发明名称 Measuring range extension of chromatographic quick tests
摘要 <p>#CMT# #/CMT# Quantitative determination of an analyte in a sample comprises: (a) contacting the analyte-specific substance with sample containing the analyte to be detected; (b) measuring the signal and checking whether the signal measured enables a quantitative determination of the analyte with a desired accuracy; and (c) quantitatively determining the analyte on the basis of the signal measured if the desired accuracy is reached. #CMT# : #/CMT# Quantitative determination of an analyte in a sample comprises: (A) providing an analyte-specific substance which is able to undergo a reaction, which generates a detectable signal when it is contacted with an analyte; (B) providing at least two calibration graphs, which have been generated by reacting in each case the same analyte-specific substance with different amounts of in each case the same test analyte for in each case a predetermined reaction time; (C) contacting the analyte-specific substance with sample, which contains the analyte to be detected; (D) measuring the signal at a first predetermined reaction time for which a first calibration graph in (b) is provided; (E) checking whether the signal measured in (d) enables a quantitative determination of the analyte with a desired accuracy; (F) quantitatively determining the analyte on the basis of the signal measured in (d) if the desired accuracy is reached, or measuring the signal at a second predetermined reaction time for which a second calibration graph in (b) is provided; (G) checking whether the signal measured in (f(ii)) enables a quantitative determination of the analyte with a desired accuracy; and (H) quantitatively determining the analyte on the basis of the signal measured in (f(ii)) if the desired accuracy is reached, or continuing the determination of at least one further predetermined reaction time. #CMT#USE : #/CMT# The methods are useful for quantitative determination of an analyte in a sample (claimed). It can be used for determining analytes such as drugs, pregnancy hormones; infectious diseases or cardiac markers. It can be used to identify patients with acute coronary syndrome and for improving the early detection of acute coronary events, for example to improve the early detection of acute myocardial infarction. #CMT#ADVANTAGE : #/CMT# The invention provides a rapid determination of analytes using immunological test strips. The method extends the quantitative measuring range of an analyte in a sample. It enables the upper limit of the measuring range to be increased by more than three-fold compared to the known methods. The methods thus improve the diagnostic competence of the attending physician. #CMT#BIOTECHNOLOGY : #/CMT# Preferred Method: In quantitative determination of an analyte in a sample, the accuracy of the quantitative determination of the analyte is checked using the slope of the calibration graphs. The analyte and the analyte to be determined quantitatively are identical. Two or three calibration graphs are determined. A support is used to provide the analyte-specific substance. Preferably, the support is a test strip. The limits of the measuring range for the analyte to be determined are extended by a factor of 2-5. The limits of the measuring range for the analyte to be determined are extended by a factor greater than 3. The sample is derived from a body fluid selected from blood, plasma, serum, saliva, and/or urine. The method further comprises qualitatively and/or quantitatively determining one or more additional analytes at the same time as the analyte to be determined quantitatively. The analyte is selected from nucleic acids, lipids, carbohydrates, and proteins. It is selected from DNA, RNA, antibodies, antigens, metabolic products, hormones, viruses, microorganisms, cells, cardio specific markers, neurohormonal markets, ischemic markers, or muscle-specific markers. At least one cardiospecific marker selected from troponin T, myoglobin, D-dimer, or NT-proBNP is determined. The analyte specific substance is selected from antibodies, receptors that can bind to the analyte, antigens, lectin, nucleic acids and nucleic acid analogues. The analyte specific substance is coupled to a detection reagent. The reaction between analyte and analyte-specific substance is an immunological reaction. Quantitative determination is carried out by optical methods. The optical method is selected from reflection photometric or fluorimetric detection or electrochemiluminescence. The method proceeds in an automated fashion. Quantitative determination of an analyte in a sample comprises: (A) providing an analyte-specific substance which is able to undergo a reaction which generates a detectable signal when it is contacted with an analyte; (B) providing at least two calibration graphs which have been generated by reacting in each case the same analyte-specific substance with different amounts of in each case the same test analyte for in each case a predetermined reaction time; (C) contacting the analyte-specific substance with a sample which contains the analyte to be detected; (D) measuring a first signal at a first predetermined reaction time for which a first calibration graph in (b) is provided; (E) measuring a second signal at a second predetermined reaction time for which a second calibration graph in (b) is provided; (F) optionally measuring a further signal; (G) checking which of the signals measured in (d), (e), or (f) enables accuracy for the quantitative determination of the analyte; and (H) quantitatively determining the analyte on the basis of the signal which enables an adequate accuracy. #CMT#EXAMPLE : #/CMT# No suitable example given.</p>
申请公布号 EP1909207(B1) 申请公布日期 2015.03.04
申请号 EP20070017673 申请日期 2007.09.10
申请人 F.HOFFMANN-LA ROCHE AG;ROCHE DIAGNOSTICS GMBH 发明人 SPINKE, JÜRGEN;THIELE, MARCEL;SCHÄFFLER, JÜRGEN;NUFER, ANDREAS
分类号 G01N33/543 主分类号 G01N33/543
代理机构 代理人
主权项
地址