# US 12,000,847 B2 · Instrument for processing cartridge for performing assays in a closed sample preparation and reaction system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,000,847 B2 - Document ID: US12000847B2 - Status: Granted - Kind: B2 - Application number: 17/685,318 - Filed: 2022-03-02 - Published: 2022-12-01 - Granted: 2024-06-04 - Earliest claimed: 2016-09-19 - Assignees: Roche Molecular Systems, Inc. - Applicants: Roche Molecular Systems, Inc. - Inventors: Michael Thomas Nguyen; Sean Ford; Nikolas James Hansen - Web page: https://patentgrep.com/patent/US12000847B2 ## CPC - G01N 35/00732: {Identification of carriers, materials or components in automatic analysers} - B01L 3/502715: {characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces} - B01L 3/50273: {characterised by the means or forces applied to move the fluids} - B01L 3/502738: {characterised by integrated valves (throttle valves in microfluidic sample containers B01L3/502746)} - C12Q 1/6888: for detection or identification of organisms - G01N 35/00029: {provided with flat sample substrates, e.g. slides (G01N35/028 takes precedence)} - G01N 35/00871: {Communications between instruments or with remote terminals} - B01L 7/52: {with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples} - B01L 2200/04: Exchange or ejection of cartridges, containers or reservoirs - B01L 2200/10: Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept - B01L 2300/123: Flexible; Elastomeric - B01L 2300/18: Means for temperature control - B01L 2300/1822: using Peltier elements - B01L 2300/1827: using resistive heater - B01L 2400/0427: Electrowetting - B01L 2400/0481: squeezing of channels or chambers - B01L 2400/0683: mechanically breaking a wall or membrane within a channel or chamber - C12Q 1/686: Polymerase chain reaction [PCR] - G01N 2035/00148: {Test cards, e.g. Biomerieux or McDonnel multiwell test cards} - G01N 2035/00326: {Analysers with modular structure} - G01N 2035/00376: {Conductive heating, e.g. heated plates} - G01N 2035/00841: {results of the analyses} - G01N 2035/00851: {process control parameters} - G01N 2035/0477: {Magnetic} - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - B01L: CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE - C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES ## Abstract In one embodiment, a diagnostic system includes an instrument coupled to a client device and having at least one sample processing bay. The diagnostic system has a software architecture including instrument software (ISW) associated with the instrument. The ISW receives an assay definition file (ADF) that has a control file and an assay analysis module (AAM) file. The processing bay prepares and senses the sample according to parameters in the OPUS file and then generates sensor scan data. The diagnostic system then analyzes the sensor scan data and prepares a report according to the AAM file. ## Claims ### Claim 1 An apparatus for processing and analyzing a sample comprising: a system that comprises a sample processing bay and an assay analysis module (AAM), the system including a processor coupled to a non-transitory computer readable medium, the non-transitory computer readable medium storing instructions directing the processor to: receive and read an Assay Definition File (ADF) from an external source comprising control parameters for processing a fluid sample, sensing parameters that are a function of a particular molecular detection taking place in the apparatus, and analysis parameters for analyzing the data, wherein the analysis parameters comprise the selection of one or more digital filters to be applied from a group of two or more digital filters to process the data; send control instructions based on the control parameters and the sensing parameters to the sample processing bay; send analysis instructions based on the analysis parameters to the AAM; receive the sample; utilize the ADF to process the sample; sense an analyte or molecule; and report results from sensing. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the analysis parameters define the selection of two or more digital filters from the group of two or more digital filters to process the data. ### Claim 3 (depends on 1) The apparatus of claim 1, further comprising a component that can transmit/receive information to or from a Laboratory Information System (LIS). ### Claim 4 (depends on 1) The apparatus of claim 1, wherein the apparatus is configured to generate a result based on the analysis parameters and generate a detection report. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the apparatus is configured to receive a pending test order directly from a hospital LIS. ### Claim 6 (depends on 5) The apparatus of claim 5, wherein the apparatus is configured to process the sample based on the pending test order and the ADF. ### Claim 7 (depends on 4) The apparatus of claim 4, wherein the apparatus is configured to send the detection report to a component that can transmit/receive information to/from a LIS. ### Claim 8 (depends on 4) The apparatus of claim 4, wherein the apparatus is configured to send the detection report directly to a physician or to a hospital LIS. ### Claim 9 (depends on 4) The apparatus of claim 4, wherein the apparatus is configured to allow an operator to apply comments to the detection report. ### Claim 10 (depends on 1) The apparatus of claim 1, wherein the apparatus is configured to send control reports, system usage reports or service notification reports. ### Claim 11 An apparatus for processing and analyzing a sample comprising: a system that comprises a sample processing bay and an assay analysis module (AAM), the system including a processor coupled to a non-transitory computer readable medium, the non-transitory computer readable medium storing instructions directing the processor to: receive and read an ADF from an external source comprising a first set of control parameters for processing a fluid sample, sensing parameters that are a function of a particular molecular detection taking place in the apparatus, and analysis parameters, wherein the analysis parameters comprise the selection of one or more digital filters to be applied from a group of two or more digital filters to process the data; send control instructions based on the control parameters and the sensing parameters to the sample processing bay; and send analysis instructions based on the analysis parameters to the AAM. ### Claim 12 (depends on 11) The apparatus of claim 11, wherein the analysis parameters further comprise protocols for determining how to interpret digitally processed data, protocols for determining the presence of one or more targets, or report generators to analyze the data. ### Claim 13 (depends on 11) The apparatus of claim 11, wherein the analysis parameters further comprise the selection of at least a second digital filter from the group of two or more digital filters for analyzing the data. ### Claim 14 (depends on 11) The apparatus of claim 11, further comprising a sample processing bay having a sample preparation module to prepare the sample for detection according to a first set of the control parameters. ### Claim 15 (depends on 14) The apparatus of claim 14, wherein the sample processing bay operates a sample reaction module to detect a target analyte according to a second set of the control parameters. ### Claim 16 (depends on 11) The apparatus of claim 11, wherein the first set of control parameters define the operation of a blister compression assembly. ### Claim 17 (depends on 11) The apparatus of claim 11, wherein the ADF further comprises a second set of control parameters that define electrowetting parameters. ### Claim 18 An apparatus for processing and analyzing a sample comprising: a system that comprises a sample processing bay and an assay analysis module (AAM), the system including a processor coupled to a non-transitory computer readable medium, the non-transitory computer readable medium storing instructions directing the processor to: receive and read an ADF from an external source comprising a first set of control parameters for processing a fluid sample, sensing parameters for generating sense electrode data from the sample processing bay, and analysis parameters that define the selection of one or more digital filters to be applied from a group of two or more digital filters to process the sense electrode data, and optionally further define one or more of (1) which sense electrode data is to be analyzed, (2) which electrodes are to be processed for a given digital processing filter, (3) protocol for determining how to interpret digitally processed data, or (4) a protocol for determining the presence of one or more targets. ### Claim 19 (depends on 18) The apparatus of claim 18, wherein the sensing parameters are electrosensing parameters. ### Claim 20 (depends on 18) The apparatus of claim 18, wherein the sensing parameters comprise a number of electrons exchanged in a given redox reaction during detection or activation energy of a reaction measured in volts.