EXTERNAL FILES FOR DISTRIBUTION OF MOLECULAR DIAGNOSTIC TESTS AND DETERMINATION OF COMPATIBILITY BETWEEN TESTS

• US 20130217013A1
• Filed: 02/01/2013
• Published: 08/22/2013
• Est. Priority Date: 02/03/2012
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Steel, Adam, Wojeck, Thomas, Young, Mike, Larsen, Mark
• Granted Patent: US 10,822,644 B2
• Time in Patent Office: Days
• US Class Current: 435/6.11
• CPC Class Codes: C12Q 1/6844 Nucleic acid amplification reactions
• CPC Class Codes: G01N 2035/0094 optimisation; experiment design
• CPC Class Codes: G01N 35/0092 Scheduling
• CPC Class Codes: G16B 30/00 ICT specially adapted for sequence analysis involving nucleotides or amino acids

Abstract

Embodiments disclosed herein relate to methods and systems for performing an automated assay, and particularly to performing an assay on a plurality of samples on an automated instrument.

Claims

1. A method of performing an automated assay on a plurality of samples, said method comprising:

providing an automated instrument comprising a first workstation and a second workstation, each of said first and second workstations configured to receive and processes a plurality of samples according to a plurality of different automated assay workflows, wherein each different automated assay workflow has an associated unique assay definition or user-defined protocol file;

determining whether two discrete assay workflows are compatible or incompatible with each other for concurrent processing on the automated instrument; and

performing said discrete assay workflows concurrently on said instrument when said assays are compatible.

2. The method of claim 1, wherein said assay definition or user defined protocol file comprises a first level compatibility index value, and wherein said determining step comprises:

(a) selecting a first assay from among a first list of available assays; and

(b) evaluating which of a plurality of other available assays have an assay definition file comprising the same first level compatibility index value as said first assay, wherein the same first level compatibility index value is indicative of first-level compatibility.

3. The method of claim 2, wherein said evaluating step comprises:

(b1) identifying any assays which have first level compatibility index values different from the first compatibility index value of said first assay; and

(b2) providing a second list of second assays, wherein said second list excludes any assay having a first level compatibility index value different from the first compatibility index value of said first assay.

4. The method of claim 2, wherein each assay definition file comprises a second level compatibility index value, and wherein said determining step further comprises:

(c) evaluating which of a plurality of other available assays have an assay definition file comprising the same second level compatibility index value as said first assay, wherein the same second level compatibility index value is indicative of second-level compatibility.

5. The method of claim 4, wherein said evaluating step comprises:

(c1) identifying any assays which have second level compatibility index values different from the second compatibility index value of said first assay; and

(c2) providing a second list of second assays, wherein said second list excludes any assay having a second level compatibility index value different from the second compatibility index value of said first assay.

6. The method of claim 2, wherein said first level compatibility comprises compatibility of performing two assays concurrently at a single workstation, said parameters selected from the group consisting of:

incubation time, lysis time, reagent volume, reagent type, incubation temperature, lysis temperature, workstation time demands, regulatory classification, business considerations, and a combination thereof.

7. The method of claim 4, wherein said second level compatibility comprises compatibility of performing two assays concurrently on said automated instrument, said parameters selected from the group consisting of:

regulatory classification, workflow incompatibility, business considerations, and a combination thereof.

8. The method of claim 6, wherein said instrument prevents the concurrent performance of incompatible assays within the same workstation when the first compatibility indexes are different.

9. The method of claim 8, wherein said two discrete assay workflows are performed in the same workstation.

10. The method of claim 7, wherein said instrument is prevented from concurrently performing assays with different second compatibility index values.

14. The method of claim 1, wherein if said assays are compatible, said method further comprises one or more of the following:

(d) initiating an assay-specific sample preparation script on the instrument;

(e) comparing identifying indicia on a consumable package to a set of assay-specific identifying data stored on the instrument;

(f) initiating an assay-specific load cartridge script on the instrument;

(g) comparing fluorescence ratios in a loaded cartridge to a set of assay-specific fluorescence ratio data stored on the instrument to determine whether said cartridge was successfully loaded;

(h) initiating an assay-specific reaction script on the instrument;

(i) initiating an assay-specific data analysis algorithm on the instrument;

(j) deriving a final call for the assay, based on one or more assay-specific result algorithms or scripts.

15. The method of claim 14, wherein said assay protocol comprises a reaction selected from the group selected from:

Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Ligation Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Strand Displacement Amplification (SDA), and a hybridization reaction.

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16. A system for performing an automated assay comprising:

an automated instrument comprising a first workstation and a second workstation, each of said first and second workstations configured to receive and processes a plurality of samples according to a plurality of different automated assay workflows, wherein each different automated assay workflow has an associated unique assay definition file or user-defined protocol file;

a processor;

a storage capacity; and

a program for performing an automated assay, said program comprising instructions for;

determining whether two discrete assay workflows are compatible or incompatible with each other for concurrent processing on the automated instrument; and

performing said discrete assay workflows concurrently on said instrument when said assays are compatible.

17. The system of claim 16, wherein said assay definition file or user defined protocol file comprises a first level compatibility index value, and wherein said determining step comprises:

(a) selecting a first assay from among a first list of available assays; and

(b) evaluating which of a plurality of other available assays have an assay definition file comprising the same first level compatibility index value as said first assay, wherein the same first level compatibility index value is indicative of first-level compatibility.

18. The system of claim 17, wherein said evaluating step comprises:

(b1) identifying any assays which have first level compatibility index values different from the first compatibility index value of said first assay; and

(b2) providing a second list of second assays, wherein said second list excludes any assay having a first level compatibility index value different from the first compatibility index value of said first assay.

19. The system of claim 17, wherein each assay definition file comprises a second level compatibility index value, and wherein said determining step further comprises:

(c) evaluating which of a plurality of other available assays have an assay definition file comprising the same second level compatibility index value as said first assay, wherein the same second level compatibility index value is indicative of second-level compatibility.

20. The system of claim 19, wherein said evaluating step comprises:

(c1) identifying any assays which have second level compatibility index values different from the second compatibility index value of said first assay; and

(c2) providing a second list of second assays, wherein said second list excludes any assay having a second level compatibility index value different from the second compatibility index value of said first assay.

21. The system of claim 17, wherein said first level compatibility comprises compatibility of performing two assays concurrently at a single workstation, said parameters selected from the group consisting of:

incubation time, lysis time, reagent volume, reagent type, incubation temperature, lysis temperature, workstation time demands, regulatory classification, business considerations, and a combination thereof.

29. The system of claim 16, wherein if said assays are compatible, said method further comprises one or more of the following:

(d) initiating an assay-specific sample preparation script on the instrument;

(e) comparing identifying indicia on a consumable package to a set of assay-specific identifying data stored on the instrument;

(f) initiating an assay-specific load cartridge script on the instrument;

(g) comparing fluorescence ratios in a loaded cartridge to a set of assay-specific fluorescence ratio data stored on the instrument to determine whether said cartridge was successfully loaded;

(h) initiating an assay-specific reaction script on the instrument;

(i) initiating an assay-specific data analysis algorithm on the instrument;

(j) deriving a final call for the assay, based on one or more assay-specific result algorithms or scripts.

30. The system of claim 29, wherein said assay protocol comprises a reaction selected from the group selected from:

Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), Oligonucleotide Ligation Assay (OLA), Ligase Chain Reaction (LCR), Rolling Circle Amplification (RCA), Strand Displacement Amplification (SDA), and a hybridization reaction.

31. The system of claim 16, wherein said system further comprises a bar code reader.

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