Single-use Microfluidic Cartridge for Detection of Target Chemical Presence in Human Breath

Abstract

The present disclosure describes a single-use microfluidic cartridge that is can be utilized with a portable and handheld breath collection and analysis device to detect a presence of a target chemical in human breath. The cartridge receives an air sample of human breath, processes it to extract the target chemical in solution, and reacts the solution with chemical reagent(s) to determine a concentration level of the target chemical present in the collected breath sample. Additionally, a portion of the collected sample can be contained in a separate reservoir of the cartridge of evidence preservation. The cartridge may further contain a cryptographic computing chip to store information regarding the sample processed within the cartridge.

What is claimed is: 
     
         1 . A single-use microfluidic cartridge for detection of a target chemical present in human breath via a breath collection and analysis device, the cartridge comprising:
 a breath collection module configured to collect a desired volume of air from the human subject, and extract a target chemical from the collected air;   an evidence sample storage chamber configured to preserve a sample of the extracted target chemical from the collected air for later analysis; and   a multi-channel reaction chamber configured to process a competitive immunoassay to generate a signal representing a concentration amount of the target chemical present in the collected air from the human subject.   
     
     
         2 . The cartridge of  claim 1 , wherein the multi-channel reaction chamber comprises a calibrator channel, a sample channel, and a positive control channel. 
     
     
         3 . The cartridge of  claim 1 , wherein the multi-channel reaction chamber comprises a calibrator channel, the calibrator channel containing a fluid of antibodies. 
     
     
         4 . The cartridge of  claim 1 , wherein the multi-channel reaction chamber comprises a positive control channel, the positive control channel containing a fluid of a known concentration of the target chemical. 
     
     
         5 . The cartridge of  claim 1 , wherein the competitive immunoassay process comprises utilizing a reagent to bind the target chemical to a reaction surface of the multi-channel reaction chamber. 
     
     
         6 . The cartridge of  claim 1 , wherein the multi-channel reaction chamber is further configured to undergo a wash process and then a substrate process, after processing the competitive immunoassay. 
     
     
         7 . The cartridge of  claim 1 , wherein the multi-channel reaction chamber is further configured to emit a low level light, that can be captured by a detector device of a base station compatible with the breath collection and sampling device. 
     
     
         8 . The cartridge of  claim 1 , further comprising a cryptographic computing chip configured to be read by a computer, the cryptographic computing chip comprising at least one or more of identifying information about the human subject, information about the breath collection workflow, the assay workflow, and subsequent quantities of the target chemical. 
     
     
         9 . The cartridge of  claim 1 , further comprising a cryptographic computing chip configured to be read by a computer, the cryptographic computing chip comprising information to verify the cartridge to the breath collection and analysis device. 
     
     
         10 . The cartridge of  claim 1 , further comprising a cryptographic computing chip with an RFID tag. 
     
     
         11 . The cartridge of  claim 1 , wherein the breath collection module of the cartridge is connected to a mouthpiece of the breath collection and analysis device, the mouthpiece configured to be placed in the human subject mouth to receive air from the human subject. 
     
     
         12 . The cartridge of  claim 1 , wherein the target chemical is extracted in the breath collection module via an elution buffer solution configured to extract and solubilize the target chemical from aerosol droplets in the collected air. 
     
     
         13 . The cartridge of  claim 1 , wherein the desired volume of air collected from the human subject is 18 liters. 
     
     
         14 . A method for detection of a target chemical present in human breath via a single-use microfluidic cartridge, the method comprising:
 receiving a desired volume of air from a human subject in a breath collection module of the single-use microfluidic cartridge;   processing the received air in the breath collection module to solubilize and extract the target chemical present in the received air;   combining the extracted target chemical with an antibody;   saving a portion of the extracted target chemical for evidence preservation;   reacting a remainder portion of the extracted target chemical in a multi-channel reaction chamber with one or more chemical reagents;   washing the reacted chemicals in the multi-channel reaction chamber with a wash solution;   introducing a substrate to the washed chemicals in the multi-channel reaction chamber, the substrate configured to emit a low level light from the single-use microfluidic cartridge, communicating with a detector device to determine a concentration level of the target chemical from the emitted low level light.   
     
     
         15 . The method of  claim 14 , further comprising saving a result of analysis on a cryptographic computing chip present on the single-use microfluidic cartridge. 
     
     
         16 . The method of  claim 14 , further comprising saving identifying information for the human subject on a cryptographic computing chip present on the single-use microfluidic cartridge. 
     
     
         17 . The method of  claim 14 , further comprising saving identifying information for the human subject on an RFID tag of a cryptographic computing chip present on the single-use microfluidic cartridge. 
     
     
         18 . The method of  claim 14 , further comprising calibrating a result from the multi-channel reaction chamber based on a positive control channel of the reaction chamber and a calibrator channel of the multi-channel reaction chamber. 
     
     
         19 . The method of  claim 14 , wherein the target chemical is THC. 
     
     
         20 . The method of  claim 14 , wherein the reacting the remainder portion of the extracted target chemical in a multi-channel reaction chamber with one or more chemical reagents further comprises utilizing a competitive immunoassay process.