朗道RANDOX 特定蛋白质控-1 靶值单

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LIQUIDASSAYEDSPECIFICPROTEINCONTROL

LEVEL1(SPCONTROL1)

LotNo.164LPCCat.No.PS2682

Level13x1mlExpiry: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°Cifkeptcapped

inoriginalcontainerandfreefromcontamination.Onlytherequiredamountofproductshouldberemoved.After

use,anyresidualproductshouldNOTBERETURNEDtotheoriginalvial.

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

PREPARATION

TheLiquidProteinControlsaresuppliedreadyforuse.

MATERIALSPROVIDED

LiquidProteinControlLevel13x1ml

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

LIQUIDASSAYEDSPECIFICPROTEINCONTROLLEVEL1(SPCONTROL1)Cat.No.PS2682Lot.No.164LPCSize3x1mlExpiry2011-08

Range

Analyteunittargetlowhighmethods

Albuming/l13.611.615.6Vitros(IFCCCal.)

g/dl1.361.161.56

g/lBromocresolGreen(IFCCCal.)

g/dl1.911.622.20

g/lBromocresolPurple(IFCCCal.)

g/dl1.911.622.20

g/l18.415.621.2Nephelometric(IFCCCal.)

g/dl1.841.562.12

g/l19.616.722.5BromocresolGreen(NonIFCCCal.)

g/dl1.961.672.25

g/l18.715.921.5BromocresolPurple(NonIFCCCal.)

g/dl1.871.592.15

g/l20.017.023.0TurbidimetricAssays(IFCCCal.)

g/dl2.001.702.30

Alpha-1-Acid

Glycoprotein

g/l0.4230.3380.508Turbidimetric(IFCCCal.)

mg/dl42.333.850.8

g/l0.4800.3840.576Nephelometric(IFCCCal.)

mg/dl48.038.457.6

Alpha-1-Antitrypsing/l0.8200.6560.984Turbidimetric(IFCCCal.)

mg/dl82.065.698.4

g/l0.8500.6801.02Nephelometric(IFCCCal.)

mg/dl85.068.0102

g/l0.8300.6640.996Nephelometric(NonIFCCCal.)

mg/dl83.066.4100

g/l0.8200.6560.984Turbidimetric(NonIFCCCal.)

mg/dl82.065.698.4

Alpha-2-Macroglobuling/l1.080.8641.30Nephelometric(IFCCCal.)

mg/dl10886.4130

AlphafoetoproteinKIU/l=lU/ml14.411.517.3Chemiluminescence(IFCCCal.)

ng/ml17.413.920.9

KIU/l=lU/ml14.311.417.2Chemiluminescence(NonIFCCCal.)

ng/ml17.313.820.8

KIU/l=lU/ml14.511.617.4EnzymeImmunoassay(NonIFCCCal.)

ng/ml17.514.021.0

AntiStreptolysinOIU/ml171128214Turbidimetric(IFCCCal.)

IU/ml96.972.7121Neph.Beckman(IFCCCal.)

IU/ml94.570.9118Neph.Beckman(NonIFCCCal.)

IU/ml171128214Neph.Behring(IFCCCal.)

IU/ml176132220Neph.Behring(NonIFCCCal.)

AntithrombinIIImg/l13299.0165Nephelometric(NonIFCCCal.)

mg/dl13.29.9016.5

Beta-2-microglobulinµg/ml=mg/l1.331.061.60EnzymeImmunoassay(IFCCCal.)

___________________________________________________________________________________________________

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

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

Email:applications@Website:

ABC

LIQUIDASSAYEDSPECIFICPROTEINCONTROLLEVEL1(SPCONTROL1)Cat.No.PS2682Lot.No.164LPCSize3x1mlExpiry2011-08

Range

Analyteunittargetlowhighmethods

Beta-2-microglobulinµg/ml=mg/l1.821.462.18Nephelometric(IFCCCal.)

µg/ml=mg/l1.801.442.16Nephelometric(NonIFCCCal.)

µg/ml=mg/l1.671.342.00Turbidimetric(IFCCCal.)

C-ReactiveProteinmg/l31.225.037.4Vitros(IFCCCal.)

mg/l22.918.327.5Turbidimetric(IFCCCal.)

mg/l20.816.625.0Nephelometric(IFCCCal.)

mg/l21.417.125.7Nephelometric(NonIFCCCal.)

mg/l22.417.926.9Turbidimetric(NonIFCCCal.)

Caeruloplasming/l0.1580.1260.190Nephelometric(IFCCCal.)

mg/dl15.812.619.0

g/l0.2360.1890.283Turbidimetric(IFCCCal.)

mg/dl23.618.928.3

g/l0.1370.1100.164Neph.Beckman(IFCCCal.)

mg/dl13.711.016.4

ComplementC3g/l0.6500.5200.780Turbidimetric(IFCCCal.)

mg/dl65.052.078.0

g/l0.6500.5200.780Nephelometric(IFCCCal.)

mg/dl65.052.078.0

g/l0.6600.5280.792Nephelometric(NonIFCCCal.)

mg/dl66.052.879.2

g/l0.6700.5360.804Turbidimetric(NonIFCCCal.)

mg/dl67.053.680.4

ComplementC4g/l0.1700.1360.204Turbidimetric(IFCCCal.)

mg/dl17.013.620.4

g/l0.1800.1440.216Nephelometric(IFCCCal.)

mg/dl18.014.421.6

g/l0.1800.1440.216Nephelometric(NonIFCCCal.)

mg/dl18.014.421.6

g/l0.1600.1280.192Turbidimetric(NonIFCCCal.)

mg/dl16.012.819.2

Ferritinng/ml=µg/l10987.2131Turbidimetric(IFCCCal.)

ng/ml=µg/l10281.6122Turbidimetric(NonIFCCCal.)

ng/ml=µg/l10785.6128Chemiluminescence(IFCCCal.)

ng/ml=µg/l11390.4136Chemiluminescence(NonIFCCCal.)

ng/ml=µg/l11592.0138EnzymeImmunoassay(NonIFCCCal.)

ng/ml=µg/l10584.0126Nephelometric(IFCCCal.)

FreeKappaLightChainsmg/L13.410.716.1Nephelometric(NonIFCCCal.)

mg/L13.911.116.7Nephelometric(IFCCCal.)

FreeLambdaLightmg/L12.39.8414.8Nephelometric(NonIFCCCal.)Chains

mg/L11.28.9613.4Nephelometric(IFCCCal.)

Haptoglobing/l0.7000.5600.840Nephelometric(IFCCCal.)

mg/dl70.056.084.0

g/l0.7200.5760.864Turbidimetric(IFCCCal.)

mg/dl72.057.686.4

g/l0.7200.5760.864Nephelometric(NonIFCCCal.)

mg/dl72.057.686.4

___________________________________________________________________________________________________

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

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

Email:applications@Website:

ABC

LIQUIDASSAYEDSPECIFICPROTEINCONTROLLEVEL1(SPCONTROL1)Cat.No.PS2682Lot.No.164LPCSize3x1mlExpiry2011-08

Range

Analyteunittargetlowhighmethods

Haptoglobing/l0.7300.5840.876Turbidimetric(NonIFCCCal.)

mg/dl73.058.487.6

ImmunoglobulinAg/l1.170.8781.46Turbidimetric(IFCCCal.)

mg/dl11787.8146

g/l1.220.9151.53Nephelometric(IFCCCal.)

mg/dl12291.5153

g/l1.220.9151.53Nephelometric(NonIFCCCal.)

mg/dl12291.5153

g/l1.160.8701.45Turbidimetric(NonIFCCCal.)

mg/dl11687.0145

ImmunoglobulinEKIU/l=IU/ml87.369.8105Chemiluminescence(IFCCCal.)

KIU/l=IU/ml83.666.9100Chemiluminescence(NonIFCCCal.)

KIU/l=IU/ml87.970.3105Nephelometric(IFCCCal.)

KIU/l=IU/ml82.465.998.9Nephelometric(NonIFCCCal.)

KIU/l=IU/ml78.462.794.1EnzymeImmunoassay(IFCCCal.)

KIU/l=IU/ml80.464.396.5Turbidimetric(IFCCCal.)

ImmunoglobulinGg/l6.535.357.71Turbidimetric(IFCCCal.)

mg/dl653535771

g/l6.785.568.00Nephelometric(IFCCCal.)

mg/dl678556800

g/l6.905.668.14Nephelometric(NonIFCCCal.)

mg/dl690566814

g/l6.345.207.48Turbidimetric(NonIFCCCal.)

mg/dl634520748

ImmunoglobulinMg/l0.8200.6560.984Turbidimetric(IFCCCal.)

mg/dl82.065.698.4

g/l0.8300.6640.996Nephelometric(IFCCCal.)

mg/dl83.066.4100

g/l0.8200.6560.984Nephelometric(NonIFCCCal.)

mg/dl82.065.698.4

g/l0.8300.6640.996Turbidimetric(NonIFCCCal.)

mg/dl83.066.4100

KappaLightChaing/l1.711.372.05Neph.Behring(IFCCCal.)

mg/dl171137205

g/l1.731.382.08Neph.Behring(NonIFCCCal.)

mg/dl173138208

g/l5.934.747.12Neph.Beckman(IFCCCal.)

mg/dl593474712

g/l1.681.342.02Turbidimetric(IFCCCal.)

mg/dl168134202

LambdaLightChaing/l0.8900.7121.07Neph.Behring(IFCCCal.)

mg/dl89.071.2107

g/l0.8900.7121.07Neph.Behring(NonIFCCCal.)

mg/dl89.071.2107

g/l2.792.233.35Neph.Beckman(IFCCCal.)

mg/dl279223335

___________________________________________________________________________________________________

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

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

Email:applications@Website:

ABC

LIQUIDASSAYEDSPECIFICPROTEINCONTROLLEVEL1(SPCONTROL1)Cat.No.PS2682Lot.No.164LPCSize3x1mlExpiry2011-08

Range

Analyteunittargetlowhighmethods

LambdaLightChaing/l0.7900.6320.948Turbidimetric(IFCCCal.)

mg/dl79.063.294.8

Prealbuming/l0.1600.1120.208Nephelometric(IFCCCal.)

mg/dl16.011.220.8

g/l0.1600.1120.208Turbidimetric(IFCCCal.)

mg/dl