Detection of bacterial infections in subjects suffering from dyspnea
AssigneeB.R.A.H.M.S GmbH
InventorsAndreas Bergmann, Oliver Hartmann
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Abstract
The field of the present invention is the diagnosis and/or prediction and/or therapy follow-up of bacterial infections in subjects suffering from dyspnea. It is a subject of the present invention to provide a method for the diagnosis and/or prediction and/or therapy follow-up of bacterial infections in subjects suffering from dyspnea.
Claims17
An in vitro method for determining that a subject having dyspnea has a bacterial infection, for determining the prognosis of a subject suffering from dyspnea caused by a bacterial infection, and/or for determining follow-up prognosis of the progression of a bacterial infection in a subject having dyspnea, comprising detecting and quantitating, in a biological fluid sample from said patient, marker analytes selected from
- a) neopterin as a first marker, and
- b) at least one second marker selected from
- i) a cytokine,
- ii) a cardiovascular marker,
- iii) a neurohumoral marker,
- iv) a precursor of said second marker,
- v) a fragment of said second marker, and
- vi) a fragment of a precursor of said second marker,
- wherein said detection and quantitation comprises contacting said sample with a diagnostic assay capture molecule which binds to the marker analyte, and detecting and quantitating the capture molecule:analyte complex, thereby determining the amount of the analyte in the sample;
- wherein if the sample contains at least the minimum cutoff value for neopterin of >10 nmol/l, and the sample contains at least a marker-specific minimum cutoff value for a second marker, the subject having dyspnea is determined to have a bacterial infection, the prognosis for the subject having a bacterial infection is determined by the amount the level of the marker is over the cutoff value, and/or if the subject having dyspnea has had a prior sample subjected to said diagnostic assays, prognosis of the progression of a bacterial infection is determined by comparison of the values of the follow up diagnostic assays with the prior values;
- wherein if the sample does not contain at least a marker-specific minimum cutoff value of both first and second markers, the subject is determined to have dyspnea due to a cause other than a bacterial infection, and
- wherein said second marker-specific cutoff has been predetermined to be the level at which the relative efficiency of prediction of bacterial infection by measuring both markers in combination is at least 23% greater than the efficiency of prediction of bacterial infection by measuring the level of neopterin alone.
A method of treating a subject with dyspnea who has been diagnosed with a bacterial infection, wherein the bacterial infection was diagnosed by detecting and quantitating in a biological fluid sample from said subject marker analytes selected from
- a) neopterin as a first marker, and
- b) at least one second marker selected from
- i) a cytokine,
- ii) a cardiovascular marker,
- iii) a neurohumoral marker,
- iv) a precursor of said second marker,
- v) a fragment of said second marker, and
- vi) a fragment of a precursor of said second marker,
- wherein said detection and quantitation comprises contacting said sample with a diagnostic assay capture molecule which binds to the marker analyte, and detecting and quantitating the capture molecule:analyte complex, thereby determining the amount of the analyte in the sample;
- wherein if the sample contains at least the minimum cutoff value for neopterin of >10 nmol/l, and the sample contains at least a marker-specific minimum cutoff value for a second marker, the subject having dyspnea is diagnosed with a bacterial infection;
- and
- wherein said second marker-specific cutoff has been predetermined to be the level at which the relative efficiency of prediction of bacterial infection by measuring both markers in combination is at least 23% greater than the efficiency of prediction of bacterial infection by measuring the level of neopterin alone;
- comprising administering to the subject an effective treatment for a bacterial infection.
An in vitro method for determining that a subject having dyspnea has a bacterial infection, for determining the prognosis of a subject suffering from dyspnea caused by a bacterial infection, and/or for determining follow-up prognosis of the progression of a bacterial infection in a subject having dyspnea, comprising
- detecting and quantitating, in a biological fluid sample from said patient, marker analytes selected from
- a) neopterin as a first marker, and
- b) at least one second marker selected from
- i) a cytokine,
- ii) a cardiovascular marker,
- iii) a neurohumoral marker,
- iv) a precursor of said second marker,
- v) a fragment of said second marker, and
- vi) a fragment of a precursor of said second marker,
- wherein said detection and quantitation comprises contacting said sample with a diagnostic assay capture molecule which binds to the marker analyte, and detecting and quantitating the capture molecule:analyte complex, thereby determining the amount of the analyte in the sample;
- wherein, if
- A. the sample contains at least the minimum cutoff value for neopterin of >10 nmol/l, and
- B. the sample contains at least a marker-specific minimum cutoff value for at least one second marker, wherein the second marker is a cardiovascular marker selected from MR-proADM, MR-proANP, CT-ProET-1, CT-proAVP, BNP and/or NT-proBNP and/or fragments thereof of at least 12 amino acids and/or precursors thereof, having a marker-specific cutoff value selected from, respectively:
- (i) MR-proADM >1 nmol/l;
- (ii) CT-proAVP >10 pmol/l;
- (iii) CT-proET1 >100 pmol/l;
- (iv) MR-proANP >100 pmol/l;
- (v) NT-proBNP >600 pg/ml;
- and/or
- (vi) BNP >280 pg/ml;
- the subject having dyspnea is determined to have a bacterial infection, the prognosis for the subject having a bacterial infection is determined by the amount the levels of the markers are over the cutoff values, and/or if the subject having dyspnea has had a prior sample subjected to said diagnostic assays, prognosis of the progression of a bacterial infection is determined by comparison of the values of the follow up diagnostic assays with the prior values;
- and
- wherein if the sample does not contain at least a marker-specific minimum cutoff value of both first and second markers, the subject is determined to have dyspnea due to a cause other than a bacterial infection.
Dependencies are inferred from the claim text.