WO2020174273A1

WO2020174273A1 - A modular all in one cartridge for testing electrolytes in a sample of body fluid

Info

Publication number: WO2020174273A1
Application number: PCT/IB2019/060022
Authority: WO
Inventors: Vijaywanth MATHUR; Ramesh MAMDAPURKAR; Nikhil SANE; Amardeep Singh SAINI; Guenther Gorka
Original assignee: Diasys Diagnostics India Pvt. Ltd.
Priority date: 2019-02-27
Filing date: 2019-11-21
Publication date: 2020-09-03

Abstract

A device for testing one or more electrolytes and other parameters in a sample of body fluids is disclosed that is based on a disposable, modular and all in one cartridge. The modular cartridge 200 includes a sensor module 300 having sensors including one or more sensors sensitive to the electrolytes to be tested, and working based on ion-selective electrode technology; a set of bags 204 to store one or more reference reagents and waste. The cartridge 200 is inserted in an analyser on which it mechanically couples with the analyser. A silicone valve selectively couples a probe 210 to the bags 204 storing reference reagents and a sample port of the analyser. A RFID label is provided to store data related to the cartridge, and is wirelessly readable and editable by a RFID reader in the analyser.

Description

A MODULAR ALL IN ONE CARTRIDGE FOR TESTING ELECTROLYTES

IN A SAMPLE OF BODY FLUID

TECHNICAL FIELD

[0001] The present disclosure relates to the field of clinical diagnostics. In particular, it pertains to an analyser for point of care diagnostic analysis of multiple constituents in small volume samples of body fluids.

BACKGROUND

[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Diagnostic tests play an important role in treatment of patients. Doctors typically wait for diagnostic test results rather than starting treatment based on clinical symptoms. Therefore, in most cases, timely availability of diagnostic test results is crucial, not only for well-being of the patient, but also for achieving an efficient overall cost of treatment.

[0004] Typically, when a doctor needs to ascertain electrolytes in a body fluid of a patient, he refers the patient to a pathology lab, who collects a sample of the body fluid and subject the sample to examination using an electrolyte analyser. Conventional electrolyte analysers for measurements of electrolyte parameters include sensors, reagents, sampler, pump and other tubing, valve etc. that require heavy periodic maintenance, such as weekly, monthly, quarterly etc., adding to cost per test. Besides, the reagents and parts have short shelf life and are expensive. Moreover, the costs required to maintain such Lab instrumentation being high, use of such devices is limited to sophisticated labs, and handling being limited to only highly specialized personnel.

[0005] Since conventional devices for testing electrolytes in samples of body fluids are available at specialized sophisticated labs, obtaining these test results takes time, delaying start of treatment. Though few analysers are available that have been specifically designed for physicians’ offices and critical-care settings, they require maintenance in terms of replacement of reagent pack, electrodes and pump tube, thereby requiring expertise to handle them. Besides, they also require larger blood sample in vacutainers, sample cups and syringes, therefore needing specialist paramedic to withdraw sample when blood is involved. Even when, reagent pack, electrodes and pump tube etc. are provided in form of disposable cartridges there is no means to store cartridge data as the cartridge is used. This necessitates maintaining usage data so that the cartridge is replaced when due.

[0006] In order overcome drawbacks of the conventional devices, and to provide healthcare diagnostics to all at affordable costs, there is a need for a device that is modular, not requiring any maintenance, and enables point of care testing of electrolytes in samples of body fluids that is easy to maintain and use to be useful for point of care diagnostic tests.

[0007] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.

[0008] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term“about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0009] As used in the description herein and throughout the claims that follow, the meaning of“a,”“an,” and“the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of“in” includes“in” and“on” unless the context clearly dictates otherwise.

[0010] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g.“such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.

[0011] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

OBJECTS OF THE INVENTION

[0012] A general object of the present disclosure is to provide a device for testing electrolytes that overcomes drawbacks of conventional devices used for testing electrolytes.

[0013] An object of the present disclosure is to provide a device for testing electrolytes that can be used in low resource settings such as in urban, semi-urban and rural areas in the developing countries at point of care.

[0014] Another object of the present disclosure is to provide a device for testing electrolytes that requires minuscule quantity, such as less than a drop, of sample that can be obtained from patient without any expertize.

[0015] Another object of the present disclosure is to provide a device for testing electrolytes that has capability to conduct more than one test on the sample.

[0016] Another object of the present disclosure is to provide a device for testing electrolytes that does not require periodic replacement of reagents and sensors.

[0017] Yet another object of the present disclosure is to provide a device for testing electrolytes that is modular, thereby does away with requirement of periodic replacement of reagents and sensors.

[0018] Yet another object of the present disclosure is to provide a device for testing electrolytes that is easy to maintain.

[0019] Yet another object of the present disclosure is to provide a device for testing electrolytes that provides adequate shelf life for reagents to remain useful during the shelf life even under low use conditions. [0020] Yet another object of the present disclosure is to provide a device for testing electrolytes that maintains real-time usage data of the disposable so that user is able to take required actions.

[0021] Still another object of the present disclosure is to provide a device for testing electrolytes that is low cost both in respect of cost of the device and cost per test.

SUMMARY

[0022] Aspects of the present disclosure relate to a cartridge for conducting tests for electrolytes present in a sample of body fluid of a patient or more, and other parameters of the sample. In an aspect, the proposed cartridge is truly modular all in one module, which comprises required wherewithal for testing one or more electrolytes present in the sample along with certain other parameters, for a certain numbers of samples, and is disposable thereafter. In another aspect, the proposed cartridge can be used for the given number of tests within a given shelf life before being disposed, and user does not need to provide for reagents, worry about disposal of waste, calibration of sensors, and other aspects required to be attended in the conventional devices.

[0023] In an aspect, the present disclosure provides a cartridge that couples with an analyser to provide test results for one or more electrolytes, and other parameters of a sample of body fluid that is deposited at a sample port of the analyser, and after life of the cartridge is over, in terms of shelf life or number of tests, the cartridge can be replaced by a new cartridge, to continue with further tests. In an aspect, the cartridge, on being inserted in the analyser, gets mechanically coupled to the port for movement of the sample from the port to the cartridge for testing. In another aspect, electronics hardware and software for the measurement purpose is provided in the analyser.

[0024] In an aspect, the proposed cartridge for testing one or more electrolytes in a sample of a body fluid comprises one or more sensors. The one or more sensors include one or more sensors that work based on ion-selective electrode technology, and are sensitive to the one or more electrolytes. A sampler is provided in the cartridge to aspirate a measured amounts of the sample or one or more reference reagents that are stored in a set of bags of the cartridge. A silicone valve of the cartridge selectively couples the sampler to the bags storing the one or more reference reagents and the sample port.

[0025] In an aspect, the set of bags also includes a bag to store waste. [0026] In an aspect, the cartridge includes a RFID label to store data related to the cartridge, the stored data being wirelessly readable and editable by a RFID reader in the analyser.

[0027] In an aspect, the cartridge comprises a tube configured to carry the sample to the sampler, said tube, on insertion of the cartridge in the analyser, gets coupled to a peristaltic pump in the analyser. The peristaltic pump is configured to pump the sample from the sample port to the sampler.

[0028] In an aspect, the sampler comprises a probe moved by a lead screw that is configured to get coupled to a stepper motor in the analyser when the cartridge is inserted in to the analyser.

[0029] In an aspect, the stored data in the RFID label can include data pertaining to shelf- life of the cartridge, use-life of the cartridge, vendor details and reagent consumption information.

[0030] In an aspect, the RFID reader can be configured to write use-life information of the cartridge on the RFID once a day.

[0031] In an aspect, the RFID reader can be configured to write number of times power failure occurred and durations of the power failures on the RFID label. Time stamp of power failure is stored in memory of the analyser and the RFID reader extracts the information on power failure from the memory and writes on the RFID label once a day.

[0032] In an aspect, the one or more reference reagents are aqueous salt reagents comprising sodium chloride and potassium chloride for calibrating the sensors, and a microbicide is added to the aqueous salt reagents to prevent microbial growth, to thereby increase shelf life of the cartridge.

[0033] In an aspect, the sample of a body fluid can be any of a whole blood, serum, plasma, urine and Cerebrospinal fluid. The urine sample can be a diluted urine sample.

[0034] In an aspect, the one or more sensors can also include a sensor to measure pH value of the sample.

[0035] In an aspect, the one or more sensors can include one or more sensors for a testing a combination of at least one or more of Na, K, Cl and Li ions. Different combinations can be Na/K/Cl, Na/K/Li and Na/K/Ca/pH.

[0036] In an aspect, the one or more sensors include at least one reference sensor to calibrate the electrolyte sensors.

[0037] In an aspect, after the cartridge is inserted into the analyser, the RFID reader is located at a distance less than 10mm from the RFID label. [0038] In an aspect, the cartridge can be configured to carry out tests on up to 500 samples.

[0039] In an aspect, the cartridge can have shelf life of up to 4 months.

[0040] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0042] FIGs. 1A and IB respectively illustrate exemplary images of the proposed device for testing electrolytes and the proposed all in one modular cartridge for use with the device, in accordance with embodiments of the present disclosure.

[0043] FIG. 2 illustrates an exemplary exploded view of the proposed all in one modular cartridge, in accordance with embodiments of the present disclosure.

[0044] FIG. 3 illustrates an exemplary exploded view of sensor module used in the all in one modular cartridge, in accordance with embodiments of the present disclosure.

[0045] FIGs. 4A and 4C illustrate exemplary graphs showing comparison of results obtained for Na, K and Cl ions respectively using a conventional device and using the proposed cartridge, in accordance with embodiments of the present disclosure.

DETAILED DESCRIPTION

[0046] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

[0047] Each of the appended claims defines a separate invention, which for infringement purposes is recognized as including equivalents to the various elements or limitations specified in the claims. Depending on the context, all references below to the "invention" may in some cases refer to certain specific embodiments only. In other cases it will be recognized that references to the "invention" will refer to subject matter recited in one or more, but not necessarily all, of the claims.

[0048] Various terms are used herein. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.

[0049] Embodiments explained herein relate to a disposable, modular and all in one cartridge for conducting tests for electrolytes and other parameters of a sample of body fluid, such as a whole blood or serum or plasma or diluted urine or Cerebrospinal fluid, of a patient. In an embodiment, the proposed cartridge comprises required wherewithal for testing one or more electrolytes, such as Na, K, Cl and Li ions, present in the sample along with certain other parameters, such as pH, for a certain numbers of samples, and is disposable after use for the given number of tests within a given shelf life. Therefore, user does not need to carryout periodic replacement of reagents, worry about disposal of waste, calibration of sensors, and other aspects required to be attended in the conventional devices. Accordingly, the proposed device can be successfully used in low resource settings such as in urban, semi-urban and rural areas in the developing countries at point of care.

[0050] In an embodiment, the present disclosure provides a cartridge that couples with an analyser to provide test results in respect of a sample of body fluid that is deposited at a sample port of the analyser, and after life of the cartridge is over, in terms of shelf life or number of tests, the cartridge can be replaced by a new cartridge, to continue with further tests. In an aspect, the cartridge, on being inserted in the analyser, gets mechanically coupled to the port for movement of the sample from the port to the cartridge for testing. In another aspect, electronics hardware and software for the measurement purpose are provided in the analyser.

[0051] In an embodiment, quantity of sample required is only 75 pi, which can be deposited at the sample port through a 130 plEppendorf tube or a 130 plVaccutainer or a 75 pi Capillary. Therefore, the sample of the blood can be obtained from patients without requirement of a trained personnel.

[0052] In an embodiment, the cartridge includes sensors to test the electrolytes present in the sample and other parameters. The sensors for electrolyte sensors work based on ion- selective electrode technology and do not require any reagents.

[0053] In an embodiment, the cartridge is configured for automatic one point calibration (CAL A) with every sample, and two-point calibration (CAL B) every 4-8 hours. Reagents required for calibration are stored within the cartridge in a set of bags provided in the cartridge. The reagents are aqueous salt reagents and include a microbicide to prevent microbial growth, which increases shelf life of the cartridge, and can be as high as 4 months. The reagents stored in the bags can be sufficient for up to 500 tests.

[0054] In an embodiment, the set of bags also includes a waste bag to store waste so that user does not have to worry about disposal of waste after each test.

[0055] In an embodiment, data regarding usage of the cartridge, such as shelf-life of the cartridge, use-life of the cartridge and reagent consumption information, along with vendor details is stored in a RFID label provided within the cartridge. The data is updated once a day by a RFID reader. The RFID reader also writes information regarding power failures. Time stamp when power failure occurs is stored in memory of the analyser, and the RFID reader extracts the information on number of times power failure occurred and durations of the power failures from the memory and writes on the RFID label once a day. This enables a service person to know how many times power failure has occurred, and for how long. Thus, the RFID label provides a means for real-time updating usage data of the cartridge which is not possible with other means of storage of data such as a bar code.

[0056] In an embodiment, the cartridge can be configured with different combination of sensors to enable testing of parameters of different clinical chemistry panels that are routinely ordered to determine a person's general health status. Different combinations can be Na/K/Cl, Na/K/Li and Na/K/Ca/pH.

[0057] Referring to FIGs. 1A and IB where exemplary images of the proposed device for testing electrolytes and other parameters in a sample of body fluid are shown, the device includes an analyser 100 and a cartridge 200. The cartridge 200 can be inserted into the analyser 100 after removing a top cover 102, thereafter the top cover 102 can be positioned back in position.

[0058] In an aspect, when the cartridge 200 is inserted into the analyser 100, it gets mechanically coupled to the analyser 100 for transfer of a sample deposited at a sample port 104, from the port to the cartridge 200 for testing of the sample.

[0059] In an aspect, the cartridge 200 includes wherewithal for testing one or more electrolytes present in the sample along with certain other parameters. A certain number of samples can be tested, and thereafter the cartridge 200 can be disposed and a new cartridge 200 can be placed in the analyser 100. Thus, the disclosed cartridge 200 is a modular, all in one disposable cartridge, which enables testing of a given number of samples of body fluids without any refilling of reagents and maintenance of the device. [0060] In an aspect, the cartridge 200 includes one or more sensors to test the electrolytes present in the sample and other parameters, a set of bags to store one or more reagents to calibrate the results, and to store waste from testing process, a sampler to aspirate a measured amounts of the sample or one or more reference reagents that are stored in a set of bags of the cartridge, and a silicone valve to selectively couple the sampler to the bags storing the one or more reference reagents and the sample port of the analyser 100.

[0061] In an aspect, the sensors for testing one or more electrolyteswork based on ion- selective electrode technology and do not require any reagents. The sensors provided in the cartridge 200 can be in combination to enable testing of parameters of different clinical chemistry panels that are routinely ordered to determine a person's general health status. Different combinations can be Na/K/Cl, Na/K/Li and Na/K/Ca/pH. Thus, the device can be used for testing different clinical chemistry panels by changing the cartridge with another one that is configured for testing the desired clinical chemistry panels.

[0062] In an aspect, the sensors include at least one calibration sensor for automatic one point calibration with every sample, and two-point calibration every 4-8 hours. Reagents required for calibration are stored within the cartridge in the set of bags provided in the cartridge 200. The reagents are aqueous salt reagents and include a microbicide to prevent microbial growth, which increases shelf life of the cartridge, and can be as high as 4 months. The reagents stored in the bags can be sufficient for up to 500 tests.

[0063] In an embodiment, the cartridge 200 includes a RFID label that stores data regarding usage of the cartridge, such as shelf-life of the cartridge, use-life of the cartridge and reagent consumption information, along with vendor details. A RFID reader is provided in the analyser 100 to wirelessly write use-life information of the cartridge on the RFID once a day. When the cartridge 200 is inserted in the analyser 100, distance between the RFID reader and the RFID label is less than 10mm

[0064] In an aspect, the RFID reader can be configured to write number of times power failure occurred and durations of the power failures on the RFID label. Time stamp of power failure is stored in memory of the analyser and the RFID reader extracts the information on power failure from the memory and writes on the RFID label once a day. Wireless connectivity between the RFID reader and the RFID label also enables automatic loading and display of information about the cartridge 200. The RFID reader also writes information regarding power failures. Time stamp when power failure occurs is stored in memory of the analyser, and the RFID reader extracts the information on number of times power failure occurred and durations of the power failures from the memory and writes on the RFID label once a day. This enables a service person to know how many times power failure has occurred, and for how long.

[0065] FIG. 2 illustrates an exemplary exploded view of the proposed all in one modular cartridge 200, in accordance with embodiments of the present disclosure. As shown, the cartridge 200 can include a set of bags 204, a sensor module 300, a probe 210, a lead screw 212 and a pump tube 208. All the constituent parts of the cartridge can be located within a back cover 202 and a front cover 206 to make a single module.

[0066] In an aspect, the sensor module 300 can include one or more sensors that work based on ion- selective electrode technology, and are sensitive to the one or more electrolytes. It can also include a sensor for measuring pH of the sample.

[0067] In an aspect, the probe 210 is part of the sampler to aspirate a measured amounts of the sample or one or more reference reagents that are stored in a set of bags of the cartridge. A silicone valve of the cartridge selectively couples the sampler to the bags storing the one or more reference reagents and the sample port.

[0068] In an aspect, the set of bags 204 includes bags for calibrant reagents for CAL A & CAL B. the reagents can be aqueous salt reagents comprising of sodium chloride and potassium chloride with microbicide to prevent microbial growth. The set of bags 204 also includes a bag to store waste from the testing process.

[0069] In an aspect, the pump tube 208 is configured to carry the sample to the sampler said tube, on insertion of the cartridge in the analyser, gets coupled to a peristaltic pump in the analyser 100. The peristaltic pump is configured to pump the sample from the sample port 104 to the sampler.

[0070] In an aspect, the cartridge 200 is of modular construction wherein each of important aggregates, namely, the set of bags 204, the sensor module 300, the probe 210, the lead screw 212 and the pump tube 208 is provided as a separate module and can be easily replaced. This is especially helpful in configuring the cartridge 200 for different different clinical chemistry panels, or for enhancing shelf life of the cartridge 200. For example, the cartridge 200 can be configured for different clinical chemistry panels by replacing the set of bags 204 and the sensor module 300. Likewise, when shelf life of a particular aggregate is over, it can be replaced to enhance the shelf life of the cartridge 200. For instance, mechanical components, such as sampler, lead screw 212, silicon valve etc., have shelf life of 1 year as compared to sensor module 300 and reagents that have shelf life of only 4 months, and if the cartridge is not used for the designated number of tests within 4 months, its life can be extended by replacing the sensor module 300 and set of bags 204 containing fresh reagent. Thus, the modular construction helps in optimum utilization of the cartridge to reduce cost of testing.

[0071] In an aspect, since the RFID label is in communication with the RFID reader in the analyser 100, it need not be visible to the end user and can be installed inside the cartridge 200. For example, in a preferred embodiment, it is fixed to the pump tube 208.

[0072] In an aspect, the probe 210, which is part of the sampler, is moved by the lead screw 212, which gets coupled to a stepper motor in the analyser 100 when the cartridge 200 is inserted in to the analyser 100.

[0073] FIG. 3 illustrates an exemplary exploded view of sensor module 300, and as shown, the sensor module includes a bubble sensor 306 held within a bubble sensor holder 308, one or more sensors, such as sensors 310-1, 310-2, 310-2...(collectively referred to as sensor(s) 310), a reference electrode 312 and a reference membrane 314. The constituents parts of the sensor module 300 can be held within a sensor module housing 302 and secured within the sensor module housing 302 by a locking clip 304 and a reference cap 316.

[0074] In an aspect, the one or more sensors out of the sensors 310 can be for testing one or more electrolytes in the sample. The sensors for electrolyte testing can work based on ion- selective electrode technology and do not require any reagents. These sensors can be plastic parts with a chemical exchanger, which is sensitive to the ions (Na or K or Clor Li) of interest. There can be other sensors to teat other parameters such as pH.

[0075] FIGs. 4A and 4C illustrate exemplary graphs showing comparison of results obtained for Na, K and Cl ions respectively using a conventional device and using the proposed cartridge, in accordance with embodiments of the present disclosure. As shown, test results for Na, K and Cl ions obtained using the proposed cartridge 200 correlate very well with corresponding results from a conventional device. Thus, performance of the prosed cartridge is reliable giving accurate results for different electrolytes.

[0076] Thus the present disclosure provides a device for testing electrolytes and other parameters in a sample of a body fluid that provides accurate result, has minimal requirement of maintenance in terms of requirement of periodic replacement of reagents and sensors and has adequate shelf life. Therefore, the present disclosure provides an apparatus that can be ideally used in low resource settings such as in urban, semi-urban and rural areas in the developing countries at point of care, for testing various clinical chemistry panels without requirement of expert personals at cheap rates.

[0077] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.

ADVANTAGES OF THE INVENTION

[0078] The present disclosure provides a device for testing electrolytes that overcomes drawbacks of conventional devices used for testing electrolytes.

[0079] The present disclosure provides a device for testing electrolytes that can be used in low resource settings such as in urban, semi-urban and rural areas in the developing countries at point of care.

[0080] The present disclosure provides a device for testing electrolytes that requires minuscule quantity, such as less than a drop, of sample that can be obtained from patient without any expertize.

[0081] The present disclosure provides a device for testing electrolytes that has capability to conduct more than one test on the sample.

[0082] The present disclosure provides a device for testing electrolytes that does not require periodic replacement of reagents and sensors.

[0083] The present disclosure provides a device for testing electrolytes that is modular, thereby does away with requirement of periodic replacement of reagents and sensors.

[0084] The present disclosure provides a device for testing electrolytes that is easy to maintain.

[0085] The present disclosure provides a device for testing electrolytes that provides adequate shelf life for reagents to remain useful during the shelf life even under low use conditions.

[0086] The present disclosure provides a device for testing electrolytes that is low cost both in respect of cost of the device and cost per test.

Claims

We Claim:

1. A modular cartridge for testing one or more electrolytes in a sample of a body fluid, said cartridge configured for insertion in an analyser, wherein insertion of said cartridge in the analyser results in coupling of a sample port provided on the analyser to said cartridge, said cartridge comprising:

a sensor module comprising one or more sensors sensitive to the one or more electrolytes, and working based on ion-selective electrode technology;

a set of bags to store one or more reference reagents and waste;

a sampler to aspirate the sample or the one or more reference reagents;

a silicone valve to selectively couple the sampler to the bags storing the one or more reference reagents and the sample port; and

a RFID label to store data related to the cartridge, the stored data being wirelessly readable and editable by a RFID reader in the analyser.

2. The cartridge as claimed in claim 1, wherein the cartridge comprises a tube configured to carry the sample to the sampler, said tube, on insertion of the cartridge in the analyser, gets coupled to a peristaltic pump in the analyser, the peristaltic pump being provided to pump the sample from the port to the sampler.

3. The cartridge as claimed in claim 1, wherein the sampler comprises a probe moved by a lead screw, said lead screw configured to get coupled to a stepper motor in the analyser when the cartridge is inserted in to the analyser.

4. The cartridge as claimed in claim 1, wherein the stored data in the RFID label includes one or more of shelf-life of the cartridge, use-life of the cartridge, vendor details, reagent consumption information.

5. The cartridge as claimed in claim 1, wherein the RFID reader is configured to write use-life information of the cartridge on the RFID once a day.

6. The cartridge as claimed in claim 1, wherein the RFID reader is configured to write number of times power failure occurred and durations of the power failures on the RFID label, and wherein time stamp of power failure is stored in memory of the analyser and the RFID reader extracts the information on power failure from the memory and writes on the RFID label once a day.

7. The cartridge as claimed in claim 1, wherein the one or more reference reagents are aqueous salt reagents comprising sodium chloride and potassium chloride for calibrating the sensors.

8. The cartridge as claimed in claim 5, wherein a microbicideis added to the aqueous salt reagents to prevent microbial growth.

9. The cartridge as claimed in claim 1, wherein the body fluid is any of a whole blood, serum, plasma, urine and Cerebrospinal fluid.

10. The cartridge as claimed in claim 1, wherein the one or more sensors sensitive to the one or more electrolytes include sensors for testing a combination of at least one or more of Na, K, Cl and Li ions.

11. The cartridge as claimed in claim 1, wherein the sensor module also includes a sensor to measure pH value of the sample.

12. The cartridge as claimed in claim 1, wherein the sensor module also includes at least one reference sensor.

13. The cartridge as claimed in claim 1, wherein after the cartridge is inserted into the analyser, the RFID reader is located at a distance less than 10mm from the RFID label.

14. The cartridge as claimed in claim 1, wherein the cartridge is configured to carry out tests on up to 500 samples.

15. The cartridge as claimed in claim 1, wherein the set of bags, the sensor module, the sampler, the silicon valve are of modular construction that enables their replacement in the cartridge to account of their varying shelf life, thereby enabling optimal utilization of the cartridge.