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AbstractsandprogramMASTERCLASSThesubject:“(POCT)Qualityspecificationsinmedicallaboratorydiagnosticsrevisited”.V11MondayJuly12th2021CET14:00to18:00hoursHowcanonejudgeifaPOCinstrumentwithtestmaterialshastherightquality?Isitreliable?Isitpossibletodefineaminimalsetofinformationtojudgethis?ThequalityofPOCTinstrumentsisincreasedoverthelastdecadeandmanyofthemcannowcompetewiththecentrallaboratory.Examplesofsucharee.g.-POCTglucosefromRocheACCUChekinformationIIsystem,-POCTPCRCOVID-19fromABBOTTIDNOWrapidtest,-POCTCRPfromOrionQuikReadGOandmanyothers.Importantfeaturessuchasprice,user-friendliness,andcorrelationwithotherkitswereexcludedfromthisstudy.Withinthehierarchyoffeaturestheyarelessimportant.Dependingonthesettingthethresholdscanbeadaptedtoserveaspecificpurpose.Apregnancytest(Y/N)answerstoadifferentquestionasaglucosemonitoringresult.Lay-outMASTERCLASS14:00 sharp intro,design,goalsandspeakers14:10 entreeexam14:15 lecture1-QualitygoalsinPOCT ProfSharonEhrmeyer(UniversityofWisconsin, Madison,USA) onlaboratoryPOCregulations ISO 22870:2016 defines the POCT requirements for quality and competence. CLIA includes minimum standards of practice and CLSI has guidelines concerning equipment as well as the operations. CLIA also specifies educational and training levels. But are these standards and guidelines still realistic and appropriate in today’s testing environment? What is needed to ensure quality? A global survey gave a lot of information on current

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POCT practices and what features are desired by operators to improve result quality. The survey found that operator educational level and the role of the central laboratory differ from continent to continent (Sten Westgard et al., J Appl Lab Med, 2020, 480-93). POCT quality is dependent on many factors seemly making results more vulnerable to error (Maurice O’Kane et al., Clin Chem, 2011, 1267- 71). Are these metrics relevant in real life practice today? How can testing variability be eliminated or at least reduced? It is obvious that more work must be done but, also due to the current pandemic and the need for even more POCT, we are running out of time. The profession of laboratory diagnostics should define the test result quality and what is needed to ensure attainment of that quality (abstract finalized). 14:45 Q&AcoordinatedbyDrStacyWalz(ArkansasStateUniversity,Jonesboro,USA)14:55 intermission15:05 lecture2-POCTbytheend-user DrSnežanaJovičić(CenterofMedicalBiochemistry, Belgrade,Serbia)and DrChristianSchoenmakers(ElkerliekHospital,Helmond, TheNetherlands) onthePOCgoalsoftheend-user DuetotheCOVID-19pandemiceverybodynowknows whatamedicallaboratorytestmeansaswellasconcepts suchassensitivity,specificity,falsepositiveandfalse negativetestresultsarenowmorewidespread.Soeven qualityisdiscussedandtheappreciationofthose executingthetestsdidgrow.Sotheroleofthetraditional laboratorywillchangeasamatterafact:isalready changing.Oldissuessuchas–theanalyticaltechnique used,-thereferencerangetobeapplied,-thevalid interpretationofthetestresult,-thecorrelationwiththe conditionofthepatientandsoon,aresurfacingagain. Howeverfortheend-user,andheorsheisinchargenow, theyareirrelevant.Theend-user(patient,physician, passer-by)presumesthatallofthisistakencareofand thatthefinalresultisunambiguously.Thespeakers outlinehowthecurrentsituationischangedandwhat thedemandsoftheend-userarethesedays(abstract finalized).

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15:35 Q&AcoordinatedbyDrStacyWalz15:45 intermission15:55 lecture3-POCTandstatisticalconsiderations ProfJamesWestgard(UniversityofWisconsin,Madison, USA)and StenWestgardMS(WestgardQCInc.,Madison,USA) onstatisticalrequirementsonPOCtestsandinstruments InacomprehensiveoverviewStenwillteachthecohesion betweentheQCapproachesofSigma-metricsand Westgardrules.Howdoeshealthcareingeneraland medicaldiagnosticsinparticularperformthesedays?It evidentthatoneneedstosetpropergoalsforthequality oflaboratorytests.Examplesofcurrentperformancewill begivenandtoolssuchasthemethoddecisionchart explained. "Characterizingtheperformanceofaqualitative test."ParticularlyintheCOVIDera,thereisaneedto understandhowtovalidatethemanynewPOCtests- antibody,antigen,andmolecular.Sothevalidationof qualitativetestswillbeoutlined.Thisbasedonthe assumptionthatfuturePOCTtestswillbeofthisnature.Theperformance characteristicsofquantitativevsqualitativetestsarethelimitofdetection, theCutoffInterval,theclinicalagreementstudyandcrossreactivity, amongotherthings.Calculationswithbinarydatahavetobemadetakinginto accountproportionsandcumulativedistributions,resultingin"hitrates".Are thetraditionalcharacteristicssuchasPrecision,LimitofDetection,andCutoff Intervalstilluseful?OrshouldtheybereplacedbyConfidencelimitsfor proportionsandProbitanalysis.TheproveofthepuddingisintheClinical agreementstudyprovidinginfoonPPA(Sensitivity),PNA(Specificity), ConfidencelimitsandAcceptablePPA,PNAA.InadditionMedicalusefulness andpredictivevalueisdiscussed.Onlinecalculationtoolsareshownand throughpracticalexampleshighlighted.Thisduopresentationprovidesthe toolsneededtojudgethereliabilityandusefulnessofcurrentandfuture POCTassays(abstractpending,workinprogress).16:40 Q&AcoordinatedbyDrStacyWalz16:55 intermission

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17:10 lecture4-futurePOCT-futureproofyourlaboratory ProfIvanBrandslund(SDU,Denmark) onthefutureoflaboratoryPOC Wehavetorethinkthefuture.“Ifyoucan’t measureit,youcan’tmanageit”isoftenquoted asasayingfromDr.W.EdwardsDeming.Butthis isonlyoneaspectofmedicaldecisionmaking throughlaboratorydiagnostics.Majorissuesare qualityandspeed.Sothefutureoflaboratory serviceswillbe‘qualitysufficienttoanswerthemedicalquestionasked’and ‘ondemand’.Sowearelookingfortestsettingsthatcanliveuptothesenew standards.Consequentlytheroleofthetraditionalmedicallaboratorywill change.Moreoveritwillbeachallengeforthetraditionalmedicallaboratory tostayinvolved.Newtechniquessuchasimmunosensors(graphene electrochemicalsensors,JournalSensors,BiljanaMojsoskaetal.,2021,21, 390)willbeexplainedandtheirpossibleapplicationsoutlined.Howfarcan thisanalyticalplatformbeenstretched,whichassayscanbeperformed?The DutchSpiroNosehassomepossibilitiestoo:fastbutisitreliableenough? Futureisanattitude!Howbrightwillitbe?(abstractpending,workin progress). 17:40 Q&AcoordinatedbyDrStacyWalz17:50 exitexam,conclusion byDrHenkGoldschmidt (QualityintheSpotlightFoundation,Tilburg, TheNetherlands)18:00 sharp closingSponsorsSelectedreadingsavailableonthewebsiteaftermailedrequestandregistrationTheregistrationfeeis75euro,theregistrationformcanbefoundonthewebsitehttps://qualityinthespotlight.com/.Thefeeincludesdigitalconferencematerials.

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ThisMASTERCLASS‘QualityintheSpotlight’onPOCTdiagnosticlaboratorytestingofJuly12th2021isexecutedundertheauspicesofIFCC(InternationalFederationofClinicalChemistryandLaboratoryMedicine)andundertheauspicesoftheEFLM(EuropeanFederationofClinicalChemistryandLaboratoryMedicine).

EMTunderreview