Calibration of Fluidic Devices

Abstract

The present invention provides methods of calibrating a fluidic device useful for detecting an analyte of interest in a bodily fluid. The invention also provides methods for assessing the reliability of an assay for an analyte in a bodily fluid with the use of a fluidic device. Another aspect of the invention is a method for performing a trend analysis on the concentration of an analyte in a subject using a fluidic device.

1 . A method for detecting an analyte contained in a biological fluid sample, comprising:
 receiving a cartridge into a reader assembly, the cartridge comprising:
 a sample collection unit configured to receive the biological fluid sample; and 
 an assay assembly, wherein the assay assembly comprises a plurality of reaction sites each having a reactant contained therein; 
   receiving a protocol associated with the cartridge at the reader assembly, based on an identifier of the cartridge;   flowing a portion of the biological fluid sample to the reaction sites in response to receiving the protocol such that the analyte contained in the biological fluid sample reacts with a reactant within one of the reaction sites and produces an optical signal indicating the presence of the analyte; and   detecting the optical signal with a detection assembly included in the reader assembly.   
     
     
         2 . The method of  claim 1 , further comprising:
 transmitting the detected optical signal to an external device via a communication assembly.   
     
     
         3 . The method of  claim 2 , wherein the protocol is received via a wired connection from the external device. 
     
     
         4 . The method of  claim 1 , wherein the identifier is disposed on the cartridge and comprises an identifier selected from one of a bar code, an alphanumeric value, and a color. 
     
     
         6 . The method of  claim 1 , further comprising:
 detecting the identifier via an identifier detector; and   transmitting the identifier from the identifier detector to an external device for the protocol to be determined by the external device; and   subsequently receiving the determined protocol at the reader assembly.   
     
     
         7 . The method of  claim 1 , further comprising:
 controlling, via a controller, fluid flow of a first portion of the biological fluid sample to a first reaction site including a first reactant and fluid flow of a second portion the biological fluid sample to a second reaction site including a second reactant different from the first reactant, wherein the first and second reactants are configured to react with different analytes contained in each of the first and second portions of the biological fluid sample.   
     
     
         8 . The method of  claim 1 , wherein the detection of the optical signal is achieved via a charge coupled device having multiple detection areas. 
     
     
         9 . The method of  claim 1 , wherein the optical signal is a luminescent signal. 
     
     
         10 . The method of  claim 1 , wherein the sample comprises one of blood and urine. 
     
     
         11 . The method of  claim 1 , wherein the bounding area of a reaction site is constructed from an optically opaque material. 
     
     
         12 . The method of  claim 1 , further comprising:
 diluting the biological fluid sample according to the protocol.   
     
     
         13 . A method for detecting an analyte contained in a biological fluid sample, comprising:
 inserting a cartridge into a reader assembly, the cartridge comprising:
 a sample collection unit configured to receive the biological fluid sample; and 
 an assay assembly, wherein the assay assembly comprises a plurality of reaction sites each having a reactant contained therein; 
   receiving a protocol associated with the cartridge at the reader assembly, based on an identifier;   flowing a portion of the biological fluid sample to the reaction sites in response to receiving the protocol such that the analyte contained in the biological fluid sample reacts with each reactant within the reaction sites and produces a plurality of optical signals indicating the presence of or absence of the analyte;   detecting the optical signals with a detection assembly included in the reader assembly; and   transmitting the optical signals to an external device for aggregation of the plurality of signals by the external device.   
     
     
         14 . The system of  claim 13 , further comprising analyzing the aggregated signals to trend the presence of the analyte at various time points over a given period of time, wherein the optical signals are transmitted concurrently with performance of the analyzing the aggregated signals to trend the presence of the analyte. 
     
     
         15 . The system of  claim 13 , further comprising analyzing the aggregated signals to trend the presence of the analyte at various time points over a given period of time, wherein the optical signals are transmitted prior to performance of the analyzing the aggregated signals to trend the presence of the analyte. 
     
     
         16 . The system of  claim 13 , further comprising:
 performing on-board calibration of the assay assembly.   
     
     
         17 . The system of  claim 13 , wherein the sample comprises one of blood and urine. 
     
     
         18 . The system of  claim 13 , wherein the system is configured to detect a plurality of analytes that generate distinct signals based on the position of a particular reaction site. 
     
     
         19 . The system of  claim 13 , wherein detecting of the optical signals further comprising detecting that a luminescent signal is present at a particular reaction site. 
     
     
         20 . The system of  claim 13 , further comprising:
 detecting a second signal from a sensor selected from one of a temperature sensor, a conductivity sensor, a potentiometric sensor, or amperometric sensor.