System and method for detecting a periprosthetic infection
Inventors
Miller, Forrest • Gupta, Samit Kumar • Kuraguntla, David John • Swanson, Elsa
Assignees
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Publication Number
US-11898961-B2
Publication Date
2024-02-13
Expiration Date
Abstract
A system, device and method for measuring markers for a periprosthetic joint infection in a sample of synovial fluid. A sensor reader device includes a vial receptacle for receiving a vial containing synovial fluid. A light source illuminates the vial and an optical sensor detects light scattered and/or absorbed by white blood cells in the fluid sample. An electrical signal corresponding to the intensity of the light received at the optical sensor is detected. A white blood cell concentration is determined from the electrical signal value. The sensor reader device also includes one or more immunoassay strip receptacles. Immunoassay strips for other marker are inserted into the receptacles. Immunoassay optical sensors detect light generated by the immunoassay reaction on the immunoassay strip to determine the concentration of the marker. In example implementations, the device includes an immunoassay strip reader for leukocyte esterase and c-reactive protein.
Core Innovation
The invention provides a point-of-care system for detecting an infection in a fluid sample drawn from a patient. The system includes a WBC concentrator having a vial receptacle sized to receive a vial containing the fluid sample, one or more light sources to illuminate the fluid sample in the vial, and a vial optical sensor oriented to detect scattered light intensity, absorbed light intensity, or both by white blood cells in the fluid sample. The vial optical sensor converts the light intensity to a vial electrical signal.
The system further includes at least one immunoassay strip reader with an IA strip receptacle sized to receive an IA strip having an analyte reagent configured to generate an analyte light intensity from a reaction between the analyte reagent and an analyte in the fluid sample. An IA strip optical sensor oriented to detect the analyte light intensity converts the analyte light intensity to an IA analyte electrical signal. A processor receives the vial electrical signals and the IA analyte electrical signals, stores the vial sensor data and the IA analyte sensor data, and communicates the sensor data over a communications interface.
The processor determines a WBC concentration from the vial sensor data and a leukocyte concentration from the IA analyte sensor data. In embodiments for synovial fluid, the processor is configured to diagnose a presence or absence of a periprosthetic joint infection in the fluid sample based on the sensor data. Optional analytes and optical detection ranges are described for immunoassay light and quality control, and derived metrics such as a neutrophil percentage (PMN) based on leukocyte concentration divided by WBC concentration are described.
Claims Coverage
The provided set includes four independent claims: clm-00001, clm-00007, clm-00012 (method), and clm-00018 (system measuring analytes). Across these claims, the coverage centers on a multimodal architecture combining vial-based optical WBC sensing with immunoassay strip optical sensing, followed by processor-based signal conversion, storage, communication, calculation of concentrations, and diagnosis for periprosthetic joint infection.
Vial optical WBC sensing with immunoassay strip reader for infection detection
A system that includes a WBC concentrator with a vial receptacle, light sources, and a vial optical sensor configured to detect scattered and/or absorbed light by white blood cells and convert the light intensity to a vial electrical signal, and includes at least one immunoassay strip reader with an IA strip receptacle, an IA strip optical sensor configured to detect analyte light intensity and convert it to an IA analyte electrical signal, where a processor receives both electrical signals, stores and communicates sensor data, and determines a WBC concentration and a leukocyte concentration from the sensor data.
Synovial fluid diagnosis combining vial scattered light and immunoassay strip wavelength-specific detection
A system for detecting an infection in synovial fluid that includes a vial receptacle with a light source and a vial optical sensor to detect light scattered by white blood cells and generate a vial electrical signal, at least one immunoassay strip receptacle with a reagent configured to generate light substantially within a wavelength range corresponding to an analyte substance, at least one optical sensor different from the vial optical sensor oriented to detect the light within the wavelength range corresponding to the analyte substance to generate an immunoassay electrical signal, and a processor configured to receive vial and immunoassay electrical signals as sensor data and diagnose a presence or absence of a periprosthetic joint infection based on the sensor data.
Method for evaluating PJI analytes using vial optical signals and LE immunoassay electrical signals
A method for evaluating analytes for periprosthetic joint infection in a synovial fluid sample comprising providing a vial receptacle, providing one or more light sources, providing a vial optical sensor configured to detect light scattered, light absorbed, or both by white blood cells and generate a vial electrical signal indicative of an intensity of detected light, providing an LE immunoassay strip receptacle with an LE analyte reagent configured to generate an analyte light intensity from a reaction, providing an immunoassay optical sensor to convert the analyte light intensity to an LE immunoassay analyte electrical signal, and providing a processor configured to receive indication of presence of the vial containing fluid sample and presence of the LE immunoassay strip, provide instructions to illuminate and initiate the sensors, receive vial and LE immunoassay electrical signals, and calculate a WBC concentration and a leukocyte concentration from the vial electrical signal and the LE immunoassay analyte electrical signal.
Dual immunoassay wavelength-range system combined with vial scattered-light sensing for diagnosis
A system for measuring analytes for an infection in synovial fluid comprising a vial receptacle, light source, and vial optical sensor to detect light scattered by white blood cells and generate a vial electrical signal, a first immunoassay strip receptacle with a first reagent to react with a first substance as an analyte and generate light substantially within a first wavelength range, a first optical sensor to detect light in the first wavelength range and generate a first immunoassay electrical signal, a second immunoassay strip receptacle with a second reagent to react with a second substance as a second analyte and generate light substantially within a second wavelength range, a second optical sensor to detect light in the second wavelength range and generate a second immunoassay electrical signal, and a processor to receive the vial, first, and second immunoassay electrical signals as sensor data, communicate the sensor data to a communications interface, and analyze the sensor data to diagnose a presence or absence of a periprosthetic joint infection in the fluid sample.
Across the independent claims, the inventive coverage is directed to multimodal point-of-care detection in which a vial optical sensor provides electrical signals indicative of white blood cell light scattering and/or absorption, immunoassay strip optical sensors provide electrical signals indicative of analyte reaction-generated light, a processor converts, stores, and communicates the sensor signals, calculates WBC concentration and leukocyte concentration, optionally determines neutrophil percentage, and diagnoses presence or absence of periprosthetic joint infection based on the sensor data.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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