Detection meter and mode of operation

Abstract

A method for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method includes: applying a first sample to the analyte quantification member; and detecting the presence or absence of an adequate sample volume; wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member. Associated arrangements and devices are also disclosed.

1 . A method of performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid by using a device comprising at least one analyte quantification member and a sensor associated therewith, the method comprising:
 applying a first sample to the analyte quantification member; and   detecting the presence or absence of an adequate sample volume;   wherein upon detection of the absence of an adequate sample volume, initiating a finite timed period, and signaling the user to introduce a second sample of body fluid to the analyte quantification member.   
     
     
         2 . The method of  claim 1 , further comprising:
 interrogating the analyte quantification member with the sensor during the finite timed period to detect the presence or absence of an adequate sample volume applied to the at least one analyte quantification member.   
     
     
         3 . The method of  claim 2 , wherein upon detection of the absence of an adequate sample volume within the timed period, signaling the user that the assay is being terminated. 
     
     
         4 . The method of  claim 2 , wherein upon detection of an adequate sample volume during the timed period, continuing with the assay. 
     
     
         5 . The method of  claim 4 , further comprising interrogating the analyte quantification member subsequent to the timed period to ascertain the presence or concentration of the analyte. 
     
     
         6 . The method of  claim 1 , where the analyte comprises glucose and the body fluid comprises blood. 
     
     
         7 . The method of  claim 1 , wherein the at least one analyte quantification member comprises an assay pad containing a chemical reagent formulated to produce a color change upon reaction with the analyte. 
     
     
         8 . The method of  claim 1 , wherein the device comprises a plurality of the analyte quantification members. 
     
     
         9 . The method of  claim 8 , wherein the device comprises a removable cartridge containing a plurality of the analyte quantification members. 
     
     
         10 . The method of  claim 7 , wherein the sensor comprises an optical sensor constructed to produce signals indicative of the color change. 
     
     
         11 . The method of  claim 1 , wherein the finite time period is less than 1 minute. 
     
     
         12 . The method of  claim 11 , wherein the finite time period is 45 seconds or less. 
     
     
         13 . The method of  claim 1 , wherein the signaling comprises producing at least one of a visual signal and an audible signal. 
     
     
         14 . The method of  claim 1 , wherein the device further comprises at least one skin-penetration member, the method further comprising: piercing the skin of a user with the least one skin-penetration member thereby creating a wound opening for expression of body fluid therefrom. 
     
     
         15 . The method of  claim 14 , wherein the skin is pierced prior to introducing the first sample of body fluid to the least one analyte quantification member. 
     
     
         16 . The method of  claim 1 , further comprising, subsequent to signaling the user to introduce a second sample of body fluid to the analyte quantification member, at least one of: (i) manually milking a wound to express the second sample therefrom, and (ii) applying a catalyst to the skin in the vicinity of a wound. 
     
     
         17 . (canceled) 
     
     
         18 . The method of  claim 14 , further comprising applying a catalyst to the skin of the user prior to, during, or subsequent to piercing the skin with the at least one skin-penetration member. 
     
     
         19 . (canceled) 
     
     
         20 . The method of  claim 1 , further comprising providing the device with an anticoagulant material on at least portions thereof that normally contact the body fluid. 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . A device for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid, the device comprising:
 at least one analyte quantification member;   at least one passageway in fluid communication with the at least one analyte quantification member;   a sensor constructed and arranged to interrogate the least one analyte quantification member and to detect the presence or absence of an adequate sample volume applied to the at least one analyte quantification member; and   a controller in signal communication with the sensor, the controller is configured and arranged such that upon detection of the absence of an adequate sample volume, the controller initiates a finite timed period and signals the user to introduce another sample of body fluid into the at least one passageway.   
     
     
         24 - 46 . (canceled) 
     
     
         47 . A device for collecting a sample of body fluid, the device comprising:
 a skin interface member and a skin penetration member, wherein at least one of the skin interface member and the skin penetration member comprises a guide element configured to direct a flow of body fluid placed thereon.   
     
     
         48 - 53 . (canceled)