viernes, 18 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 17, 2014

  • Managing Risk at the Point-of-Care
  • Study: Fasting Before Lipid Panel Unnecessary
  • Herbal Medicine & Lab Results
  • New Rapid RT-PCR Assay Detects All HIV-1 Groups
  • A Multi-Cancer Diagnostic?
  • Stem Cells Turned into Blood
  • New Imaging Method May Be Better Than Biopsies
  • WHO Releases Guidelines for HIV Prevention Among Gay Men, Other Key Populations
  • CMS to Cover HCV Screening
  • Lawmakers Look to Exempt Medicare Labs From e-health Records


View Previous Issues - Healthcare News Archive


Leading News

Managing Risk at the Point-of-Care
Although point-of-care testing (POCT) provides rapid test results and the opportunity for faster medical decisions, the unique risk of errors with POCT raises concern over the quality and reliability of test results. In contrast to the central laboratory, where errors predominately occur in the pre- and postanalytic phases, POCT errors occur primarily in the analytic phase of testing. This might be related to the non-laboratory staff involved in POCT, but might also be due to test limitations and misuse of POCT in extreme environmental conditions. 
Study: Fasting Before Lipid Panel Unnecessary
Requiring patients to fast for 8 to 12 hours before a lipid panel blood draw is common practice, but fasting adds no clinical value and is an unnecessary burden on patients, researchers said. Analysis of data from the National Health and Nutrition Survey III (NHANES-III) revealed no significant difference between fasting and nonfasting LDL cholesterol levels when it came to predicting all-cause and cardiovascular mortality, New York University associate professor of medicine Sripal Bangalore, MD, and colleagues wrote in Circulation. The study is not the first to find no benefit for fasting prior to a lipid panel blood draw. Another population analysis, published in Archives of Internal Medicine in 2012, failed to show an impact on lipid panel outcomes associated with the practice, and researchers concluded that fasting for routine lipid levels is "largely unnecessary."
Fasting Widely Recommended
Many national and international guidelines for cholesterol management do recommend fasting blood draws, however, including the 2013 joint LDL cholesterol measurement recommendations of the American College of Cardiology and the American Heart Association. "I think it's time to change this recommendation, which is based on expert consensus without any data to back it up," Bangalore told MedPage Today. "Fasting is inconvenient for the patient, and doing away with it could simplify the process of assessing patient risk."

Do Doctors Understand Test Results?
Are doctors confused by statistics? A new book by one prominent statistician says they are - and that this makes it hard for patients to make informed decisions about treatment.  [Gerd] Gigerenzer, director of the Harding Center for Risk Literacy in Berlin, is an expert in uncertainty and decision-making. His new book, Risk Savvy, takes aim at health professionals for not giving patients the information they need to make choices about healthcare. But it's not just that doctors and dentists can't reel off the relevant stats for every treatment option. Even when the information is placed in front of them, Gigerenzer says, they often can't make sense of it. Gigerenzer's research shows just how confused doctors often are about survival and mortality rates. In a survey of 412 doctors in the US he found three-quarters mistakenly believed that higher survival rates meant more lives were saved. He also found more doctors would recommend a test to a patient on the basis of a higher survival rate, than they would on the basis of a lower mortality rate.

Culture Shock: HIV Back in Mississippi Baby
The "Mississippi baby" -- hoped to have been cured of HIV by extremely early therapy -- has seen her virus rebound. Researchers, including the baby's doctors, made the announcement in a telephone media briefing organized by the National Institute of Allergy and Infectious Diseases. The child had been born with HIV and was treated within hours with a full-scale, three-drug antiretroviral regimen. After about 18 months of therapy, she was lost to follow-up for several months, during which time she did not get antiretroviral therapy. When the child was 23 months old, care resumed. Surprisingly, there was little or no sign of HIV and there had been no sign of viral rebound until a routine clinical visit earlier this month. The child is now nearly 4 and was found to have an HIV RNA level of 16,750 copies per milliliter of plasma, researchers told reporters in the telebriefing. Repeat testing confirmed the finding, as well as showing the HIV-characteristic drop in CD4-positive T cells and the presence of antibodies to the virus. Genetic testing showed the viral strain is the same as the one she originally acquired from her mother.

Herbal Medicine & Lab Results
Amitava Dagsputa, PhD, DABCC, professor of pathology and laboratory medicine at the University of Texas, has literally written the book on the chaos herbal medicines bring on lab results. Though some herbs are generally safe, others can yield abnormal test results in an otherwise healthy individual, drug-herb interactions, or interference between the herb component and immunoassay. "The most serious drug interactions occur when herbal supplements interact with warfarin," he said. 
Abnormal Liver Function Results
It's all too common for certain herbal supplements to cause significant liver damage. Dagsputa pointed to kava, chaparral, germander, mistletoe, pennyroyal oil, green tea extract, and noni juice as having significant hepatitixicity. These supplements have elevated concentrations of alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphates (ALP) and gamma glutamyl transpeptidase (GGT) in serum, which are all common causes of elevated liver enzymes.

Newborn Screening
The Clinical and Laboratory Standards Institute (CLSI) has produced a new version of the video Making a Difference Through Newborn Screening: Blood Collection on Filter Paper (NBS01-A6 DVD). This video is an updated version of the LA04-A5 DVD and is based off of CLSIExternal Web Site Icon document Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard—Sixth Edition (NBS01-A6).
Source: Web Site Icon


Laboratory Testing / Diagnostics

New Rapid RT-PCR Assay Detects All HIV-1 Groups
As part of a larger project aimed at producing a handheld molecular diagnostic for use in the developing world, researchers at Dartmouth have developed an assay to rapidly and reliably detect all subtypes of HIV-1 in plasma samples.  The molecular work was done in the lab of Gregory Tsongalis, a professor of pathology at Dartmouth-Hitchcock Medical Center and the Geisel School of Medicine at Dartmouth. Researchers there have developed a test that uses intercalating dye RT-PCR and melt curve-based controls to detect the most common HIV-1 M, as well as O, N, and P subtypes.

Source: Web Site Icon 

A Multi-Cancer Diagnostic?
Researchers from Arizona State University in Tempe have created an inexpensive blood test that can detect several common cancers based on the immune responses they evoke. They used arrays of randomly generated peptides to bind antibodies from human blood samples belonging either to healthy controls or to people with one of five different cancers. Based on the binding patterns—or immunosignatures—the researchers were able to distinguish between all five cancer types. The team also used another array of randomly generated peptides to differentiate among a broader range of cancers and other diseases. The results appeared in PNAS.  “I have to admit it sounds almost too good to be true,” said Harald Mischak, who studies proteomic biomarkers at the University of Glasgow.

Predicting Preterm Birth With a Simple Urine Test
Experts have developed a simple urinary test that can help predict the risk of a preterm birth or poor fetal development, helping expecting mothers gain valuable information that could preserve their child's health. According to a study published in BMC Medicine researchers have conducted the largest human study to date that measures the urinary metabolomics - or 'chemical fingerprints' - that cellular processes involved in pregnancy leave behind. These biomarkers could help form the basis for a screening test that researcher hope could one day predict the presence of preterm or poor fetal growth conditions.

New TB Test Could Mean Quicker, More Reliable Diagnosis 
A new test for tuberculosis that is undergoing clinical trials could eventually improve the speed and accuracy of diagnosis for the disease, enabling healthcare providers to report results to patients within minutes. So says a study published in the journal Angewandte Chemie. Jeffrey Cirillo, PhD, professor at the Texas A&M Health Science Center College of Medicine, in collaboration with GBDbio, and investigators at Stanford University have identified a new chemical compound to spot the bacteria that cause TB, and results of the first human trial data are promising. Findings show the test can determine that a patient has tuberculosis with 86% sensitivity and 73% specificity. Smear microscopy, the most widely used test in the world, has a significantly lower ability to detect TB, ranging between 50% and 60% sensitivity.

New Test Predicts Survival and Disease Progression in Blood Cancer Patients
Scientists have developed a test which accurately predicts the prognosis for patients with the most common form of leukaemia. The findings could also inform the development of a prognostic test for patients with other forms of cancer. Researchers from Cardiff University's School of Medicine used pioneering techniques for measuring the length and function of tiny structures known as 'telomeres' - repeating sections of DNA found at the ends of chromosomes. They used these techniques to determine if the telomeres were working or not in cells from patients with chronic lymphocytic leukaemia (CLL). Patients with short dysfunctional telomeres displayed a considerably poorer clinical outcome compared to those with long and functional telomeres.

Smell Test May Help Detect Alzheimer's
In the future, a test of your sense of smell may help doctors predict your risk of developing Alzheimer's disease, according to new research presented at the Alzheimer's Association International Conference in Copenhagen, Denmark, this week. In two separate studies, scientists found that people who were unable to identify certain odors were more likely to experience cognitive impairment. The researchers believe that brain cells crucial to a person's sense of smell are killed in the early stages of dementia.

Saliva Test Might Someday Replace Needle Prick for Diabetics
But device is still a long way from use by people
A new type of sensor for people with diabetes is being developed to measure sugar levels in the body using saliva instead of blood, researchers report. Scientists at Brown University in Providence, R.I., created the sensor and successfully tested it using artificial saliva. It uses light, metal and a special enzyme that changes color when exposed to blood sugar. The sensor won't be available anytime soon, however. "The process of [U.S. Food and Drug Administration] approval will take a long time, and we have to see how accurate this device is in humans, especially humans who are eating and drinking, which will possibly contaminate the sample," Zonszein said.

Microchip to ID Type 1 Diabetics Developed by Stanford Team
Stanford University team has developed a small invention to spot an increasingly large health problem: Type 1 diabetes. The palm-size chip can analyze a few blood drops and diagnose the disease in new diabetics, as well as identify people who are at risk of developing the disease, the scientists say. They are filing for a patent, seeking federal regulatory approval and helping to form a startup to commercialize the chip, which they say works more quickly and is cheaper than existing diagnostic tools.

New Technology Developed to Diagnose Cancer Cells
In pathology, cells and cell nuclei are usually examined using a microscope for bio-marker expressions in tumours. This analysis is used to weigh up the treatment options for patients who have cancer, for example. The certainty of the diagnosis depends greatly on the individual pathologist. A study led by Lukas Kenner at the MedUni Vienna at the Clinical Institute of Pathology, as well as at the Ludwig Boltzmann Institute for Cancer Research (LBI-CR) and the VetMedUni Vienna, has demonstrated that two independent pathologists only agreed on one in three diagnoses. New computer software that has been developed jointly will help in future to double diagnostic certainty. This is the outcome of the recent study, which has now been published in the highly respected journal PlosOne. The scientists investigated and analysed 30 liver cell carcinomas and were able to classify them into categories ranging from "negative" to "strongly positive" using the software developed jointly by the MedUni Vienna and the Vienna-based firm "Tissuegnostics".
Source: Web Site Icon


Research and Development

Stem Cells Turned Into Blood
Researchers at the University of Wisconsin-Madison, along with colleagues at three other institutions, report the discovery of two genetic programs responsible for turning stem cells into both the red and white cells that make up human blood. The scientists say their finding is important because it identifies how nature itself makes blood products at the earliest stages of development and provides researchers with the tools to make the cells themselves, investigate how blood cells develop, and produce clinically relevant blood products. The study (“Direct induction of haematoendothelial programs in human pluripotent stem cells by transcriptional regulators”) was reported in Nature Communications. “This is the first demonstration of the production of different kinds of cells from human pluripotent stem cells using transcription factors,” explained Igor Slukvin, Ph.D., from the department of pathology and laboratory medicine in the UW School of Medicine and Public Health and the Wisconsin National Primate Research Center.

New Imaging Method May Be Better Than Biopsies
In order to determine if a patient’s tumor has the cancer-causing KRAS mutation, a biopsy would usually be done but that could lead to problems for sensitive areas of the body including the lungs. However, a new medical imaging technique may help clinicians determine a more accurate treatment and enhance treatment management for lung cancer patients, according to a recent study published in the journal PLOS ONE. Quantitative computed tomography-based texture analysis (QTA) is a non-invasive alternative to biopsies and other invasive procedures to collect and analyze biological samples. Researchers at the Translational Genomics Research Institute scanned 48 patients with non-small cell lung cancer (NSCLC) with QTA and found that it can determine if the patients’ tumors had the KRAS gene mutation with 90 percent accuracy.

Anal HPV, Dysplasia Associated With Cervical HPV
Women with high-grade cervical dysplasia associated with human papillomavirus (HPV) infection also are likely to have abnormal anal cytology and high-risk anal HPV, the authors of a new study report. The findings add to a growing body of evidence suggesting "that in addition to being at higher risk of developing cervical cancer, women with high-grade cervical dysplasia may have an elevated risk of anal cancer," lead author Jacqueline Lammé, MD, from the Department of Obstetrics Gynecology, Naval Medical Center, San Diego, California, and colleagues write in an article published in the August issue of Obstetrics & Gynecology.

Malaria Parasite 'Gets down to the bone'
Malaria parasites can hide inside the bone marrow and evade the body's defences, research confirms. The discovery could lead to new drugs or vaccines to block transmission. The research, published in Science Translational Medicine, fills a "key knowledge gap" in the biology of the disease, say scientists at Harvard. Carried by mosquitoes, the parasite causes the most severe form of malaria, which leads to more than 500,000 deaths every year globally. The study found parasites that cause malaria could bury into bone marrow, where they escaped the immune system and caused disease. The idea that they hide in the bone marrow while they mature has been around for decades. But a team led by Prof Matthias Marti, of the Harvard School of Public Health, in Boston, pinpointed exactly where the parasites found sanctuaries in bone marrow by analysing tissue samples from autopsies.

Vasectomy and Prostate Ca: How Serious the Link?
Men who had a vasectomy had a significantly greater risk of developing aggressive, potentially fatal prostate cancer, according to data from a 50,000-patient cohort study. Overall, vasectomy increased the risk of prostate cancer by about 10%, increasing to about 20% for high-grade and lethal cancers. A subgroup analysis showed more than a 50% greater risk of prostate cancer among men who underwent regular prostate-specific antigen (PSA) screening for prostate cancer, as reported online in the Journal of Clinical Oncology. The authors emphasized that the overall association between vasectomy and prostate cancer was modest. "The cumulative incidence of lethal prostate cancer during a 24-year follow-up was 1.6%," Lorelei A. Mucci, ScD, of Harvard School of Public Health, and colleagues concluded. "Thus, these relative risks translate into small increases in absolute risk. The decision to opt for a vasectomy remains a highly personal one in which the potential risks and benefits must be considered."

Your Genes May Help Pick Your Friends
Study says DNA between close friends is as similar as that
A person's DNA may play a big role in who they decide to hang with, a new study suggests. "Looking across the whole genome, we find that, on average, we are genetically similar to our friends," study co-author James Fowler, a professor of medical genetics and political science at the University of California, San Diego, said in a university news release. "We have more DNA in common with the people we pick as friends than we do with strangers in the same population," he said. In the study, Fowler's team analyzed the genes of more than 1,900 people who were either pairs of unrelated friends or unrelated strangers.
Source: Web Site Icon


Public Health and Patient Safety

WHO Releases Guidelines for HIV Prevention Among Gay Men, Other Key Populations
Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care for key Populations
In this new consolidated guidelines document on HIV prevention, diagnosis, treatment and care for key populations, the World Health Organization brings together all existing guidance relevant to five key populations – men who have sex with men, people who inject drugs, people in prisons and other closed settings, sex workers and transgender people – and updates selected guidance and recommendations.
These guidelines aim to:
  • provide a comprehensive package of evidence-based HIV-related recommendations for all key populations;
  • increase awareness of the needs of and issues important to key populations;
  • improve access, coverage and uptake of effective and acceptable services; and
  • catalyze greater national and global commitment to adequate funding and services.

First Dengue Vaccine 'Shows promise'
Scientists say they have developed the world's first vaccine against dengue fever seen to work in large-scale trials. Research in the Lancet journal suggests more than 50% of children who are given the vaccine are protected against the disease. Half the world's population is at risk of catching the mosquito-borne virus. Experts say though the long-awaited study is promising, vaccines with greater effectiveness are crucial. There are currently no treatments to prevent dengue fever - an illness which affects more than one million people a year.

CMS to Cover HCV Screening
The Centers for Medicare & Medicaid Services (CMS) announced on June 2 that Medicare and Medicaid will cover screening for Hepatitis C virus (HCV). CMS's recent determination to cover HCV screening is consistent with the recommendations by the U. S. Preventive Services Task Force. CMS indicated that it will cover screening for HCV with the appropriate U. S. Food and Drug Administration (FDA) approved/cleared laboratory tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the beneficiary's primary care physician or practitioner within the context of a primary care setting and performed by an eligible Medicare provider

Hotter Weather Linked to Kidney Stones
As temperatures increased above 50°F (10°C) in several large U.S. cities, risk of kidney stones also increased significantly researchers said. A study of 60,433 privately insured patients across five cities -- Atlanta, Chicago, Dallas, Los Angeles, and Philadelphia -- found that the maximum risk for kidney stone presentation occurred within 3 days of a high daily temperature and was likely mediated by an effect on patients' hydration. The risk was statistically significant in all cities except Los Angeles, according to the paper, published online in Environmental Health Perspectives.
Source: Web Site Icon


Health IT and Other

Lawmakers Look to Exempt Medicare Labs From e-health Records
House lawmakers are pressing the Centers for Medicare and Medicaid Services (CMS) to remove penalties on Medicare diagnostic labs that don’t use electronic medical records.
The 2009 American Recovery and Reinvestment Act (ARRA) requires Medicare providers to upgrade to Electronic Health Record (EHR) systems or receive less in reimbursements. The College of American Pathologists (CAP), though, says the requirement puts too much of a financial burden on labs that do clinical tests for Medicare patients, and is seeking an exemption from the rule.

OIG Identifies Questionable Billing for Laboratory Services
More than 20 percent of all claims for Medicare Part B clinical laboratory services submitted in 2010 are tied to “questionable billing patterns,” according to a July report from the Health and Human Services Office of Inspector General (OIG). The OIG identified 13 measures describing questionable billing. Any laboratory that exceeds the established thresholds for five or more of the 13 measures may warrant further scrutiny, said the OIG in the report.

Docs Cite EHRs as top IT Concern; Shun Telehealth, Social Media
When it comes to implementing electronic health records into daily workflow, 17 percent of physicians responding to a newly published survey say it is their top IT concern. For the second straight year, the adoption of EHRs is the most pressing tech problem physicians face, according to the Physicians Practice 2014 Technology Survey, conducted by Kareo [a medical office software company]. Of the 1,442 respondents to the survey, lack of interoperability between EHRs also was a pressing issue--with 16 percent calling it a major concern, according to an announcement on the study.

Other News
NIH to Fund New Studies of Ethical, Legal, and Social Implications of Genomics
The National Institutes of Health will fund new projects that delve into the ethical, legal, and social implications (ELSI) of human genomics research, such as efforts to identify, analyze, and address the ways in which advances in genomics impact health sciences and medicine. These studies may examine the ways in which genomics is affecting society and use approaches from different disciplines, such as ethics, economics, law, clinical and computational sciences, philosophy, epidemiology, and other areas.

Tricare Restores Coverage for Some Genetic lab Tests
The Defense Health Agency, relying on medical laboratory experts and existing authority to conduct medical “demonstrations,” will restore TRICARE coverage this month for up to 40 genetic tests used in patient care. Many of these laboratory-developed tests -- also called molecular pathology tests -- are viewed as medically necessary. But TRICARE had stopped reimbursing for more than 100 such tests in January 2013, believing it lacked authority to pay for them when such tests are ordered by civilian physicians delivering care through TRICARE provider networks.
Source: Web Site Icon

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.

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