System and method for detecting a periprosthetic infection

A system for detecting an infection in synovial fluid drawn from a patient, the system comprising:

• a vial receptacle sized to receive a vial containing the fluid sample;
• a light source disposed in the vial receptacle and operable to illuminate the fluid sample in the vial;
• a vial optical sensor disposed in the vial receptacle and operable to detect light scattered by white blood cells in the fluid sample and to generate a vial electrical signal indicative of an intensity of the light detected;
• at least one immunoassay strip receptacle sized to receive a corresponding at least one immunoassay strip, wherein each at least one immunoassay strip includes a reagent configured to react with a corresponding at least one analyte substance and to generate light substantially within a wavelength range corresponding to the analyte substance when the immunoassay strip is in contact with the fluid sample;
• at least one optical sensor associated with the at least one immunoassay strip receptacle and different than the vial optical sensor, the at least one optical sensor corresponding to the at least one analyte substance and oriented to detect light within the wavelength range corresponding to the one of the at least one analyte substance when the at least one immunoassay strip is inserted into the at least one immunoassay strip receptacle, wherein the at least one optical sensor is configured to generate an immunoassay electrical signal indicative of an intensity of light detected within the wavelength range corresponding to the one of the at least one analyte substance;
• and
• a processor configured to receive the vial electrical signal and the immunoassay electrical signal as sensor data and to communicate the sensor data to a communications interface, wherein the processor in communication with the communications interface is configured to diagnose a presence or absence of a periprosthetic joint infection in the fluid sample based on the sensor data.

A method for evaluating analytes for periprosthetic joint infection (PJI) in a synovial fluid sample, the method comprising:

• providing a vial receptacle sized to receive a vial containing a fluid sample;
• providing one or more light sources oriented to illuminate the fluid sample in the vial;
• providing a vial optical sensor oriented to detect light scattered, light absorbed, or both by white blood cells in the fluid sample, wherein the vial optical sensor is configured to generate a vial electrical signal indicative of an intensity of detected light;
• providing at least one immunoassay strip receptacle sized to receive a leukocyte esterase (LE) immunoassay strip having an LE analyte reagent and a portion of the fluid sample,
• wherein the LE analyte reagent is configured to generate an analyte light intensity from a reaction between the LE analyte reagent and an analyte in the fluid sample;
• providing an immunoassay optical sensor oriented to detect the analyte light intensity and to convert the analyte light intensity to an LE immunoassay analyte electrical signal;
• and
• providing a processor communicatively coupled to the vial optical sensor and the immunoassay strip optical sensor via a communications interface, the processor configured to (i) receive an indication of a presence of the vial containing fluid sample in a vial receptacle, (ii) provide an instruction to apply to the one or more light sources directed at the vial containing the fluid sample, (iii) provide an instruction to initiate the vial optical sensor (iv) receive the vial electrical signal from the vial optical sensor indicative of the intensity of detected light, (v) receive an indication of a presence of the LE immunoassay strip in the at least one immunoassay receptacle, (vi) provide an instruction to initiate the immunoassay optical sensor, (vii) receive LE immunoassay analyte electrical signal from the immunoassay optical sensor, and (viii) calculate a white blood cell (WBC) concentration and a leukocyte concentration from the vial electrical signal and the LE immunoassay analyte electrical signal.

A system for measuring analytes for an infection in synovial fluid drawn from a patient, the system comprising:

• a vial receptacle sized to receive a vial containing a fluid sample;
• a light source disposed in the vial receptacle to illuminate the fluid sample in the vial;
• a vial optical sensor disposed in the vial receptacle to detect light scattered by white blood cells in the fluid sample and to generate a vial electrical signal indicative of an intensity of the light detected;
• a first immunoassay strip receptacle sized to receive a first immunoassay strip having a first reagent configured to react with a first substance as a analyte for a periprosthetic infection and to generate light substantially within a first wavelength range when the first immunoassay strip is in contact with the fluid sample;
• a first optical sensor configured to detect light in the first wavelength range when the first immunoassay strip is inserted into the first immunoassay strip receptacle and to generate a first immunoassay electrical signal indicative of the intensity of light detected within the first wavelength range;
• a second immunoassay strip receptacle for holding a second immunoassay strip having a second reagent configured to react with a second substance as a second analyte for a periprosthetic infection and to generate light substantially within a second wavelength range when the second immunoassay strip is in contact with the fluid sample;
• a second optical sensor configured to detect light in the second wavelength range when the second immunoassay strip is inserted into the second immunoassay strip receptacle and to generate a second immunoassay electrical signal indicative of the intensity of light detected within the second wavelength range;
• and
• a processor configured to receive the vial electrical signal, the first immunoassay electrical signal, and the second immunoassay electrical signal as sensor data, and to communicate the sensor data to a communications interface, wherein the processor in communication with the communications interface is configured to analyze the sensor data and diagnose the presence or absence of a periprosthetic joint infection in the fluid sample based on the sensor data.