Table 1.

List of available chromogenic substrate assay kits

Factor VIII Kits
NameManufacturerFDA StatusDetection Limitc,e
Biophen FVIII:CaHyphen-BiomedNone (RUO)2%
Coamatic Factor VIIIaChromogenixApproved0.5%
Coatest SP FVIIIbChromogenixApproved1%
Coatest SP4 FVIIIbChromogenixApproved1%
FVIII Chromogenic AssaybSiemens HealthcareApprovedNR
Hemosil Electrachrome FVIIIaInsturmentation LaboratoryNone (RUO)0.5%
Technoclone FVIII:CabTechnocloneNone (RUO)0%
Factor IX Kits
NameManufacturerFDA StatusDetection Limit
Biophen Factor IXaHyphen-BiomedNone (RUO)0.5%
ROX Factor IXaRossixNone (RUO)0.5%

FDA, U.S. Food and Drug Administration; N.R., not reported; RUO, research use only; a High range and low range calibration curves suggested; b Single calibration curve; c Value obtained from reagent package insert; d Value for low range calibration curve listed.