Method for assaying lower respiratory tract infection or inflammation

Abstract

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.