Rapid diagnostic method for distinguishing allergies and infections and nasal secretion collection unit

Abstract

A method for clinical scoring that involves evaluating certain parameters found in nasal secretia is disclosed. Contact of a nasal secretion with indicators for pH, protein content, leukocyte esterase activity, nitrite content, eosinophil content and/or TAME esterase activity permits diagnosis and differentiation between allergic, bacterial and viral conditions.

1 . A method of determining whether a patient has bacterial sinusitis, said method comprising obtaining a nasal secretion sample from said patient;
 providing a first indicator that is responsive to a pH of said sample;   assigning a first score to said sample based on information from said first indicator upon contacting said first indicator with said sample;   providing a second indicator that is responsive to a protein content of said sample;   
     assigning a second score to said sample based on information from said second indicator upon contacting said second indication with said sample;
 providing a third indicator responsive to leukocyte esterase activity; and 
 assigning a third score to said sample based on information from said third indicator upon contacting said third indication with said sample; 
 
     wherein bacterial sinusitis is indicated if a sum of said first, second and third scores is at a predetermined level. 
   
   
       2 . The method of  claim 1 , wherein said first score is +3 when said pH is greater than or equal to 8.5, +2 when said pH is between 8.0 and 8.4, +1 when said pH is between 7.25 and 7.90, and 0 when said pH is between 5.0 and 7.25. 
   
   
       3 . The method of  claim 1 , wherein said second score is +4 when said protein content is greater than 2000 mg/dl; +3 when said protein content is between 300 mg/dl and 2000 mg/dl, +2 when said protein content is between about 100 mg/dl and 300 mg/dl, and +1 when said protein content is between 30-100 mg/dl. 
   
   
       4 . The method of  claim 1 , wherein said third score is +3 for high leukocyte esterase activity, +2 for moderate leukocyte esterase activity and +1 for low leukocyte esterase activity. 
   
   
       5 . The method of  claim 1 , further comprising providing a fourth indicator responsive to nitrite content in said sample; assigning a fourth score to said sample based on information from said fourth indicator upon contacting said fourth indicator with said sample; wherein bacterial sinusitis, allergic rhinitis or upper respiratory tract viral infection is indicated if a sum of said first, second, third, and fourth scores are at a predetermined level. 
   
   
       6 . The method of  claim 5 , wherein said fourth score is +3 for high nitrite content; +2 for moderate nitrite content; and +1 for low nitrite content. 
   
   
       7 . The method of  claim 1 , wherein
 said first score is +3 when said pH is greater than or equal to 8.5, +2 when said pH is between 8.0 and 8.4, +1 when said pH is between 7.25 and 7.90, and 0 when said pH is between 5.0 and 7.25;   said second score is +4 when said protein content is greater than 2000 mg/dl; +3 when said protein content is between 300 mg/dl and 2000 mg/dl, +2 when said protein content is between about 100 mg/dl and 300 mg/dl, and +1 when said protein content is between 30-100 mg/dl;   said third score is +3 for high leukocyte esterase activity, +2 for moderate leukocyte esterase activity and +1 for low leukocyte esterase activity; wherein bacterial sinusitis is indicated if the sum of said first, second and third scores is 3 or greater.