Coagulation controls for prothbombin time (pt) and activated...

G - Physics – 01 – N

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G01N 33/86 (2006.01) G01N 33/96 (2006.01)

Patent

CA 2334582

Coagulation control compositions suitable for use in connection with PT and/or APTT assays are disclosed along with their methods of preparation and methods of use. Preferred coagulation controls comprise plasma and an anticoagulant having activity for enhancing the activity of antithrombin III (ATIII) or of heparin co-factor II (HCII) against thrombin or against a clotting factor selected from the group consisting of factors IXa, Xa and XIa. The anticoagulant is preferably a glycosaminoglycan such as heparin, a heparin derivative or a heparin analog. The anticoagulant is preferably combined with (1) an abnormal plasma (e.g. activated plasma or factor-deficient plasma) and/or (2) a primate plasma (e.g. human plasma), and a non-primate mammalian plasma (e.g. bovine plasma). In the latter case, the non-primate mammalian plasma is preferably present in the coagulation control composition in an amount of not more than about 12 % by volume, relative to total volume.

La présente invention concerne, d'une part des compositions de régulation de la coagulation s'utilisant dans le cadre d'essais PT et/ou APTT, et d'autre part les procédés d'élaboration et d'utilisation correspondants. Parmi les régulateurs préférés, on compte notamment le plasma et un anticoagulant doté d'une activité renforçant l'activité de l'antithrombine III (ATIII) ou du cofacteur II de l'héparine (HCII), et ce, par rapport à la thrombine ou à un facteur de coagulation choisi dans le groupe des facteurs IXa, Xa et XIa tels que l'héparine, un dérivé de l'héparine ou un analogue de l'héparine. L'anticoagulant est combiné de préférence avec (1) un plasma anormal tel qu'un plasma activé ou un plasma à déficience de facteurs, et/ou (2) un plasma de primate tel qu'un plasma humain, et un plasma de mammifère non primate, notamment du plasma de bovin. Dans ce dernier cas, le plasma de mammifère non primate est présent de préférence dans la composition de régulation de coagulation dans une proportion volumique n'excédant pas 12 % du volume total.

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