TECHNICAL FIELD

The present disclosure relates in general to laboratory instruments for testing patient sample.

BACKGROUND

Generally, immunoassay analyzers may be used for testing a patient sample for 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 a test required. Typically, reagents are stored in containers/ reagent packs and are placed in reagent carousels in an immunoassay analyser. Likewise, patient samples are stored on containers/test tubes and are placed in sample carousels in an immunoassay analyser. Conventional analyzers like normally use a common pipette for aspirating the patient sample and reagents. The aspirated patient sample and reagent are dispensed in a reaction vessel present in the analyzer, for performing the test.

Typically, quality of results from immunoassay analyzers may be dependent on various factors and can be influenced by contamination of the pipette. Since the conventional analyzers have a common pipette for aspirating both the patient sample and the reagent, the pipette may carryover patient sample and/or reagents for a subsequent test. When the pipette is drawing from a reagent pack comprising the sample of the previous test, the reagent may be contaminated and thus lead to several issues including reducing the life of the reagent pack.

Further, the carryover of a remnant sample from a previous test may result in inaccurate results. Particularly, the effect of carryover of patient sample may result in false-positives in a test.

Generally, level sensors (for e.g., ultrasound sensors) are used in pipetting systems to detect level of reagents in reagent packs. When the level sensors detect the reagent, the pipette aspirates the reagent. Often time the level sensors fail to operate properly and do not detect the presence of reagents inside the reagent packs. Thus, reagent packs are discarded due to improper working of the level sensors.

Further, pipetting units are prone to damages due to collision with the reagent packs and replacing the pipetting units may be an expensive process.

SUMMARY

In an embodiment, the present disclosure discloses a laboratory instrument (also referred as immunoassay analyzer) for performing tests on patient samples. The laboratory instrument comprises a sensor communicatively coupled to a computing system to detect insertion of a container (generally referred as a reagent pack) in a carousel of the laboratory instrument. In an embodiment, the sensor may also detect when the container (reagent pack) is replaced. The sensor can include but is not limited to a weight sensor, an Infra-Red (IR) sensor or any other sensor that is capable of detecting insertion of the container/ reagent pack into the carousel. In an embodiment, when the sensor detects the insertion of the reagent pack, the computing system can be used to initiate a test. A laboratory technician generally operates the computing system. In an embodiment, the laboratory technician places a plurality of patient samples and the reagent packs comprising chemical substance in respective carousels (reagent packs are placed in a reagent carousel and patient sample is placed in a sample carousel). In a further embodiment, the laboratory technician may select a test to be performed on a patient sample, using the computing system. Thereafter, the computing system configures the laboratory instrument to perform the test on a selected patient sample. Typically, the selected patient sample and appropriate chemical substances from reagent packs are aspirated and are dispensed into a reaction vessel. The reaction vessel is used to mix the patient sample and the chemical substance. The mixture is then observed and analysed for performing the test.

In an embodiment, the laboratory instrument comprises one or more pipetting pins configured for piercing the reagent packs placed in the reagent carousel. Specifically, the reagent carousel comprises the one or more pipetting pins. The laboratory instrument also comprises one or more tubes (also referred as pipes), where one end of each tube connected to a pipetting pin. Other end of each tube terminates at the reaction vessel. The aspirated chemical substance present in the reagent packs is transported to the reaction vessel by corresponding channels. In one embodiment the one or more pipetting pins and the corresponding tubes are referred as pipetting lines. In an embodiment, each reagent pack may be provided with pipetting line. In an alternate embodiment, one pipetting line may be provided in the laboratory instrument and the reagent carousel may be rotated such that the selected reagent pack is positioned along the pipetting line which enables the plurality of pipetting to aspirate predefined amount of the chemical substances from the reagent packs. In an embodiment, the patient sample is dispensed in to the reaction vessel using the one or more tube of the pipetting line. The dispensed chemical substance and the patient sample are mixed in the reaction vessel to facilitate testing of the patient sample. In an example embodiment, the one or more pipetting pins may be attached to a bottom surface of the reagent carousel. Alternatively, the one or more pipetting pins can be attached to any surface of the reagent carousel. In an embodiment, the reagent packs may be placed inverted in the reagent carousel, for the one or more pipetting pins to aspirate the chemical substance present in the reagent pack.

In an embodiment, the computing device is configured to operate the laboratory instrument for performing tests on patient samples. The computing device may be communicatively connected to the laboratory instrument. In an embodiment, the computing device is configured to receive inputs from a sensor in the laboratory instrument for performing a test/ several tests on a patient sample. The inputs may include name/ identity of patient sample, and names of the tests to be performed. In a further embodiment, upon receiving the inputs, the computing device may detect insertion of reagent packs and patient sample in the respective carousels. The computing device may use sensors for detecting the insertion of the reagent packs and patient sample.

In an embodiment, the computing device provides the pipetting line of the laboratory instrument with instructions to aspirate the chemical substance present in each compartment of the reagent packs and dispense the aspirated chemical substance into the reaction vessel. In a further embodiment, the computing device operates the pipetting line to aspirate a predefined amount of sample from each compartment. In an embodiment, the computing device may operate actuators associated with the pipetting line for aspirating and dispensing the chemical substance.

The foregoing summary is 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 conjunction 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 exemplary diagram of a laboratory set-up for performing immunoassay analysis, in accordance with embodiments of the present disclosure;

Figure 2 illustrate simplified diagram of internal structure of a laboratory instrument for performing immunoassay analysis, in accordance with embodiments of the present disclosure;

Figure 3 illustrates an exemplary container for holding chemical substance, in accordance with embodiments of the present disclosure;

Figure 4 illustrates an exemplary container for holding patient sample, in accordance with an embodiment of the present disclosure; and

Figure 5 shows an exemplary diagram illustrating aspiration of chemical substance from a container, 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.

DETAILED DESCRIPTION

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 disclosure(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 terms "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 be readily apparent that more than one device/article (whether or not they cooperate) may be used in place of a single device/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, 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. The 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, a laboratory instrument for performing tests on patient samples is disclosed. The laboratory instrument is also referred as immunoassay analyzer in the present disclosure. In one embodiment, the laboratory instrument comprises a reagent carousel to hold a plurality of containers (generally referred as reagent packs) comprising chemical substance. In an example embodiment, the reagent packs comprise compartments (a typical reagent pack may comprise five compartments). In a further embodiment, each compartment comprises a unique chemical substance. In a further embodiment, each compartment of the reagent pack has an opening provided for aspirating the chemical substance. In a further embodiment, the opening is covered with an elastomer material. The elastomer can be pierced by a pipette/ pipetting pin of a pipetting line for aspirating the chemical substance. Alternatively, the opening can be covered with any other suitable material. In one embodiment, the reagent packs are inserted/ placed into the reagent carousel by a laboratory technician.

In one embodiment, the reagent carousel comprises one or more sensors to detect insertion of the reagent packs into the reagent carousel. In one embodiment, the one or more sensors are placed in the laboratory instrument. In an embodiment, the one or more sensors may be connected to the computing device via a wireless or a wired interface. In a further embodiment, the computing device may control the one or more sensors using software modules. In one embodiment, the one or more sensors can include but is not limited to a weight sensor, an IR sensor, or any sensor that is capable for detecting insertion of the reagent pack in the reagent carousel. For example, a weight sensor can be mounted at a bottom surface of the reagent carousel. When the reagent pack is inserted into the reagent carousel, the weight sensor can sense the insertion and indicate the lab technician. In a further embodiment, the one or more sensors are configured to detect replacement of a reagent pack. In one embodiment, the one or more sensors can provide an indication to the lab technician upon detecting the insertion of the reagent pack. In one embodiment, the indication can be displayed on a monitor of a computing system communicatively coupled with the laboratory instrument. In one embodiment, the laboratory instrument comprises a sample carousel for holding one or more patient samples. The one or more patient samples are placed in one or more containers (generally referred as test tubes). The one or more test tubes are placed in the laboratory instrument by the laboratory technician. In one embodiment, the one or more sensors can be mounted in the sample carousel as well. The one or more sensors can also be used to detect insertion/ replacement of the one or more test tubes into the sample carousel.

Reference is now made to Figure 1, which illustrates exemplary diagram of a laboratory set-up for performing immunoassay analysis. Figure 1 shows laboratory instrument (101), computer system (102) and a cable (103) connecting laboratory instrument (101) to computing system (102). As mentioned above, laboratory instrument (101) is an immunoassay analyzer. Computing system (102) is used to operate laboratory instrument (101). The computing system ( 102) is provided with inputs by the laboratory technician for performing the tests on the patient samples. When the patient samples and the reagent packs are inserted into the respective carousels, computing system (102) displays a message on a display associated with computing system (102), confirming successful insertion. Generally, the reagent carousel and the sample carousels comprise a plurality of slots to hold the reagent pack and the patient samples. In one embodiment, each slot is provided with a unique identity. The reagent pack and the patient samples are identified by the identity of the slots in which they are inserted. In one embodiment, a sensor from one or more sensor is mounted in each slot of the reagent carousel/ sample carousel. When a reagent pack is inserted in a dedicated slot, the sensor present in the slot detects the insertion and communicates to computing device (102). Computing device (102) detects that the reagent pack has been placed in the carousel and further operates the laboratory instrument (101) for performing tests on the patient sample. In one embodiment, the one or more sensors are placed in the laboratory instrument. In an embodiment, the one or more sensors may be connected to the computing device via a wireless or a wired interface. In a further embodiment, the computing device may control the one or more sensors using software modules. In case of wireless interface, a wireless module may be integrated with the computing device and the one or more sensors. For example, a transmitter module may be present at the computing device end and a receiver module may be present at the sensor end. The computing device can communicate, for example provide instructions to the one or more sensors via the transmitter module and the receiver module can receive the instructions. The one or more sensors then operates according to the instructions. In another embodiment, the one or more sensors can have the transmitter module and the computing device can have the receiver module. The one or more sensors detect the insertion of the reagent pack into the reagent carousel and transmits the detection via the transmitter module. The receiver module receives the information and the computing unit determines the insertion of the reagent pack into the reagent carousel. In an embodiment both of the one or more sensors and the computing device can have a transceiver module for establishing communication.

In one embodiment, the laboratory technician uses computing system (102) to initiate a test on a patient sample. The laboratory technician selects specific patient sample using the unique identity of the slot into which the patient sample is inserted. Also, the laboratory technician selects the test/ tests to be performed on the selected patient sample. In one embodiment, for a selected test, the reagents/ chemical substances to be used are predefined, and computing system (102) may display the reagents/ chemical substances to the laboratory technician. In a further embodiment, computing system (102) operates laboratory instrument

(101) by providing signals via cable (103). For example, computing system (102) instructs laboratory instrument (101) to aspirate a 5ml of the patient sample from a test tube placed in a specific slot in the sample carousel and dispense it in a reaction vessel. In another example, computing system (102) instructs laboratory instrument ( 101 ) to aspirate a 2ml of the chemical substance from a reagent pack placed in a specific slot in the sample carousel and dispense it in a reaction vessel.

In one embodiment, laboratory instrument (101) is connected to the computing system

(102) via a wired/ wireless network. In a further embodiment, the network 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 802.1 la/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 one embodiment, the results of the tests performed are displayed on the display associated with computing system (102). In one embodiment, computing system (102) may include a personal computer, a laptop, a tablet, a Personal Digital Assistant (PDA), a server, and the like. Reference is now made to Figure 2. Figure 2 illustrate a simplified diagram of internal structure of laboratory instrument (101) for performing immunoassay analysis. As shown in Figure 2, laboratory instrument (101) comprises the reagent carousel (201), a sample carousel (202), one or more reagent packs (203) comprising the chemical substance, one or more test tubes (204) comprising the patient samples, one or more tubes (205), a reaction vessel (206) and a conventional pipetting system (207).

Reagent carousel (201) is configured to hold the one or more reagent packs (203). Reagent carousel (201) comprises the one or more sensors (not shown in figure) for detecting insertion of one or more reagent packs (203). The sensors configured to detect insertion of the reagent packs (203) is also referred as first set of sensors. In one embodiment, reagent carousel (201) comprises a plurality of slots, each slot configured to hold one reagent pack (203). Each slot is associated with the unique identity. When a reagent pack (203) is inserted into a slot, reagent pack (203) is associated with the unique identity of the slot into which it is inserted. The unique identity is used to detect if the specific reagent pack required for performing the test is inserted into the slot. Upon detecting the insertion of the specific reagent pack, the computing device ( 102) operates the laboratory instrument ( 101 ) to aspirate chemical substance from specific reagent pack (203).

In one embodiment, sample carousel (202) is configured to hold one or more test tubes (204) comprising the patient sample. Sample carousel (202) may comprise the one or more sensors (not shown in figure) for detecting insertion of one or more test tubes (204). In one embodiment, sample carousel (202) comprises a plurality of slots, each slot configured to hold one test tube (204). Each slot is associated with the unique identity. When a test tube (204) is inserted into a slot, test tube (204) is associated with the unique identity of the slot into which it is inserted. The specific patient sample to be tested is placed in the dedicated slot. The identity associated with the dedicated slot is registered in the computing device (102). The computing device (102) operates the laboratory instrument (101) for pipetting predefined amount of sample from the specific patient sample.

In an embodiment, the laboratory instrument (101) may comprise a plurality of reaction vessels (206). In an embodiment, the test may be performed on the patient sample only when all the reaction vessels are filled with the specific patient sample and appropriate reagents. Reference is now made to Figure 3, which illustrates a typical reagent pack (203) used in laboratory instrument (101). Reagent pack (203) as shown in Figure 3 comprises five compartments (301A, 301B, 301C, 301D and 301E). In one embodiment, each compartment comprises a unique chemical substance. In a further embodiment, each compartment has an opening on a surface, masked by an elastomer layer. Any material can be used to mask the opening in each compartment. The elastomer layer is provided to secure the chemical substance present inside each compartment during transportation of reagent pack (203). Also, the elastomer can be easily pierced by a pipette. In an embodiment, the opening is provided in a top surface or a bottom surface of reagent pack (203). In one embodiment, each compartment is isolated thermally and chemically.

Reference is now made to Figure 4. Figure 4 shows atypical test tube used in laboratory instrument (101) for performing tests.

Reference is now made to Figure 5. Figure 5 illustrates an exemplary diagram for aspirating chemical substance from reagent packs (203). In one embodiment, reagent packs (203) are placed inverted in reagent carousel (201) such that the openings in each compartment face the bottom surface of reagent carousel (201). In one embodiment, lab instrument (101) comprises one or more pipetting pins (501) configured for piercing reagent packs (203) placed inverted in reagent carousel (201). One or more pipetting pins (501) are attached to reagent pack (203) to pierce the elastomer in each compartment to aspirate the chemical substance present in each compartment. In one example, one or more pipetting pins (501) may extend from a bottom surface of reagent carousel (201). The pipetting pins (501) are configured to pipette the chemical substance from the reagent pack (203). In an embodiment, the pipetting pins (501) work on the principle of suction. In a n embodiment, the reagent carousel (201) comprises a mechanism to push the pipetting pins into an opening on the top of the reagent pack (203).

In a further embodiment, each slot of reagent carousel (201) may comprise one or more pipetting pins (501) such that each reagent pack (203) placed in its slot has corresponding pipetting pins (501). In an alternate embodiment, the reagent carousel (201) may comprises one or more pipetting pins (501) common to each reagent pack (203). When a reagent pack (203) is selected, the reagent carousel (201) rotates to align the selected reagent pack (203) with the one or more pipetting pins (501). In one embodiment, laboratory instrument (101) comprises a first mechanism to push reagent packs (203) towards the bottom surface of reagent carousel (201). There could be other mechanisms to push reagent packs towards the bottom surface and there fall within the scope of the present disclosure. The first mechanism is used to press the reagent pack (203) against one or more pipetting pins (501) such that one or more pipetting pins (501) pierce reagent pack (203). For example, a weight may be used to press the reagent pack (203) against the one or more pipetting pins (501). Alternatively, an actuator comprising an arm may be used to apply force on the bottom surface of the reagent pack (203) which is placed inverted for pressing the reagent pack (203) against the one or more pipetting pins (501).

In one embodiment, when one or more pipetting pins (501) pierce the reagent pack (203), a pressure is created inside the reagent pack (203) and the chemical substance flows into one or more pipetting pipes (501). In an exemplary embodiment, one or more pipetting pins (501) are manufactured from polypropylene. A person of ordinary skill in the art may acknowledge that any existing pipetting materials can be used to manufacture one or more pipetting pins (501). In one embodiment, for regulating flow of the chemical substance into one or more pipetting pins (501) a second mechanism is used. The second mechanism can include a combination of a second set of sensors and actuators and a control unit. The second set of sensors measures the rate of aspiration/ rate of flow of chemical substance into one or more pipetting pins (501). The control unit regulates rate of aspiration of the chemical substance into one or more pipetting pins (501) by operating the second set of actuators.

In one embodiment, the amount of aspiration of the chemical substance can be set using the computing system (102). For example, the aspiration rate for every test can be set as 5ml. Examples of first set of sensors can include a flow rate sensor and the first actuator can include a valve. The sensor and the actuator may not be limited to the examples provided in this disclosure. In one embodiment, the second mechanism may be combination of software, hardware and firmware.

In one embodiment, laboratory instrument (101) comprises one or more tubes (205) for dispensing the aspirated chemical substance into reaction vessel (206). One end of each tube (205) is attached to a corresponding pipetting pin (501). Other end of each tube (205) terminates at the reaction vessel (206). The aspirated chemical substance from reagent pack (203) flows through the tube (205) and is dispensed in the reaction vessel (206). In one embodiment, athird mechanism is used to regulate flow of the chemical substance through the tube (205). The third mechanism may include a third set of sensors and actuators for regulating the flow of the chemical substance. In one embodiment, the third set of sensors may include flow rate sensor and the third set of actuators may include a valve. In one embodiment, the third set of sensors and actuators are operated by the control unit. In an embodiment, the control unit is the computing device (102). In an embodiment, the control unit can be any electronic device like a tablet, a mobile, a Personal Digital Assistant (PDA) and the like. In an embodiment, the aspirated chemical substance is dispensed into the reaction vessel (206). In an exemplary embodiment, one or more tubes (205) may be pipes. In one embodiment, the inner surface of the pipes are non-sticky pipes so that the aspirated chemical substance does not stick to the inner surface. In one embodiment, the pipes are non -reactive with the aspirated chemical substance. In one embodiment, pipes are provided with non-sticky coatings. Alternatively, pipes are manufactured using materials exhibiting non-sticky characteristics. Dimension of the pipes may be varied based on requirement and type of laboratory instrument is used. In one exemplary embodiment, one end of each tube (205) is detachably attached to a corresponding pipetting pin (501). In another embodiments, one end of each tube (205) is permanently attached to a corresponding pipetting pin (501).

In one embodiment, one or more pipetting pins (501) and one or more tubes (205) are rinsed after every test. In an exemplary embodiment, one or more pipetting pins (501) and one or more tubes (205) are cleansed with bleach and then rinsed with water for decontaminating the pipetting pins (501) and tubes (205).

In one embodiment, the conventional pipetting system (207) comprises a pipette connected to a slider. As shown, the pipette is suspended from the slider. In an embodiment, the slider facilitates movement of the pipette in at least two axes. For example, the slider may move the pipette in a horizontal direction and a vertical direction. The conventional pipetting system (207) is used for aspirating the patient sample from the selected test tube (204). The sample carousel (202) rotates such that the pipette is enabled to aspirate the patient sample from the test tube (204). In an embodiment, the vertical axis movement of the pipette facilitates pipetting the patient sample from the selected test tube (204). In a further embodiment, the horizontal movement of the pipette facilitates transporting of the pipette to the reaction vessel (206). In a further embodiment, the pipette is configured to dispense the aspirated patient sample into the reaction vessel (206). The patient sample is mixed with the chemical substance in the reaction vessel (206). In a further embodiment, the mixture is observed and analyzed for performing the test. The result of the test may be displayed on the display associated with the computing system (102).

In one embodiment, the laboratory instrument (101) disclosed herein reduces contamination of chemical substance in the reagent pack (203). Thus, life of reagent pack (203) is preserved.

In one embodiment, the sample carryover is eliminated in the pipette, thus reducing false-positives in the tests performed on patient samples.

In one embodiment, discarding reagent packs (203) are reduced. Thus, each reagent pack (203) is used effectively.

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 matter. 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. The 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.

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