This application claims priority from the Indian patent application number 201841008963, filed on March 12, 2018, and entitled“Monitoring of Reagents”, which is herein incorporated by reference in its entirety.

The present disclosure relates in general to monitoring temperature of chemical substances stored in containers, and specifically for monitoring temperature of reagents stored in reagent packs.

Generally, immunoassay analyzers may be used for testing a patient sample for any infectious diseases, allergies, cardiac markers, endocrine hormone, protein, presence of viral or bacterial substances, and toxin determinations. Immunoassay analyzer may be also used for antiarrhythmic, antibiotic, anticonvulsant, or cardiac glycoside drug concentration determination .

Usually, operation of immunoassay analyzers involves analysing patient samples with the use of suitable reagents based on the required test. Typically, quality of results from immunoassay analyzers may be dependent on various factors including temperature at which the reagents are maintained. Typically, these reagents used in performing test on the patient samples play a vital role in the operation of immunoassay analyzers. Generally, reagents may be stored in reagent packs (also hereinafter referred to as containers.) and these reagents packs therefore need to be maintained at very specific temperatures. Usually, the temperature would be around 2-8 degrees Celsius, from a date of manufacture to a date of expiry . Generally, it is observed that temperature deviation of reagent packs may impact the constitution of the reagents and thereby affect the results of the operation, causing errors in readings.

SUMMARY

In an embodiment, the present disclosure discloses a container (also generally referred to as a reagent pack) comprising chemical substances (also generally referred to as reagents), wherein the reagents are used for performing tests on patient samples on a laboratory instrument. In one specific embodiment, tire laboratory instrument is a diagnostic instrument. In one embodiment, the container includes at least one embedded sensor, wherein the sensor may be configured for monitoring a temperature of the reagents stored in the container. In one embodiment, the sensor may be configured to provide a signal when the temperature of at least one of reagents or an area surrounding the reagent pack, proximate to the reagent pack is outside a predefined threshold range, and provide at least one of a optical sign or a visual sign or an alert transmitted to an external device or an audio alert or a graphical sign or and audio visual sign or a combination thereof. In a further embodiment, the reagent pack further comprises an indicator associated with the at least one sensor to indicate the temperature of the at least one reagent being monitored in the reagent pack. In a further embodiment, the indictor is further configured to provide an intimation to at least one device coupled to the at least one sensor, when the temperature is outside a predefined temperature range.

The foregoing summary i s illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

Features and characteristic of the disclosure are set forth in the appended claims. The disclosure itself, however, as well as a preferred mode of use, further objectives and advantages thereof, may best be understood by reference to the following detailed description of an illustrative embodiment when read in con _j unction with the accompanying figures. One or more embodiments may be described, by way of example only, with reference to the accompanying figures wherein like reference numerals represent like elements and in which:

Figure 1 illustrates an exemplar _} ' diagram of a temperature monitoring container comprising chemical substances for performing tests on a sample of a patient, in accordance with an embodiment of the present disclosure;

Figure 2A, illustrate an alternate exemplary variant of a container for monitoring temperature, in accordance with an embodiment of the present disclosure;

Figure 2B illustrates an exemplary' carousel provisioning numerous container, in accordance with an embodiment of the present disclosure; Figure 3 illustrates an exemplary block diagram of a temperature monitoring unit of a container, in accordance with an embodiment of the present disclosure; and

Figure 4 illustrates an exemplary diagram of a container communicating with one or more entities, in accordance with an embodiment of the present disclosure.

It should be appreciated by those skilled in the art that any block diagrams herein represent conceptual views of illustrative systems embodying the principles of the present disclosure. Similarly, it will be appreciated that any flow charts, flow diagrams, state transition diagrams, pseudo code, and the like represent various processes which may be substantially represented in computer readable medium and executed by a computer or processor, whether or not such computer or processor is explicitly shown.

In the present document, the word "exemplary" is used herein to mean "serving as an example, instance, or illustration " Any embodiment or implementation of the present subject matter described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

While the disclosure may be susceptible to various modifications and alternative forms, specific embodiment thereof has been shown by way of example in the drawings and will be described in detail below . It should be understood, however that it is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover modifications, equivalents, and alternative falling within the scope of the disclosure.

The terms“comprises”,“comprising”, or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a setup, device or method that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such setup or device or method. In other wOrds, one or more elements in a system or apparatus proceeded by“comprises.. a” does not, without more constraints, preclude the existence of other elements or additional elements in the system or apparatus.

The terms "an embodiment", "embodiment", "embodiments", "the embodiment", "the embodiments", "one or more embodiments", "some embodiments", and "one embodiment" mean "one or more (but not all) embodiments of the disc!osure(s)" unless expressly specified otherwise.

The terms "including", "comprising”,“having” and variations thereof mean "including but not limited to", unless expressly specified otherwise.

The enumerated listing of items does not imply that any or all of the items are mutually exclusive, unless expressly specified otherwise. The tenns "a", "an" and "the" mean "one or more”, unless expressly specified otherwise.

A description of an embodiment with several components in communication with each other does not imply that all such components are required. On the contrary a variety of optional components are described to illustrate the wide variety of possible embodiments of the disclosure.

When a single device or article is described herein, it will he readily apparent that more than one device/article (whether or not they cooperate) may be used in place of a single de ice/article. Similarly, where more than one device or article is described herein (whether or not they cooperate), it will be readily apparent that a single device/article may be used in place of the more than one device or article or a different number of devices/articles may be used instead of the shown number of devices or programs. Tire functionality and/or features of a device may be alternatively embodied by one or more other devices which are not explicitly described as having such functionality/features. Thus, other embodiments of the disclosure need not include the device itself.

In one embodiment, reagents (herein after also generally referred to as chemical substances) used for testing patient samples in a laboratory or diagnostic instrument may be stored in reagent packs (herein after also referent to as containers). In a further embodiment, the reagent packs may be then stored in dedicated storage systems before being used in an analyser, which may be a diagnostic instrument. In a further embodiment, storage systems may be configured to monitor the reagent packs stored in the storage systems. In a further embodiment, when temperature of the storage system deviates from a threshold, personnel may be notified regarding the temperature deviation, so that appropriate measures may be taken to ensure that reagents used for testing patient samples in the analyser are not tainted resulting in an incorrect analysis of the patient sample. In one embodiment, the threshold may be set by a user and/or by the manufacturer of the reagent. In one embodiment, within the analyser, the container containing the reagent may also be monitored continuously for temperature changes.

In one embodiment, from the time of manufacturing the reagents and packaging the reagents in the reagent packs, the reagent packs containing the reagents may generally be subjected to transportation from one place to another. In an example embodiment, transportation may be from a manufacturing site to a laboratory site or a hospital hosting the analyser. In a further embodiment, during transportation, it may be critical to maintain the temperature of the reagent within prescribed limits, and it may occur that if temperature is not closely monitored, temperature of the reagent packs may vary, and such variation may lead to break down of the reagent wliich may not be noticed, resulting in usage of a reagent that is tainted and providing incorrect results for a given test. In a further embodiment, usage of such reagents which are broken down due to temperature variations inadvertently by a lab technician in an analyser for performing tests on a patient sample may lead to incorrect results.

Embodiments of the present disclosure relate to a reagent pack that may include at least one reagent for performing tests on a patient sample. In one embodiment, the reagent pack may include an embedded sensor (also referred to as a temperature sensor) specifically for monitoring the temperature of the reagent pack and/or the temperature of the reagents stored in the reagent pack. In a further embodiment, the reagent pack may include one or more indicators, preferably a visual indicator or a signal (for example an audio signal) to indicate that the temperature may have breached the prescribed limits and user discretion/intervention may be required for using the reagents in performing tests on a patient sample, which when breached may lead to incorrect results.

In a further embodiment, the sensor m aybe configures to monitor a temperature of the at least one reagent stored in the reagent pack, which includes a plurality of reagents. In a further embodiment, an indicator may be configured to indicate the temperature associated with each or the reagents in the reagent pack. In one embodiment, the indicator may be a visual indicator on the reagent pack. In a further embodiment, the indicator may be a sensor configure to transmit temperature readings periodically to a system and provides a user with data on the temperature monitored. In one embodiment, a visual indicator may be a different colour of light indicating that the temperature is within prescribed limits and/or the temperature has breached the prescribed limits. In a further embodiment, each well/compartment of the container that includes the chemical substance may be provided with such a visual indicator. In one embodiment, the reagent pack may need to be transported from a manufacturing site to a laboratory' and/or hospital site that hosts a laboratory instrument (also referred to as an analyzer) that uses the reagents to perform tests on a patient sample, in which case, it may be essential to continuously monitoring temperature of the reagent inside the reagent pack regularly during transportation. In one embodiment, the indicator may be configured to provide an intimation to at least one external device coupled to the one or more sensors, for example a mobile phone or a computer system, when the monitored temperature falls outside a predefined temperature range. In a further embodiment, the temperature of the reagents may be monitored at one of - a predefined time interval, continuous time interval and initiation of a trigger. In a further embodiment, the trigger comprises at least one of - application of a pressure on the container, vibration in the container, and manual initiation of the one or more sensors.

In a further embodiment, the one or more sensors may include at least one of a thermistor, a thermocouple, a resistance thermometer and a silicon bandgap temperature sensor or other temperature monitoring devices. In a further embodiment, the one or more sensors may be associated with at least one of - a Radio Frequency Identifier (RFID), a Micro-Electro Mechanical System (MEMS) and a Nano-Electro Mechanical System (NEMS). In a further embodiment, the one or more sensors may also be configured to monitor temperature in a surrounding area proximate to the container. In a further embodiment, the monitored temperature and a time stamp may be transmitted to one or more entities, which may include a laboratory information system and/or a hospital information system . In a further embodiment, tire one or more sensors and the indicator may be coupled to a processor and a memory.

Reference is now' made to Figure 1, which illustrates an exemplary container (reagent pack) comprising a plurality _' of compartments (wells), and each compartment configured to hold at least one chemical substance (reagent), wherein each compartment may be configured to hold a unique chemical substance. Figure 1 show's container 102. Container 102 includes a plurality of compartments (also referred to as wells) to store chemical substance in each of the compartments. The plurality of compartments may be collectively represented by referral numeral 101. Container 102 further includes a sensor 103, for monitoring temperature of container 102 and/or monitoring the temperature of the at least one chemical substance in compartment 101. Container 102 further includes indicator 104 for providing an indication on the monitored temperature to a user when temperature of the chemical substance deviates from a predefined temperature range. Sensor 103 and Indicator 104 are embedded to container 102. In one embodiment, each of the plurality of compartments 1 01 may include a unique chemical substance. As an exemplar) case, Figure 1 show's reagent pack 102 having five compartments, which can be denoted by 101A, 101B, 101C, 101D and 1G1E.

In one embodiment, each compartment 101 may be thermally and chemically isolated from other compartments 101 In a further embodiment, each compartment 101 may be of different shapes and size based on type of chemical substance stored. In a further embodiment a single sensor 103 and a single indicator 104 may be provided on container 102. In a further embodiment, each compartment 101 of container 102 may be provided with a sensor 103 and an indicator 104. In a further embodiment, container 102 may be provided with a single sensor 103 and each compartment 101 may be provided with indicator 104. In one embodiment, it should be obvious to one skilled in the art that various other combination between sensor 103 and indicator 104 may be constructed and such combination fall within the scope of the present disclosure. In a further embodiment, the working of single sensor 103 and single indicator 104 may be extended to one or more sensors and one or more indicators. In a further embodiment, the present disclosure makes reference to single sensor 103 and in some other embodiments the present disclosure makes reference to one or more sensors 103. In a further embodiment, die present disclosure makes reference to single indicator 104 and in some other embodiments the present disclosure makes reference to one or more indicators 104. In a further embodiment, sensor 103 and one or more sensors 103 may be used interchangeably throughout the present disclosure while explaining various embodiments. In a further embodiment, indicator 104 and one or more indicators may be used interchangeably throughout the present disclosure while explaining various embodiments.

In one embodiment, each of the plurality of compartments 101 may have sensor 103 and indicator 104. Each sensor 103 may monitor temperature of the chemical substance stored in with respect to that particular compartment 101. In an example embodiment, consider a first chemical substance stored in first compartment 101A, and a second chemical substance stored in second compartment 10 IB . In one embodiment, first sensor 103 A and first indicator 104A may be embedded alongside first compartment 101 A. Likewise, in a further embodiment, second sensor 103B and second indicator 104B may be embedded alongside second compartment 10 IB. In a further embodiment, each compartment 101 may' be individually monitored using corresponding sensor 103 and may be individually alerted using corresponding indicator 104. In one embodiment, temperature of the at least one chemical substance may be monitored at one of a predefined time interval, continuous time interval and initiation of a trigger. In an example embodiment, temperature of the at least one chemical substance may be monitored in a fixed interval, ever}' 5 minutes. In a further example embodiment, temperature of the at least one chemical substance may be monitored continuously. In yet a further example embodiment, temperature of the at least one chemical substance may be monitored when a trigger such as a pressure on container 102 changes, a vibration occurs in container 102, or a manual instruction may be provided to sensor 103 to monitor temperature of the at least one chemical substance. In a further embodiment, other types of trigger may be considered for initiating monitoring of temperature of the at least one chemical substance.

In one embodiment, in addition to monitoring temperature of at least chemical substance stored in container 102, sensor 103 may monitor temperature in an area surrounding container 102, proximate to container 102. In a further embodiment, where temperature around container 102 may affect temperature of the at least one chemical subs tance inside container 102, surrounding temperature may be imperatively monitored. In a further embodiment, sensor 103 may be configured to monitor temperature of environment proximate to container 102.

In one embodiment, temperature of container 102 may be monitored from a date of manufacture of container 102 until a date of disposal of container 102. In a further embodiment, temperature of the at least one chemical substance in container 102 may be monitored from a date of preparation of the at least one chemical substance until a date of expiry' of the at least one chemical substance.

In one embodiment, sensor 103 may include at least one of a thermistor, a thermocouple, a resistance thermometer, a silicon bandgap temperature sensor and the likes. In a further embodiment, it should be obvious to one skilled in the art that any other sensors may be used to monitor the temperature, and such sensors would fall within the scope of the present disclosure. In one embodiment, sensor 103 may be associated with at least one of a Radio Frequency Identifier (RFID), a Micro-Electro Mechanical System (MEMS) and a Nano- Electro Mechanical System (NEMS). In a further embodiment, RFID, MEMS or NEMS may be embedded in container 102. In a further embodiment, if the RFID, the MEMS or the NEMS is capable of communicating with one or more entities 401 (as shown in figure 4), sensor 103 may be configured to provide monitored temperature of the at least one chemical substance stored in container 102 to the one or more entities via the RFID, the NEMS or the MEMS.

In an embodiment, indicator 104 may indicate temperature of the at least one chemical substance stored in container 102. In one embodiment, indicator 104 may be a visual indicator 104. In an example embodiment, indicator 104 may be a LED that may be capable of displaying different colour light. In an example embodiment, when die temperature of the chemical substance is within the prescribed limits, indicator 104 may display a green light. In an example embodiment, when the temperature of a chemical substance has breached a prescribed limit, indicator 104 may be configured to display the compartment number in red or a red light above tire compartment may be activated. In one embodiment, indicator 104 may indicate a temperature value for a particular container. In a further embodiment, indicator 104 may provide an indication when the temperature of the at least one chemical substance is outside a predefined threshold range. In an example embodiment, die predefined temperature threshold may be based on the chemical properties or physical properties of the at least one chemical substance. In an example embodiment, for few chemical substance temperature thresholds may vary between 2 degrees to 8 degrees Celsius. In an alternate example embodiment, for other chemical substances the temperature threshold may vary' between 4 degrees to 10 degrees Celsius. In a further embodiment, the threshold range may be set based on the chemical substance stored in container 102. In an example embodiment, the predefined threshold range may be set by a lab technician and/or by die manufacturer providing container 102 with the chemical substance. In an example embodiment, indicator 104 may include at least one of a Light Emitting Diode (LED), a display', temperature scale, and the like. In one embodiment, indicator 104 may be controlled by a software component, a hardware component, a firmware component, or a combination thereof.

Reference is now made to Figure 2A, which illustrates an alternate type of container

102 used for storing the chemical substance. Figure 2A shows an exemplary _' container 102A, and it should be obvious that any shape is not imperative to the present disclosure and all shapes of container 102 fail within the scope of the present disclosure. Container 102A may be configured to hold a chemical substance. Container I02A is embedded with sensor 103 and indicator 104, wherein sensor 103 is configured for monitoring temperature of the chemical substance stored in container 102A. Figure 2B illustrates an exemplar _} - carousel 201 for holding a number of container 102. Carousel 201 may be part of the analyser. Carousel 201 includes a number of chambers (not shown in the figure) configured to hold the containers. In one embodiment, a number of container 102 containing separate chemical substances may be placed in carousel 201 of the laboratory instrument. In a further embodiment, an external Laboratory Information System/Hospital Information System (LIS/HIS) may be configured to maintain a list of the chemical substance in each container 102 placed within carousel 201, such that correct chemical substance is used for performing a test.

Reference is now made to Figure 3, which illustrates an exemplary _' block diagram of a temperature monitoring unit 300. As illustrated in the Figure 3, monitoring unit 300 includes processor 301, memory _' 302, sensor 103, indicator 104 and optionally' communication module 303. In one embodiment, monitoring unit 300 may be a temperature monitoring unit. In one embodiment, sensor 103 may be a temperature monitoring sensor 103. In one embodiment, monitoring unit 300 may be embedded m container 102. In one embodiment, monitoring unit 300 may' be embedded in each compartment of container 102. In a further embodiment, each temperature monitoring unit 300 may individually monitor each compartment of container 102

Processor 301 is configured to receive monitored temperature from sensor 103 and store in memory 302 along with a corresponding time stamp. Processor 301 is further configured to store a predefined threshold range of the at least one chemical substance. When processor 301 receives the monitored temperature from sensor 103, processor 301 may be configured to compare the recorded temperature value with the predefined threshold range corresponding to the at least one chemical substance stored in container 102. When the temperature value is within the predefined threshold range, processor 301 may configure indicator 104 to indicate temperature of the at least one chemical substance. When temperature of the at least one chemical substance is outside the predefined threshold range, processor 301 may configure indicator 104 to alert one or more entities that may be configured to receive such alerts in one embodiment, indicator 104 may provide an alert by displaying a predefined color or blinking temperature value as discussed previously. In another embodiment, indicator 104 may communicate with one or more entities using communication module 303. In one embodiment a power source e.g., a battery (not shown in figure) may supply power to temperature monitoring unit 300. In one embodiment, processor 301 may comprise a software component, a hardware component, a firrmvare component, or a combination thereof.

In one embodiment, it should be obvious to a person skilled in the art that sensor 103, indicator 104, processor 301, memory 302 and communication module 303 together may be referred as temperature monitoring unit 300. In a further embodiment, processor 301, memory 302, communication module 303, indicator 304 may be integrated with sensor 102, and the integrated sensor 102 may be configured to perform the tasks of each module of monitoring unit 300.

Reference is now made to Figure 4, which illustrates container 102 communicating with one or more entities 401 , which may be coupled to container 102. In one embodiment, communication module of monitoring unit 300 facilitates communication between temperature monitoring unit and one or more entities 401. In a further embodiment, the communication module may be part of the hardware of the monitoring unit. In a further embodiment, the communication module may be a separate software module coupled to the monitoring unit or an embedded software module of the monitoring unit in a further embodiment, communication module may communicate using one of a wired interface and a wireless interface. In one embodiment, monitoring unit 300 may be disposed in communication with one or more entities 401 via a network interface (not shown). In a further embodiment, the network interface may employ connection protocols including, without limitation, direct connect, Ethernet (e.g., twisted pair 10/100/1000 Base T), transmission control protocol/Intemet protocol (TCP/IP), token ring, IEEE 802.11a/b/g/n/x, etc. In a further embodiment, communication network 104 may include, without limitation, a direct interconnection, wired connection, e-commerce network, a peer to peer (P2P) network, Local Area Network (LAN), Wide Area Network (WAN), wireless network (e.g., using Wireless Application Protocol (WAP)), the Internet, Wireless Fidelity (Wi-Fi), etc.

In a further embodiment, one or more entities 401 may include at least one device include, but are not limited to, a lab technician, a server, a Personal Computer (PC), a laptop, a Personal Digital Assistant (PDA), a tablet, a mobile phone and the like.

In one embodiment, monitoring unit 300 may be configured to generate a report. In a further embodiment, the report generated by monitoring unit 300 may be transmitted to a LIS/HIS or an any external device coupled to receive the report. In a further embodiment, the report may include temperature values monitored at predefined intervals, time stamp associated with temperature values, chemical substances in container 102, predefined threshold range of the chemical substance. In a further embodiment, the report may include date of manufacture and date of expiry' of container 102, date of manufacture and date of expiry' of the chemical substance, and the like. In a further embodiment, monitoring unit 300 may be further configured to communicate generated report to one or more entities 401.

In one embodiment, a carousel within a laboratory instrument (analyzer) is used for provisioning container 102. In further embodiments, container 102 may comprise a plurality of compartments. In a further embodiment, each of the plurality of compartments comprises a unique chemical substance.

In one embodiment, container 102 may be used to monitor temperature of a chemical substance stored in container 102 at regular time intervals. In one embodiment, container 102 may alert one or more entities 401 when temperature of the chemical substance stored in container 102 exceeds a predefined threshold. In a further embodiment, an action may be taken immediately to restore temperature of the chemical substance. In a further embodiment, in scenarios where the chemical substance cannot be used as a result of temperature variation, the specific container 102 comprising the chemical substance may be identified and discarded. In one embodiment, container 102 may be used from a date of manufacture to date of expiry of container 102.

Finally, the language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject mater. It is therefore intended that the scope of the disclosure be limited not by this detailed description, but rather by any claims that issue on an application based here on. Accordingly, the disclosure of the embodiments of the disclosure is intended to be illustrative, but not limiting, of the scope of the disclosure, which is set forth in the following claims.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. Tire various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims. REFERRAL NUMERALS: