Control and calibration solutions and methods for their use

Abstract

Control and calibration solutions are described that provide control and calibration data that is recognized by a test meter allowing the meter to segregate the control and calibration data from regular test data. Recognition and segregation of the control and calibration data can occur automatically with no additional input from the meter's user. Methods for use of the solutions are also provided.

1 . A control/calibration solution for a device designed to analyze a biological fluid, the solution containing at least one analyte and containing a sufficient amount of a modulator to cause the solution to provide two electrochemical responses to an applied signal, wherein one electrochemical response is characteristic of blood and one electrochemical response is uncharacteristic of blood, wherein said modulator is selected from the group consisting of an ionic modulator, and a combination of an ionic modulator and an organic modulator. 
     
     
         2 . The solution of  claim 1 , wherein a combination thereof is selected. 
     
     
         3 . The solution of  claim 2 , wherein the solution is a control solution suitable for testing the performance of the device. 
     
     
         4 . The control solution of  claim 3 , wherein the ionic modulator is a water soluble salt. 
     
     
         5 . The control solution of  claim 4 , wherein the water soluble salt is an inorganic salt. 
     
     
         6 . The control solution of  claim 4 , wherein the organic modulator is a water soluble, non-polymeric organic material. 
     
     
         7 . The control solution of  claim 6 , wherein the composition additionally comprises a buffer. 
     
     
         8 . The control solution of  claim 7 , wherein the buffer comprises HEPES and sodium HEPES. 
     
     
         9 . The control solution of  claim 8 , wherein the ionic modulator is selected from the group consisting of sodium chloride, potassium chloride, and calcium chloride. 
     
     
         10 . The control solution of  claim 5 , wherein the ionic modulator is sodium chloride. 
     
     
         11 . The control solution of  claim 10 , wherein the organic modulator is selected from the group consisting of ethylene glycol, propylene glycol, dipropylene glycol, sorbitol, and glycerin. 
     
     
         12 . The control solution of  claim 11 , wherein the organic modulator is propylene glycol. 
     
     
         13 . The control solution of  claim 12 , further comprising a preservative. 
     
     
         14 . The control solution of  claim 13 , wherein the preservative is Germall® II preservative. 
     
     
         15 . The calibration solution of  claim 14 , wherein the medically significant component is glucose. 
     
     
         16 . The calibration solution of  claim 15 , wherein the known concentration of glucose is from about 0 to 1000 mg/100 g of solution. 
     
     
         17 . The control solution of  claim 10 , wherein the water is dionized water. 
     
     
         18 . The solution of  claim 2 , wherein the composition is a calibration solution and additionally comprises a known concentration of a medically significant component. 
     
     
         19 . The calibration solution of  claim 18 , wherein the ionic modulator is an inorganic salt. 
     
     
         20 . The calibration solution of  claim 19 , wherein the organic modulator is a water soluble, non-polymeric organic material. 
     
     
         21 . The calibration solution of  claim 20 , wherein the composition additionally comprises a buffer. 
     
     
         22 . The calibration solution of  claim 21 , wherein the buffer comprises HEPES and sodium HEPES. 
     
     
         23 . The calibration solution of  claim 22 , wherein the ionic modulator is selected from the group consisting of sodium chloride, potassium chloride, and calcium chloride. 
     
     
         24 . The calibration solution of  claim 23 , wherein the ionic modulator is sodium chloride. 
     
     
         25 . The calibration solution of  claim 23 , wherein the organic modulator is selected from the group consisting of ethylene glycol, propylene glycol, dipropylene glycol, sorbitol, and glycerin. 
     
     
         26 . The calibration solution of  claim 24 , wherein the organic modulator is propylene glycol. 
     
     
         27 . The calibration solution of  claim 25 , further comprising a preservative. 
     
     
         28 . The calibration solution of  claim 27 , wherein the preservative is Germall® II preservative. 
     
     
         29 . The calibration solution of  claim 28 , wherein the medically significant component is glucose. 
     
     
         30 . The calibration solution of  claim 29 , wherein the known concentration of glucose is from about 0 to 1000 mg/100 g of solution. 
     
     
         31 . The calibration solution of  claim 30 , wherein the water is deionized water.