News Trends Analysis

Oct. 1, 2011


Reports highlight the evolving role of clinical microbiology laboratories.

With the increasing availability of sophisticated technologies to rapidly diagnose and treat infectious diseases, the duties and the role of clinical laboratory microbiologists, who traditionally perform these tests, could see significant changes in the next few years. That is one of the conclusions of a series of reports published in a special supplement to the September 2011 Journal of Clinical Microbiology.

“This is a very exciting and dynamic period for clinical microbiology: not only are we seeing changes in the way we practice, but we also have a very sophisticated array of tools that are increasingly at our disposal. These tools, and the changes they impart, can substantially improve the quality and delivery of service being provided for our patients,” writes Duane Newton of the University of Michigan Medical School in one report on enhancing the function of clinical microbiology laboratories.

The supplement is based on a symposium held in February 2011 to consider a number of issues facing clinical microbiologists today. Laboratory directors from across the United States as well as a representative of the Food and Drug Administration and individuals from eight companies currently active in the field of clinical microbiology came together to plot a new way forward for the profession over the next five years, encourage relationships between labs and industry, and develop plans to address important unanswered questions in the field.

Participants identified 19 different specific subjects within five primary topic areas: Antimicrobial susceptibility testing, the role of the clinical laboratory in the diagnosis of selected infectious processes, conventional versus molecular methods for pathogen detection and the role of clinical microbiology in infection control, clinical microbiology in the year 2015, and the business of clinical microbiology.

ASCP and Siemens to award more than $125,000 in scholarships for Medical Laboratory Students in 2011-2012.

Annually the American Society of Clinical Pathology and the Siemens Healthcare Diagnostics group celebrate the future of the medical laboratory profession by awarding scholarships to students who have achieved a level of success that merits recognition. Scholarships assist our students in balancing their full-time studies and expenses which arise in the course of their educational endeavors.

As a result of the scholarships, ASCP and Siemens continue to meet the critical shortage of medical laboratory professionals in the United States. Application deadline is November 15, 2011. The purpose of these scholarships is to help defray education costs, promote medical laboratory science as a rewarding career, and help address the workforce shortage of qualified professionals. Visit Siemens-ASCP for scholarship information

Infectious Diseases

Fatal fungal infections resist newest class of drugs.

Fungi that cause severe infections in those with compromised immune systems are resisting the action of the latest group of antifungal drugs. Uncovering their strategies for doing this will lead to more effective treatments, says a scientist speaking at the Society for General Microbiology's Autumn Conference at the University of York.

Candida albicans is the most common hospital-acquired fungal infection and can cause illness by sticking to and colonizing plastic surfaces implanted in the body such as catheters, cardiac devices or prosthetic joints. From there the fungus can spread through the bloodstream to the major organs. While normally harmless to healthy individuals, C. albicans can cause fatal infections in immunocompromised people such as those suffering from cancer, trauma and organ transplantation.

Fungi such as C. albicans are covered in a sugar-rich outer layer (cell wall) that protects the fungus from the environment. The newest class of antifungal drugs, the echinocandins, targets the enzyme that makes one of the two key sugar polymers found in the cell wall, called beta-glucan. Scientists at the University of Aberdeen are investigating how C. albicans responds to echinocandins and have shown how the fungus is able to change the structure of its cell wall to render the drug ineffective.

Dr. Carol Munro, who is leading the research along with Professor Neil Gow, explained, “If levels of drug are used that do not kill the fungus straight away, C. albicans responds by producing an excess of the other key cell wall sugar polymer, called chitin. Fungal cells displaying higher levels of chitin can survive treatment with echinocandins, allowing infection to progress.”

Echinocandins are given by IV injection and have a relatively broad spectrum of activity against most Candida species. The increasing number of reports of sporadic breakthrough infections in patients receiving echinocandin therapy is worrying, explained Dr. Munro.

Bird flu back again, U.N. agency warns.

A new vaccine-resistant strain of avian H5N1 influenza has begun circulating in poultry flocks in Vietnam and China, posing “unpredictable risks to human health,” the Food and Agriculture Organization (FAO) warned on Monday. “In Vietnam, which suspended its springtime poultry vaccination campaign this year, most of the northern and central parts of the country—where H5N1 is endemic—have been invaded by the new virus strain, known as H5N1-,” the FAO said in a statement.

No cases of human infection with the novel strain have yet been reported by the FAO or its sister group, the World Health Organization. Vietnam has remained free of human infections with any avian H5N1 strains this year, according to WHO.

The new strain is “apparently able to sidestep the defenses provided by existing [poultry] vaccines,” the agency said. But the FAO indicated that poultry infections have been rising again. It said nearly 800 outbreaks had been identified since January 2010, compared with about 300 in 2008. Recent poultry infections have been spotted in Israel, the Palestinian territories, Romania, and Bulgaria. The FAO's chief veterinary officer, Juan Lubroth, said the H5N1 virus was most entrenched in Egypt, Indonesia, China, Bangladesh, India, and Vietnam. Most recent human H5N1 infections have been in Egypt, with another small outbreak underway in Cambodia, according to WHO.

The ignored virus that causes liver cancer: Should we be screening blood for hepatitis GB?

Hepatitis G virus was identified in 1995. Some little research was carried out on the virus and the U.S. Food and Drug Administration (FDA) declared it a non-harmful virus in 1997. Researchers in Saudi Arabia, writing in the International Journal of Immunological Studies, present evidence to suggest that this may have been the wrong decision. They claim that transmission of the virus through donated blood that was not screened for the virus as well as infection through other routes has led to an increase in cirrhosis of the liver and liver cancer.

Hepatitis G virus (HGV) was renamed as GB virus C (GBV-C) and is a virus in the Flaviviridae family but has not yet been assigned to a genus. Intriguingly, some evidence suggests that co-infection with the AIDS virus, HIV, somehow enhances the immune system in those patients. However, it is the effects of the virus on the livers of otherwise healthy patients that is of concern to Mughis Uddin Ahmed of the King Abdulaziz Hospital (NGHA) in Al-Ahsa, Saudi Arabia. He points out that since the FDA declared the virus not to cause health problems to humans in 1997, no donated blood has been screened for this virus.

However, Mughis Uddin Ahmed has carried out a review of the scientific literature for the last 16 years that shows the virus to be quite prevalent around the globe. Moreover, there is a correlation with infection with this virus and hepatitis and cirrhosis of the liver, and it is possibly linked to hepatocellular carcinoma.

Infectious Prevention

U.S. blood supply vulnerable to parasitic infection spread by ticks.

Babesia, a tickborne parasite of red blood cells, is being transmitted through blood transfusions, according to results of a collaborative study, led by the Centers for Disease Control and Prevention, of data from the past three decades. Transfusion-associated cases of babesiosis have been increasingly recognized since 1979, the year the first known case occurred. In the report, CDC and collaborators describe 159 transfusion-related babesiosis cases that occurred between 1979 and 2009, most (77 percent) from 2000 to 2009. No Babesia test approved by the Food and Drug Administration is available for screening prospective blood donors, who can feel fine despite being infected.

Babesiosis is a potentially fatal but treatable complication of transfusion. Severe consequences, such as multi-organ failure and death, are most often seen in persons without a spleen, the elderly, and those with a weak immune system. The study authors say prevention strategies, including development of a screening test, are needed. Some manufacturers are working with investigators at blood establishments to develop FDA-approved tests for Babesia for donor-screening purposes.

Protein in the urine spells kidney failure for African-Americans.

African- Americans are four times more likely to develop kidney failure than whites. A new study has found that a condition that occurs when the kidneys are damaged and spill protein into the urine contributes to this increased risk. The study, conducted by William McClellan, MD, of Emory University and his colleagues, appears in an upcoming issue of the Journal of the American Society of Nephrology (JASN), a publication of the American Society of Nephrology. Kidney failure was most common in individuals who excreted large amounts of protein in their urine. African-Americans were more likely to excrete large amounts of protein in their urine than whites.

HPV test beats cytology for cervical screening.

For the last decade cancer research has been guided by a common vision of how a single cell, outcompeting its neighbors, evolves into a malignant tumor. Through a series of random mutations, genes that encourage cellular division are pushed into overdrive, while genes that normally send growth-restraining signals are taken offline. With the accelerator floored and the brake lines cut, the cell and its progeny are free to rapidly multiply. More mutations accumulate, allowing the cancer cells to elude other safeguards and to invade neighboring tissue and metastasize.

A DNA test for cancer-causing human papillomavirus (HPV) catches risky cervical lesions better than liquid-based cytology, researchers found. Detection of the most dangerous HPV-16 and HPV-18 types predicted high-grade cervical intraepithelial neoplasia with 92% sensitivity compared with cytology's 53.3% (P<0.0001), Philip E. Castle, PhD, of the American Society of Clinical Pathology Institute in Washington, D.C., and colleagues reported.

Combining HPV testing with liquid-based cytology held little advantage over HPV testing alone, according to the results of the ATHENA trial published in the September issue of The Lancet Oncology.

Association news

CLMA-ASCLS merger announcement.

The Boards of Directors of the Clinical Laboratory Management Association (CLMA) and the American Society for Clinical Laboratory Science (ASCLS) are excited to announce their mutual support for the concept of merging the two organizations. Both boards are entering into a period of final due diligence, outlined in further detail below.

Members of both organizations were notified by their respective boards in March 2011 of the formation of the CLMA/ASCLS Strategic Alliance (CASA) taskforce. The 10-member task force, 5 from CLMA and 5 from ASCLS, studied how such a combined organization might operate-including areas such as (but not limited to) programs, services, governance, culture, and mission. CASA delivered its final report to the boards of CLMA and ASCLS on June 24.

The CLMA Board voted unanimously, on June 27, to accept the findings of The CASA Report. During the week of July 25th the ASCLS Board of Directors and the House of Delegates voted unanimously to accept the findings of the CASA Report.

As indicated above, both boards have entered into individual final due diligence efforts. These efforts include a detailed review of financials and a review and consideration of a legal opinion on how to best effectuate a merger.

Should the final due diligence yield favorable information, both boards will likely vote on a proposition to merge the associations into a new or combined organization-it is presumed that final due diligence will require approximately 3 to 4 months.

Membership, local leaders, sponsors/supporters, partners, and all stakeholders are being notified of the recent “official” decisions by each board. Based on the CASA report, there is a presumption that the news will be received VERY favorably by all. Both boards are fully committed to maintaining an open and transparent dialogue with membership and stakeholders as discussions progress.

Specific statements and issues from The CASA Report:

CLMA and ASCLS share a vision that the combined organization will be the premier resource for medical laboratory professionals and laboratory leadership to maintain and enhance their knowledge of medical laboratory science and best practices. Its mission will be to promote the practice of excellence in medical laboratory medicine through education, advocacy, and networking.

The combined organization would remain international in scope, with a national governing board, and have local representation. There would be significant opportunities for member engagement via committees, task forces, volunteer involvement, and advocacy. Membership would be open to scientific and technical personnel; laboratory managers and administrators; students; educators; and all those who support medical laboratories and medical laboratory professionals.

The mission and goals of the new combined organization would also include publications such as a peer-reviewed journal, regularly scheduled newsletters, weekly e-newsletters, the Body of Knowledge for Clinical Laboratory Professionals, and the Body of Knowledge for Medical Laboratory Management.