POCTCreatinine

SchemeGuide

CopyrightWEQAS2015.Allrightsreserved.Nopartofthisdocumentmaybe
reproduced orutilisedinanyformwithoutpermissionfromWEQAS

Contents

1. Introduction ...............................................................................................................3
2. SchemeDetailsandRepertoire...................................................................................3
2.1

ListofAnalytesandFrequencyofDistribution ................................................................................... 3

2.2

SourceMaterialandSampleIntegrity................................................................................................. 3

2.3

SampleStability ................................................................................................................................... 4

2.3.1 Shorttermstability.............................................................................................................................. 4
2.3.2 Longtermstability............................................................................................................................... 4

3 Sampleinstructionsforuse.........................................................................................5
4 StatisticalAnalysis ......................................................................................................5
4.1

SchemeTargetValues ......................................................................................................................... 5

4.2

Typicalreport....................................................................................................................................... 5

4.3

PerformanceCriteria ........................................................................................................................... 5

5 PoorperformanceandreferraltoNQAAP...................................................................6

Filename:SPQL1
POCTCreatguide0515

Approvedby:
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1.

Introduction

EQAistheinterlaboratorycomparisonandperformanceevaluationthatextendsthroughoutallphasesofthe
healthcarediagnostictestingcycle,includingpreanalyticalassessmentandinterpretationofresults.External
QualityAssessment(EQA)isanessentialpartofprovidingqualitylaboratorydiagnosticservices,and
participationinEQAisrequiredforlaboratoryaccreditationtoISO15189andISO17025.

Creatinineisprimarilyusedasamarkerofkidneydamage,andisusedtocalculateestimatedGlomerular
FiltrationRate(eGFR).Inpointofcaresettingsitisoftenusedasascreentoexcludekidneydamage
immediatelypriortotheadministrationofpotentiallynephrotoxicdrugsorcontrastmedia.

2.

SchemeDetailsandRepertoire

2.1 ListofAnalytesandFrequencyofDistribution

Frequencyofdistribution:BiMonthly

Numberofsamplesperdistribution:3

Analyte

ApproximateRange
Covered

Units

Creatinine

25 700

mol/L

eGFR

<1590

mls/min/1.73m2

2.2 SourceMaterialandSampleIntegrity

ForthePOCTCreatinineSchemethematerialislysedanimalblooddispensedasepticallyinto0.5mlaliquots
andstoredat20Cuntildispatched.Thesamplesaredispatchedbyfirstclassmailpackagedincontainers
conformingtoPostOfficeguidelines

Althougheveryeffortismadetoensurethatthematerialisfreefromanyknowninfectiousagent,thesamples
shouldbehandledasforclinicalspecimens.

Filename:SPQL1
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2.3 SampleStability

2.3.1 Shorttermstability

Creatinine (umol/L)

Thelysedbloodwassplitinto3poolswithonepoolleftunadultarated,onepoolspikedwith200mol/L
Creatinineandonespikedwith500mol/LCreatinine.Eachpoolwasaliquottedandstoredat+20C,+4Cand
20C.Thesampleswerethenanalyseddailyfor21days.ThestabilitystudyshowedthattheCreatinine
concentrationinthesamplesincreasedafter1dayafterwhichtimetheyremainedstablefortheremaining20
daysat+4Cand20C.Anextendedstabilityat20Cofthelowerpoolsuggestedthatthesamplesarestable
forlongtermstorageatthistemperatureforatleast2months.

Spiked Lysed Blood Stability Study (POCT Creatinine Scheme)

700.0

600.0

Base 20 deg
500.0

Base 4 deg

Base -20 deg

400.0

Base+200 20 deg

Base+200 4 deg
300.0

Base+200 -20 deg

Base+500 20 deg
200.0

Base+500 4 deg

Base+500 -20 deg

100.0

0.0

0
2
4
6
8
10
12
14
16
18
20
22
24
Day

2.3.2

Longtermstability

Lysed Blood Long term Stability Study at -20C

100
90
80
70
Creatinine (umol/L)

60
50
40
30
20
10
0
0

10

20

30

40

50

60

70

80

90

Day

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Sampleinstructionsforuse

Thesampleshouldbeassayedonthedayyoureceiveit.Ifyouareunabletoassaythesampleimmediately,
pleasestoreat4Cuntilanalysis(analysewithin10daysofreceipt).Samplesstoredat4Cpriortoanalysis
mustbebroughttoroomtemperatureandassayedwithin30minutes.

1.

Mixthesamplewellbygentlyinverting5to6timesthengentlyswirlingthevialfor510seconds
ensuretherearenoairbubblesinthesample.

2.

Wearglovesandhandlethesampleasanormalpatientsample.

3.

Carefullyremovethewhitelidfromthesample.

4.

Gentlysqueezethebottletoformasmallhangingdropandapplythesampletothetestingstripas
permanufacturerinstructionsforyourmeter.

5.

Safelydisposeofexcesssampleinaccordancewithlocalwastepolicyguidelines.

StatisticalAnalysis

PleaserefertotheWEQASParticipantsManualforfulldetailsonstatisticalanalysisandinterpretationof
results.

4.1 SchemeTargetValues

ThetargetvalueusedforcalculatingtheSDIScoreisthemethodmeanwhenthenumberofparticipantsusing
themethod8.Theoverallmeanisusedwhenthenumberofparticipantsusingthemethod<8.

4.2 Typicalreport

PleaserefertotheWEQASParticipantsManualforfulldetailsonthetypicalreportformatandinterpretation.

4.3 PerformanceCriteria

TheWEQASParticipantsManualcontainsinformationregardinghowperformancecriteriaisderivedforall
WEQASschemes.DuringthePilotSchemeapreliminaryperformancecriteriaofmethodmean+/30%was
usedforthePOCTCreatinineScheme.

Filename:SPQL1
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SD

Theactualstandarddeviationobservedduringthepilotwasusedtocalculateaprecisionprofileforthis
analyte.ThefollowingFigurereflectsthestateoftheartofPOCTCreatininemethodsandisdefinedas
target+/2*WeqasSD,wheretheWEQASSDiscalculatedfromtheprecisionprofilegraph.
Itwasidentifiedthatthelineofbestfitfollowedapowerrelationship(r2=0.8499),alinearrelationship
equivalenttoainterlaboratoryCoefficientofvariation(CV)of10%producedalowerr2of0.7477.Forserum
creatininethebiologicalgoalTotalErroristarget+/8.9%.ThisiscurrentlynotachievableforthePOCT
screeningmethod.Theprecisionprofilesareregularlymonitoredandreviewedannually.

POCT Creatinine Precision Profile

0.8724
y = 0.2129x
2

R = 0.8499

60

50

fresh samples

40

lysed blood

30

20

10

0
0

100

200

300

400

500

600

700

Overall Mean (umol/L)

PoorperformanceandreferraltoNQAAP

PleaserefertotheWEQASParticipantsManualforfulldetailsonpoorperformanceandreferraltotheNational
QualityAssessmentAdvisoryPanel.

Filename:SPQL1
POCTCreatguide0515

Approvedby:
MAThomas

Version1.3

DateofRevision:
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Filename:SPQL1
POCTCreatguide0515

Approvedby:
MAThomas

Version1.2

DateofRevision:
13/02/15

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CopyrightWEQAS2015.Allrightsreserved.Nopartofthisdocumentmaybereproduced
orutilisedinanyformwithoutpermissionfromWEQAS