VISIT WORLD’S CLINICAL LABORATORY NEWS LEADER · Byron Caughey, PhD, senior investigator in the NIAID Laboratory of Persistent Viral Diseases, said, “The eQuIC assay in particular

Vol. 28 No.6 • 10/2011ISSN 1068-1760

Genetic Test DiagnosesLipid Metabolism Disorder

AA genetic diagnostic platform canbe used to identify patients

with inherited disorder of lipopro-tein metabolism characterized byelevated levels of total and low-den-sity lipoprotein (LDL) cholesterol.

The platform includes the use ofa DNA micro array, the detection of

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Breath Test for ImmuneResponse to H1N1 Virus

AA novel breath test detects peo-ple who have an immune

response to the Influenza A virusstrain H1N1. The test would helpto ease future vaccine shortages byidentifying the people who havealready been infected with the fluvirus.

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AA n evaluation has been madeof the factors that influence

the performance of an antigencapture assay and other markersof dengue disease severity.

Dengue nonstructural protein1 (NS1) may be used in simpleantigen-capture enzyme-linkedimmunosorbent assay (ELISA) for

early detection of dengue virusinfection.

A team from the InstitutePasteur in Phnom Penh (Cam-bodia; www.pasteur-kh.org) col-lected blood from patients hospi-talized during the 2006 and 2007dengue epidemics in Cambodia.Blood samples were tested for

Clinical and Virological FactorsInfluence Dengue Immunoassay

DAILY CLINICAL LAB NEWS

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Multiplex Assay Detects Drugs in Oral Fluid


See article on page 12

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Adigital pathology viewing application withbuilt-in educational content from insti-

tutes and pathologists was released for iPadand iPhone.

Users can try Digital Pathology for freeand view, zoom and navigate digital slidesthrough the high performance viewer.

Tumor Profiling Assay toImprove Cancer Care

AA tumor-profiling assay will bebased on targeted panel

enrichment and next generationsequencing (NGS). It will improvecancer care by providing specificinformation about individualpatients, thereby facilitating per-sonalized treatment strategies.

The assay will detect mutations

Gene Test Predicts Cancer in Pancreatic Cysts

AA gene-based test has beendeveloped that distinguishes

precancerous pancreatic cystsfrom benign vesicles by parallelsequencing.

Genetic analysis of precancer-ous fluid filled cysts and the searchfor mutations may eventually helpmore than a million patients each

Sensitive Blood TestDetects Prion Diseases

AA novel assay has been devel-oped that will rapidly screen

blood plasma for variantCreutzfeldt-Jacob disease (vCJD).

An integrated antibody-basedapproach with an improved real-time quaking-induced proteinconversion (RT-QuIC) reactionenhanced the detection of vCJD

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Asolid-state device ontowhich antibodies spe-

cific to different drug com-pounds are immobilizedand stabilized, allows thesimultaneous detection ofmultiple drug classes anddrug metabolites from asingle undivided specimen.

In a study, published July 15, 2011, inIOP Publishing’s Journal of BreathResearch, scientists investigated the easy,noninvasive breath test to measure biomol-ecules that accumulate in response to theH1N1 strain of the flu virus.

Investigators from Cleveland Clinic(Ohio, USA; http://my.clevelandclinic.org)and Syft Technologies (Christchurch, NewZealand; www.syft.com) included 11 indi-viduals in their study. Nine of these partic-ipants were given the live attenuated

H1N1 vaccine via a nasal spray and thebreath test was administered on each of thefollowing seven days.

Samples of exhaled NO were providedby six participants prior to vaccination.Nitric oxide is a test approved by the USFood and Drug Administration (FDA;Silver Spring, MD, USA; www.fda.gov) formonitoring inflammation and asthma.Production of exhaled nitric oxide (NO)has also been linked to influenza and viralinfection.

The breath test examined exhalednitric oxide (NO) – a biomoleculewhose production has previously beenlinked to influenza and viral infectionand has been speculated to play a ben-eficial role in viral clearance.

The results showed a peak in NOlevels in all subjects on the third dayafter vaccination. There were no signif-icant differences in NO levels on anyother day.

Of the 11 other compounds exam-ined in the study, only one compound– isoprene – showed an elevated level,also on day three. Increased levels ofisoprene, a compound produced withinthe body and a major constituent ofexhaled breath, have been reported toreflect oxidative stress in airways.

Previous findings show that thehighest number, and severity, of symp-toms related to a H1N1 infection occuron day three, suggesting, along withthis study, that this is when an immuneresponse is triggered in the body.

A breath test, measuring theimmune response to the H1N1 fluvirus, could help to ease future vaccineshortages by identifying the peoplewho have already been infected withthe flu virus.

Study coauthor Dr. Raed Dweik,professor of medicine and director ofthe pulmonary vascular program at theCleveland Clinic, said when the H1N1epidemic occurred in 2009 physicianswere faced with a dilemma related topatient treatment.

“We all have nitric oxide in ourbreath because our lungs make it, butwith different levels,” said Prof. Dweik.“If you have an infection or an inflam-mation or if you have asthma, it goesup.”

Prof. Dweik cautions that while thework is “rather preliminary,” he sees itas proof of the concept that breath canbe used to monitor the vaccinationand, it is hoped, the infection.

Image: Colored scanning electron micro-graph (SEM) of H1N1 flu virus particles(virions, orange) on a cell (Photo cour-tesy of the NIBSC).

Breath Test for Immune Response to H1N1 Virus

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hematocrit and platelet count as well as for other bio-logical parameters necessary for patients’ follow-up.Sera were tested for dengue using serology andmolecular methods at the Institute Pasteur inCambodia. Dengue infection was confirmed in 243of 339 symptomatic patients and in 17 asymptomaticindividuals out of 214 household members tested.

Overall sensitivity and specificity of Platelia NS1Ag kit were 57.5% and 100% respectively. When theNS1 Ag assay was combined with immunoglobulinIgM antibody capture ELISA, the sensitivity was sig-nificantly increased for dengue diagnosis. NS1 Agpositivity rate was found significantly higher indengue fever (DF) cases than in fatal dengue hemor-rhagic fever (DHF) and dengue shock syndrome(DSS). It was higher in primary rather than in second-ary infections, in patients with a high viremia (>5log/mL), and in patients infected with the dengueviral strain DENV-1. In asymptomatic individuals, theNS1 Ag capture sensitivity tends to be lower thanthat in symptomatic patients. Milder disease severitywas observed independently in patients with ribonu-cleic acid (RNA) copy number >5 log10 complemen-tary DNA (cDNA) equivalents/mL or in high level ofNS1 antigen ratio or in DENV-1 infection.

The authors concluded that the overall sensitivityof the Platelia Dengue NS1 Ag detection kit (BioRad;Hercules, CA, USA; www.bio-rad.com) varied wide-

ly across the various forms of dengue infection or dis-ease. Sensitivity was highest in patients sampled dur-ing the first three days after onset of fever, in patientswith primary infection, DENV-1 infection, with highlevel of viremia and in DF rather than DHF/DSS. Thesemi-quantitative approach of the test, demonstratedthat the NS1 antigen level was significantly correlat-ed to the level of viremia and that the low level ofNS1 antigen was associated with more severe dis-ease. The study was published online on July 19,2011, in the Public Library of Science NeglectedTropical Diseases.

Image: The Platelia Dengue NS1 Ag detection kit (Photocourtesy of Bio-Rad Laboratories).

Clinical and Virological Factors Influence Dengue Immunoassay

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brain tissue diluted into human plasma. Scientists at theUS National Institute of Allergy and Infectious Diseases,(NIAID; Bethesda, MD, USA; www.niaid.nih.gov), col-laborated with scientists from Prionics AG, (Schlieren-Zurich, Switzerland; www.prionics.com), to developthe sensitive bioassay. RT-QuIC, developed only recent-ly, detects the abnormal form of prion protein, which,

in purified form, resembles amyloid fibrils. This com-bined assay, which they call enhanced QuIC (eQuIC),detects approximately 2 attograms (10-18 grams) per mLof proteinase K–resistant prion protein, a 1014-fold dilu-tion, indicating a 10,000-fold increase in sensitivitycompared with previously reported methods of vCJDbrain tissue detection.

In addition, in early preclinical studies, the eQuICscreening tool has been found to distinguish betweenplasma and serum samples from scrapie-infected anduninfected hamsters. This rapid and sensitive screeningtool that detects prion diseases, also known as transmissi-ble spongiform encephalopathies, would aid in the pre-vention of prion disease transmission within and betweenspecies because animals and people are commonly infect-ed for years before symptoms of the disease appear.

Byron Caughey, PhD, senior investigator in theNIAID Laboratory of Persistent Viral Diseases, said,“The eQuIC assay in particular provides a practical,high-throughput, and rapid means of testing foramounts of partially protease-resistant form of the host’sprion protein that are several orders of magnitudebelow those typically required to cause prion disease byintracerebral inoculation into animals.”

The authors concluded that the remarkable resist-ance to inactivation of prions relative to otherpathogens also makes it important to develop practicalassays for prion contamination in a wide variety ofmaterials, such as foods, feeds, transplanted tissues,medical devices, agricultural wastes and by-products,soils, water sources, and other environmental samples.The article was published on May 10, 2011, in the jour-nal mBIO.

Sensitive Blood Test Detects Prion Diseases

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Gene Test Predicts Cancer in Pancreatic Cysts

cont’d from cover

year avoid the possibility of needless surgery toremove the benign growths. Scientists at JohnsHopkins Kimmel Cancer Center (Baltimore, MD,USA; www.hopkinskimmelcancercenter.org) ana-lyzed DNA from the cyst fluid of 19 intraductal pap-illary mucinous neoplasms and the correspondingnormal tissue by massively parallel sequencing formutations in 169 cancer genes. Fourteen of the 19tumors showed mutations in the known pancreaticoncogene Kirsten rat sarcoma viral oncogenehomolog (KRAS), and 6 of the 19 carried a mutationin the stimulatory G-protein alpha subunit (GNAS),a well-known oncogene in other tumor types. Alarger set of fluid samples from these cystic neo-plasms, 96% carried a mutation in at least one of thetwo oncogenes. In contrast, 44 benign cysts exhib-ited no GNAS or KRAS mutations. KRAS mutationsdid appear occasionally in a rare type of cyst with arelatively low potential to become cancerous.According to the investigators, these rare, mostlybenign cysts are less challenging to diagnosebecause of their location within the pancreas andtype of patient.

Generally, patients with a cyst that appearsharmless and is less than 3 cm in size are moni-tored to watch for growth of the cyst or other con-cerning features such as a solid nodule. With cyststhat appear more worrisome, surgical removal isoften recommended, but the procedure requiresremoval of a portion of the pancreas as well, andcomplications like a pancreatic fistula where fluidfrom the pancreas leaks through the surgical inci-sion, eating difficulties, and prolonged recoverycan develop.

Bert Vogelstein, MD, a lead author of the study,said, “Further studies on a larger number of patientsmust be done before the gene-based test can bewidely offered. However, that the technology fordeveloping a gene-based test in this case is relative-ly straightforward because the mutation occurs atone spot in both of the genes.” The study was pub-lished the July 20, 2011, issue of ScienceTranslational Medicine.

Image: A diagram showing five different types of pan-creatic cysts (Photo courtesy of Johns HopkinsMedical Institutions).



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at informative loci, forming part of an integratedworkflow that translates test results into clear clini-cal decisions. Such a solution would ultimately beprovided either as a testing service or by an analy-sis kit that could be used in-house by existing clini-cal laboratories.

Oxford Gene Technology (OGT; Oxford, Unitedkingdom; www.ogt.co.uk), a provider of clinicalgenetics and diagnostic solutions, has received afunding award of US$1.86 million from the UKgovernment-backed Technology Strategy Board(Swindon, United Kingdom; www.innovateuk.org)to develop the tumor profiling assay. OGT has con-siderable experience in providing solutions to theclinical research market and already offers sequenc-ing and microarray services and products as part ofits Genefficiency and CytoSure offerings

For the new project, OGT will utilize its expert-ise in the design of high-throughput genomic serv-

ices to develop a flexible tumor-profiling assay thatreduces sample processing costs and turnaroundtimes. In addition, OGT will use its experience indata interpretation to adapt its CytoSure Interpretsoftware to analyze the results provided by the newassays, making it simple to generate informative,easy-to-understand reports.

The new assay will minimize the use of untar-geted, aggressive primary treatments, which areoften unnecessary and ineffective, while simultane-ously improving the patient experience and increas-ing survival rates.

James Clough, OGT’s vice president of clinicaland genomic solutions, commented, “The new can-cer profiling assay will complement OGT’s othermicroarray and sequencing solutions, furtherexpanding the analytical options we provide. Sucha service facility is novel in the UK and will benefitthe patient, clinician, and healthcare funder interms of quality of care and cost-effectiveness.”

Tumor Profiling Assay to Improve Cancer Care

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large gene rearrangements and the complete rese-quencing of the low-density lipoprotein receptorgene and identifies patients with familial hyperc-holesterolemia (FH).

The platform, called the LipoChip, provides arapid diagnosis, studying all the genes known tocause FH, such as low density lipoprotein recep-tor, (LDLR), apolipoprotein B (APOB), proproteinconvertase subtilisin/kexin type 9 (PCSK9),which permits the specialist to include them intheir daily routine. It identifies the largerearrangements of at least 10% of the mutationsnot detected by sequencing.

The LipoChip genetic test (Progenika Biophar-ma; SA, Vizcaya, Spain; www.progenika.com) isCE-marked (European Conformity), and needsonly to be performed once in a life time at any ageto identify the mutations that cause FH, even in

young relatives that have notdeveloped the clinical symptoms.The description of the mutation(s)encountered will confirm the exis-tence of FH or not.

The detection of a Class Amutation is directly associatedwith FH, and these are mutationswhose pathogenicity has been vali-dated in vitro, or they produce anull allele. For Class B mutations,the analysis of the LDLR andAPOB genes will define the presence of a muta-tion that has been previously associated with FHin reports where it has been described in otherpopulations with FH, or that its association withthe phenotype has been validated in familial stud-ies. These are mutations in the LDLR and APOBgenes that could be associated with FH, but have

not been described in the literature. The muta-tions occur in regions of the genes where theycould have a functional effect related to FH, andare known as class C mutations.

Image: The LipoChip, designed as a genetic diag-nostic platform to diagnose lipid metabolism disorder(Photo courtesy of Progenika Biopharma).

Genetic Test Diagnoses Lipid Metabolism Disorder

8LabMedica InternationalOctober/2011105LMI-10-11LINKXPRESS COM

Digital Pathology ApplicationReleased for iPad and iPhone

cont’d from cover

Existing Digital Image Hub users can connectthe application to their own server to explore andview images from their own image collection.

SlidePath Gateway provides access to high qual-ity whole slide images captured on the Leica Microsystems (Wetzlar, Germany; www.leica-microsystems.com) SCN400 slide scanner,with expert review findings and content providedby contributing bodies including the AmericanSociety for Clinical Pathology (ASCP) CheckPathAnatomical Pathology External Quality Assessment(EQA) Program (2006), Cerviva Cervical CytologyEQA Pilot (2009), National health Service (NHS)Breast Screening Pathology EQA Program (2010),UK National Urologic Pathology EQA Program(2009), and the United Kingdom National ExternalQuality Assessment Service (UKNEQAS) HER2Breast Interpretive EQA Pilot (2011).

Browsing folders of images from each of theEQA programs is possible. Individual cases can beselected and the user can view, zoom, and navigatearound the slides. Each case includes expert pathol-ogist assessments, which can be viewed with theslides, giving increased insight into the samples.They can also see a sample set of Leica Biosystems’Novocastra antibody range.

Leica Microsystems’ Biosystems Division, alsoknown as Leica Biosystems, offers histopathologylaboratories a large product range with appropriateproducts for each work step in histology and for ahigh level of productivity in the working processesof the entire laboratory.

Dr. Donal O’Shea, Head of Digital Pathology inLeica Microsystems says, “The release of theSlidePath Gateway App displays Leica Micro-systems’ commitment to develop and expand itsDigital Pathology portfolio. With this App we aregiving everyone the opportunity to try DigitalPathology, access high resolution whole slideimages and expert opinions, through a highly intu-itive user interface.”


FFour diverse methods were evaluated for thedetection of Clostridium difficile in stool speci-

mens collected in liquid transport medium. The methods for detection included an enzyme

immunoassay for the antigen glutamate dehydroge-nase (GDH), a toxin A and B enzyme immunoassay(Toxin EIA), cell culture cytotoxicity neutralizationassay (CT) and a real time polymerase chain reac-tion (PCR) assay.

Scientists from the University of Michigan HealthSystem (Ann Arbor, MI, USA; www.med.umich.edu)analyzed a total of 357 stool specimens collected inCary-Blair transport media (Meridian Diagnostics,Cincinnati, OH, USA; www.meridianbioscience.com). The goal of their study was to establish an ana-lytically accurate and efficient algorithm for the detec-tion of C. difficile infection (CDI) in a patient popula-tion using samples collected in a specific transportmedium and to determine whether the sensitivityand specificity of PCR was affected by freezing sam-ples before testing.

The analytic sensitivity and specificity of each asdetermined using a combined gold standard were asfollows: for the Wampole C. DIFF CHEK-60 Assay,GDH (Inverness Medical; Princeton, NJ, USA;www.invernessmedicalpd.com) were 100% and93.2%, respectively; for the C. difficile Toxin A/BMicroplate Assay, Toxin EIA (Remel; Lenexa, KS,USA; www.remel.com) were only 82.9% for both.The cell culture cytotoxicity neutralization assay(TrinityBioTech; Carlsbad, CA; USA; www.trinity-biotech.com) achieved 100% sensitivity and specifici-ty, while for the PCR that was performed on frozenspecimens, they were 74.3% and 96.6%, respective-ly. However, the sensitivity and specificity of theGeneOhm Cdiff PCR Assay improved to 100%,when performed on 50 fresh stool samples collectedin Cary-Blair media. This molecular assay is a prod-uct of Becton, Dickinson and Company (FranklinLakes, NJ, USA; www.bd.com).

Clostridium difficile infection (CDI) caused by tox-igenic strains of C. difficile is primarily a nosocomial

infection with increasing prevalence. The authorsconcluded that while CT remains a sensitive methodfor the detection of CDI, GDH offers an excellent ini-tial screening method to rule out CDI. The authorsconcluded that while the performance of each assaydid not appear to be affected by collection in Cary-Blair medium, the PCR method performed betterusing fresh specimens. While PCR on all stool speci-mens currently carries a high cost per test, thismethod may offer a more rapid alternative to CT forthe confirmation GDH-positive samples. The studywas published in July 2011 in the online journalInfectious Disease Reports.

Blood Test for PredictingChildhood Diabetes

Reconsidered

TThe glycosalated hemoglobin (HbA1c) blood testis a rapid and convenient way of diagnosing dia-

betes. The HbA1c test has become the preferred wayto diagnose diabetes among the millions of patientswho have the disease, but are asymptomatic. Thesimple test measures longer-term blood sugar levelswithout requiring patients to fast overnight.

Scientists at the University of Michigan, (AnnArbor, MI, USA; www.umich.edu), studied whetherthe assay could be used to make a diagnosis of dia-betes mellitus in adolescents, using the standardizedvalues for adults. For the study, they evaluated thetesting results of 1,156 obese and overweight adoles-cents, aged 12-18 years. The American DiabetesAssociation, (Alexandria, VA, USA; www.diabetes.org), recommends screening only obese and over-weight children because their weight puts them athigher risk for developing diabetes.

Individuals were defined as having diabetes melli-tus if their fasting plasma glucose (FPG) was equal toor greater than 126 mg/dL; a 2-hour plasma glucose(2-hr PG) equal to or greater than 200 mg/dL or wereprediabetic where the FPG is between 100 and 126mg/dL; and the 2-hr PG is between 140 and 200mg/dL. According to the guidelines, individuals with-out symptoms would be classified as having diabetes ifHbA1c values reach 6.5% and as having prediabetes ifHbA1c values were between 6.0% and 6.4% on twoseparate tests. Only four of the adolescents studiedhad undiagnosed diabetes mellitus. When assessingFPG to detect diabetes, an HbA1c of 6.5% had sensi-tivity rates of 75.0% for adolescents and 53.8% adults,although the specificity was higher. Additionally, whenassessing FPG to detect diabetes mellitus, an HbA1c of5.7% had sensitivity rates of 5.0% and 23.1%, andspecificity rates of 98.3% and 91.1% for adolescentsand adults, respectively. These analyses suggest thatHbA1c is a poorer predictor of diabetes mellitus andprediabetes for adolescents compared with adults andperformance was poor regardless of whether FPG or 2-hr PG measurements were used.

Joyce M. Lee, MD, MPH, a pediatric endocrinol-ogist, and lead author of the study, said, “We foundthat hemoglobin A1c is not as reliable a test foridentifying children with diabetes and prediabetescompared with adults and using this test in childrenmay lead to missed cases.” The study was pub-lished online ahead of print on December 30,2010, in the Journal of Pediatrics.




Different Methods Compared for Diagnosis of Clostridium Difficile Infection




AA single multiplex assay detects up to 97 drugsand drug metabolites from an undivided oral

fluid sample. Matrix dedicated kits ensure reliableassay performance including good specificity, evenat lower drug concentrations.

Randox Laboratories (Crumlin, United King-dom; www.randox.com) biochip array technologyoffers a diagnostic grade testing solution with repro-ducible results. The Biochip arrays provide a rapidturnaround time, which is advantageous for onsiteworkplace drug testing. In comparison, a four-plateautomated enzyme linked immunosorbent assay(ELISA) system requires thirteen times longer toprocess the same results.

A point of collection biochip analyzer wasrecently launched by Randox – the “EvidenceMultiStat,” which processes multiple results in lessthan twenty minutes. The Biochip platform is mul-timatrix; therefore, a number of sample typesincluding oral fluid, whole blood, urine, and post-mortem tissue can be run on the system. TheRandox line of Evidence immunoassay analyzersgenerate quality control data automatically withevery run, ensuring that each test has been carriedout successfully.

Randox biochip arrays meet the limit of detec-tion requirements for both the European WorkplaceDrug Testing Society (EWDT; www.ewdts.org)

guidelines for oral fluid testing (2010) and theAustralian and New Zealand procedures for speci-men collection and the detection and quantificationof drugs in oral fluid AS 4760-2006 (2006).

Testing of oral fluid specimens is becomingincreasingly popular in the workplace, prisons, andin drug rehabilitation clinics. With a number of ben-efits to be gained from onsite testing, oral fluid willcontinue to be put into practice for drugs of abusescreening. As the prevalence of designer drugs andnew variations of drugs enter the market, work-place drug testing is set to increase in a bid to detectand deter use. Oral fluid testing is also used as anaid in clinical diagnosis.


TThe Ziehl-Neelsen staining (ZNS) technique hasbeen evaluated for the diagnosis of helminth

eggs in sputum and different modifications of thetechnique have been compared.

Eggs of the parasitic lung fluke, that causesparagonimiasis, can be found in sputum and canbe stained with the classical reagents for acid – fastbacilli, and with some alterations, ZNS is veryeffective for diagnostic purposes.

An international team working with a non-governmental organization in Laos, (ServiceFraternel d’Entraide; Vientiane, Lao People’sDemocratic Republic; www.sfe-laos.org), exam-ined a paragonimiasis index case’s sputum withwet film direct examination (WF) and ZNS. Theyalso reexamined stored ZNS slides from twoprovinces and compared prospectively WF, ZNS,and formalin-ether concentration technique(FECT) for sputum examination of patients withchronic cough, from September 2009 until April2010. Finally, they compared the three techniquesand assessed excess direct costs associated withthe use of different diagnostic methods.

Paragonimus eggs were clearly visible in WFand ZNS sputum samples of the index case. They

appeared brownish-reddish in ZNS andwere detected in six of 263 archived ZNSslides corresponding to five patients. Onehundred sputum samples from 43patients were examined with three tech-niques, which revealed that six patientshad paragonimiasis, from 13 positivesamples. Sensitivity per slide of the FECTwas 84.6%; for ZNS it was 76.9%; and forthe WF technique, it was 61.5%. Brieflyheated ZNS slides contained more eggs than slidesheated for five minutes, 42 eggs per slide (eps) ver-sus 29 eps. Bloodstained sputum portions con-tained more eggs than unstained parts.

The authors concluded that Paragonimus eggscould easily be detected in today’s widely usedZNS of sputum slides. The ZNS technique appearssuperior to the standard WF sputum examinationfor paragonimiasis and eliminates the risk of tuber-culosis transmission. Additional operational costsper slide were zero for ZNS, US$0.10 for WF, and$0.79 for FECT. The authors recommend that inaddition to ZNS use for the diagnosis of TB, rou-tine examination for Paragonimus eggs of eachslide with the x10 lens, total magnification x100,

in geographic areas where paragonimiasis may beendemic.

Paragonimiasis is a food-borne parasitic infec-tion caused by the lung fluke, most commonlyParagonimus westermani. It infects an estimated22 million people worldwide and Paragonimusspecies are distributed throughout the Americas,Africa, and Southeast Asia. P. westermani is dis-tributed in Southeast Asia and Japan and P. kelli-cotti is endemic to North America. The study waspublished online on May 17, 2011, in the journalPublic Library of Science Neglected TropicalDiseases.

Image: An egg from the parasite Paragonimus west-ermani (Photo courtesy of the CDC).

Modified Tuberculosis Stain Reveals Worm Eggs

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AA real-time polymerase chain reaction (PCR) assay pro-vides consistent results for cutaneous leishmaniasis

within hours of sample receipt.The diagnostic test, which is called the SMART Leish Real-

Time PCR assay, gives results even when the numbers of par-asites in the skin are so low that microscopy and cultureresults will be negative at day 30.

The SMART Leish PCR assay was developed in partner-ship among Walter Reed Army Institute of Research (WRAIR;Silver Spring, MD, USA; http://wrair-www.army.mil), theArmy Medical Research and Materiel Command (FortDetrick, MD, USA; https://mrmc.det-rick.army.mil), and the commercialpartner, Cepheid USA, Inc. (Sunnyvale,CA, USA; www.cepheid.com) toaddress the global health issue of cuta-neous leishmaniasis that occurred inthousands of US troops serving in Iraqand Afghanistan. The SMART LeishReal-Time PCR assay has now beenapproved by the US Food and DrugAdministration (FDA; Silver Spring,MD, USA; www.fda.gov).

“In the near future, this assay maybe utilized at additional strategicallylocated [Department of Defense] DoDmedical facilities, enhancing our capa-bility to provide rapid diagnosis to serv-ice members and improve patient man-agement,” said Col. Max Grogl, WalterReed Army Institute of Research’sdirector.

Endemic throughout Africa, Asia,Europe, as well as the Americas, leish-maniasis is a protozoan parasitic dis-ease caused by single-cell organismstransmitted through the bite of a sandfly. Cutaneous leishmaniasis is the mostcommon form of the disease. Thoughnot considered life threatening, the dis-ease can cause disfiguring skin ulcersthat take months to heal and causescarring.

Traditional testing methods requirea small tissue sample of the skin ulcerlesion. The samples are examinedunder microscope and culture to deter-mine the presence of the intracellularform of the Leishmania parasites calledamastigotes. These traditional testingmethods can require anywhere from30 minutes to four weeks to produceresults.

Image: Colored scanning electron micro-graph (SEM) of Leishmania sp. protozoa(Photo courtesy of SPL).

Real-Time PCR Assay Diagnoses Cutaneous Leishmaniasis

LabMedicaLabMedicafor daily laboratory medicine news click to www.labmedica.comfor daily laboratory medicine news click to www.labmedica.com

13 LabMedica InternationalOctober/2011




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IImproved polymerase chain reac-tion (PCR) technology enables

millions of PCR reactions in a singletube. Following fragmentation usingspecifically selected restrictionendonucleases, and denaturing ofthe DNA sample, a selector probelibrary is added. Each probe canhybridize to both ends of a targetedDNA restriction fragment; it guidesthe targeted fragments to form cir-cular DNA molecules. Only circularDNA targets are amplified, ready forsequencing using any next-genera-tion procedure, and results are high-ly reproducible.

The new HaloPlex Target Enrich-ment Kit is available exclusively inthe UK from Cambio (Cambridge,United Kingdom; www.cambio.co.uk). It represents a new concept innext-generation sequencing, reduc-ing costs and saving up to 80 % insample preparation time.

According to Dr. Naeem Ahmed,Cambio’s technical support specialist,“This new Halo Genomics kit pro-

vides a ‘lab-in-a-tube’ solution, whichgreatly simplifies PCR workflow, withno need for expensive instrumenta-tion or automation. With next-genera-tion nanoscale PCR, reactions are par-allelized at the molecular level so thatno separate time-consuming librarypreparation stage is required. For aproject targeting 100 genes in 1,000samples, HaloPlex Target EnrichmentKit reduces the total sample prepara-tion time by as much as 80 percent.Genomic regions of interest areenriched at the same time as theintroduction of sample barcoding andsequence motifs.”

The HaloPlex PCR reagent kit forhigh performance targeted rese-quencing applications include studiesof candidate genes involved in rareinherited diseases, pathway sequenc-ing in matched tumor and normalsamples, and clinical sequencing forBRCA gene assays.

Image: The HaloPlex Target EnrichmentKit (Photo courtesy of Cambio).

Millions of PCR Reactions Occur in Single Tube

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AAn assay has been evaluated thatgenotypes human papillo-

mavirus (HPV) in cytology samplesfrom women with atypical squamouscells of undetermined significance(ASC-US). The qualitative multiplexassay provides specific genotypinginformation for HPV Types 16 and18, while concurrently detecting theother 12 high-risk HPV types in apooled result. From cellular input, ß-globin is used as an internal controlto assess specimen quality and identi-fy specimens containing factors thatinhibit the amplification process.

In a collaborative study, the clini-cal performance of the cobas 4800HPV Test was evaluated by genotyp-ing liquid cytology samples of 47,208women during routine screening.The screening was carried out from

May 2008 to August 2009 at 61 clin-ical centers across the US. The studyfocused on 1,578 (82.3%) of the1,918 women who had ASC-UScytology; all 1,578 women under-went colposcopy and had valid HPVtests and cervical biopsy results. Twofirst generation HPV assays werecompared to the second-generationcobas 4800 HPV test.

The cobas 4800 HPV Test (RocheMolecular Systems; Pleasanton, CA,USA; http.// molecular.roche.com)detected an overall prevalence ratesof 32.6% with high risk HPV (14genotypes), 8.2% with HPV-16, and2.9% with HPV-18. The performanceof the cobas 4800 HPV Test is verysimilar to that of the Hybrid Capture2 test (Qiagen; Gaithersburg, MD,USA; www.qiagen.com) for all stan-

dard parameters of test performancefor those diagnosed with cervicalintraepithelial neoplasia (CIN) 2 orworse and CIN 3 or worse endpoints. Both tests were highly concor-dant for patients characterized as lessthan CIN 2 and for those equal to orgreater than CIN 2 with minorinsignificant disagreement.

Mark H. Stoler, MD, professor ofsurgical pathology at the University ofVirginia Health System, (Charlottes-ville, VA, USA; www.healthsystem.virginia.edu), said, “Screening for

high-risk HPV genotypes providesimportant additive information toPapanicolaou (Pap) testing. Screeningfor the two highest risk types, HPV-16 and HPV-18, can provide predic-tive information about a woman’srisk for having cervical precancer orcancer.” The cobas 4800 HPV Testhas now been granted US Food andDrug Administration, (FDA; SilverSprings, MD, USA; www.fda.gov)approval. The study was published inMarch 2011, in the AmericanJournal of Clinical Pathology

Human Papillomavirus Assays Identify Risk of Cervical Cancer

TThe hemoglobin A1C (HbA1C)blood test should be used in con-

junction with the oral glucose toler-ance test for screening overweightchildren for diabetes.

Although the glycosalated HbA1Cblood test is easier on the patient, as itdoes not require fasting, it may not besensitive to catch overweight childrenwho are at a high risk of developingtype 2 diabetes.

Scientists at the Children’s MercyHospital (Kansas City, MO, USA;www.childrensmercy.org) evaluatedthe charts of 629 overweight and ado-lescent patients who had both theHbA1c and an oral glucose test. Theyfound that 40% of type 2 diabetespatients and 67% of high-risk patientsidentified through the oral glucose tol-erance test would have shown a nor-mal glycemic status if only the hemo-globin A1C test were used to diagnosethem. Nearly nine out of ten patientshad normal blood glucose levelsaccording to their hemoglobin A1C

results. The study found that the recom-

mended blood test may not be enoughto detect type 2 diabetes in over-weight children, missing more thantwo-thirds of children at high-risk forthe condition. The investigators foundthat performing two tests, both therecommended hemoglobin A1C testand an oral glucose tolerance test,could dramatically reduce the risk ofdelayed diagnosis in overweight chil-dren.

Wayne Moore, MD, PhD, chiefand medical director of the en-docrine/diabetes section at Children’sMercy Hospital, said, “Lifestylechanges and early treatment can helpdelay disease progression of diabetes.It is important that patients are diag-nosed as early as possible for the bestoutcomes.” The findings were pre-sented at the Pediatric AcademicSocieties Annual Meeting, held fromApril 30 – May 3, 2011, in Denver(CO, USA; www.pas-meeting.org).

Dual Testing Recommended for Diabetic Children

LABORATORY LABELSCILS

The CILS-9000 computer-printable,durable label range provides perma-nent bonding to tubes, straws, andother container stored at -196 °C.The labels are considered ideal forsample identification during long-term, multi-freeze thaw cycles andcryogenic storage.

SPECIFIC PROTEIN ANALYZER

Goldsite DiagnosticsThe Nephstar analyzer is a benchtopnephelometric analyzer for rapidquantitative measurements of spe-cific proteins in blood and urine sam-ples. Key features include automaticcalibration and blanking, with resultsavailable in less than three minutes.

AUTOMATIC CHEMISTRY ANALYZER

iCubio Biomedical TechnologyThe iChem-740 offers constantspeed 400T/H or 500T/H with ISE,designed with a user-friendly soft-ware interface, automatic barcode,and LIS system. Additional benefitsinclude high performance and accu-rate results.

SLIDE SCANNERVentana Medical Systems

The iScan HT holds 360 slides, andis designed to increase operationalefficiencies in anatomic pathologylaboratories. Key features includefast scan speeds and high qualityimages, along with a slide transportsystem that improves reliability andsafe handling of slides.


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Image: The Accu-Chek Inform II blood glucose meter(Photo courtesy of Roche Diagnostics).

TThe National Health Service (NHS; UnitedKingdom; www.nhs.uk) Trust has installed

wireless blood glucose meters in wards, clinics,and theaters across all three of its acute hospitalsites in Mid Yorkshire (United Kingdom). Wirelessdevices, connected by intelligent IT systems arevital for patient safety and for meeting ClinicalPathology Accreditation (CPA) requirements forPoint of Care (POC) testing.

The meters are linked wirelessly to theHospital Information System (HIS) via the RochePOC data management solution, cobas IT 1000,allowing them to be managed centrally in accor-dance with national guidelines for POC devices.

In addition to transmitting patient results, RocheDiagnostic’s (Burgess Hill, United Kingdomwww.roche-diagnostics.co.uk) blood glucose meter,Accu-Chek Inform II records quality control (QC)results, operator and patient details, consumable

details, configuration information, and comments.The data transmitted by the meters is managed bycobas IT 1000, which permits patient validation,operator recognition, and material lot tracking.

“Our new blood glucose testing system helpsus to fulfill CPA requirements in a number ofways,” explained Tracey Eastwood, senior BMSresponsible for POC testing within the Trust. “Itprovides a central record of all data, including QCrecords, which, in turn, provide an importantaudit trail. The system also enables us to managereagents, calibrations, and quality control central-ly. Centralized calibration of glucose meters hasremoved the risk of operator errors and the QClockout feature ensures that operators perform thenecessary QC activities at the required intervals,otherwise the meter cannot be used.” While thereis no cure for diabetes at the moment, manage-ment of the disease has become more effective.

Wireless Connectivity Transforms POC Blood Glucose Testing

Alcohol OveruseOften Undiagnosed in HIV-Infected Persons

SScientists evaluated the ability of the carbohy-drate-deficient transferrin (CDT) biomarker to

detect unhealthy alcohol consumption among peopleinfected with Human immunodeficiency virus (HIV).

Although CDT, often measured as %CDT, candetect very heavy drinking, whether it does so inpeople with HIV in a clinically useful manner has yetto be established.

Investigators at the Boston University School ofMedicine (BUSM; MA, USA; www.bumc.bu.edu)and colleagues evaluated the ability of %CDT andgamma glutamyltransferase to detect three levels ofunhealthy alcohol consumption: at-risk, heavy, andfrequent heavy drinking as determined by a refer-ence standard questionnaire.

Of 300 subjects, 103 reported current consump-tion at at-risk amounts, and 47 reported heavyamounts. For at-risk drinking, sensitivity of %CDTwas 28%, meaning the test detected only 28% ofthose with unhealthy alcohol use. For heavy drink-ing, sensitivity was 36%. According to the scientists,these findings suggest that %CDT is not sufficientlysensitive for use in screening for unhealthy alcoholuse by people with HIV infection.

“There is evidence that early intervention forunhealthy alcohol use can be effective but earlyclinical signs are often missed and unhealthy alco-hol use often goes undiagnosed by HIV healthcareproviders,” explained principal investigator JeffreySamet, MD, MA, MPH, professor of medicine atBUSM. “Unfortunately among HIV-infected adultswith alcohol problems, %CDT had poor overallaccuracy for detecting unhealthy drinking,” headded.

Alcohol use is common in HIV-infected persons. Itcan interfere with HIV medication adherence, lowerCD4 cell count, and even cause hepatic injury.Furthermore, HIV coinfection with viral hepatitis iscommon and both HIV and viral hepatitis areadversely impacted by alcohol. For these reasons,detection of unhealthy alcohol use is important inthe clinical care of HIV-infected individuals.




AAnew electronic pipette accurately dispenses smallvolumes of liquid. The pipette is suitable for han-

dling 0.1 µL - 5 µL of liquid and is targeted especiallyfor molecular biology laboratories. It is especially usefulfor applications such as polymerase chain reaction(PCR) and microplate pipetting.

The liquid is dispensed from the pipette tip veryrapidly, which ensures that the tip is completely emp-tied. There is no need to touch the receiving vesselwall during pipetting and no drop of liquid is left atthe tip. As a result, the handling of the liquid is con-tamination free, more precise, and faster than withother pipettes.

The biotechnology company Biohit (Neptune, NJ,USA; www.biohit.com) launched the electronic pipetteunder the commercial name eLINE 0.1–5 µL. The newpipette has a Super Pipetting (SP) feature and its rapid

piston movement allows complete emptying of the tip,making it possible to dispense very small volumes fromthe air.

Pipetting small volumes against receiving vesselwall or under the liquid surface to get all liquid out ofthe tip causes contamination risk, decreased precision,and slow pipetting work. Usually contaminations canbe avoided by changing the tip between dispensing,but with the eLINE 0.1–5 µL dispensing from the airenables continuous work with the same tip, as there isno need to touch the vessel or liquid.

Biohit Inc. is a subsidiary of Biohit Oyj (Helsinki,Finland) a company that develops, manufactures, andmarkets liquid handling and diagnostic products for usein health care, research, and industrial laboratories.

Image: The eLINE electronic pipette (Photo courtesy ofBiohit).

Electronic Pipette Dispenses Volumes of 0.1 µL - 5 µL

Phagocyte SignaturesDifferentiate Between Viral

and Bacterial infections

AA rapid blood test that accurately tells the differ-ence between bacterial and viral infections will

lead to better treatment outcomes for infectedpatients.

The immune systems of patients with bacterialinfections behave differently than the immune sys-tems of patients with viral infections, and the testwas based on these differences.

Robert S. Marks at National Institute ofBiotechnology in the Negev, Ben-Gurion Universityof the Negev (Be’er Sheva, Israel; www.bgu.ac.il/nibn), Daria Prilutsky, and colleagues differentiat-ed between viral and bacterial acute infections usingchemiluminescent signatures of circulating phago-cytes.

Bacterial and viral infections can produce thesame symptoms but it is very important to distin-guish between them when deciding on treatment.For example, antibiotics work for bacterial infec-tions but not for viruses.

If left untreated until results of a throat culture,for instance, are received, bacterial infections canget worse. But needlessly giving antibiotics topatients with a viral infection could contribute tothe growing problem of antibiotic-resistant bacteria.Since current diagnostic methods to sort out thetwo kinds of infection are time-consuming and maynot be completely accurate, the scientists decided todevelop a new test that would enable doctors tomake the right diagnosis rapidly.

The method is time saving, easy to perform andcan be commercially available. It could be imple-mented in various medical institutions as an adjunctto clinical decision making said the scientists.

A report of the new rapid blood test appears inACS’ journal Analytical Chemistry. The scientistsconcluded, “The two infections exhibit completelydifferent types of chemiluminescent signatures,each one described by its own characteristics,proving that the oxidative potential of the innateimmunity can indeed serve as a prognostic or diag-nostic marker.”




AAmultiplex analytical control for cystic fibrosistesting is now labeled for in vitro diagnostic

use. The Accurun 644 cystic fibrosis control isavailable to clinical pathologists in the Europeanmarket. The synthetic, multiplex control is an effec-tive mechanism for identifying mutations in the cys-tic fibrosis CFTR gene, covering all mutations in theLuminex (Austin, TX, USA; www.luminexcorp.com) xTag cystic fibrosis 39 kit v2 IVD assay. Thekit is a device used to simultaneously detect andidentify a panel of mutations and variants in thecystic fibrosis transmembrane conductance regula-tor (CFTR) gene in human blood specimens.

By covering the largest number of mutations ina single vial of any commercial control, theAccurun 644 control offers labs advantages interms of both quality control and cost. Using themultiplex control allows for detection of significanterrors missed or more difficult to identify using

rotating genomic DNA controls – enabling labs toimprove error detection with fewer controls, reduc-ing costs, improving throughput, and increasingrevenue potential.

A product of SeraCare (Milford, MA, USA;www.seracare.com), the Accurun 644 control forcystic fibrosis testing with CE marking is availablein Europe for IVD testing after serving as a highlyeffective tool for research purposes in the UnitedStates for two years.

Cystic Fibrosis (CF) is a multisystem disease thatcan affect the respiratory tract, pancreas, sweatglands, intestine, male genital tract, and liver.Pulmonary disease is one of the most notable char-acteristics of CF and is the leading cause of death inCF patients.

SeraCare’s portfolio includes diagnostic controls,plasma-derived reagents and molecular biomarkers,biobanking, and contract research services.

Image: The Accurun 644 cystic fibrosis control (Photocourtesy of SeraCare).

Multiplex Analytical Control Introduced for Cystic Fibrosis Testing

IMMUNOASSAY READERNewScen Coast BioPharmaceuticalThe NewSign is an open systemreader, and can read any manufac-turer’s test strips or cassettes with-out any modification to the instru-ment. The easy-to-use system alsoallows the input of all patient data.

URINALYSIS SYSTEMAve Science & Technology

The fully automated system com-bines the efficiency of AVE-764Band AVE-752, maximizing the bene-fits of both into one effective and reli-able system. Key features includeaccurate results, rapid processing,and comprehensive reporting.

CHEMISTRY ANALYZERBeckman Coulter

The AU5800 series is designed toimprove processing time, and meetthe demands of high- and ultra-high-volume clinical labs. Specific modelsin the series are available in one- tofour-module configurations, with theoption of including either a single ordual ISE flow cell.

PIPETTE SERIESBiohit

The eLINE 0.1-5 µl single-channelfamily of pipettes with SuperPipetting feature offers rapid pistonmovement and complete emptyingof the tip, making it possible to dis-pense small volumes from the air.The pipettes serve to avoid contam-ination, while increasing throughput.


21 LabMedica InternationalOctober/2011 118LMI-10-11LINKXPRESS COM

NNoninvasive cholesterol testing technology willbe available to the public through a clinical ref-

erence laboratory testing for the first time. PreVu isa noninvasive risk assessment technology that eval-uates the additional risk a person may have for coro-nary artery disease (CAD) by conveniently and pain-lessly testing their skin cholesterol level.

High levels of skin cholesterol have been shownto be correlated to CAD as measured by stress test,angiography, coronary calcium, carotid intima-media thickness, inflammatory markers of vasculardisease, previous heart attack incidents, andFramingham risk score.

Miraculins Inc. (Winnipeg, Canada; www.miraculins.com), a medical diagnostic companyfocused on developing and commercializing diag-nostic tests and risk assessment tools for unmet clin-ical needs, has signed a Letter of Intent with

Gamma-Dynacare Medical Laboratories (Brampton,Canada; www.gamma-dynacare.com), one ofCanada’s largest and medical laboratories, to intro-duce a laboratory processed format of its PreVu non-invasive cholesterol test technology.

Under the terms of the agreement, Gamma-Dynacare will be responsible for all costs related tothe final development stages of the PreVu LP test aswell as the development and implementation of anautomated system to process the test at a central-ized facility. Gamma-Dynacare will also providelogistical support for collection, transportation andresults reporting utilizing Gamma’s internal infra-structure, which handles tens of thousands of spec-imens daily, and delivers more than 40 million testsannually. As part of the agreement, Miraculins hasawarded Gamma-Dynacare the exclusive rights toprocess all PreVu LP Tests sold in Canada.

The PreVu LP test noninvasively measures theamount of cholesterol that has been deposited inskin tissues by painlessly and rapidly collecting skincells from the palm of the hand using a medicaladhesive collection device, which would then besealed and sent to a Gamma-Dynacare laboratory forprocessing.

Image: The PreVu point-of-care skin cholesterol test(Photo courtesy of Miraculins).

Noninvasive Cholesterol Testing Becomes Available to Public

Protein Biomarker ImprovesEarly Diagnosis of Alzheimer’s

TThe level of specific biomarkers in the plasma andcerebrospinal fluid (CSF) facilitates the early

diagnosis of dementia in Alzheimer patients. The bio-marker, soluble circulating low-density lipoproteinreceptor-related protein-1 (sLRP), provides key plas-ma binding activity for Alzheimer’s disease (AD)amyloid-β peptide (Aβ).

Scientists at the University of Gothenburg(Gothenburg, Sweden; www.gu.se) investigated thepresence of sLRP in a total of 60 patients who werebeing investigated for dementia and took part in thestudy, along with 20 healthy controls. The study groupincluded 14 patients with mild cognitive impairment(MCI) who progressed to AD (MCI-AD), 14 with AD,and 14 neurologically healthy controls. The investiga-tors determined the amount of plasma oxidized sLRPand Aβ40/42 sLRP-bound, other proteins-bound andfree plasma fractions, CSF tau/Aβ42 ratios, and mini-mental state examination (MMSE) scores in the studyparticipants. The sLRP normally binds 70% - 90% ofplasma Aβ preventing free Aβ access to the brain. InAD, Aβ binding to sLRP is compromised by increasedlevels of oxidized sLRP, which does not bind.

In MCI-AD patients prior to conversion to AD and ADpatients, the increases in oxidized sLRP and free plasmaAβ40 and Aβ42 levels were 4.9 and 3.7-fold, 1.8, and1.7-fold and 4.3 and 3.3-fold, respectively. In MCI-ADand AD patients, increases in oxidized sLRP and free plas-ma Aβ40 and Aβ42 correlated with increases in CSFtau/Aβ42 ratios and reductions in MMSE scores. The 24patients who were considered as stable MCI patientswere followed over a 2-4 years period had normal CSFtau/Aβ42 ratios, but increased oxidized sLRP levels.

The scientists concluded that these measurementscould also be used to identify AD during the earlystages of the disease. In such cases, the biomarkers canbe used to identify those patients with mild symptomswho are most likely to benefit from treatment. Theinvestigators also saw that patients who had not yetmet all the clinical criteria for AD had similar levels ofthe biomarkers in their spinal fluid to patients who haddeveloped the disease fully. The study was published inApril 2011, in the Journal of Alzheimer’s Disease.




HH igh throughput pathogen examination of stoolsamples identifies the enterohemorrhagic

Escherichia coli (EHEC) responsible for the epi-demic of bloody diarrhea associated with hemolyt-ic-uremic syndrome (HUS) that appeared inGermany.

The automated MagNA pure sample preparationsystem for nucleic acid isolation and LightCyclerReal-Time polymerase chain reaction (PCR) instru-ment from Roche Applied Science (Penzberg,Germany; www.roche-applied-science.com) havebeen used for high throughput examination ofEHEC pathogens in primary stool samples duringthe E.coli epidemic.

In a study carried out by Ralf Bialek [Laboratoryof Dr. Krause and colleagues] (MVZ GmbH; Kiel,Germany), human stool samples were processedusing the high throughput MagNA Pure 96 work-station, isolating high quality total genomic DNAfrom primary fecal specimens. Targeting the toxingenes of EHEC by a LightCycler Real-Time PCRtest demonstrated that fecal specimens could beused as starting material to detect EHEC infectionin epidemic situations reducing the turnaroundfrom at least overnight incubation to hours.

The fully automated robotic MagNA Pure 96Instrument used in this study isolates nucleic acidsfrom 96 samples in approximately one hour. TheRoche platform is an efficient, cost-effective way toprepare template DNA from large numbers of stoolsamples in epidemic situations. SubsequentLightCycler 480 Real-Time PCR was found to beaccurate and reproducible using proven specific,sensitive PCR primers and probes, targeting theShiga toxin genes of EHEC, available as LightMixkit EHEC.

A new pathogen universal protocol was estab-lished using a 200 µL sample volume and 100 µLelution volume. E. coli Shiga toxin genes wereamplified in the presence of two pairs of fluores-cently labeled hybridization probes targeting stx-1and stx-2, followed by LightCycler system melting

curve analysis discriminating the toxin gene sub-types. The bacterial parC gene (encoding the topoi-somerase IV subunit of Enterobacteriaceae) wasused as an extraction control to prove presence ofextracted DNA and to exclude PCR inhibitors.

The team evaluated a novel four-color multiplexassay using hydrolysis probes for the LightCycler480 Instrument, targeting both toxin genes (stx1and stx2), the wzx gene (marker for the O104serotype), and an internal control. This new assayenables the analysis of suspected samples in a sin-gle reaction, for a faster more cost-effective time-to-result, which is particular important during an out-break, when many samples have to be studied inshort time.

More than 3,400 laboratory confirmed EHECand HUS cases have been reported, 39 of themwith fatal outcome according to the Robert KochInstitute’s (Berlin, Germany; www.rki.de) report,dated June 20, 2011. The majority of EHEC infect-ed individuals live in Germany, but significant num-bers of infections have also been reported inSweden, Russia, as well as other European coun-tries.

Image: The MagNA Pure 96 instrument, designed toisolate nucleic acids from samples (Photo courtesy ofRoche Applied Science).

Genomic DNA from Fecal Specimens Helps Identify EHEC


RANDOM ACCESS SYSTEMBio-Rad Laboratories

The Tango Optimo benchtop, fullyautomated system is designed forblood group serology assays, withseven-day on-board reagent stor-age. Key benefits include flexibleoperations, low operating costs,easy sample loading and operation,and increased productivity.

TURBIDIMETRY REAGENTBioSystems

The latest reagent is designed forthe measurement of AT-III concen-tration in human serum or plasma.AT-III plays an important role in mod-ulating hemostasis as a natural anti-coagulant mechanism, with individu-als with low AT-III levels reported tohave an increased thrombosis risk.

MOLECULAR DIAGNOSTICS SYSTEM

CepheidThe GeneXpert Infinity-80 has beenredesigned for increased capacity,improved efficiency of operation, andgreater reliability. Added featuresinclude adjustable touch screen,expanded conveyor and loadingzone, and expanded test shuttle.

HBA1C/HEMOGLOBINANALYZER

Ceragem MedisysThe Cera-Stat 2000 features a full-color touch screen, built-in printer,and multilingual operation. Additionalfeatures include voice guide, patientID, large capacity memory, fast andreliable results, and a three-minuteassay time.

TThe current outbreak strain of theenterohemorrhagic Escherichia coli

(EHCH) in Germany belongs to theEscherichia coli O104 serogroup.Production and distribution of a chro-mogenic screening plate for rapid detec-tion of extended spectrum β-lactamase-producing (ESBL) organisms, such as E.coli O104, has been increased.

In the past, most outbreaks ofhemolytic uremic syndrome (HUS) havebeen associated with E. coli O157, butthe current outbreak strain belongs tothe E. coli O104 serogroup. Thecausative strain produces Shiga toxin 2and shows high resistance to 3rd gen-eration cephalosporins (due to theESBL resistance mechanism), as wellas broad antimicrobial resistance to, among others, trimethoprim/sulphonamide and tetracycline.

The Oxoid (Basingstoke, England;www.oxoid.com) and Remel (Lenexa,KS, USA; www.remel.com) includeculture on Oxoid brilliance ESBL agar,which gives results within 24 hours.

Dr. Roger Stephan, Institute forFood Safety and Hygiene, University ofZurich (Switzerland; www.ils.uzh.ch),suggested a diagnostic strategy basedon the capability of the VTEC O104outbreak strain to produce an ESBL.He commented, “Positive fecal sam-ples or food enrichment cultures canbe streaked onto Brilliance ESBL agar.On this medium, ESBL-producing E.coli appear as blue colonies after 24 hr.incubation. Suspect colonies will thenbe confirmed by [polymerase chainreaction] PCR for the vtx genes. Sincethe prevalence of ESBL-producing E.coli in healthy people and food itemsshould be low, this could reallyimprove chances to isolate the strainsresponsible for the positive PCRscreening.”

Other methods of identificationinclude direct toxin detection usingthe Remel ProSpecT Shiga Toxin E.coli microplate assay; isolation onmedia, such as Oxoid MacConkeyAgar; toxin detection using the OxoidVTEC-RPLA kit, following growth onOxoid brain heart infusion agar;

antimicrobial susceptibility testing onOxoid Iso-Sensitest agar or Mueller-Hinton agar with cefpodoxime combina-tion discs and identification using theDuPont Qualicon RiboPrinter microbialcharacterization system.

Oxoid and Remel are brands ofThermo Fisher Scientific.

Image: The Brilliance ESBL is a chro-mogenic screening plate for the detection ofESBL organisms within 24 hours (Photocourtesy of Oxoid).

Chromogenic Screening PlateProduction for E. coli Increased





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AA blood test for depression has been simplifiedand it could contribute to early detection of

the condition if performed during regular med-ical checkups. According to Human MetabolomeTechnologies (Tsuruoka, Japan; http://humanmetabolome.com), clinical depression can bedetected by measuring the concentration ofphosphoric acid in blood. The company did acomparative study of 66 people – 31 patientsdiagnosed with depression at the NationalCenter of Neurology and Psychiatry in Kodaira,(Japan) and 35 healthy test subjects of similar ageand gender.

Using the concentration of ethanolamine phos-phate as a diagnostic tool, the investigators wereable to identify the clinically depressed patients82% of the time. They deduced that subjects camefrom the healthy group 95% of the time.

Human Metabolome Technologies is developinga reagent to determine the level of ethanolaminephosphate in minutes. The company expects tocomplete the reagent in a year. Several other meth-ods of diagnosing depression using blood testsunder development involve analysis of about 20 dif-ferent types of white-blood cell DNA, a time-con-suming process.

Details of the new testing regimen were dis-cussed at a conference of the Japanese Society ofBiological Psychiatry in Tokyo (Japan) on May 22,2011.

C-Reactive Protein LevelsPredict Breast Cancer Prognosis

EE levated C-reactive Protein (CRP) levels werepredictive of a poor prognosis for breast cancer

sufferers. This was independent of their lifestyle,menopause status, and presence of cardiovasculardisease. Danish investigators studied more than2,000 breast cancer patients and followed theirprogress for up to seven years from diagnosis (aver-age follow up was three years). The five-year sur-vival decreased from 90% for low CRP to 74% forhigh levels of CRP, disease-free survival reducedfrom 87% to 74%, and deaths from breast cancerincreased from 11% to 20%.

Dr. Kristine Allin from Herlev Hospital (Denmark;www.herlevhospital.dk) said, “While measuringCRP levels gives a general indication of health andlongevity, measuring CRP levels for breast cancerpatients seems to be an easy way to predict the sever-ity of the patient’s disease. This may allow cliniciansto alter their treatment tactics and improve cancersurvival rates.”

CRP is a critical component of the immune sys-tem, a complex set of proteins that are produced bythe liver, in response to infection or injury, whenstimulated by the cytokine IL-6. Tumor sites areoften associated with inflammation and this inflam-mation contributes to tumor growth, invasion, andmetastasis. The study was published in BioMedCentral’s open access journal Breast CancerResearch (www.biomedcentral.com/bmccancer).

Rapid Blood Test for Clinical Depression

AAnew type of microscope provides a high-resolu-tion image of skin areas of any size with results

in just a few fractions of a second. It can be held byhand without blurring the resulting picture.

The new microscope examines to a resolution offive µm–for results with comparable resolution val-ues, a conventional microscope would either berestricted to a tiny field forced to scan the surface:conventional equipment slowly sweeps the surface,point by point, recording countless images beforecombining them to create a complete picture. Thedrawback–it takes quite a while before the image iscomplete.

Designed by researchers at the FraunhoferInstitute for Applied Optics and Precision Engineer-ing IOF (Jena, Germany; www.|fraunhofer.de), thenew microscope combines the best of both types ofmicroscope: because it foregoes the grid, it needs tomake just a single measurement, and that is whatmakes it very fast.

“Our ultrathin microscope consists of not justone but a multitude of tiny imaging channels, withlots of tiny lenses arrayed alongside one another.Each channel records a tiny segment of the object atthe same size for a 1:1 image,” explained IOF groupmanager Dr. Frank Wippermann. Each slice is

roughly 300 µm x 300 µm in size and fitsseamlessly alongside the neighboringslice; a computer program then assemblesthese to generate the overall picture. Thedifference between this technology and ascanner microscope: all of the imageslices are recorded simultaneously.

The imaging system consists of threeglass plates with the tiny lenses applied tothem, both on top and beneath. Thesethree glass plates are then stacked on topof one another. Each channel also con-tains two achromatic lenses, so the light passesthrough a total of eight lenses. Several steps areinvolved in applying the lenses to glass substrates:first, the scientists coat a glass plate with photoresis-tant emulsion and expose this to UV light through amask. The portions exposed to the light becomehardened. If the plate is then placed in a specialsolution, all that remains on the surface are lots oftiny cylinders of photoresist; the rest of the coatingdissolves away. Now, the scientists heat the glassplate: the cylinders melt down, leaving sphericallenses. Working from this master tool, an inversetool is developed that can be used use as a die. A dielike this can then be used to launch mass produc-

tion of the lenses: simply take a glass substrate,apply liquid polymer, press the die down into it, andexpose the polymer layer to UV light. In a processsimilar to the dentist’s method of using UV light toharden fillings, here, too, the polymer hardens inthe shape the die has printed into it. What remainsare tiny lenses on the glass substrate. “Because wecan mass-produce the lenses, they’re really prettylow-cost,” Wippermann added.

Image: The thin handheld microscope, designed forobtaining high-quality images in less time than tradi-tional scanning microscopes (Photo courtesy ofFraunhofer Institute for Applied Optics and PrecisionEngineering).

Handheld Microscope Detects Melanomas


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RR apid virological response (RVR)is now considered the strongest

predictor of sustained prognosis inpatients with Hepatitis C (HCV)undergoing antiviral treatment.

The HCV ribonucleic acid (RNA)can be quantified and antibodies toHCV and genotyping can all be usedto follow the sustained virologicalresponse (SVR) of patients whohave persistently normal alanineaminotransferase (ALT) levels.

In a multicenter study carriedout in Italy, scientists assessedwhether RVR might be predictive ofSVR also in a particular subset ofpatients with HCV, and to evaluatethe cost effectiveness to determineHCV RNA at four weeks in thesesubjects. A total of 137 patientswith persistently normal ALT weretreated appropriately, and theirresponse to the drug therapy wasmeasured.

Antibodies to HCV were testedby an enzyme-linked immunosor-bent assay (ELISA III); HCV RNAquantification was obtained using apolymerase chain reaction (PCR)-based commercially available test;and genotyping was performedusing a commercial kit (INNO-LiPAHCV II). Aminotransferases andother serum liver function testswere determined by routine meth-ods in the local laboratory. Theupper limit of normal ALT value was40 IU/L. Liver biopsy specimensobtained within six months beforestudy onset were evaluated usingthe Metavir classification. Formalin-fixed, paraffin-embedded specimenswere routinely stained with hema-

toxylin–eosin and reviewed by localpathologists blinded to clinical andbiochemical data.

RVR was observed in 68% of the patients, 42% patients with HCV-1, 90% with HCV-2, and 64%with HCV-3. An end-of-treatmentresponse was observed in 86% ofthe patients, 68% of those withHCV-1, all the patients with HCV-2,and 91% with HCV-3. SVR wasmaintained 46% of the HCV-1patients, 97% from the HCV-2group, and 82% with HCV-3.Overall, 92% patients with rapidresponse did obtain HCV eradica-tion versus only 38% of those with-out rapid response. HCV-1 patientswith baseline HCV RNA less than400 x 103 IU/mL as measured byPCR-based commercially availabletest (Cobas Amplicor HCV Monitorv 2.0; Roche Molecular Systems;Basel, Switzerland; www.roche.com), were more likely to achieveRVR and SVR than those with high-er HCV RNA levels.

The ELISA III test used was aproduct of Ortho Diagnostic System(Raritan, NJ, USA; www.orthoclinical.com), and the HCV geno-typing was performed using thecommercial kit INNO-LiPA HCV IIfrom Innogenetics (Ghent, Belgium;www.innogenetics.be). The authorsconcluded that those patients withHCV genotype 1 and normal ALTand reached HCV RNA negativity atweek four, might have excellentprobability to eradicate their infec-tion. The study was published inJune 2011, in the Journal of ViralHepatitis.

Rapid Virological Response Predicts Patients Prognosis

2011-2012CATALOG

BiokitThe available catalogoffers products forresearch and develop-ment, as well as forproduction and distri-bution of clinical diag-nostic instruments andreagents.

REAL-TIME TESTSeegene

The Anyplex Plus pro-vides a total solutionfor TB diagnosis in one assay system byscreening a broadrange of specimens forvarious mutationscausing resistance.

RAPID TESTCoris BioConcept

The Legionella V-Testis a rapid and easy toread diagnostic test forin vitro detection ofLegionella pneumophi-la antigen in urine, withresults available in 15minutes.

ELISADRG

The TM-CA 72-4 ELISAkit is a solid phaseenzyme immunoassayfor the quantitative invitro diagnostic meas-urement of CA 72-4(TAG-72) in serum andplasma.

MICT SYSTEMMagnaBioSciences

The MICT FSH is amagnetic immunochro-matographic test sys-tem that features a rapidturnaround time, easyoperation, and accu-rate, quantitative resultsfrom a serum sample.

RANDOM ACCESS SYSTEM

RadimThe Zephyr features awalkaway capacity of400 tests, an on-board96-sample wheel withcontinuous feed capac-ity, and only 15 minutesto first results.


The IFCC Office is based in Milanand is responsible for carrying out,

under the direction of the EB and inconjunction with Division and Com-mittee members, all the administrativeand communication activities of theFederation. The IFCC Office reportsto the EB through the Secretary.

The IFCC Office is responsible forthe efficient administration of IFCCaffairs and maintains the Archives ofthe organization. The IFCC Office isresponsible for day-to-day financialoperations, for all contacts withMember societies and it also assiststhe regional organizations with whichthe IFCC has agreements. The IFCCOffice is staffed by two full-time andone part-time paid employee.

Paola Bramati, in IFCC since2005, is responsible for the contactswith the Executive Board Members.She is in charge for the activitiesrelated to the IFCC membership (FullMembers, Affiliates and Corporate),as well as the Scientific Division, TaskForces and Administrative dutieslinked to IFCC Finances.

Paola’s background is connectedto communication, tourism and mar-keting. Before joining IFCC, she hasbeen working for more than 15 yearsin the airline business dealing withday-to-day passengers’ operations,sales, marketing, and pricing. Her edu-cation is related to foreign cultures andlanguages, as she had the chance tostudy abroad learning English,Spanish, French, and German.

Silvia Cattaneo, in IFCC sinceFebruary 2010, is in charge for theactivities of the Congresses andConferences Committee, as well as ofthe Education and ManagementDivision. She is also the contact personinside the IFCC Office for the EuropeanFederation of Clinical Chemistry andLaboratory Medicine (EFCC).

Silvia has a past as CongressOrganizer. For more than twodecades, she collaborated with theItalian Society of Clinical Chemistryand Clinical Molecular Biology whereshe was responsible for the organiza-tion of the educational activities. Silviahas strong organizational skills and agreat aptitude for analyzing problemsand developing solutions as well ascreating logical working procedures.

Silvia Colli-Lanzi, in IFCC sinceJanuary 2011, is in charge for theactivities of the Communication andPublications Division as well as thoserelated to IFCC special projects, suchas Professional Exchange Programs,

Scholarships, and Awards.Silvia Colli-Lanzi has been work-

ing in the communication industry formore than a decade and she isresponsible for the office activities fortwo Italian scientific Associations.She is also responsible for the pressdesk and the communication activi-ties for some Italian and internationalcompanies, managing the relationswith the press and carrying on all thePR activities on their behalf.

Photo: (From left to right) Silvia Colli-Lanzi, Paola Bramati, and SilviaCattaneo.

Introducing: The IFCC Office

Edited by Edgard Delvin, Ph.D., FCACBIFCC members may send news to: Edgard Delvin, Ph.D., FCACB, Head, Dept of Clin Biochemistry, CHU Ste-Justine, 3175 Cote Ste-Catherine, Montreal, Quebec H3T1C5Tel: (1) 514-345-4831 (ext. 5635); E-mail: [email protected] NEWS


IFCC OFFICE

Via Carlo Farini 81, 20159 Milan, ITALYTel: (39) 02-6680-9912 • Fax: (39) 02-6078-1846E-mail: [email protected] • Web: www.ifcc.orgOffice Hours: 9.00-13.00 and 14.00-18.00Staff Members: Paola Bramati, Silvia Cattaneo,Silvia Colli-Lanzi

College of Pathologists of East, Centraland Southern Africa established

SAACB members Dr. Zemlin, Dr. George, Mr.Hassan, Dr. Hoffman and Prof. Matsha as well asits president, Prof. Erasmus were founding mem-

bers of the newly established College ofPathologists of East, Central and Southern Africa.The College was inaugurated on September 16,2010, and a Council established. Prof. Erasmus thecurrent SAACB president was elected to be its firstVice President.

Educational Workshop of Inborn Errors ofMetabolism held January 2011 in Durban

SAACB held an educational workshop of InbornErrors of Metabolism in the last week of January2011 in Durban. It was hosted by the University ofKwazulu Natal, one of the premier universities ofSouth Africa. It was hugely successful and veryinformative.

Prof. Steenkamp elected to the IFCC Executive Board

Former president of the IFCC, Prof. Steenkampwas elected to the IFCC Executive Board at theIFCC meeting in Berlin on May 15, 2011.

Hosting IFCC Congress in 2017Durban, South Africa will be the venue for the IFCCCongress in 2017.

Prof. Erasmus invited by IFCCProf. Erasmus has been invited by the IFCC to bepart of a Laboratory Management Course to begiven just before the Africa Federation of ClinicalChemistry Congress (AFCC) in Nairobi onSeptember 26, 2011.

Dr. Jocelyn Naicker appointed Chair of theNational Health Laboratory Services (NHLS)Expert Committee on Chemical Pathology

SAACB Council member Dr. Jocelyn Naicker wasappointed to Chair the National Health LaboratoryServices (NHLS) Expert Committee on ChemicalPathology. The SAACB would like to congratulateher on this appointment.

SAACB involved in the organization of the Africa Health Medilab Meeting

SAACB was involved in the organization of theAcademic Program of the Africa Health Medilabmeeting that took place at NASREC, Johannesburgfrom May 10-12, 2011. This meeting brought vari-ous health organizations and medical specialtiesincluding Surgery, Medicine, Obstetrics, andRadiology under one roof. SAACB would like tothank Prof. Delport, Prof. Erasmus, Dr. Naicker andDr. Zemlin for participating in this meeting.

Dr. Remaley from the NIH (USA) Guest at the SAACB Annual Congress

This year’s invited guest to the South AfricanAssociation for Clinical Biochemistry (SAACB)annual congress (Sandton City Convention Center)is Dr. Remaley (NIH) from the USA. Please visit theSAACB website to get more details. The meetingwill be held from September 1-4, 2011. This year’smeeting will also involve medical technologists.

News from the South African Association for Clinical Biochemistry (SAACB)

by Prof. Rajiv Erasmus, IFCC eNewsletter WG Member

The Sociedad Española de Bioquímica Clínica yPatología Molecular (Spanish Society of

Clinical Biochemistry and Molecular Pathology),first known as the Sociedad Española de QuímicaClínica, SEQC (Spanish Society of ClinicalChemistry), was founded in 1975 by Prof. EnriqueConcustell and counted 25 Founding Members. Itis presently presided over by Prof. FranciscoAlvarez.

The first scientific meeting was held in the firstyear, and the General Assembly of members creat-ed the first two committees: Education and Quality.The Commission of Units, Standards andNomenclature rapidly followed in 1977, and a rela-tionship with the IUPAC Committee of ClinicalChemistry was established in 1978. The same yearthe SEQC organized its First National Congress,which was followed by an International Symposiumon Automation in Clinical Chemistry in 1979: thatwas the beginning of the future InternationalCongress of Automation.

The Scientific Committee that joined all the com-missions and working groups, and the first Bulletin(Newsletter) were created the same year. In 1992,SEQC created the Publications Committee, which

publishes books and translations of NCCLS docu-ments, in addition to the newsletter and the scientificjournal.

The year 1980 saw the creation of the QualityControl Commission with the initial participation of147 laboratories. This achievement was howevermarred by the premature death of the Society’sPresident Prof. Enrique Concustell, in car acci-dent.

The 1980’s reflected an intense scientific involve-ment of the SEQC. The first issue of Society’s journalQuimica Clinica appeared in 1982. It was also thesame year that the Society organized the FirstInternational Congress on Automation and NewTechnologies in Barcelona, and that was followed bya second congress in 1984. In 1986, it hosted theThird Mediterranean and Near East AfricanCongress of Clinical Chemistry in Seville. At the locallevel, the SEQC has regularly organized courses onvarious topics and annual scientific “Jornadas” since1987.

The scientific activities culminated in 1990 withthe organization of the joint IX National Congress,the IV International Congress on Automation andNew Technologies and the II International Congress

of TDM-Tox in Barcelona with 1,300 registered par-ticipants, 30 symposia, four plenary conferences, 22workshops, 475 posters, 37 oral presentations, 1,400m2 of commercial area and 35 exhibitors.

In 1993, the SEQC changed its name to the“Sociedad Española de Bioquímica Clínica yPatología Molecular” (Spanish Society of ClinicalBiochemistry and Molecular Pathology) to reflect thescientific and professional development that hadoccurred in the last 20 years. The acronym SEQC, ishowever, still widely used, as it is deeply rooted in theprofessional community.

The establishment of the Society’s website in1997, which coincided with new phase of the annualEducation program, is another hallmark of the SEQChistory as it led in 1992 to the creation of the IFCCRincón Iberoamericano website that was hosted andmaintained by the Society for many years.

The involvement of the SEQC in the developmentof the profession has never failed through the years.It did so by organizing or sponsoring National andInternational meetings such as the CongresoNacional del Laboratorio Clínico and the 3rdInternational Symposium of the Federation ofEuropean Societies on Trace Elements and Minerals(FESTEM) in Santiago de Compostela in 2007, andthe 22nd AACC International Symposium on Criticaland Point-of-Care testing. In terms of publication, theSociety together with 2 other sister societies sponsorthe new journal Revista del Laboratorio Clínico since2008.

Nowadays, SEQC counts more than 2,100 mem-bers of which over 300 are involved in commissions,committees, and working groups including those ofIFCC and EFCC.

News from the World of the International Federation of Clinical Chemistry and Laboratory Medicine

Visit www.ifcc.org for more informationNEWSSpanish Society of Clinical Biochemistry and Molecular

Pathology: A Historyby Felip Antoja, Secretary of the Spanish Society of Clinical Biochemistry and Molecular Pathology, Member of the IFCC Newsletter Working Group

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For many years, the leading organization that dealt with the develop-ment of the profession of medical biochemistry in Serbia has been

the Society of Medical Biochemists of Serbia (formerly Society ofMedical Biochemists of Yugoslavia). As part of the healthcare systemreforms conducted in the last decade, the Law of Healthcare WorkersChambers, was adopted six years ago. Medical biochemists were thefirst that completely implemented the law, constituted Assembly of theChamber and five years ago delivered the first licenses. Prof. Dr. NadaMajkic-Singh was the first elected president of the Assembly, and Dr.Velibor Canic the first elected director of the Chamber.

The Chamber of Biochemists is profes-sional organization of medical biochemistsand clinical chemists with the mandatorymembership for colleagues working in publichealthcare institutions and private practice. Inaccordance with the Law, the Chamber has anumber of public authorities, including the def-inition of codex of professional ethics, keepingdirectory of all the members of the Chamber,issuing, renewing and depriving the licensesfor independent practice to all of the mem-bers, representing and protecting professionalinterests of members, proposing the list ofsupervisors for external quality audit, organiz-ing Court of Honor for determination of viola-tion of professional duties and responsibilitiesof members, and many others.

What are the first and obvious benefits ofthe work of such an organization? First of all,with the introduction of licenses, which have tobe renewed every seven years, professionaldevelopment has achieved continuity. Medicalbiochemists and clinical chemists in Serbiatoday are more focused to continuous educa-tion after graduation - in order to keep theirlicense they need to collect 24 credits per yearminimum. Thanks to attendance of variouscourses, seminars, symposia, congresses,more colleagues are now up-to-date with latestdevelopments in the practice of laboratorymedicine, which enable them to implement thisnew knowledge in their every day workload.Also, more educational courses are organizedthroughout the year than before. In addition,with one of the major activities of the Chamber--the enhancement of control of the work of lab-oratories throughout the whole territory ofRepublic of Serbia, the quality of their work issignificantly improving, which is evident in theresults of our national external quality assess-ment scheme (SNEQAS). Furthermore, all lab-oratories, both in private and in public health-care system, are encouraged and advised bythe Chamber to commence the accreditationprocess according to standard ISO 15189.

The Chamber of Biochemists of Serbiahas been created five years ago. Every fouryears delegates for the Assembly, Super-visory Board, Steering Committee, Commis-sion for Mediation, Director, and Court ofHonor are elected. Last year, we had elec-tions and the first convening, when the ses-sion of the constituent assembly handedover its duties to new delegates. We are allconfident that they will continue the fruitfulwork of their predecessors.

News from the World of the International Federation of Clinical Chemistry and Laboratory MedicineVisit www.ifcc.org for more information NEWS

29 LabMedica InternationalOctober/2011 126LMI-10-11LINKXPRESS COM

Chamber of Biochemists:Beginning the New Age of

Laboratory Practice in Serbiaby Dr. Snezana Jovicic, Institute of

Medical Biochemistry, Belgrade, Serbia

Photo: Assembly of the Chamber of Biochemists of Serbia

Immunizations are a cornerstone ofa nation's efforts to protect people

from a host of infectious diseases.Large-scale implementation of vacci-nation programs during the past thir-ty years has led to a spectacularreduction in illness and death due todiseases preventable by vaccines.

The European region of WorldHealth Organization (WHO) wasdeclared free of poliomyelitis in 2002,and for these past 6 years, cases ofmeasles in the Region havedecreased by more than 90%.However, further efforts are neces-sary. In Europe, nearly 650,000 chil-dren do not receive their first dose ofmeasles vaccine, a fundamentalrequirement to satisfy for vaccination;and there remain still vulnerable pop-ulations in every country. Para-doxically, the fact that vaccination hasled to a situation where numerousinfectious disease have become rareor seldom heard from, sometimesleads some parents and health pro-fessionals to believe that vaccines areno longer necessary. As a result, thepublic confidence in these vaccina-tions is regularly shaken by accusedharmful, even dramatic, side effects,and may be threatened by the influ-ence of groups opposed to vaccina-tion and websites dedicated to theirmovement. It has reached the pointthat parents are increasingly hesitantto immunize their children, becausethey are afraid of making them sickrather than protecting them.

For the first time since 1994, the

American Institute of Medicine (IOM)published a well-documented reporton the risks linked to eight common-ly administered vaccines. This syn-thesis of more than a thousand stud-ies shows that serious side effectscaused as a result of injectionsremain very rare. The vaccines stud-ied are those that protect againstseasonal influenza (H1N1 excluded),hepatitis B, papillomavirus (HPV)(notably responsible for cervical can-cer), hepatitis A, meningitis (menin-gococcal vaccines), the measles-mumps-rubella (MMR) triple combi-nation, tetanus, or even varicella.The IOM has studied more than ahundred cause-effect relationshipsbetween a vaccine and a more orless serious side effect. They reject-ed the existence of a link betweenMMR and autism; a study publishedin 1998 on this subject had created apanic in the English-speaking world.The same vaccine does not lead totype 1 diabetes either. As for season-al flu vaccines, they do not aggra-vate asthma and are not responsiblefor peripheral facial paralysis.

Conversely, side effects alreadyknown to physicians were confirmed.All the vaccines studied, exceptthose against hepatitis A and papillo-mavirus (HPV), can cause strongallergic reactions called anaphylacticshock. All, without exception, regular-ly cause shoulder pain and fainting.MMR may cause febrile convulsionsfollowing very high fevers in youngchildren, even rare cases of

encephalitis with inclusions that dam-age the nervous system. However, inthe large majority of cases, the exist-ing studies are not sufficient for theexperts to be able to validate or rejectthe cause-effect link. This wasnotably the case when the number ofcases counted was too low to gener-alize, like for the papillomavirus vac-cine. In France, two girls filed a claimbecause they believed they were thevictim of Gardasil side effects.However, the link yet remains to beproven scientifically.

The IOM report was not intendedto guide nervous parents, but ratherto inform the organization that com-pensates people who contracted anillness after a vaccine. It does notspecify the frequency at whichadverse effects are observed. Itsauthors point out, however, that vac-cines remain one of the most power-ful tools in the health system.Nevertheless, having a basic under-standing of how patients and parentsof patients view vaccine risk anddeveloping effective approaches toaddress vaccine safety concerns areimperative for vaccination providers.Each person understands and reactsto vaccine information based on dif-ferent factors, including previousexperience, education, personal val-ues, method of data presentation,perceptions of the risk for diseaseand perceived ability to control these risks, and risk preference.Increasingly, decisions about vacci-nation are based on inaccurate infor-

mation about risk provided by themedia and certain websites.Websites and other sources of vac-cine information might be inaccurateor incomplete. The specialist in labo-ratory medicine together with health-care providers can be a pivotalsource of science-based credibleinformation by discussing the risksfrom and benefits of vaccines, whichhelp patients make informed deci-sions. When a parent or patient initi-ates a discussion about a perceivedvaccine adverse reaction, the health-care provider should discuss thespecific concerns and provide factu-al information. Effective, empatheticvaccine risk communication usingappropriate language is essential inresponding to misinformation andconcerns.

Vaccines are continually moni-tored for safety and like any medica-tion; a decision not to immunize achild also involves risk and could putthe child and others who come intocontact with him or her at risk of con-tracting a potentially deadly disease.

Every year, vaccination savesmillions of human lives and this greatsuccess in terms of public healthmust continue. European countriesmust share precise, nuanced, andclear information on the risks linkedto diseases and the advantages ofvaccination. By recognizing thateach child deserves good healthfrom the beginning of their existence,specialists in laboratory medicinecan benefit from the impetus givenby WHO to conduct an awarenesscampaign and to enhance vaccina-tion systems. As health careprovider, we should work closely withpublic health agencies and otherhealth partners to improve and sus-tain immunization coverage and tomonitor the safety of vaccines sothat this public health success storycan be maintained and expanded inthis beginning of this new century.

by Dr. Bernard GougetSFBC-EFCC Representative; Secretary General International Francophone Federation of Clinical Biology and Laboratory Medicine (FIFBCML); IFCC Executive Board Member, Secretary General

Promoting Vaccination Programs

European Federation of Clinical Chemistry and Laboratory Medicine

EFCC CORNER


Edited by Dr. Bernard Gouget

Prof. Mauro PanteghiniProf. Mauro Panteghini, MD, is full professor of ClinicalBiochemistry and Clinical Molecular Biology atUniversity of Milan (Italy) Medical School. Prof.Panteghini holds directorships in the chairs of ClinicalBiochemistry and Clinical Molecular Biology at theMedical School of the University of Milan and at theCenter for Metrological Traceability in LaboratoryMedicine (CIRME) of the University of Milan, and leadsthe Accredited Reference Laboratory for EnzymeStandardization (a JCTLM listed reference laboratory).Prof. Panteghini has served in numerous internationaland national scientific capacities in laboratory medi-cine, and has held many positions within the IFCC andthe JCTLM. He is editor-in-chief of Biochimica Clinica,the official journal of the Italian Society of ClinicalBiochemistry and Clinical Molecular Biology (SIBioC).He has published numerous manuscripts and abstract,and lectures at many national and international con-gresses, meetings, and symposia.

Dr. Ana-Maria SimundicAna-Maria Simundic, PhD, heads the EmergencyLaboratory department at the Sestre MilosrdniceUniversity Hospital in Zagreb (Croatia). Dr. Simundicgraduated from the faculty of Pharmacy andBiochemistry University of Zagreb, where she defend-ed her masters and PhD theses, and was awarded thetitle Assistant Professor. Dr. Simundic also receivedtraining at the university of Connecticut (USA) HealthCenter, where worked on molecular genetic techniquesand did research on developmental biology. CurrentlyDr. Simundic is the Editor-in-Chief of BiochemiaMedica, the journal of the Croatian Society of MedicalBiochemists. She chairs the Committee for PublicRelations for the Croatian Society of Biochemistry, andis the EFCC National representative for Croatia. Dr.Simundic also functions as ISO 15189 accreditationassessor for Molecular Diagnostics and General clini-cal chemistry. Her work experience includes teachingcourses at the undergraduate and postgraduate levels.

Dr. Huibert StormDr. Huibert Storm is a clinical chemist, head of labora-tory at the Stichting KCL Medical Center inLeeuwarden (The Nederlands). Dr. Storm, a graduatebiochemist, received his PhD from the University ofLeiden (The Nederlands). He is the past president ofthe Netherlands Society for Clinical Chemistry andLaboratory Medicine (NVKC). During his tenure aspresident of NVKC he hosted the successfulEUROMEDLAB 2007 in Amsterdam (TheNederlands), which was honored by a visit from HMQueen Beatrix. Dr. Storm founded the NVKC workinggroup for molecular biology, and was member of acommittee on DNA-diagnostics of the Health Councilof The Netherlands advising the minister of health. Atpresent, Dr. Storm is the national representative ofNVKC for IFCC and EFCC. His major professional,scientific, and clinical interests lie in the field of molec-ular biology, hematooncology, and flow cytometry.

New EFCC Executive Board Members

Cont’d on page 32

At the end of June this year, the Society of Medical Biochemists of Serbia once again hadthe pleasure to welcome colleagues to the 7th IFCC Symposium for the Balkan Region

organized traditionally under the auspicesof the International Federation of ClinicalChemistry (IFCC) and European Fede-ration of Clinical Chemistry and LaboratoryMedicine (EFCC) in Belgrade. This year,the Symposium was dedicated to theburning issue of biomarkers, entitled“Biomarkers: From Standardization toPerformance.” As in the past six years,many prominent lecturers marked thismeeting.

In the first section, Prof. Nada Majkic-Singh (Institute for Medical Biochemistry,Clinical Center of Serbia, Belgrade,Serbia) acquainted us with biomarkers,the process of their validation, and devel-opment of guidelines for biomarker appli-cation in her lecture entitled “What is aBiomarker? From Discovery to ClinicalApplication.” Prof. Mauro Pantheghini'slecture (Department of Clinical Sciences“Luigi Sacco,” University of Milan, Italy)was about standardization approachesand definition of performance require-ments for heterogeneous biomarkerassays. Professor Patrick M. M. Bossuyt(Department of Clinical Epidemiologyand Biostatistics, Academic MedicalCenter, University Amsterdam, TheNetherlands) defined biomarker perform-ance and clinical validity, expressed interms of the marker's accuracy, and sum-marized and presented the availablemeasures of diagnostic accuracy.

The second section was dedicated tothe use of biomarkers in cardiovascularevents and it opened with Prof. VictorBlaton's talk (Department of ClinicalChemistry, Hospital AZ Sing-Jan AV,Brugge, Belgium) about noveltiesamong prospective markers in this field.Prof. Grazyna Sypniewska (Departmentof Laboratory Medicine, CollegiumMedicum, Nicolaus CopernicusUniversity, Bydgoszcz, Poland) present-ed results of her group's study about theperformance of apolipoproteins B and Aby comparing apolipoprotein concentra-tions and apoB:apoA-I with traditionallipid measures and atherogenic indicesas biomarkers in acute coronary syn-drome patients. Adriana Unic (ClinicalDepartment of Laboratory Diagnostics,Dubrava University Hospital, Zagreb,Croatia) summarized the recentprogress in the diagnostic use of copep-tine, C-terminal part of the argininevasopressin precursor peptide found tobe stable and sensitive marker for anti-diuretic hormone release in cardiovas-cular diseases. The section was closedby Sanja Stankovic (Institute of MedicalBiochemistry, Clinical Centre of Serbia,

7th EFCC Symposium for Balkan Region

Biomarkers: From Standardization to Performance

by Snezana Jovicic, Institute of Medical Biochemistry, Clinical Centre of Serbia, Belgrade, Serbia



EFCC CORNER

Cont’d on page 32

Photo IMG-0961: Symposium lecturers dur-ing trip to Mokra Gora (from left to right):Aslan Diler, Grazyna Sypniewska, BernardGouget, Nada Majkic-Singh, Patrick MMBossuyt, Sanja Stankovuc, Victor Blaton.

Belgrade, Serbia) with an overview ofpotential new roles for myeloperoxi-dase as biomarker in cardiovasculardisease.

The second day of the symposiumstarted with Dr. Bernard Gouget(Federation Hospitailiere France,Paris, France), who opened the thirdsection with his special lecture onbiomarkers, biospecimen andEuropean biobanking infrastructuresfor translational research. Prof.Philippe Gillery (Laboratory ofPediatric Biology and Research -

University Hospital of Reims andLaboratory of Medical Biochemistryand Molecular Biology, Faculty ofMedicine of Reims, France) intro-duced non-enzymatic posttransla-tional modification-derived productsas new biomarkers of protein aging.This section was concluded withProf. Diler Aslan's lecture (Pamuk-kale University School of Medicine,Department of Medical Biochemistry,Denizli, Turkey), where biomarkersrecommended for prediction or diag-nosis of diabetes complications in theclinical practice and laboratory medi-

cine guidelines were reviewed andthe results of several clinical studieswere summarized.

The fourth section started with thelecture about a novel combination ofbiomarkers for the prediction of ovari-an cancer, including human epididymisprotein 4 (HE4) and CA125, presentedby Prof. Demetrios Rizos (MedicalSchool, University of Athens, Greece).Prof. Andrea Griesmacher (CentralInstitute of Medical and ChemicalLaboratory Diagnostics, LKH -University Hospital of Innsbruck,Austria) continued with the overview ofbiomarkers for bone turnover. Thissection was concluded with the reviewof biomarkers of fetal anomalies incor-porated in first and second trimesterscreening strategies presented byProf. Svetlana Ignjatovic (Institute ofMedical Biochemistry, Clinical Centerof Serbia, Belgrade, Serbia).

The fifth and last section was tra-ditionally dedicated to experiencefrom Balkan region in the use anddevelopment of biomarkers. It startedwith the lecture of Miroslava Jankovic(Institute for the application ofNuclear Energy - INEP, University ofBelgrade, Serbia) about the statusand perspective of glycans as bio-markers, and about the glycome aspromising source of new biomarkers.Afterwards, Prof. Majkic-Singh, Prof.Blaton, and Prof. Ignjatovic chairedthe round table discussion on pre-sented topics.

This closed the formal part of thesymposium, but it continued outsideBelgrade. The two following weekenddays the participants and lecturersspent on the road, or on the railroadto be precise. They went on the nos-talgic travel through time with theBlue Train - a special train used forthe needs of Josip Broz Tito, lifelongPresident of the Socialistic FederalRepublic of Yugoslavia. It is one ofthe most famous and most populartrains in the whole world, built in 1959for special needs of President Tito.Designed as a place that provides

accommodation, working conditionsand opportunity to complete all proto-col obligations while traveling, thistrain was real residence on wheels inthe country and abroad. The destina-tion was Mokra Gora, a mountain inthe western part of Serbia, betweenmountains Zlatibor and Tara. Therethey have changed the accommoda-tions of the presidential train with“Sargan eight,” another curiosity ofthe Railway Museum of Serbia. From1925 to 1974, this was the popularroute from Belgrade to Dubrovnik andZelenika on the Adriatic coast, whereon 760 mm narrow-gauge track,through tunnels, over the bridges andthrough mountain gorges, ran thefamous steam locomotive train “Cira.”Now, one part of this railway isrenewed on the route from stationSargan Vitasi to Mokra Gora, whichrepresents unique construction work,as it passes through 22 tunnels, overfive bridges, overcoming a grade of300 meters, and all that on a total dis-tance of 15,440 meters. Here, theparticipants had an opportunity to seeall the beauty and richness of thenature of this region. The visit to thetown of Drvengrad was unforgettable.Situated on the top of Mecavnik hill,Drvengrad (Wooden Town) was builtby the world famous film director EmirKusturica after the shooting of his film“Life is a miracle” in the site of MokraGora. Drvengrad presents uniqueethno village, typical settlement of thisarea of 19th century, consisting ofwooden buildings, such as so-calledcottages, characteristic for living onthe nearby mountains.

After two days of enjoying theintact nature of Western Serbia andits food specialties, the caravan ofbiochemists arrived back toBelgrade's Main Railway Station.This definitely ended this year'sEFCC Symposium for BalkanRegion, leaving all participants withvaluable new knowledge of biomark-ers, as well as with some unforget-table memories.

EFCC CORNER


Biomarkers: From Standardization to Performance

cont’d from page 31



Prof. Tomás ZimaProf. Tomás Zima, MD, DSc, PhD,MBA, is the Dean of the First Faculty ofMedicine, Charles University Prague(Czech Republic), consultant to theCzech Republic Ministry of Education,and professor of Medical Chemistryand Biochemistry. Prof. Zima graduat-ed with honors from Charles University,where he obtained his MD, a PhD inbiochemistry, and the higher doctorate,DSc. He has also earned an MBA fromPrague International Business Schoolat the University of Economics (PIBS).His research is focused on oxidativestress, new diagnostic techniques,

screening for Down's syndrome, tumormarkers, and the metabolism of alco-hol. He is a PhD lecturer in Biochem-istry and Pathobiochemistry. Prof. Zimais the author of four monographs andmany articles. He is the winner ofnumerous awards, among them Awardof the Rector of Charles University.Prof. Zima is a member of the CzechMedical Academy, president of theCzech Society of Clinical Biochem-istry, Chairperson of the ExecutiveCommittee of FEBS (Federation of theSocieties of Biochemistry and Molecu-lar Biology), and several other nationaland international professional organi-zations. He is the Editor-in-Chief ofFolia Biologica and Addictology.

New EFCC Executive Board Memberscont’d from page 30


INDUSTRY NEWSINDUSTRY NEWS

Roche and Stago to Part Ways

RRoche Professional Diagnostics (Basel,Switzerland; www.roche.com) and

Diagnostica Stago (Asnières sur Seine,France; www.stago.com) announced thatthe companies have decided to pursue sep-arate paths in the business of LaboratoryCoagulation in the territories where Rochedistributed the Stago product range. Theexclusive sales of Stago products by Rochewill continue throughout the entire year of2011. With the exception of Japan whereRoche Diagnostics Japan will continue todistribute the Stago portfolio within theJapanese market under a separate agree-ment, Stago will sell its products directly orthrough other distribution channels.

PerkinElmer to AcquireCaliper for $600 Million

PPerkinElmer, Inc. (Waltham, MA, USA;www.perkinelmer.com) announced that

it has signed a definitive agreement toacquire Caliper Life Sciences, Inc. (Hopkin-ton, MA, USA; www.caliperls.com), a com-pany that develops imaging and detectionsolutions for life sciences research, diagnos-tics, and environmental markets, for a totalnet purchase price of approximately $600million in cash.

Robert F. Friel, chairman and chief exec-utive officer, PerkinElmer, said, “The acqui-sition of Caliper Life Sciences brings inno-vative molecular imaging and detectiontechnologies to our portfolio, complement-ing our world-leading offerings in life sci-ence, diagnostics, environmental, and foodmarkets. The R&D, application expertise,and intellectual property of the combinedorganization will provide our customerswith enhanced knowledge and services anda strong pipeline of innovation.”

Siemens and Nephromicsin Preeclampsia Alliance

SS iemens Healthcare Diagnostics (Tarry-town, NY, USA; www.medical.siemens.

com) has entered into a licensing agree-ment with Nephromics, LLC (ChestnutHill, MA, USA) to develop two assays to beused as an aid in the diagnosis ofpreeclampsia.

The assays being developed are for thedetection of two biomarkers, soluble fms-like tyrosine-kinase-1 (SFLT-1) and placentalgrowth factor (PLGF). Clinical studies haveshown that these two assays, when used inconjunction with each other, are better pre-dictors of preeclampsia than either markeralone. Under the terms of the agreement,Siemens Healthcare Diagnostics will obtainrights for the development of the SFLT-1and PLFG assays.

BB ioSystems SA (Barcelona, Spain; www.biosystems.es) a researcher, designer, manufac-

turer, and marketer of reagents and instruments forclinical laboratories, marks the 30th year of its estab-lishment.

The company, now headquartered in an 18,000-m2

facility in Barcelona (Spain), was founded by Dr. JosepBach in 1981. Today, the company headed by Dr.Antonio Elduque has an extensive commercial salesnetwork of representatives and subsidiaries supplyingworldwide customers. The company exports 98% of itssales to 106 countries overseas.

BioSystems' evolution has been marked by adap-tation to the continuous changes in the area of clin-

ical diagnosis. The company has sustained itsgrowth through an innovative research and develop-ment, production, and marketing teams dedicatedto quality and service. Biosystems’ products are sub-jected to a continuous process of improvement andinnovation.

BioSystems offers a comprehensive range of clinicaldiagnostic products that help to streamline laboratoryworkflow, enhance operational efficiency, andimprove patient treatment. The range of productscomprises five segments: clinical chemistry, automat-ed systems, autoimmunity, quality control, and rapidtests. BioSystems notes their 30th anniversary withvarious events held around the world.

BioSystems Marks 30 Years in Service of Healthcare

SEPTEMBER 2011RNAi and miRNA Europe. September 8-9;Munich, Germany; Web: www.selectbiosciences.com

qPCR Europe. Sep 8-9; Munich, Germany;Web: www.selectbiosciences.com

Epigenetics Europe September 8-9; Munich,Germany; Web: www.selectbiosciences.com

CAP 2011 – The Pathologists’ Meeting.September 11-14; Grapevine, TX, USA; Web:www.cap.org

7th European Course on Clinical Cytometryand 11th Euroconference on Clinical CellAnalysis. September 13-17; Dublin, Ireland;Web: www.cytometry2011.eu

19th ECDO Euroconference on Apoptosis –European Cell Death Organization. Sep 14-17; Stockholm, Sweden; Web: www.ecdo.eu

11th Analytica Latin America. September 20-22;Sao Paulo, Brazil; Web: www.analiticanet.com.br

14th Annual Meeting of the European Societyfor Clinical Virology. Sep 21-24; Funchal,Portugal; Web: www.escv.org

BCLF 2011 - 19th Annual Meeting of theBalkan Clinical Laboratory Federation.September 21-23; Bucharest, Romania; Web:www.bclf.info

36th European Congress of Cytology.September 22-25; Istanbul, Turkey; Web:www.cytologyistanbul2011.com

10th Czech National Congress of ClinicalBiochemistry. September 25-27; Pilsen, CzechRepublic; Web: www.sjezdcskb2011.cz

50th Annual ESPE Meeting – EuropeanSociety of Paediatric Endocrinology. Sept 25-28; Glasgow, UK; Web: www.espe2011.org

OCTOBER 201112th International Congress of TherapeuticDrug Monitoring & Clinical Toxicology.October 2-6; Stuttgart, Germany; Web: www.iatdmct2011.de

Biotechnica 2011. October 11-13; Hannover,Germany; Web: www.biotechnica.de

12th International Congress of HumanGenetics. October 11-15; Montreal, Quebec,Canada; Web: www.ichg2011.org

Analytica Anacon India. October 12-14;Mumbai, India; Web: www.analyticaindia.com

ASHG 2011 - Annual Meeting of theAmerican Society of Human Genetics.October 13-15; Montreal, QC, Canada; e-mail:[email protected]; Web: www.ashg.org

67th Annual Meeting of the American Societyfor Reproductive Medicine. October 15-19;Orlando, FL, USA; www.asrm.org

37th Annual Meeting of the American Societyfor Histocompatibility and Immunogenetics(ASHI). October 17-21; New Orleans, LA, USA;e-mail: [email protected]; Web: www.ashi-hla.org

26th WASPaLM – World Association ofPathology and Laboratory Medicine. October19-23; Las Vegas, NV, USA; Web: www.waspalm.org

NOVEMBER 2011Annual Assembly of the Swiss Society ofClinical Chemistry & Tri-National Congressof Laboratory Medicine. November 2-4;Zurich, Switzerland Web: www.congress-info.ch/sscc2011/p1.html

58th Annual Scientific Meeting of the

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American Society of Cytopathology. Nov 4-8;Baltimore, MD, USA; Web: http://cytopatholo-gymeeting.org/2011

JIB 2011 - Journées Internationales deBiologie. November 8-10; Paris, France; Web:www.jib-sdbio.fr

Mass Spec Europe. Nov 8-9; Dublin, Ireland;Web: www.selectbiosciences.com

Advances in Metabolic Profiling. Nov 8-9;Dublin, Ireland; Web: www.selectbiosciences.com

Medica 2011. November 16-19; Düsseldorf,Germany; Web: www.medica.de

Association for Molecular Pathology (AMP).Nov 17-19; Grapevine, TX, USA; Web:www.amp.org/meetings/2011

22nd Asian Regional Congress of the ISBT –International Society for Blood Transfusion.November 20-23; Taipei, Taiwan; Web:www.isbtweb.org

RNAi Asia.. Nov 22-23; Singapore; Web:www.selectbiosciences.com

Screening Asia. Nov 22-23; Singapore; Web:www.selectbiosciences.com

COLABIOCLI 2011 - 30th Latin AmericanCongress of Clinical Biochemistry. November26-28; Punta Cana, Dominican Republic; Web:www.colabiocli.org

23rd National Congress of Biochemistry ofthe Turkish Biochemical Society (TBD). Nov29-Dec 2; Adana, Turkey; Web: www.biyokimyakongresi.org

California Society of Pathologists 63rd AnnualConvention. Nov 29-Dec 3; San Francisco, CA,USA; Web: www.calpath.org/events.php

DECEMBER 201138th National Conference of "Association ofClinical Biochemists of India". Dec 2-6;Gwalior, India; Web: acbicon2011.com

Annual Meeting of the American Society forCell Biology. Dec 3-7; Denver, CL, USA; Web:

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22nd World Allergy Congress. December 4-8;Cancun, Mexico; Web: www.worldallergy.org

53rd Annual American Society of Hematology(ASH) Meeting and Expositio. Dec 10-13; SanDiego, CA, USA; Web: www.hematology.org/Meetings/Annual-Meeting

41st Annual Scientific Meeting for theAustralasian Society for Immunology. Dec11-15; Adelaide, SA, Australia; Web:www.asi2011.org

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