US-20260126371-A1 - MULTIMODAL ANALYTICAL SYSTEM FOR ANALYZING BIOLOGICAL FLUIDS

US20260126371A1US 20260126371 A1US20260126371 A1US 20260126371A1US-20260126371-A1

Abstract

A modular, point-of-care diagnostic system for analyzing blood is provided comprising a blood sample preparation module and one or more analytical modules including a hematology analysis module and a chemistry analysis module disposed within a housing. The system comprises common biological fluid handling hardware disposed in the housing and configured to convey blood samples or portions thereof between the blood sample preparation module, the one or more analytical modules, and a consumable reagent cartridge comprising one or more reagents for a first set of tests or controls. The system comprises common wash fluid handling hardware for preparing the common fluid handling hardware and fluid-contacting surfaces of the one or more analytical modules for interaction with a second consumable reagent cartridge containing reagents for a second set of tests or controls by the one or more analytical modules.

Inventors

Robert GRANIER
Daniel Morris HARTMANN
Jesse Newton Jones, IV
Anthony Lawrence Maida

Assignees

GENERAL FLUIDICS CORPORATION

Dates

Publication Date: 20260507
Application Date: 20251107

Claims (20)

1 . An analytical system for analyzing fluids, the system comprising: a fluid sample staging module disposed within a housing and configured to stage fluid samples for one or more analyses; one or more analytical modules disposed within the housing and comprising one or more of: a cytometry analysis module configured to perform particulate counts; a chemistry analysis module configured to perform chemistry assays; and an immunoassay analysis module configured to perform immunoassay testing; common fluid handling hardware disposed in the housing and configured to convey fluid samples or portions thereof between the fluid sample staging module, the one or more analytical modules, and a consumable reagent cartridge inserted into the housing, the consumable reagent cartridge comprising an array of wells accessible to the fluid handling hardware, the array of wells containing reagents for a first set of tests or controls by the one or more analytical modules; and common waste fluid and wash fluid handling hardware disposed in the housing and in fluid communication with the one or more analytical modules and the common fluid handling hardware, for cleaning the common fluid handling hardware and fluid-contacting surfaces of the one or more analytical modules before interaction with a second consumable reagent cartridge containing reagents for a second set of tests or controls by the one or more analytical modules.
2 . The analytical system of claim 1 , wherein the common waste fluid and wash fluid handling hardware is configured to clean the fluid handling hardware and fluid-contacting hardware of the one or more analytical modules between each set of tests by the one or more analytical modules for reuse of the fluid handling hardware with second and subsequent consumable reagent cartridges, each of the second and subsequent consumable reagent cartridges containing only enough reagents to operate respective second and subsequent set of tests or controls by the one or more analytical modules.
3 . The analytical system of claim 1 , wherein the one or more analytical modules disposed within the housing comprise two or more of: a cytometry analysis module configured to perform complete blood count analysis; a chemistry analysis module configured to perform clinical chemistry assays; and an immunoassay analysis module configured to perform immunoassay testing.
4 . The analytical system of claim 1 , wherein the fluid sample staging module is a plasma-preparation module configured to separate plasma or serum from whole blood samples.
5 . The analytical system of claim 1 , wherein the one or more analytical modules comprise a hematology analysis module configured to perform a complete blood count with 5-part differential, and a chemistry analysis module configured to perform one or more multiplexed panels of clinical chemistry assays, including a comprehensive metabolic panel (CMP).
6 . The analytical system of claim 1 , wherein the one or more analytical modules comprise a hematology analysis module that uses dual-angle Mie-scattering to measure the mean corpuscular hemoglobin concentration (MCHC), mean corpuscular volume (MCV), and mean platelet volume (MPV).
7 . The analytical system of claim 1 , wherein the one or more analytical modules comprise a cytometry analysis module comprising a flow cytometer.
8 . The analytical system of claim 1 , wherein the one or more analytical modules comprise a chemistry analysis module comprising a photometric module that determines the concentration of analytes through fluorescence and/or absorbance measurements through a fluid sample.
9 . The analytical system of claim 1 , wherein the one or more analytical modules comprise an immunoassay analysis module that performs magnetic-bead based chemiluminescent tests.
10 . The analytical system of claim 1 , wherein the common fluid handling hardware comprises one or more probes configured to aspirate and transfer fluids and/or reagents from the consumable reagent cartridge to the one or more analytical modules.
11 . The analytical system of claim 1 , wherein the common fluid handling hardware comprises at least two automated pipettors configured to operate independently, each of the two automated pipettors being mounted to a separate movable arm and/or gantry robot configured to move in two or three dimensions.
12 . The analytical system of claim 1 , further comprising: a control system disposed within the housing and configured to control the common fluid handling hardware and common waste fluid and wash fluid handling hardware to enable simultaneously or nearly simultaneously analyzing a single fluid sample using two more of the analytical modules.
13 . The analytical system of claim 1 , wherein the fluid handling hardware comprises one or more independently controllable pipette probes configured to: aspirate liquids from the consumable reagent cartridge; and transfer the aspirated liquids to vessels within the one or more analytical modules.
14 . The analytical system of claim 1 , wherein the consumable reagent cartridge: is made from a monolithic piece of molded or thermoformed plastic; and has one or more wells filled with one or more reagents useable by the one or more analytical modules; and wherein each well in the consumable reagent cartridge is independent and fluidically isolated from every other well in the consumable reagent cartridge, and wherein the consumable reagent cartridge is sealed with a pierceable foil seal covering its array of wells, making the array of wells and reagents therein accessible to the fluid handling hardware.
15 . A modular, point-of-care diagnostic system for analyzing blood, the system comprising: a blood sample preparation module disposed within a housing and configured to separate plasma or serum from whole blood samples; one or more analytical modules disposed within the housing and comprising one or more of: a hematology analysis module configured to perform particulate counts and perform a complete blood count analysis; and a chemistry analysis module configured to perform chemistry assays; common biological fluid handling hardware disposed in the housing and configured to convey blood samples or portions thereof between the blood sample preparation module, the one or more analytical modules, and a consumable reagent cartridge inserted into the housing, the consumable reagent cartridge comprising one or more reagents for a first set of tests or controls, the one or more reagents being accessible to the common biological fluid handling hardware for transfer to the one or more analytical modules; and common wash fluid handling hardware disposed in fluid communication with the one or more analytical modules and the common biological fluid handling hardware for preparing the common fluid handling hardware and fluid-contacting surfaces of the one or more analytical modules for interaction with a second consumable reagent cartridge containing reagents for a second set of tests or controls by the one or more analytical modules.
16 . A modular, point-of-care diagnostic system for analyzing blood, the system comprising: a blood sample preparation module disposed within a housing and configured to separate plasma or serum from whole blood samples; and two analytical modules disposed within the housing, comprising: a hematology analysis module configured to perform particulate counts and perform a complete blood count analysis; and a chemistry analysis module configured to perform chemistry assays.
17 . A modular analytical system for analyzing fluids, the system comprising: a fluid sample staging module disposed within a housing and configured to stage fluid samples for one or more analyses; two or more analytical modules disposed within the housing and comprising one or more of: a cytometry analysis module configured to perform particulate counts; a chemistry analysis module configured to perform chemistry assays; and an immunoassay analysis module configured to perform immunoassay testing; common fluid handling hardware disposed in the housing and configured to convey fluid samples or portions thereof between the fluid sample staging module, the one or more analytical modules, and a consumable reagent cartridge inserted into the housing, the consumable reagent cartridge comprising an array of wells accessible to the fluid handling hardware; common waste fluid and wash fluid handling hardware disposed in the housing and in communication with the two or more analytical modules and the common fluid handling hardware; and a controller configured to control the common fluid handling hardware to simultaneously interact with the two or more analytical modules, to generate a diagnostic report of a fluid sample based on outputs received from the two or more analytical modules, and to control the common wash fluid handling hardware to clean the common fluid handling hardware before analysis of a second fluid sample.
18 . The modular analytical system of claim 17 , wherein the controller is further configured to control the common fluid handling hardware to convey portions of a fluid sample from the fluid sample staging module to wells of the consumable reagent cartridge, and to simultaneously convey fluid from two or more wells of the consumable reagent cartridge to vessels of the two or more analytical modules.
19 . The modular analytical system of claim 17 , wherein the controller is further configured to control the common waste fluid and wash fluid handling hardware to clean the common fluid handling hardware and fluid-contacting surfaces of the two or more analytical modules between analyses of second and subsequent fluid samples using second and subsequent consumable reagent cartridges.
20 . The modular analytical system of claim 17 , wherein the controller is further configured to: use outputs from the two or more analytical modules to identify correlations between the outputs, organize the outputs relative to a particular diagnosis or set of diagnoses, or initiate or recommend additional analysis based on the outputs; and control the movement of fluid between the fluid sample staging module, wells of the consumable reagent cartridge, vessels of the two or more analytical modules to minimize time to produce the outputs from the two or more analytical modules.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S) This patent application claims the benefit of priority to U.S. Provisional Application No. 63/717,852, filed on Nov. 7, 2024, the entireties of which is incorporated herein by reference. TECHNICAL FIELD Various embodiments of the present disclosure relate generally to systems and methods for a multimodal analytical system and, more particularly, to systems and methods for a multimodal analytical system for analyzing biological fluids. BACKGROUND In vitro diagnostic tests are used throughout healthcare systems to identify, treat and monitor illness. In the majority of these clinical cases, a variety of tests are ordered which may include clinical chemistry, hematology and immunoassay tests. Currently, to perform these tests, multiple systems are required. For example, to perform a complete blood count (CBC), a hematology analyzer is required; to perform comprehensive metabolic panel (CMP), a chemistry analyzer is required; and to perform a cardiac panel, an immunoassay analyzer is required. In the case of very high-throughput equipment, chemistry and immunoassay testing has been integrated into a single instrument. However, these high-throughput systems are typically large, expensive, and designed for central laboratory environments with high sample volumes. They use bulk reagents for assays making the cost of ownership high, and require dedicated, trained staff to operate. Such systems are not suitable for point-of-care applications where space, cost, and operational complexity constraints exist. Existing point-of-care in vitro diagnostic products only offer a single testing modality, requiring users to operate multiple instruments to generate information used to support a clinical treatment decision. This approach results in increased operational complexity, higher costs, and longer turnaround times. Healthcare providers must maintain multiple instruments, each requiring separate training, maintenance, and quality control procedures. Similarly, for each instrument, providers must manage separate purchasing, inventory, and waste-stream management, resulting in additional overhead effort and expense. The separation of testing modalities also creates workflow inefficiencies during testing. Blood samples must be divided and processed through different instruments sequentially or in parallel. This process increases the risk of sample handling errors and extends the total time required to obtain comprehensive diagnostic results. Finally, because existing point-of-care instruments offer only single modalities, there is no way for any one instrument to provide a synergistic analysis of the multiple data sets being generated. For instance, many disease states require the results from both a chemistry and a hematology analyzer for an accurate diagnosis; for these diseases, the burden of combining and analyzing the results from both instruments falls exclusively on the healthcare provider; the instrument cannot provide a comprehensive dataset. To address these deficits, a number of multimodal point-of-care instruments are under development. These instruments typically make use of microfluidic, or “lab-on-chip” consumables that combine reagent storage, sample processing, and assay read-out on a disposable chip. These lab-on-chip consumables are not cleaned; waste products from the assays stay in the reaction chamber(s), and the entire consumable is disposed of. Some of these systems do use pipettors to aliquot the sample and transport it to the lab-on-chip disposable, but most of the assay processing is on the disposable cartridge. Although this approach may provide an attractively simple workflow, it comes with many limitations. First, lab-on-chip consumables tend to be costly. The reaction chambers and fluid channels that enable their function require post-molding assembly processes, such as inserting desiccated reagents, adding filters, and bonding covers. In some cases, the lab-on-chip consumables may also require assembly of additional components such as trocars, pipette tips, and read-chambers. These assembly operations add to the cost and complexity of the consumable. Second, the integration of tests into a microfluidic format often results in an unavoidable coupling of certain processing steps. For instance, some point-of-care devices use disc-shaped consumables which are spun in order to drive reagent transfers and mixing. Since every assay on the consumable is subjected to the same spin-operations at the same times, the process-flow for each assay must be tolerant of these bulk processing steps. This introduces unnecessary complexity to the workflow and may result in inefficiencies in process timing. The complexity of the consumables and the coupling of certain process flow steps drives a third limitation of such systems, which is a lack of flexibility. Adding a new assay to a lab-on-chip system may require a brand-new consumable with new molded features. It may furt