Rapid diagnostic method for distinguishing allergies and infections

• US 5,910,421 A
• Filed: 03/25/1996
• Issued: 06/08/1999
• Est. Priority Date: 12/21/1995
• Status: Expired due to Fees

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida (State University System of Florida)
• Inventors: Small, Parker A. Jr., Huang, Shih-Wen
• Primary Examiner(s): GITOMER, RALPH J
• Application Number:
  US08/621,557
• Time in Patent Office: 1,170 Days
• Field of Search: 435/19, 435/34, 436/811
• US Class Current: 435/19
• CPC Class Codes: C12Q 1/44 involving esterase
• CPC Class Codes: G01N 2800/24 Immunology or allergic disorders
• CPC Class Codes: G01N 33/56911 Bacteria
• CPC Class Codes: G01N 33/56983 Viruses
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

This method for non-invasively, rapidly and simply distinguishing between allergies, viral infections and sinusitis involves testing nasal secretions, preferably with commercially available (Ames Division, Miles Laboratories, Inc., Elkhart, Ind. 46515; or from Boehringer Mannheim Corporation, Advanced Diagnostics, 9115 Hague Road, P.O. Box 50457, Indianapolis, Ind. 46250-0457) or novel, modified reagent test strips. The commercially available strips, also referred to as dipsticks, test for pH, protein, nitrite, glucose, ketone, white blood cell esterase, bilirubin and blood. In the method of this invention, a sample of a patient'"'"'s nasal secretions is tested and, based on the pH, amount of protein, nitrite, esterase and a measure of eosinophil infiltration, it can quickly be determined if the patient is suffering from an allergy, from a viral infection or a bacterial infection. The method has the potential to supplant much more expensive and invasive clinical procedures.

Claims

1. A method for differentiating between allergic rhinitis, upper respiratory tract viral infection and bacterial sinusitis, which comprises measuring a sample of a patient'"'"'s nasal secretion, for pH, protein content, nitrite content, esterase activity and eosinophil counts of the sample, such that a combination of:

(a) a pH between about 7.5 and 9, a moderately strong presence of protein, at least a trace of nitrite and esterase, and low or absent eosinophil counts is indicative of bacterial sinusitis;

(b) a pH between about 5.0 and 7.0, little or no protein, little or no nitrite, little or no esterase activity and moderate to high eosinophil counts is indicative of allergic rhinitis; and

(c) a pH between about 5.0 and 7.0, little or no protein, at least a trace of nitrite and esterase and low or absent cosinophil counts indicates an upper respiratory tract viral infection.

2. The method of claim 1 wherein for each measurement obtained for pH, protein, nitrite, esterase, and eosinophil counts in a patient'"'"'s nasal secretion, an arbitrary clinical score is assigned such that by summing and graphing the clinical score assigned for each measurement to produce a graph of said clinical scores, a first grouping of clinical scores for patients having bacterial sinusitis occurs, a second grouping of clinical scores for patients having upper respiratory tract viral infection occurs, and a third grouping of clinical scores for patients having allergic rhinitis occurs, such that said graph separates said first, said second and said third grouping of clinical scores.

3. The method of claim 1 wherein said method is practiced with a reagent test strip.

4. The method according to claim 1 which comprises contacting and measuring nasal secretion from said patient with a urinalysis reagent test strip, which measures protein, pH, nitrite, and esterase concentrations of the secretion, wherein said reagent test strip is adapted to in addition provide a measurement of the eosinophil concentration of said nasal secretion.

5. The method according to claim 1 which comprises:

(a) contacting and measuring nasal secretion from said patient with a urinalysis reagent test strip, which measures protein, pH, nitrite, and esterase concentrations of the secretion; and

(b) measuring eosinophil concentration of said nasal secretion.

6. A method for differentiating between viral infectious rhinitis, bacterial sinus infection and allergic rhinitis in a patients which comprises:

(a) contacting nasal secretion from said patient with a reagent test strip adapted for providing measurements of eosinophil, protein, pH, nitrite, and esterase concentrations of the secretion, wherein said reagent test strip is adapted to provide said measurements by providing reactants on said reagent test strip which specifically indicate eosinophil, protein, pH, nitrite, and esterase concentrations upon contact of said nasal secretion with said reactants;

(b) measuring the pH, protein content, nitrite content, esterase activity and cosinophil concentration of said nasal secretion such that a combination of;

(i) a pH between about 7.5 and 9, a moderately strong presence of protein, at least a trace of nitrite and esterase, and low or absent eosinophil counts is indicative of bacterial sinusitis;

(ii) a pH between about 5.0 and 7.0, little or no protein, little or no nitrite, little or no esterase activity and moderate to high eosinophil counts is indicative of allergic rhinitis;

(iii) a pH between about 5.0 and 7.0, little or no protein, at least a trace of nitrite and esterase and low or absent cosinophil counts indicates an upper respiratory tract viral infection; and

(c) correlating the results obtained front said measuring with a control.