Device and method for detection of humidity-compromised urine test strips

Abstract

The timing of the reaction of moisture-sensitive reagents for detecting the presence of analytes, e.g. leukocytes in urine samples, is used to detect when the reagents have been compromised by excess humidity. The ratio of light reflectance at wavelengths characteristic of the products of reaction between the reagents and the analyte and an infra-red reference dye is measured at two preset times after a urine sample has been applied to a test strip and used to determine whether the reagents have been compromised by excessive humidity. The presence of unusually dark samples is determined from the reflected light at 470 and 625 nm in order to confirm that the test strips are humidity-compromised.

1 .- 27 . (canceled) 
     
     
         28 . The use of an infra-red dye as a reference in a method of detecting a humidity compromised moisture-sensitive reagent disposed on a test strip, wherein the moisture-sensitive reagent is based on proteolytic substrates to detect protease enzymes or protease inhibitors, said moisture-sensitive reagent including a diazonium salt and developing color or other response just after applying a sample, which color or other response is measured and compared to the infra-red reference dye. 
     
     
         29 . The use as claimed in  claim 28 , wherein the infra-red dye is combined with said moisture-sensitive reagent. 
     
     
         30 . The use as claimed in  claim 28 , wherein the infra-red dye is located separately from said moisture-sensitive reagent. 
     
     
         31 . The use as claimed in  claim 28 , wherein the infra-red dye is selected from the group consisting of phthalocyanine, naphthalocyanine, metal complex dyes, preferably dithiolene metal complex dyes, polymethine dyes, cyanine dyes, diphenylmethane dyes, triphenylmethane dyes, quinone dyes, azo dyes, charge transfer dyes and charge resonance dyes. 
     
     
         32 . The use as claimed in  claim 28 , wherein the infra-red dye has a characteristic absorbance in the infra-red region of about 700 to about 2500 nm. 
     
     
         33 . The use as claimed in  claim 28 , wherein the moisture-sensitive reagent is a reagent to detect leukocytes in urine samples. 
     
     
         34 . The use as claimed in claim  6 , wherein the diazonium salt is 1-diazo-2-naphthol-4-sulfonic acid. 
     
     
         35 . A method of analyzing a moisture-sensitive reagent disposed on a substrate and contacted with a urine sample, the method comprising:
 (a) measuring the reflectance of light at a first wavelength and a second wavelength at a first predetermined time after contacting said reagent with said sample;   (b) measuring the reflectance of light at the first wavelength and the second wavelength at a second predetermined time after contacting said reagent with said sample, the second predetermined time being after the first predetermined time;   (c) calculating a first ratio of the reflectance measurements in (a) and a second ratio of the reflectance measurements in (b);   (d) determining a level of activity of the reagent between the first and the second predetermined times by comparing the first ratio and the second ratio calculated in (c);   (e) when the level of activity of the reagent determined in (d) is at or above an expected level, determining a concentration of an analyte in the sample;   (f) when the level of activity of the reagent determined in (d) is less than the expected level, determining whether a primary cause of the less than expected activity is due to a color of the sample;   (g) when it is determined in (f) that the primary cause is the color of the sample, determining the concentration of an analyte in the sample; and   (h) when it is determined in (f) that the primary cause is not due to the color of the sample, identifying the primary cause as being a humidity reduced sensitively of the moisture-sensitive reagent and rejecting the moisture-sensitive reagent as being humidity compromised.   
     
     
         36 . The method of  claim 35 , wherein said moisture-sensitive reagent is based on esterases hydrolyzing derivatized esters. 
     
     
         37 . The method of  claim 35 , wherein said moisture-sensitive reagent is based on proteolytic substrates used to detect protease inhibitors. 
     
     
         38 . The method of  claim 35 , said analyte is leukocytes. 
     
     
         39 . The method of  claim 35 , wherein said analyte is urinary trypsin inhibitors. 
     
     
         40 . The method of  claim 35 , wherein said moisture-sensitive reagent includes a diazonium salt and an ester subject to hydrolysis in a presence of leukocytes. 
     
     
         41 . The method of  claim 35 , wherein the second wavelength is separated from the first wavelength by at least 120 nm. 
     
     
         42 . The method of  claim 35 , wherein each of (a) through (h) are performed by an optical inspection apparatus. 
     
     
         43 . The method of  claim 35 , wherein the first wavelength is between about 520-570 nm. 
     
     
         44 . The method of  claim 35 , wherein the second wavelength is about 825 nm. 
     
     
         45 . The method of  claim 35 , wherein the first wavelength or the second wavelength corresponds to a characteristic reflectance of a reference dye disposed on the substrate.