Molecular Diagnostics Specimen Selection Guide - Focus Diagnostics
Molecular Diagnostics Specimen Selection Guide - Focus Diagnostics
Molecular Diagnostics Specimen Selection Guide - Focus Diagnostics
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<strong>Molecular</strong> <strong>Diagnostics</strong> <strong>Specimen</strong> <strong>Selection</strong> <strong>Guide</strong>Overview<strong>Focus</strong> <strong>Diagnostics</strong> offers a growing number of molecularbasedassays for the detection, quantitation, and genomicanalysis of different infectious pathogens. <strong>Focus</strong> iscontinually expanding its molecular diagnostics test menuto provide more advanced tools for disease management,as described in the medical and scientific literature. Newassays are developed for emerging pathogens and also forknown pathogens, where more sensitive detection orspecific genomic information is desired.At <strong>Focus</strong> <strong>Diagnostics</strong>, our reputation stands on the qualityof our test results. We therefore go the extra mileto provide a test result that is as accurate as possible.In addition to positive and negative target amplificationcontrols, <strong>Focus</strong> <strong>Diagnostics</strong> incorporates additional qualitycontrols. An internal amplification control is evaluated foreach specimen that verifies the successful DNA/RNAextraction and amplification from the patient’s specimen.Each assay run includes controls to detect possiblecontamination not only during amplification anddetection, but also during the specimen processing step.These controls, used in conjunction with physicalcontainment barriers, minimize false-positive and falsenegativeresults.PCRFor clinical studies and diagnostic use, PCR testing isconsidered by many to be the gold standard. In an effortto provide test results in as timely a manner as possible,<strong>Focus</strong> <strong>Diagnostics</strong> utilizes Real-Time PCR technology inmany of its molecular assays to decrease test turn-aroundtime.Real-Time PCR combines the amplification anddetection steps of the molecular assay to provide fasterresults with greater standardization.Test Request Information<strong>Focus</strong>’ <strong>Molecular</strong> <strong>Diagnostics</strong> Department requests that asmuch information as possible be provided with eachspecimen. This should include specimen source, patientage and date of birth, and physician name.Collection Time, Transportationand Storage <strong>Guide</strong>lines<strong>Specimen</strong>s should ideally be collected in the acute phaseof infection and transported to the laboratory as soon aspossible, usually 24 hours post collection. The chartsincluded in this section describe optimal collection andtransport procedures by organism. This information servesas a guide only. Please do not hesitate to call <strong>Focus</strong>’ ClientService Representatives or <strong>Molecular</strong> <strong>Diagnostics</strong>Department for further details regarding the selection,collection and transport of specimens.12Collection and Transport <strong>Focus</strong> <strong>Diagnostics</strong> 2008
<strong>Molecular</strong> <strong>Diagnostics</strong> <strong>Specimen</strong> <strong>Selection</strong> & Transport <strong>Guide</strong>Refer to individual assays for exact specimen requirements and transport temperatures.Assay Validated <strong>Specimen</strong>s Unacceptable <strong>Specimen</strong>s 1Adenovirus DNA,Qualitative and QuantitativeAnaplasma phagocytophilum DNAAspergillus DNAAtypical Pneunomia PanelPanel includes:ChlamydiaLegionellaMycoplasmaWhole blood or Plasma (EDTA, ACD),Serum, CSF, Urine, BAL, Sputum,Respiratory swab in transport mediaWhole blood (EDTA, ACD), TicksWhole blood (EDTA, ACD), BAL,Serum, TissueBAL/wash, Sputum, Respiratoryspecimen in transport mediaCalcium alginate swabs, Tissueunacceptable for quantitation.Calcium alginate swabsAvian Influenza Virus H5 Gene RNA NPA/wash, NP/throat swab; Sputum TissueBabesia microti DNABartonella DNABK Virus DNA,Qualitative and QuantitativeBK and JC Virus DNABordetella pertussis/parapertussis DNABorrelia burgdorferi DNAChlamydophilia pneumoniae DNAClostridium difficile (Toxigenic) DNAWhole Blood (ACD, EDTA), TicksWhole Blood (ACD, EDTA), TissueWhole blood and Plasma (EDTA, ACD),Urine, Serum, CSFWhole blood and Plasma (EDTA, ACD),Urine, Serum, Plasma, CSFNPA/wash, Nasal swabWhole blood, (EDTA, ACD), Tick;Synovial fluid, CSF, UrineBAL/wash, Sputum, Respiratoryspecimen in transport mediaStoolTissue unacceptable for QuantitationCalcium alginate swabsCalcium alginate swabsCytomegalovirus DNA,Qualitative and QuantitativeCytomegalovirus GenotypingWhole blood, Plasma, Serum, CSF,Amniotic fluid, Urine, TissueWhole blood and Plasma (EDTA, ACD),CSF, BAL, Buffy coat, Cultured cells,<strong>Specimen</strong> in transport mediaTissue unacceptable for quantitationAll other specimensCoronavirus (Non-SARS) RNA NPA, BAL, NP/Throat swab Calcium alginate swabs, TissueDengue Virus RNA Serum Tissue1. All specimens (Whole Blood, Plasma, Bone Marrow) using Heparin as the anticoagulant are unacceptable.Continued on Next PageClient Services: 800-445-4032www.focusdx.comCollection and Transport13
<strong>Molecular</strong> <strong>Diagnostics</strong> <strong>Specimen</strong> <strong>Selection</strong> & Transport <strong>Guide</strong>Assay Validated <strong>Specimen</strong>s Unacceptable <strong>Specimen</strong>sEhrlichia chaffeensis DNAEhrlichia ewingii DNAEnterovirus RNAEpstein-Barr Virus DNA,Qualitative and QuantitativeHepatitis B Virus DNA,Qualitative and QuantitativeWhole blood, TickWhole blood, TickCSF, Plasma (EDTA, PPT, ACD), Stool,Throat/rectal swabWhole blood and Plasma (EDTA, ACD),Serum, Bone marrow, CSF, TissueSerum, Plasma (EDTA, PPT, ACD)Calcium alginate swabs, TissueTissue unacceptable for quantitationTissue and Whole blood areunacceptable for quantitationHepatitis C Virus Genotyping Plasma (EDTA, PPT, ACD), Serum All other specimensHepatitis C Virus RNA,Qualitative and QuantitativePlasma (EDTA, PPT, ACD), SerumAll other specimensHepatitis D Virus RNA Serum TissueHepatitis G Virus RNAHerpes Simplex Virus 1/2 DNA,Qualitative and QuantitativeHerpesvirus-6 DNA,Qualitative and QuantitativeHerpesvirus-7 DNA, QuantitativeHerpesvirus-8 DNA,Qualitative and QuantitativeHistoplasma capsulatum DNAHIV-1 Proviral DNAHIV-1 GenotypeHIV-1 RNA, QuantitativeHIV-2 DNA/RNAHTLV I/II DNASerum, Plasma (EDTA, PPT, ACD)CSF, Serum, Tissue, Swab, Pleural fluid,Pericardial fluid, Amniotic fluid,Vitreous fluidWhole blood and Plasma (EDTA, ACD),Serum, CSFWhole blood and Plasma (EDTA, ACD),SerumWhole blood and Plasma (EDTA, ACD),SerumWhole blood (EDTA, ACD), BAL, CSF,Urine, TissueWhole blood (EDTA, ACD)Plasma (EDTA, PPT, ACD), SerumPlasma (EDTA, PPT, ACD)Whole blood (EDTA, ACD)Whole blood (EDTA, ACD)TissueTissue unacceptable for quantitationTissue unacceptable for quantitationTissueTissue unacceptable for quantitationAll other specimensAll other specimensAll other specimensAll other specimensHuman metapneumovirus RNA NP aspirate or swab, BAL Tissue, Calcium alginate swabsContinued on Next Page14Collection and Transport <strong>Focus</strong> <strong>Diagnostics</strong> 2008
<strong>Molecular</strong> <strong>Diagnostics</strong> <strong>Specimen</strong> <strong>Selection</strong> & Transport <strong>Guide</strong>Assay Validated <strong>Specimen</strong>s Unacceptable <strong>Specimen</strong>sInfluenza Virus A/B RNABAL/wash, Sputum, Respiratoryspecimen in transport mediaTissue, Calcium alginate swabsJC Virus DNA,Qualitative and QuantitativeCSF, Plasma (EDTA, PPT, ACD), Serum,UrineTissue unacceptable for quantitationLegionella pneumophila DNABAL/wash, Sputum, Respiratoryspecimen in transport mediaCalcium alginate swabsMycobacterium tuberculosis (MTB)DNARespiratory specimen, CSF or tissueWhole blood, Serum, Plasma, Bonemarrow, Bactec bottles, UrineMycoplasma pneumoniae DNABAL/wash, Sputum, Respiratoryspecimen in transport mediaCalcium alginate swabsNorovirus RNAStoolTissueParainfluenza Virus RNABAL/wash, Sputum, Respiratoryspecimen in transport mediaTissue, Calcium alginate swabsParechovirus RNA CSF, Stool TissueParvovirus B19 DNAQualitative and QuantitativeWhole blood, Plasma, Serum, Amnioticfluid, Tissue, Bone MarrowTissue unacceptable for quantitationRespiratory Syncytial Virus RNABAL/wash, Sputum, Respiratoryspecimen in transport mediaTissue, Calcium alginate swabsRespiratory Virus PanelPanel includes:Influenza Virus A/B RNARespiratory Syncytial Virus RNAParainfluenza Virus RNAAdenovirus DNABAL/wash, Sputum, Respiratoryspecimen in transport mediaTissue, Calcium alginate swabsRhinovirus RNA NPA or swab, BAL TissueRickettsia rickettsiiWhole blood (EDTA, ACD), TickSARS Coronavirus RNA NPA/Swab, BAL, Sputum, Rectal swab Tissue, Calcium alginate swabsContinued on Next PageClient Services: 800-445-4032www.focusdx.comCollection and Transport15
<strong>Molecular</strong> <strong>Diagnostics</strong> <strong>Specimen</strong> <strong>Selection</strong> & Transport <strong>Guide</strong>Assay Validated <strong>Specimen</strong>s Unacceptable <strong>Specimen</strong>sTick Borne Disease PanelPanel includes:Anaplasma phagocytophilum DNABabesia microti DNABorrelia burgdorferi DNAErlichia chaffeensis DNAToxoplasma gondii DNA,Qualitative and QuantitativeTropheryma whipplei DNAVaricella Zoster Virus DNA,Qualitative and QuantitativeWhole blood (EDTA, ACD), TickAmniotic fluid, CSF, Whole blood andPlasma (EDTA, ACD), Serum, Vitreousfluid, TissueWhole blood (EDTA, ACD), CSF, TissueWhole blood (EDTA, ACD), CSF,Bronchial Wash/Brush, Swab intransport media, TissueTissue unacceptable for quantitationCalcium alginate swabs,Tissue unacceptable for quantitationWest Nile Virus RNA CSF, Plasma (EDTA, PPT, ACD), Serum Tissue16Collection and Transport <strong>Focus</strong> <strong>Diagnostics</strong> 2008
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