The Technochrom FVIII:C 2G is an in vitro diagnostic reagent kit for the quantitative, WHO standardized determination of coagulation factor VIII (FVIII) activity as an aid to diagnosis and monitoring of congenital or acquired FVIII deficiencies in patients with bleeding disorders, those at risk of FVIII deficiency, and for elevated levels in patients, by means of automated or manual chromogenic methods. In addition, the chromogenic FVIII assay can be used for monitoring FVIII substitution therapy. Technochrom FVIII:C can be used to assay FVIII in the presence of emicizumab.

Test principle

Technochrom FVIII:C 2G is a two-stage chromogenic assay of FVIII cofactor activity.4 In the first stage, diluted plasma containing the FVIII to be measured is activated with thrombin, whereupon it is reacted with exogenous FIXa, FX, phospholipids, and Ca2+, to form the tenase assembly. The product of tenase is activated FX (FXa), the amount generated being proportional to the FVIII level. In the second stage, FXa cleaves the chromogenic substrate to release a colored product, para-nitroaniline, the intensity of which is proportional to the FXa, and hence, proportional to the FVIII cofactor activity. Absorbance is measured at 405 nm.

Reagents and stability (reconstituted)

Unopened reagents are stable until the stated expiration date indicated on the label at 2-8 °C. Do not freeze!

Store reagents upright in their packaging.