IP Library Granted Patent US 11,268,126
Granted Patent B2
US 11,268,126 · App. 16/367,081 · Granted Mar 8, 2022

System, method and interface for parallel processing of antimicrobial susceptibility tests using different samples

Inventors: Eric Stern (Charlestown, MA); Kelly Flentie (Charlestown, MA); Aleksandar Vacic (Charlestown, MA); Frederick P. Floyd, Jr. (Charlestown, MA)
Assignee: SELUX DIAGNOSTICS, INC.
C12Q1/18B01L3/0237B01L3/5085G01N33/56916G01N35/00732B01L2200/16B01L2300/0893G01N2035/0091
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Quick Facts
Patent No.
US 11,268,126
App. No.
16/367,081
Granted
Mar 8, 2022
Kind
B2
Abstract

An improved system, method and interface for automated rapid antimicrobial susceptibility testing (AST) is disclosed which includes, in one aspect, a carrier population station comprising a workstation having a graphic user interface (GUI). The GUI accepts information from a lab technologist, including information related to a scope of testing to be performed on a microorganism containing sample. The GUI controls intelligent assignment of microorganism containing samples to test panels in a manner that maximize utilization of the test carrier by grouping together samples of similar tests scopes and advantageously testing those samples using one multiplexed test panel. Customizing workflow in accordance with test scope to facilitate parallel processing of multiple samples advantageously reduces laboratory waste, decreases test latencies, increases AST system throughput and efficiency, and thus lowers the costs to the AST lab.

Claims (31)

1. A method for automated multiplex antimicrobial susceptibility testing (AST) comprising:

selecting an AST cartridge comprising:

384 or 1536 reservoirs;

8 or more different antimicrobials in dried form, each present at 4 or more different concentrations, wherein a plurality of antimicrobials at a plurality of concentrations are replicated in two or more reservoirs;

wherein a plurality of antimicrobial concentration ranges are present in dilution series;

wherein dilution series of different antimicrobials are present in geometric reservoir blocks on the cartridge; and

wherein antimicrobial replicates are present across the geometric reservoir blocks such that the AST cartridge comprises multiple antimicrobial blocks; and

wherein at least one reservoir per antimicrobial block comprises no antimicrobial agent; and

inoculating the AST cartridge with two or more distinct microorganism-comprising samples, such that each sample is inoculated into a distinct antimicrobial block;

incubating the cartridge under conditions promoting microorganism growth for a period between 2 and 12 hours;

performing one or more AST assays in a plurality of reservoirs;

optically interrogating a plurality of reservoirs; and

determining the minimum inhibitory concentration (MIC) for each microorganism-comprising sample for a plurality of antimicrobials on the cartridge.

2. The method of claim 1 , wherein 2, 3, 4, 5, 6, 7, or 8 different micro-organism comprising samples are inoculated into the AST cartridge.

3. The method of claim 1 , wherein the two or more distinct microorganism-comprising samples are of the same Gram type.

4. The method of claim 1 , wherein the two or more microorganism-comprising samples are inoculated into a plurality of reservoirs in the AST cartridge at approximately the same concentration.

5. The method of claim 1 , wherein two or more different nutrient broths are inoculated into different AST cartridge reservoirs.

6. The method of claim 1 , wherein each microorganism-comprising sample is inoculated at two or more different concentrations into the AST cartridge.

7. The method of claim 1 , wherein the one or more antimicrobial dilution series replicates on the AST cartridge are sufficiently similar to provide MICs for each antimicrobial for every microorganism-comprising sample under test.

8. The method of claim 1 , wherein one or more sufficient growth assays are performed during cartridge incubation.

9. The method of claim 8 , wherein a predetermined sufficient growth assay threshold must be achieved before AST assays are initiated.

10. The method of claim 9 , wherein the one or more sufficient growth assays associated with each microorganism-comprising sample on the AST cartridge each meet or exceed a pre-determined sufficient growth assay threshold before AST assays are initiated for the AST cartridge.

11. The method of claim 8 , wherein the one or more sufficient growth assays comprise one or more of an optical density read and/or a metabolic reagent formulation comprises a chemical capable of reduction by a plurality of bacteria.

12. The method of claim 1 , wherein no more than 90%, 95%, or 98% of the reservoirs are utilized to provide MIC results.

13. The method of claim 1 , wherein two or more AST assays are performed in a plurality of reservoirs on the AST cartridge.

14. The method of claim 1 , wherein a number of AST assay results used to determine the minimum inhibitory concentration (MIC) and/or a qualitative susceptibility result (QSR) is different for different antimicrobials.

15. The method of claim 1 , wherein at least one AST assay is selected from the group consisting of: a metabolic probe assay, a surface-binding probe assay, a chemical probe assay, a biochemical probe assay, an enzymatic biochemical probe assay, an ATP assay, a nucleic acid probe assay, a double-stranded nucleic acid probe assay, an optical density assay, a visual assay, and a pH molecular probe assay.

16. The method of claim 15 , wherein the metabolic probe assay comprises:

(a) the addition of a metabolic probe formulation to a plurality of reservoirs;

(b) an assay growth incubation period; and

(c) one or more of an absorbance, fluorescent, luminescent, or electrochemical read.

Assignments (2)
SECURITY INTEREST Recorded Jul 1, 2024
From: SELUX DIAGNOSTICS, INC.
To: OXFORD FINANCE LLC
Reel/Frame 068103/0559 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 14, 2021
From: STERN, ERIC; FLENTIE, KELLY; VACIC, ALEKSANDAR; FLOYD, FREDERICK P., JR.
To: SELUX DIAGNOSTICS, INC.
Reel/Frame 058379/0929 →
Continuity (2)
Provisional Application 62648819 · Mar 27, 2018
Related Publication 20190323057A1 · Oct 24, 2019