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[podcast] Ron van Schaik: Clinical Implementation of Pharmacogenetics

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Prof. Dr. Ron H.N. van Schaik, PhD is a registered European Specialist (2003) and Full Professor Pharmacogenetics (2013). He is working at the department of Clinical Chemistry (AKC) at the Erasmus University Medical Center (Erasmus MC) in Rotterdam since 1998. Prof. van Schaik leads a research group on pharmacogenetics, in which the translation to implementation for patient diagnostics is the main topic. Current lines of research include Transplantation/immunosuppression, Oncology, Psychiatry, Pain treatment, anticoagulation and HIV.

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[podcast] Roger Levy: Latin American Congress of Autoimmunity 2017

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Professor Roger A. Levy, MD, PhD.

Roger Levy is Associate Professor of Rheumatology at The State University of Rio de Janeiro. Graduating from medical school at the Federal University of Rio de Janeiro in 1986, he subsequently completed a fellowship programme at the Hospital for Special Surgery, Cornell Medical College, New York in 1989 and received his PhD in Biological Sciences from the Biophysics Institute – Immunology, at the Federal University of Rio de Janeiro in 1994. Professor Levy’s research is based around the clinical and immunologic aspects of systemic lupus erythematosus, antiphospholipid syndrome, Sjogren’s syndrome and pregnancy in rheumatic patients. He has published 110 articles in medical journals, over 200 abstracts, four books, 20 book chapters and has lectured in many countries.

EuroLabNews Issue N°6 2017

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In this issue:

  • President’s Season Greetings
  • 10th EFLM Anniversary
  • Hot Topics in Laboratory Medicine: Patient safety and laboratory-related errors
  • EFLM events: Announcement of the 2nd EFLM Strategic Conference EFLMAACB
  • Test Evaluation Course 2018
  • Updates on EFLM Publications list
  • News from National Societies
  • News about EFLM National Societies
  • Calendar of EFLM events and events under EFLM auspices

Editorial information

  • Newsletter Editor: Dr. Harjit Bhattoa, Faculty of Medicine, Dept of Laboratory Medicine, University of Debrecen, Hungary
  • EFLM Executive Board: S. Sandberg, M. Panteghini, M. Neumaier, AM. Simundic, H. Storm, G. Sypniewska, T. Zima

Click here to download the EFLM newsletter (PDF)

The accurate diagnosis of von Willebrand disease (VWD)

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Two new World Federation of Hemophilia (WFH) articles explore the latest laboratory approaches to VWD diagnosis: phenotypic (observed traits) and genotypic (genetic analysis).

Together these approaches help ensure an accurate diagnosis which is essential to optimal management.

Diagnosis of von Willebrand Disease: Phenotypic Characterization

The accurate diagnosis of von Willebrand disease (VWD) is crucial to its management. This resource describes laboratory tests based on the observable traits, or phenotype, of a person with bleeding symptoms and a positive family bleeding history that can be used to determine the specific type and variant of VWD. The companion monograph, TOH 56 Molecular Diagnosis of von Willebrand Disease, provides a detailed review of the genotypic approach to diagnosing VWD.

Year: 2017

Language: English

Author(s): Luciano Baronciani, Francesca Stufano, Flora Peyvandi

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Molecular Diagnosis of von Willebrand Disease

The accurate diagnosis of von Willebrand disease (VWD) is crucial to its management. This resource describes the techniques used to determine the genetic nature, or genotype, of a suspected case of VWD. The companion monograph, TOH 55 Diagnosis of von Willebrand Disease: Phenotypic Characterization, provides a detailed review of the laboratory tests that can be used to diagnose VWD type and variant.

Year: 2017

Language: English

Author(s): Luciano Baronciani, Anne Goodeve, Flora Peyvandi

Download now

 

Source: elearning.wfh.org

Free Webinar: Harmonization of preanalytical phase in Europe

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The recording of the EFLM webinar “Harmonization of preanalytical phase in Europe” is now freely available for replay  and no login is required.

Speaker: Ana-Maria Simundic (HR)

Moderator: João Tiago Guimarães (PT)

Recorded on 21st November 2017.

European National Societies, members of EFLM, have agreed in Porto, during the 3rd EFLM-BD European Preanalytical Phase Conference that harmonization of preanalytical practices and policies is necessary and possible in each and every country in Europe as well as internationally, at the European level. The Working group for Preanalytical phase (WG-PRE) of the European Federation for Clinical Chemistry and Laboratory Medicine (EFLM), has taken the leading role in this process.

The aim of this e-seminar is to present past, ongoing and future WG-PRE activities and various projects which aim is to improve the quality of preanalytical phase in Europe as well as to promote wide harmonization of preanalytical practices, patient safety improvement and reduction of unnecessary waste and healthcare expenses.

Screening for Epstein-Barr Virus DNA to Find Early Stage Nasopharyngeal Cancer

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Now, a recent study in the New England Journal of Medicine has found that testing for Epstein-Barr virus (EBV) DNA in the blood is a useful way to screen for early nasopharyngeal cancer in high-risk individuals without symptoms. Early detection can be lifesaving because radiation therapy can often cure early-stage nasopharyngeal cancer.

Epstein-Barr virus infections are very common in childhood and typically asymptomatic. About 25% of teens and young adults infected with EBV develop symptoms associated with infectious mononucleosis (mono), such as fever, sore throat, swollen glands, and fatigue, that usually resolve in two to four weeks. While EBV infections rarely lead to nasopharyngeal cancer, they are one of the risk factors for the disease.

Nasopharyngeal carcinoma (NPC) is a cancer that starts in the upper part of the throat, behind the nose. It is rare in the United States but more common in China, where the study took place. Symptoms, such as a lump in the neck, deafness or ringing (tinnitus) in one ear, nosebleeds and stuffy nose or nasal blockage, often do not appear until the cancer has spread. If diagnosed in its earliest stage, NPC is potentially curable with a five-year survival rate as high as 95%, so a screening test that could identify NPC early, before symptoms develop, is needed.

Recently, researchers have been investigating EBV DNA as a potential biomarker in the blood for nasopharyngeal cancer detection, monitoring, and prognosis. NPC tumor cells contain some EBV DNA and fragments of this DNA are often detected in the blood of patients with symptoms of NPC. The new study is a step forward because it demonstrates that the persistent presence of EBV DNA circulating in the blood of asymptomatic people can help identify early nasopharyngeal carcinoma.

The new study included a group of more than 20,000 men of Chinese descent aged 40 to 62 years. (This cancer occurs more commonly in middle-aged Chinese men compared to women, younger men and those who live outside of Southeast Asia.) EBV DNA was persistently positive on repeat testing in 309 participants who were then offered examination of their nasopharynx with an endoscope and by magnetic resonance imaging (MRI). Of the 300 men examined, 34 (11%) were ultimately diagnosed with nasopharyngeal carcinoma.

Sixteen of the 34 individuals with the cancer (47%) were diagnosed with stage I disease. Typically, only 5% to 7% of people with nasopharyngeal carcinoma are diagnosed with stage I disease, noted the researchers. Individuals undergoing early screening also had better 3-year progression-free survival.

Only one individual who tested negative for EBV DNA developed nasopharyngeal carcinoma after one year. In this study, the EBV DNA test detected roughly 97 out of 100 NPC (97.1% sensitivity) and was correctly negative in about 98 out of 100 people without NPC (98.6% specificity).

In the study, 89% of the men with persistently positive blood tests for EBV DNA did not develop nasopharyngeal cancer. A positive result does not mean that an individual has cancer, only that further testing is needed.

In an editorial accompanying the study, Richard F. Ambinder, a Johns Hopkins School of Medicine oncologist, views this approach to early screening for nasopharyngeal cancer as promising in the right settings. He does caution that outside of regions where the cancer is most common, such as Southeast Asia, EBV DNA is not as effective at predicting nasopharyngeal cancer. For instance, a retrospective survey conducted at Johns Hopkins showed that only 1% of individuals with EBV DNA detected in blood samples had nasopharyngeal carcinoma.

Also, since the study only included middle-aged Chinese men, the test may not be as useful for screening others even if they live in Southeast Asia. However, in appropriate settings—such as areas where the cancer is common and in people with risk factors—EBV DNA screening has the potential to become a useful liquid biopsy.

Source: LTO

#HM2018 Haploid Markers 2018 Conference

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The previous conferences have taken place in the magnificent cities of Berlin, Porto, Innsbruck, Ancona, and Brussels. This year, we have organized the conference in Bydgoszcz, founded over 670 year ago in central Poland, situated along the picturesque banks of the Vistula and Brda rivers. The Department of Forensic Medicine of Nicolaus Copernicus University located in Bydgoszcz, one of the most experienced in haploid markers’ research in Poland, will be hosting the conference.

We have chosen “Inferring Ancestry from DNA” to be the main theme of this year’s conference. For some time now, we have been gathering knowledge on how to decipher DNA sequences for the purpose of extracting information regarding their ancestral origin. We will be exploring contemporary biogeographical analysis based on genetic testing, not only encompassing Y chromosome or mtDNA, but of equal importance, autosomal DNA. Therefore, attendees who specialize in biogeographic analysis are encouraged to submit relevant abstracts.

This biennial event attracts the most prominent researchers from all over the world. It is one of the most valuable opportunities to exchange ideas, thoughts and build new scientific networks.

The conference will take place over three days of strictly technical and poster sessions on cutting edge issues and perspectives crucial for forensic geneticists. The previous conference which was held in Berlin attracted over 200 scientists from 43 countries worldwide. This year we are anticipating an even larger turnout.

Venue of the Conference: Opera Nova Congress Centre, Focha 5, 85-070 Bydgoszcz

Web pagehaploidmarkers2018.umk.pl

Infobioquimica.org no dispone más datos que los aquí publicados.
Por favor, si necesita más información envíe una consulta directa a los organizadores del evento.

From Many One A Case Study on Standardizing Point of Care Testing Instrumentation

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Point-of-care testing (POCT) goes a long way toward helping institutions improve patient care by returning fast and reliable results near patients, thereby enabling prompt clinical interventions.

POCT’s vital role in patient management makes it popular across clinical settings but often with different device types for the same test. Our institution is no exception to this POCT device creep, as at one point we had more than four types of blood gas analyzers, three table tops and one hand-held. Realizing that this confounded many of our quality and efficiency aims, we undertook a deliberate and durable process to standardize these instruments, using the general process outlined in Figure 1.

Our first step was to acknowledge the challenges having multiple device types presented. The devices’ different processes and steps put us at risk for decreased compliance with accreditation standards, if for example, required quality control (QC) was not run. This also increased the risk for pre-analytical error, as all the instruments weren’t interfaced owing to the expense involved. At the same time, having multiple types of blood gas analyzers actually increased our costs. A smaller volume of tests purchased from four vendors combined with yearly maintenance fees meant that our overall costs were higher than they would have been if we just had one instrument type.

Finally, using non-interfaced analyzers put a lot on our respiratory therapists (RTs) who were the operators for the inpatient floors. Our inefficient, non-interfaced devices and processes disrupted their workflows and required many manual steps. So our journey to a single type of POCT blood gas analyzer promised us improved efficiencies and quality as well as cost savings.

In the Beginning, Data

Our POCT team started our efforts with data. We clearly outlined the issues involved, compiled non-compliance and error data, existing cost and potential savings information from manufacturers, and determined our test volume. We looped in our hospital compliance officer about the risks associated with the status quo, then talked individually to stakeholders in each area that had blood gas analyzers. Our goal was to get them to see the serious issues we faced as well as the advantages of moving to one instrument type.

Having gained the support of these individuals, we established a multidisciplinary team tasked with identifying a blood gas analyzer that would meet the needs of all areas. This team consisted of providers, administrative directors, managers, and POCT operators from the different areas, including RTs.

The team rolled up its sleeves and did an extensive analysis, considering the pros and cons of each instrument and documenting the clinical needs of all users. Concurrently, the lab performed analytical comparisons of all four blood gas instruments, distilling and clearly communicating this information to the team and to stakeholders.

After reviewing clinical and operator needs, analytical performance, and division preferences, we determined no single instrument type would meet the needs of all areas. In the end, the team recommended one hand-held and one table-top analyzer.

Going with a single type of table-top analyzer would meet the clinical needs of all areas, including offering co-oximetry and measured hemoglobin, both unavailable via hand-held. However, this would run contra to the hospital’s goal of keeping care at patients’ bedsides and improving RTs’ workflow because we kept the table-top analyzers in a central location on patient floors and RTs had to walk to and from the analyzers for each test.

Adding the already interfaced hand-held analyzer would enable near-patient testing, decrease pre-analytical errors associated with delays in testing, and simplify RT workflow. Nurses also were trained to perform testing on the hand-held, giving additional relief to RTs.

Consolidating to a single table-top analyzer also afforded the hospital cost savings from decreased maintenance fees, more consumables purchased at lower prices thanks to increased test volume, and a more affordable cost of interfacing just a single type of analyzer.

A Piloted Approach

Armed with our recommendation, we moved forward with a 5-month pilot implementation in an area of the hospital with high provider and staff buy-in for the change. During the pilot we assessed several factors including: ease of instrument use; personnel satisfaction; number of instruments needed; RT workflow; compliance; error rate; test volumes; and lab test utilization.

At the pilot’s conclusion, the team reviewed the data we collected and discussed it with all stakeholders to determine whether it was appropriate to adopt both instruments hospital-wide. With a green light to proceed, we focused on educating providers on appropriate test utilization and planned an extensive program of personnel training, since many staff members had not used the instruments. To ensure that we had instrument availability, we submitted a budget for approval early-on for the approved new instruments and a data management system.

Next, we set a go-live date that all stakeholders had approved, and from there we have continued to monitor and maintain these two types of blood gas analyzers.

Though our process was long and painstaking, our efforts paid off and we achieved our aims. In my view, one of the most critical factors in our success was in identifying the stakeholders in each affected area early and gaining their support, which helped an already challenging situation go smoothly.

Author: Brenda Suh-Lailam, PhD, DABCC, FACB, is assistant director of clinical chemistry and mass spectrometry and director of point-of-care testing at Ann & Robert H. Lurie Children’s Hospital of Chicago, and an assistant professor of pathology at Northwestern University Feinberg School of Medicine.

Source: AACC

New drugs: will they solve the problem of resistance to antibiotics?

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Despite a large arsenal of usually effective antibiotics, the therapeutic options are few in cases of infections caused by multidrug-resistant (MDR) organisms, and even more so by extensively drug-resistant (XDR) strains, often leaving only colistin as reliable option. Reports of pan-drug resistance, for which no antibiotic options exist, are accumulating in some parts of the world. The production of carbapenemases together with other resistance mechanisms, including those to unrelated antibiotic groups, has hampered the usefulness of carbapenems as the therapy of choice for extended-spectrum b-lactamase producing MDR Gram-negative bacteria.

Author: U. Theuretzbacher. Center for Anti-Infective Agents, Vienna, Austria

Clinical Microbiology and Infection 23 (2017) 695e696

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