Berichrom F XIII Assay
A fully automated, WHO-standardized, convenient method for patient results within 13 minutes.
Berichrom® F XIII assay1 is an automated in vitro diagnostic reagent for the quantitative, WHO-standardized determination of factor XIII (FXIII) activity as aid to diagnosis and monitoring of congenital or acquired FXIII deficiencies in patients at risk for or suspected to have FXIII deficiency. It can be used as a functional activity assay in the first-line screening of the diagnostic algorithm of FXIII testing.2,3 In addition, Berichrom F XIII assay1 can be used for monitoring FXIII substitution therapy.
Benefits
- Recommended quantitative and true kinetic first-line screening assay with good reproducibility to help reduce misdiagnosis.
- Measuring range of 5.5–150% of norm helps reduce number of undiagnosed patients.
- This fully automated, one-step assay gives results within 13 minutes.
- Assay is standardized against WHO.
- Recommended quantitative and true kinetic first-line screening assay with good reproducibility to help reduce misdiagnosis.
- Measuring range of 5.5–150% of norm helps reduce number of undiagnosed patients.
Berichrom F XIII kit components
Berichrom F XIII assay1 consists of three components that can be ordered as a kit.
Activator Reagent: Thrombin, calcium chloride, and clot-inhibitor
Activator Diluent: NADH
Detection Reagent:
- Glutamate dehydrogenase (GLDH)
- Synthetic peptide (FXIIIa substrate)
- Glycine-ethylesterhydrochloride
- α-ketoglutarate
Technical Details
Required sample volume
20 µl on CS-2500 and CS-5100 Systems and CN-3000 and CN-6000 Systems
Onboard stability
96 hours on CS-2500 and CS-5100 Systems, 100 hours on CN-3000 and CN-6000 Systems
Within-device/lab CV
2.9% Control Plasma N on CS-2500 and CS-5100 Systems
2.5% Control Plasma N on CN-3000 and CN-6000 Systems
Measuring range
5.5–150% of norm
Tests per kit
200
Evidence
Clinical use and diagnostic algorithm
Diagnosis of FXIII deficiency is challenging and may require a variety of approaches. Normal routine parameters are not prolonged in screening tests and, depending on geographical or laboratory availability, advanced laboratory techniques might not be available.
One crucial step in the clinical algorithm is the use of a quantitative functional FXIII activity assay, such as Berichrom F XIII assay1, as a first-line screening test.
FXIII concentrate monitoring
Several studies have demonstrated that treatment with FXIII concentrates is an effective prophylactic, on-demand treatment for congenital and acquired FXIII deficiency, reducing the incidence of both spontaneous and postoperative bleeding.4 Because the concentrate dosage should be based on certain plasma levels, concentrate manufacturers recommend monitoring of FXIII concentration.5
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