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US 12,761,221 B2Granted
Method for determining lupus anticoagulant in a single coagulation reaction
AssigneeSiemens Healthcare Diagnostics Products GmbH
InventorsNorbert Zander, Carina Gerlach, Michael Timme, Regina Gebauer
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Abstract
The invention is in the field of coagulation diagnostics and relates to a method for detecting lupus anticoagulant.
Claims7
A method for detecting a lupus anticoagulant in a reaction mixture, the method comprising the steps of:
- (i) preparing a reaction mixture by combining a plasma sample of a patient with a lupus anticoagulant-sensitive activated partial thromboplastin time (APTT) reagent, which reagent contains ellagic acid and phospholipids and leads to prolonged coagulation time measurements in lupus anticoagulant-containing samples compared to coagulation time measurements in normal, lupus anticoagulant-free samples in a reaction vessel, and starting the coagulation reaction,
- (ii) continuously measuring a measurement variable S of the reaction mixture over time, resulting in a function S(t) of time-dependent measurement values for the reaction mixture, and
- (iii) determining the coagulation time for the reaction mixture, characterized in that
- a) the maximum reaction velocity vmax and/or the maximum reaction acceleration amax of the function S(t) for the reaction mixture are determined,
- b) the absolute value of the difference between a first measurement value SB at the start of measurement and a second measurement value SE at the end of measurement (|DeltaS|) is ascertained for the reaction mixture, and
- c) a relative maximum reaction velocity vmax rel and/or a relative maximum reaction acceleration amax rel for the reaction mixture are determined using the following formulae:
- v
- max
-
- rel
- =
- v
- max
- /
- |
- Delta
-
- S
- |
- and
-
- a
- max
-
- rel
- =
- a
- max
- /
- |
- Delta
-
- S
- |
- ,
- respectively, and
- (iv) detecting the lupus anticoagulant in the reaction mixture when the coagulation time of the reaction mixture is prolonged compared to a predetermined reference value, and the relative maximum reaction velocity vmax rel value and/or the relative maximum reaction acceleration amax rel value for the reaction mixture are within a predetermined lupus anticoagulant-specific range of value(s) for the reaction mixture.
34 more elements
Dependencies are inferred from the claim text.