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I N N O - L I A ™ S y p h i l i s S c o r e

48488. INNO-LIA™TSyphilisTScore

8.1TStripTcomposition

A purposefulTchoiceTofThighlyTpurifiedTsyntheticTpeptideandTrecombinantTproteins

TpN47

TpN17

TpN15

TmpA

AntigenTsource

• RecombinantTproteinsConformational antigensIncreased sensitivity

• SyntheticTpeptide-TveryTspecificTreaction

Higher specificity

What’sTinTaTline?

RecombinantTproteins

SyntheticTpeptide

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8.2gStripginterpretation

InterpretationgofgthegINNO-LIA™gSyphilisgScore

Positive: -RtwoRorRmoreRsyphilisRantigenRlinesRshowaRreactivityRofR±RorRhigher

Indeterminate: -RoneRsyphilisRantigenRlineRshowsaRreactivityRofR1+RorRhigher

Negative: -RallRsyphilisRantigenRlinesRhaveaRnegativeRreactivityRrating

-RifRoneRsyphilisRantigenRlineRscoresR±

Backgroundicontrol

Leveli3+

Leveli1+

Leveli+/-

TpN47

TpN17

TpN15

TmpA

Positive Positive Negativecontrol

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R- Indeterminate Negativecontrol

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8.3uTestuperformance

Sensitivity

ClinicaluandupotentiallyuinterferingusamplesAuto)immuneGastroGeriatricsHIVIntensive9careNefroPediatricsObstetricsRheumatoid9factorSurgeryGranduTotal

Neg2Ejj

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166

Ind™™™™™™™™™™0

Pos™™™™2™™™™™1

Number2Ejj

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Specificity

The9specificity9was9determined9on9%™™9blood9donors(922F9samples9from9hospitali)zed9patients9wincluding9pregnant9womenl9and94™9samples9containing9potentiallyinterfering9substances.

BloodudonorsA9total9of9%™™9blood9donors9were9tested9internally9with9the9INNO)LIA™9SyphilisScore9using9the9manual9procedure.9After9initial9testing(96E™9samples9were9scorednegative9and92™9samples9scored9indeterminately(9resulting9in9an9initial9specificityof9E©.F939w6E™L%™™l.

ClinicaluandupotentiallyuinterferingusamplesA9total9of92©F9clinical9and9potentially9interfering9samples9were9tested9internally.All9but9one9sample9reacted9negative.9This9sample9was9retested9in9duplicate9andwas9found9negative9twice.9On9this9set9of9samples(9an9initial9specificity9of9EE./93w2©©L2©Fl9was9obtained9and9after9retesting9the9specificity9is92™™93.

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A9total9of96™29syphilis)positive9samples(9were9tested9internally9with9theINNO)LIATM9Syphilis9Score9using9the9manual9procedure.9All9samples9gave9apositive9result9on9the9assay(9resulting9in92™™939sensitivity9w6™2L6™2l.


5151

gfvhPublications

Articles

™fhEbelhA-hVannestehL-hCardinaelshM-hSablonhE-hSamsonhI-hDehBosscherehK-HulstaerthF-hZreinhMfhJhClinhMicrobiolhyOOO;pg7y™69™)f

ValidationhofhthehINNO9LIA™hSyphilishKithashahConfirmatoryAssayhfor Treponema pallidium Antibodies

Sensitivity7h))f%J

Specificity7h))f6J;includinghindeterminates3

Conclusion

ThisB singleB multiparametricB assayB providesB reliableB confirmatoryB diagnosticinformationBthatBmustBcurrentlyBbeBobtainedBbyBtheBperformanceBandBinterpretationofBresultsBofBaBcombinationBofBserologicalBassaysw

yfhHagedornhH9J-hKraminer9HagedornhA-hDehBosscherehK-hHulstaerthF-hPottelH-hZreinhMfhJhClinhMicrobiolhyOOy;vO7)(p9(gf

EvaluationhofhINNO9LIA™hSyphilishAssayhashaConfirmatoryhtesthfor Syphilis

Sensitivity7h™OOJ

Specificity7h))fpJ;includinghindeterminates3

Conclusion

ComparedB toB TPHA andB IgG)FTA)ABS<B theB INNO)LIA™B SyphilisB gavesignificantlyB higherB numberB =P=RwR©EB andB P<RwRRRE<B respectively0B ofB currentresultsB thanB eitherB ofB theB otherB twoB testswB TheB multiparameterB INNO)LIA™SyphilisBassayB isBaBusefulBconfirmatoryB testB forBsyphilisBbecauseB itB increasesB thereliabilityBofBsyphilisBdiagnosisBwithBrespectBtoBcurrentBconventionalBtechniquesw

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”ylFrenchlP“lGomberglM“lJanierlM“lSchmidtlB“lvanlVoorstlVaderlP“YounglH“lInternationallJournalloflSTDl2lAIDSl)EE1Rl)E5l”EEp”E1

INNO-LIA™.Syphilis.Score.is.referenced.as.the.gold.standard.method,.recom-mended.by.European.Guidelines.as.a.reproducible.and.accurate.confirmatory.testfor.Syphilis.diagnosis.

“ThelIgGlimmunoblotlusinglrecombinantlantigenlislrecommendedaslalsupplementarylconfirmatoryltest“lwhenlalpositivelEIAlscreeningltest

islnotlconfirmedlbylthelTPPAl9TPHA;lorlalpositivel TPPAl9TPHA;screeningltestslislnotlconfirmedlbylthelEIAltesty

ThelFTApabslislnotlrecommendedlaslalstandardlconfirmatoryltesty”

4ylChucklA“lOhinmaalA“lTilleylP“lSinghlS“lJacobslPylInternationallJournallofSTDl2lAIDSl)EE8Rl(15”1”p”11

Despite.relative.high.cost.of.reagents.for.Syphilis.diagnosis.by.means.of.EIA.andINNO-LIA™.Syphilis.Score,.this.algorithm.remains.less.costly.and.at.the.sametime.more.cost.effective

Alcohortl9C(C)”lprenatalldiagnosislsampleslandl”8()4lnonpprenatal;simulationlstudylwaslconducted“lwherelcostlandleffectivenesslof

)ltestinglalgorithms5lRPRl-lTPPAl9TPHA;landlEIAl-lIgGlimmunoblotwerelcomparedylCostlincludedltestslreagentslandllabour“ltreatment

andlfollowlupletc“lwhileleffectivenesslmeantlcostloflfalselresults“iyeylcostloflobtaininglcorrectldiagnosisy

(ylTotallcostlwerel5l Can&l4l))Cl1E)lforlRPRl-lTPPA9TPHA;andlCan&l4l(41l”C”lforlEIAl-lIgGlimmunoblot

)ylAlgorithmlEIAl-IgGlimmunoblotlwaslmorelcostleffective

IUSTI5l)EE8lEuropeanlGuidelineslonlthelManagementloflSyphilis

Conclusion

Costleffectivenessloflenzymelimmunoassayandlimmunoblotltestinglforltheldiagnosisloflsyphilis

Conclusion

8y4lPublications

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53538.5 INNO-LIA™CSyphilisCScoreCvs

Mikrogen recomLineCTreponemaCIgG


Mikrogen recomLine6Treponema6IgG6was6compared6to6INNO9LIA™6Syphilis6Score5R6h6protocol6on6results6obtained6from6R26syphilis6IgG6samples86The6following6table6andfigures6give6an6overview6of6the6scoring6of6both6assays8

Comparison6between6the6INNO9LIA™6Syphilis6Score6andMikrogen recomLine6Treponema6IgG

Conclusion

INNO9LIA™6Syphilis6Score6(5R6h) positivity was respectively 8 % higher,

indeterminates were 3 % lower:6and6the negativity was 5 % lower than6MikrogenrecomLine6Treponema6IgG6for6the6R26tested6syphilis6IgG6samples86Three6samples6testednegative6on6Mikrogen recomLine6Treponema6IgG:6none6of6the6samples6tested6negativeon6INNO9LIA™6Syphilis6Score86The6INNO9LIA™6Syphilis6Score65R6h6protocol6givesmore clear-cut results.

INNO-LIA™CSyphilisCScoreC16ChPositive:6jF6.:6Indeterminate:6E6.:6Negative:626.

Mikrogen recomLineCTreponemaCIgGPositive6j26.:6Indeterminate:646.:6Negative:646.

INNO9LIA™6Syphilis6Score65R6h

NEG IND POS TOTAL

MikrogenrecomLine

Treponema6IgG

NEG 2 2 D D

IND 2 2 D D

POS 2 5 4D 43

TOTAL 2 5 4j R2

INNO-LIA™TSyphilisTScoreT16Th

Positive Indeterminate Negative

Mikrogen recomLineTTreponemaTIgG


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Comparison study performed at Fujirebio Europe N.V. in 2013

54548.6 INNO-LIA™ Syphilis Score vs Trep-Sure™

I NN O- L I A ™ S y p h i l i s S c o r e

Trep%Sure™0was0compared0to0INNO%LIA™0Syphilis0Score0EF0h0protocol0on0resultsobtained0from0F30syphilis0IgG0samples20The0following0table0and0figures0show0anoverview0of0the0scoring0of0both0assays2

Comparison0between0the0INNO%LIA™0Syphilis0Score0andTrep%Sure™

Conclusion

INNO%LIA™0Syphilis0Score0,EF0hP positivity was respectively 1 % higher andindeterminates were 2 % lower than0Trep%Sure™0for0the0F30tested0syphilis0IgG0samples2Two0samples0tested0negative0on0Trep%Sure™80none0of0the0samples0tested0negative0onINNO%LIA™0Syphilis0Score20The0INNO%LIA™0Syphilis0Score0EF0h0protocol0gives0moreclear-cut results2

INNO-LIA™ Syphilis Score 16 hPositive:0940C80Indeterminate:0D0C80Negative:030C

Trep-Sure™Positive09j0C80Indeterminate:030C80Negative:050C

INNO%LIA™0Syphilis0Score0EF0h

NEG IND POS TOTAL

Trep%Sure™

NEG 3 3 D D

IND 3 3 3 3

POS 3 E ©j ©4

TOTAL 3 E ©9 F3

INNO-LIA™ Syphilis Score 16 h


Trep-Sure™


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Comparison study performed at Fujirebio Europe N.V. in 2013

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