Analytical test pack and process for analysis

Abstract

Performing analytical tests more easily, quickly and accurately by using a specially designed pouch-like container of pliable material. The container has within it a plurality of compartments, each compartment being capable of containing a different reagent and each compartment also being capable of releasing its contained reagent, independently of any other reagents present in the other compartments, into the area of the container not occupied by compartments. This latter area of the container is also adapted to receive the test sample for reaction with any single reagent or any combination of reagents released from the compartments.

What is claimed is: 
     
       1. An analytical test pack consisting essentially of a pouch-like container of pliable material; said container having a plurality of compartments, the compartments occupying less than the total volume of said container to leave a reaction chamber, the compartments being adapted to be charged with predetermined quantities of testing reagents and each compartment being further adapted to release said reagents independently of any other reagents present in the other compartments into the reaction chamber; and means communicating with said reaction chamber for introducing the test sample into said reaction chamber, said means being adapted to prevent backflow of said test sample after its introduction into the reaction chamber. 
     
     
       2. An analytical test pack as in claim 1 wherein information for identifying and for processing said pack are affixed to said pack. 
     
     
       3. An analytical test pack composed of two opposed layers of pliable polymeric material of substantially equal dimensions; the first of said layers having at least one recess therein, said recess occupying less than the total area of first first layer; a predetermined amount of analytical reagent in said recess; the second layer bonded to said first layer in the area about said recess, the bonded area being adapted to be ruptured sufficiently to release reagent from said recess independently of any other reagent present in any other recess upon the application of pressure into the space between said two opposed layers not occupied by said recess; means communicating with the space between said two opposed layers not occupied by said recess for introducing the material to be tested into the said space; the second layer being further bonded to said first layer in an area remote from said recess, the further bonded area being substantially permanent, to provide an enclosed reaction chamber communicating with sid means for introducing the material to be tested. 
     
     
       4. An analytical test pack as in claim 3 wherein said means for introducing the material to be tested comprises a substantially rigid header bonded to at least one of said opposed layers of polymeric material, said header having a substantially cylindrical channel disposed laterally therein and at least one opening, said opening communicating with said channel and with an opening in said layer of polymeric material, said channel adapted to receive a cartridge in snug-fitting relationship, said cartridge having an opening communicating with the opening in the header. 
     
     
       5. An analytical test pack as in claim 3 wherein information for identifying and for processing said pack are affixed to said pack.  6. An analytical test pack composed of two opposed layers of pliable polymeric material of substantially equal dimensions; the first of said layers having a plurality of recesses therein, said recesses occupying less than the total area of said first layer; predetermined amounts of analytical reagents in at least two of said recesses; the second layer bonded to said first layer in areas about each of said recesses, the bonded areas being adapted to be ruptured sufficiently to release said reagents from each of said recesses independently of each other and independently of any reagents in any other recesses upon the application of pressure into the space between said two opposed layers not occupied by said recesses; means communicating with the space between said two opposed layers not occupied by said recesses for introducing the material to be tested into said space; the second layer being further bonded to said first layer in an area remote from said recesses, the further bonded area being substantially permanent, to provide an enclosed reaction chamber communicating with said means for introducing the material to be tested. 
     
     
           An analytical test pack as in claim 6 wherein information for 
     
     
        identifying and for processing said pack are affixed to said pack. 8. An analytical test pack as in claim 6 wherein said means for introducing the material to be tested comprises a substantially rigid header bonded to at least one of said opposed layers of polymeric material, said header having a substantially cylindrical channel disposed laterally therein and at least one opening, said opening communicating with said channel and with an opening in said layer of polymeric material, said channel adapted to receive a cartridge in snug-fitting relationship, said cartridge having an 
     
     
        opening communicating with the opening in the header. 9. An analytical test pack as in claim 8 wherein said cartridge contains means for removing 
     
     
        undesirable components from the material to be tested. 10. An analytical test pack as in claim 8 wherein information for identifying and for 
     
     
        processing said pack are affixed to said header. 11. A process for preparing an analytical test pack which comrises forming a plurality of depressions in a sheet of polymeric material, said depressions occupying less than the total areas of the sheet; placing pre-measured quantities of reagents in at least one of said depressions; placing a second sheet having substantially the same dimensions as the first sheet over the first sheet; bonding the second sheet to the first sheet substantially along the outer periphery of the sheets to provide a reaction chamber between the sheets; bonding the second sheet to the first sheet in areas about each of said reagent-containing depressions, said bonded areas being adapted to be ruptured sufficiently to release said reagents from each of said depressions independently of any other reagents present in the other 
     
     
        depressions into the reaction chamber. 12. A process for preparing an analytical test pack which comprises forming a plurality of depressions in a sheet of polymeric material, said depressions occupying less than the total area of the sheet; placing pre-measured quantities of reagents in at least one of said depressions; placing a second sheet having substantially the same dimensions as the first sheet over the first sheet; bonding the second sheet to the first sheet in the areas about each of said depressions, said bonded areas being adapted to be ruptured sufficiently to release said reagents from each depression independently of any other reagents present in the other depressions into the remaining space between said sheets; bonding the second sheet to the first sheet substantially along the outer periphery of the sheets; bonding a substantially rigid header to said sheets, said header having an inlet port communicating with an opening in the sheet adjacent to said header; and bonding said header to said sheet adjacent thereto in the area surrounding the opening in said 
     
     
        sheet. 13. A method of analyzing a test sample in a reaction chamber provided by the space between two sheets of pliable material bonded together at their outer peripheries, the space between the sheets also containing at least one reagent, each reagent enclosed by an area in which the two sheets are bonded to each other, comprising introducing the test sample into the reaction chamber; applying pressure to at least one of the sheets in an area adjacent at least one of said reagents sufficient to rupture the bonded area enclosing said reagent to release said reagent into said reaction chamber independently of any other reagents in other bonded areas whereby any single reagent or combination of reagents may be released; applying a pulsating pressure to the sheets encompassing the reaction chamber to mix said test sample and said reagent; and reading out 
     
     
        the result of the reaction between said reagent and said test sample. 14. A method as in claim 13 wherein said reaction chamber is formed into an analytical cell and the result of the reaction is read out in said cell. .Iadd. 15. An analytic test pack comprising a container having at least one wall of pliable material; said container having at least two compartments occupying less than the total volume of said container and a reaction chamber, the compartments being adapted to be charged with predetermined quantities of testing reagents and each compartment being further adapted to release said reagents independently of any other reagents present in the other compartments into the reaction chamber; and means communicating with said reaction chamber for introducing a test sample into said reaction chamber. .Iaddend..Iadd. 16. The analytic test pack of claim 15 wherein at least a portion of the walls of said reaction chamber are sufficiently optically transparent so that said reaction chamber can be utilized as an optical cell for optical analysis. .Iaddend..Iadd. 17. The analytic test pack of claim 15 wherein said reaction chamber comprises at least one compartment and wherein each of said compartments has at least one wall of a pliable polymeric material. .Iaddend..Iadd. 18. The analytic test pack of claim 17 wherein at least a portion of the walls of each of said compartments are sufficiently optically transparent so that each of said compartments can be utilized as an optical cell for optical analysis. .Iaddend. .Iadd.19. A method of analyzing a test sample comprising: providing an analytic test pack having a reaction chamber, at least one wall of which is of pliable material, and at least one reagent compartment containing reagents and separated from said reaction chamber; introducing the test sample into said reaction chamber; releasing at least one reagent contained in at least one reagent compartment into said reaction chamber, independently of any other reagents in other reagent compartments, whereby any single reagent or combination of reagents may be introduced into said reaction chamber; mixing said test sample and said reagent; and reading out the result of the reaction between said reagent and said test sample. .Iaddend. .Iadd. 20. The method of claim 19 wherein at least a portion of the walls of said reaction chamber are optically transparent and wherein the step of reading out the result of the reaction between said reagent and said test sample is accomplished by monitoring the optical properties of the reaction mixture by directing electromagnetic radiation through the reaction mixture while it is in the test pack, and generating a signal in response to the transmitted radiation, and processing said signal to produce an analytical result. .Iaddend. .Iadd. 21. The method of claim 19 wherein the step of releasing reagents into said reaction chamber takes place by first releasing at least one reagent into said reaction chamber, and, then, after a period of time, releasing at least one other reagent into said reaction chamber. .Iaddend..Iadd. 22. The method of claim 19 wherein said reaction chamber is divided into two compartments, wherein each of said compartments is conditioned differently, and wherein the step of reading out the reaction between said reagents and said test sample is accomplished differentially. .Iaddend. .Iadd. 23. The method of analyzing a test sample comprising providing a disposable test pack having a reaction compartment and at least one reagent stored within said test pack but separated from said reaction compartment, at least a portion of the test pack being sufficiently optically transparent so that the test pack can be utilized as an optical cell for optical analysis, the test pack carrying information for identifying and for processing the test pack, adding a measured quantity of a sample to the reaction compartment, adding at least one reagent stored within the disposable container to the reaction compartment to form a reaction mixture, incubating said reaction mixture within said test pack for a period of time sufficient to bring the reaction mixture to the desired state for analysis, and monitoring at least one of the optical properties of said reaction mixture while it is within said test pack by directing electromagnetic radiation through said reaction mixture, and generating a signal in response to the transmitted radiation, and processing said signal to produce an analytical result. .Iaddend. .Iadd. 24. The method of claim 23 wherein a plurality of stored reagents are added to the reaction compartment. .Iaddend..Iadd. 25. The method of claim 23 wherein a plurality of stored reagents are added each at different times to the reaction compartment. .Iaddend. .Iadd. 26. The method of claim 23 further including mixing the measured quantity of sample after each reagent is added thereto. .Iaddend..Iadd. 27. The method of analyzing a test sample comprising providing a disposable test pack having a reaction compartment and a plurality of reagents stored within said test pack but separated from said reaction compartment, at least a portion of test pack being sufficiently optically transparent so that the test pack can be utilized as an optical cell for optical analysis, adding a measured quantity of a sample to the reaction compartment, adding at least one reagent stored within the test pack to the reaction compartment to form a reaction mixture, incubating said reaction mixture within said reaction compartment, adding at least one further reagent stored within the disposable container to the reaction mixture, and monitoring at least one of the optical properties of said reaction mixture while it is within said test pack by directing electromagnetic radiation through said reaction mixture, and generating a signal in response to the transmitted radiation, and processing said signal to produce an analytical result. .Iaddend..Iadd. 28. A disposable test pack comprising: a reaction compartment, for the mixing of materials added thereto; a storage section having a plurality of separate reagent storage chambers, said reagent storage chambers being adapted to be charged with predetermined quantities of reagents, each of said reagent storage chambers being further adapted to release said reagents independently of any other reagents present in other reagent storage chambers into said reaction compartment; and means communicating with said reaction compartment for introducing a sample into said reaction compartment. .Iaddend..Iadd. 29. A disposable test pack comprising: a reaction compartment for the mixing of materials added thereto; a storage section having a plurality of separate reagent storage chambers, said reagent storage chambers being adapted to be charged with predetermined quantities of reagents, each of said reagent storage chambers being further adapted to release said reagents independently of any other reagents present in other reagent storage chambers into said reaction compartment; and means communicating with said reaction compartment for introducing a sample into said reaction compartment; at least a portion of said test pack being sufficiently optically transparent so that said test pack can be utilized as an optical cell for optical analysis. .Iaddend..Iadd. 30. The disposable test pack of claim 30 wherein said test pack comprises a plurality of reaction compartments. .Iaddend..Iadd. 31. The disposable test pack of claim 30 wherein at least a portion of said reaction compartment is made from a pliable material. .Iaddend..Iadd. 32. The disposable test pack of claim 30 having data stored thereon. .Iaddend..Iadd. 33. The disposable test pack of claim 30 wherein said storage section comprises a layer having a plurality of reagent-storing chambers formed therein. .Iaddend. .Iadd. 34. The method of analyzing a test sample in a disposable test pack having a reaction compartment, at least one reagent stored within said disposable container but separated from said reaction compartment, and at least a portion of said test pack being sufficiently transparent so that the reaction compartment can be utilized as an optical cell for optical analysis, said method comprising adding a measured quantity of a sample to the reaction compartment, adding at least one reagent stored within the test pack to said reaction compartment, and monitoring at least one of the optical properties of said reaction mixture while it is within said test pack, said monitoring including defining an optical path through the reaction mixture in the test pack by cooperation of external optical path-defining means with the sufficiently flexible walls of said test pack and passing a beam of electromagnetic radiation through said reaction mixture along said optical path. .Iaddend..Iadd. 35. The method of analyzing a test sample comprising providing a disposable test pack having a reaction compartment and at least one reagent stored within said disposable test pack but separated from said reaction compartment, the test pack carrying information for identifying and for processing the test pack, adding a measured quantity of a sample to the reaction compartment, adding a reagent stored within the test pack to the sample to form a reaction mixture, incubating said reaction mixture within said test pack for a period of time sufficient to bring the reaction mixture to the desired state for analysis, and reading out the result of the reaction between the reagent and the test sample while the reaction mixture is within said test pack. .Iaddend.