Infectious Disease
The World Health Organization (WHO) is tracking the Ebola virus epidemic in West Africa. As this issue of MLO goes to press, the Ebola Virus Disease (EVD) epidemic remains restricted to three countries: Guinea (351 confirmed, probable, or suspected cases, 226 deaths), Sierra Leone (89 cases, seven deaths), and Liberia (one death). WHO has not recommended travel or trade restrictions related to the epidemic. The organization and local partners have been supporting the implementation of control and preventive measures in all three countries. In Guinea, healthcare experts have been sent to the hardest-hit Gueckedou and Macenta districts to manage cases and data, to provide guidance on preparedness activities, and to address the issue of community resistance to public health efforts. In Sierra Leone, healthcare workers are being trained to conduct outreach and active search for clinical cases of EVD. The virus was first identified in 1976 in what is now the Democratic Republic of Congo; 280 people died in that outbreak.
Detection of MERS virus by airport scanners may still be several years from becoming effective. According to the international consulting firm GlobalData, the effective detection of the Middle East Respiratory Syndrome (MERS) virus will not become a reality for several years and will require the collaborative efforts of many arms of science. Andrew S. Thompson, PhD, GlobalData’s Senior Analyst covering in vitro diagnostics, states that flawed equipment, the lack of technology for accurately detecting viral particles in breath, and the narrow window during which MERS sufferers shed viral particles are the most significant obstacles to successful airport scanning for MERS.
“The ineffectiveness of infra-red thermal imaging for detecting infected passengers at airports has been well documented,” Thompson says. “While scanners have been reasonably successful at identifying feverish symptoms, they perform poorly in attempts to specifically identify passengers with influenza. It has also been reported that the use of common medications, such as aspirin, can reduce a patient’s fever and allow the virus to evade the scanner.”
Thompson states, however, that despite the shortage of available technologies, there are some prospects on the horizon. “One promising approach is the use of silicone nanowires, in which a protein or DNA biomarker is detected electronically rather than through optical means. Such extremely sensitive techniques, when combined with a suitable means to collect the breath of passengers, could provide a more targeted method to detect recently infected carriers of the MERS virus.” However, even if silicone nanowires were introduced, there would remain the issue of passengers exhaling a particle that can be linked directly to the pathogen, such as viral particles.
Cardiovascular
Urine test could help clinicians spot blood clots in at-risk patients. A new study indicates a simple urine test can indicate the presence of venous thromboembolism, a blood clot that has broken free from its point of origin and which travels through the bloodstream, eventually lodging in a vein. The test evaluates the levels of fibrinopeptide B (FPB), a small peptide that’s released when a thrombosis forms and which is removed from the body through urine.
Lead author Timothy Fernandes, MD, MPH, suggests that urine FPB levels could be used as a screening tool for venous thromboembolism in patients at risks for clots. “The urine FPB test offers advantages over other screening methods because it doesn’t require blood to be drawn and it can provide more accurate results than the D-dimer test,” Fernandes says.
The researchers used stored urine samples taken from 344 patients who participated in the Pulmonary Embolism Diagnosis Study (PEDS), a multicenter study of 1,417 patients considered likely to have an acute pulmonary embolism. For all urine samples, the researchers measured the FPB concentration and evaluated the sensitivity and specificity of the test at various cut-off points in relation to its ability to predict the presence of venous thromboembolism.
What they found was that at concentrations of 2.5 ng/ml, urine FPB demonstrated sensitivity comparable to previously published values for plasma latex and whole blood D-dimer levels, but with greater specificity. Future studies are planned to assess urine fibrinopeptide B in other settings where D-dimer is used, including use of urine fibrinopeptide after anticoagulation to determine the risk of recurrent venous thromboembolism.
Cancer
Bacteria in mouth may diagnose pancreatic cancer. Patients with pancreatic cancer have a different and distinct profile of specific bacteria in their saliva compared to healthy controls and even patients with other cancers or pancreatic diseases, according to research presented recently at the annual meeting of the American Society for Microbiology. These findings could form the basis for a test to diagnose the disease in its early stages.
In the study, researchers compared the diversity of saliva bacteria across 131 patients, 63 female and 68 male, being treated at the University of California, San Diego (UCSD) Moores Cancer Center. Of these patients, 14 had been diagnosed with pancreatic cancer, 13 with pancreatic disease, 22 with other forms of cancer, and 10 disease free. Results showed that patients diagnosed with pancreatic cancer had higher levels of two particular oral bacteria, Leptotrichia and Campylobacter, when compared to any other healthy or diseased state including non-cancerous pancreatic disease. Those with pancreatic cancer also had lower levels of Streptococcus, Treponema and Veillonella.
Blood Bank
FDA issues guidelines on blood container labels. The Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration (FDA) has issued “Guidance for Industry: Recognition and Use of a Standard for Uniform Blood and Blood Component Container Labels.” The guidance can be accessed at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073362.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.
The agency writes: “FDA is issuing this guidance for immediate implementation in accordance with 21 CFR 10.115(g)(4)(i). Submit one set of either electronic or written comments on this guidance at anytime. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You should identify all comments with Docket No. FDA-1998-D-0067 (formerly Docket No. 1998D-0965).”
Molecular Diagnostics
Next-generation sequencing technique saves critically ill teen suffering with encephalitis. In a story that gained wide coverage after it was featured in The New York Times (“In a First, Test of DNA Finds Root of Illness, NYT, June 4, 2014), the value of DNA sequencing not only in the research lab but in the clinical lab was dramatically demonstrated when next-generation sequencing (NGS) was used to diagnose the cause of encephalitis in a critically ill teenage boy. The 14 year old, who was born with SCID, an immune deficiency syndrome, lay in a coma in a Madison, Wisconsin, hospital as his doctors worked to identify the pathogen causing the symptoms. Then the decision was made to use DNA testing, conducted at the University of California, San Francisco, on a sample of his cerebrospinal fluid, and within 48 hours it was confirmed that the cause of symptoms was the rare bacterium Leptospira santarosai. With the pathogen identified, physicians were promptly able to treat the teen with effective antibiotics.
The work by the UCSF group is a dramatic indication that this technology may be ready for widespread use in the diagnoses of individual cases of infectious disease. Next-generation sequencing, in which genetic fragments from patient samples are analyzed for DNA that belong to pathogens, has been used to investigate disease outbreaks, but the time it requires has been a stumbling block when it comes to diagnosing individual infections. What might make this feasible going forward, however, is software developed by researchers at UCSF that quickly compares isolated DNA fragments with genetic sequences that are stored in databases. This technology is described in a paper published in Online Genetics. (http://genome.cshlp.org/content/early/2014/05/16/gr.171934.113.full.pdf+html). An article on the patient whose life was saved by it, published in the New England Journal of Medicine, can be read at http://www.nejm.org/doi/full/10.1056/NEJMoa1401268#t=articleTop.
Diabetes
Research helps clarify how obesity leads to type 2 diabetes. New findings about the biological links between obesity, insulin resistance, and type 2 diabetes may also shed light on the connection between obesity and cancer. In a study published online in the journal Cell, researchers found that a protein called HIF-1 alpha plays a key role in the development of insulin resistance and type 2 diabetes in obese mice.
The scientists genetically engineered mice to lack the HIF-1 alpha protein within their adipocytes (fat cells). The mice still made HIF-1 alpha in other types of cells and tissues in their bodies. The animals became obese when fed a high-fat diet but did not develop insulin resistance and diabetes to nearly the extent that genetically normal obese mice did.
“There is clearly a greater chance among the obese human population to develop insulin resistance and diabetes. We still don’t know the exact mechanism, but now we know that HIF-1 alpha is very active in the pathogenesis of these diseases from obesity,” says Jung-whan Kim, PhD, co-lead author of the study. Kim says the findings about HIF-1, which stands for hypoxia inducible factor-1, are significant for their possible application to fighting insulin resistance and diabetes.
Professional
ASCP and Siemens award 173 scholarships to medical laboratory students in 2014. Siemens Healthcare Diagnostics and the American Society for Clinical Pathology (ASCP) awarded a combined $180,000 in scholarships to the nation’s top undergraduate and graduate medical laboratory students for the 2013-2014 academic year through the Siemens-ASCP Scholarship Program. According to spokespersons, the Program was established to address the nation’s shortage of qualified medical laboratory personnel, to defray education costs, and to promote the profession.
“We extend our congratulations to all of the scholarship recipients,” says Michael Reitermann, CEO, Siemens Healthcare Diagnostics Division. “As these outstanding individuals enter the vital profession of diagnostic medicine, they will without a doubt play a critical role in the delivery of quality healthcare to patients. Siemens is privileged to support them in this endeavor.”
A recent ASCP survey reveals that the national average of job vacancy rates for medical laboratory professionals ranges between 4% and 8%, depending upon the specific area. However, staffing shortages will continue to significantly challenge laboratories as the bulk of the current workforce is expected to retire within the next decade.
“In addition to a continuing workforce shortage, laboratories anticipate seeing a greater demand for testing as the U.S. population ages,” says Mark Bailey, MA HTL(ASCP)CM, Chair of the ASCP Scholarship Committee. “The Siemens-ASCP Scholarships address this challenge by fostering the next generation of skilled laboratory professionals and leaders.”
Awards are available to eligible students in the U.S. pursuing associate bachelor or master’s degrees in medical laboratory science. Special Legacy Scholarships are awarded to students who follow family members into the laboratory profession. Scholarships are awarded by the ASCP, which also administers the program.
Worth Re-quoting
In the article “Lab testing is not a commodity”, Peter Francis makes an interesting point about the perception that testing is a commodity, rather than a service: It can be an impediment to successful outreach. He asserts that labs will not successfully differentiate themselves from their competition by stressing components of their organization’s performance that are, however excellent, what all labs are expected to do. He makes a compelling case that differentiation—that is, training sales staff to point out discrepancies between the lab and the competition—is an important key to success. He suggests this provocative exercise for lab directors.
“Copy the About Us section of several local competitors, scrub logos and names, and paste them on a blank document. Give the page to members of your lab’s staff, and ask them to indicate which one describes their employer. The results may surprise you…and if an employee struggles to see the differentiators, a customer probably will too.”
Why not give it a try, and let MLO know the results of this “assignment”?
