2.3. Commutabilityofreferencemateri

2.3. Commutabilityofreferencematerials Commutabilityisdefinedas“theequivalenceofthemathematicalrelationshipbetweentheresultsofdifferent measurementproceduresforRMsandforrepresentativesamplesfromhealthyanddiseasedindividuals”[7].IncaseanRM isnot-commutableanddemonstratesbehaviourthatdiffers fromthatofnativepatientmaterial,variabletestresultswill beobtainedforpatientsampleswithidenticalanalyteconcentrationswhenusingtheRMasacalibrator.Thismeansthata non-commutablecalibrationmaterialbreaksthetraceability chain. SampleprocessingofRMcanresultinmodificationsofthe measurandandmightberesponsiblefornon-commutability [7].Forexample,preparationofRMforlipidsandapolipoproteinsaccordingtoastrictprotocol(CLSIC37-A)hasshown muchbettercommutabilitythancommerciallyavailable patientserumpoolsorRMpreparedbyregularprocedures [7,43].Forseveralanalytes,whicharecurrentlytestedby immunoassays,standardizationeffortsprovedunfeasible, becauseofthelackofcommutableRM(e.g.,thetestsofcardiac troponinI,B-typenatriureticpeptideandprostate-specific antigen)[44].Insuchacomplicatedsystemof(two-step) immunoassays,molecularheterogeneityandminorchanges inthemolecularstructureorconformationoftheRMcan influencethetestresultandcausenon-commutability. ForstandardizationofqCCPmethods,commutable,valueassignedsecondaryRMs,traceabletoprimaryRMs,should bedevelopedinordertoproducetestresultstraceableto standardsofhigherorder.Asmentionedabove,theuseofpeptidereferencestandardsnecessitates,perdefinition,complete proteolysistoguaranteefullmetrologicaltraceabilityofthe proteinmeasurand.Inaddition,SIS-peptidesarecommonly addedafterthedigestionprocessanddonotcorrectforpeptide instabilityduringproteolysis.Therefore,proteinquantitation basedonpeptidereferencestandardsshouldincludetheadditionofSIS-peptidespriortodigestiontoreducevariationsin peptideresponse.Alternatively,theuseofmoresophisticated SIS-strategies,suchaswingedpeptides[45,46],quantification concatemers[47],concatenatedwingedpeptides[48],orfulllengthproteins[49,50]canbeconsidered. Anadditionalproblemwiththeuseofsyntheticreference peptidesorproteinsistheabsenceofanalyte-freematrix forpreparationofcalibrationcurves.Inrespecttoallabovementionedconcernsaboutthecommutabilityofsynthetic peptideorproteinreferencestandards,matrix-based,native, andvalue-assigned,proteincalibratorswillprovidemostreliableabsolutequantitationofendogenousproteins[51,52]. Becausetheproteinstandardsaresubjectedtoawork-up thatisidenticaltothatoftheunknownsamples,theyare likelytocorrectforanyvariabilityinthe(pre-)analyticalworkf low.Theuseofa(single-point)matrix-basedhumanplasma externalcalibratorhas,forexample,showntobeeffectivefor thequantitationofapolipoproteins[51].Obviously,absenceof matrix-effectshastobeassuredbeforenativeproteincalibratorscanbeusedas(commutable)referencematerials. 3. qCCP Pre-analyticalqualityrequirementsfor Inthecurrentlaboratorydiagnostics,70%ofdiagnosticmistakesaretheresultofpre-analyticalerrors[53].Tothisend, standardizationofspecimencollectionandsamplepreparationinqCCPworkflows(Fig.1,leftandmiddlepart)is pivotal.ThequalityguidelinesasposedbytheInternational ConferenceonHarmonisationofTechnicalRequirementsfor RegistrationofPharmaceuticalsforHumanUse(ICH)can functionasaframeworkfordraftingqualityrequirementsfor qCCPworkflows(www.ich.org).SuchrequirementswillbediscussedthroughoutinSections3and4.Notethatthisoverview leavesroomfordiscussionwhetherthequalityrequirements forpre-analysisandanalyticaltestperformanceeitherhave tobemetorshouldbeinterpretedasaconsiderationorspecification. 3.1. Specimencollectionandsamplehandling The(qCCP)processstartswithspecimencollection,e.g., blood,urine,salivaorcerebrospinalfluid(CSF),frompatients whovisitthehospital(Fig.1).Inthisrespect,thehospital

ผลลัพธ์ (ไทย) 1:

2.3. Commutabilityofreferencematerials Commutabilityisdefinedas "theequivalenceofthemathematicalrelationshipbetweentheresultsofdifferent measurementproceduresforRMsandforrepresentativesamplesfromhealthyanddiseasedindividuals" [7]IncaseanRM สูงประมาณ commutableanddemonstratesbehaviourthatdiffers fromthatofnativepatientmaterial, variabletestresultswill beobtainedforpatientsampleswithidenticalanalyteconcentrationswhenusingtheRMasacalibrator.Thismeansthata commutablecalibrationmaterialbreaksthetraceability ไม่ใช่ลูกโซ่ SampleprocessingofRMcanresultinmodificationsofthe measurandandmightberesponsiblefornon-commutability [7]Forexample, preparationofRMforlipidsandapolipoproteinsaccordingtoastrictprotocol(CLSIC37-A) hasshown muchbettercommutabilitythancommerciallyavailable patientserumpoolsorRMpreparedbyregularprocedures [7,43]Forseveralanalytes, whicharecurrentlytestedby immunoassays, standardizationeffortsprovedunfeasible, becauseofthelackofcommutableRM (e.g.,thetestsofcardiac troponinI ตรวจหาเฉพาะ typenatriureticpeptideandprostate B) [44]Immunoassays Insuchacomplicatedsystemof(two-step), molecularheterogeneityandminorchanges inthemolecularstructureorconformationoftheRMcan influencethetestresultandcausenon-commutability ForstandardizationofqCCPmethods, commutable, valueassignedsecondaryRMs, traceabletoprimaryRMs ควร bedevelopedinordertoproducetestresultstraceableto standardsofhigherorderAsmentionedabove, theuseofpeptidereferencestandardsnecessitates, perdefinition ทำ proteolysistoguaranteefullmetrologicaltraceabilityofthe proteinmeasurandInaddition, instabilityduringproteolysis addedafterthedigestionprocessanddonotcorrectforpeptide SIS peptidesarecommonlyดังนั้น proteinquantitation basedonpeptidereferencestandardsshouldincludetheadditionofSIS peptidespriortodigestiontoreducevariationsin peptideresponseหรือ theuseofmoresophisticated SIS-กลยุทธ์ suchaswingedpeptides [45,46], concatemers นับ [47] concatenatedwingedpeptides [48], orfulllengthproteins [49,50] canbeconsidered Anadditionalproblemwiththeuseofsyntheticreference peptidesorproteinsistheabsenceofanalyte freematrix forpreparationofcalibrationcurvesPeptideorproteinreferencestandards Inrespecttoallabovementionedconcernsaboutthecommutabilityofsynthetic ตามเมตริกซ์ พื้นเมือง andvalue กำหนด proteincalibratorswillprovidemostreliableabsolutequantitationofendogenousproteins [51,52] สาย Becausetheproteinstandardsaresubjectedtoawork thatisidenticaltothatoftheunknownsamples, theyare likelytocorrectforanyvariabilityinthe (ก่อน) analyticalworkf ต่ำTheuseofa(single-point) externalcalibratorhas basedhumanplasma เมตริกซ์ forexample, showntobeeffectivefor thequantitationofapolipoproteins [51]อย่างชัดเจน absenceof effectshastobeassuredbeforenativeproteincalibratorscanbeusedas เมตริกซ์ (commutable) referencematerials 3. qCCP Inthecurrentlaboratorydiagnostics analyticalqualityrequirementsfor ก่อน 70% ofdiagnosticmistakesaretheresultofpre-analyticalerrors [53]Tothisend, standardizationofspecimencollectionandsamplepreparationinqCCPworkflows (Fig.1,leftandmiddlepart) เป็นวัตถุThequalityguidelinesasposedbytheInternational ConferenceonHarmonisationofTechnicalRequirementsfor RegistrationofPharmaceuticalsforHumanUse (ICH) สามารถ functionasaframeworkfordraftingqualityrequirementsfor qCCPworkflows (www.ich.org)SuchrequirementswillbediscussedthroughoutinSections3and4.Notethatthisoverview leavesroomfordiscussionwhetherthequalityrequirements forpre analysisandanalyticaltestperformanceeitherhave tobemetorshouldbeinterpretedasaconsiderationorspecification 3.1. Specimencollectionandsamplehandling processstartswithspecimencollection (qCCP) เช่น เลือด ปัสสาวะ salivaorcerebrospinalfluid (CSF) frompatients whovisitthehospital(Fig.1)Inthisrespect, thehospital

ผลลัพธ์ (ไทย) 2:

2.3 Commutabilityofreferencematerials Commutabilityisdefinedas "theequivalenceofthemathematicalrelationshipbetweentheresultsofdifferent isnot-commutableanddemonstratesbehaviourthatdiffers fromthatofnativepatientmaterial, variabletestresultswill ห่วงโซ่ที่ไม่ commutablecalibrationmaterialbreaksthetraceability- SampleprocessingofRMcanresultinmodificationsofthe measurandandmightberesponsiblefornon-commutability patientserumpoolsorRMpreparedbyregularprocedures muchbettercommutabilitythancommerciallyavailable [7,43] .Forseveralanalytes, whicharecurrentlytestedby immunoassays, standardizationeffortsprovedunfeasible, becauseofthelackofcommutableRM (เช่น thetestsofcardiac troponinI, B-typenatriureticpeptideandprostate เฉพาะแอนติเจน) [44] .Insuchacomplicatedsystemof (สองขั้นตอน) immunoassays, molecularheterogeneityandminorchanges inthemolecularstructureorconformationoftheRMcan influencethetestresultandcausenon-commutability ForstandardizationofqCCPmethods, เปลี่ยนได้, valueassignedsecondaryRMs, traceabletoprimaryRMs ควร bedevelopedinordertoproducetestresultstraceableto proteolysistoguaranteefullmetrologicaltraceabilityofthe proteinmeasurand.Inaddition, SIS-peptidesarecommonly addedafterthedigestionprocessanddonotcorrectforpeptide instabilityduringproteolysis.Therefore, proteinquantitation peptideresponse.Alternatively, theuseofmoresophisticated SIS กลยุทธ์, suchaswingedpeptides [45,46] concatemers ปริมาณ [47] concatenatedwingedpeptides [48] orfulllengthproteins [49,50] canbeconsidered Anadditionalproblemwiththeuseofsyntheticreference peptidesorproteinsistheabsenceofanalyte-freematrix peptideorproteinreferencestandards เมทริกซ์ตามพื้นเมือง Becausetheproteinstandardsaresubjectedtoawork ขึ้น thatisidenticaltothatoftheunknownsamples, theyare likelytocorrectforanyvariabilityinthe (ก่อน) analyticalworkf low.Theuseofa (จุดเดียว) externalcalibratorhas เมทริกซ์ basedhumanplasma, เช showntobeeffectivefor thequantitationofapolipoproteins [51] .Obviously, absenceof เมทริกซ์ effectshastobeassuredbeforenativeproteincalibratorscanbeusedas (เปลี่ยนได้) referencematerials 3. qCCP Pre-analyticalqualityrequirementsfor standardizationofspecimencollectionandsamplepreparationinqCCPworkflows (รูปที่ 1, leftandmiddlepart) เป็น pivotal.ThequalityguidelinesasposedbytheInternational ConferenceonHarmonisationofTechnicalRequirementsfor RegistrationofPharmaceuticalsforHumanUse (ICH) สามารถ functionasaframeworkfordraftingqualityrequirementsfor leavesroomfordiscussionwhetherthequalityrequirements forpre-analysisandanalyticaltestperformanceeitherhave tobemetorshouldbeinterpretedasaconsiderationorspecification 3.1 Specimencollectionandsamplehandling (qCCP) processstartswithspecimencollection เช่นเลือดปัสสาวะ salivaorcerebrospinalfluid (CSF) frompatients whovisitthehospital (รูปที่ 1) .Inthisrespect, Thehospital

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2.3 commutabilityofreferencematerials commutabilityisdefinedas " theequivalenceofthemathematicalrelationshipbetweentheresultsofdifferent measurementproceduresforrmsandforrepresentativesamplesfromhealthyanddiseasedindividuals " [ 7 ] incaseanrm ไม่ fromthatofnativepatientmaterial commutableanddemonstratesbehaviourthatdiffers ,variabletestresultswill beobtainedforpatientsampleswithidenticalanalyteconcentrationswhenusingthermasacalibrator . thismeansthata ไม่ commutablecalibrationmaterialbreaksthetraceability โซ่ sampleprocessingofrmcanresultinmodificationsofthe measurandandmightberesponsiblefornon การ commutability [ 7 ]preparationofrmforlipidsandapolipoproteinsaccordingtoastrictprotocol ( clsic37-a ) hasshown muchbettercommutabilitythancommerciallyavailable patientserumpoolsorrmpreparedbyregularprocedures [ 7,43 ] forseveralanalytes whicharecurrentlytestedby standardizationeffortsprovedunfeasible becauseofthelackofcommutablerm ( , , , ( เช่น โทรโปนิน ไอ thetestsofcardiac ,b-typenatriureticpeptideandprostate-specific antigen ) [ 44 ] insuchacomplicatedsystemof ( 2 ) ( molecularheterogeneityandminorchanges inthemolecularstructureorconformationofthermcan , influencethetestresultandcausenon commutability . forstandardizationofqccpmethods commutable valueassignedsecondaryrms traceabletoprimaryrms , , , ,ควร bedevelopedinordertoproducetestresultstraceableto standardsofhigherorder . asmentionedabove theuseofpeptidereferencestandardsnecessitates perdefinition , , , proteolysistoguaranteefullmetrologicaltraceabilityofthe proteinmeasurand สมบูรณ์ และพี่ peptidesarecommonly addedafterthedigestionprocessanddonotcorrectforpeptide instabilityduringproteolysis ดังนั้นproteinquantitation basedonpeptidereferencestandardsshouldincludetheadditionofsis peptidespriortodigestiontoreducevariationsin peptideresponse อีกวิธีหนึ่งคือ theuseofmoresophisticated กลยุทธ์พี่ suchaswingedpeptides [ 45,46 ] , ปริมาณ concatemers [ 47 ] concatenatedwingedpeptides [ 48 ] , [ 49,50 orfulllengthproteins ] canbeconsidered .anadditionalproblemwiththeuseofsyntheticreference peptidesorproteinsistheabsenceofanalyte freematrix forpreparationofcalibrationcurves . inrespecttoallabovementionedconcernsaboutthecommutabilityofsynthetic peptideorproteinreferencestandards Matrix ตามพื้นเมือง andvalue มอบหมาย , proteincalibratorswillprovidemostreliableabsolutequantitationofendogenousproteins [ 51,52 ]becausetheproteinstandardsaresubjectedtoawork ขึ้น thatisidenticaltothatoftheunknownsamples พบ likelytocorrectforanyvariabilityinthe ( ก่อน ) analyticalworkf ต่ำ theuseofa ( จุดเดียว ) basedhumanplasma externalcalibratorhas เมทริกซ์ คือ showntobeeffectivefor , thequantitationofapolipoproteins [ 51 ] . อย่างชัดเจน ,absenceof เมทริกซ์ effectshastobeassuredbeforenativeproteincalibratorscanbeusedas ( commutable ) referencematerials . 3 . qccp ก่อน analyticalqualityrequirementsfor inthecurrentlaboratorydiagnostics 70% ofdiagnosticmistakesaretheresultofpre analyticalerrors [ 53 ] tothisend standardizationofspecimencollectionandsamplepreparationinqccpworkflows ( leftandmiddlepart ” , , ) เป็นสำคัญ .thequalityguidelinesasposedbytheinternational conferenceonharmonisationoftechnicalrequirementsfor registrationofpharmaceuticalsforhumanuse ( ICH ) สามารถ functionasaframeworkfordraftingqualityrequirementsfor qccpworkflows ( www.ich . org ) suchrequirementswillbediscussedthroughoutinsections3and4 .notethatthisoverview leavesroomfordiscussionwhetherthequalityrequirements forpre analysisandanalyticaltestperformanceeitherhave tobemetorshouldbeinterpretedasaconsiderationorspecification . 3.1 . specimencollectionandsamplehandling ( qccp ) processstartswithspecimencollection เช่น เลือด ปัสสาวะ salivaorcerebrospinalfluid ( CSF ) frompatients whovisitthehospital ( ” ) inthisrespect thehospital ,