Urine testing equipment

Abstract

The present invention relates to a handheld urinalysis device (1) comprising a handle (11) and a measurement head (12) configured to be immersed in a urine sample, the measurement head (12) comprising a conductivity probe, an illumination module (14) configured to emit light, and a multispectral optical sensor (13) configured to receive light. The present invention also relates to a method and a urinalysis system for analyzing urine.

Description

[Technical Field]

[0001] The present invention is in the field of urinalysis. In particular, the present invention relates to a handheld urinalysis device and a method for urinalysis. [Background technology]

[0002] Clinical urinalysis, also known as urinalysis, is the testing of urine for specific biomarkers. Urinalysis is widely used for health screening and / or disease diagnosis.

[0003] Currently, urine testing is primarily performed in clinical laboratories using various machines that measure various parameters or biomarker concentrations. This method has several drawbacks, including logistical challenges and the need for highly trained personnel and expensive equipment. The main drawback of laboratory-based urine testing is the long time it takes to obtain results. Indeed, urine samples must first be prepared and separated into several tubes, most often through the use of chemicals, for parallel testing on different machines measuring different parameters (optical or electrical). A major drawback of using chemicals is sample degradation. The results from each machine then need to be compiled into a report and returned to the practitioner. Results are generated long periods (4 to 48 hours) after sampling, resulting in diagnostic delays and unnecessary and undesirable stress for patients.

[0004] Urine testing is also performed using urine test strips, which can be read as a color change. This allows for rapid testing, with results available within 10 minutes. However, this method requires a large amount of disposable consumables and, more importantly, has proven to be inaccurate and lead to false positives. While urine dipstick tests are considered to provide a near-instant diagnosis, these strips can lead to misdiagnosis, potentially resulting in additional testing, anxiety, and unnecessary follow-up. Summary of the Invention [Problem to be solved by the invention]

[0005] Therefore, there is a need for a point-of-care urinalysis device that can simultaneously measure multiple parameters in a urine sample, enabling immediate, sufficient, and reliable diagnosis. The above drawbacks can be overcome by using a single reusable urinalysis device that combines several measurement technologies, including visible spectroscopy, near-infrared spectroscopy, autofluorescence spectroscopy, and conductivity measurement. [Means for solving the problem]

[0006] The present invention provides a handheld urinalysis device comprising a handle and a measurement head configured to be immersed in a urine sample, the measurement head comprising: a. A conductivity probe; b. an illumination module configured to emit light within the urine sample; c. a multispectral optical sensor configured to receive light emitted by and / or transmitted through the urine sample; and The present invention relates to an apparatus comprising:

[0007] In one embodiment, the handheld urinalysis device further comprises a rechargeable battery. In one embodiment, the handheld urinalysis device further comprises a connectivity system that enables data transfer. In one embodiment, the conductivity probe is configured to measure conductivity with DC or AC current at two different frequencies, the frequencies being in the range of approximately 1 Hz to 1 MHz. In one embodiment, the illumination module comprises a NIR-Vis light source that emits light in the range of 390 nm to 1100 nm. In one embodiment, the illumination module comprises a UV light source that emits UV light in the range of 270 nm to 400 nm. In one embodiment, the illumination module comprises an IR light source that emits IR light in the range of 800 nm to 2600 nm. In one embodiment, the multispectral optical sensor collects light in the range of 400 nm to 1100 nm. In one embodiment, the multispectral optical sensor collects light in the range of 800 nm to 2600 nm. In one embodiment, the handheld urinalysis device further comprises a temperature sensor. In one embodiment, the handheld urinalysis device further comprises a pH sensor.

[0008] The present invention also provides a method for analyzing urine, comprising the steps of: i. collecting a urine sample in a container; ii. immersing a handheld urine testing device of the present invention into the urine sample; iii. The following physical characteristics of said sample: ·conductivity, NIR-Vis spectrum, IR spectrum, and / or fluorescence spectrum, measuring The present invention relates to a method comprising:

[0009] The present invention also relates to a urinalysis system including a handheld urinalysis device according to the present invention and a docking station comprising a charging module and / or a cleaning module. In one embodiment, the cleaning module comprises a disinfectant solution.

[0010] The present invention also provides a method for analyzing urine, comprising the steps of: i. collecting a urine sample in a container; ii. immersing a measurement head of a handheld urine testing device of the urine testing system according to the present invention into the urine sample; iii. The following physical characteristics of said sample: ·conductivity, NIR-Vis spectrum, IR spectrum, and / or fluorescence spectrum, measuring iv. Placing the handheld urine testing device in a docking station of the urine testing system of the present invention to allow charging and / or cleaning; v. Cleaning the measuring head with a disinfectant; The present invention relates to a method comprising:

[0011] definition In the present invention, the following terms have the following meanings:

[0012] "Autofluorescence spectroscopy" refers to the measurement of light emitted by tissue or a solution after exciting said tissue or solution with light of a particular wavelength, particularly ultraviolet light.

[0013] "Conductivity measurement" refers to the measurement of the electrolytic conductivity of a solution.

[0014] "IR" refers to wavelengths in the infrared range of 780nm to 2600nm.

[0015] "NIR" refers to wavelengths in the near-infrared range of 780nm to 1100nm.

[0016] "NIR-Vis" refers to wavelengths in the near-infrared and visible range from 390 nm to 1100 nm.

[0017] "Near-infrared spectroscopy" refers to the quantitative measurement of the absorbance of light in the near-infrared range, i.e., the ratio of transmitted light to incident light in the near-infrared range. This technique allows the detection of molecules that absorb low-energy radiation.

[0018] "UV" refers to ultraviolet light between 270nm and 400nm.

[0019] "Visible spectroscopy" refers to the characterization of the light absorption of a sample in the visible range. Involved in the extraction of quantitative information is usually the intensity (I) of light transmitted or reflected by the sample, - the intensity of the light emitted by the light source, - the intensity of the light incident on the sample, or - the intensity of light transmitted or reflected by the reference sample, The intensity of the reference light (I) is measured, which can represent the intensity of the reference light. Then, several calculations are performed to calculate the ratio I / I (commonly called transmittance) or the common logarithm of this ratio (commonly called absorbance).

[0020] The following detailed description will be better understood when read in conjunction with the drawings. For illustrative purposes, the devices are shown in preferred embodiments. It should be understood, however, that the present invention is not limited to the precise arrangement, structure, features, embodiments, and aspects shown. The drawings are not drawn to scale and are not intended to limit the scope of the claims to the embodiments shown. Thus, when features recited in the appended claims are followed by reference signs, it should be understood that such signs are included merely to enhance comprehension of the claims and in no way limit the scope of the claims.

[0021] The present invention provides a handheld urine testing device comprising a handle and a measurement head configured to be immersed in a urine sample, the measurement head comprising: a. A conductivity probe; b. an illumination module configured to emit light within the urine sample; c. a multispectral optical sensor configured to receive light emitted by and / or transmitted through the urine sample; and The present invention relates to an apparatus comprising:

[0022] This handheld urine testing device provides non-invasive scanning of urine samples based on four technologies: visible spectroscopy, near-infrared spectroscopy (or infrared spectroscopy), autofluorescence spectroscopy, and conductivity measurement, allowing for a full physicochemical characterization of the urine sample.

[0023] The multispectral optical sensor is configured to receive light, such as visible light and near-infrared light, transmitted through the urine sample, thereby enabling the handheld urinalysis device to perform visible and near-infrared spectroscopic analysis on the urine sample. With respect to visible spectroscopic analysis, it is possible to detect biomarkers such as minerals (e.g., Na, K, Ca, Mg, Cl, P), creatinine, urea, urine osmolality, urine specific gravity, uric acid, urine pH, ammonium, citrate, oxalate, albumin, total protein, bilirubin, urobilinogen, red blood cells, white blood cells, ketones, glucose, or the presence of bacteria or crystals. Near-infrared spectroscopy can detect biomarkers such as minerals (e.g., Na, K, Ca, Mg, Cl, P), creatinine, urea, urine osmolality, urine specific gravity, uric acid, urine pH, ammonium, citrate, oxalate, albumin, total protein, bilirubin, urobilinogen, red blood cells, white blood cells, ketones, glucose, or the presence of bacteria or crystals. Urine osmolality and urine specific gravity are biomarkers of hydration and are very useful for determining how well the kidneys are functioning. Creatinine is also a biomarker that indicates the proper functioning status of the kidneys.

[0024] The multispectral optical sensor is also configured to receive light emitted by the urine sample to estimate urinary autofluorescence, thus enabling the handheld urinalysis device to perform autofluorescence spectroscopy on the urine sample. Fluorescence spectroscopy allows for the detection of biomarkers such as red blood cells, heavy metals, NADH (hydrogenated nicotinamide adenine dinucleotide), NADPH (nicotinamide adenine dinucleotide phosphate), FAD (flavin adenine dinucleotide), elastin, collagen, tryptophan, porphyrins, riboflavin, or other endogenous fluorescent dyes.

[0025] Finally, the conductivity probe allows the handheld urinalysis device to perform conductivity measurements on urine samples. The conductivity of urine arises primarily from the mobility of components (hydrated ions) present in the sample and therefore provides a measure of the sample's ability to conduct an applied charge. Therefore, measuring the conductivity of a urine sample can determine the concentration of ions (e.g., Na) in the sample. + , K. + , Ca 2+ , Mg 2+ , H + / CO3 - , or Cl - ) can be calculated.

[0026] Combining biomarker detection by conductivity measurement with biomarker detection by optical spectroscopy is particularly advantageous because it allows for sufficiently fast scanning of urine samples to simultaneously determine the presence and / or concentration of several biomarkers in a single urine sample. This also provides better results than separate optical and electrical measurements, i.e., more accurate and fewer false negatives. Furthermore, these measurements can be repeated several times without degrading the sample or affecting its future use. Finally, simultaneous measurement of sample temperature can improve the accuracy of optical and conductivity measurements.

[0027] For example, near-infrared spectroscopy and conductivity measurements are complementary for accurately measuring mineral concentrations (e.g., Na, K, Ca, Mg, Cl, and P). In fact, inorganic ions in aqueous solutions do not directly absorb NIR light but affect the spectral pattern of specific wavelengths through ion-water interactions. Similarly, urinary saturation and crystallization (e.g., calcium oxalate) can be detected optically. Therefore, optical spectra provide both qualitative and quantitative information. This initial estimation of each mineral concentration is completed by conductivity measurements, which reflect the total concentration of cations and anions in the solution, and each ion has a specific molar conductivity. Conductivity measurements at different frequencies allow for accurate determination of each ion concentration. Furthermore, because ion mobility increases with temperature, simultaneous temperature measurements in addition to optical spectra and conductivity measurements can further accurately determine mineral concentrations.

[0028] Furthermore, the visible, NIR, and IR spectra contain specific wavelengths that are closely associated with similar urinary biomarkers. Therefore, combining these spectral information significantly improves the prediction of biomarker concentrations. For example, osmolality information is found below 700 nm, between 800 and 850 nm, near 1000 nm, near 1150 nm, and above 1200 nm. This means that information is included across all ranges, sometimes redundant and sometimes not, allowing for improved osmolality measurements. Finally, fluorescence spectroscopy can be used in combination with visible spectroscopy to identify specific biomarkers. For example, hematuria can change the color of urine from pale yellow to pink or red, detectable in the visible spectrum. In this case, the presence of blood can be confirmed by fluorescence by measuring the emission peak occurring between 450 and 520 nm.

[0029] To perform the detection of biomarkers, the handheld urinalysis device is immersed in a urine sample, activated to perform the measurement, and then cleaned after use. Alternatively, the urine sample contained in a measurement cuvette can be placed in the measurement head, i.e., between the two walls of the measurement head.

[0030] The urine sample may be provided by a human or an animal, such as a cow, sheep, pig, horse, or any other animal.

[0031] According to one embodiment, the handheld urinalysis device has a cylindrical shape. In a particular configuration of this embodiment, the device has a pen shape, which makes the device handheld, easy to use, and easy to transport from one location to another.

[0032] According to one embodiment, the measurement head comprises two walls carrying the sensor, the illumination module, and the conductivity probe. In a particular configuration of this embodiment, the walls face each other (i.e., face each other) and extend along the longitudinal axis of the handheld urinalysis device. Preferably, the two walls of the measurement head are separated by an open space that forms an optical path length. This allows the open space between the walls to be filled with urine to immerse the sensor, the illumination module, and the conductivity probe. The optical path length is particularly important because it determines the volume of sample through which light passes. The larger the volume, the more information is available for measurement. Preferably, the optical path length ranges between 1 mm and 30 mm.

[0033] Preferably, the sensor, lighting module and conductivity probe are arranged on the inner surface of the wall, i.e. on the surface facing towards the other wall.

[0034] In a particular configuration of this embodiment, the wall has a convex shape. Preferably, the wall is two halves of a cylinder extending from the handle and separated by an open space. In this configuration, the sensor, lighting module, and conductivity probe are located on the concave surface of the wall.

[0035] In a particular configuration of this embodiment, one wall is thicker than the other wall, in particular said thicker wall carrying the lighting module and the thinner wall carrying the multispectral optical sensor.

[0036] In a particular configuration of this embodiment, one wall is thicker than the other wall, in particular said thicker wall carrying the multispectral optical sensor and the thinner wall carrying the lighting module.

[0037] In certain configurations of this embodiment, the conductivity probe is positioned closer to the proximal end of the measurement head than the illumination module and the multispectral optical sensor, or the conductivity probe is positioned at the proximal end of the measurement head. As used herein, the proximal end of the measurement head refers to the end connected to the handle, while the distal end of the measurement head refers to the end configured to be immersed in the sample.

[0038] In a particular configuration of this embodiment, the electrodes of the conductivity probe are located on the same wall. In an alternative configuration, the electrodes of the conductivity probe are located on opposite walls.

[0039] In a particular configuration of this embodiment, two electrodes of the conductivity probe are located on the same wall. In an alternative configuration, one electrode of the conductivity probe is located on each wall, i.e., the two electrodes are opposite each other.

[0040] According to one embodiment, the handheld urinalysis device further comprises an activation button (also called an on / off button) located at the end of the handle opposite the measurement head.

[0041] According to one embodiment, the handheld urinalysis device is configured so that at least 10% of its length is immersed in the urine sample. In certain configurations of this embodiment, the length of the handheld urinalysis device that is immersed in the urine sample ranges from 10% to 50% of its total length.

[0042] According to one embodiment, the handheld urine testing device has a length in the range of 5 cm to 30 cm, preferably 10 cm to 25 cm, and more preferably 10 cm to 20 cm.

[0043] According to one embodiment, the handheld urine testing device has a width in the range of 1 cm to 10 cm, preferably 1 cm to 5 cm, and more preferably 2 cm to 4 cm.

[0044] According to one embodiment, the measurement head has a length in the range of 0.5 cm to 10 cm, preferably 0.5 cm to 5 cm, more preferably 0.5 cm to 3 cm, and therefore the handheld urinalysis device is configured so that a length in the range of 0.5 cm to 10 cm, preferably 0.5 cm to 5 cm, more preferably 0.5 cm to 3 cm is immersed in the urine sample.

[0045] According to one embodiment, the measurement head has a length in the range of 3% to 80% of the length of the handheld urinalysis device, preferably 10% to 40% of the length of the handheld urinalysis device, and more preferably 20% to 30% of the length of the handheld urinalysis device.

[0046] According to one embodiment, the handheld urine testing device is not disposable: the device is configured to be cleaned after use.

[0047] According to one embodiment, the handheld urinalysis device is made of or coated with a hydrophobic material. This embodiment is particularly advantageous because the handheld urinalysis device does not require a solution wash between two samples.

[0048] According to one embodiment, the conductivity probe is configured to measure DC conductivity.

[0049] According to one embodiment, the conductivity probe is configured to measure conductivity at one or more different frequencies, said frequencies being in the range of about 1 Hz to 1 MHz, preferably about 1 Hz to 100 kHz. In a preferred configuration of this embodiment, said frequencies are in the range of about 10 Hz to 10 kHz. Higher frequencies result in higher power consumption and more complex devices.

[0050] According to one embodiment, the conductivity probe includes two or more electrodes.

[0051] According to one embodiment, the lighting module comprises a NIR-Vis light source, emitting light in the range of 390 nm to 1100 nm. In a particular configuration of this embodiment, the NIR-Vis light source is an LED (light emitting diode), a laser, a superluminescent LED (sLED), or an incandescent bulb.

[0052] According to one embodiment, the lighting module comprises a UV light source, emitting UV light in the range of 270 nm to 400 nm, preferably 365 nm to 400 nm. In a particular configuration of this embodiment, the UV light source is a UV LED (light emitting diode), a laser, a superluminescent LED (sLED), or an incandescent bulb.

[0053] According to one embodiment, the lighting module comprises an IR light source, emitting IR light in the range of 800 nm to 2600 nm, preferably 800 nm to 1350 nm.

[0054] According to one embodiment, the multispectral optical sensor collects light in the range of 400 nm to 1100 nm.

[0055] According to one embodiment, the multispectral optical sensor collects light in the range of 800 nm to 2600 nm.

[0056] According to one embodiment, the multispectral optical sensor includes at least one photodetector, preferably two or more photodetectors. In a particular configuration of this embodiment, the multispectral optical sensor includes a first photodetector, i.e., a visible light collector, that collects light in the range of 400 nm to 1100 nm, and a second photodetector, i.e., an infrared light collector, that collects light in the range of 800 nm to 2600 nm.

[0057] According to one embodiment, the handheld urinalysis device further comprises a temperature sensor, which allows measurement of the temperature of the urine sample, which is then converted into an electrical signal related to said temperature, and which may also normalize the optical and conductivity signals.

[0058] According to one embodiment, the handheld urinalysis device further comprises a pH sensor that allows for measurement of the pH of the urine sample, which is then converted into an electrical signal related to said pH.

[0059] According to one embodiment, the sensor is integrated into the measurement head.

[0060] According to one embodiment, a handheld urine testing device includes a handle and a measurement head configured to be immersed in a urine sample, the measurement head including: a. A conductivity probe; b. an illumination module configured to emit light into the urine sample; wherein the lighting module includes a NIR-Vis light source emitting light in the range of 390 nm to 1100 nm, a UV light source emitting UV light in the range of 270 nm to 400 nm, and an IR light source emitting IR light in the range of 800 nm to 2600 nm; c. a multispectral optical sensor configured to receive light emitted by and / or transmitted through the urine sample; and Here, the multispectral optical sensor includes a first photodetector that collects light in the range of 400 nm to 1100 nm and a second photodetector that collects light in the range of 800 nm to 2600 nm. d. a temperature sensor; e. pH sensor; Equipped with.

[0061] According to one embodiment, the handheld urinalysis device further comprises an ultrasound sensor that provides information regarding the physical, mechanical, and chemical properties of the urine sample, such as density, presence of cells and / or crystals, etc.

[0062] According to one embodiment, the handheld urine testing device further comprises a rechargeable battery.

[0063] In a particular configuration of this embodiment, the rechargeable battery is configured to operate for 24 hours without needing to be charged. To conserve battery power, a standby mode can be automatically activated when the device is not in use.

[0064] In another particular configuration of this embodiment, the rechargeable battery is configured to charge quickly, for example, the battery is fully charged in one hour.

[0065] In another particular configuration of this embodiment, the rechargeable battery has a size of less than 2 cm by 6 cm.

[0066] According to one embodiment, the rechargeable battery is a lithium ion battery, LiCF x Battery, Li-FeS2 Battery, LiFePO4 Battery, Li-SO2 Battery, Li-I2 Battery, Li-Ag2CrO4 Battery, Li-Ag2V4O 11 The rechargeable battery is selected from a Li-SVO battery, a Li-CSVO battery, or a lithium polymer battery. Preferably, the rechargeable battery is a lithium-based battery.

[0067] In an alternative embodiment, the handheld urine testing device further comprises a non-rechargeable battery, for example an alkaline battery.

[0068] In an alternative embodiment, the handheld urine testing device can be recharged by induction.

[0069] According to one embodiment, the handheld urine testing device further comprises a connectivity system that allows for data transfer. In a particular configuration of this embodiment, the handheld urine testing device is configured to communicate via a wired or wireless (Bluetooth, wifi) connection with a computing module, such as a smartphone, tablet, or computer, for example, via a wireless connection.

[0070] According to one embodiment, the handheld urinalysis device further comprises a display module configured to display data collected by the sensor / probe of the device and / or results obtained after processing of the data.

[0071] According to one embodiment, the handheld urine testing device further comprises a cap configured to cover the measurement head when the handheld urine testing device is not in use.

[0072] According to one embodiment, the handheld urinalysis device further comprises an LED on the measurement head configured to indicate to a user whether the urine sample level is sufficient for measurement.

[0073] The present invention also provides a method for analyzing urine, comprising: i. collecting a urine sample in a container; ii. immersing a handheld urine testing device of the present invention into the urine sample; iii. The following physical characteristics of said sample: ·conductivity, NIR-Vis spectrum, IR spectrum, and / or fluorescence spectrum, measuring The present invention relates to a method comprising:

[0074] Urine samples can be collected in any container.

[0075] The handheld urinalysis device can be turned on prior to immersion. In certain configurations, the device further comprises a first external LED, e.g., a blue, green, or red LED, preferably a blue LED, that emits light to indicate whether the device has been successfully turned on.

[0076] Prior to dipping, the handheld urine testing device may also be connected via a wireless connection to a computing module such as a computer, smartphone, or tablet.

[0077] The immersed handheld urinalysis device is activated by engaging the activation button to measure the physical properties of the urine sample. Upon immersion in the urine sample, the handheld device performs a measurement when the sensor, conductivity probe, and illumination module are all submerged in the urine. The start of the measurement can be commanded manually by the user or automatically when the device detects that all measurement elements have been submerged in the urine.

[0078] In certain configurations, the device further comprises a second external LED, such as a blue, green or red LED, preferably a green LED, that indicates whether a measurement has been performed by emitting light and / or vibrating.

[0079] The method of the present invention does not require the sample to be prepared, separated, or otherwise treated before immersing the measurement head of the handheld device in the sample. In fact, the measurement head can be immersed immediately after collection of the urine sample. Nevertheless, the urine sample can be mixed with a reagent before immersing the handheld urinalysis device. Such a reagent can be a fluorescent probe.

[0080] The present invention also relates to a urinalysis system including a handheld urinalysis device according to the present invention and a docking station with a charging module and / or a cleaning module.

[0081] The docking station is configured to clean, recharge, and / or dry the handheld urinalysis device.

[0082] After measuring the urine sample, the handheld urinalysis device is placed in a docking station where it can be recharged and / or cleaned and / or dried by immersing the measurement head in a cleaning module.

[0083] According to one embodiment, the docking station includes a storage location for recharging and storing the handheld urine testing device.

[0084] According to one embodiment, the docking station comprises an arm, preferably a mechanical articulated arm, for supporting the handheld urinalysis device on said docking station and for immersing the measurement head in the cleaning module.

[0085] According to one embodiment, the cleaning module comprises a disinfecting solution (also called a cleaning solution).

[0086] In a particular configuration of this embodiment, the disinfecting solution is an aqueous solution that includes a surfactant, which is particularly advantageous as the solution forms foam, preferably a heat-induced foam, which helps to prevent biomolecules from adhering to the handheld urinalysis device.

[0087] In a particular configuration of this embodiment, the disinfectant solution comprises didecyldimethylammonium chloride, polyhexamethylene biguanide hydrochloride, a complex detergent (polyalkoxylated fatty alcohol, lauryldimethylamine oxide), a sequestering agent, and a dispersing agent.

[0088] In an alternative configuration of this embodiment, the disinfectant solution refers to an alternating solution of water and a solvent (e.g., ethanol), i.e., the measurement head is first immersed in water and then in the solvent, or first rinsed with water and then rinsed with the solvent.

[0089] According to one embodiment, the docking station may further comprise a drying module. In a particular configuration of this embodiment, the drying module is an airflow module, which is particularly useful for evaporating residual disinfectant after cleaning without contacting the handheld urinalysis device.

[0090] Preferably, the docking station does not include a drying module and the handheld urinalysis device is dried by ambient air in a non-contact manner.

[0091] According to one embodiment, a charging module is located within the arm, and can use contact (via wires) or magnetic induction to recharge the battery of the handheld urine testing device.

[0092] According to an alternative embodiment, a charging module is placed in a storage location for recharging and storing the handheld urine testing device. The charging module can use contact (via wires) or magnetic induction to recharge the battery of the handheld urine testing device. In this embodiment, the storage location includes two electrical pins configured to cooperate with two holes in the handle to enable recharging when the handheld urine testing device is placed in the storage location.

[0093] According to one embodiment, the docking station further comprises a support for a tablet, or tablet, which in this embodiment serves as a display and / or computing module for the results obtained after measuring the urine sample.

[0094] According to one embodiment, the docking station may be configured to transport the handheld urinalysis device. In this embodiment, the docking station is portable, i.e., the docking station can be converted into a carrying case and the handheld urinalysis device is inside the carrying case. During transportation, the handheld urinalysis device is placed in a storage position for recharging and storing the handheld urinalysis device, and the tablet is placed in a storage position on the docking station.

[0095] The present invention also provides a method for analyzing urine, comprising: i. collecting a urine sample in a container; ii. immersing a measurement head of a handheld urine testing device of the urine testing system according to the present invention into the urine sample; iii. The following physical characteristics of said sample: ·conductivity, NIR-Vis spectrum, IR spectrum, and / or fluorescence spectrum, measuring iv. Placing the handheld urine testing device in a docking station of the urine testing system of the present invention to allow charging and / or cleaning; v. Cleaning the measuring head with a disinfectant; The present invention relates to a method comprising:

[0096] The disinfectant is as described above.

[0097] The cleaning step (v) is a quick and non-hazardous step that allows the user to reuse the device almost immediately.

[0098] The present invention also relates to the use of a handheld urinalysis device for analyzing urine, which may be human urine or animal urine.

[0099] The present invention also relates to the use of a handheld urinalysis device for the analysis of body fluids such as, for example, blood, sweat, tears, saliva, or breast milk.

[0100] While various embodiments have been described and illustrated, the detailed description should not be construed as limiting thereof. Those skilled in the art may make various modifications to the embodiments without departing from the true spirit and scope of the present disclosure, as defined by the appended claims. [Brief explanation of the drawings]

[0101] [Figure 1A] 1 is a schematic side view of a handheld urine testing device of the present invention. [Figure 1B] 1 is a schematic diagram of a handheld urine testing device of the present invention. [Figure 2A] 1 is a schematic side view of a handheld urinalysis device of the present invention including a conductivity probe, an illumination module, and a multispectral optical sensor. [Figure 2B] 1 is a schematic side view of a handheld urinalysis device of the present invention further comprising a temperature sensor. [Figure 3] 1 is a schematic diagram of a handheld urine testing device and docking station of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0102] 1A-1B, the handheld urinalysis device 1 includes a handle 11 and a measurement head 12 configured to be immersed in a urine sample. The measurement head 12 includes a first wall 121 and a second wall 122, each configured to carry at least one of a conductivity probe, an illumination module 14, and a multispectral optical sensor 13.

[0103] The handheld urinalysis device 1 further comprises an activation button 111 located at the end of the handle 11. When immersed in a urine sample, the handheld device 1 performs a measurement when the conductivity probe, illumination module 14, and multispectral optical sensor 13 are all immersed in the urine. Advantageously, the start of the measurement can be manually commanded by the user by pressing the activation button 111.

[0104] The walls (121, 122) are opposed and extend along the longitudinal axis of the handheld urinalysis device 1. They are separated by an open space that defines the optical path length.

[0105] This is particularly advantageous as it allows the empty space between the walls (121, 122) to be filled with urine to immerse the conductivity probe, the illumination module 14 and the multispectral optical sensor 13.

[0106] Furthermore, the optical path length created by the open space separating the walls (121, 122) is particularly important as it determines the volume of the sample through which the light passes: the larger said volume, the more information is available for measurement.

[0107] 2A, the handheld urinalysis device 1 includes a handle 11 and a measurement head 12 configured to be immersed in a urine sample. The handle 11 includes an actuation button 111. The measurement head 12 includes a first wall 121 and a second wall 122.

[0108] The first wall 121 is thicker than the second wall 122; the electrodes 15 of the conductivity probe; a multispectral optical sensor 13 comprising an infrared light collector 131 and a visible light collector 132; It is equipped with:

[0109] The second wall 122 is the second electrode 15 of the conductivity probe; an illumination module 14 configured to emit light into the urine sample; It is equipped with:

[0110] Once immersed in a urine sample, the handheld urinalysis device 1 is activated, for example by pressing activation button 111. Illumination module 14 then emits light into the urine sample, which is collected by both infrared light collector 131 and visible light collector 132 depending on the wavelength of light transmitted through the sample. Simultaneously with this optical measurement, two electrodes 15 of the conductivity probe measure the conductivity of the sample.

[0111] This is particularly advantageous as the handheld urinalysis device 1 provides non-invasive scanning of urine samples based on four techniques: visible spectroscopy, near-infrared spectroscopy, autofluorescence spectroscopy, and conductivity measurement, which allows for a full physicochemical characterization of the urine sample.

[0112] In FIG. 2B, the handheld urinalysis device 1 has the same configuration (same as in FIG. 2A) and further includes a temperature sensor 16.

[0113] The temperature sensor 16 allows for measurement of the temperature of the urine sample, which is then converted into an electrical signal related to said temperature. It is also possible to normalize the optical and conductivity signals.

[0114] Advantageously, simultaneous measurement of urine sample temperature can improve the accuracy of the optical and conductivity measurements.

[0115] As shown in Figure 3, the docking station 2 can carry the handheld urinalysis device 1 supported by an articulated arm 21 and a tablet 3 for reading out the results of the optical and conductivity measurements. The docking station 2 further includes a cleaning module 22 configured to serve as a receptacle for disinfectant solution, and a drawer 23 in which the handheld urinalysis device 1 can be stored after use. The articulated arm is configured to support the handheld urinalysis device 1 for recharging purposes and to immerse the handheld urinalysis device 1 in the disinfectant solution stored in the cleaning module 22.

[0116] After measuring the urine sample, the handheld urinalysis device 1 is placed in a docking station 2 where it can be recharged and / or cleaned and / or dried by immersing the measurement head 12 in a cleaning module 22.

[0117] Advantageously, the docking station provides a unique station for recharging, cleaning and drying the handheld urinalysis device 1, as well as support for the tablet for easy readout of results.

[0118] Example The present invention is further illustrated by the following examples.

[0119] Example 1: method Freshly collected urine samples were collected in 120 mL sterile urine containers without additives / preservatives. To evaluate the analytical performance of the handheld urinalysis device of the present invention, a reference test was performed at a central laboratory using gold standard methodology.

[0120] The same samples were analyzed in parallel using the handheld urinalysis device of the present invention to measure optical spectra (visible spectroscopy, near-infrared spectroscopy, autofluorescence spectroscopy) and electrical conductivity. The numerical data were then processed with specific algorithms to determine concentration values ​​for each sample, i.e., concentration values ​​based on the optical data on the one hand, and on the other hand, a combination of the optical and electrical data.

[0121] The concentrations determined by the reference instrument were then used as control values ​​to compare with both the concentration values ​​based on optical data and the combined optical and electrical data obtained by the handheld urinalysis device.

[0122] result Table 1 shows the correlation between biomarker concentrations from the gold standard device and results obtained with the handheld urinalysis device using optical data and a combination of optical and electrical data. [Table 1]

[0123] It has been observed that using algorithms on a combination of optical and electrical data, rather than optical data alone, results in better prediction accuracy for the handheld device of the present invention compared to reference values.

[0124] Example 2: material: Freshly collected early morning urine samples were collected. A selection of patients with urolithiasis was conducted to assess the presence of crystals in the urine samples. Each first urine sample was collected in a 120 mL sterile urine container without additives / preservatives.

[0125] Urine samples are analyzed using a handheld urinalysis device, and the resulting physicochemical profile is characterized by optical analysis (visible spectroscopy, near-infrared spectroscopy, autofluorescence spectroscopy) and electrical analysis (conductivity measurements) to determine the sample concentration.

[0126] result The urine profile measured by the handheld device is highly specific and varies from person to person. These differences depend on parameters such as the individual's health status and can be caused by pathologies such as urolithiasis, which cause the formation of crystals in the urine.

[0127] When analyzing a sample, the data obtained by the instrument varies depending on the physicochemical parameters. For example, conductivity varies depending on the ion concentration and the presence of crystals in the sample. In healthy individuals, the conductivity ranges from 11.49 to 16.85 mS.cm. -1 The range varies.

[0128] Conductivity values ​​measured by the handheld device allowed for differentiation of samples from healthy to samples at high risk of crystallization (conductivity >25 mS.cm -1The researchers were able to identify crystals up to 100% and adapt algorithms to predict biomarker concentrations. The presence of crystals was confirmed by observing urine samples under a contrast microscope equipped with a polarizing device. [Explanation of symbols]

[0129] 1: Handheld urine testing device 11: Handle 111: Activation button 12: Measuring head 121: The First Wall 122: The Second Wall 13: Multispectral optical sensor 131: Infrared light collector 132: Visible light collector 14: Lighting module 15: Conductivity probe electrode 16: Temperature sensor 2: Docking Station 21: Articulated Arm 22: Cleaning module 23: Drawer 3: Tablet

Claims

1. A urine testing system, comprising: A handheld urinalysis device (1) comprising a handle (11) and a measurement head (12) configured to be immersed in a urine sample, said measurement head (12) comprising: a. a conductivity probe; b. an illumination module (14) configured to emit light into the urine sample; c) a multispectral optical sensor (13) positioned opposite the illumination module (14), the multispectral optical sensor (13) configured to receive light emitted by and / or transmitted through the urine sample; A handheld urine testing device (1) comprising: a docking station (2) equipped with a charging module and / or a cleaning module (22); A urine testing system comprising:

2. A urine testing system as described in claim 1, wherein the handheld urine testing device (1) further comprises a rechargeable battery.

3. A urine testing system as described in claim 1, further comprising a connection system that enables the handheld urine testing device (1) to transfer data.

4. 10. The urinalysis system of claim 1, wherein the conductivity probe is configured to measure conductivity at two different frequencies, the frequencies being in the range of approximately 1 Hz to 1 MHz.

5. 2. The urinalysis system of claim 1, wherein the illumination module (14) comprises a NIR-Vis light source and emits light in the range of 390 nm to 1100 nm.

6. The urinalysis system of claim 1, wherein the illumination module (14) comprises a UV light source and emits UV light in the range of 270 nm to 400 nm.

7. The urinalysis system of claim 1, wherein the illumination module (14) comprises an IR light source and emits IR light in the range of 800 nm to 2600 nm.

8. 2. The urinalysis system of claim 1, wherein the multispectral optical sensor (13) collects light in the range of 400 nm to 1100 nm.

9. 2. The urinalysis system of claim 1, wherein the multispectral optical sensor (13) collects light in the range of 800 nm to 2600 nm.

10. A urine testing system as described in claim 1, wherein the handheld urine testing device (1) further comprises a temperature sensor (16).

11. A urine testing system as described in claim 1, wherein the handheld urine testing device (1) further comprises a pH sensor.

12. 1. A method for analyzing urine, comprising: i. collecting a urine sample in a container; ii. Immersing the handheld urinalysis device (1) of the urinalysis system according to any one of claims 1 to 11 into the urine sample; iii. The following physical characteristics of the sample: ·conductivity, NIR-Vis spectrum, IR spectrum, and / or fluorescence spectrum; measuring A method comprising:

13. 12. The urinalysis system of claim 11, wherein the cleaning module (22) comprises a disinfectant solution.

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