Method for the diagnosis of Helicobacter pylori infection, and a diagnostic kit for performing the method

Abstract

The method for the diagnosis of Helicobacter pylori infection by the oral administration of defined amounts of 13 C-labeled urea and examination for 13 C content of blood samples removed at a defined time is effected by a) removing from 0.1 to 0.6 ml of capillary blood from the finger or ear lob of a patient or venous blood of a patient, in both cases with an empty stomach before the beginning of the test; b) administering an exact amount of from 10 to 50 mg of 13 C-urea in aqueous solution with a pH value of 2 to 4 to the patient; c) again removing capillary or venous blood exactly after 10 to 15 min from the administration; and d) determining the 13 C content of the blood samples by isotope ratio mass spectrometry (IRMS), and deducing the presence of Helicobacter pylori from the increase of the 13 C values.

1 - 5 . (canceled)  
     
     
         6 . A kit for diagnosing  Helicobacter pylori  infection comprising: 
 a) an aqueous solution having a pH of 2 to 4 containing a dose of exactly 10 to 50 mg of  13 C-urea and a pharmacologically acceptable organic acid;    b) a patient instruction sheet; and    c) two sample vessels for receiving blood samples, the sample vessels being suitable for holding a strong, non-volatile acid.    
     
     
         7 . The diagnostic kit of  claim 6  further comprising a strong, non-volatile acid in each of the two sample vessels.  
     
     
         8 . The diagnostic kit of  claim 6 , wherein the organic acid is citric acid.  
     
     
         9 . The diagnostic kit of  claim 7 , wherein the organic acid is citric acid.  
     
     
         10 . The diagnostic kit of  claim 6  further comprising a blood sampling device.  
     
     
         11 . The diagnostic kit of  claim 7  further comprising a blood sampling device.  
     
     
         12 . The diagnostic kit of  claim 8  further comprising a blood sampling device.  
     
     
         13 . The diagnostic kit of  claim 9  further comprising a blood sampling device.  
     
     
         14 . A kit for diagnosing  Helicobacter pylori  infection comprising: 
 a) a 1 st  container holding 10 to 50 mg of  13 C-urea,    b) a 2 nd  container holding a solid, pharmacologically acceptable organic acid,    d) a patient instruction sheet, and    e) two sample vessels for receiving blood samples, the sample vessels being suitable for holding a strong, non-volatile acid.    
     
     
         15 . The diagnostic kit of  claim 14 , further comprising a strong, non-volatile acid in each of the two sample vessels.  
     
     
         16 . The diagnostic kit of  claim 14 , wherein the organic acid is citric acid.  
     
     
         17 . The diagnostic kit of  claim 15 , wherein the organic acid is citric acid.  
     
     
         18 . The diagnostic kit of  claim 14 , further comprising a blood sampling device.  
     
     
         19 . The diagnostic kit of  claim 15 , further comprising a blood sampling device.  
     
     
         20 . The diagnostic kit of  claim 16 , further comprising a blood sampling device.  
     
     
         21 . The diagnostic kit of  claim 17 , further comprising a blood sampling device.