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Clinical and forensic toxicology proficiency testing

(EQA) catalogue2011/2012

Tel: +44 (0)161 762 2500 Fax: +44 (0)161 762 2501

Contents

Introduction

• Promotingexcellencethrough 3

proficiencytesting

• Aimof proficiencytesting 3

• Qualitystandards 3

• Benefitsof proficiencytesting 4

• Whoshouldparticipatein 4

proficiencytestingschemes?

• WhoparticipatesinLGCStandards 4

proficiencytestingschemes?

• WhychooseLGCStandardsas 4

yourproficiencytestingprovider?

• WhydoIneedproficiencytesting? 4

• PT/EQAschemesforclinicaland 5

forensictoxicology

• Benefitsof participationin 5

HEATHCONTROLPT/EQAschemes

Clinical and forensic PT schemes

• HEATHCONTROL–Therapeutic 6

DrugMonitoring(TDM)

• HEATHCONTROL–Toxicology(TOX) 8

• HEATHCONTROL–Drugsof Abuse 9

inUrine(DAU)

• HEATHCONTROL–DrugsinOral 10

Fluid(DOF)

• QUARTZ–Forensicblood 11

toxicologyscheme

• FORENSICSPTtrialscheme 12

• Confidentiality 13

• Reports 13

• OtherPTservices 13

• Productdevelopment 13

• Referencematerials 14

• Summary 14

LGC Standards

Promoting excellence through

proficiency testing

LGCStandardsisanaccreditedinternational

providerof proficiencytesting(PT)services

alsoknownasExternalQualityAssessment

(EQA).Wehaveovertwentyfiveyears

experienceinallaspectsofprovidingPTservices

tolaboratoriesundertakingclinical,chemical,

microbiological,andphysicalmeasurements.

LGCStandardsoperates39proficiencytesting

schemesservingmorethan7,000laboratories.

Weproduceinexcessof 100,000testmaterials

whicharedistributedtoover140countries

worldwide.

Weofferanunprecedentedbreadthof clinical,

chemical,microbiologicalandphysicaltesting

schemesacrossawiderangeof industries

includingclinicalandforensic,pharmaceutical

andphytochemicalsectors,meat,dairyandother

foodsectors,water,soilandotherenvironmental

sectors,brewing,distilling,malting,sugarand

otherbeveragesectors,cosmetics,toysand

otherconsumersafetysectors.

Inadditiontothevarietyof schemesoffered,

LGCStandardscanalsoprovidemanaged

solutionsforin-houseproficiencytestingproviders

andtrainingforparticipantsandtheircustomers.

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Email:[email protected]:www.lgcpt.com 3

Aim of proficiency testing

ProficiencytestingisdefinedinISO/IEC17043

astheevaluationof participantperformance

againstpre-establishedcriteriabymeansof

interlaboratorycomparisons.Theterms“External

QualityAssessmentorEQA”areoftenusedfor

proficiencytestinginthemedical/clinicalarea.

LGCStandardsProficiencyTestingprovides

awiderangeof schemesdesignedtoimprove

thequalityof analysisinthosesectorscovered.

Theschemesinvolvetheregulardistribution

of testmaterialsinorderforparticipantstotest

fordefinedparameters,andtohavetheirresults

statisticallyanalysed.Participationprovides

laboratorieswithameansof assessingthe

accuracyandcomparabilityof theirresults

withpeerlaboratoriesovertime.

Whenperformedwithinthecontextof a

comprehensivequalityassuranceprogramme,

proficiencytestingisanindependentmeans

of assuringthequalityof testandcalibration

results,asdescribedinISO/IEC17025and

ISO15189.

Quality standards

LGCStandardsProficiencyTestingiscommitted

tocontinualimprovementinqualityand

efficiencythroughproceduresbasedupon

qualityassurance.Thiscommitmentis

demonstratedthroughcertificationtoISO9001

forallitsactivitiesandaccreditationto

ISO/IEC17043fortheoperation,management

anddesignof proficiencytestingschemes.

LGCStandardsProficiencyTestingisaccredited

bytheUnitedKingdomAccreditationService

(UKAS,certificatenumber:0001).Clinical

schemesarecurrentlyaccreditedtothe

UKClinicalPathologyAccreditation(CPA)

guidelinesreferencenumber028/0054,

0028/0055,028/0060,028/0315.Acopyof our

currentscopeof accreditationisavailableon

ourwebsite:www.lgcpt.com

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Benefits of proficiency testing

Proficiencytestingisanessentiallaboratorytool

asitdemonstratesalaboratory’scommitment

togoodperformanceandenablesparticipants

toconfirmtheirabilitytoperformtests

competently;essentialinthelaboratory

accreditationprocess.

Participationinproficiencytestingwill:

• Enableparticipantstomeasuretheir

performanceagainstothers.

• Giveanearlyindicationof potentialproblems

ortrainingrequirements.

• Encouragegoodperformanceandreinforce

aninterestinqualityassurance.

• Demonstrateanabilitytocomplywith

internationalregulations.

• Provideavaluablesourceof information.

• Providethemeanstomeasureconsistency

acrossagroupof laboratories.

Who should participate in proficiency

testing schemes?

Anyonewhoneedstoindependentlydemonstrate

thequalityof theiranalyticalresultsshould

participateinPT/EQAschemes-becausequality

of resultsrelatesdirectlytoqualityof product,

reputationinthemarketand,ultimately,brand

value.Whetheroperatingintheclinical,forensic,

food,pharmaceutical,beverages,environmental

monitoringorothersectors,manyregulators

viewPTschemesasanessentialpartofquality

monitoringandmanylaboratorieslinkPT

resultstokeyperformanceindicatorsinthe

qualityassuranceprocess.

Who participates in LGC Standards

proficiency testing schemes?

LGCStandardsexportstolaboratoriesinover

140countriesworld-wideandourcustomer

baserangesfromsinglesmallenterprises

toinspectionorganisationsof globalrepute.

Ourcustomersincludehospitalsandclinics,

pharmaceuticalscompanies,government

agencies,majorinternationalfoodmanufacturers,

researchorganisations,commercialand

contractlaboratories.Atpresentwehaveover

7,000participantsacrossthe39schemes

currentlyinoperation.

LGCStandardsmanagesanumberof bespoke

schemesformulti-nationalcompaniestomeet

theirparticularrequirements.Thesespecial

schemescoverupto200laboratories.

Why choose LGC Standards as your

proficiency testing provider?

• Accesstoawiderangeof schemesfrom

asinglesupplier.

• Rapidturnaroundof results.

• Accesstoexpertsupportandadvice.

• Localrepresentationandsupport.

Why do I need proficiency testing?

Accreditationbodiesstronglyrecommend

thatlaboratoriesparticipateinappropriate

PTschemesastheyaretheonlyqualitytool

whichcanassessthewholequalitysystem.

PTisatrulyindependentmeasureof laboratory

performanceandanonymouslycompares

performancewithpeerlaboratories.Itallows

thelaboratorytocompareandcontrastthe

performanceof analyticalmethodsandcan

assistinthevalidationof newmethods.

ParticipationinaPTschemeiseducational

andcanbeusedasatoolforstaff training,

allowinglaboratoriestolearnfrombothpositive

andnegativeperformance.

PT/EQA schemes for clinical

and forensic toxicology

LGCStandards,recentlyacquiredCardiff

BioanalyticalServicesLtdandnowoperates

therangeofHEATHCONTROL(EQA)schemes

forlaboratoriesandscreeningclinicscovering:

• TherapeuticDrugMonitoring(TDM).

• Toxicology(TOX).

• Drugsof AbuseinUrine(DAU).

• DrugsinOralFluid(DOF).

Thedefinitiveaimof PT/EQAschemesina

clinicalsettingisimprovementinanalytical

performanceinsupportof improvedpatientcare.


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Benefits of participation in HEATHCONTROL

PT/EQA schemes

HEATHCONTROLisarespectednameinthe

fieldof EQAwithover450participantsinmore

than36countries.

ByparticipatingintheHEATHCONTROL

schemeseachparticipantgainsthebenefits

of aglobalproficiencytestingscheme:

• Theschemesareatrulyindependent

assessmentof measurementquality,which

enableslaboratoriestodemonstratetheir

competenceandcompliancewithrespect

toregulatorystandards.

• Performanceassessmentsobtainedinthe

schemesarerecognisedasademonstration

of laboratoryqualitybyarangeof ‘third

parties’,suchas,customers,regulatorsand

accreditationbodies.

• Thecomprehensiveschemereportsprovide

invaluablefeedbackonlaboratory

performanceandarewidelyusedasatraining

toolforlaboratorypersonnel.

• Performanceassessmentbymethodprovides

amechanismforlaboratoriestocompare

theirmeasurementswithothersusingsimilar

techniquesandassistsintheevaluationand

developmentof methodsandinstrumentation.

• Widevarietyof analytesfromonesupplierfor

allyourneeds.

• Significantnumbersof participantsworldwide

meansstatisticallyrobustresults.

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HEATHCONTROL – Therapeutic Drug

Monitoring (TDM)

TheTherapeuticDrugMonitoring(TDM)

schemeisdesignedtoprovideanindependent

performanceassessmentforlaboratories

andclinicswhoareinvolvedintheroutine

quantificationof therapeuticdrugsinserum.

TheTDMschemeisfullyaccreditedintheU.K.

byClinicalPathologyAccreditation(CPA).

TDMisthemeasurementof specificdruglevels

(concentrations)attimedintervalsinpatients,

usuallythroughbloodsamples,andisnecessary

wherecontrolof drugconcentrationsis

requiredtoachieveoptimumtreatmentfor

thepatient.

Formostdrugs,monitoringisnotrequired

astheyhaveawidetherapeuticindexi.e.the

differencebetweenatherapeuticandtoxic

concentrationislarge.Therefore,mostindividuals

willbeeffectivelytreatedwithoutextremeside

effectsorsymptomsof toxicity.

However,drugswithanarrowtherapeuticindex

mayresultinahighorlowserumconcentration

if notmonitoredandcontrolled.Drug

concentrationsinthebloodstreamthataretoo

highhavethepotentialtoexertadverseeffects

associatedwithtoxicorevenfatalconsequences.

Drugconcentrationsbelowthetherapeutic

indexcanleadtopoorresponsetotreatment.

Forsomedrugs,maintainingthissteadystate

isnotassimpleasgivingastandarddoseof

medication.

Therearemanyfactorswhichinfluencean

individual’sserumdruglevels,theseincludebut

arenotrestrictedtotheage,sex,andweightof

thepatient;therouteof administrationof the

drug;thedrug’sabsorptionrate,excretionrate,

deliveryrate,anddosage;othermedicationsthe

patientistaking;pregnancy,temporaryillness,

infection,emotionalandphysicalstress,

trauma,andsurgery;thepatient’scompliance

regardingthedrugtreatmentregimen;andthe

laboratorymethodsusedtomeasurethedrug.

EffectiveTDMfollowsthesechangesand

tailorsthedosagestofitthecurrentneeds

of thespecificpatient.

Drugconcentrationsinserumorwholeblood

areonlymeaningfulif thecorrectprocedures

arefollowedregardingthetimingof specimens.

Failuretomeettheserequirementsaccountsfor

mosterrorsinTDM.Itisveryimportanttonote

theexacttimethesampleistakenandwhen

eachdoseof thedrugisgivenasitallowsfor

accurateinterpretationof themeasuredlevels

andthepatient’sresponsetotheirdosing

regimen.

Althoughserumdrugconcentrationsandthe

therapeuticintervalareusefulinevaluatingdrug

therapy,theyshouldnotbetheonlycriteriaon

whichtreatmentisbased.Therapeuticdrug

monitoringisamultidisciplinaryfunction,requiring

collaborationbetweenscientists,clinicians,

nursesandpharmacistsinordertoensurethat

bestpracticeinTDMisachieved.Theteam

mustremembertoalwaystreatthepatient,

notthelevel.

Thefullrangeandavailabilityof testmaterials

inTDMisdeterminedonanannualbasisand

furtherdetailscanbefoundintheTDMapplication

formandschemeinformationdocument.

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Test material

Humanserum: Therapeutic15analyte drugmixture

Humanserum: Anti-epilepticdrugs

Humanserum: Neweranti-epilepticdrugs AE1mixture

Humanserum: Neweranti-epilepticdrugs AE2mixture

Humanserum: Cardiacdrugsmixture

Newborncalf serumor Humanserum:Psychoactivedrugs

Humanserum: Anti-cancerdrug

Humanserum: Antibioticdrugs*

Humanblood/plasma: Immunosuppressivedrugs**

Analytes

Caffeine,Carbamazepine, Carbamazepine10,11-epoxide, Clonazepam,Digoxin, Ethosuximide,Gentamicin, Lamotrigine,Lithium,Phenobarbital,Phenytoin,Primidone,Theophylline,Valproate,Vancomycin.

Clobazam/Norclobazam.

OH-oxcarbazepine,Gabapentin,Levetiracetam,Pregabalin.

Felbamate,Lacosamide, Rufinamide,Tiagabine,Topiramate,Vigabatrin,Zonisamide.

Amiodarone,Desethylamiodarone,Flecainide.

Amitriptyline/nortriptyline, Clomipramine/norclomipramine, Clozapine/norclozapine, Imipramine/desipramine.

Amisulpride, Aripiprazole/dehydroaripiprazole, Citalopram/norcitalopram, Dosulepin(dothiepin)/northiaden, Doxepin/nordoxepin, Fluoxetine/norfluoxetine, Fluphenazine,Fluvoxamine, Haloperidol, Maprotiline/normaprotiline, Mirtazapine/normirtazapine, Olanzapine,Paroxetine, Perphenazine,Quetiapine, Risperidone/HO-risperidone, Sertraline/norsertraline, Thioridazine, Trimipramine/nortrimipramine, Venlafaxine/norvenlafaxine, Zuclopenthixol.

Methotrexate.

Amikacin,Chloramphenicol, Flucytosine,Gentamicinwith vancomycin,Netilmicin,Teicoplanin,Tobramycin.

Cyclosporin,Everolimus, Mycophenolate,Sirolimus, Tacrolimus.

Note:Testmaterialsandanalytesmaybeaddedorremoved,pleaseseecurrentapplicationform.

*TheseanalytesareproducedincollaborationwithUKNEQASschemeforantibioticdrugs.

**PleasenotethisisnotaHEATHCONTROLschemeandassuchisnotcoveredbytheLGCStandardsscopeof accreditation.ItismanagedandoperatedbyASILtd.Participantsmaysubscribetotheschemethrough LGCStandards.

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HEATHCONTROL – Toxicology (TOX)

TheToxicology(TOX)schemeisdesignedto

provideanindependentperformanceassessment

forlaboratoriesandclinicsthatprovidea

pathologyservice,toxicologicalservice,or

forensicinvestigationservicefordrugand

ethanoldetermination.TheTOXschemeis

fullyaccreditedintheU.K.byClinicalPathology

Accreditation(CPA).

Drugandalcoholanalysesmaybeundertaken

foravarietyof reasonswhichincludebutare

notrestrictedto:

• Determinewhetheranindividualisunderthe

influenceof alcoholand/ordrugsthatmay

requiretreatmentorinterferewithany

medicalcarenecessary(Theseanalysesare

usuallyrequiredquicklyinordertofacilitate

effectivemedicaltreatment).

• Determinewhetheranindividualisunderthe

influenceof alcoholand/ordrugswhichmay

puttheirownlifeorthatof othersatrisk

whilstatwork.

• Determinewhetheranindividualmayhave

beenaffectedbyalcoholand/ordrugswhilst

eitheravictimorasuspectinacriminal

offence.

• Determinewhetheralcoholand/ordrugsmay

beimplicatedinadeath.

Toxicologicalanalysesmaybeundertakenona

numberof biologicalspecimens,predominantly

blood,serumandurine.Ingeneral,analyses

arecommonlyundertakenforarangeof

prescriptionandnon-prescriptiondrugs,illegal

drugsandalcohol.Theaimof theanalyses

istoestablishtheidentityof anysubstances

presentandatwhatquantity,andtothen

determinewhateffectthesubstance(s)

identifiedmayhavehadontheindividual.

Theanalyticalfindingswouldthenbesubjectto

interpretationbyasuitablyqualifiedindividual.

TheTOXschemeprovidesarangeof test

materialssuitableforavarietyof clinicaland

forensicsettings:

• Serum,bloodandurine.Thebloodand

serumspecimenscontainethanol,paracetamol

andsalicylate(thebloodalsocontains

carboxyhaemoglobin).Theurinecontains

alcoholonly.Theseareresultdrivensamples

andnointerpretationisrequired.

• Casestudy.Acasestudyisprovidedalong

withrelevantserumandurinespecimens.

Participantsanalysethespecimensand

submittheanalyticalfindingsalongwiththe

relevantinterpretation,whichisthenmarked

byanindependentscoringpanel.

• Toxicologicalquantitativespecimens.Blood

testmaterialscontainingvariabledrugsand

compoundsthatmaybemonitoredincases

of possibledrugoverdose.


inTOXisdeterminedonanannualbasisand

furtherdetailscanbefoundintheTOX

applicationformandschemeinformation

document.

Test material

Humanserum

Blood

Urine

Humanserumandurine

Bloodtoxicologyanalytes

Analytes

Ethanol,Paracetamol,Salicylate.

Carboxyhaemoglobin, Ethanol,Paracetamol,Salicylate.

Ethanol.

Variousanalyteswithclinicalorforensicscenario.

Antipsychotics,Benzodiazepines,Opiates,Opioids,Selective SerotoninRe-uptakeInhibitors (SSRIs),Tricyclicantidepressants,andotherdrugsof interest.



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HEATHCONTROL – Drugs of Abuse in Urine

(DAU)

TheDrugsof AbuseinUrine(DAU)scheme

isdesignedtoprovideanindependent

performanceassessmentof laboratories

andclinicsthatprovideroutineservicesfor

detectionof drugsof abuseinurine.TheDAU

schemeisfullyaccreditedintheU.K.byClinical

PathologyAccreditation(CPA).

Humanurinehasbeenusedformanyyears

todetectthepresenceof frequentlyabused

drugs.Aurinedrugtestmaybeundertaken

whenorderedbyadoctortomonitoraknown

orsuspectedsubstanceabusepatient,and

wheneverapersonhassymptomsthatsuggest

druguse.Urinedrugtestsmayberequested

foravarietyof reasons,includingoccupational

monitoring,insurancescreening,legaland

forensicpurposesandinsports.

Formostdrugsof abusetesting,resultsof

initialscreeningtestingarecomparedwitha

predeterminedcut-off.Anythingbelowthat

cut-off isconsideredanegativeresult.A

negativeresultdoesnotnecessarilymeanthat

thepersondidnottakeadrugatsomepoint,

onlythatthedrugwasnotpresentata

concentrationgreaterthanthereporting

threshold.Anythingabovethecut-off is

consideredapositiveresult.If thesampleis

confirmedaspositiveaftersecondarytesting

thena“detected”findingisreported.

Drugtestingisextremelyaccurateandreliable

whenallaspectsof thetestingprocessare

carriedoutcorrectly.However,if poorprocedures

andinadequatetestingmethodsareutilised,the

informationobtainedmaybeverymisleadingand

inaccurate.Inordertominimisethisrisk,clinical

laboratoriesshouldperformroutinequality

controltestsandparticipateinsuitablePT/EQA

schemes.


inDAUisdeterminedonanannualbasisand

furtherdetailscanbefoundintheDAUapplication

formandschemeinformationdocument.

Test material

Urinetestmaterialsobtainedfromvolunteers,patientsandknowndruguserswhichregularlycontainmixturesof drugsandtheir metabolitesfromsixmajorclasses

Analytes

Amfetamines&stimulants, Cannabinoids,Cocaine&metabolites Minortranquillizers, Non-opiatenarcotics,Opiates.


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HEATHCONTROL – Drugs in Oral Fluid (DOF)

TheDrugsinOralFluid(DOF)schemeis

designedtoprovideanindependentperformance

assessmentof laboratoriesandclinicsthat

provideanalyticalservicesfordrugsinoral

fluid.TheDOFschemeisfullyaccreditedinthe

U.K.byClinicalPathologyAccreditation(CPA).

Drugabuseisaglobalproblemaffecting

manyinsociety.Advancesintechnologyhave

enabledoralfluidtestingforthepresenceof

manydrugs,suchastheamfetaminesand

stimulants,benzodiazepines,cannabinoids,

cocaineandmetabolites,opiatesand

non-opiatenarcotics.

Oralfluidasatestingmatrixisincreasingly

beingutilisedinarangeof applications,such

asworkplacemonitoring,clinicaltoxicology

andcriminaljustice.

Theadvantagesof oralfluidovertraditional

fluidssuchasbloodandurine,arethat

collectionisalmostnon-invasive,isrelatively

easytoperform,and,inforensicsituations,can

beachievedunderclosesupervisiontoprevent

adulterationorsubstitutionof thesamples.

Therearenowsensitiveandreliableanalytical

methodsavailablefororalfluidspecimen

collection,point-of-collectiontestingdevices

(POCT),screeningandconfirmationmethods.

Duetotheimportanceof resultsobtainedit

isessentialthatlaboratoriesundertakingthe

analysesareabletodemonstratethetesting

theyperformisdependable,reproducibleand

accurate.ParticipationintheDOFscheme

willprovidevaluablefeedbacktolaboratories/

on-sitescreeningclinicswhoundertakethese

analyses,andarecordof resultsovertime.


inDOFisdeterminedonanannualbasisand

furtherdetailscanbefoundintheDOF

applicationformandschemeinformation

document.

Test material

Oralfluidtestmaterialsobtainedfromvolunteersandknowndrugusers.Theseregularlycontain mixturesof drugsandtheir metabolitesfromsixmajorclasses

Analytes

Amfetamines&stimulants, Benzodiazepines,Cannabinoids,Cocaine&metabolites, Non-opiatenarcotics,Opiates.



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QUARTZ – Forensic blood toxicology scheme

QUARTZisabloodtoxicologyschemedesigned

forlaboratoriesundertakinganalysisof drugs

inpost-mortemandotherbloodsamplesfor

toxicologicalpurposes,particularlyinaforensic

context.Testmaterialsarepreparedusing

pre-screenedhumanblood.Targetanalytes

areaddedatanappropriatelevelandthetest

materialmixedtoensurehomogeneityprior

todespatch.

Theanalytestobedeterminedineachround

arefromalistof non-prescription,prescription

andcontrolleddrugs,aswellasothertoxins,

compiledbytheAdvisoryGroup,whichreflects

whatparticipantsarelikelytoencounterin

forensiccasework.

Thetestmaterialsaresubdividedintotwo

groups:

Group A:thosedrugsthataremorefrequently

determinedbyparticipants.

Group B:thosedrugsthatmaybeless

frequentlydeterminedbyparticipants.

Uptothreetestmaterialsareprovidedineach

roundcontainingbetween0and4drugs.

Alcoholismajorcauseof roadcasualtiesand

deathsandaspenaltiesfordrink-drivingare

severeitisessentialtheaccuracyof analysis

canbeproveninthelegalcase.Thetestmaterial

comprises10mlvialof wholebloodcontaining

alcoholforanalysis.


inQUARTZisdeterminedonanannualbasis

andfurtherdetailscanbefoundintheQUARTZ

applicationformandschemedescription.

Test material

GroupA Morefrequentlydetermineddrugs

GroupB Lessfrequentlydetermineddrugs

Analytes

6MAM(MACM),Amfetamine, Amisulpride,Amitriptyline, Benzoylecgonine,Buprenorphine,Carbamazepine,Chlordiazepoxide, Chlorpromazine,Citalopram,Clomipramine,Clozapine,Cocaine,Codeine,Cyclizine, Desmethyldiazepam,Diazepam, Diclofenac,Dihydrocodeine, Diphenhydramine,Dosulepin, Fentanyl,Fluoxetine,Ibuprofen,Imipramine,Ketamine, Lamotrigine,MDA,MDMA,Methadone,Methamphetamine,Midazolam,Mirtazepine,Morphine,Olanzapine,Oxazepam,Oxycodone, Paracetamol,Paroxetine,Pethidine,Phenytoin,Procyclidine, Promethazine,Propoxyphene,Quetiapine,Risperidone,Salicylate,Sertraline,Temazepam,THC,THC-COOH,Tramadol,Venlafaxine,Zolpidem,Zopiclone.

Amlodipine,Amobarbital,Atenolol,Benzylpiperazine(BZP), Butobarbital,Clobazam, Clomethiazole,Clonazepam, Dextromoramide,Dipipanone,Gabapentin,Loprazolam,Lormetazepam,MefenamicAcid,Methylphenidate,Naltrexone,Pentobarbital,Phenelzine, Propranolol,Secobarbital, Sildenafil,Thioridazine,Trazadone,Zaleplon.

Note:Metabolitesof theabovesubstancesmayalsobeadded.

Analytes

Participantswillbeaskedtoidentifythedrug(s)only.Thetestmaterialwillalways(if positive)containonedrugfromGroupA.UptothreeotherdrugsmaybeinthetestmaterialfromeitherGroupAand/orGroupB.

Participantswillbetoldtheidentity,orgenericclassification,of thedrug(s),andaskedtoquantifytheconcentration.Theywillalsobeaskedtogiveaninterpretationof theresultsinrespecttoacasestudyprovided.ThetestmaterialwillalwayscontainadrugfromGroupA.AnyotherdrugspresentwillbefromGroupAand/orGroupB.

Standardsolutionscontainingdrugsfortheevaluationof instrumentation.

Participantswillberequiredtoquantifythealcoholconcentrationbytheirusualmethods.

Test material

DrugIdentification

DrugQuantification

DrugQuantification

AlcoholQuantification


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FORENSICS PT trial scheme

LGCStandardsProficiencyTestinghas

developedarangeof trialsfortheForensic

Sciencesector.Theseareintendedto

complementthequalitycontrolandquality

assuranceproductsalreadywellestablishedin

thesespecialisedlaboratories,inordertohelp

demonstratetheefficacyof thesemeasures.

Thetrialsmaycomprise:

• Qualitativetests;confirmatorytestingand/or

identification.

• Quantitativetests;analysisof specified

component(s).

• Post-analyticalchallenges/scientific

conclusion;interpretationbasedonacase

studyandanalyticaldata.

Participantsmayuseanymethodtheydeem

appropriatetoperformthetestoranalysethe

data.If themethodusedinfluencestheresult,

itwillbepossibletoidentifythisthroughanalysis

of thedatasubmitted,andgivefeedbackin

thereport.


inFORENSICSPTisdeterminedonanannual

basisandfurtherdetailscanbefoundinthe

FORENSICSPTapplicationformandscheme

description.

Test material

AlcoholTechnicalDefence*

DNA*

Drugs*

QuestionedDocuments*

Analytes

Participantswillbeaskedtousetheavailableinformationtoestablishthelikelylevelof intoxicationof asuspectatagiventime.Data providedwillincludeanalytical resultsandanallegedcase scenarioorwitnessstatement.

Participantswillbeaskedtousetheavailableinformationtoestablishthesuitabilityof amixtureof DNAprofilesfordesignation.Dataavailablemayincludeprintoutsof electrophoretogramsfromGMID,anexceltableof peakdataexportedfromGMID,and.fsafilesgeneratedbyABDataCollectionsoftware.

Participantswillbeaskedtousetheavailableinformationtoestablishtheidentityof anunknownpowdersubmittedfordrugsprofiling.Dataprovidedwillincludeabriefsummaryof theinvestigativeapproach, chromatogramsorsimilarof thesuspectpowderfromappropriateanalyticaltechnique(e.g.GC-MS).Resultsforreferencematerials/ calibrantsanalysedsimultaneously.

Participantswillreceiveapieceof paperwithaseriesof inkmarks,anduptothreesuspectwritingimplementsorcomparison documents.Thehypothesistobetestedwillbedescribedindetail.


*Pleasenotethesetrialsarecurrentlynotincludedinourscopeof accreditation.


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Confidentiality

Inordertoensureconfidentiality,participantsin

allschemesareallocatedauniquelaboratory

referencenumber.Thisnumberenablesresults

tobereportedwithoutdivulgingtheidentities

of participantlaboratories.

Howeveritshouldbenotedthat,whererequired,

theperformanceof U.K.participantsisreported

totheNationalQualityAssuranceAdvisory

PanelsforChemicalPathologyandforMedical

Microbiologyasappropriate.

Reports

If PT/EQAschemesaretobeeffectivein

facilitatingimprovementsinthetesting

undertakenbyparticipatinglaboratories,

analysesof theresultsneedtobereturnedto

participantsquickly.TheHEATHCONTROL

reportsareissuedpromptlywithintwo-four

weeksof thereportingdeadlineandare

receivedaspapercopies.Thecontentof

thereportsvaryfromschemetoschemebut

includesdetailsof thecompositionof thetest

materials,theassignedvalue,thespikedvalue,

performancescores(BISscore)foreach

laboratory,andtabularand/orgraphical

representationof participantresults.

TheQUARTZschemeandFORENSICPTTrial

resultsarereturnedthroughourelectronic

reportingsoftware,PORTAL.Fullinstructions

fortheuseof thePORTALsystemareprovided

onregistration;featuresincluderesultreporting

bymultipleanalystsandusingmultiplemethods.

Followingevaluationof theresults,the

QUARTZandForensicsPTTrialreportsare

availableonthewebsite,orsentbyemailwithin

10-15workingdays,respectivelyof round

closure.Participantswillbeemailedalinkto

thereportwhenitisavailable.

Other PT services

• Adviceandconsultancyforpotential

PTproviders.

• ConsultancyforPTprovidersinthe

implementationof appropriatequality

systems.

• TrainingcoursesforPTparticipantsandtheir

customers.

• Prominentroleinthedevelopmentof policy

andguidanceforproficiencytestingby

representingtheUKonanumberof key

internationalcommittees.

Product development

LGCStandardsProficiencyTestingiscontinually

strivingtoimprovecurrentproductsandto

introducenewtestmaterialsandPTschemes

whereappropriate.Newproductsmaybe

introducedinitiallyonatrialbasisandofferedto

participants.Itwillbemadecleartoparticipants

whentheyareparticipatinginatrial.

If youhavearequirementforanewanalyte,

testmaterialmatrix,orawholenewscheme

pleasecontact:[email protected]

14 Tel: +44 (0)161 762 2500 Fax: +44 (0)161 762 2501

Clin

ical

an

d F

ore

nsi

c P

T s

chem

es

Reference materials

Beforeacorrectinterpretationcanbeapplied

toadiagnosticmeasurement,cliniciansmust

haveconfidencethattargetanalyteshavebeen

correctlyidentifiedandquantified.Formany

analyticalmethods,thiscanonlybeachieved

throughtheuseof appropriatelycertifiedand

characterisedreferencematerials

Asaleadingglobalsupplierof reference

materials,LGCStandardsoffersabroadrange

of measurementstandardsforroutineclinical

applications,suchastherapeuticdrugmonitoring,

occupationalhealth,drugsanddrugsof abuse,

molecularbiologyandveterinarymedicine.

Weofferarangeofcertifiedreferencematerials

(CRM)toassist,forexample,manufacturers

complyingwiththeEuropeaninvitrodiagnostics

Directive98/79/EC.Thesehigherorderreference

materialsareproducedbymetrological

institutesandorganisationsandareprecisely

characterised.

Forfurtherinformationortoreceiveour

catalogue,pleasecontactyourlocalofficeor

visitourwebsite:www.lgcstandards.com

Summary

Proficiencytesting(orEQA)iswidelyused

acrossmanyscientificdisciplinesasanintegral

partof thequalitycontrolandriskreduction

process.Participationintheseschemesprovides

theanalyticallaboratorywiththeabilitytoassess

performanceonanongoingbasisand

benchmarkthatperformanceagainstother

laboratorieswhilemaintaininganonymity.

Theongoingassessmentof performanceusing

proficiencytestingallowstheidentificationof

areasfortrainingandimprovementandmay

alsoassistwithauditprocesses.

Our range of materials is constantly expanding. If you are unable to find what you want from our catalogues, please contact your local office who will be able to help you further.

Brazil • Bulgaria • China • Czech Republic • Finland • France • Germany • Hungary • India • Ireland • ItalyNetherlands • Poland • Romania • Russia • Spain • Sweden • Turkey • UAE • United Kingdom • USA

No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording or any retrieval system, without the written permission of the copyright holder. © LGC Limited, 2011. All rights reserved. 3006/SS/0711

www.lgcstandards.com

LGC Standards has been serving the clinical and forensic toxicology sector for many years, providing a wide range of reference materials in different presentations. Our product range, covering solid materials to solutions, from pure substances to complex multi-component matrix controls, has been assembled to allow laboratories a single source of materials to fulfil their needs.

The collection of materials assembled from manufacturers and suppliers all over the world include:• Parent drugs• Phase 1 metabolites• Glucuronide and

sulphate conjugates

• Pure substances• Matrix materials• Isotopically labelled

internal standards

LGC Standards appreciates that laboratories require reference materials for a wide range of substances and has ensured that the available materials cover all the major drug groups including:• Anti-epileptics• Antibiotics• Immunosuppressants• Anti-psychotics• Cardiac drugs

• Drugs of abuse• Anti-cancer drugs• Vitamins• Steroids (endogenous)• Anabolic agents

LGC Standards clinicaland forensic toxicologyreference materials

@LGCStds_For

3006_CBSL_Flyer_SS.indd 1 29/07/2011 10:25:45

LGC Standards

LGCStandardsProficiencyTestinghasdedicatedlocalofficesworldwidetohelpwithyourneedsfromplacing

anorderthroughtospecificenquiries.Pleaseseethelistbelowtocontactyournearestoffice.

Brazil

Tel:+551233025880 Email:[email protected]

Territoriesserved:Brazil.

Bulgaria

Tel:+359(0)297149555 Email:[email protected]

Territoriesserved:Bulgaria,Macedonia.

China


Territoriesserved:China,HongKong,Macau,Taiwan.

Czech Republic


Territoriesserved:CzechRepublic, SlovakRepublic.

Finland


Territoriesserved:Finland.

France


Territoriesserved:Algeria,Belgium,Benin,Burkina,Burundi,Cameroon,France, Gabun,Ivorycoast,Jordan,Lebanon,Libya,Liechtenstein,Luxembourg, Madagascar,Mali,Mauritania,Mauritius,Monaco,Morocco,Rwanda,Senegal,Syria,Tanzania,Tunisia.

Germany


Territoriesserved:Albania,Austria, Bosnia-Herzegovina,Cyprus,Germany,Greece,Iran,Israel,Japan,Korea,Kosovo,Mongolia,Montenegro,Singapore, Switzerland,Vietnam.

Hungary


Territoriesserved:Croatia,Hungary,Slovenia.

India


Territoriesserved:India.

Italy

Tel: +390224126842 Email:[email protected]

Territoriesserved:Italy.

Netherlands

Tel: +31(0)643775422 Email:[email protected]

Territoriesserved:Netherlands.

Poland

Tel: +48(0)227513140 Email:[email protected]

Territoriesserved:Armenia,Azerbaijan,Belarus,Georgia,Kazakhstan,KyrgyzRepublic,Lithuania,Poland,Tajikistan,Turkmenistan,Ukraine,Uzbekistan.

Romania


Territoriesserved:Moldova,Romania,Serbia.

Russia


Territoriesserved:Russia.

Spain


Territoriesserved:Andorra,Argentina,Bolivia,Belize,Chile,Columbia,CostaRica,Ecuador,ElSalvador,FrenchGuiana,Guyana,Guatemala,Honduras,Mexico,Nicaragua,Panama,Paraguay,Peru, Portugal,Spain,Suriname,Uruguay,Venezuela.

Sweden


Territoriesserved:Denmark,Estonia,Greenland,Iceland,Latvia,Norway,Sweden.

Turkey


Territoriesserved:Turkey.

United Kingdom

Tel: +44 (0) 161 762 2500 Email:[email protected]

Territoriesserved:Australia,Bangladesh,Bermuda,Botswana,Brunei,Canada,ChannelIslands,Ethiopia,Ghana,Indonesia,Ireland,Kenya,Kuwait,Malaysia,Malta,Nepal,NewZealand,Nigeria,Oman,Pakistan,Philippines,Qatar,SaudiArabia,SouthAfrica,Sudan,Tobago,Trinidad,UnitedArabEmirates,UnitedKingdom,USA,Yemen,Zambia,Zimbabwe.

Nopartof thispublicationmaybereproducedortransmittedinanyformorbyanymeans,electronic or mechanical, including photocopying, recording or any retrieval system, without the written permissionof thecopyrightholder.©LGCLimited,2011.Allrightsreserved.3013/CF/0711