Single-tube, ready-to-use assay kits, and methods using same

Abstract

Abstract of the Disclosure An assay kit is provided that includes assay reagents stored in a single-tube container, and a data storage medium containing information about the contents of the container. Methods are provided for using the data provided with the kit to direct instruments and/or processes, for example, to control an instrument to perform amplification and/or sequencing reactions.

What is Claimed is: 
     
         1.  An assay kit comprising:   
       a container, the container containing a mixture having reagents adapted to perform an allelic discrimination or expression analysis reaction when admixed with at least one target polynucleotide sequence, and  
       a data storage medium containing data about the contents of the first container. 
     
     
         2.  The assay kit of  claim 1 , further comprising a second container that contains assay reagents. 
     
     
         3.  The assay kit of  claim 1 , wherein the container has a machine-readable label that provides information about the contents of the container. 
     
     
         4.  The assay kit of  claim 1 , further comprising at least one first probe, wherein the at least one first probe has a first marker dye. 
     
     
         5.  The assay kit of  claim 1 , wherein the container is sealed. 
     
     
         6.  The assay kit of  claim 1 , wherein the kit further comprises a target polynucleotide. 
     
     
         7.  The assay kit of  claim 1 , wherein the reagents utilize fluorogenic 5' nuclease chemistry during the performance of the reaction. 
     
     
         8.  The assay kit of  claim 1 , wherein the mixture further comprises a DNA polymerase, one or more polynucleotide monomers, at least one salt, and a buffer. 
     
     
         9.  The assay kit of  claim 8 , wherein the polynucleotide monomers are peptide nucleic acids. 
     
     
         10.  The assay kit of  claim 1 , wherein the container is a tube. 
     
     
         11.  The assay kit of  claim 5 , wherein the sealed container is sealed with a removable cap. 
     
     
         12.  The assay kit of  claim 1 , wherein the data storage medium is a compact disk (CD) and the data is electronically formatted. 
     
     
         13.  The assay kit of  claim 1 , wherein the data includes sequence information about at least one of at least one first probe and at least one primer. 
     
     
         14.  The assay kit of  claim 4 , wherein the data includes information about the first marker dye. 
     
     
         15.  The assay kit of  claim 4 , wherein the data includes information that is capable of controlling at least one scientific laboratory instrument. 
     
     
         16.  The assay kit of  claim 15 , wherein the at least one instrument is an instrument designed to perform at least one of a polymerase chain reaction and a polynucleotide sequencing reaction. 
     
     
         17.  The assay kit of  claim 15 , wherein the data storage medium is a compact disk (CD) and the data is electronically formatted. 
     
     
         18.  The assay kit of  claim 1 , wherein the data storage medium contains a software program that can be utilized with data contained on the data storage medium to control at least one scientific or laboratory instrument. 
     
     
         19.  The assay kit of  claim 18 , wherein the software program is adapted to receive output data from at least one scientific or laboratory instrument. 
     
     
         20.  The assay kit of  claim 1 , further comprising a second data storage medium, and the second data storage medium contains a software program that can be utilized to control at least one scientific or laboratory instrument. 
     
     
         21.  The assay kit of  claim 20 , wherein the software program is adapted to receive output data from at least one instrument. 
     
     
         22.  The assay kit of  claim 1 , wherein the data storage medium is separate from the container. 
     
     
         23.  The assay kit of  claim 1 , wherein the data storage medium is affixed to the container. 
     
     
         24.  The assay kit of  claim 23 , wherein the data storage medium includes an optically detectable code. 
     
     
         25.  The assay kit of  claim 23 , wherein the data storage medium is the form of a 2-dimensional barcode. 
     
     
         26.  The assay kit of  claim 1 , wherein the data storage medium is etched in the container. 
     
     
         27.  A method of performing an assay, comprising: 
       providing an assay kit according to  claim 1 , using the data to control an instrument to process the assay reagents, and performing an assay. 
     
     
         28.  The method of  claim 27 , further comprising processing the data with a software program to control the instrument. 
     
     
         29.  A method comprising: 
       providing the assay kit of  claim 1 ; and 
       shipping the assay kit to a user. 
     
     
         30.  The method of  claim 29 , wherein the assay kit comprises reagents for conducting a homogeneous assay. 
     
     
         31.  A genetic-analysis kit, comprising:   
       a first container;  
       a reaction mixture held in the first container, the reaction mixture being adapted for allelic discrimination or expression analysis;  
       a data storage medium including information in electronic form thereon, the information pertaining at least in part to the reaction mixture; and  
       a second container holding the first container and the data storage medium for transport as a unit. 
     
     
         32.  The kit of  claim 31 , wherein the first container comprises a tube. 
     
     
         33.  The kit of  claim 31 , wherein the second container comprises a package. 
     
     
         34.  The kit of  claim 31 , wherein the data storage medium comprises a disk. 
     
     
         35.  The kit of  claim 34 , wherein the disk comprises a removable disk. 
     
     
         36.  The kit of  claim 31 , wherein the reaction mixture comprises a homogeneous reaction mixture. 
     
     
         37.  The kit of  claim 36 , wherein the homogeneous reaction mixture comprises components for conducting a fluorogenic 5' nuclease assay. 
     
     
         38.  The kit of  claim 31 , wherein the information is comprised, at least in part, of American Standard Code for Information Interchange (ascii)-formatted text. 
     
     
         39.  The kit of  claim 31 , wherein the data storage medium further includes machine-readable code thereon. 
     
     
         40.  A method for facilitating genetic analysis:   
       receiving from a user a request for one or more genetic-analysis assays; and  
       providing to the user (i) the one or more assays, with each assay being provided in a single-tube format, and (ii) information relating to the one or more assays, with the information being in electronic form. 
     
     
         41.  The method of  claim 40 , wherein the one or more assays each comprises a homogeneous reaction mixture. 
     
     
         42.  The method of  claim 41 , wherein the homogeneous reaction mixture comprises components for conducting a fluorogenic 5' nuclease assay. 
     
     
         43.  The method of  claim 40 , wherein the information is provided on a disk. 
     
     
         44.  The method of  claim 43 , wherein the disk is a removable disk. 
     
     
         45.  The method of  claim 40 , wherein the information is provided via a computer network. 
     
     
         46.  The method of  claim 45 , wherein the information is transmitted to the user via electronic mail. 
     
     
         47.  The method of  claim 45 , wherein the information is provided via a file transfer protocol (FTP). 
     
     
         48.  The method of  claim 40 , wherein the information is comprised, at least in part, of ascii-formatted text. 
     
     
         49.  The method of  claim 40 , wherein at least one of the one or more assays and the information are shipped to the user together in a single package. 
     
     
         50.  A method for genetic analysis, comprising: 
       requesting a plurality of assay mixtures for genetic analysis from a supplier;   
       receiving from the supplier (i) the plurality of assay mixtures, and (ii) information, in electronic form, pertaining to each assay mixture;  
       transferring at least a portion of the electronic information to a computer system adapted for electronic communication with a thermal cycler; and  
       employing the computer system and at least a portion of the information, instructing the operation of the instrument, whereby each of the assay mixtures is analyzed. 
     
     
         51.  The method of  claim 50 , wherein each of the plurality of assays comprises a homogeneous reaction mixture. 
     
     
         52.  The method of  claim 51 , wherein the homogeneous reaction mixture comprises components for conducting a fluorogenic 5' nuclease assay. 
     
     
         53.  The method of  claim 50 , wherein the information is provided on a removable disk. 
     
     
         54.  The method of  claim 50 , wherein the thermal cycler is configured to perform a real-time polymerase chain reaction. 
     
     
         55.  The method of  claim 50 , wherein the information is provided via a computer network. 
     
     
         56.  The method of  claim 55 , wherein the information is transmitted by the supplier via electronic mail. 
     
     
         57.  The method of  claim 55 , wherein the information is downloaded by the user from a server. 
     
     
         58.  The method of  claim 50 , wherein the information is comprised, at least in part, of American Standard Code for Information Interchange (ASCII)-formatted text. 
     
     
         59.  The method of  claim 50 , wherein at least one of the plurality of assays and the information are shipped to the user together in a single package. 
     
     
         60.  The method of  claim 50 , wherein each of the plurality of assay mixtures is contained in a single tube. 
     
     
         61.  The method of  claim 50 , wherein the requesting step is carried out via the Internet. 
     
     
         62.  A method for facilitating genetic analysis, comprising:   
       receiving a request for a plurality of assay mixtures for genetic analysis from a user; and  
       supplying to the user (i) the plurality of assay mixtures, (ii) information, in electronic form, pertaining to each assay mixture, and (iii) a program storage device readable by a computer system, embodying a program of instructions executable by the computer system to perform method steps for genetic analysis, the method steps comprising (a) transferring at least a portion of the electronic information to a memory of the computer system, (b) employing at least a portion of the information, generating instructions for the operation of a thermal cycler adapted to perform real-time polymerase chain reaction, and (c) sending the instructions to the thermal cycler whereby the thermal cycler acts upon the assay mixtures. 
     
     
         63.  The method of  claim 62 , wherein the plurality of assay mixtures and the information is supplied to the user together, at the same time. 
     
     
         64.  The method of  claim 62 , wherein the information is provided on a removable disk. 
     
     
         65.  The method of  claim 64 , wherein the removable disk comprises a compact disk (CD). 
     
     
         66.  The method of  claim 62 , wherein the information is provided via a computer network. 
     
     
         67.  The method of  claim 62 , wherein each of the plurality of assay mixtures comprises a homogeneous reaction mixture. 
     
     
         68.  The method of  claim 67 , wherein each homogeneous reaction mixture comprises a fluorogenic 5' nuclease assay. 
     
     
         69.  The method of  claim 62 , wherein each of the plurality of assay mixtures is contained in a single tube. 
     
     
         70.  The method of  claim 62 , wherein the program storage device comprises a removable disk. 
     
     
         71.  The method of  claim 62 , further comprising providing a web site configured for receiving requests from users for assay mixtures for genetic analysis. 
     
     
         72.  A program storage device readable by a computer system, embodying a program of instructions executable by the computer system for genetic analysis, the method steps comprising:   
       (i) uploading electronic information relating to a plurality of assay mixtures from a data storage device to the computer system,  
       (ii) employing the information, generating a file containing instructions for operation of a thermal cycler; and  
       (iii) tranferring the file to the thermal cycler for implementation. 
     
     
         73.  The device of  claim 72 , wherein the method steps further comprise:   
       monitoring for electronic information ready for uploading. 
     
     
         74.  The device of  claim 72 , wherein the method steps further comprise:   
       receiving a results file from the thermal cycler, and causing the results file to be saved. 
     
     
         75.  The device of  claim 72 , wherein the method steps further comprise:   
       building an assay information database. 
     
     
         76.  The device of  claim 72 , wherein the method steps further comprise:   
       generating plate documents and providing the plate documents in the file for transfer to the thermal cycler. 
     
     
         77.  The device of  claim 72 , wherein the method steps further comprise:  generating or updating an activity log. 
     
     
         78.  The device of  claim 72 , wherein the method steps further comprise:   
       outputting the instructions to a printer for printing. 
     
     
         79.  The device of  claim 72 , wherein the method steps further comprise:   
       determining errors in the information or instructions that could adversely impact analysis of the assay mixtures. 
     
     
         80.  The device of  claim 72 , wherein the data storage device is a removable disk. 
     
     
         81.  The device of  claim 72 , wherein the thermal cycler is adapted to perform a real-time polymerase chain reaction.