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BioMedica ACTICHROME - Heparin (Anti-FIIa) Activity Assay
ACTICHROME Heparin (Anti-FIIa) is an in vitro diagnostic three-stage assay. It begins with plasmas containing heparin interacting with human antithrombin III to form a heparin-ATIII complex. In the second stage, thrombin is added, which the complex inhibits. The third stage involves the residual thrombin activity hydrolyzing SPECTROZYME TH, a chromogenic substrate. This design ensures that the measured thrombin activity is inversely proportional to the plasma heparin concentration. The assay uses bovine thrombin and a specific human antithrombin III reagent, making it a suitable choice for evaluating thrombin inhibition in clinical anticoagulation settings. It is noted for its compliance with CE Marking, FDA 510(K) clearance, and Health Canada registration standards.
ACTICHROME® Heparin (Anti-FIIa) is an amidolytic chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma via the measurement of Factor IIa (thrombin) activity. The inhibitory effect of antithrombin III (ATIII) on Factor IIa (thrombin), Factor Xa, and other coagulation serine proteases in plasma is increased several thousand-fold by heparin. This inhibition accounts for the anticoagulant effect of heparin. Assaying plasma heparin levels by the measurement of their Anti-Factor IIa activity is a necessary tool for monitoring the efficacy of heparin treatment efficacy. Low molecular weight heparin (LMWH) preparations appear to catalyze the reaction between thrombin (FIIa) and AT-III less readily than the reaction between Factor Xa and AT-III. Unfractionated heparin (UFH) catalyzes both reactions equally.
ACTICHROME Heparin (Anti-FIIa) is a three stage assay. First, plasmas containing heparin incubate with human antithrombin III forming a heparin- ATIII complex. Second, thrombin is added which is inhibited by the heparin-ATIII complex. Last, the residual thrombin activity hydrolyzes SPECTROZYME® TH, a thrombin specific chromogenic substrate. As both thrombin and antithrombin III are in excess, the residual thrombin activity measured is inversely proportional to the heparin concentration in the plasma.
- 6 Vials of Bovine Thrombin Reagent, 2 mL (lyophilized)
- 6 Vials of Human Antithrombin III Reagent, 5 mL (lyophilized)
- 6 Vials of SPECTROZYME® TH, 2 mL (lyophilized)
- SAMPLES : Citrate collected plasma
- SAMPLE PREPARATION : 1:16 dilution in Human Anti- Thrombin III Reagent
- SAMPLE VOLUME : 25 μL of diluted plasma
- TOTAL ASSAY TIME : 10 minutes
- STANDARD RANGE : 0 – 0.6 Units/mL
- LOWER LIMIT OF DETECTION : N.D.
- PRECISION : Intra-assay CV < 10.8%
- Inter-assay CV < 9.6%
- NUMBER OF TESTS : 120