WO2019116289A1

WO2019116289A1 - Monitoring reagent usage in laboratory instruments

Info

Publication number: WO2019116289A1
Application number: PCT/IB2018/059985
Authority: WO
Inventors: Nilesh K SINHA
Original assignee: Beckman Coulter Inc.
Priority date: 2017-12-14
Filing date: 2018-12-13
Publication date: 2019-06-20

Abstract

Embodiments of the present disclosure relate to a method and system for monitoring and metering use of lab reagents in lab instruments by packaging reagents into capsule, the capsule membrane being a bio-degradable and inert materials, wherein based on a test condition, a reagent compartment containing the capsule with a specific reagent is identified, the capsule is selected and released into a reaction vessel containing the patient sample, which is then mixed with a substrate and/or incubated for a specific period and then tested in an illuminometer.

Description

“MONITORING REAGENT USAGE IN LABORATORY INSTRUMENTS”

RELATED APPLICATIONS):

This application claims priority from Indian Patent Application Number: 201741045008, titled“Monitoring and Metering reagent usage in Lab Instruments” filed at the Indian Patent Office on December 14, 2017.

DISCLAIMER:

A portion of the disclosure of this patent document may contain material subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.

FIELD OF TECHNOLOGY:

This disclosure is related to laboratory instruments, more particularly, but not exclusively to monitoring and metering reagent usage in laboratory instruments. BACKGROUND:

Generally, laboratory (hereinafter referred to as lab or diagnostic) instruments are used for performing tests on samples and fall under various categories for example biochemistry, microbiology, pathology and so on. Typically, in performing tests using lab instruments, samples collected from patients, which includes living organisms such as humans and animals, are normally tested for various known parameters. After testing of the samples, a report on the various parameters tested for may be provided to the patient or a physician.

Usually, a sample is first collected from a patient, and the sample collected is then prepared for testing by adding a number of chemicals (also collectively referred to as reagents) by aspirating the chemicals that are stored in a well (chamber or compartment) of the instrument into a reaction vessel and then preparing the mixture of the sample with the reagent for testing by mixing it with a substrate, incubating and then processing the sample in an illuminometer. Each substance (reagent) is stored in separate compartment of a reagent pack, for example in a Beckman Coulter® Access 2 Immunoassay System Analyzer each reagent pack has five compartments or wells, each of the compartment capable of storing a different reagent and each compartment may be of a different dimension. A reagent carousel of the lab instrument are slots capable of holding reagent packs, and the number of reagent slots may vary for different instruments. The reagent from the reagent pack are administered to the sample following a well-defined methodology, currently using a pipetting mechanism A disadvantage with the present lab instruments is that due to limitations/shortcomings of the instruments hardware and/or software, a lot of different reagents are wasted in a given reagent pack, as consumption of different reagents in a reagent pack are pre-metered, which may result in a wastage of the reagent packs as the remaining reagents in a well may be useless to conduct further tests, and therefore the reagent packs are to be discarded. Further, if during pipetting a reagent, the instrument is unable to aspirate a reagent multiple times, the reagent pack is typically rendered unusable and is disabled, however such a reagent pack may contain significant amount of usable reagents that is discarded resulting in wastage of reagents and associated costs. Also, a mechanical pipettor/probe built into the instrument is used to select and administer the quantity of reagent from the reagent pack, by aspirating the reagent and the patient sample into a reaction vessel, requiring the pipette to be washed and/or sterilized before using the next reagent and/or sample. Alternatively, disposable tips may be attached to a pipe and used to aspirate the reagents and/or the sample into the reaction vessel for a particular test to be done. A disadvantage with using disposable tips is the recurring cost associated with replacing the disposable tips, which need to be changed for each reagent that is administered and/or each patient sample. A further disadvantage with the use of the current system as a whole with respect to the current reagent packs is the use of plastics that result in environmental pollution. Also, the probe may use ultrasonic to determine the level of the regent fluid present in the reagent compartments or wells. Sometimes, due to impurity or inaccurate alignment, the level sensor fails that again resulting in disabling and discarding of reagent packs that, otherwise, may contain good reagent to be used.

SUMMARY

An object of the present disclosure is to ameliorate one or more shortcomings associated with the present lab instruments used in testing of patient samples. Embodiments of the present disclosure relate to monitoring and efficiently metering the use of reagents (chemical substances) in lab instruments in an eco-friendly, cost effective and pollution free manner, wherein reagents used for performing test on a sample are packaged into inert capsules, and depending on the test specified, a required number of reagent capsule in a predetermined order is picked up from a compartment and mixed with the sample for performing the specific test. Other embodiments are also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS:

For a better understanding of the nature and desired objects of the present invention, reference is made to the following detailed description taken in conjunction with the accompanying drawing figures wherein like reference character denote corresponding parts throughout the several views. Objects, features, and advantages of embodiments disclosed herein may be better understood by referring to the following description in conjunction with the accompanying drawings. The drawings are not meant to limit the scope of the claims included herewith. For clarity, not every element may be labeled in every Figure. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating embodiments, principles, and concepts. Thus, features and advantages of the present disclosure will become more apparent from the following detailed description of exemplary embodiments thereof taken in conjunction with the accompanying drawings in which: FIGURE 1 illustrates an exemplary embodiment of an Immunoassay System Analyzer;

FIGURE 2 illustrates an exemplary embodiment of a reagent carousel along with an illustration of patient sample holder and an exemplary reagent pack with five wells that can be placed in the reagent carousel;

FIGURE 3 illustrates an exemplary embodiment the reaction vessel and process of mixing the reagent and patient sample;

FIGURE 4 illustrates an exemplary embodiment of a method of testing a patient sample; and

FIGURE 5 is an exemplary embodiment a method of monitoring and determining replacement of capsules in a given well of the reagent pack. DETAIUED DESCRIPTION:

Hereinafter, various embodiments of the present disclosure will be described with reference to the accompanying drawings. It should be noted that all of these drawings and description are only presented as exemplary embodiments. It is to note that based on the subsequent description, alternative embodiments may be conceived that may have a structure and method as disclosed herein, and such alternative embodiments may be used without departing from the principle of the disclosure as claimed herein.

It may be appreciated that these exemplary embodiments are provided herein only for enabling those skilled in the art to better understand and then further implement the present disclosure and is not intended to limit the scope of the present disclosure in any manner. Besides, in the drawings, for a purpose of illustration, optional steps, modules, and units are illustrated in dotted-line blocks.

The terms “comprise(s),”“include(s)”, their derivatives and like expressions used herein should be understood to be open, i.e.,“comprising/ including, but not limited to.” The term“based on” means“at least in part based on.” The term“one embodiment” means“at least one embodiment”; and the term “another embodiment” indicates “at least one further embodiment.” Relevant definitions of other terms will be provided in the description below.

An embodiments of the present disclosure may or may not include the use of a reagent pack as used in a conventional lab. In a further embodiment, reagents that are used for performing test on samples may be packaged into capsules and stored in compartments/wells in a reaction carousel. In an example embodiment, a first reagent may be packaged into capsules and stored in first compartment of the carousal, a second reagent may be packaged into capsules and stored in a second compartment and so on. In a further embodiment, depending on the test to be performed on the sample, a reagent stored in the capsule may be picked up from the specific compartment and dropped into the reaction vessel, in a specific pre-determined order, thereby eliminating the need to wash the pipette or use disposable tips of the pipette, and also eliminate the need for use of plastics used for the reagent packs, as currently performed on lab instruments.

In one embodiment the material of the capsule containing the reagent may include a non-reactive degradable material. In a further embodiment, the capsule containing the reagent, on coming into contact with the sample and/or on being dropped into the reaction vessel, dissolves and/or splits and allows the reagent to come into contact with the sample. In a further embodiment, the material of the capsule containing the reagent may be inert (non-reactive) in nature, thereby on being dropped into the reaction vessel, the capsule may not react with the sample. In one embodiment, based on the test, the instrument may be configured to identify the specific compartment containing the reagent capsule, select a capsule (pick up one or more capsules) from the compartment and then drop (release) the capsule into the reaction vessels. In a further embodiment, the material of the capsule hosting the reagent may be non-reactive in nature and may or may not dissolve on coming into contact with the sample fluid, but configured to release the reagent from the capsular, which ensures that the sample is not contaminated. In a further embodiment, the capsule remnant, if any, may be easily separated by centrifugation. In a advantage embodiment, since the capsules containing the reagent are inert (do not react with the sample) in nature, the testing process may prevent reagent with reagent and/or sample contamination.

In a further advantage embodiment, replacement of the current reagent pack containing the reagent, with capsules that are packaged with the reagent prevents loss of reagents by incorrectly discarding any good reagent packs due to any hardware/software issues during the aspiration process, which is also eliminated in the current setup. In a further advantage embodiment, this results in cutting down on pollution that result from plastic waste, washing of chemicals and saves on costs associated with disposable parts

In a further embodiment, the compartment (well or chamber) of the current reagent packs may be embedded into the lab instrument or a single reagent pack that is currently being used only once may be used multiple times by just refilling the required reagent well with capsules. In a further embodiment, amount of capsules disposed from the compartment can be easily monitored.

In one embodiment, monitoring the number of capsules may be done by the lab instrument, wherein the instrument may be configured to record the number of capsules being dispensed from each compartment. In a further embodiment, an amount of reagent used in testing of the samples can be easily and efficiently metered as there is a direct dependency on the number of capsules of each type of reagent used for testing of samples. In a further embodiment, recording the exact number of capsules dispensed from each compartment provides for efficiently metering the amount of reagents used in a lab instrument, and may advantageously allow for efficient billing of reagent usage in a service related environment.

In one embodiments, a module with a sensor may be coupled to a compartment and/or a sensor may be coupled to each well of the reagent pack that may be configured to monitor usage of the capsules in each of the compartment in the reagent pack. In a further embodiment, the sensor may be configured to trigger an alert to a user to refill a particular well/compartment with the specific reagent when the number of capsules in a particular well falls below a pre determined threshold. In a further embodiment, the pre-defmed threshold may be set by the instrument manufacturer and/or the laboratory and/or the user of the instrument. In an alternate embodiment, a single sensor in the laboratory instrument may be configured to monitor all the compartments and trigger an alert to a laboratory technician for refilling a specific compartment that falls below a threshold.

A further embodiment may include monitoring the use of reagents (chemical substances) in lab instruments in an eco-friendly, cost effective and pollution free manner. Yet a further embodiment may include accurately metering usage of the reagents used in lab instruments for purpose of billing and tracking consumables used in lab instruments, especially in a service related engagement. A further embodiment may include preventing loss of reagents in lab instruments because of the reagents being packaged into capsules. A further embodiment may or may not include the use of a reagent pack as currently used in a laboratory instrument, and reagent packs that are being currently used may be replaced by compartments or a reagent pack may be used multiple times before being discarded as the reagent packs/compartments may be refilled with capsules.

According to a further embodiment, reagents that are used for performing test on samples are packaged into capsules (a small case or compartment containing the reagent, the compartment including a membrane enclosing the reagent). In a further embodiment the membrane of the capsule containing the reagent may include a degradable material, which on coming into contact with the contents in the reaction vessel may degrade and allow the reagent to mix with the contents therein. In an alternate embodiment, the capsule may be break upon being dropped into the reaction vessel allowing the reagent to come into contact with the contents in the reaction vessel. In an example embodiment, a sharp object may be placed inside each reaction vessel that will split the capsule on being dropped into the reaction vessel.

In a further embodiment, the membrane of the capsule containing the reagent may be inert in nature and may be non-reactive with the contents in the reaction vessel. In a further embodiment, the membrane of the capsule may range between 0.01 mm to about 0.5 mm and may be sufficiently strong and elastic to hold the reagent packaged within it. In a further embodiment, the membrane may be sufficiently thin such that it ruptures on being dropped into the reaction vessel and disperses the reagent into the reaction vessel, ensuring that the membrane does not react with the contents of the reaction vessel.

In one embodiment, based on the test to be performed, the lab instrument may be configured to identify a compartment (well of the reagent pack) containing a particular/specific reagent packaged in the capsule. In a further embodiment, once the compartment is identified, one or more capsules may be selected (picked up) from the identified compartment. In a further embodiment, the selected capsules may be released into a specific reaction vessel containing the patient sample, depending on the test specified. In a further embodiment, a mapping of the compartments (wells of the reagent packs) may be done prior to the lab instrument being used and the lab instrument may be calibrated accordingly. In a further embodiment, on releasing the specific capsule into a reaction vessel, the capsule may either dissolve/degrade and/or rupture and release the reagent into the reaction vessel.

In a further embodiment, the membrane of the capsule hosting the reagent may or may not dissolve in the sample fluid. In a further embodiment, when the capsule does not dissolve, but ruptures and allows the reagent to mix with the sample in the reaction vessel, the capsule remnant (membrane), if any, may be easily separated by centrifugation. In an advantageous embodiment, since the capsules containing the reagent are inert (do not react with the sample) in nature, reagent and/or sample contamination is largely prevented.

In an advantageous embodiment, replacement of the current reagent pack containing the reagent, with capsules packaged with reagent results in preventing loss of reagents, by incorrectly discarding any good reagent packs due to any hardware/software issues during the aspiration process. In a further advantageous embodiment, replacing the reagents packs with packaged capsule reagents may result in cutting down on pollution that results from plastic waste, washing of chemicals and also further save on costs associated with disposable parts. In a further embodiment, the compartment (well) of the current reagent packs may be embedded into the lab instrument, as a permanent chambers built into the lab instrument, thereby eliminating the need for manufacturing reagent packs. In a further embodiment, a single reagent pack that is currently being used may be used multiple times by just refilling compartment when the capsules in the compartment are identified to be falling below threshold. In a further embodiment, the amount of capsules disposed from each compartment of the reagent pack may be accurately monitored. In one embodiment, monitoring the number of capsules may be done by the lab instrument by either a sensor or a hardware or a software or a combination thereof, wherein the instrument may record the number of capsules being dispensed from each specific compartment, and providing an accurate number of capsules dispensed, which in turn will provide an accurate amount of reagent used. In a further embodiment, an amount of reagent used in testing of the samples can be easily metered as there is a direct dependency on the number of capsules of each type of reagent used for testing of samples. In a further embodiment, capsules used for calibration the lab instrument may not be considered for metering.

In one embodiments, a separate hardware module and/or a separate software module and/or a sensor and/or combination thereof may be provided with the lab instrument for monitoring usage of the capsules in each of the compartment in the reagent pack. In a further embodiment, when the number of capsules in any compartment goes below a pre-defmed threshold, the instrument may be configured to trigger an alert a user to refill a particular compartment with the capsules containing the required reagent. In a further embodiment, sensor coupled to each compartment of the reagent pack may be configured to monitor usage of the capsules in each of the compartment in the reagent pack and trigger an alert to a user to refill a particular well with the required reagent when the number of capsules in the well/compartment falls below a pre -determined threshold. In an alternate embodiment, a single sensor may be configured to monitor all the compartments or the reagent pack and alert the user to refill a compartment that falls below a threshold.

In a further embodiment a method for efficiently and accurately monitoring and metering use of reagents (chemical substances) used in testing of samples (patient samples) in a lab instrument is disclosed herein. A further embodiment includes maintaining a unique reagent, used for analysis/testing of a sample, for example a patient blood sample, separately in a compartment amongst a plurality of compartments of a reagent pack. In a further embodiment, patient may include human or animal or any living organism.

In a further embodiment, the lab instrument may be pre-programmed by mapping a compartment to a particular reagent, wherein the reagent are stored as capsules in the compartment. In an example embodiment, compartment M may be configured to hold reagent X, which is packaged into capsules, with the slot number if required. In a further embodiment, on determination of at least one test condition to be performed on a sample, the instrument may be configured for identifying a compartment containing a reagent required for the specific test and selecting (picking up) and dispending (releasing) the reagent (chemical used for testing of the sample) into a reaction vessel containing the sample. In a further embodiment, the volume of reagent is known, as the reagents are pre-packaged into capsules. In a further embodiment, when more than one reagent may be required for the test, the instrument may be configured to select the reagents in a particular/specific order to be dispensed and then dispense the capsule containing the reagents at a pre -determined time into a reaction vessel containing the sample.

In a further embodiment, the test sample in the reaction vessel containing the patient sample and the reagent, which is dispensed, may be then mixed. In one embodiment, the compartment may also contain a substrate (which also has been referred to as reagent or chemical substance) and the capsule containing the substrate may be dispensed into the contents of the reaction vessel in a specific order or time. In a further embodiment, the sample is prepared for test by dispensing the reagents into the reaction vessel in a pre -determined order and/or centrifuging the contents of the reaction vessel. In a further embodiment, the sample after mixing with the substrate may be incubated for a pre-determined time before performing the test. A further embodiment may include preparing the sample for a test and analysis based on specific test conditions by repeating the step of dispensing the reagent of a known volume, which in in a pre-selected order and at a given pre-determined time, mixing with a substrate and then incubating if required until the sample is ready for performing the test analysis.

In a further embodiment, the pre-defmed threshold for monitoring the reagents may be different for each of the plurality of compartments. In an example embodiment for compartment 1 the pre-defmed threshold may be different from the pre-defmed threshold for compartment 2. In a further embodiment, when the reagent in one of the plurality of compartment reaches a pre-determined threshold, the instrument may be configured to place an order for the substance from the manufacturer and/or alert a user to place an order to refill the compartment

In a further embodiment, a conventional reagent pack may generally include at least five compartments, and a conventional reagent pack fits into one slot of a reagent carousel of the lab instrument. In a further embodiment, there may be a number of slots in a reagent carousel to store a number of reagent packs. In an example embodiment, one immunoassay analyzer may include twenty-four slots, capable of holding up to twenty reagent packs, and each reagent pack containing five compartments. In a further embodiment, the number of slots in a reagent carousel may vary.

In a further embodiment, suing reagent capsules, will provide the instrument with higher capacity to add more chambers/compartment for other additional reagents or other hardware into the instrument to enhance the capabilities of the lab instrument. In a further embodiment, each compartment may be mapped into a lookup table and the instrument may be automatically configured to determine the compartment for a reagent based on the lookup table. In an example embodiment, if a current reagent pack is used, then a mapping could be specified as reagent pack in slot 2, compartment 4 includes reagent X. In a further embodiment, a rule table/lookup table or any other known means for lookup to determine the compartment and the reagent may be built into the instrument for all the reagents being used. In a further embodiment, depending on the number of reagents used for a particular test, if the current combination of substances can be combined or replaced with a new reagent, then the new reagent may be placed in a compartment and a mapping done so that the instrument can use the reagent for performing a test on the sample. In an example embodiment one compartment amongst a plurality of compartments in the reagent pack, preferably the first compartment, may include magnetic particles. In an example embodiment one compartment amongst a plurality of wells in the reagent pack, preferably the last compartment, may include an alkaline phosphatase. In a further example embodiment, at least the remaining three compartments of the reagent pack, preferably a second compartment, and a third compartment and a fourth compartment may include miscellaneous chemicals used for analysis of the patient sample.

A further embodiment may include an external system, for example a computing device, which includes at least a processor and a memory to operate the lab instrument. In a further embodiment, a computing system may be interfaced within the lab instrument (immunoassay analyzer), to be a part of the lab instrument itself.

Figure 1 illustrates an exemplary embodiment of a Beckman Coulter® Access 2 Immunoassay System Analyzer 100. It should be obvious to a person skilled in the art that other Immunoassay Analyzers capable of performing test on patient samples using reagents would broadly fall within the scope of the embodiments of the present disclosure. Immunoassay Analyzer 110 illustrated in Figure 1 is used for performing test on samples, and complete details or description of the various parts of the analyzer are not discussed here as this is not within the scope of the embodiments of the present disclosure (general information on immunoassay analyzer may be available at ‘https://en.wikipedia.org/wiki/Immunoassay’ and links therein). Immunoassay analyzer 110 is used fortesting patient samples, wherein patient samples fortesting may include blood samples of a patient or a urine sample of a patient or any other form of fluid drawn from the body of a patient. Immunoassay Analyzer 110, typically includes reaction carousel 120, wherein reaction carousel 120 includes a number of slots (not illustrated in the figure), wherein each slot is configured to hold a reagent pack, and each reagent pack typically includes different types of reagents (chemical substances), used to perform a test on the sample. The reagents may be in liquid form or solid form, and an appropriate reagent is mixed with the sample to prepare the sample for further testing in the analyzer. The reagents need to be maintained at a specific temperature or between a specific temperature range, and reaction carousel 120 is normally configured to maintain the required temperature to preserve the reagents. Immunoassay analyzer 110 also comprise sample carousel 130 for holding patient samples in tubes, preferably in one embodiment these may be test tubes. Immunoassay analyzer 110 also include test bed 140 that is configured to hold reaction vessels (not shown in this Figure), which includes a mixture of patient sample and reagent based on the specific test, for performing the test, and then mixed with a substrate, which for example may include a mixture of the patient sample, the reagent and a substrate.

Figure 2 illustrates a cross section of reaction carousel 120. Reaction carousel includes a number of slots 225 that are configured to hold reaction packs 227. Immunoassay analyzer also includes sample carousel 230 which typically has a number of slots to hold tubes, preferably test tubes, containing patient sample. Sensor 240 may be placed on each of the compartments to monitor the number of capsules being dispensed for a particular reagent. Sensor 240 is also configured to alert a user or the lab technician when the number of capsules fall below a pre-defmed or pre-configured threshold, to refill the capsules. Reaction packs 227 advantageously contains reagents packaged as capsules and eases the tasks of refilling the reagent packs with a required reagent resulting is lesser wastage of reagents. Further, each time a particular reagent is replaced, the analyzer need not be calibrated which saves time and effort for the laboratory. In one embodiment, reaction carousel 120 may include at least twenty-four slots 225, configured to hold twenty -four reagent packs 227. In a further embodiment, each reagent pack 227 is currently built to includes at least five compartments. In a further embodiment, reaction carousel 120 may comprise lesser than twenty-four slots or have more than twenty-four slots. In a further embodiment, reagent pack 227 may comprise more than five compartment to have less than five compartments, as the reagent pack containing reagents will be advantageously replaced by a reagents packaged in capsules and a particular type of reagent may be stored in a specific compartment, which may be programmed into the system. In one embodiment, reagent packs 227 instead of being replaced may be made as permanent fixture in the immunoassay analyzer such that a specific compartment may hold a specific type of reagent. In a further embodiment, reaction carousel 220 may include a number of compartments, wherein each compartment may be mapped to hold a specific reagent (such as a look up table or any other mapping means). In a further advantageous embodiment in accordance with the present disclosure, the reagents are packaged into capsules, instead of being filled into wells of a reagent pack as being currently implemented. In a further embodiment, packaging the reagent in capsules will ameliorate environmental pollutions arising due to chemical and plastics and also save cost. In one embodiment, a single sensor may be placed on each reagent pack to monitor the compartments. In a further embodiment a hardware module and/or a software module or a combination thereof without or without a sensor may be configured to monitor the compartments. In a further embodiment, the pipette may be attached with a clip to pick up the reagent from the compartment and drop the reagent into the reaction vessel. In a further embodiment, the pipette may be provided with an additional mechanism that is configured to pick up a specific reagent that is packaged into the capsule and drop the reagent into the reaction vessel for preparing the sample for further testing. In an example embodiment, a suction and release mechanism may be used to achieve this controlled either by the software or hardware or a combination thereof.

In accordance with the embodiments of the present disclosure, the compartment of a reagent pack typically include the reagent either a solid or a fluid, is replaced with each compartment including capsules containing the reagent. In a further embodiment, each reagent is stored in different compartments and a mapping is made between the reagent and the compartment, such that the computer system associated with the analyzer is configured to identify and use the right reagents. In an example embodiment, considering that the structure of the analyzer is not changed and that the analyzer is configured to hold twenty-four reaction packs 227 in reaction carousel 225, instead of the reaction packs including the reagents, each reagent pack is filled with capsules that is packaged with a specific reagent. In an example embodiment, reagent A, which previously used to be filled in compartment X of the reagent pack is now packaged into capsules containing the reagent A and the capsules are placed into compartment X. In another example embodiment, reagent B, which previously used to be filled in compartment Y of the reagent pack is now packaged into capsules containing reagent B and the capsules are placed into compartment Y. In a further embodiment, a mapping between the specific reagent and the compartment in which the reagent is placed is created and stored in the instrument for identification of the compartment containing the reagent.

In a further exemplary embodiment, if capsules with reagent A in compartment X falls below a pre-defmed threshold or a pre-configured threshold, sensor 240 or hardware module (not shown in figure) or a software module (not shown in figure) or a combination thereof may be configured to alert the lab technician or a user to refill compartment X with reagent A. In one embodiment, the software module may be configured to count the reagent capsules in the compartment and track the number of capsules that are dispensed from the compartment. In a further embodiment, the weight associated with each compartment may be used to measure the number of capsules within the compartment, and when the weight fall below the threshold, a user may be alerted to order the capsules and/or refill the compartment with the specific capsule. In a further embodiment, two thresholds may be set, wherein the first threshold is a warning indicator to refill the compartment and if the threshold falls below the second threshold, to stop the instrument from performing further testing, until the compartment is refilled with the reagent capsule. In a further embodiment, if the lab technician fails to replace/refill the compartment with the capsules, then the instrument may be configured to halt further testing until the compartment is re-filled. In one embodiment, sensor 240 may be directly configured to interact with an external computer system. In a further embodiment, sensor 240 may be configured to transmit data to an external computer system using wired means or wireless means or a combination thereof. In one embodiment, a sensor (which may include a hardware module or a software module or a combination thereof) may be defined as a device, a module, or a subsystem whose purpose is to detect events or changes in its environment and send the information to other electronic components, such as a computer system. In one embodiment the sensor may include MEMS, and it should be obvious to one skilled din the art that other sensors may be used to achieve the same results Figure 3 illustrates an exemplary embodiment of preparing a mixture for testing 300 in an immunoassay analyzer. Patient sample is stored in tube 330 and reagent are stored in compartments 327 in the form of capsules. Each compartment may have a sensor (not labelled in the figure) or the reagent pack/reagent carousel as such may have a single sensor. Test bed 340 includes reaction vessels 350, in which the patient sample is first aspirated and then depending on the test required, the specific reagent is identified from a mapping (lookup table for example) of the reagent type to the compartment, the identified reagent is then selected (picked up) from the compartment and dropped (released) into the reaction vessel. In one embodiment, preparation of the patient ample for testing may including performing a series of steps using different reagents, which may be programmed into the system/analyzer and executed by the system. In one embodiment, a software module may be configured to execute these steps. In an advantageous embodiment, by picking and dropping a capsule into a reaction vessel, the process of aspirating reagents is eliminated and results in saving on chemical pollution, because the aspirator means does not need washing or to be discarded. In a further embodiment, once the mixture in the reaction vessel is prepared with the patient sample and the specific reagents, the mixture is then integrated with a substrate and prepared for the final testing in the immunoassay analyzer.

In a further embodiment, the capsule containing the reagent may include a degradable material, which degrades on being released into the reacting vessel or on coming into contact with the patient sample. In a further embodiment, the capsule containing the reagent may be an inert material or a non-reactive material. In a further embodiment, the capsule containing the reagent may be such that it may or may not dissolve on coming into contact with the sample, and when the capsule membrane does not dissolve, the capsule membrane remnant in one embodiment may be removed using centrifugation. In a further embodiment, the capsule membrane on dissolving with the sample does not contaminate the sample as it comprise a non reactive inert material. In a further embodiment, the immunoassay analyzer may be manufactured with permanent compartments (wells) configured to hold the different reagents, instead of inserting reagent packs into the slots in the reaction carousel, wherein the compartment may host the capsules containing the reagents. In a further embodiment, the interfacing computer system and/or the lab instrument itself may be configured to be pre programmed or map the compartment number having the reagent, for selecting the reagent based on the test. In an example embodiment, a mapping may be made that compartment X may include reagent A, compartment Y may include reagent Y etc. In a further embodiment, for a specific test, patient sample is taken from tube 330 and aspirated into a reaction vessel, and reagent N is picked from compartment Y for the particular test and dropped into the reaction vessel, wherein the capsule may or may not dissolve into the sample, the sample is then mixed with a substrate and prepared for final testing after incubation, if required. It should be noted that since the capsule membrane is an inert and non-reactive material, it will not contaminate the patient sample.

Figure 4 illustrates an exemplary embodiment of a method of performing a testing using the immunoassay analyzer. In step 410. Patient sample is selected from the tube stored in the sample carousel for testing and aspirated (taken out from the sample holding tube and injected into) a reaction vessel. In step 420, a test needed to be performed on the patient sample is determined, which is tagged to a particular reaction vessel. In step 430 based on the test, the particular reagent compartment containing the reagent capsule is identified, for example the reagent required from the test may be identified from the lookup table, or alternatively the series of reagents in a particular order may be identified. In step 440, the reagent capsule from the identified reagent compartment is picked up and dropped into the reaction vessel containing the patient sample to prepare the sample for final testing in the analyzer. Immediately on coming into contact with the patient sample, the reagent in the capsule is configured to mix with the sample, as the capsule ruptures on being dropped into the sample compartment (reaction vessel) and the capsule itself may or may not dissolve in the sample. However, it is important to note that the reagent capsule being degradable and inert, will not pollute or contaminate the sample. In step 450, a mixture of the patient sample and the reagent is mixed with a substrate during the sample preparation process. In step 460, the mixture of the sample with the reagent and the substrate may be incubated for a particular time period, specified by the lab technician, in preparation for the final testing of the sampl3 e in the analyzer. In step 470, the mixture of the sample, reagent and substrate, after incubation, is sent for testing to an illuminometer and the require test is performed on the prepared sample. In step 480 a report is generated and send to the lab technician, a physician and/or the patient.

In one embodiment, different available techniques could be used instead of aspirating using a pipette. In a further embodiment, the pipette itself may be used for aspirating the sample and then use a suction and release mechanism for the reagent. In a further embodiment, each reaction vessel may be tagged and incubated for different time periods. In a further embodiment, after the period of incubation, the mixture containing the patient sample, the reagent and the substrate may be sent for final testing. In yet a further embodiment, a small robotic arm may be configured to pick up the reagent capsule from the compartment and release the reagent capsule into the reaction vessel. In a further embodiment, other techniques may be used to pick and drop the reagent capsule from the compartment into the reaction vessel, and all such techniques would fall within the scope of the present disclosure and hence not discussed here. In one embodiment, the operation of selecting the reagent from the compartment and dropping the reagent capsule in the reaction vessel may be controlled by software on the machine, which may be loaded into the program memory and execute to perform the operation required. Figure 5 illustrates an exemplary embodiment of a working of the immunoassay analyzer. In step 510, a sensor (which may also include a hardware module or a software module or a combination thereof) attached to a particular reagent compartment or a reagent pack is configured to monitor the number of regent capsules in a compartment. In a further embodiment, the number of reagent capsules in a compartment may be mapped to the weight of the compartment. In step 520 the sensor may periodically determine if the reagent capsules are above a pre-defmed threshold or below a pre-defmed threshold. In step 530, when the sensor and/or the instrument determines that the reagent capsules is above a pre-defmed or pre- configured threshold, the instrument is allowed to work normally (got to Step 430). In step 540, if the reagent capsules in the compartment falls below the pre-defmed threshold or pre- configured threshold, then testing on the analyzer is stopped and user is intimated to refill the particular reagent capsules in the required compartment. Once the capsules are re-filled, the analyzer goes to step 430. In one embodiment, as discussed previously, two threshold levels may be used, one for warning that the specific compartment needs to be refilled and the other threshold to halt operation of the analyzer. In a further embodiment, the analyzer and/or the system coupled to the analyzer may be configured to send messages to the technician when any of the compartments need to be refilled with the reagent capsules.

In one embodiment a computing system having at least a memory and processor may be integrated within the lab instrument (not represented in Figures), as being an integral part of the lab instrument. In a further embodiment, the computing system may reside outside the lab instrument and may be configured to operate the lab instrument. It should be understood that such a computing system is only intended to depict the representative major components of the computing system and that individual components may have greater complexity. Moreover, in addition other components such as the number, type, and configuration of such components may vary for such computer systems. Several particular examples of such additional complexity or additional variations are disclosed herein; it being understood that these are by way of example only and are not necessarily the only such variations. The computing system is interfaced with a laboratory information system (LIS) or a hospital information system (HIS) and/or a repository which may be part of the LIS/HIS or may be separate.

This computing system embodiment may include a plurality of central processing units (herein generically referred to as a processor or a CPU) connected to a main memory unit, a mass storage interface, a terminal/display interface, a network interface, and an input/output ("I/O") interface by a system bus. The mass storage interfaces, in turn, connect the system bus to one or more mass storage devices, such as a direct access storage device or a readable/writable optical disk drive. The network interfaces allow the computing system to communicate with other computing systems over the communications medium. The main memory unit in this embodiment also comprises an operating system, a plurality of application programs (such as the application component manager that may control the lab instrument), and some program data.

The computing system is a general-purpose computing device. Accordingly, the CPU’s may be any device capable of executing program instructions stored in the main memory and may themselves be constructed from one or more microprocessors and/or integrated circuits. The computing system may contain multiple processors and/or processing cores, as is typical of larger, more capable computer systems; however, the computing systems may include a single processor system and/or a single processor designed to emulate a multiprocessor system.

When the computing system starts up, the associated processor(s) initially execute the program instructions that make up the operating system, which manages the physical and logical resources of the computing system. These resources include the main memory, the mass storage interface, the terminal/display interface, the network interface, and the system bus. As with the processor(s), some computing system may utilize multiple system interfaces and buses, which in turn, may each include their own separate, fully programmed microprocessors.

The system bus may be any device that facilitates communication between and among the processors; the main memory; and the interfaces. Moreover, although the system bus is relatively simple, single bus structure that provides a direct communication path among the system bus, other bus structures are within the scope of the present disclosure, including without limitation, point-to-point links in hierarchical, star or web configurations, multiple hierarchical buses, parallel and redundant paths, etc.

The main memory and the mass storage devices work cooperatively in this to store the operating system, the application programs, and the program data. The main memory is a random-access semiconductor device capable of storing data and programs. This device as a single monolithic entity, the main memory may be a more complex arrangement, such as a hierarchy of caches and other memory devices. For example, the main memory may exist in multiple levels of caches, and these caches may be further divided by function, so that one cache holds instructions while another holds non-instruction data, which is used by the processor or processors. Memory may be further distributed and associated with different CPUs or sets of CPUs, as is known in any of various so-called non-uniform memory access (NUMA) computer architectures. Moreover, some embodiments may utilize virtual addressing mechanisms that allow the computing systems to behave as if it has access to a large, single storage entity instead of access to multiple, smaller storage entities such as the main memory and the mass storage device.

Although the operating system, the application programs, and the program data are typically contained within the main memory, some or all of them may be physically located on different computing systems and may be accessed remotely, e.g., via the network. Thus, while the operating system, the application programs, and the program data are typically contained within the main memory, these elements are not necessarily all completely contained in the same physical device at the same time, and may even reside in the virtual memory of other computing systems.

The system interface units support communication with a variety of storage and I/O devices. The mass storage interface unit supports the attachment of one or more mass storage devices, which are typically rotating magnetic disk drive storage devices, although they could alternatively be other devices, including arrays of disk drives configured to appear as a single large storage device to a host and/or archival storage media, such as hard disk drives, tape (e.g., mini-DV), writable compact disks (e.g., CD-R and CD-RW), digital versatile disks (e.g., DVD, DVD-R, DVD+R, DVD+RW, DVD-RAM), holography storage systems, blue laser disks, IBM Millipede devices and the like. The terminal/display interface is used to directly connect one or more display units to the computing system. These display units may be non-intelligent (i.e., dumb) terminals, such as a cathode ray tube, or may themselves be fully programmable workstations used to allow IT administrators and users to communicate with the computing system or the lab instrument itself. Note, however, that while the interface is provided to support communication with one or more displays, the computing systems does not necessarily require a display because all needed interaction with users and other processes may occur via network interface.

The computing system with multiple attached terminals, such as might be typical of a multi-user“mainframe” computer system. In such a case, the actual number of attached devices is typically a larger number. The computing systems may alternatively be a single- user system, typically containing only a single user display and keyboard input, or might be a server or similar device which has little or no direct user interface, but receives requests from other computer systems (clients). In other embodiments, the computing systems may be implemented as a personal computer, portable computer, laptop or notebook computer, PDA (Personal Digital Assistant), tablet computer, pocket computer, telephone, pager, automobile, teleconferencing system, appliance, or any other appropriate type of electronic device.

The network may be any suitable network or combination of networks and may support any appropriate protocol suitable for communication of data and/or code to/from multiple computing systems. Accordingly, the network interfaces can be any device that facilitates such communication, regardless of whether the network connection is made using present day analog and/or digital techniques or via some networking mechanism of the future. Suitable communication media include, but are not limited to, networks implemented using one or more of the IEEE (Institute of Electrical and Electronics Engineers) 802.3x“Ethernet” specification; cellular transmission networks; and wireless networks implemented one of the IEEE 802.1 lx, IEEE 802.16, General Packet Radio Service (“GPRS”), FRS (Family Radio Service), or Bluetooth specifications. Those skilled in the art will appreciate that many different network and transport protocols can be used to implement the communication medium. The Transmission Control Protocol/Intemet Protocol ("TCP/IP") suite contains suitable network and transport protocols.

The embodiments described with reference to Figures 1-5 generally may also use a client-server network architecture. These embodiments are desirable because the clients can utilize the services without either computer system requiring knowledge of the working details about the other. However, those skilled in the art will appreciate that other network architectures are within the scope of the present invention. Examples of other suitable network architectures include peer-to-peer architectures, grid architectures, and multi-tier architectures. Accordingly, the terms web server and client computer should not be construed to limit the invention to client-server network architectures.

The computing system may be operating on different operating systems such Linux, Windows, iOS etc. However, those skilled in the art will appreciate that the methods, systems, and apparatuses of the present disclosure apply equally to any computing system and operating system combination, regardless of whether one or both of the computer systems are complicated multi user computing apparatuses, a single workstations, lap-top computers, mobile telephones, personal digital assistants ("PDAs"), video game systems, or the like.

Although the present disclosure has been described in detail with reference to certain examples thereof, it may be also embodied in other specific forms without departing from the essential spirit or attributes thereof. For example, those skilled in the art will appreciate that the present disclosure is capable of being distributed as a program product in a variety of forms, and applies equally regardless of the particular type of tangible, computer-readable signal bearing medium used to actually carry out the distribution. Examples of suitable tangible, computer-readable signal bearing media include, but are not limited to: (i) non-writable storage media (e.g., read only memory devices ("ROM"), CD-ROM disks readable by a CD drive, and Digital Versatile Disks ("DVDs") readable by a DVD drive); (ii) writable storage media (e.g., floppy disks readable by a diskette drive, CD-R and CD-RW disks readable by a CD drive, random access memory ("RAM"), and hard disk drives); and (iii) communications media (e.g., computer networks, such as those implemented using“Infmiband” or IEEE 802.3x“Ethernet” specifications; telephone networks, including cellular transmission networks; and wireless networks, such as those implemented using the IEEE 802.1 lx, IEEE 802.16, General Packet Radio Service (“GPRS”), Family Radio Service ("FRS"), and Bluetooth specifications). Those skilled in the art will appreciate that these embodiments specifically include computer software down-loaded over the Internet.

Embodiments of the present disclosure may also be delivered as part of a service engagement with a client corporation, laboratory information system, hospital system, nonprofit organization, government entity, internal organizational structure, or the like. Aspects of these embodiments may include configuring a computing system to perform, and deploy software, hardware, and services that implement, some or all of the methods described herein. Aspects of these embodiments may also include analyzing the client’s operations, creating recommendations responsive to the analysis, building systems that implement portions of the recommendations, integrating the systems into existing processes and infrastructure, metering use of the systems, allocating expenses to users of the systems, and billing for use of the systems. Any service engagement may be directed at providing both the client services and the application management services may be limited to only application management services, or some combination thereof. Accordingly, these embodiments may further comprise receiving charges from other entities and associating that charge with users of the application manager.

The various software components illustrated in Figures 1-5 and implementing various embodiments of the disclosure may be implemented in a number of manners, including using various computer software applications, routines, components, programs, objects, modules, data structures, etc., referred to hereinafter as "computer programs," or simply "programs." The computer programs typically comprise one or more instructions that are resident at various times in various memory and storage devices in the computer system, and that, when read and executed by one or more processors in the computing system, cause the computing system to perform steps necessary to execute steps or elements comprising various aspects of an embodiment of the disclosure. The various software components may also be located on different systems. Some embodiments may reside on a computing system and request services from itself or from another computer system. Some embodiments may reside on one or more separate physical devices that are communicatively coupled into a larger, logical computer system.

The accompanying figures and description depicted and described embodiments of the present disclosure, and features and components thereof. Those skilled in the art will appreciate that any particular program nomenclature used in this description was merely for convenience, and thus the present disclosure should not be limited to use solely in any specific application identified and/or implied by such nomenclature. Thus, for example, the routines executed to implement the embodiments of the invention, whether implemented as part of an operating system or a specific application, component, program, module, object, or sequence of instructions could have been referred to as a "program", "application", "server", or other meaningful nomenclature. Indeed, other alternative hardware and/or software environments may be used without departing from the scope of the invention. Therefore, it is desired that the embodiments described herein be considered in all respects as illustrative, not restrictive, and that reference be made to the appended claims for determining the scope of the invention.

Although embodiments of the invention have been described using specific terms, such description is for illustrative purposes only, and it is to be understood that changes and variations may be made without departing from the spirit or scope of the following claims.

Claims

We Claim:

1. A method implemented on a laboratory analyzer for monitoring use of reagents in the laboratory instrument, the method comprising:

on determination of at least one test condition, identifying a compartment comprising a reagent specified for the test, wherein the reagent is stored in a capsule within the compartment, the compartment located in a reagent carousel, the capsule containing a pre-defmed amount of the reagent;

selecting at least one or more capsules containing a specific reagent and/or a substrate from the identified compartment in a pre-determined order specified for the test; and

releasing the at least one or more capsules containing the reagent and/or the substrate into a reaction vessel comprising a patient sample thereby preparing the sample for incubation for a pre-defmed time period and final testing in an illuminometer of the analyzer.

2. The method as claimed in claim 1, wherein a reagent pack comprises a plurality of compartments, and the reagent pack is placed in the reaction carousel.

3. The method as claimed in claim 1, wherein the reagents and/or the substrate comprises a chemical substance encapsulated into an inert membrane forming a capsule.

4. The method as claimed in claim 1, wherein the capsule containing the reagent and/or the substrate is selected from a specific compartment and released into the reaction vessel comprising of patient sample, in a pre-selected order and at a pre-determined time.

5. The method as claimed in claim 2, wherein the membrane of the capsule comprises an inert, a non-reactive and a degradable material.

6. The method as claimed in claim 1, further comprises:

monitoring a number of capsules in the compartment; and

on determination that the number of capsule in the compartment fall below a pre-defmed threshold, intimating a user to re-fill the compartment with the capsules.

7. The method as claimed in claim 6, wherein the number if capsules used is tracked and metered for billing of reagent usage and/or substrate usage by a manufacturer and/or supplier in a service level engagement.

8. The method as claimed in claim 7, wherein the number of capsules in each compartment is tracked by

a sensor coupled to a compartment of the instrument and/or

a sensor coupled to the instrument and/or

a hardware element of the instrument and/or

a software module and/or a combination of a hardware element and a software module.

9. A lab instrument configured to perform the method as claimed in any of the preceding claims 1 to 8.

10. A computer system built into the lab instrument or interfaced externally with the lab instrument carrying computer code configured to perform the method as claimed in any of the preceding claims 1 to 8.