Description:FIELD OF INVENTION
[0001] The present invention relates to point-of-care diagnostic testing systems, and more particularly to a unified modular point-of-care diagnostic analyzer, method of operating the analyzer, and disposable assay carriers configured for multi-modal optical detection with manifest-driven auto-configuration and release-blocking verification to enable robust, interpretable diagnostics across diverse test types in resource-limited environments.
BACKGROUND OF THE INVENTION
[0002] Point-of-care testing (POCT) systems enable rapid diagnostic analysis at or near the patient location, providing immediate results that can guide clinical decision-making without the delays associated with centralized laboratory testing. These systems typically employ optical detection methods such as colorimetry, fluorescence, absorbance, and turbidimetry to analyze biological samples including blood, urine, and other bodily fluids. Traditional POCT devices often focus on single-parameter testing or utilize dedicated instruments for specific optical modalities, requiring healthcare providers to maintain multiple analyzers for comprehensive diagnostic capabilities.
[0003] The growing demand for decentralized healthcare, particularly in resource-limited settings and emergency situations, has highlighted the need for versatile diagnostic platforms that can perform multiple test types while maintaining accuracy and reliability. Modern POCT systems increasingly incorporate digital imaging sensors, programmable illumination sources, and automated sample handling to reduce operator dependency and improve reproducibility. However, existing solutions face several technical and operational challenges that limit their effectiveness in diverse clinical environments.
[0004] Conventional POCT analyzers typically require manual configuration for each test type, including wavelength selection, exposure settings, and quality control parameters. This manual setup process introduces potential for operator error and increases the complexity of device operation, particularly in settings where trained laboratory personnel may not be available. The lack of automated configuration systems results in inconsistent test performance and reduced reliability of diagnostic outcomes.
[0005] Many existing POCT devices lack robust quality control mechanisms and verification systems that can detect and prevent the release of unreliable results. Without real-time verification of sample quality, optical stability, and cross-modality confirmation, these systems may produce false results that could compromise patient safety. The absence of release-blocking verification logic means that unstable, noisy, or out-of-specification measurements may be reported without appropriate quality gates.
[0006] Current POCT platforms often suffer from limited connectivity and data management capabilities, particularly in environments with unreliable internet access. Many systems require continuous cloud connectivity for operation and result reporting, making them unsuitable for use in remote locations or during network outages. The lack of offline-capable operation and secure local data storage limits the deployment of these systems in resource-constrained settings where connectivity infrastructure may be inadequate.
[0007] Environmental factors such as ambient lighting, temperature variations, and mechanical vibrations can significantly affect the performance of optical diagnostic systems. Existing POCT analyzers often lack adequate compensation mechanisms for these environmental influences, leading to drift in measurement accuracy over time. The absence of adaptive correction systems and environmental monitoring capabilities reduces the reliability of these devices in field deployment scenarios.
[0008] Patent document US2015/0224499A1 discloses a point-of-care testing device with automated sample processing and optical detection capabilities for analyzing biological samples. The system includes a sample processing unit with microfluidic channels, optical detection components with LED illumination and photodetectors, and automated fluid handling mechanisms for reagent mixing and sample preparation. The device performs colorimetric and fluorescence-based assays with digital image capture and automated result interpretation. However, this system lacks manifest-driven auto-configuration with cryptographically signed parameters, release-blocking verification mechanisms that compute orthogonality certificates from cross-modality agreement, and multi-modal optical detection spanning ultraviolet to near-infrared wavelengths with time-synchronized dual-sensor capture that would enhance diagnostic reliability and prevent erroneous result release in resource-limited environments.
[0009] Patent document EP3516401B1 describes a point-of-care diagnostic device for analyzing biological samples using optical detection methods. The system includes a sample processing chamber with integrated microfluidics, LED-based illumination sources for colorimetric and fluorescence measurements, photodetector arrays for signal capture, and automated fluid handling for reagent delivery and mixing. The device incorporates image processing algorithms for automated result interpretation and wireless connectivity for data transmission to external systems. However, this system lacks unified multi-modal optical detection with manifest-driven auto-configuration, release-blocking verification mechanisms that enforce orthogonality certificates based on cross-modality consensus, and offline-capable operation with secure store-and-forward synchronization that would enable robust diagnostic performance in resource-limited environments where connectivity may be intermittent.
[0010] Keeping in view the challenges associated with the state of art, there is a need for a unified modular point-of-care diagnostic analyzer that combines multi-modal optical detection capabilities with manifest-driven auto-configuration and release-blocking verification systems. Such a solution would provide automated hardware configuration, real-time quality control with cross-modality validation, and offline-capable operation with secure data export, thereby enabling robust and interpretable diagnostics across diverse test types while reducing operator dependency and enhancing patient safety in resource-limited environments.
OBJECTIVE OF THE INVENTION
[0011] The primary objective of the present invention is to provide a unified, modular point-of-care diagnostic analyzer that combines multi-modal optical and electrochemical detection with manifest-driven auto-configuration, spanning approximately 365–1650 nm with filter-optional and tunable spectral selection, to reduce operator dependency across diverse test types.
[0012] Another objective is to implement release-blocking verification (RBV) that computes an Orthogonality Certificate (OC) from QC-zone integrity, kinetic stability, and inter-modality agreement, compares the OC to a manifest-declared threshold Smin, and blocks result release unless OC ≥ Smin to enhance patient safety.
[0013] Another objective is to enable orthogonal confirmation via a SecondaryMethod executed without repositioning the sample, including time-synchronized dual-sensor top/bottom capture for reflectance and transmission to improve diagnostic accuracy and reliability.
[0014] Another objective is to provide offline-capable operation with secure store-and-forward, encrypted local storage, and standards-based export (e.g., HL7/FHIR/JSON/PDF), together with secure boot, signed updates, and immutable audit logs for integrity and compliance.
[0015] Another objective is to incorporate adaptive environmental compensation using temperature, humidity, and pressure sensors; ambient-light rejection via time-coded illumination and synchronous demodulation; time-resolved fluorescence (TRF) gating; high-dynamic-range (HDR) fusion; and motion/bubble sentinels to maintain accuracy in field deployments.
[0016] Another objective is to integrate an electrochemical module for potentiometry, amperometry, and impedance spectroscopy time-aligned to optical frames, with proportionality and inflection-time checks for cross-channel verification and fused decision-making.
[0017] Another objective is to deliver high throughput and biosafety via a rotary loader with indexed positions, presence detection, and contamination-preventing interlocks for sequential, automated sample processing.
[0018] Another objective is to enforce single-use and deter counterfeits through cryptographically signed manifests, monotonic counters, per-run nonces, and one-time run tokens recorded in immutable audit trails.
[0019] Another objective is to provide calibration robustness through lot-warp transforms that align lot-specific responses without changing clinical decision thresholds, inter-instrument normalization using calibration-lineage tokens, and SI-traceable transfer procedures.
[0020] Another objective is to integrate explainable AI interpretation with overlays, ROI heatmaps, kinetic plots, and confidence metadata to provide transparent reasoning and enhance clinical trust and decision support.
[0021] Another objective is to offer a modular optical engine with programmable illumination and configurable selectors supporting at least sixteen modalities, including colorimetric reflectance, dual-wavelength ratiometry, absorbance/OD, turbidimetry, nephelometry, multi-angle scatterometry, continuous-wave fluorescence, TRF, chemiluminescence, polarization/anisotropy, reflectance interferometry, near-infrared spectroscopy/reflectance, lateral-flow line-scan with T/C ratioing, and electrochemical potentiometry, amperometry, and impedance.
[0022] Another objective is to implement panel-aware arbitration with reflex rules, sentinel pairs, and cross-marker concordance, enabling partial release under manifest-bounded degraded policies while blocking release on sentinel violations.
[0023] Another objective is to employ eco-compatible, single-use disposable carriers formed from biodegradable or recyclable polymers with optional barrier and anti-fog coatings, compatible with standard sterilization methods to reduce environmental impact.
[0024] Yet another objective is to maintain portability and ease of use in point-of-care settings where trained laboratory personnel may not be available, while ensuring consistent, reproducible performance across varied environments.
[0025] Other objectives and advantages of the present invention will become apparent from the following description taken in connection with the accompanying drawings, wherein, by way of illustration and example, the aspects of the present invention are disclosed.
SUMMARY OF THE INVENTION
[0026] In a first aspect, a point-of-care diagnostic analyzer is provided. The point-of-care diagnostic analyzer comprises: a sample interface configured to receive a disposable assay carrier; a machine-readable code reader (40) positioned to read an assay manifest on the disposable assay carrier; an optical engine (803) comprising at least one digital imaging sensor (208), a multi-wavelength LED illumination system, and at least one spectral selection element; a rotary loader including a central hub (400) with multiple cartridge slots (401) and an index marker (402) for positioning multiple disposable assay carriers at an active position (403) for sequential processing; an electrochemical module configured to acquire potentiometric, amperometric, or impedance signals from electrodes on the disposable assay carrier and to time-align said signals with optical acquisitions for data fusion; and an electronic controller (804) operatively coupled to the code reader (40) and the optical engine (803), and configured to perform automated diagnostic analysis.
[0027] The disposable assay carrier may be selected from a cartridge or a test tube. The assay manifest may comprise a digitally signed payload encoding assay-specific parameters, including optical modalities, illumination schedules, spectral selection, exposure timing, quality-control thresholds, and inference model references. The at least one digital imaging sensor (208) may have a minimum of 12-bit quantization. The multi-wavelength LED illumination system may include wavelengths ranging from ultraviolet to near-infrared.
[0028] The spectral selection element may be selected from a filter wheel, an indexed filter cassette, a tunable filter, or a polarization selector. The electronic controller (804) may be further configured to authenticate and parse the manifest and configure hardware and software modules accordingly; execute, without repositioning the sample, a sequence comprising a primary optical modality and an orthogonal SecondaryMethod scheduled by the manifest; acquire images per modality and apply deterministic pre-processing including dark-frame correction, flat-field normalization, and fiducial-based homography for region-of-interest alignment; generate provisional results by applying signal quantification and calibration lookup together with at least one of statistical or machine-learning inference; apply release-blocking quality-control logic including kinetic-stability checks, agreement between primary and SecondaryMethod modalities, and verification of target control zones; generate a structured diagnostic report with overlays and confidence metadata and export said report in a standards-based format; perform ambient-light rejection by time-coded illumination and synchronous demodulation; and modulate illumination timing, exposure, or decision thresholds responsive to environmental sensors for temperature, humidity, or pressure.
[0029] The sample interface may comprise a dual-chamber configuration including a cartridge chamber door (14) and a tube chamber door (16), wherein interlocked doors prevent simultaneous opening of both chambers. The optical engine (803) may comprise a top image sensor (1101) and a bottom sensor housing (1103) positioned on opposed sides of the disposable assay carrier for time-synchronized orthogonal capture of reflectance and transmission measurements. The multi-wavelength LED illumination system may comprise LED elements (508) at wavelengths selected from 365 nm, 405 nm, 450 nm, 525 nm, 560 ±10 nm, 590 ±10 nm, 630 nm, 660 nm, 740 nm, 850 ±15 nm, 950 nm, 1050 ±20 nm, 1250 nm, 1300 ±25 nm, 1450 nm, and 1550–1650 nm, each programmable for intensity, duty cycle, and sequence. The spectral selection element may comprise a filter wheel assembly including a rotation hub (600), a filter wheel disk (601) with multiple filter positions (F1–F4), a motor drive (602), and a position sensor (606) for indexed positioning of optical filters.
[0030] In a second aspect, a disposable assay carrier for use with the point-of-care diagnostic analyzer is provided. The disposable assay carrier comprises: a carrier body configured as a cartridge or test tube; a sample inlet (703) for receiving biological samples; a machine-readable manifest (702) encoding assay-specific parameters for auto-configuration of the diagnostic analyzer; and an optical measurement region positioned for optical detection by the analyzer.
[0031] The carrier body may comprise a diagnostic cartridge (700) including a first reagent blister (710), a second reagent blister (711), a third reagent blister (712), a reaction chamber (714) with an optical window (715), a quality control chamber (718) with a quality control window (719), and a waste reservoir (720) connected by an outlet channel (722). The unified, modular architecture enables automated multi-modal optical detection with manifest-driven configuration, reducing operator dependency while providing release-blocking verification systems that enhance diagnostic reliability and patient safety across diverse test types, particularly in resource-limited or decentralized environments.
BRIEF DESCRIPTION OF FIGURES
The present invention will be better understood after reading the following detailed description of the presently preferred aspects thereof with reference to the appended drawings, in which the features, other aspects and advantages of certain exemplary embodiments of the invention will be more apparent from the accompanying drawing in which:
[0032] FIG. 1 is a front perspective view of the point-of-care diagnostic analyzer showing the sample interface with cartridge chamber door (14) and tube chamber door (16), and the machine-readable code reader (40) positioned for manifest scanning;
[0033] FIG. 2 is a sectional view of the optical engine showing the sealed housing (201), digital imaging sensor (208), and control board (210) for electronic processing;
[0034] FIG. 3 is an exploded view of the optical assembly showing the optical window (301), LED ring (302), filter plate (303), lens group (304), lens barrel (305), focusing ring (306), and coupling mount (307);
[0035] FIG. 4 is a top view of the rotary loader showing the central hub (400), multiple cartridge slots (401), index marker (402), active position (403), and queue positions (404) for sequential sample processing;
[0036] FIG. 5 is a perspective view of the LED illumination system showing the LED ring array (501), main housing (502), heat dissipation sleeve (503), and electrical connector (504);
[0037] FIG. 5A is a sectional view of the illumination module showing the central aperture (505), LED array ring (506), mounting ring (507), LED elements (508), substrate (509), protective ring (510), electrical connector (511), and housing wall (512);
[0038] FIG. 6 is an exploded view of the filter wheel assembly showing the rotation hub (600), filter wheel disk (601) with filter positions (F1-F4), motor drive (602), actuator module (603), active filter slot (604), position sensor (606), and protective ring (607);
[0039] FIG. 7 is a plan view of the disposable assay carrier showing the diagnostic cartridge (700), machine-readable manifest (702), sample inlet (703), reagent blisters (710, 711, 712), reaction chamber (714) with optical window (715), quality control chamber (718) with quality control window (719), waste reservoir (720), and outlet channel (722);
[0040] FIG. 8 is a detailed view of the thermal management system showing the LED array (901), circular substrate (902), control board (903), heat spreader (904), and white LED (905);
[0041] FIG. 9 is an alternative view of the motorized filter assembly showing the central hub (1001), filter disk (1002), motor actuator (1003), filter slots (1004), position sensor (1010), and protective housing (1011);
[0042] FIG. 10 is a sectional view of the dual-sensor optical detection configuration showing the top image sensor (1101), optical window (1102), bottom sensor housing (1103), backlight source (1104), illumination array (1105), filter module (1106), fiducial marker (1107), and cartridge body (1108).
DETAILED DESCRIPTION
[0043] The following description describes various features and functions of the disclosed system. The illustrative aspects described herein are not meant to be limiting. It may be readily understood that certain aspects of the disclosed system can be arranged and combined in a wide variety of different configurations, all of which have not been contemplated herein.
[0044] Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
[0045] Features that are described and/or illustrated with respect to one embodiment may be used in the same way or in a similar way in one or more other embodiments and/or in combination with or instead of the features of the other embodiments.
[0046] The terms and words used in the following description are not limited to the bibliographical meanings, but, are merely used to enable a clear and consistent understanding of the invention. Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustrative purposes only and not for the purpose of limiting the invention.
[0047] It is to be understood that the singular forms “a”, “an” and “the” include plural referents unless the context clearly dictates otherwise.
[0048] It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, steps or components but does not preclude the presence or addition of one or more other features, steps, components or groups thereof. The equations used in the specification are only for computation purpose. As used herein, “SecondaryMethod” denotes a modality that is orthogonal to the primary modality and used for independent verification; “Orthogonality Certificate (OC)” denotes a composite metric derived from QC-zone integrity, kinetic stability, and inter-modality agreement; and “Smin” denotes a manifest-declared minimum assurance threshold for release-blocking verification (RBV).
[0049] Accordingly, the present invention relates to point-of-care diagnostic testing systems, and more particularly to a unified modular point-of-care diagnostic analyzer, method of operating the analyzer, and disposable assay carriers configured for multi-modal optical detection with manifest-driven auto-configuration and release-blocking verification to enable robust, interpretable diagnostics across diverse test types in resource-limited environments.
[0050] The point-of-care diagnostic analyzer comprises several interconnected components that work together to provide automated multi-modal diagnostic capabilities. Each component may be described in detail as follows:
[0051] Sample Interface
[0052] The sample interface provides a modular, carrier-agnostic configuration that accommodates different types of disposable assay carriers including cartridges and test tubes. As shown in FIG. 1, the sample interface comprises a cartridge chamber door (14) and a tube chamber door (16) that enable the analyzer to accept both cartridge-based and tube-based assay formats. The dual-chamber interface includes interlocked doors that prevent simultaneous opening of both chambers, thereby maintaining sample containment and preventing cross-contamination between different assay types. The sample interface incorporates presence sensing and optional mechanical/electronic interlocks for secure loading and contamination prevention. The interface is positioned at the front of the analyzer housing to provide convenient access for operators while maintaining proper sealing during analysis operations. The modular design enables safe, flexible handling of cartridges or tubes without re-instrumentation, allowing rapid multi-patient testing and plug-and-play recognition of assay carriers via manifest scanning.
[0053] Machine-Readable Code Reader
[0054] The machine-readable code reader (40) is strategically positioned to automatically read digitally signed, machine-readable manifests encoded on disposable assay carriers. As illustrated in FIG. 1, the QR code scanner (40) is integrated into the front panel of the analyzer to provide direct line-of-sight access to manifest codes on inserted carriers. The code reader (40) supports various encoding formats including QR codes, DataMatrix codes, RFID, NFC, and other machine-readable formats that contain cryptographically signed payloads encoding assay-specific parameters including optical modalities, illumination schedules, spectral selection, exposure timing, quality-control thresholds, and inference-model references. The positioning of the code reader (40) enables automatic manifest detection upon carrier insertion, triggering the auto-configuration sequence without requiring manual operator intervention. The reader validates manifest signatures with pre-installed keys and aborts testing upon failed validation, ensuring secure auto-configuration and preventing unauthorized or counterfeit cartridge usage.
[0055] Optical Engine
[0056] The optical engine (803) represents the core multi-modal detection system of the analyzer and comprises multiple integrated components for executing two or more optical detection modalities per assay. As depicted in FIG. 2, the optical engine includes at least one high-resolution digital imaging sensor (208) with ≥12-bit quantization (including CMOS or sCMOS) for precise optical measurements across multiple modalities including reflectance/colorimetry, dual-wavelength ratiometry, transmission/absorbance (OD), turbidimetry/nephelometry, fluorescence (continuous-wave or time-gated), chemiluminescence, polarization reflectometry, lateral-flow line-scan, kinetic rate measurement, and near-infrared reflectance. Collectively, the platform supports sixteen or more diagnostic modalities across optical and electrochemical domains, with manifest-driven scheduling and multi-modal fusion. The optical engine (803) incorporates a sealed housing (201) that protects sensitive optical components from environmental interference and provides light-sealed operation. FIG. 11 illustrates the dual-sensor configuration where the optical engine (803) comprises a top image sensor (1101) and a bottom sensor housing (1103) positioned on opposed sides of the disposable assay carrier for time-synchronized orthogonal capture of reflectance and transmission measurements, enabling cross-validation and modality fusion.
[0057] The multi-wavelength LED illumination system is implemented as shown in FIG. 5 and FIG. 5A, featuring a programmable LED ring array (501) with multiple LED elements (508) spanning ultraviolet to extended near-infrared. The LED elements (508) are mounted on a circular substrate (902) as shown in FIG. 9, with non-limiting wavelengths including 365 nm, 405 nm, 450 nm, 525 nm, 560 ±10 nm, 590 ±10 nm, 630 nm, 660 nm, 740 nm, 850 ±15 nm, 950 nm, 1050 ±20 nm, 1250 nm, 1300 ±25 nm, 1450 nm, and 1550–1650 nm, each programmable for intensity, duty cycle, and sequence timing. The system includes a high-CRI white LED (905) for broadband reflectance illumination and supports time-coded illumination with synchronous demodulation for ambient-light rejection. The illumination system incorporates active thermal management via heat spreader (904) and photometric feedback sensors to maintain intensity stability and spectral consistency across assays.
[0058] The spectral selection element comprises a filter wheel assembly as illustrated in FIG. 6, including a rotation hub (600), a filter wheel disk (601) with multiple filter positions (F1, F2, F3, F4), a motor drive (602), and a position sensor (606) for precise indexed positioning of optical filters. FIG. 10 shows an alternative filter disk (1002) configuration with a motor actuator (1003) and multiple filter slots (1004) for automated spectral selection. The system may alternatively employ tunable filters including acousto-optic tunable filters (AOTF) or liquid-crystal tunable filters (LCTF), or exchangeable filter cassettes, providing band-pass, long-pass, neutral-density, and polarization control for comprehensive spectral selection capabilities. In filter-optional embodiments, narrowband sources with intra-frame strobing and rolling-shutter lock-in can obviate dedicated emission filters for long-Stokes dyes.
[0059] Rotary Loader
[0060] The rotary loader provides automated high-throughput sample handling capabilities for sequential processing of multiple assay carriers with contamination-preventing interlocks. As shown in FIG. 4, the rotary loader includes a central hub (400) with multiple cartridge slots (401) arranged in a circular configuration for radial positioning. An index marker (402) indicates the active position (403) where optical analysis occurs, while additional queue positions (404) hold pending samples for sequential processing. The rotary loader incorporates indexed motor control with stepper-motor alignment, chamber presence detection, and biosafety interlocks. The system enables automated positioning of disposable assay carriers without manual repositioning, thereby reducing operator intervention and improving throughput efficiency in multi-sample clinical settings. The carousel supports indexed slot sensing and contamination-prevention mechanisms to maintain sample integrity across sequential analyses.
[0061] Electrochemical Module
[0062] The electrochemical module is integrated within the analyzer housing to provide complementary detection capabilities alongside optical measurements through electrochemical-optical fusion. This module is configured to acquire potentiometric signals for pH and ion-selective measurements, amperometric signals for enzymatic and redox reactions, and impedance signals for cellular analysis and sample characterization from micro-patterned electrodes embedded in the disposable assay carrier. The electrochemical module incorporates a miniature potentiostat and signal conditioning circuitry with analog-to-digital conversion capabilities to time-align electrochemical signals with optical acquisitions for data fusion. The module enables parallel or interleaved acquisition with optical capture, synchronized by the manifest, and subjects both channels to the same release-blocking verification logic. The system supports fused outputs at feature or decision level, with both optical and electrochemical channels required to pass release thresholds for enhanced diagnostic accuracy and cross-validation.
[0063] Electronic Controller
[0064] The electronic controller (804) serves as the central processing unit that coordinates all analyzer functions and performs automated diagnostic analysis through manifest-driven orchestration. As illustrated in the system architecture, the electronic controller (804) is operatively coupled to the code reader (40) and optical engine (803) through digital communication interfaces. The controller (804) may be realized on an embedded system-on-module (SOM) or single-board computer (SBC) based on ARM or x86 architectures, with optional hardware accelerators for neural-network inference including NVIDIA Jetson Orin modules, Google Coral Edge TPU, Hailo-8/8L accelerators, NXP i.MX 8M Plus, Texas Instruments AM62A series, Renesas RZ/V series (DRP-AI), Rockchip RK3588 (integrated NPU), Intel® Movidius-class VPUs, or functionally equivalent processors. FIG. 2 shows the control board (210) that houses the electronic controller (804) along with associated processing and communication circuitry. The electronic controller (804) executes a Universal Assay Runtime Engine (UARE) that compiles validated manifests into executable timelines for deterministic orchestration of acquisition, processing, and verification. The controller performs manifest authentication and parsing, hardware and software module configuration, LED/filter sequence execution, deterministic pre-processing including dark-frame correction and flat-field normalization, AI-assisted interpretation with explainable outputs, release-blocking quality-control logic with kinetic-stability checks and cross-modality validation, and structured diagnostic report generation with overlays and confidence metadata in standards-based formats including HL7/FHIR with secure store-and-forward capability for offline operation.
[0065] Primary System Embodiment
[0066] In the primary embodiment, the diagnostic analyzer comprises a dual-chamber sample interface with interlocked cartridge and tube doors, a multi-modal optical engine with programmable LED illumination spanning 365–1650 nm, and a motorized filter wheel assembly for spectral selection. The system incorporates a rotary loader with indexed positioning for high-throughput sequential processing of multiple assay carriers. The electronic controller executes the Universal Assay Runtime Engine (UARE) on an embedded system-on-module platform with optional AI accelerators for neural-network inference. This embodiment may support comprehensive diagnostic capabilities including colorimetry, fluorescence (CW/TRF), absorbance/OD, turbidimetry/nephelometry, scatterometry, polarization, chemiluminescence, and electrochemical detection through manifest-driven configuration, enabling automated multi-modal analysis with cross-validation between primary and orthogonal secondary modalities for enhanced diagnostic reliability.
[0067] Optical Assembly and Rotary Loader Embodiment
[0068] The optical assembly comprises a precision lens system as illustrated in FIG. 3, featuring an optical window (301) that provides a protective interface and wipe-clean surface for the measurement aperture. An LED ring (302) surrounds the optical window (301) to deliver uniform, near-coaxial illumination across the sample region. A filter plate (303) provides spectral selection capabilities in embodiments utilizing fixed optical filters for wavelength-specific measurements. The lens group (304) comprises multiple optical elements housed within a lens barrel (305) that maintains precise alignment and focal characteristics across the supported spectral range from ultraviolet to near-infrared wavelengths. A focusing ring (306) establishes the working distance during assembly to ensure consistent optical performance, while a coupling mount (307) provides mechanical interface to the image sensor assembly for maintaining optical axis alignment. The multi-wavelength LED illumination system may include a photometric feedback sensor such as a reference photodiode positioned to monitor illumination output and provide closed-loop correction of intensity drift, thereby maintaining photometric stability across the assay duration. The digital imaging sensor (208) incorporated within the optical assembly provides at least 12-bit quantization to ensure adequate dynamic range and measurement precision for quantitative diagnostic applications.
[0069] The rotary loader system provides automated sample handling capabilities through a mechanical carousel configuration as shown in FIG. 4. A central hub (400) serves as the rotational axis and structural foundation for the carousel mechanism, supporting multiple cartridge slots (401) arranged in a radial pattern around the hub circumference. Each cartridge slot (401) is dimensioned to securely hold disposable assay carriers while constraining tilt and maintaining proper optical alignment during measurement operations. An index marker (402) works in conjunction with position sensing systems to establish precise angular positioning and slot identification for automated sample selection. The carousel positions selected samples at an active position (403) where optical analysis occurs, while maintaining additional samples in queue positions (404) for sequential processing without manual intervention. The rotary loader incorporates stepper motor control for precise angular positioning and indexed slot advancement, enabling automated progression through multiple samples in high-throughput workflows.
[0070] The positioning mechanism includes contamination-preventing interlocks that ensure sample containment and prevent cross-contamination between different assay carriers during carousel operation. The system incorporates presence detection sensors that verify proper sample loading and positioning before initiating optical measurements. Mechanical interlocks prevent carousel rotation when the measurement chamber is open or when samples are improperly seated, maintaining biosafety protocols during automated operation. The carousel design enables sequential processing of multiple disposable assay carriers without requiring manual repositioning, thereby reducing operator intervention while maintaining sample integrity and measurement accuracy across the entire sample batch. The indexed positioning system ensures repeatable sample placement at the active position (403) for consistent optical path geometry and measurement reproducibility.
[0071] LED Illumination System Embodiment
[0072] The LED illumination system may be implemented with enhanced thermal management and photometric stability features as illustrated in FIG. 5 and FIG. 5A. FIG. 5 shows an LED ring array (501) integrated within a main housing (502) that provides mechanical support and electromagnetic shielding for the illumination components. The main housing (502) incorporates a heat dissipation sleeve (503) that conducts thermal load away from the LED elements to maintain photometric stability during extended operation. An electrical connector (504) provides power distribution and control signal routing to the LED array components. FIG. 5A provides a detailed sectional view of the illumination module architecture, showing a central aperture (505) that admits the optical beam path while an LED array ring (506) surrounds the measurement region to deliver uniform, near-coaxial illumination. The LED array ring (506) is secured to a mounting ring (507) that provides precise positioning and mechanical stability for individual LED elements (508). The LED elements (508) are mounted on a substrate (509) that incorporates electrical traces and thermal conduction pathways for heat dissipation. A protective ring (510) shields the LED elements (508) from environmental contamination and may function as an optical diffuser to enhance illumination uniformity. An electrical connector (511) routes drive power and control signals to the LED array components, while a housing wall (512) provides stray-light control and mechanical retention for the assembly.
[0073] The multi-wavelength LED illumination system comprises LED elements (508) at wavelengths selected from 365 nm, 405 nm, 450 nm, 525 nm, 560 ±10 nm, 590 ±10 nm, 630 nm, 660 nm, 740 nm, 850 ±15 nm, 950 nm, 1050 ±20 nm, 1250 nm, 1300 ±25 nm, 1450 nm, and 1550–1650 nm, each programmable for intensity, duty cycle, and sequence timing. The LED elements (508) span ultraviolet to extended near-infrared wavelengths to support comprehensive optical modalities including fluorescence excitation (CW/TRF), colorimetric analysis, absorbance measurements, scatterometry, polarization analysis, and near-/short-wave infrared reflectance applications. Each LED element (508) incorporates individual current control and pulse-width modulation capabilities to enable precise intensity regulation and temporal sequencing according to manifest-defined protocols. The system implements synchronous demodulation for time-coded illumination to reject ambient interference and flicker; typical TRF gates are ~20–800 µs with ≤10 µs jitter.
[0074] The thermal management system incorporates active temperature monitoring and adaptive power control to maintain spectral stability across varying environmental conditions. The heat dissipation sleeve (503) transfers thermal energy from the LED elements (508) to the main housing (502) and external heat sinks, preventing temperature-induced wavelength drift and intensity variations. The substrate (509) may incorporate thermal vias and copper traces to enhance heat conduction pathways from the LED elements (508) to the mounting ring (507) and heat dissipation sleeve (503). Photometric feedback sensors may be integrated within the illumination assembly to provide closed-loop intensity control and spectral monitoring. The feedback sensors monitor LED output in real-time and enable the electronic controller to compensate for aging effects, temperature variations, and component drift. The photometric feedback system maintains consistent illumination parameters across multiple assays and extends the operational lifetime of the LED elements (508) through adaptive power management.
[0075] The spectral selection system:
[0076] The spectral selection system provides programmable wavelength control through multiple implementation approaches to accommodate different performance requirements and cost constraints. As shown in FIG. 6, a filter wheel assembly comprises a rotation hub (600) that serves as the central mounting point for a filter wheel disk (601) containing multiple filter positions including a first filter position (F1), a second filter position (F2), a third filter position (F3), and a fourth filter position (F4) for discrete optical filter elements. A motor drive (602) coupled to an actuator module (603) provides precise rotational control to position selected filters at an active filter slot (604) within the optical path. A position sensor (606) reads index features on the filter wheel disk (601) to confirm slot identity and ensure repeatable positioning accuracy, while a protective ring (607) encloses the assembly to minimize contamination and stray light interference. FIG. 10 illustrates an alternative motorized filter assembly featuring a central hub (1001) supporting a filter disk (1002) with multiple filter slots (1004) for interchangeable optical elements. A motor actuator (1003) provides indexed positioning control, while a position sensor (1010) confirms alignment accuracy and a protective housing (1011) maintains environmental protection for the filter mechanism.
[0077] Alternative spectral selection implementations may employ tunable filter technologies including acousto-optic tunable filters (AOTF) driven by radio-frequency sources or liquid-crystal tunable filters (LCTF) actuated by liquid-crystal control voltages for rapid, vibration-free wavelength selection without mechanical motion. The tunable filter variants provide programmable bandwidth control and continuous wavelength adjustment across the supported spectral range from ultraviolet to near-infrared wavelengths. The spectral selection element may alternatively comprise indexed filter cassettes for field-replaceable spectral customization or polarization selectors including linear polarizers, quarter-wave plates, and polarization scramblers to enable polarization-sensitive measurements. The system supports band-pass, long-pass, neutral-density, and polarization control functions through the selected spectral selection mechanism, with manifest-driven configuration determining the appropriate filter sequence and timing for each assay type.
[0078] The disposable assay carrier comprises a diagnostic cartridge (700) as illustrated in FIG. 7, which provides a comprehensive sample processing platform configured for automated diagnostic analysis. The diagnostic cartridge (700) incorporates a machine-readable manifest (702) that encodes assay-specific parameters for auto-configuration of the diagnostic analyzer, implemented using QR codes, DataMatrix codes, RFID tags, or NFC tags with cryptographically signed payloads for security validation. A sample inlet (703) receives biological samples and directs specimen flow through integrated microfluidic channels to processing regions within the diagnostic cartridge (700). The diagnostic cartridge (700) includes a first reagent blister (710), a second reagent blister (711), and a third reagent blister (712) that contain pre-dispensed reagents in lyophilized or liquid form for specific assay chemistries. A reaction chamber (714) provides the primary analysis region where sample and reagents interact, covered by an optical window (715) that enables optical detection by the analyzer while maintaining sample containment. A quality control chamber (718) with a quality control window (719) provides on-carrier quality verification through control zones and reference standards. A waste reservoir (720) connected by an outlet channel (722) collects post-reaction fluids and maintains sealed containment of biological waste materials. The diagnostic cartridge (700) incorporates fiducial markers for geometric registration and maintains defined optical pathlength and region-of-interest positioning for repeatable measurement accuracy.
[0079] The disposable assay carrier may be formed from biodegradable or recyclable polymers including polylactic acid (PLA), polyhydroxyalkanoates (PHA), or recycled polyethylene terephthalate (rPET) with optional barrier layers including ethylene vinyl alcohol (EVOH) or silicon oxide (SiOx) coatings to enhance chemical resistance and optical clarity. Anti-fog coatings may be applied to optical surfaces to prevent condensation interference during temperature-sensitive assays. The diagnostic cartridge (700) maintains compatibility with ethylene oxide (EtO), gamma radiation, or plasma sterilization processes to ensure sterility for clinical applications while preserving optical performance and dimensional stability. The carrier body configuration supports both cartridge and test tube formats through modular design approaches that accommodate different sample volumes and assay requirements. The optical measurement region positioned within the diagnostic cartridge (700) provides standardized geometry for optical detection by the analyzer, with the optical window (715) and quality control window (719) fabricated from optical-grade materials that maintain transparency across ultraviolet to near-infrared wavelengths. The eco-compatible materials reduce environmental impact while maintaining diagnostic integrity and measurement accuracy throughout the assay process.
[0080] System Architecture and Thermal Management Embodiment
[0081] The system architecture incorporates comprehensive thermal management and power distribution capabilities as illustrated in FIG. 9, featuring a power management module (808) that provides regulated electrical power distribution to all analyzer subsystems including the optical engine (803), electronic controller (804), and illumination components. A thermal management module (809) monitors temperature conditions throughout the analyzer housing and implements active thermal control to maintain stable operating conditions for temperature-sensitive optical components. An LED array (901) comprises multiple LED elements arranged on a circular substrate (902) that provides electrical interconnection and thermal conduction pathways for heat dissipation. A control board (903) houses the electronic circuitry for LED current regulation, pulse-width modulation, and communication interfaces with the electronic controller (804). A heat spreader (904) transfers thermal energy from the LED array (901) to external heat sinks and the analyzer housing to prevent temperature-induced wavelength drift and intensity variations. A white LED (905) provides broadband illumination for colorimetric measurements and general sample visualization, integrated within the LED array (901) configuration for uniform illumination distribution.
[0082] The thermal management module (809) incorporates temperature sensors positioned throughout the analyzer housing to monitor ambient conditions and component temperatures, enabling the electronic controller (804) to modulate illumination timing, exposure parameters, and decision thresholds responsive to thermal variations. The system performs high-dynamic-range fusion by capturing multiple exposures at different gain and integration time settings, then combining the exposures to extend the dynamic range for high-contrast scenes where single-exposure imaging may result in saturation or insufficient signal levels. Motion gating functionality detects sample movement during acquisition through frame-to-frame comparison algorithms and temporal stability analysis, enabling the electronic controller (804) to compensate for sample movement by triggering re-acquisition or applying motion correction algorithms to maintain measurement accuracy. The analyzer includes bubble or foam detection capabilities using region-of-interest variance and turbidity metrics that analyze spatial intensity variations within the measurement region, with the ability to delay or repeat readings when bubbles are detected to ensure accurate optical measurements without interference from air inclusions or foam artifacts.
[0083] Dual-Sensor Optical Detection Embodiment
[0084] The dual-sensor optical detection configuration provides enhanced measurement capabilities through time-synchronized orthogonal capture of reflectance and transmission measurements as illustrated in FIG. 11. The optical engine (803) comprises a top image sensor (1101) positioned above an optical window (1102) to capture reflectance, fluorescence, polarization, and near-infrared measurements from the upper surface of the disposable assay carrier. A bottom sensor housing (1103) is positioned on the opposed side of the disposable assay carrier and aligned with a backlight source (1104) to enable transmission, optical density, turbidimetry, and scatter measurements through the sample. An illumination array (1105) provides programmable multi-wavelength excitation coordinated with a filter module (1106) for spectral selection and wavelength-specific measurements. The dual-sensor configuration eliminates temporal skew between reflectance and transmission measurements by capturing time-synchronized frames from both the top image sensor (1101) and bottom sensor housing (1103), enabling simultaneous acquisition of orthogonal optical modalities without sample repositioning or sequential measurement delays.
[0085] The system incorporates cross-path alignment and homography correction features through a fiducial marker (1107) integrated within a cartridge body (1108) that provides geometric reference points for precise spatial registration between the top image sensor (1101) and bottom sensor housing (1103) measurement planes. The fiducial marker (1107) enables the electronic controller (804) to perform fiducial-based homography correction that compensates for mechanical tolerances, optical distortion, and perspective differences between the dual sensor paths. The homography correction process aligns corresponding regions of interest between the top and bottom sensor images, enabling accurate cross-modality comparison and consensus validation. The backlight source (1104) provides calibrated illumination intensity for transmission measurements while the illumination array (1105) delivers excitation wavelengths for reflectance and fluorescence detection, with the filter module (1106) coordinating spectral selection for both optical paths. The dual-sensor architecture enables cross-validation between primary and orthogonal secondary modalities, improving measurement robustness against single-path failure modes and providing enhanced diagnostic confidence through modality fusion and agreement verification.
[0086] Multi-Modal Optical Detection Capabilities
[0087] The analyzer supports comprehensive multi-modal optical detection capabilities that enable quantitative analysis across diverse diagnostic assay types through programmable wavelength selection and mathematical signal processing algorithms. Reflectance colorimetry measurements utilize RGB color space analysis with mathematical transformation to CIELAB color space, where color differences are quantified using the formula ΔEab = √[(ΔL)² + (Δa*)² + (Δb*)²] to provide objective colorimetric assessment of chromogenic reactions in dipstick assays, glucose measurements, and bilirubin detection. Dual-wavelength ratiometry employs sequential illumination at two specific wavelengths λ₁ and λ₂ to calculate intensity ratios R = I(λ₁)/I(λ₂) that suppress matrix effects and background variations in hemoglobin analysis, creatinine measurements, and multi-analyte panels. Transmission absorbance measurements apply the Beer–Lambert relationship A = log10(I₀/I), where I represents transmitted intensity and I₀ represents reference intensity, enabling optical density quantification for enzymatic assays, protein analysis, and concentration-dependent measurements. Turbidimetry and nephelometry detection methods measure forward light scattering and ~90° scatter respectively to quantify immune complex formation and particle aggregation in C-reactive protein assays, latex agglutination tests, and immunoturbidimetric measurements. The analyzer supports lateral-flow line-scan capabilities with test-to-control ratio extraction through baseline-corrected profile analysis and geometric alignment correction, kinetic rate measurements with temporal derivatives ΔOD/Δt and ΔRFU/Δt calculations over manifest-defined time windows, polarization analysis using degree of linear polarization DoLP = (I∥ − I⊥)/(I∥ + I⊥) for structure-sensitive contrast and interference rejection, and chemiluminescence detection with photon emission capture from acridinium ester and luminol-based reactions through long-exposure integration and decay curve analysis.
[0088] Fluorescence detection encompasses both continuous-wave fluorescence for FITC-labeled lateral flow assays and time-gated fluorescence for europium and terbium chelate-based immunoassays, with background subtraction algorithms and spectral unmixing capabilities to isolate specific emission signals from complex sample matrices. Time-resolved fluorescence may be acquired using gate widths of approximately 20–800 µs with ≤10 µs timing jitter. Polarization anisotropy may be computed as r = (I∥ − G·I⊥)/(I∥ + 2·G·I⊥), where G is a calibration factor determined from the instrument response. Near-infrared reflectance detection utilizes wavelengths from ~740–1650 nm to minimize hemoglobin interference in whole blood samples, with VIS↔NIR normalization ratios providing enhanced measurement accuracy in turbid matrices.
[0089] The electronic controller (804) provides automated diagnostic analysis through manifest-driven orchestration implemented on an embedded system-on-module or single-board computer with optional AI accelerators including NVIDIA Jetson Orin modules, Google Coral Edge TPU, Hailo-8/8L accelerators, NXP i.MX 8M Plus, Texas Instruments AM62A series, or equivalent processors. The controller authenticates manifests, configures hardware modules, and executes primary and secondary optical modalities without sample repositioning. It applies deterministic pre-processing including dark-frame correction, flat-field normalization, and fiducial-based homography for alignment. Signal quantification uses calibration lookup tables and machine-learning inference to generate provisional results. The AI module provides explainable outputs including region-of-interest heatmaps and confidence visualizations. Quality control logic applies release-blocking verification including kinetic-stability checks and cross-modality agreement. The controller features adaptive auto-recapture with parameter adjustment and environmental compensation. It performs ambient-light rejection through time-coded illumination and generates structured reports in HL7/FHIR formats with secure offline operation.
[0090] Method of Operation Embodiment
[0091] A method of operating the point-of-care diagnostic analyzer comprises reading a machine-readable manifest on a disposable assay carrier, configuring optical hardware according to manifest parameters, executing multi-modal optical detection without repositioning the sample, processing acquired data through deterministic algorithms, applying release-blocking verification logic, and generating structured diagnostic reports with audit metadata.
[0092] In an exemplary embodiment, the method begins with:
[0093] reading machine-readable manifests encoded on disposable assay carriers using the machine-readable code reader (40), decoding digitally signed manifests containing assay-specific parameters including optical modalities, illumination schedules, spectral selection sequences, exposure timing, quality-control thresholds, and inference-model references using the electronic controller (804), validating manifest signatures with pre-installed cryptographic keys and aborting testing upon failed validation to ensure secure auto-configuration and prevent unauthorized cartridge usage, and parsing the manifest to extract configuration parameters and compile executable timelines for deterministic orchestration of acquisition, processing, and verification steps;
[0094] configuring optical hardware and software components in accordance with manifest parameters using the electronic controller (804), programming the multi-wavelength LED illumination system to execute specified wavelength sequences, intensity levels, and duty cycles according to manifest-defined protocols, positioning the spectral selection element to align appropriate optical filters, polarizers, or tunable filter settings for each measurement modality, configuring the digital imaging sensor (208) with exposure timing, gain settings, and acquisition parameters optimized for the specific assay requirements, and scheduling at least a primary optical modality and an orthogonal SecondaryMethod according to the manifest to enable cross-validation and consensus verification;
[0095] acquiring image frames using programmable LED illumination and spectral selection as specified by the manifest without moving the sample between modality acquisitions, executing time-sequenced illumination protocols where individual LED elements (508) are activated according to manifest-defined timing and intensity parameters, positioning the spectral selection element to match excitation and emission requirements for each optical modality, capturing frames with the digital imaging sensor (208) using manifest-specified exposure times and gain settings, acquiring both primary and secondary modality measurements through temporal sequencing or dual-sensor configurations, and incorporating synchronous demodulation for time-coded illumination to reject ambient interference and flicker, comparing modulated and unmodulated frames to extract assay-specific signals while suppressing background noise;
[0096] pre-processing images through deterministic correction algorithms including dark-frame subtraction, flat-field normalization, and fiducial-based homography for region-of-interest alignment, subtracting dark-frame reference frames captured without illumination from measurement frames to remove sensor noise and thermal artifacts, normalizing measurement frames against reference flat-field images captured with uniform illumination to compensate for illumination non-uniformity and optical vignetting, utilizing geometric reference markers on the disposable assay carrier to perform spatial registration and perspective correction through fiducial-based homography, and aligning regions of interest between different modality measurements and compensating for mechanical tolerances or sample positioning variations to enhance measurement accuracy and enable precise spatial correlation between primary and secondary modality acquisitions;
[0097] The exemplary method further incorporates synchronous demodulation for ambient rejection, HDR fusion for dynamic range extension, lot-warp and inter-instrument transforms for normalization, and orthogonality scoring for RBV, thereby improving robustness across varied matrices and environments.
[0098] applying analysis and inference procedures to derive provisional diagnostic results through signal quantification, calibration lookup, and statistical or machine-learning inference, extracting measurement values specific to each optical modality using signal quantification algorithms, including colorimetric analysis using calculations in CIELAB color space (e.g., ΔE*ab), calculating transmission absorbance measurements using A = log10(I₀/I) with baseline and pathlength correction, computing dual-wavelength ratiometry calculations using R = I(λ₁)/I(λ₂), quantifying fluorescence with background subtraction and spectral unmixing, estimating kinetic rates using slope calculations over manifest-defined time windows (e.g., ΔOD/Δt, ΔRFU/Δt), applying stored calibration curves and correction factors to convert raw measurement values to diagnostic units through calibration lookup procedures, and processing quantified signals using statistical inference algorithms and machine-learning models to generate provisional diagnostic results with associated confidence scores and quality control flags;
[0099] evaluating quality-control conditions through release-blocking verification logic that prevents result release unless specified criteria are satisfied, verifying measurement consistency over time using kinetic-stability checks with linearity analysis and drift detection algorithms, confirming agreement between primary and secondary modalities within manifest-defined tolerance limits (e.g., ratio/Δ thresholds or correlation), validating target control zones on the disposable assay carrier against expected reference values, analyzing on-carrier quality control regions, temporal stability metrics, and cross-modality consensus scoring to ensure measurement reliability, triggering adaptive auto-recapture with adjusted exposure, wavelength, filter selection, or gain parameters when quality control thresholds are not satisfied using the electronic controller (804), implementing bounded retry algorithms with escalating parameter adjustments, and placing tests in hold status with operator notification rather than result release when unresolved quality control failures occur;
[0100] generating diagnostic reports incorporating overlays, confidence metadata, and structured data export in standards-based formats, creating comprehensive diagnostic outputs including quantitative results, region-of-interest heatmaps showing spatial analysis regions, kinetic trajectory plots displaying temporal measurement behavior, confidence-trend visualizations indicating measurement reliability, and machine-reasoning summaries explaining inference logic, exporting reports in standards-based formats including HL7/FHIR for healthcare information system integration, PDF for human-readable documentation, and JSON for structured data exchange using the electronic controller (804), incorporating secure store-and-forward synchronization for offline operation with encrypted result queuing when network connectivity is unavailable and automatic transmission upon connectivity restoration, including integrity hashes and immutable audit records containing device identifiers, model versions, timestamps, operator logs, and manifest hashes for regulatory compliance and post-hoc traceability, and associating device identifiers, operator information, timestamps, manifest hashes, model versions, and configuration events with each diagnostic result through immutable audit trails to enable post-hoc traceability and regulatory compliance verification;
[0101] mplementing adaptive error recovery through bounded retry mechanisms that automatically adjust acquisition parameters when quality control criteria are not satisfied, modifying exposure timing, LED wavelength selection, optical filter positioning, or sensor gain settings within manifest-defined parameter ranges using the electronic controller (804), repeating acquisition sequences to achieve acceptable measurement quality, detecting sample movement during acquisition through frame-to-frame comparison algorithms using motion gating functionality, triggering re-acquisition when movement artifacts are detected, analyzing region-of-interest variance and turbidity metrics using bubble or foam detection algorithms to identify air inclusions or foam artifacts, implementing delayed or repeated measurements to avoid interference with optical detection, and maintaining diagnostic accuracy while accommodating variable sample conditions and environmental factors that may affect measurement quality through the adaptive recovery process.
[0102] Table 1: System Modules and Functions
Ref No. Module / Step Function
800 Patient Sample Input Introduction of biological sample (blood, urine, swab extract, etc.) into cartridge.
801 Diagnostic Cartridge Microfluidic routing of sample into reaction chambers containing reagents.
802 Cartridge Holder Module Secures and aligns cartridge in analyzer; provides interface for optics/electronics.
803 Optical Engine Provides illumination (LEDs) and captures assay signals through filters, lenses, and sensors.
804 Control Electronics Processes signals (MCU/SoC), controls LEDs, filter wheels, motors, and synchronization.
805 AI-Based Interpretation Analyzes optical data, classifies results, and applies diagnostic algorithms.
810 Quality Control (QC) / Error Detection Validates cartridge integrity, checks calibration, ensures test validity, flags errors.
811 Report Generation / Data Export Converts results into PDF, JSON, LIS/EHR-compatible formats for clinical reporting.
806 User Interface Displays results, provides operator control, ensures clinical usability.
807 Connectivity Module (Branch from 804) Communicates with LIS, EHR, or cloud; enables remote physician access and data transfer.
808 Power Management (Branch from 804) Regulates and distributes stable power to all analyzer modules.
809 Thermal Management (Branch from 804) Maintains stable optical/electronic operating conditions through cooling/heating.
[0103] In an embodiment, the advantages of the present invention are discussed herein:
[0104] (a) the present invention provides automated manifest-driven hardware configuration reducing operator dependency and setup errors through digitally signed manifests that encode assay-specific parameters including optical modalities, illumination schedules, spectral selection, exposure timing, quality-control thresholds, and inference-model references, enabling the electronic controller to automatically configure LED wavelength sequences, filter positioning, sensor parameters, and analysis protocols without manual intervention, thereby eliminating human error in parameter selection and ensuring consistent assay execution across different operators and testing environments;
[0105] (b) the present invention enables multi-modal optical detection within a single platform eliminating need for multiple analyzers by incorporating programmable LED illumination spanning ultraviolet to extended near-infrared wavelengths, spectral selection elements, and high-resolution digital imaging sensors capable of executing reflectance colorimetry, dual-wavelength ratiometry, transmission absorbance, turbidimetry, nephelometry, continuous-wave fluorescence, time-gated fluorescence, chemiluminescence, polarization reflectometry, lateral-flow line-scan, kinetic rate measurement, scatterometry, and near-/short-wave infrared reflectance within one unified instrument, reducing capital expenditure, spatial footprint, and operator training requirements while increasing diagnostic flexibility;
[0106] (c) the present invention implements release-blocking verification with cross-modality validation preventing unreliable results through quality-control logic that evaluates kinetic-stability checks, agreement between primary and secondary modalities within manifest-defined tolerance limits, verification of target control zones on disposable assay carriers, temporal stability metrics, and cross-modality consensus scoring, automatically triggering adaptive auto-recapture with adjusted parameters or placing tests in hold status rather than releasing potentially inaccurate diagnostic results, thereby enhancing patient safety and diagnostic reliability;
[0107] (d) the present invention supports offline-capable operation with secure data export suitable for resource-limited environments through store-and-forward synchronization that enables complete test execution, verification, and standards-based report generation without continuous internet connectivity, incorporating trusted boot, signed firmware and model packages, encrypted result queuing, and HL7/FHIR-compatible data export with immutable audit trails, addressing connectivity constraints in decentralized healthcare settings where reliable internet access may be unavailable;
[0108] (e) the present invention provides environmental adaptation through sensor monitoring and parameter adjustment by incorporating temperature, humidity, and pressure sensors that enable the electronic controller to modulate illumination timing, exposure parameters, and decision thresholds responsive to environmental variations, implementing thermal management for LED stability, motion gating for sample movement detection, and bubble detection algorithms for air inclusion identification, maintaining measurement accuracy under variable field conditions and mobile deployment scenarios;
[0109] (f) the present invention delivers enhanced diagnostic accuracy through orthogonal confirmation between primary and secondary modalities by executing time-synchronized or time-sequenced acquisition of different optical detection methods without sample repositioning, enabling cross-validation between reflectance and transmission measurements, continuous-wave and time-gated fluorescence, or colorimetry and absorbance detection, providing consensus verification that improves robustness against single-path failure modes and increases diagnostic confidence through modality fusion;
[0110] (g) the present invention offers eco-compatible disposable carriers reducing biomedical waste burden through biodegradable or recyclable polymer construction including polylactic acid, polyhydroxyalkanoates, or recycled polyethylene terephthalate with optional barrier layers and anti-fog coatings, maintaining optical performance and sterilization compatibility while reducing environmental impact compared to conventional non-biodegradable plastic consumables, addressing sustainability concerns in healthcare waste management;
[0111] (h) the present invention enables explainable AI outputs with confidence metadata improving clinical trust through region-of-interest heatmaps, kinetic trajectory plots, confidence-trend visualizations, and machine-reasoning summaries that provide transparency into diagnostic decision-making processes, incorporating statistical inference algorithms and machine-learning models with interpretable outputs that enable healthcare providers to understand measurement reliability, spatial analysis regions, temporal behavior, and inference logic, thereby facilitating clinical verification and regulatory compliance in AI-assisted diagnostic applications.
[0112] While this invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims.
, Claims:. A point-of-care diagnostic analyzer comprising:
• a sample interface configured to receive a disposable assay carrier;
• a machine-readable code reader positioned to read an assay manifest on the disposable assay carrier, the assay manifest comprising a digitally signed payload encoding assay-specific parameters;
• an optical engine comprising at least one digital imaging sensor, a multi-wavelength illumination system, and at least one spectral selection element;
• a rotary loader including a central hub (400) with multiple cartridge slots (401) and an index marker (402) for positioning multiple disposable assay carriers at an active position (403) for sequential processing;
• an electrochemical module configured to acquire potentiometric, amperometric, or impedance signals from electrodes on the disposable assay carrier and to time-align the signals with optical acquisitions for data fusion; and
• an electronic controller (804) operatively coupled to the code reader (40) and the optical engine (803) and configured to perform automated diagnostic analysis.
2. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the analyzer supports multiple optical modalities selected from colorimetric reflectance, dual-wavelengthratiometry, transmission absorbance, turbidimetry, nephelometry, multi-angle scatterometry, continuous-wave fluorescence, time-resolved fluorescence, chemiluminescence, polarization reflectometry, reflectance interferometry, near-infrared spectroscopy, lateral-flow line-scan, electrochemical potentiometry, electrochemical amperometry, and electrochemical impedance.
3. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the disposable assay carrier is selected from a cartridge or a test tube.
4. The point-of-care diagnostic analyzer as claimed in claim 1, wherein said assay manifest comprises assay-specific parameters including optical modalities, illumination schedules, spectral selection, exposure timing, quality-control thresholds, and inference-model references.
5. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the at least one digital imaging sensor has a minimum of 12-bit quantization.
6. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the multi-wavelength illumination system spans approximately 365–1650 nm.
7. The point-of-care diagnostic analyzer as claimed in claim 6, wherein the multi-wavelength illumination system includes LED elements at wavelengths selected from 365 nm, 405 nm, 450 nm, 525 nm, 560 ±10 nm, 590 ±10 nm, 630 nm, 660 nm, 740 nm, 850 ±15 nm, 950 nm, 1050 ±20 nm, 1250 nm, 1300 ±25 nm, 1450 nm, and 1550–1650 nm.
8. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the at least one spectral selection element is selected from a filter wheel, an indexed filter cassette, a tunable filter, or a polarization selector.
9. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the sample interface comprises a dual-chamber configuration including a cartridge chamber door and a tube chamber door, wherein interlocked doors prevent simultaneous opening of both chambers.
10. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the optical engine comprises a top image sensor and a bottom sensor housing positioned on opposed sides of said disposable assay carrier for time-synchronized orthogonal capture of reflectance and transmission measurements.
11. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the electronic controller generates a structured diagnostic report including per-region overlays, kinetic plots, explainable-AI metadata, and is exportable in PDF, JSON, and HL7/FHIR formats.
12. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the electronic controller (804) executes a Universal Assay Runtime Engine (UARE) configured to interpret the manifest and schedule LED/laser channels, sensor captures, spectral selection, and model paths.
13. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the analyzer comprising secure store-and-forward synchronization for offline operation and audit integrity, including hash validation of firmware, models, manifests, and exported result files with immutable audit records.
14. The point-of-care diagnostic analyzer as claimed in claim 1, further comprising a photometric feedback sensor positioned to monitor illumination output and provide closed-loop correction of intensity drift.
15. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the disposable assay carrier comprises fiducial markings for geometric registration and on-carrier QC zones referenced by verification logic.
16. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the housing incorporates comprising environmental sensors for temperature, humidity, or pressure, and the electronic controller (804) modulates illumination timing, exposure, or decision thresholds responsive to the sensors.
17. The point-of-care diagnostic analyzer as claimed in claim 1, wherein, in a filter-optional embodiment, narrowband sources with intra-frame strobing synchronized to a rolling shutter enable lock-in demodulation and emission-filter-free capture for long-Stokes fluorescence.
18. The point-of-care diagnostic analyzer as claimed in claim 1, wherein the electronic controller applies lot-warp transforms to align lot-specific responses to an instrument baseline and performs inter-instrument normalization using calibration-lineage tokens.
19. The point-of-care diagnostic analyzer as claimed in claim 1, wherein single-use of the disposable assay carrier is enforced by a manifest-encoded monotonic counter and per-run nonce, and the analyzer writes a one-time token after a successful run.
20. The point-of-care diagnostic analyzer as claimed in claim 1, further comprising secure boot, signed updates, and mutually authenticated links, wherein the analyzer exports results in HL7/FHIR/JSON/PDF with store-and-forward capability.
21. A method of operating the analyzer as claimed in claim 1, comprising:
a) receiving a disposable assay carrier bearing a digitally signed manifest and verifying the signature with pre-installed keys;
b) configuring optical hardware and software in accordance with manifest parameters;
c) acquiring image frames using programmable illumination and spectral selection without moving the sample;
d) pre-processing by dark-frame subtraction, flat-field correction, and fiducial-based alignment;
e) applying analysis and inference to derive a provisional diagnostic result;
f) evaluating quality-control conditions including kinetic consistency and modality agreement; and
g) releasing a diagnostic report upon meeting quality thresholds.
22. The method as claimed in claim 21, wherein the applying analysis and inference comprises at least one of: colorimetry with color space transformation and difference calculation, transmission absorbance with baseline and pathlength correction, dual-wavelength ratiometry, turbidimetry and nephelometry, continuous-wave fluorescence or time-resolved fluorescence with gated integration, chemiluminescence with time integration or decay fitting, polarization analysis, lateral-flow line-scan with test-to-control ratios, kinetic rate estimation, and near-infrared reflectance spectroscopy.
23. The method as claimed in claim 21, wherein the method comprising acquiring electrochemical signals in parallel with or interleaved between optical captures and fusing said signals at feature or decision level with mandatory quality control agreement and proportionality or inflection-time bounds.
24. The method as claimed in claim 21, wherein the method comprising ambient-rejection demodulation using time-coded illumination synchronized to sensor exposure, and performing high-dynamic-range fusion where specified by said manifest.
25. The method as claimed in claim 21, wherein the method comprising adaptive error recovery in which bounded retries adjust exposure, wavelength, filter selection, or gain, followed by re-capture; unresolved cases are flagged as quality control not met.
26. The method as claimed in claim 21, wherein the method comprising manifest-driven updates of assay parameters, optical schedules, inference logic, and quality control thresholds without modifying hardware components.
27. The method as claimed in claim 21, wherein the diagnostic results are encrypted and queued when offline and uploaded upon connectivity restoration with time-stamped audit records and integrity hashes.
28. The method as claimed in claim 21, wherein dual-sensor top and bottom frames are time-synchronized and cross-path regions aligned by homography prior to consensus evaluation.
29. A non-transitory computer-readable medium storing instructions upon executed by the electronic controller of the point-of-care diagnostic analyzer as claimed in claim 1, cause said analyzer to validate a signed manifest, schedule a primary modality and an orthogonal secondary method across a specified wavelength band, compute an orthogonality certificate and compare said certificate to a minimum threshold to enforce release-blocking verification, perform time-coded acquisition with synchronous demodulation, apply lot-warp and inter-instrument normalization, and export standardized reports with immutable audit logs.
30. The non-transitory computer-readable medium storing instructionsas claimed in claim 29, wherein, a method for manifest-driven orchestration, comprising the steps of:
a) receiving, by a machine-readable code reader, a digitally signed manifest on a disposable assay carrier, and validating the signature against onboard keys;
b) parsing said manifest to obtain: modality sequences, LED and filter maps, exposure and gain tables, time-resolved fluorescence gate windows, kinetic windows, quality-control thresholds including minimum threshold, secondary method definitions, capability requirements, and model identifiers and hashes;
c) performing a capability handshake that compares manifest requirements to an instrument profile including available spectral bands, selector type, time-resolved fluorescence support, dual-sensor availability, electrochemical module, and accelerator type;
d) compiling, when said handshake succeeds, a microsecond-granularity directed acyclic graph schedule that coordinates illumination drives, spectral selection or tuning, polarization state, time-resolved fluorescence gates, and sensor exposures such that a primary modality and an orthogonal secondary method are acquired without moving the sample; and
e) executing time-coded illumination synchronized to sensor exposure for ambient-light rejection and, in filter-optional embodiments, performing rolling-shutter lock-in demodulation.
31. A software method for release-blocking verification and orthogonality-based gating in the point-of-care diagnostic analyzer of claim 1, said method comprising:
a) pre-processing acquired data deterministically including dark-frame subtraction, flat-field normalization, and fiducial-based homography for region-of-interest alignment, and generating quantified modality features comprising at least one of: colorimetry, absorbance, ratiometry, time-resolved fluorescence lifetime and intensity metrics, turbidimetry and nephelometry measures, polarization metrics, and lateral-flow test-to-control ratios with geometric correction;
b) computing an orthogonality certificate as a weighted combination of quality control zone integrity, kinetic stability, and inter-modality agreement, and comparing said certificate to a manifest-declared threshold to block or permit result release;
c) upon certificate below threshold, executing a bounded auto-recapture policy that adjusts at least one of exposure, wavelength, intensity, selector position, polarization state, sensor gain, or time-resolved fluorescence gate within manifest limits and re-acquires data up to a capped number of retries before asserting quality control not met;
d) performing panel-aware arbitration in which sentinel-pair violations block a panel release while non-sentinel outputs may be partially released under a manifest-bounded degraded policy with explicit annotations; and
e) writing immutable audit records that include device and cartridge identifiers, operator, manifest and model hashes, capability outcome, certificate and threshold values, and both wall-clock and monotonic timestamps.
32. The non-transitory computer-readable medium storing instructionsas claimed in claim 29, wherein the electronic controller causes the diagnostic analyzer to:
• enforce single-use of disposable assay carriers by validating monotonic counters and nonces from said manifest and writing a post-run token, rejecting re-presented carriers or token collisions;
• perform store-and-forward operation by encrypting results and overlays with integrity hashes and idempotency tokens while offline, and upon connectivity restoring, exporting HL7, FHIR, JSON, and PDF outputs validated against expected schemas;
• maintain an immutable, hash-chained audit log binding device and cartridge unique device identifier, operator, UTC and monotonic time, manifest and model hashes, selector and illumination states, certificate and threshold decisions, and capability outcomes;
• run golden-vector self-tests on install or update of firmware, models, or policies and automatically rollback on mismatch; and
• preserve time integrity by combining authenticated network time, when available, with a bounded-drift monotonic clock and signed time tokens, thereby ensuring reproducible ordering of acquisition, release-blocking verification, and export events across a fleet.