Method for performing activated clotting time test with reduced sensitivity to the presence of aprotinin and for assessing aprotinin sensitivity
AssigneeSienco, Inc.
InventorsJennifer C. Aiken, Jon H. Henderson, Barbara A. DeBiase
Life of this patent
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Abstract
A coagulation test for determining the activated clotting time (ACT) of blood in the presence of heparin that produces test results that are substantially insensitive to the drug aprotinin. The activator is formulated to be a combination of celite and bentonite. The ACT results obtained with this formulation are similar to celite ACT tests on heparinized blood while simultaneously being unaffected by aprotinin. Additionally, a method for quantifying the aprotinin effect of different ACT formulations is disclosed.
Claims11
An in vitro diagnostic process for measuring blood coagulation, the process comprising the steps of:
- providing a test container for holding a blood sample, wherein said blood sample contains heparin and aprotinin therein;
- adding a reagent for contact activation to said blood sample, the reagent containing a contact activator selected from the group of clay minerals consisting of bentonite, illite, shale, montmorillonite, rectorite, and dickite, and measuring the coagulation of the blood sample, wherein said reagent serves to reduce the sensitivity and variability of the process to aprotinin in said heparinized blood sample.
An in vitro diagnostic process for measuring blood coagulation, the process comprising the steps of:
- providing a test container for holding a blood sample, wherein said blood sample contains heparin and aprotinin therein;
- adding said blood sample to said test container;
- adding one or more additive reagents for contact activation to said blood sample;
- adding a further additive reagent to said blood sample and measuring the coagulation of the blood sample, wherein said further additive reagent serves to reduce the sensitivity and variability of the process to aprotinin in said heparinized blood sample.
A method for characterizing the undesired affect of aprotinin on an activated clotting time in vitro diagnostic test, the method comprising the steps of:
- (a) performing an activated clotting time test on a sample of blood containing heparin;
- (b) performing an activated clotting time test on a sample of blood containing both heparin and aprotinin;
- and
- (c) computing a quantified sensitivity of the activated clotting time to the aprotinin from the results of the tests performed in previous steps (a) and (b).
Dependencies are inferred from the claim text.