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LIQUIDASSAYEDSPECIFICPROTEINCONTROL

LEVEL2(SPCONTROL2)

LotNo.165LPCCat.No.PS2683

Level23x1mlExpiry:2011-08

INTENDEDUSE

Thisproductisintendedforinvitrodiagnosticuseinthequalitycontrolofserumonclinicalchemistryand

immunoassaysystems.TheAssayedLiquidProteinControlsareforthecontrolofaccuracy.

DEVICEDESCRIPTION

TheLiquidProteinControlsaresuppliedat3levels,level1,2and3.Targetvaluesandrangesaresuppliedfor

theanalyteslistedinthevaluetablesatall3levels.Note:FreeKappaandFreeLambdalightchainsnotfor

useintheUS.

SAFETYPRECAUTIONSANDWARNINGS

Forinvitrodiagnosticuseonly.Donotpipettebymouth.Exercisethenormalprecautionsrequiredforhandling

laboratoryreagents.

HumansourcematerialfromwhichthisproducthasbeenderivedhasbeentestedatdonorlevelfortheHuman

ImmunodeficiencyVirus(HIV1,HIV2)antibody,HepatitisBSurfaceAntigen(HbsAg),andHepatitisCVirus

(HCV)antibodyandfoundtobeNON-REACTIVE.FDAapprovedmethodshavebeenusedtoconductthese

tests.

However,sincenomethodcanoffercompleteassuranceastotheabsenceofinfectiousagents,thismaterial

andallpatientsamplesshouldbehandledasthoughcapableoftransmittinginfectiousdiseasesanddisposed

ofaccordingly.

HealthandSafetyDataSheetsareavailableonrequest.

STORAGEANDSTABILITY

OPENED:Storerefrigerated(2to8°C).Proteincontrolmaterialisstablefor30daysat+2to+8°Cifkept

cappedinoriginalcontainerandfreefromcontamination.Onlytherequiredamountofproductshouldbe

removed.Afteruse,anyresidualproductshouldNOTBERETURNEDtotheoriginalvial.

UNOPENED:Storerefrigerated(2to8°C).Stabletoexpirationdateprintedonindividualvials.

PREPARATION

TheLiquidProteinControlsaresuppliedreadyforuse.

MATERIALSPROVIDED

LiquidProteinControlLevel23x1ml

MATERIALSREQUIREDBUTNOTPROVIDED

N/A

LIMITATIONS

RF:Pleasenotethatthedilutionofmulti-controlsoncertainsystemscanresultintheoverrecoveryofR.F.

comparedtotheundilutedcontrol.ThisisduetocomplexImmunoglobulinInteractions.

ASSIGNEDVALUES

EachbatchofProteinControlissubmittedtoapproximately100laboratoriesandvaluesareassignedfroma

consensusofresultsobtainedbytheselaboratories.Witheachbatch,acontrolrangeisprovidedforindividual

parametersandeachparametermethod.

27Oct’09ne

RANDOXLaboratoriesLtd.,55DiamondRoad,Crumlin,Co.Antrim,UnitedKingdom,BT294QY

Tel:+44(0)2894422413Fax:+44(0)2894452912

Email:applications@Website:

ABCA

ABC

LIQUIDASSAYEDSPECIFICPROTEINCONTROLLEVEL2(SPCONTROL2)Cat.No.PS2683Lot.No.165LPCSize3x1mlExpiry2011-08

Range

Analyteunittargetlowhighmethods

Albuming/l33.028.137.9Vitros(IFCCCal.)

g/dl3.302.813.79

g/l37.431.843.0BromocresolGreen(IFCCCal.)

g/dl3.743.184.30

g/l38.032.343.7BromocresolPurple(IFCCCal.)

g/dl3.803.234.37

g/l36.631.142.1Nephelometric(IFCCCal.)

g/dl3.663.114.21

g/l39.333.445.2BromocresolGreen(NonIFCCCal.)

g/dl3.933.344.52

g/l37.231.642.8BromocresolPurple(NonIFCCCal.)

g/dl3.723.164.28

g/l34.529.339.7Nephelometric(NonIFCCCal.)

g/dl3.452.933.97

g/l38.132.443.8TurbidimetricAssays(IFCCCal.)

g/dl3.813.244.38

Alpha-1-Acid

Glycoprotein

g/l0.8930.7141.07Turbidimetric(IFCCCal.)

mg/dl89.371.4107

g/l0.9600.7681.15Nephelometric(IFCCCal.)

mg/dl96.076.8115

Alpha-1-Antitrypsing/l1.621.301.94Turbidimetric(IFCCCal.)

mg/dl162130194

g/l1.731.382.08Nephelometric(IFCCCal.)

mg/dl173138208

g/l1.631.301.96Nephelometric(NonIFCCCal.)

mg/dl163130196

g/l1.711.372.05Turbidimetric(NonIFCCCal.)

mg/dl171137205

Alpha-2-Macroglobuling/l2.121.702.54Nephelometric(IFCCCal.)

mg/dl212170254

AlphafoetoproteinKIU/l=lU/ml28.522.834.2Chemiluminescence(IFCCCal.)

ng/ml34.527.641.4

KIU/l=lU/ml28.723.034.4Chemiluminescence(NonIFCCCal.)

ng/ml34.727.841.6

KIU/l=lU/ml29.023.234.8EnzymeImmunoassay(NonIFCCCal.)

ng/ml

AntiStreptolysinOIU/ml352282422Turbidimetric(IFCCCal.)

IU/ml190152228Neph.Beckman(IFCCCal.)

IU/ml184147221Neph.Beckman(NonIFCCCal.)

IU/ml337270404Neph.Behring(IFCCCal.)

IU/ml340272408Neph.Behring(NonIFCCCal.)

AntithrombinIIImg/l278209348Nephelometric(NonIFCCCal.)

mg/dl27.820.934.7

___________________________________________________________________________________________________

RANDOXLaboratoriesLtd.,55DiamondRoad,Crumlin,Co.Antrim,UnitedKingdom,BT294QY

Tel:+44(0)2894422413Fax:+44(0)2894452912

Email:applications@Website:

ABC

LIQUIDASSAYEDSPECIFICPROTEINCONTROLLEVEL2(SPCONTROL2)Cat.No.PS2683Lot.No.165LPCSize3x1mlExpiry2011-08

Range

Analyteunittargetlowhighmethods

Beta-2-microglobulinμg/ml=mg/l2.792.233.35Chemiluminescence(NonIFCCCal.)

μg/ml=mg/l3.462.774.15Nephelometric(IFCCCal.)

μg/ml=mg/l3.542.834.25Nephelometric(NonIFCCCal.)

μg/ml=mg/l3.442.754.13Turbidimetric(IFCCCal.)

C-ReactiveProteinmg/l51.641.361.9Vitros(IFCCCal.)

mg/l45.336.254.4Turbidimetric(IFCCCal.)

mg/l43.634.952.3Nephelometric(IFCCCal.)

mg/l43.735.052.4Nephelometric(NonIFCCCal.)

mg/l44.635.753.5Turbidimetric(NonIFCCCal.)

Caeruloplasming/l0.3650.2920.438Nephelometric(IFCCCal.)

mg/dl36.529.243.8

g/l0.5280.4220.634Turbidimetric(IFCCCal.)

mg/dl52.842.263.4

g/l0.2850.2280.342Neph.Beckman(IFCCCal.)

mg/dl28.522.834.2

ComplementC3g/l1.281.021.54Turbidimetric(IFCCCal.)

mg/dl128102154

g/l1.341.071.61Nephelometric(IFCCCal.)

mg/dl134107161

g/l1.240.9921.49Nephelometric(NonIFCCCal.)

mg/dl12499.2149

g/l1.331.061.60Turbidimetric(NonIFCCCal.)

mg/dl133106160

ComplementC4g/l0.3300.2640.396Turbidimetric(IFCCCal.)

mg/dl33.026.439.6

g/l0.3500.2800.420Nephelometric(IFCCCal.)

mg/dl35.028.042.0

g/l0.3500.2800.420Nephelometric(NonIFCCCal.)

mg/dl35.028.042.0

g/l0.3200.2560.384Turbidimetric(NonIFCCCal.)

mg/dl32.025.638.4

Ferritinng/ml=μg/l208166250Turbidimetric(IFCCCal.)

ng/ml=μg/l204163245Turbidimetric(NonIFCCCal.)

ng/ml=μg/l204163245Chemiluminescence(IFCCCal.)

ng/ml=μg/l225180270Chemiluminescence(NonIFCCCal.)

ng/ml=μg/l226181271EnzymeImmunoassay(NonIFCCCal.)

ng/ml=μg/l199159239Nephelometric(IFCCCal.)

FreeKappaLightChainsmg/L22.518.027.0Nephelometric(NonIFCCCal.)

mg/L20.516.424.6Nephelometric(IFCCCal.)

FreeLambdaLightmg/L23.318.628.0Nephelometric(NonIFCCCal.)Chains

mg/L22.417.926.9Nephelometric(IFCCCal.)

Haptoglobing/l1.391.111.67Nephelometric(IFCCCal.)

mg/dl139111167

g/l1.411.131.69Turbidimetric(IFCCCal.)

mg/dl141113169

___________________________________________________________________________________________________

RANDOXLaboratoriesLtd.,55DiamondRoad,Crumlin,Co.Antrim,UnitedKingdom,BT294QY

Tel:+44(0)2894422413Fax:+44(0)2894452912

Email:applications@Website:

ABC

LIQUIDASSAYEDSPECIFICPROTEINCONTROLLEVEL2(SPCONTROL2)Cat.No.PS2683Lot.No.165LPCSize3x1mlExpiry2011-08

Range

Analyteunittargetlowhighmethods

Haptoglobing/l1.541.231.85Nephelometric(NonIFCCCal.)

mg/dl154123185

g/l1.471.181.76Turbidimetric(NonIFCCCal.)

mg/dl147118176

ImmunoglobulinAg/l2.351.762.94Turbidimetric(IFCCCal.)

mg/dl235176294

g/l2.451.843.06Nephelometric(IFCCCal.)

mg/dl245184306

g/l2.511.883.14Nephelometric(NonIFCCCal.)

mg/dl251188314

g/l2.311.732.89Turbidimetric(NonIFCCCal.)

mg/dl231173289

g/l2.201.652.75Vitros5.1FSMicrotip(IFCC)

mg/dl220165275

ImmunoglobulinEKIU/l=IU/ml173138208Chemiluminescence(IFCCCal.)

KIU/l=IU/ml172138206Chemiluminescence(NonIFCCCal.)

KIU/l=IU/ml171137205Nephelometric(IFCCCal.)

KIU/l=IU/ml163130196Nephelometric(NonIFCCCal.)

KIU/l=IU/ml170136204EnzymeImmunoassay(IFCCCal.)

KIU/l=IU/ml163130196Turbidimetric(IFCCCal.)

ImmunoglobulinGg/l12.910.615.2Turbidimetric(IFCCCal.)

mg/dl129010601520

g/l13.511.115.9Nephelometric(IFCCCal.)

mg/dl135011101590

g/l13.711.216.2Nephelometric(NonIFCCCal.)

mg/dl137011201620

g/l12.910.615.2Turbidimetric(NonIFCCCal.)

mg/dl129010601520

g/l12.410.214.6Vitros5.1FSMicrotip(IFCC)

mg/dl124010201460

ImmunoglobulinMg/l1.601.281.92Turbidimetric(IFCCCal.)

mg/dl160128192

g/l1.661.331.99Nephelometric(IFCCCal.)

mg/dl166133199

g/l1.641.311.97Nephelometric(NonIFCCCal.)

mg/dl164131197

g/l1.611.291.93Turbidimetric(NonIFCCCal.)

mg/dl161129193

KappaLightChaing/l3.212.573.85Neph.Behring(IFCCCal.)

mg/dl321257385

g/l3.332.664.00Neph.Behring(NonIFCCCal.)

mg/dl333266400

g/l11.89.4414.2Neph.Beckman(IFCCCal.)

mg/dl11809441416

g/l3.222.583.86Turbidimetric(IFCCCal.)

mg/dl322258386

___________________________________________________________________________________________________

RANDOXLaboratoriesLtd.,55DiamondRoad,Crumlin,Co.Antrim,UnitedKingdom,BT294QY

Tel:+44(0)2894422413Fax:+44(0)2894452912

Email:applications@Website:

ABC

LIQUIDASSAYEDSPECIFICPROTEINCONTROLLEVEL2(SPCONTROL2)Cat.No.PS2683Lot.No.165LPCSize3x1mlExpiry2011-08

Range

Analyteunittargetlowhighmethods

LambdaLightChaing/l1.771.422.12Neph.Behring(IFCCCal.)

mg/dl177142212

g/l1.711.372.05Neph.Behring(NonIFCCCal.)

mg/dl171137205

g/l5.374.306.44Neph.Beckman(IFCCCal.)

mg/dl537430644

g/l1.641.311.97Turbidimetric(IFCCCal.)

mg/dl164131197

Prealbuming/l0.3200.2560.384Nephelometric(IFCCCal.