Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving fixed or stabilized – nonliving microorganism,...
Patent
1997-08-11
2000-12-05
Saucier, Sandra E.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving fixed or stabilized, nonliving microorganism,...
435 13, A61K 944, C12Q 156
Patent
active
06156530&
DESCRIPTION:
BRIEF SUMMARY
FIELD OF INVENTION
The present invention pertains, in general, to the field of haemostasis or to the study of the haemostatic system of mammals, in particular humans. More specifically, it pertains to a new, simple and thereby clinically useful analytical method which allows evaluation of either coagulative or fibrinolytic activity or even total haemostatic activity in a biological fluid. Primarily, this means analysis, in a simple yet reproducible and reliable manner, of blood or blood plasma in order to detect haemophilia and/or thrombophilia. The technique according to the invention is based on contact between the biological fluid and a reagent which effects the coagulative process, after which coagulated material is detected according to prior art principles. The novelty in relation to the invention is the utilization of a reagent that highly resembles the factors that in vivo effect coagulation in a mammalian individual, which gives better possibilities than the prior art to obtain a total picture of the haemostatic activity.
The invention also pertains to a kit for performing this method.
BACKGROUND OF THE INVENTION
Circulatory disturbances can lead to illness with bleedings or thrombi, clinical conditions which are denoted haemophilia or thrombophilia, respectively. Such disturbances may result from perturbations in the ability of the blood to coagulate or to dissolve coagulated material or from perturbations of the balance between these. Coagulum formation and coagulum dissolution are both precisely regulated processes, both of which can be regarded as composed of a driving and a restraining part. The coagulum-forming process is called coagulation and is hence a balance between pro-coagulative and anti-coagulative activities. Analogously, the coagulum dissolving process is called fibrinolysis and displays a pro-fibrinolytic and an anti-fibrinolytic part. The balance between coagulation and fibrinolysis is denoted haemostasis, which thus comprises all processes that prevent leakage of blood from the circulatory tract and which keep these open. The two concepts circulatory disturbances and haemostatic disturbances are in this context practically synonymous.
The understanding of haemophilia and the development of effective treatments for this condition has been strongly dependent on simple global functional laboratory methods, which have revealed altered coagulative properties of blood and blood plasma from the individuals in question. The principle of these methods is to add, to blood or blood plasma, reagents that trigger coagulation, and to register the reaction time necessary for a certain coagulum formation. Abnormally slow or weak coagulum formation has been characteristic of haemophilia, and medical treatments which have normalized the analytically determined values have proved to be effective in the alleviation of the clinical symptoms of the disease.
According to the above described view on hemostasis, the outlined prior art global functional laboratory methods for the characterizaton of coagulative activity are primarily sensitive to pro-coagulative disturbances. The methods have, however, appeared to be fairly satisfactory for the diagnosis of haemophilia because the haemostatic disturbances involved are often localized precisely to the pro-coagulative part of haemostasis. However, the prior art global methods cannot reveal disturbances in all haemophiliacs, and they are practically of no use for thrombophilia. This may be due to the fact that the methods do not give any indication, or only slight indication, of disturbances in the anti-coagulative part of the coagulation process, and that they lack sensitivity to fibrinolytic disturbances. The lack of or the need of a more comprehensive method, useful in practice, for analyzing or detecting coagulative, fibrinolytic and haemostatic properties of blood and blood plasma, is therefore obvious. A simple and especially a more reliable method relating to global haemostasis would doubtless result in improved diagnostics, improved treatment an
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Global Hemostasis Institute MGR AB
Saucier Sandra E.
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