Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1995-02-17
1997-06-17
Housel, James C.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 794, 4241391, 4241581, G01N 3353
Patent
active
056396171
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a method for sepsis diagnosis, in particular to early detection and detection of the severity of a sepsis as well as for a treatment-accompanying survey of the therapeutical success of a sepsis treatment which is based on the new knowledge that a certain peptide known per se and possibly certain of its fragments represent reliable biological markers for diseases of this kind appearing in high concentrations and which may be determined relatively simple according to classical detection measures.
According to a more modern understanding of this disease, the term "sepsis" as used in the present application summarizes clinical pictures, for which, as a rule, fever, leucocytosis, consciousness changes, a hyperdynamic circulation ("warm shock"), and a hyper-metabolic status, mainly as a consequence of the invasion of the normally sterile tissue by microorganisms, are observed, whereas the positive detection of germs in the blood, which was previously understood to be a characteristic for a sepsis, has become less important for the diagnosis "sepsis". For in clinical studies it could be shown that the prognosis of patients with sepsis is not dependent on the severity of an infection, in particular a bacterial infection, but on the severity of the septic reaction of the organism (see G. Pilz, S. Fateh-Moghadam and K. Werdan in: Krankenpflege-Journal 29 (1991), pp. 483-492 and publications cited therein). Accordingly, in addition to the positive blood culture or instead of it, for a sepsis assessment at present various laboratory parameters and hemodynamic parameters are determined and taken into account for making a diagnosis and assess the course of the disease, if necessary, using computer-aided so-called Score systems, such as the APACHE (Acute Physiology and Chronic Health Evaluation) II Score described in the above-indicated publication. However, so far no individual parameter suitable as a reliable biological marker is known, the determination of which is highly expressive for a sepsis diagnosis. All parameters used up to now have either an insufficient specificity or do not allow a reliable assessment of the severity of a sepsis and no therapy survey and, in addition to this, the determination of substances, such as the tumor necrosis factor (TNF), or interleukines, such as interleukin 6 (IL-6), is much too complicated, expensive and/or time-consuming for a bedside determination.
Therefore, there is still an urgent need of a reliable biological marker which can be determined relatively easy and the qualitative and particularly quantitative determination of which is highly indicative for making a diagnosis and assessing the progression of a sepsis.
It is the object of the present invention to provide a method for early detection and for detection of the severity of a sepsis wherein a new biological marker is determined in a way which is also practicable under clinical conditions, the determination of which gives highly relevant results for making a diagnosis and assessing the progression of a sepsis.
This object has been achieved by a method and means according to the claims. The invention is based on the surprising finding that the peptide procalcitonin known per se and, if necessary, certain of its higher molecular cleavage products, represent highly relevant biological markers for sepsis and that their concentrations in samples of biological liquids of patients allow highly relevant conclusions on the severity of a septic disease and, thus, represent valuable parameters for the progression assessment and therapy survey of a sepsis.
Therefore, the possibility of a sepsis diagnosis by determination of the peptide procalcitonin is of a great practical interest, since other known possible biological markers appearing in the case of sepsis, such as certain cytokines (interleukines, TNF) represent unstable molecules which normally are present only in very small concentrations, so that their determination is much too complicated, time-consuming and thus expensive for a routine bedside di
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B.R.A.H.M.S. Diagnostica GmbH
Housel James C.
Portner Ginny Allen
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