Bio-Rad Laboratories B I O P L E X 2 2 0 0 S Y S T E M

BioPlex™ 2200 Syphilis IgMThe first and only fully-automated, random access, multiplex platform for Syphilis IgM

Bio-Rad Laboratories B I O P L E X 2 2 0 0 S Y S T E M

Like no otherThe Syphilis IgM kit delivers a composite result for a comprehensive examination of the causative agent. Reportable results include:

• SyphilisIgMComposite*

• T. pallidum17kDa**

• T. pallidum47kDa**

*SyphilisIgMCompositeisarollupoftheindividualresults.**IndividualresultsavailableoutsideUS.

The BioPlex™ 2200 Syphilis IgM kit simultaneously detects two of the most clinically relevant antibodies directed against individual recombinant proteins to Treponema pallidum in a multiplex format.

TheBioPlex™ 2200SyphilisIgMkitisamultiplexflowimmunoassayforthe

qualitativenumericdetectionofT. pallidumIgMantibodiesinhuman

serum.ThetestsystemcanbeusedinconjunctionwithaSyphilisIgGtest

asascreenofactiveorpastinfection.Inaddition,theSyphilisIgMkitcan

beuseinconjunctionwithtreponemaland/ornon-treponemalbasedtests

asanaidinidentificationofacuteinfectionwithT. pallidum.

Performance Characteristics

PrecisionFollowingCLSIEP%-A2guidelines,theBioPlex™ 2200SyphilisIgMkit

demonstrated%CV’sofunder11%.

Low % CV’s can be attributed to:

a)fullautomation

b)magneticbead,heterogenousassayformat

c)minimumof150measurementsperanalyte

Specificity

BioPlex™ 2200 Syphilis IgM

Specificitycanbedefinedastheabilityofatesttogiveanegativeresultinnormalserafrompopulationsthatmay

betested.ThespecificityoftheBioPlex™2200SyphilisIgMassayon1247sampleswasexcellentat98%orbetter.

Detailedresultsareshownbelow.

Sensitivity

BioPlex™ 2200 Syphilis IgMData Summary:

• IgMwaspositivein43%(39/90)ofpatientswithprimary

andsecondarysyphilisinfection,helpingdistinguishacute

(primaryandsecondary)vs.non-acutediseasestatus.

• IgMandIgGcombinedwerepositivein94%*(85/90)of

patientswithprimaryandsecondarysyphilisinfection.

Please reference the IgM and IgG results, shown in the bar graph to the right.

* Of the 5 samples nonreactive by BioPlex, 3 out of 5 were also nonreactive for all other testing methods including RPR, TPPA and Western Blot. By excluding these 3 samples, BioPlex assay sensitivity is further improved.

3

1

1

45

40

35

30

25

20

15

10

5

0Untreated Treated Untreated Treated

Primary Secondary

Clinical Status

Co

unt

61.5% (8/13)

76.9% (10/13)

n=20

95.0% (19/20)

30.0% (6/20)

n=17

94.1% (16/17)

47.1% (8/17)

100% (40/40)

42.5% (17/40)

n=40Syphilis Nonreactive

Syphilis IgG Reactive

Syphilis IgG & IgM Reactive

n=13

Near Cutoff 1 – Tp 17kDa

Near Cutoff 2 – Tp 17kDa

Near Cutoff 1 – Tp 47kDa

Near Cutoff 2 – Tp 47kDa

80

80

80

80

1.0

1.0

1.0

1.2

Syphilis IgM Panel Members

Sample

N

Grand

Mean AI SD

0.05

0.06

0.06

0.08

Within-Run Between-Day Between-Run Total

%CV

5.4%

6.4%

6.1%

6.5%

SD

0.03

0.05

0.04

0.03

%CV

3.3%

5.8%

4.4%

2.6%

SD

0.07

0.10

0.07

0.09

%CV

7.3%

10.6%

7.6%

7.5%

SD

0.03

0.05

0.00

0.03

%CV

3.3%

5.8%

0.3%

2.6%

Population N BioPlex™ 2200 Syphilis IgM 95% CI

Unselected pregnant women 497 99.4% (494*/497) 98.2 to 99.8%

Pregnant women with known RPR/TPPA nonreactive results 250 98.0% (245**/250) 95.4 to 99.1%

Patients who had a Syphilis test ordered 500 98.2% (491***/500) 96.6 to 99.1%

* Two(2)sampleswereSyphilisIgMreactive,one(1)samplewasSyphilisIgMequivocal,andallthree(3)sampleswereRPR/TPPAnonreactive.

** Five(5)sampleswereSyphilisIgMreactive,allfive(5)sampleswereRPR/TPPAnonreactive.

***Eight(8)sampleswereSyphilisIgMreactive.Ofthoseeight(8)samples,five(5)sampleswereRPR/TPPAnonreactive,two(2)sampleswereRPR/TPPAreactive, andone(1)samplewasRPRnonreactive/TPPAreactive.One(1)samplewasSyphilisIgMequivocalandRPR/TPPAnonreactive.

Syphilis IgM Assay Procedure

Ordering InformationCatalog No. Description

BioPlex™ 2200 Syphilis IgM

665-1550 SyphilisIgMReagentPack...................................................................................................................................1pack663-1500 SyphilisIgMCalibratorSet...................................................................................................................................... 1set663-1520 SyphilisIgMCalibratorLotDataCD........................................................................................................................ 1CD663-1530 SyphilisIgMControlSet ......................................................................................................................................... 1set663-1540 SyphilisIgMControlLotDataCD........................................................................................................................... 1CD665-1560A SyphilisIgMInstructionsforUsePackage......................................................................................................1package

BioPlex™ 2200 System and Bulk Reagents

660-0000 BioPlex™ 2200....................................................................................................................................................1system660-0800 SampleRacks(30perbox) ................................................................................................................................... 1box660-0801 SampleTray.......................................................................................................................................................... 1tray660-0817 InstrumentSheathFluid(2perbox)....................................................................................................................... 1box660-0818 InstrumentWashBuffer......................................................................................................................................... 1box660-2003 ReactionVessels(1000perbag)........................................................................................................................... 1bag666-0001 InstrumentDetectorCalibrationPack...................................................................................................................1pack666-0002 InstrumentDetectorCleanPack...........................................................................................................................1pack666-0003 InstrumentProbeCleaningSolution(4perbox)..................................................................................................... 1box

B I O P L E X 2 2 0 0 S Y S T E M

1.Patientsample(5μL)automaticallyaddedtoReactionVessel

2.Samplediluent&beads(dilution1:60addedandincubatedat37°C

3.Washstep4.Conjugateaddedand

incubatedat37°C

5.Washstep6.Beadresuspended

inwashbuffer

7.Flow-based,duallaserdetect

Syphilis IgM Reagent Pack

Containsallthenecessaryreagents(samplediluent,

beadsandconjugate)toprocess100patientsper

packandupto100resultsperpatient.

Syphilis IgM Calibrator Set

Calibratorsareready-to-useand

prebar-codedforeaseofuse.

Syphilis IgM Control Set

QualityControlsareready-to-use

andprebar-codedforeaseofuse.

For further information, please contact the Bio-Rad office nearest you or visit our website at www.bio-rad.com/diagnostics

© 2009 Bio-Rad Laboratories, Inc. Printed in USA 12/09 DG09-0960 T-145

Clinical Diagnostics Group

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