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rologie i - European Congress of Virology

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5 th <strong>European</strong> <strong>Congress</strong> <strong>of</strong> <strong>Virology</strong>has been decreasing, although it remained an issue in specific areas, i.e.detection <strong>of</strong> fungal pathogens. Commercial assays were the favouredmethod <strong>of</strong> choice, however in house tests still remained an important part<strong>of</strong> the diagnostics, particularly where commercial assays are not readilyavailable. A move towards the use <strong>of</strong> real time assays was also evidentwhilst the use <strong>of</strong> non PCR methods was uncommon.REF 459Quality assurance: Monitoring assay performance with external runcontrols from QnosticsAlastair RICKETTS 1 , Joanna PHILLIPS 1 , Sadhia MOHAMMED 1 , PaulWALLACE 11 Qnostics, Glasgow, UNITED KINGDOM; 2 QCMD, Glasgow, UNITEDKINGOMThe application <strong>of</strong> nucleic acid based detection technologies has becomeroutine within the modern clinical microbiology laboratory with molecularassays available for the causative agents for a wide range <strong>of</strong> humaninfectious diseases. Each <strong>of</strong> these assays brings a requirement to monitorperformance and laboratories are finding themselves under increasingpressure to become fully accountable for the quality <strong>of</strong> the services theyprovide. The challenge for laboratory medicine is to be able to demonstratethat the results from a patient’s sample will be consistent and independent<strong>of</strong> which laboratory generated the results. The performance <strong>of</strong> an assayis monitored through the use <strong>of</strong> internal and external controls. Internalcontrols monitor the intra sample fitness and external controls monitorthe inter run performance. By monitoring both internal and externalcontrols a laboratory can identify trends and shifts in assay performance,allowing them to more readily demonstrate control and consistency <strong>of</strong>the assay during the QC review process. In effect monitoring the assaycontrols allows laboratories to balance the requisite high error detectionrate while maintaining a low false rejection rate. In order to achieve this,the use <strong>of</strong> well characterised, consistent, external controls are <strong>of</strong> greatbenefit as laboratories require controls that are traceable and consistentbetween technologies and institutions. The data presented shows how theuse <strong>of</strong> well characterised controls can be used to monitor performance anddemonstrates control in a clinical setting.REF 460Impact <strong>of</strong> External Quality Assurance on Improvement <strong>of</strong> Virus Diagnosticsand Virus Safety Testing <strong>of</strong> BloodHeinz ZEICHHARDT 1,3 , Vanessa LINDIG 1 , Carlos TELLEZCASTILLO 1,4 , Oliver DONOSO MANTKE 2 , Hans PeterGRUNERT 1,2,31 Charité University Medicine Berlin, Campus Benjamin Franklin, Institute<strong>of</strong> <strong>Virology</strong>, Berlin, GERMANY; 2 Gesellschaft fuer BiotechnologischeDiagnostik (GBD) mbH, Berlin, GERMANY; 3 INSTAND e.V. Gesellschaftzur Foerderung der Qualitaetssicherung in medizinischen Laboratoriene.V., Duesseldorf, GERMANY; 4 Researcher Excellence Grant HLT08INFECT MET in the <strong>European</strong> Metrology Research Project (EMRP) <strong>of</strong>EURAMETCorrect laboratory diagnosis <strong>of</strong> virus diseases is the basis for reliabletherapy <strong>of</strong> patients and virus safety testing <strong>of</strong> blood. Preventive measurementsagainst virus diseases as well as solid epidemiological datarely on good virus diagnostic results. In Europe accreditation <strong>of</strong> laboratoriesaccording to international norms (e.g. ISO EN DIN 15189)and certification <strong>of</strong> manufacturers <strong>of</strong> diagnostic test kits, i.e. in vitrodiagnostic (IVD) medical devices give the administrative fundament fordiagnostic laboratories on the one hand and for manufacturers <strong>of</strong> diagnostictest kits on the other hand. Specified test materials applied inexternal quality assessment (EQA) schemes are efficient tools to measurethe competence <strong>of</strong> diagnostic laboratories and the reliability <strong>of</strong>diagnostic test kits. The presentation will concentrate on an internationalEQA scheme network for quality assurance and standardizationwhich has resulted in improvement <strong>of</strong> virus diagnostics for the benefit<strong>of</strong> patients and blood services. INSTAND EQA schemes in virusdiagnostics have been implemented in Germany in 1988 (>40 EQAschemes with >1100 participating laboratories from >40 countries). Theseschemes are performed on behalf <strong>of</strong> the German Medical Association(Bundesaerztekammer) under the scientific auspices <strong>of</strong> the German Associationagainst Virus Diseases (DVV) and Society <strong>of</strong> <strong>Virology</strong> (GfV).Examples for improved virus diagnostics as outcome <strong>of</strong> EQA schemeswill focus on diagnostics <strong>of</strong> HIV/AIDS and hepatitis B and C with emphasison training aspects and surveillance <strong>of</strong> performance <strong>of</strong> IVD medicaldevices.Vi<strong>rologie</strong>, Vol 17, supplément 2, septembre 2013S247

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