Description:
Technochrom®anti-Xa isasystemofreagentsforthechromogenicdeterminationof directandindirectXainhibitorsinhumancitratedplasma.Theassayisbasedontheinhibition ofactivatedfactorX(FXa)byAntithrombin(AT)inthepresenceofheparinasmeasuredbya chromogenicFXasubstrate.
KitComposition:
- Reagent1(R1): 1x20ml,anti-Xabuffer,TRIS-EDTAbuffer;pH8.4;containssodiumazide (<1g/l)asapreservative
- Reagent2(R2): 1x4ml,BovineFactorXa,lyophilized;1vial;about24nkat
- Reagent3(R3): 1x4ml,Chromogenicsubstrate,lyophilized;1vial;4.8mg
MATERIALREQUIRED(notprovidedwiththekit)
- Distilledwater
- Aceticacid(20%)or2%citricacid(endpointmethod)
- PlasmaCalibratorswithaknownconcentrationof:
- Fondaparinux(Technoview®Arixtra®CalibratorSet)(catalog#5090010)
- Technoview®LMWHeparinCalibratorSet (catalog# 5090040)
- Technoview®UF HeparinCalibratorSet (catalog#5090070)
- Technoview®RivaroxabanCalibratorSet (catalog#5090170)
- Technoview®Apixaban CalibratorSet(catalog#5090269)
- Controlplasmasfor:
- Fondaparinux(Technoview®Arixtra®Controls)(catalog#5090012,5090014)
- Technoview®LMWHeparinControls(catalog#5090042, 5090044,5090046)
- Technoview®UFHeparin Controls(catalog#5090072,5090074)
- Technoview®RivaroxabanControls(catalog#5090172,5090173,5090174)
- Technoview®ApixabanControls(catalog#5090270, 5090271)
- Commonclinicallaboratoryequipment(spectrophotometersetat405nm,water-bathsetat37°C, stop-watch,testtubes,Pipettes,…)
MeasurementPrinciple:
| [Xa-Inhibitor]+Xa(excess) | → | [Xa-Inhibitor–Xa]+Xa(residual) |
| Xa(residual)+substrate | → | pNA |
TheamountofpNA,releasedbyenzymatichydrolysis,ismeasuredat405nm.Thereisan inverserelationshipbetweentheamountofheparinpresentinthesampleandcolor development.
PerformanceandPrecision:
CalibrationCurve
- ForFondaparinux(Arixtra®)research,acalibrationcurveisconstructedusingTechnoview Arixtra®CAL(catalog#5090010)
- ForLMWHeparinresearch,acalibrationcurveisconstructedusingTechnoview®LMWCAL(catalog#5090040)
- ForUFHresearch,acalibrationcurveisconstructedusingTechnoview®UFHCAL(catalog#5090070)
- ForRivaroxabanresearch,acalibrationcurveisconstructedusingTechnoview®Rivaroxaban CAL(catalog#5090170)
Ceveron®alpha
TechnocloneprovidesapplicationsheetsforCeveron®alpha.Theapplicationsheetscontainanalyzer/assayspecifichandlingandperformanceinformationwhichmaydifferfromthatprovidedinthisinstructionforuse.Inthiscasetheinformationcontainedintheapplicationsheetssupersedestheinformationinthisinstructionforuse.PleaseconsulttheinstructionmanualoftheCeveron®alpha.
Precision
Reproducibilitywasdeterminedwithdifferentsamples(inseriesanddaytoday).Thefollowingresultswereobtained:
| Intraassay | Intraassay | ||||
| CV% | N | CV% | N | ||
| LMWlevel1(1.37u/ml) | 1.6% | 24 | LMWlevel1(1.36u/ml) | 1.5% | 6 |
| LMWlevel2(0.52u/ml) | 2.5% | 24 | LMWlevel2(0.37u/ml) | 2.5% | 6 |
| UFHlevel1(1.26u/ml) | 0.7% | 24 | UFHlevel1(1.45u/ml) | 2.6% | 6 |
| UFHlevel2(0.42u/ml) | 2.1% | 24 | UFHlevel2(0.06u/ml) | 5.7% | 6 |
