**End-user must supply Sodium Barbital (C8H11N2NaO3)
FIB Clauss Reagent
Catalog No.: DCP-FIB
Size:
75 mL
Sterile: Filtered 0.1-micron membrane TWICE, 0.04-micron membrane TWICE
Storage: -20°C
Shelf Life: ≤ 15 days at 2-8°C after thaw
*Use before the expiry date given on the product label.
Description:
A reagent fully compatible (not exclusive) with the Blood Coagulation Analyzer (Catalog No.: DCBio-SACA)
[Link]
A precision-standardized, lyophilized or liquid-stable coagulation reagent containing a high concentration of purified bovine or human thrombin (typically 100–150 NIH units/mL upon reconstitution), formulated for the quantitative determination of fibrinogen (Factor I) in human citrated plasma using the gold-standard Clauss clotting method.
When added to a 1:10 dilution of patient platelet-poor plasma in isotonic buffer (imidazole, pH 7.35, or Owren's Veronal Buffer), the supraphysiological thrombin concentration saturates all available fibrinogen molecules, converting them to fibrin at a rate determined solely by fibrinogen concentration. The resulting clotting time is inversely proportional to the fibrinogen level and is quantified by interpolation from a calibration curve constructed with a certified fibrinogen reference plasma. Results are reported in g/L (SI) or mg/dL. Because plasma is diluted 1:10 and thrombin is added in excess, the assay is highly tolerant of therapeutic heparin concentrations and fibrin degradation products (FDPs), making it the reference method of choice even in critically ill patients on anticoagulation therapy.
Why the Clauss Method Is the Reference Standard?
The Clauss method is universally endorsed as the reference fibrinogen assay by ISTH, CLSI, and the WHO. Three properties drive this primacy:
- Functional specificity: The assay measures only fibrinogen that is both present and capable of being converted to fibrin by thrombin — it specifically detects dysfibrinogenemia (abnormal fibrinogen polymerization kinetics produce prolonged clotting times despite normal immunologic fibrinogen mass)
- Heparin and FDP tolerance: The 1:10 plasma dilution dilutes heparin and FDPs 10-fold. Combined with the supraphysiological thrombin excess, therapeutic concentrations of UFH (up to 2.0 IU/mL) and LMWH (up to 0.4–1.0 anti-Xa IU/mL) do not significantly interfere with results. At fibrinogen levels below 150 mg/dL, high FDP concentrations (> 100 µg/mL) can begin to prolong clotting times, causing false-low results — this is an important limitation in severe consumptive coagulopathy.
- Independence from all upstream pathway factors: Because exogenous thrombin is added directly (bypassing the intrinsic, extrinsic, and common pathway entirely), the result is affected only by fibrinogen quality and quantity — not by deficiencies in Factors II, V, VII, VIII, IX, X, XI, or XII
* All DiagnoCine Precision Sterile filtered-sterilized with 40 nanometer. Thus, mycoplasma contamination is prevented. The smallest size mycoplasma type can be about 0.2 microns.
* This product is manufactured under ISO 13485-certified and CE-approved facilities (Suppliers of DiagnoCine Precision). All final packaging, quality assurance, and testing are done at the DiagnoCine R&D and Quality Testing Center. All specific customization requests and assembly were accomplished at DiagnoCine Precision in Totowa, New Jersey, USA
