Prion removal technology shows promise in dealing with vCJD “Mad Cow” disease to enhance safety of blood supply
New evidence furthers researchers’ attempts to develop a method that may eventually reduce the risk of contracting variant CDJ (Creutzfeldt-Jakob Disease) from a blood transfusion and enhance the safety of the global blood supply.
The research was conducted in cooperation with two of the nation’s prion research institutions: the Molecular Neurovirology Laboratory of the Veteran’s Administration Maryland Health Care System and the Laboratory of Immunological Neurovirology of the New York State Institute of Basic Research. Researchers used a filtration device in development by Pall Corporation (East Hills, N.Y.), that is based on the company’s surface modification chemistries that have demonstrated an affinity for prions. It was discovered that the filtration apparatus reduces infectious prions, often referred to as rogue proteins, that are present in blood but below the detection limit of current methodologies. Prions are implicated as the cause of several degenerative diseases including vCDJ, the human form of “Mad Cow disease.
Using Pall’s filtration equipment that also reduces white blood cells (leukoreduction), it was found that prions in red blood cells, whole blood and plasma are reduced to levels below the detection limit of the Western blot assay.
Due to findings, which suggest that variant CJD can be transferred via prions in a blood
transfusion, people who have lived or traveled to countries where the disease has occurred are deferred from donating blood. This deferral process has had an impact on the blood supply in several nations. There is currently no method to screen blood for the presence of prions.
Pall is continuing research on its prion reduction technology with the initiation of an infectivity assay. The company plans to complete the research and submit applications for marketing to regulatory authorities in Europe this year.
Mobile DNA found to play a role in Enterococcus resistance to Vancomycin
Scientists from The Institute for Genomic Research (TIGR), writing in the March 28, 2003 issue of Science, have described “jumping” elements of DNA that enable Enterococcus faecalis to acquire antibiotic resistance. Small segments of DNA known as “mobile elements” can jump between organisms or their chromosomes. Nearly one third of the E. faecalis genome is comprised of mobile elements; the Vancomycin resistance is found on a mobile element in the E. faecalis genome.
TIGR’s president and director, Claire M. Fraser, Ph.D., says the deciphered Enterococcus genome will provide an important tool for biomedical researchers. “The identification of a novel Vancomycin-resistant transposon in E. faecalis demonstrates the power of genomics to reveal new insights into the biology of important human pathogens,” Fraser says. “This information is critically important in the search for new antibiotics and vaccines to combat infections diseases.”
Streck Labs acquires Analys Instruments AB
Streck Laboratories of Omaha, Neb. has purchased Analys Instruments AB of Stockholm, Sweden. Analys Instruments manufactures the Sedimatic erythrocyte sedimentation rate line of instruments and accessories. Streck Laboratories has been the exclusive U.S. distributor of Sedimatic instruments, under the Streck ESR-Auto Plus brand name, and supplies controls for ESR tests to accompany the instruments.
Nikon opens 2003 search for world’s best photomicrograph
Nikon announced the start of its global contest that transforms work done in a laboratory into art. The 2003 Nikon Small World Photomicrography Competition is now open to anyone with an interest in photomicrography. The deadline for entries is Monday, June 30, 2003.
Celebrating its 29th year, the annual Nikon International Small World Competition was founded in 1975 to recognize excellence in photography through the microscope. According to Lee Shuett, Executive Vice President of nikon Instruments, “Last May, the New York Times reported that the digital photography boom and the internet’s visual platform have established photomicrography as a burgeoning art form.” Following the 2002 competition, the company launched its annual national museum tour, which is still open to the public.
Nikon expects to disclose the 2003 judges and September celebration plans in May.
Participants may submit their images in traditional 35mm format, or upload digital images directly at MicroscopyU on the Nikon Web site: www.nikonusa.com. The first and second of twenty prizewinners will receive a selection of Nikon products and equipment worth $3,000 and $2,000 respectively.
IOM issues report on microbial threats to health
The Institute of Medicine (IOM) has issued a new report titled Microbial Threats to Health, highlighting accomplishments and challenges in controlling infectious disease. As noted in a news release issued by the Centers for Disease Control and Prevention (CDC), the report comes at the moment that CDC is working with the World Health Organization and health authorities around the world to isolate and identify the cause of Severe Acute Respiratory Syndrome (SARS), a new, emerging infection.
This new IOM report updates a 1992 version, and provides a composite review of public health knowledge and policies to respond to emerging infectious diseases including human demographics and behaviors, microbial adaptation and changes, control of vector-borne infectious diseases, influence of the environment on microbe distribution and viability, human threat from zoonosis, impact of globalization, and public health safety measures.
“The public health upgrades recommended in this report can help protect the country from bioterrorist acts as well as the underlying threat of naturally occurring infectious disease,” CDC Director Dr. Julie L. Gerberding said in the Centers press release.
Since 1992, CDC has advanced a series of innovations in disease tracking, enhanced by advancements in electronic communications technology. For example, through the PulseNet system CDC can now rapidly identify and “fingerprint” specific strains of foodborne pathogens, enabling the agency to more readily link geographically dispersed cases of foodborne illness to a common source of tainted food.
CDC officials agree with the IOM committee that the emergence of new microbes, especially those that have become resistant to antimicrobial drugs, together with the enhanced threat of bioterrorism, require heightened public health vigilance and a stronger response capacity. “This is not the time to become complacent,” Gerberding said. “We have the knowledge to greatly reduce the threat of infectious diseases, and by taking a coordinated approach and using the technological resources now available, we can do just that.”
For more information on emerging and reemerging infectious diseases, visit CDC’s web site at http://www.cdc.gov/ncidod/diseases/eid/index.htm .
Bayer Diagnostics is certified to ISO 9001:2000 quality standard
The Diagnostics Division of Bayer HealthCare of Tarrytown, N.Y. announced that it has received certification to the ISO 9001:2000 Quality System Standard. It had been certified to the earlier (1994) standard for several years.
One of the underlying intentions of ISO 9001:2000 is to make organizations use external information about its customers and industry to stimulate improvements within the company. The new standard brings marketing and the quality system together in three specific areas. First, in the area of customer focus to evaluate how an organization understands the marketplace in which it operates and its ability to determine current and future customer needs. Second, the organization’s ability to meet customer requirements and enhance customer satisfaction through its customer communications and third, through customer satisfaction monitoring as an indirect measurement of the performance of the quality management system.
Breath aerosol specimen collector may aid in detection of heart and respiratory disease
Amidex, Inc., of Denver, Colo., a medical technology company, has filed a patent application for a breath aerosol collection system. According to Amidex, research on breath aerosol — the non-gaseous material in exhaled breath — shows great promise in helping to identify heart, respiratory and other types of disease.
Prior collection methods and products have used condensation of water vapor from exhaled breath in attempts to develop practical clinical detection methods. Condensation only indirectly and very irregularly captures aerosol particles, the company says, making analytical variations too high to support clinical applications. The Amidex collection system directly acts upon aerosol particles and also virtually eliminates condensation. As a result, the company believes that the aerosol specimen is substantially complete and undiluted, making it possible to obtain reproducible measurements.
Dr. Philip Silkoff, Associate Professor and Clinical Scientist at the National Jewish Medical Research Center in Denver, said the technology “could help the medical community devise new screening, diagnostic and monitoring methods that are quick and easy for the patient, and very accurate.”
Amidex is also developing a system for rapid detection and monitoring of cardiac ischemia, combining the new breath aerosol collector with a rapid analyzer to detect the presence of adenosine, a biochemical released from an ischemic heart muscle.
FDA proposes rules for medication bar coding and safety reporting to help reduce error
The Food and Drug Administration (FDA) has submitted two rules aimed at improving patient safety by reducing medication errors and by more quickly identifying potential errors that may occur.
The first proposed regulation, titled “Bar Code Label Requirements for Human Drug Products and Blood,” calls for standardized bar codes on all prescription drug products, including biological products, vaccines (except for physician samples), and OTC drugs. The bar codes would also be required on prescription drug products used in other settings such as retail pharmacies.
The required bar code under proposal would contain the National Drug Code (NDC) number, linked to identifying information about the drug, as part of the product’s label. Manufacturers would also be allowed to include additional information. The FDA speculates that bar code technology will prevent many medication errors including administering the wrong drug, administering a drug to a patient who is known to be allergic, administering the wrong dose, administering the drug at the wrong time, or using the wrong route of administration.
In addition to causing human suffering, medication errors represent a significant economic cost the United States. The expected annual benefit in reducing medication errors is equivalent to $3.9 billion. Also, the FDA estimates that the bar code rule, once implemented, will result in a 50 percent increase in the interception of medication errors at the “dispensing and administration” stages. This should result in 413,000 fewer adverse events over the next 20 years.
The second amendment proposed by the FDA would require companies to submit to the agency, within 15 calendar days, all reports they receive of actual and potential medication errors occurring in the U.S. This would include “near misses” in which a pharmacist selects the wrong medication because of a similar sounding name, but the error is caught prior to dispensing.
Under this proposal, blood establishments would be required to submit to the FDA reports of all suspected serious reactions, not just fatalities, which is currently the case.
In coordination with their proposals, the FDA is using emerging technologies such as automatic reporting systems to promote greater patient safety. These automatic programs are designed to expand with the use of sophisticated electronic information systems in health care, and in many cases will be able to provide results and safety guidance in electronic form to participating providers and organizations based on the electronic data provided.
Deferral of heart patients volunteering for smallpox vaccination is recommended
The Centers for Disease Control and Prevention (CDC) has added a temporary medical deferral to the smallpox vaccination program for persons who have been diagnosed with heart disease. CDC is investigating whether there is any association between smallpox vaccination and reports of heart problems in seven health care workers who have been vaccinated. As of this writing three volunteers have had heart attacks, including two deaths; two volunteers had chest pain, and two had heart inflammation. Ten military recruits also had heart inflammation, and one died of a heart attack.
CDC recommended deferral for persons with known cardiac disease, and a panel of medical advisors has extended the recommendation to include people with three or more major risk factors of heart disease, such as smoking, diabetes, high blood pressure or high cholesterol. Health officials did not know whether the vaccine was the cause of the heart attacks.
Committee passes funding for bioterror treatments, while House rejects cap on vaccine compensation
The Health, Education and Labor Pensions committee of the U.S. Senate unanimously approved the “Bioshield proposal” that would offer government subsidies to firms who invest in developing treatments and vaccines against potential bioterrorist weapons.
The House has voted down a plan to create a fund that would cap at $262,100 individual death or lost wages disability compensation for health care worker vaccine volunteers. The cap was considered low, and the plan to exclude workers unless they volunteer within 180 days of the start of the program was called coercive.
The fund is intended to encourage health care workers to volunteer for the vaccine by providing compensation in case of adverse reaction, but labor and organizations representing health care workers called this proposal inadequate. The Administration’s plans call for 500,000 volunteer first responders to be vaccinated; thus far about 25,000 have received the vaccine.
