viernes, 25 de julio de 2014



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services


July 24, 2014

  • Niacin and HDL Cholesterol — Time to Face Facts
  • Harvard Scientists Want Gene-manipulation Debate
  • Leapfrog Releases 2013 Annual Survey Results, Gets Record Hospital Participation
  • Reducing Sendout Lab Errors: Researchers Have Developed a Prospective Tool for Assessing Risk of Tests Sent to Reference Labs.
  • Tackling Reagent Lot-to-Lot Verification in the Clinical Laboratory
  • HPV Test Beats Pap Smear in Gauging Cervical Cancer Risk, Study Finds
  • Scientists Discover New Way to Make Human Platelets
  • Protein Temporarily Reversed Type 2 Diabetes in Mice
  • Patients Remain in Danger From Preventable Errors
  • Only 1 in 5 Sexually Active U.S. Teens HIV-tested
  • API Provides Open Access to FDA Recall Data
  • Study: Age, Sex, Socioeconomic Status Major Factors in eHealth use
  • Pathologist Michael LaPosata, M.D., Delivers the Message about Diagnostic Management Teams and Clinical Laboratory Testing to Attendees at Arizona Meeting
  • Siemens Sells Clinical Microbiology Biz to Beckman Coulter


View Previous Issues - Healthcare News Archive


Leading News

Niacin and HDL Cholesterol — Time to Face Facts
For the past four decades, the concentration of cholesterol contained in high-density lipoprotein (HDL) particles has been a major focus of research and a target for potential prevention opportunities. Data from observational epidemiologic studies have consistently shown a strong inverse association between HDL cholesterol concentration and the risk of coronary heart disease that is linear and graded, at least through the majority of the HDL cholesterol distribution encountered in the general population. But clinical trials have yet to show a causal role for HDL cholesterol or to deliver the longed-for outcome of reducing the risk of coronary heart disease and the broader cardiovascular risk by raising HDL cholesterol levels specifically.
Niacin, or nicotinic acid (also known as vitamin B3), is an essential human nutrient that increases HDL cholesterol concentrations by means of a variety of mechanisms affecting apolipoprotein A1, cholesterol ester transfer protein, and ATP-binding cassette transporter A1, all of which appear to enhance reverse cholesterol transport. Other effects of niacin also lead to modest reductions in low-density lipoprotein (LDL) cholesterol concentrations and more substantial reductions in triglyceride levels, all of which might be expected to have salutary effects on the risk of coronary heart disease. The earliest trial to test immediate-release niacin, the Coronary Drug Project, suggested that this might be the case among middle-aged men with coronary heart disease and marked hypercholesterolemia.

Harvard Scientists Want Gene-manipulation Debate
A powerful new technology could be used to manipulate nature by “editing” the genes of organisms in the wild, enabling researchers to block mosquitoes’ ability to spread malaria, for example, or to make weeds more vulnerable to pesticides, Harvard scientists said. In an unusual step, however, the Boston team called for a public debate on the wisdom of its audacious idea, which the scientists say could lead to inadvertent species extinctions, new genes spreading through the environment in unexpected ways, and unforeseen ecological ripple effects. The Harvard group, in a paper published in the journal eLife, described a technology called a “gene drive.” It would allow scientists to make changes to the DNA of organisms that would spread rapidly in the wild. 

Leapfrog Releases 2013 Annual Survey Results, Gets Record Hospital Participation
The Leapfrog Group released results from its 2013 annual survey, examining key hospital safety and quality elements at a record 37 percent of hospitals across the country. As the industry moves toward quality, value-based care, the results have never been more important. "The stakes couldn't be higher. Hospital errors remain the third leading cause of death in the U.S., so we want patients and purchasers to put safety first," Leah Binder, president and CEO of Leapfrog, said in an announcement. To learn more: - here's the report Adobe PDF fileExternal Web Site Icon 

Ebola Evidence in West Africa in 2006: USAMRIID Providing On-Site Laboratory Support to Current Outbreak
Analysis of clinical samples from suspected Lassa fever cases in Sierra Leone showed that about two-thirds of the patients had been exposed to other emerging diseases, and nearly nine percent tested positive for Ebola virus. The study, published in this month's edition of Emerging Infectious Diseases, demonstrates that Ebola virus has been circulating in the region since at least 2006 - well before the current outbreak. The laboratory testing site in Kenema is supported by the Armed Forces Health Surveillance Center-Global Emerging Infections Surveillance and Response System. In collaboration with the host country, the site enables collection of samples that can be used in research toward new medical countermeasures, and allows USAMRIID to evaluate the performance of previously developed laboratory tests using samples collected on-site. The Institute hopes to eventually obtain viral isolates for medical countermeasure development and receive data on the performance of the diagnostic assays.
Source: Web Site Icon


Laboratory Testing / Diagnostics

Reducing Sendout Lab Errors: Researchers Have Developed a Prospective Tool for Assessing Risk of Tests Sent to Reference Labs
Some specialized lab tests pose a particularly high risk for patient harm, according to a study funded by the Agency for Healthcare Research and Quality. The authors of the study developed a tool that could be used by laboratories to identify areas of highest risk to patients. Their findings were published in the journal Clinica Chimica Acta. One recent study at a major reference laboratory found that up to one-third of genetic tests were ordered incorrectly. So-called sendout laboratory tests, those sent to reference labs because the test is not performed in the primary lab, present an increased likelihood of testing-related diagnostic errors. “Sendout testing poses a risk for patients because nearly all of the activities we deem high risk for error, including increased hand-offs, manual processes, and complexity associated with rare, low-volume tests, are part of the ‘routine’ process for sendout testing,” says Corinne Fantz, PhD, one of the study’s authors and a member of the AACC board of directors.

Tackling Reagent Lot-to-Lot Verification in the Clinical Laboratory
Verifying new reagent lot performance is a common task in the clinical laboratory. It is not only considered good laboratory practice, but also laboratory regulations and accreditation standards require the evaluation of each new reagent lot prior to use. Each new reagent lot has the potential to affect quality control (QC) material and/or patient sample performance. In the clinical laboratory, immunoassays have been reported to be more prone to lot-to-lot variability than general chemistry tests. Multiple factors can affect performance of a new reagent lot, including changes in a critical reagent material or in stability of the reagents, reagent damage during transportation or storage, or incorrect calibration.  Lot-to-lot verification is, without a doubt, necessary to prevent use of suboptimal reagent lots, but it can be an additional burden to the laboratory, especially when it takes multiple attempts to obtain an acceptable reagent lot. Laboratories need to plan ahead and allow time for performing repeat new reagent lot evaluations if acceptability limits are not initially met. Accessibility to the necessary number of patient samples, availability of resources such as instrument time, remaining inventory of the current reagent lot, and technologist time also need to be taken into consideration. With EP26-A, laboratories will be able to adapt a standardized and practical process for lot-to-lot verification, in keeping with resource constraint limits of the current healthcare environment. 

HPV Test Beats Pap Smear in Gauging Cervical Cancer Risk, Study Finds
A new study involving data on more than 1 million women finds the HPV test outperforming the standard Pap test in assessing cervical cancer risk. Researchers at the U.S. National Cancer Institute (NCI) conclude that a negative test for HPV (human papillomavirus) infection is associated with an extremely low risk for cervical cancer and provides greater assurance of low cervical cancer risk than a negative Pap test. Sexually transmitted HPV infection is thought to cause the majority of cervical cancers. The findings support current guidelines that advise that both tests be used in cervical cancer screening, study lead author Julia Gage, a research fellow in the NCI's division of cancer epidemiology and genetics, said in an institute news release. She believes the findings also bolster support for use of the HPV test alone "as another alternative for cervical screening."

Urine Test for Misfolded Proteins May Diagnose Preeclampsia
The urine and placentas of women who develop preeclampsia (PE) contain aggregates of misfolded proteins, researchers report in an article published online July 16 in Science Translational Medicine. The new findings suggest that PE, a common complication of pregnancy, shares pathophysiological features with other diseases, such as Alzheimer's, that are characterized by protein misfolding. Although PE occurs in 5% to 10% of all pregnancies worldwide, its etiology is largely unknown. Most cases are characterized by new-onset hypertension and proteinuria after 20 weeks of gestation, but early signs can be "inconspicuous," and reliable diagnostics are needed.

Blood Test Might Help Predict Survival With Lou Gehrig's Disease 
Simple blood tests may one day help predict survival and the course of the disease in people with amyotrophic lateral sclerosis (ALS), also called Lou Gehrig's disease, Italian researchers report. The components in the blood that might yield clues to how fast ALS is progressing are called albumin and creatinine. These components are normally tested to follow kidney and liver health, according to the U.S. National Library of Medicine. But now it appears that these substances may be helpful for gauging the health of people with ALS, the new study suggests. "The assessment of albumin and creatinine in the blood can reliably predict the prognosis of ALS at the time of diagnosis," said lead researcher Dr. Adriano Chio, a professor of neurology in the Rita Levi Montalcini department of neuroscience at the University of Torino.

A Better Way to Identify Organ Rejection: Blood Test may Eliminate Biopsies in Detecting Heart Transplant Rejection
Stanford University researchers have developed a new blood test to determine if a heart transplant recipient will experience rejection: by analyzing the amount of donor DNA in the recipient’s bloodstream. Their recently reported study, published in Science Translational Medicine, could eliminate the need for invasive heart biopsies. The test, called a cell-free DNA test, detects the fraction of DNA in the recipient’s bloodstream that came from the donor. During an earlier study in 2011, the researchers used stored blood samples and the medical histories of seven people to track how the values changed during rejection. In transplant recipients who did not experience rejection, donor DNA accounted for less than 1% of all cell-free DNA in the recipient’s blood. That percentage increased to about 3% or 4% during rejection.

New Prostate Cancer Blood Test Now Available in the US
The most widely used screening test for prostate cancer is currently the PSA test, which measures the blood’s level of PSA—a protein that is naturally produced by the prostate gland and is typically increased when cancer is present. However, it is widely recognized that PSA results can often indicate the possibility of prostate cancer when none is present. The substantial increase in accuracy of the phi test over PSA addresses this concern. Results of a multi‐center clinical study found a 31 percent reduction in unnecessary biopsies due to false‐positives as a result of using the phi test. “The phi test helps physicians distinguish prostate cancer from benign conditions by utilizing three different PSA markers (PSA, freePSA and p2PSA) as part of a sophisticated algorithm to more reliably determine the probability of cancer in patients with elevated PSA levels,” said Kevin Slawin, MD, director, Vanguard Urologic Institute at Memorial Hermann Medical Group, clinical professor of Urology at Baylor College of Medicine and director of Urology, Memorial Hermann Hospital‐Texas Medical Center, who performed some of the key research that led to the development of the phi test and who also began using the test in February. “We have seen first‐hand how phi is much more accurate and reduces the need for prostate biopsies. And, the fact that phi is a simple blood test has been very appealing to our patients.”

New York Approves Foundation Medicine to Offer Cancer Sequencing Tests
The New York State Department of Health has given its approval to Foundation Medicine to perform its FoundationOne and FoundationOne Heme tests on residents of New York State. FoundationOne is a targeted genomic sequencing test for solid tumors that profiles the coding regions of 236 cancer-related genes, as well as 47 introns from 19 other genes for alterations associated with existing and experimental molecularly targeted therapies.
Source: Web Site Icon


Research and Development

Scientists Discover New Way to Make Human Platelets
Scientists report they have discovered a new way to make fully functional human platelets, which are the blood cells that form clots. Using human stem cells and a device called a bioreactor, which mimics the body's natural way of producing blood cells but on a larger scale, the researchers said their method eliminates risks and complications associated with donor blood transfusion. Those include a five-day shelf-life, contamination, rejection and infection. They added that their findings could help meet increasing global demand for donor blood.

Protein Temporarily Reversed Type 2 Diabetes in Mice
A single injection of a certain protein temporarily reversed symptoms of diabetes in mice, researchers report. The mice had diet-induced diabetes, which is the equivalent of type 2 diabetes in people. The injection of the protein FGF1 restored their blood sugar levels to a healthy range for more than two days. It also reversed insulin insensitivity, which is the underlying cause of diabetes. The injection did not cause the kinds of side effects commonly seen with many diabetes medications, according to the Salk Institute scientists, who report their findings in the July 16 issue of Nature.

Alzheimer’s Findings Seen as a Possible New Window to Understanding the Disease
Scientists at the Mayo Clinic have discovered a possible new link between an abnormal protein in the brain and the onset of Alzheimer’s disease, a breakthrough that could open new avenues to understanding the disease and finding effective treatments. Abnormal forms of the protein, which assists DNA in coding and building new proteins inside the cell, appear to increase the atrophy of regions of the brain important to memory. And it could be a trigger of some kind, perhaps independently initiating the onset of Alzheimer’s-related dementia when combined with two other proteins whose abnormalities have long been implicated in the disease.

Schizophrenia Has Clear Genetic Ties, New Study Finds
The largest-ever study of schizophrenia patients shows that the condition is driven by more than 100 genes – some that were expected, and some that require more research to explain. The study, published online in Nature, confirms that genes connected to regulating the brain chemical dopamine are involved in schizophrenia, as predicted. But so are genes involved in the immune system, and several associated with heavy smoking.

Exploiting Gastric Vulnerability: How Helicobacter pylori Identifies and Colonizes Sites of Small Injury in the Stomach
Helicobacter pylori infection promotes stomach ulcers and cancer. How H. pylori initially interacts with and irritates gastric tissue is not well understood. An article published in PLOS Pathogens now describes that H. pylori rapidly identifies and colonizes sites of minor injuries in the stomach, almost immediately interferes with healing at those injury sites, and so promotes sustained gastric damage. Smoking, alcohol, excessive salt intake, and non-steroidal anti-inflammatory drugs cause damage to the tissue lining the stomach, and are associated with stomach ulcers. A team of scientists led by Marshall Montrose, from the University of Cincinnati, USA, asked whether H. pylorican sense and respond to such damage and so contribute to disease development. The researchers induced small stomach lesions in anesthetized mice and observed that H. pyloribacteria can rapidly detect the injury site and navigate toward it. Within minutes, accumulation of bacteria interferes with repair of the tissue damage - and these results are the earliest indication showing H. pylori causing disease. 

Exciting' Drug Flushes Out HIV
Scientists say they have made an "exciting" step towards curing HIV by forcing the virus out of hiding. HIV can become part of someone's DNA and lie dormant for decades, making a cure impossible. Early stage research in six people, reported at the Aids 2014 conference, shows that low-dose chemotherapy can awaken the virus. Experts said it was a promising start, but it was unlikely the drug would work on its own to cure HIV. International research is aimed at flushing the virus out of its reservoirs. A team at Aarhaus University in Demark tried using a chemotherapy drug, romidepsin, which is used in lymphoma. Six HIV patients with undetectable levels of the virus were enrolled into trial.  They each received a reduced dose of romidepsin once a week for three weeks. There was a noticeable jump in viral levels in the blood in five of the patients.

HIV Said Cleared in Two Bone Marrow Transplant Patients
Two cancer patients who were also infected with HIV went through bone marrow transplants and may no longer have the AIDS-causing virus, according to Australian doctors. The DNA of HIV or antibodies against the virus weren’t found in the patients who suffered from non-Hodgkin’s lymphoma and leukemia and underwent the transplants in 2010 and 2011, according to a statement from the University of New South Wales. Both men continue to take antiretroviral therapy after the transplants, the university said.

A Call to Fight Malaria One Mosquito at a Time by Altering DNA
Every year, malaria-carrying mosquitoes kill more than 600,000 people, most of them children. In papers published in the journals Science and eLife, scientists and policy experts propose fighting malaria in a new way: by genetically engineering the mosquitoes themselves. A new technology for editing DNA may allow scientists to render the insects resistant to the malaria parasite, the authors contend. Or it might be possible to engineer infertility into mosquito DNA, driving their populations into oblivion.

'Biological Pacemaker' Tested in Lab
Grow-your-own pacemakers are a step closer to reality, after pioneering experiments in pigs. Scientists turned heart cells into pacemaker cells by injecting a gene. The "biological pacemaker" was able to "effectively cure a disease", said scientists from the Cedars-Sinai Heart Institute in Los Angeles. The British Heart Foundation said applications of the research, published in Science Translational Medicine, were "a long way off".

Researching Cancer's 'footprint' on Our Evolution
Cancer has left its 'footprint' on our evolution, according to a study which examined how the relics of ancient viruses are preserved in the genomes of 38 mammal species. Viral relics are evidence of the ancient battles our genes have fought against infection. Occasionally the retroviruses that infect an animal get incorporated into that animal's genome and sometimes these relics get passed down from generation to generation - termed 'endogenous retroviruses' (ERVs). Because ERVs may be copied to other parts of the genome they contribute to the risk of cancer-causing mutations. Now a team from Oxford University, Plymouth University, and the University of Glasgow has identified 27,711 ERVs preserved in the genomes of 38 mammal species, including humans, over the last 10 million years.
Source: Web Site Icon


Public Health and Patient Safety

Patients Remain in Danger From Preventable Errors
Patients today are no safer from harm caused by preventable errors than they were 15 years ago, a leading healthcare expert testified before the Senate Subcommittee on Primary Health and Aging. In terms of error reduction and quality improvement, "[w]e have not moved the needle in any meaningful demonstrable way overall," testified Ashish Jha, M.D., a professor at Harvard School of Public Health. "In certain areas, things are better, in certain areas things are probably worse, but we are not substantially better off compared to where we were."

Only 1 in 5 Sexually Active U.S. Teens HIV-tested
Young people account for the largest portion of new HIV infections, but only 22% of sexually active high schools students have ever been tested for HIV, the Centers for Disease Control and Prevention reports. Those between 13 and 24 accounted for about 26% of all new HIV infections in 2010, and almost 60% of youths with HIV in the U.S. don't know they are infected. The new analysis, in the biennial National Youth Risk Behavior Survey, looks at high school students from 1991 to 2013, but found that the number of students getting tested has remained stagnant since 2005. In this age group, female and black students were more likely to be tested for HIV.

HIV Diagnosis Rate Down by a Third in the U.S.
There is some good news in the fight against AIDS: The rate of diagnosis for HIV infections has fallen in the United States by a third over the past decade, a study finds. The report, released by the Journal of the American Medical Association, can be seen as a sign that the AIDS crisis, which first hit the U.S. in large numbers in the 1980s, is starting to subside. "It means treatment is working," says Thomas Coates, associate director of the AIDS Institute at UCLA, who wasn't involved with the study by the federal Centers for Disease Control and Prevention. "It means people who are infected are getting into care and not progressing to AIDS."

Stroke Rounds: Incidence Down, Survival Up -- For Some
Stroke incidence declined significantly in the U.S. among men and women and for both blacks and whites over the last 2 and a half decades, but the decline was largely confined to older adults, research showed. On the other hand, while deaths from stroke also fell for both sexes and races during the same period, the decrease was mainly seen in adults under age 65, researchers reported in the July 16 issue of JAMA.

First Chikungunya Cases Acquired in the U.S. Reported
Florida Health officials confirmed the first locally acquired cases of the mosquito-borne virus chikungunya. The two cases are the first instances in the U.S. in which the virus was not contracted during Caribbean travel, according to the Florida Department of Health. The infected individuals were described as a 41-year-old woman in Miami-Dade County who began experiencing symptoms on June 10, and a 50-year-old man in Palm Beach County, who first noticed symptoms July 1. Officials said that chikungunya (pronounced chik-un-GUHN-ya) — spread by bites from infected Aedes aegypti or Aedes albopictus mosquitoes — is not contagious from person to person, is typically not life-threatening and will likely resolve on its own.
Source: Web Site Icon


Health IT

API Provides Open Access to FDA Recall Data
As part of the Food and Drug Administration’s recently launched openFDA initiative, the regulatory agency is for the first time offering an application programming interface providing web developers and researchers direct access to millions of reports on drug adverse events and medication errors that have been submitted to the FDA since 2004. “The hope is that this API will be useful to developers and researchers interested in FDA enforcement actions,” writes Taha Kass-Hout, M.D., FDA’s chief health informatics officer and director of the FDA Office of Informatics and Technology Innovation, in a recent blog. “Developers can now call into the API to add recalls data to mobile apps or consumer websites. And researchers could use the API to study individual manufacturers, product categories, or specific foods or drugs.”

Study: Age, Sex, Socioeconomic Status Major Factors in eHealth use
Socioeconomic status, age and sex are some of the biggest predictors when it comes to U.S. residents' use of the Internet for healthcare. For instance, adults who are of lower socioeconomic status, older and male are some of the least likely people to engage in their healthcare activities online, according to a study published in the Journal of Medical Internet Research. The study's researchers used data from the National Cancer Institute's 2012 Health Information National Trends Survey. With that information, they then used variable logistic regression to model the odds that education and income, race/ethnicity, age and sex predicted eHealth usage among adults.

Using Electronic Medical Records to Identify Newly Diagnosed HIV-infected People
A new, validated software-based method for identifying patients with newly diagnosed HIV using electronic medical records (EMRs) is described in AIDS Research and Human Retroviruses, a peer-reviewed journal published by Mary Ann Liebert, Inc., publishers. Providing medical care early on to people with newly diagnosed HIV infection is important for improving clinical outcomes. Study authors developed an algorithm designed to search EMRs to identify patients with new diagnoses of HIV infection based on the sequence of HIV diagnostic testing, diagnostic code entries into the EMR, and measurements of HIV genetic material in blood samples. They tested and validated their software tool using EMRs from patients undergoing HIV testing from 2006-2012 at four large Veterans Health Administration facilities. 

Technology-based Mobile Health Takes Off in Developing Countries
Soon opticians – and even their assistants – will be able to check people's vision using just a mobile phone, and it won't matter if they're not sure what they're seeing because the phone will know what to look for. Space-age future?  Far from it. The eye-miracle phone is already here. In fact, it's being used in the world's poorest countries. "Smartphones have been getting better and better, and the fortuitous coincidence is that their optical elements are so small, in fact smaller than a pupil", explains Dr Iain Livingstone, a paediatric ophthalmologist at Peekvision, the UK-based organisation behind the technology. "With a few tweaks, we can put that to our advantage."
Source: Web Site Icon


Other News

Pathologist Michael LaPosata, M.D., Delivers the Message about Diagnostic Management Teams and Clinical Laboratory Testing to Attendees at Arizona Meeting
Most pathologists and clinical laboratory scientists are quick to agree that overutilization of medical laboratory tests is a major problem in healthcare. But underutilization of medical lab tests is an equally significant problem. That’s the message delivered here by pathologist Michael Laposata, M.D., Ph.D., during a presentation he delivered at the Sunquest Executive Summit. Laposata, recently assumed new duties as the Chair of Pathology at the University of Texas Medical Branch in Galveston, Texas.

Siemens Sells Clinical Microbiology Biz to Beckman Coulter
The deal, the terms of which were not disclosed, is slated to close in the 1st quarter of 2015. Beckman hopes the acquisition will diversify its existing diagnostics business and drive growth for the company. The clinical microbiology division comes with an installed base of more than 6,000 instruments worldwide, according to a press release.

$17.1 Million Prize for Solving Antibiotic Resistance
The person or group who can create a point-of care test for bacterial infections that is "cheap, accurate, rapid and easy to use" and can guide clinicians in appropriate antibiotic selection will earn the £10 million (US $17.1 million) prize, backed by the Nesta foundation, Technology Strategy Board of the United Kingdom, and the British Broadcasting Corporation (BBC). "Point-of-care test kits will allow more targeted use of antibiotics, and an overall reduction in misdiagnosis and prescription. Effective and accurate point of care tests will form a vital part of the toolkit for stewardship of antibiotics in the future.

The Virus Detective who Discovered Ebola in 1976
Nearly 40 years ago, a young Belgian scientist travelled to a remote part of the Congolese rainforest - his task was to help find out why so many people were dying from an unknown and terrifying disease. In September 1976, a package containing a shiny, blue thermos flask arrived at the Institute of Tropical Medicine in Antwerp, Belgium. Working in the lab that day was Peter Piot, a 27-year-old scientist and medical school graduate training as a clinical microbiologist. "It was just a normal flask like any other you would use to keep coffee warm," recalls Piot, now Director of the London School of Hygiene and Tropical Medicine. But this thermos wasn't carrying coffee - inside was an altogether different cargo. Nestled amongst a few melting ice cubes were vials of blood along with a note.

Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.

External Web Site Policy This symbol means you are leaving the Web site. For more information, please see CDC's Exit Notification and Disclaimer policy.

No hay comentarios: