration approved the idea earlier this month.
Lia’s test uses the same method for checking pregnancy as a plastic at-home test by measuring the hormone called human chorionic gonadotropin (hCG) in urine. And to get the FDA’s official clearance for medical devices, the company’s biodegradable version needed to be as accurate as existing models.
It’s made by sandwiching the diagnostic test strip between two layers of dense paper. Edwards and Simpson developed a stamp-like tool that gives one end ridges that encourage liquid to bead, while the other has a quilted pattern to absorb a urine sample. Edwards said sourcing the fibers also proved to be a challenge because the paper industry doesn’t usually accommodate the strict guidelines of the FDA.
Edwards and Simpson made 6,000 samples in their Center City office, and they partnered with Planned Parenthood to help test them. The FDA study found Lia Diagnostics’ flushable pregnancy test can be stored at higher temperatures than plastic ones, which is useful in markets without air conditioning. And once the results appear — the classic two blue lines for "pregnant," one line for "not pregnant" — they will not eventually dissolve like they do in other tests.
With FDA clearance and $50,000 won at TechCrunch’s Disrupt Berlin conference last month, Edwards said the next challenge is manufacturing to scale and keeping the cost down. The company estimates each test will cost between $9 and $22. They will be available for online purchase in mid-2018. The company plans to eventually move into stores and to expand its compostable techniques to other kinds of single-use diagnostic tools.
Accurate celiac diagnosis in trial of new blood test
An experimental blood test accurately identifies people who do, or don’t, have celiac disease, even if they are following gluten-free diets, researchers say. The two main blood tests used to screen for celiac disease rely on detecting an immune response to gluten, but that immune response gradually disappears in people who avoid gluten.
"Unfortunately, many persons with gluten sensitivity go gluten-free without consulting their clinician for exclusion of celiac disease," said lead study author Dr. Vikas K. Sarna’s from Oslo University Hospital in Norway. "In such cases, guidelines recommend . . . performing a gluten challenge involving daily consumption of gluten for up to 8 weeks, followed by an endoscopic procedure for a biopsy taken from the small intestine (duodenum). Our blood test may replace such a gluten challenge and duodenal biopsy."
The new test is designed to detect immune cells in a blood sample that are specifically targeted at gluten proteins, even when the individual hasn’t been recently exposed to gluten. Sarna’s team tried their test on 62 patients with celiac disease and 19 individuals without celiac disease who were on a gluten-free diet, 10 patients with celiac disease who were eating foods containing gluten and 52 healthy individuals following normal diets. They also used the currently available celiac tests on these participants for comparison.
The old tests detected celiac disease in 9 out of 10 patients who weren’t on a gluten-free diet. But the old tests identified celiac disease in only 4 of the 62 patients who’d been following a gluten-free diet. The new test, by comparison, was 96 percent accurate in distinguishing celiac disease patients from people who didn’t have celiac disease but were still following gluten-free diets. It was 95 percent accurate for distinguishing celiac disease patients who were eating gluten-containing foods from healthy individuals following normal diets, the researchers report in Gastroenterology.
"We calculated that our test is stronger to exclude rather than confirm the diagnosis of celiac disease in gluten sensitive persons," Sarna said. "Although we need more research in this field, we propose that the test be used to exclude celiac disease in persons on a gluten-free diet," he told Reuters Health by email.
"It is important to point out that this test is still not available for commercial use, although there is a huge demand of a test for celiac disease that can be applied for persons that are already on a gluten-free diet," Sarna said. "I do hope that the promising results from our study can initiate commercial initiatives along with more research, to allow this test to be used in the general public in the near future."
Several members of the research team have applied for a patent on this testing technology, and some disclose that they are consultants for companies. The clinical trial in the current study was paid for by the Research Council of Norway, the authors note.
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