Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1996-07-09
1998-09-29
Fitzgerald, David L.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
435 793, 435 794, 435 792, 435 795, 436517, 436518, G01N 3353, G01N 33536, G01N 33543, G01N 33566
Patent
active
058144617
DESCRIPTION:
BRIEF SUMMARY
The invention relates to a method for the determination of an analyte in a volume of a fluid sample and its use for the determination of anti-TSH receptor autoantibodies in a patient serum.
An "analyte" in the meaning of the statements relating to the present invention is primarily a biologically active substance, the presence and/or amount of which in a naturally fluid biological sample or in a biological sample converted into fluid form by an appropriate pretreatment are to be determined. In the meaning of the present invention, analytes are therefore primarily substances having hapten or antigen properties, such as hormones, peptide hormones, physiologically active peptides and proteins, the latter also comprising proteins having immunoglobulin character, that is to say antibodies or autoantibodies. The biological samples are primarily blood samples or other fluid blood fractions, such as, in particular, serum samples or plasma samples, but the sample may in principle also be another biological fluid, such as saliva or urine, or solubilized tissue extracts. However, the invention is not restricted to the determination of biologically active substances of natural origin but also includes the determination of medicaments and their metabolites in biological fluids and can also be used for the determination of any other substances in any fluids if the use of the relatively expensive method according to the present invention is useful for the determination of such analytes and the binding partners and reactants required in such a case for carrying out the method according to the invention can be found. However, the present invention is particularly important for the determination of biologically active substances, in particular of substances of a protein nature, in biological fluids, and in turn for the determination of those analytes which are difficult to determine in another manner known per se. Where the determination method according to the invention is described below primarily with reference to certain types of analytes or even with reference to certain analytes, this is not to be interpreted to imply a restriction of the method according to the invention to such analytes.
While a wide range of chemical and/or physical methods of determination are available for simple chemical substances of inorganic or organic nature, biologically active analytes, in particular naturally occurring biological molecules having certain physiological functions, must, as a rule, be determined by so-called immunodiagnostic methods since, owing to their nature and/or the amount in which they occur, other methods of determination cannot be used or, for example, are too expensive for clinical practice.
It may be assumed that such immunological methods of determination are in principle known. The known methods can be assigned to various types, depending on the reaction type, the substance to be determined or the detection method to be used. Thus, some of the methods can be assigned to so-called competitive determinations, which include the classical radioimmunoassay (RIA) and which, depending on the label, the type of molecule to be determined and the determination in homogeneous or heterogeneous phase, can in turn be assigned to various subtypes. Regarding the basic method for the determination of antigens and antibodies by competitive methods, reference may be made, for example, to the top of column 3 of US-B1-3654090. In this method, a known amount of a competitor and less than the required amount of a specific binder are added to the sample to be investigated, as a rule one of the components, competitor or binder, being present in labelled form and the other in immobilized form, and the desired amount of the analyte is determined from the amount of the label bound to the solid phase. In this method, it is thus necessary for at least one of the components, binder or competitor, to be capable of being immobilized and the other to be capable of being labelled, the possibility of subsequent indirect labelling also being suffic
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Bergmann Andreas
Kornfeld Shaul
Struck Joachim
B.R.A.H.M.S. Diagnostica GmbH
Fitzgerald David L.
Pak Michael
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