METHOD FOR ASSAYING LOWER RESPIRATORY TRACT INFECTION OR INFLAMMATION
The present invention relates to a reliable method of prediction of lower respiratory tract infection or inflammation in humans, wherein the level of pancreatic stone protein/regenerating protein (PSP/reg) is determined in serum, and a high level is indicative of the development and the severity of the disease, allowing the classification of patients according to risk.
1 .- 15 . (canceled)
16 . A method for detecting pancreatic stone protein/regenerating protein (PSP/reg) comprising:
a) obtaining a body fluid sample from a patient having a lower respiratory tract infection on a day of admission, on a day of VAP (ventilator-acquired pneumonia) onset or on day 2, 3, 4, 5, 6, 7 after VAP onset;
b) contacting the sample with an antibody against PSP/reg; and
c) detecting whether PSP/reg is present in said sample in a quantity higher than 25 ng/ml on the day of admission, higher than 150 ng/ml on the day of VAP onset or on said day 2, 3, 4, 5, 6, 7 after VAP onset via the antibody against PSP/reg.
17 . The method of claim 1 , wherein said body fluid sample is a serum sample or a plasma sample.
18 . The method of claim 1 , wherein said patient is a human.
19 . The method of claim 1 , wherein said PSP/reg protein is SEQ ID N0:1 or SEQ ID NO: 2.
20 . The method of claim 1 , wherein the quantity is higher than 30 ng/ml on the day of admission.
21 . The method of claim 1 , wherein the quantity is higher than 180 ng/ml on the day of VAP onset or on said day 2, 3, 4, 5, 6, 7 after VAP onset.
22 . The method of claim 1 , wherein the infection is acute exacerbation of COPD, community ventilator associated pneumonia, hospital-acquired pneumonia, or ventilator associated pneumonia.
23 . The method of claim 1 , wherein a level of PSP/reg equal or higher than 25 ng/ml is indicative of an infection of the airways and lungs in said patient.
24 . The method of claim 1 , wherein the quantity of PSP/reg is equal or higher than the 150 ng/ml and the patient is a ventilator-acquired pneumonia (VAP) patient.
25 . The method of claim 1 , wherein a level of PSP/reg equal or higher than 25 ng/ml, is indicative of positive sputum microbiology in a COPD patient.
26 . The method of claim 1 , wherein the level of PSP/reg in said body fluid sample is determined by Enzyme-linked immunosorbent assay (ELISA), Radioimmunoassay (RIA), Enzymoimmunoassay (EIA), mass spectrometry, or microarray analysis.
27 . The method of claim 1 , wherein the level of PSP/reg is quantified by a sandwich ELISA, wherein microtiter plates are coated with one type of antibody directed against PSP/reg, the plates are then blocked and the sample is loaded, and a second type of antibody against PSP/reg is applied, a third antibody detecting the second antibody conjugated with a label is then added, and the label is used to quantify the amount of PSP/reg.
28 . The method of claim 13 , wherein the label in the sandwich ELISA is an enzyme for chromogenic detection.
29 . A kit of parts for determining PSP/reg for diagnosis/prediction of infection of airways and lungs in a patient comprising apparatus, reagents and standard solutions of PSP/reg.
30 . The method of claim 1 , wherein the lower respiratory tract infection is VAP and the quantity of PSP/reg is higher than or equal to the 150 ng/ml and wherein mortality as a result of the VAP is assessed within a period of 28 days.
31 . The method of claim 20 , wherein, said patient is treated with an antibiotic to treat VAP during said period.
32 . The method of claim 1 wherein the quantity of PSP/reg is higher than 200 ng/ml.
33 . The method of claim 1 , wherein the method is prognostic.
34 . The method of claim 1 , wherein the lower respiratory tract infection is chronic obstructive pulmonary disease (COPD), the quantity of PSP/reg is higher than 30 ng/ml and wherein mortality is assessed within a period between 1 day to 3 years.
35 . The method of claim 24 , wherein said patient is treated with an antibiotic adapted to treat COPD.