Patent Description:
With the recent increase in human-animal infections, the epidemic of new influenza, and various other infections, increasing a lot is the demand for examining the presence or absence of disease and the state of the disease by analyzing the changes that occur after reacting biological samples, such as blood and urine collected from humans or animals, with predetermined reagents.

In this sample diagnosis process, it is very important for obtaining reproducible results that samples and reagents used for examining the samples are not affected by external factors, and that the accurate amounts of them are used each time. In the course of the examination, since the sample and the reagent may be exposed to the outside, it is necessary to effectively prevent the contamination caused by exposure of the sample and the reagent, and to secure the accuracy of the examination by using the accurate amounts.

In addition, it is also necessary to reduce the steps included in the overall examination and the spent cost by making the examination for detection and reading/analysis of the reaction product be performed accurately and quickly in one integrated system after the reaction of the reagent and the sample, thereby cutting examination time and examination cost down.

Furthermore, since a conventional in vitro diagnostic apparatus used for such an examination uses only one diagnostic kit for one diagnostic examination, it is limited in rapidly examining, analyzing and diagnosing a target object.

<CIT> is related to a station for testing a sample by means of inserting a cuvette, having a standby chamber on which a collecting member is placed, a sample chamber, a reagent chamber and a detection unit. The station comprises: a housing which has an input/output part into which a cuvette is inserted; a driving unit which is provided inside the housing, horizontally moves the cuvette, vertically moves a collecting member, reacts a sample in a sample chamber and a reagent in a reagent chamber, and injects a reaction result thereof into a detection unit; and an optical reader which is provided on the horizontal movement path of the cuvette and is for analyzing the reaction result.

The present invention intends to solve the problems of the prior art, and provides an automatic in vitro diagnostic apparatus that simultaneously performs multiple types of examinations on a single sample or performs a large number of samples at the same time by automating all of the series of examination processes from sample collection to sample pretreatment, so that it can quickly and accurately perform the examination process.

The present invention for achieving the above-mentioned objectives provides an automatic in vitro diagnostic apparatus as defined in the accompanying claims.

An automatic in vitro diagnostic apparatus according to the present invention comprises: a cuvette tray for mounting cuvette holders accommodating a plurality of cuvettes arranged alongside thereon so as to be movable back and forth in the apparatus, a tube tray for mounting tube holders accommodating a plurality of sample tubes thereon so as to be movable back and forth in the apparatus, and a mixing unit for mixing the sample contained in the sample tube, so that samples in tubes may be directly put into the apparatus and a series of inspection tasks including the sample pretreatment process may be all automatically performed, thereby minimizing the contamination caused by exposing the samples to the outside and thereby improving the accuracy and reproducibility of the examination.

In addition, according to the present invention, a cuvette holder for accommodating a plurality of cuvettes arranged alongside, and a tube holder for accommodating a plurality of capless tubes are directly put into the apparatus and then the examination is performed, so that it is possible to perform an examination for a large number of samples for one examination item or to perform an examination (analysis) for one sample for multiple examination items in one apparatus at the same time.

Specific structural or functional descriptions presented in the embodiments of the present invention are only exemplified for the purpose of describing embodiments according to the concept of the present invention, and the embodiments according to the concept of the present invention may be implemented in various forms. In addition, the present invention should not be construed as being limited to the embodiments described herein, and it should be understood to include all modifications, equivalents and substitutes that belong to the scope of the appended claims.

Meanwhile, in the present invention, terms such as first and/or second may be used to describe various components, but the components are not limited to the terms. The above terms are used only for the purpose of distinguishing one component from other components, for example, within the scope not departing from the claims according to the concept of the present invention, the first component may be named as the second component, Similarly, the second component may also be referred to as a first component.

When a component is referred to as being "connected to" or "in contact with" another component, it should be understood that a component may be directly or indirectly connected to or in contact with another component so other component(s) may exist between them in their connection or contact. On the other hand, when a component is referred to as being "directly connected to" or "in direct contact with" another component, it should be understood that no other component exists between them. Other expressions for describing the relationship between components, such as, "between" and "immediately between" or "adjacent to" and "directly adjacent to", etc., should be interpreted in the same way.

The terms used herein are used only to describe specific embodiments, and are not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly dictates otherwise. In the present specification, terms such as "comprise", "include" or "have" are intended to designate the existence of an embodied feature, number, step, operation, component, part, or combination thereof, and it should be understood that the existence or addition of one or more other features, numbers, steps, operations, components, parts or combinations thereof is not precluded in advance.

<FIG> and <FIG> are a perspective and front view, respectively, illustrating the appearance of an automatic in vitro diagnostic apparatus according to an embodiment of the present invention.

Referring to <FIG> and <FIG>, the automatic in vitro diagnostic apparatus of this embodiment is provided with a touch screen <NUM> for outputting the operation of the device and the analysis results on the front part of the housing <NUM> constituting the appearance, a first inlet into which the cuvette holders <NUM> are inserted under the touch screen <NUM>, and a second inlet into which the tube holder <NUM> is inserted in parallel with the first inlet. In this embodiment, it is shown that the cuvette holders <NUM> are placed in two rows, and each cuvette holder <NUM> has the same structure, but they can be moved forward and backward independently of each other. In the following description, since both of the cuvette holders <NUM> placed in two rows have the same structure, only one reference numeral is used without a separate distinction. Although, in the present embodiment, the cuvette holders <NUM> are illustrated as being placed in two rows, they may be placed in more rows. In addition, this embodiment may further comprise a buffer tube holder <NUM> (see <FIG>) between the two rows of the cuvette holders <NUM>. The buffer tube holder <NUM> accommodates a plurality of buffer tubes containing a buffer solution for diluting granules, and such a buffer tube holder <NUM> can be moved back and forth by a separate driving unit. On the other hand, the buffer tube holder <NUM> may further accommodate a pretreatment tube containing pretreatment solution as well as the buffer tube.

A tip collection container <NUM> for collecting the tips after use may be provided at the side of the housing <NUM>. A tip removal unit <NUM> (see <FIG>) for removing the tip after use is provided on the upper portion of the tip collection container <NUM>. The tip removal unit <NUM> has a tip removal hole 107a formed with an opening at the top. The tip removal unit <NUM> removes the tip <NUM> mounted on the tip adapter of the sampling operation unit. This will be described again in the related drawings. The housing <NUM> may include a printer 101a that outputs the diagnosis result as a printout on the upper portion of the housing <NUM>.

<FIG> and <FIG> are perspective and top views, respectively, illustrating an automatic in vitro diagnostic apparatus without its housing according to an embodiment of the present invention.

Referring to <FIG> and <FIG>, the automatic in vitro diagnostic apparatus of this embodiment comprises a base frame <NUM>, a cuvette tray <NUM> and a tube tray <NUM> that are provided to be movable in the front-rear direction (x-axis direction) on the base frame <NUM>, a sampling operation unit <NUM> and an optical analysis unit <NUM> that are provided to be movable in the left-right direction (y-axis direction) on the base frame <NUM>, and a plurality of driving units <NUM>, <NUM>, <NUM>, and <NUM> for driving each component. Preferably, the automatic in vitro diagnostic apparatus of this embodiment further comprises: a code recognition unit <NUM> fixed to the base frame <NUM>, for recognizing code information attached to the sample tube, and a mixing unit <NUM> fixed to the base frame <NUM>, for mixing the sample contained in the sample tube. Note that it should be understood that the term 'moving direction' is used to describe the front-rear direction (x-axis direction) with respect to the horizontal plane in which the cuvette tray <NUM> and the tube tray <NUM> are located, and the direction perpendicular to the 'moving direction' describes the left-right direction (y-axis direction) for the convenience of spatial explanation, respectively.

The base frame <NUM> comprises members for supporting main components or guiding the moving direction of various moving components, and may comprise a combination of a plurality of panels, or a guide member for guiding the moving direction of the moving components. It is not limited to a specific structure or form.

Specifically, the cuvette tray <NUM> and the tube tray <NUM> are movable in the front-rear direction (x-axis direction) on the base frame <NUM>, and the base frame <NUM> may have guide rails for guiding the cuvette tray <NUM> and the tube tray <NUM> in the front-rear direction.

The cuvette tray <NUM> and the tube tray <NUM> are moved back and forth by the first driving unit <NUM> and the second driving unit <NUM> provided on the base frame <NUM>. The first driving unit <NUM> and the second driving unit <NUM> may be electric motors that supply driving force through the cuvette tray <NUM>, the tube tray <NUM>, and a caterpillar type belt. According to the rotation direction of each electric motor, the cuvette tray <NUM> and the tube tray <NUM> can be precisely positioned in the front-rear direction (x-axis). Meanwhile, in order to achieve precise position control of the cuvette tray <NUM> and the tube tray <NUM>, each driving unit may further have an encoder or a position detection sensor for position control.

The sampling operation unit <NUM> and the optical analysis unit <NUM> are movable in the left-right direction (y-axis direction) on the base frame <NUM>.

A first upper frame <NUM> and a second upper frame <NUM> are installed on the base frame <NUM> in the left-right direction at a predetermined height of the front-rear moving section of the cuvette tray <NUM> and the tube tray <NUM>, so that the sampling operation unit <NUM> and the optical analysis unit <NUM> may be moved in the left-right direction according to each of upper frames <NUM> and <NUM>.

The sampling operation unit <NUM> and the optical analysis unit <NUM> move left and right by the third driving unit <NUM> and the fourth driving unit <NUM> provided on the first upper frame <NUM> and the second upper frame <NUM>. The third driving unit <NUM> and the fourth driving unit <NUM> are electric motors that supply driving force through the sampling operation unit <NUM> and the optical analysis unit <NUM>, and a caterpillar type belt. According to the rotation direction of each electric motor, the sampling operation unit <NUM> and the optical analysis unit <NUM> can be precisely positioned in the left-right direction (y-axis direction). Meanwhile, in order to achieve precise position control of the sampling operation unit <NUM> and the optical analysis unit <NUM>, each driving unit may further have an encoder or a position detection sensor for position control. In addition, in the present embodiment, each of the driving units <NUM>, <NUM>, <NUM>, and <NUM> exemplifies that the driving force of the electric motor is transmitted through a belt, but the present invention is not limited to the present embodiment, and various well-known driving force transmitting means such as a linear driving unit may be used.

Preferably, the sampling operation unit <NUM> may further comprise a camera module <NUM> for taking an image. The camera module <NUM> detects image information while moving horizontally together with the sampling operation unit <NUM>, so as to identify cartridge information, tips, and the presence or absence of a buffer tube.

Reference numeral <NUM> denotes a PCB that has a barcode reader provided on the upper portion of the front-rear moving section of the cuvette tray <NUM>, for recognizing barcodes of each cuvette disposed in the cuvette holder <NUM>.

The code recognition unit <NUM> is adjacent to the tube tray <NUM> and identifies the code information attached to the tube holder <NUM> and/or each sample tube <NUM> accommodated in the tube holder <NUM>. This code information includes information about the sample, and may be provided by a barcode or QR code. On the other hand, it may further comprise a separate camera adjacent to the code recognition unit <NUM>, and such a camera can be used for determining the type (size) of the tube accommodated in the tube holder <NUM>.

Hereinafter, each detailed configuration will be described in detail with reference to the related drawings.

The cuvette tray <NUM> is a member on which the cuvette holder <NUM> is seated, and preferably, the cuvette tray <NUM> may further comprise a temperature control unit for maintaining the seated cuvette holder <NUM> at a temperature of a predetermined condition. For example, such a temperature control unit may be provided by a known Peltier element and a fan capable of temperature control, but is not limited thereto. Known temperature control devices can be used within a range capable of controlling the temperature of the cuvette holder and maintaining a constant temperature. On the other hand, the cuvette holder <NUM> and the cuvette tray <NUM> may be integrated into each other, or the cuvette holder <NUM> and the cuvette tray <NUM> may be detachable from each other. In this cuvette holder <NUM>, a plurality of cuvettes for mixing and reacting a sample and a reagent are arranged alongside, and each cuvette includes a reagent, a tip, and an assay strip required for examination.

<FIG> shows a cuvette holder according to an embodiment of the present invention.

Referring to <FIG>, the cuvette holder <NUM> is configured to arrange a plurality of cuvettes alongside each other, wherein each cuvette includes at least one open chamber <NUM>, a reagent chamber <NUM>, at least one tip <NUM>, and a cartridge <NUM> comprising an assay strip. In the open chamber <NUM>, a sample is dispensed to be mixed with a reagent, and the reagent chamber <NUM> is filled with a reagent, such as an antibody, to react with the sample. The reagent chamber <NUM> is generally provided sealed with a sealing paper (aluminum foil), and the sealing paper needs to be removed for examination. In the present invention, the sealing paper of the reagent chamber <NUM> can be removed in the diagnostic apparatus, and a detailed description thereof will be described again in the related drawings.

The cartridge <NUM> includes an assay strip where a mixture of sample and reagent is dripped to react. However, the number of chambers and tips of the cuvette holder <NUM> can be changed according to the type of examination. For example, each row of the cuvette holder <NUM> may accommodate different examination cuvettes from those of other rows of the cuvette holder <NUM>, so that various examinations can be performed on one sample at the same time, or all the rows of the cuvette holder <NUM> accommodate the same examination cuvettes so that the same examinations can be performed on multiple samples at the same time. The same test can be performed on dog samples at the same time. Each cuvette (cartridge) may include a barcode (QR code) containing information on the sample or reagent.

While, in this embodiment, each chamber and the cartridge <NUM> including the assay strip are separately disposed in the cuvette holder, an integral type of cuvette may be used too. For example, this integral type of cuvette may be provided by a multi-well cuvette disclosed in <CIT>) of the present applicant.

<FIG> is a perspective view showing configuration of a main part of an automatic in vitro diagnostic apparatus according to another embodiment of the present invention. It shows an automatic in vitro diagnostic apparatus employing a multi-well cuvette, and the same reference numerals are used for the same components as in the previous embodiment.

Referring to <FIG>, the cuvette tray <NUM> includes a temperature control unit <NUM>, and a cuvette holder <NUM>' is mounted on and fastened to the upper end of the temperature control unit <NUM>. In the present embodiment, the cuvette holder <NUM>' comprises five rows of slots <NUM> each accommodating a multi-well cuvette <NUM>. The number of slots <NUM> can be increased or decreased. The multi-well cuvette <NUM> has a multi-well structure having a plurality of wells and barriers for separating the wells from one another to prevent reagents and samples from being mixed with each other. The multi-well cuvette <NUM> includes at least one tip <NUM>, a reaction chamber <NUM> having a plurality of chambers 41a for containing a sample and a reagent, and a detection unit <NUM> for detecting a reaction between the sample and the reagent. The detection unit <NUM> comprises a chromatographic analysis means suitable for chromatographic analysis of the reaction product that is made by reacting the sample and the reagent in the reaction chamber unit <NUM>. In addition, the detection unit <NUM> includes a sample inlet 42a and the measurement window 42b. The detection unit <NUM> may include a means suitable for chromatographic analysis of the reactant, for example, lateral flow analysis. Preferably, the detection unit <NUM> may include a cartridge for a lateral flow analysis. Reference numerals 42a and 42b denote a sample inlet and a measurement window of the cartridge, respectively.

<FIG> is a perspective view illustrating a mixing unit according to an embodiment of the present invention. <FIG> are perspective, side and front views, respectively, illustrating a mixing unit respectively according to an embodiment of the present invention.

Referring to <FIG> and <FIG>, the tube holder <NUM> accommodates a plurality of sample tubes <NUM> alongside, and the sample tubes <NUM> are seated on the tube tray <NUM> so that the sample of each sample tube <NUM> may be examined in a series of processes.

The sample tube <NUM> is a capless tube.

The mixing unit <NUM> mixes the sample (eg, blood) of each sample tube <NUM>. The mixing unit comprises: a fixing bracket <NUM> fixed to the base frame; an elevating module <NUM> supported by the fixing bracket <NUM> so as to move up and down; a fifth driving unit <NUM> for driving the elevating module <NUM> up and down; a fixing head <NUM> supported by the elevating module <NUM> so as to be able to rotate, and capable of getting fixed closely to an upper opening end of the sample tube <NUM>; and a sixth driving unit <NUM> provided for the elevating module <NUM>, for rotating the fixing head <NUM>.

The fixing bracket <NUM> is provided with a guide rail <NUM> in vertical direction, and the elevating module <NUM> is assembled with the guide rail <NUM> to vertically move by the fifth driving unit <NUM>.

The elevating module <NUM> is provided with a linear driving unit <NUM>. The linear driving unit <NUM> transmits a driving force via the fifth driving unit <NUM> and the belt <NUM> to the fifth driving unit <NUM>. The elevating module <NUM> is moved up and down by forward or reverse rotation of the fifth driving unit <NUM>.

The fixing head <NUM> is supported by the elevating module <NUM> so as to freely rotate in a rotation axis direction (C), and is fixed in close contact with the upper open end of the sample tube <NUM>. Preferably, the fixing head <NUM> may further include a contact pad having elasticity in order to increase the adhesion to the lower contact end that is in direct close contact with the sample tube <NUM>, The material of the contact pad may be a rubber material having elasticity.

The fixing head <NUM> is rotationally driven by the sixth driving unit <NUM> fixed to the elevating module <NUM>. In the present embodiment, the sixth driving unit <NUM> comprises an electric motor that rotates the driving shaft of the fixing head <NUM> through a belt. Reference numeral <NUM> denotes a tension control pulley for adjusting the tension of the belt. In the present embodiment, the sixth driving unit <NUM> has an electric motor that rotates the driving shaft of the fixing head <NUM> through a belt.

The mixing unit <NUM> configured as described above mixes the sample contained in the sample tube <NUM> as follows. The sample tube <NUM> is horizontally moved to the initial position where the sample tube <NUM> is aligned in parallel with the rotation axis direction (C) of the fixing head <NUM>. Then, the top of the sample tube <NUM> is spaced apart from the fixing head <NUM> with a predetermined gap (G) between them. Thereafter, as the elevating module <NUM> is moved down by the fifth driving unit <NUM>, the fixing head <NUM> comes into close contact with the upper opening end of the sample tube <NUM>. Next, as the fixing head <NUM> and the sample tube <NUM> are turned (rotated) together by the torque of the sixth driving unit <NUM>, the samples get mixed.

Reference numeral <NUM> is a member provided in the tube holder to support the lower end of the sample tube <NUM> to assist the rotational movement of the sample tube <NUM>.

<FIG> and <FIG> are perspective views illustrating a sampling operation unit and an optical analysis unit respectively according to an embodiment of the present invention, and omit other components except the sampling operation unit and the optical analysis unit for a better understanding. Arrow F indicates the insertion direction of the cuvette holder.

Referring to <FIG> and <FIG>, the sampling operation unit <NUM> is provided to be movable along the first upper frame <NUM> installed in the left-right direction at a predetermined height above the base frame <NUM>. The first upper frame <NUM> has a first guide beam <NUM> in the longitudinal direction. The sampling operation unit <NUM> is assembled with the first guide beam <NUM> and is movable in the left-right direction (y-axis direction) along the first upper frame <NUM>. A third driving unit <NUM> is fixed to one side of the first upper frame <NUM>. The drive shaft of the third driving unit <NUM> is connected to a belt, and the sampling operation unit <NUM> is fixed to the belt. The sampling operation unit <NUM> is controlled to be positioned in the left-right direction (y-axis direction) by the forward or reverse rotation of the third driving unit <NUM>.

The optical analysis unit <NUM> is provided to be movable along the second upper frame <NUM> installed in the left-right direction at a predetermined height above the base frame <NUM>. The second upper frame <NUM> has a second guide beam <NUM> in the longitudinal direction. The optical analysis unit <NUM> is assembled with the second guide beam <NUM> and is movable in the left-right direction (y-axis direction) along the second upper frame <NUM>. A fourth driving unit <NUM> is fixed to one side of the second upper frame <NUM>. The drive shaft of the fourth driving unit <NUM> is connected to a belt, and the optical analysis unit <NUM> is fixed to the belt. The optical analysis unit <NUM> is controlled to be positioned in the left-right direction (y-axis direction) by the forward or reverse rotation of the fourth driving unit <NUM>.

The optical analysis unit <NUM> generates data by reading the reaction result detected by the assay strip of each cuvette, so that qualitative and/or quantitative results of a specific target analyte included in the sample may be obtained using the generated data.

<FIG> is a front view illustrating a sampling operation unit according to an embodiment of the present invention. <FIG> are perspective and front views illustrating the sampling operation unit without some components (pump unit), respectively, according to an embodiment of the present invention. <FIG> are perspective and front views illustrating the sampling operation unit without some components (tip adapter unit), respectively, according to an embodiment of the present invention.

Referring to <FIG>, <FIG>, <FIG>, <FIG>, the sampling operation unit <NUM> comprises: a main plate <NUM> assembled with the first guide beam <NUM> and horizontally movable along the first guide beam <NUM>; a tip adapter <NUM> movable up and down on the main plate <NUM>, and capable of being assembled with a tip <NUM> provided in the cuvette holder; a seventh driving unit <NUM> for driving the tip adapter <NUM> up and down; a pump unit <NUM> provided on the main plate <NUM> in parallel with the tip adapter <NUM> so as to be movable up and down, and for supplying suction or discharge power to the tip adapter <NUM>; and an eighth driving unit <NUM> for driving the pump unit <NUM> up and down.

The tip adapter unit includes a tip adapter <NUM> fixed to the tip adapter block <NUM>. The tip adapter <NUM> is a hollow member, and its upper end is connected to the pump unit <NUM> by a flexible tube <NUM>. The tip adapter <NUM> has a small outer diameter at its lower end and is assembled with the tip <NUM>. In the present embodiment, the tip <NUM> is a disposable pipette tip having a substantially conical shape and is provided with a protruding part 13a on its top, and is assembled with the lower end of the tip adapter <NUM> by frictional force. On the other hand, the separation process of the tip <NUM> after use is as follows. The tip adapter <NUM> and the entire tip <NUM> move to the top of the tip removal unit <NUM> (refer to <FIG>). The tip <NUM> can be separated from the tip adapter <NUM> while the tip adapter <NUM> is raised in a state in which the protruding part 13a of the tip <NUM> is located below the end of the tip removal hole 107a. The separated tip <NUM> is collected in the tip collection container <NUM> through the tip removal unit <NUM>.

The tip adapter block <NUM> is vertically driven by a seventh driving unit <NUM>. The seventh driving unit <NUM> comprises: an electric motor <NUM>; an idle pulley <NUM> rotatable on the main plate <NUM>; and a belt <NUM> for connecting a drive shaft <NUM> of the electric motor <NUM> to the idle pulley <NUM>. The tip adapter block <NUM> is fixed to the belt <NUM> so that the vertical height of the tip adapter block <NUM> can be adjusted according to the rotation direction of the belt <NUM>. The main plate <NUM> may include a third guide beam <NUM> that guides the vertical movement of the tip adapter block <NUM>.

Preferably, the main plate <NUM> is provided at a position corresponding to the mounting height of the tip <NUM>, and further comprises a tip detection unit <NUM> capable of detecting the presence or absence of the tip <NUM>.

The pump unit <NUM> is connected to the tip adapter <NUM> by a flexible tube <NUM> so as to supply suction or discharge power, and includes a guide block <NUM> movable up and down on the main plate <NUM>, so that the height of the pump unit <NUM> can be adjusted up and down by the eighth driving unit <NUM>. The eighth driving unit <NUM> may be an electric motor that adjusts the height of the guide block <NUM> via a belt in the same way as the seventh driving unit <NUM>.

The main plate <NUM> may include a fourth guide beam <NUM> for guiding the vertical movement of the guide block <NUM>.

Preferably, the guide block <NUM> comprises a perforating structure fixed in the vertical direction. Such a perforating structure may be a perforating tip <NUM> having a pointed shape. The perforating tip <NUM> perforates the sealing paper that seals the reagent chamber of each cuvette while descending by the driving of the eighth driving unit <NUM>.

<FIG> illustrates configuration of an automatic in vitro diagnostic apparatus according to an embodiment of the present invention.

Referring to <FIG>, the automatic in vitro diagnostic apparatus of this embodiment controls a series of operations for examination according to an algorithm, and comprises a control/arithmetic unit <NUM> that calculates the detection signal made by the optical analysis unit <NUM> and derives the measurement result. The result is output to the touch screen <NUM> or the printer 101a. On the other hand, a communication unit <NUM> and a storage unit <NUM> are provided. The examination result may be transmitted/received to and from a remote location, such as a hospital system, through the communication unit <NUM> or stored in a separate storage unit <NUM>. In addition, the control/arithmetic unit <NUM> may integratedly control the driving units <NUM>, <NUM>, <NUM> and <NUM> for driving each driving element, the code recognition unit <NUM>, the mixing unit <NUM>, and the sampling operation unit <NUM>.

The schematic examination process of the automatic in vitro diagnostic apparatus configured as described above will be described.

Referring to <FIG> and <FIG>, the cartridge <NUM> of the item to be measured is inserted into the cuvette holder <NUM>. At this time, whether the cartridge <NUM> is inserted can be determined by a sensor. By operating an operation button, the cuvette tray <NUM> moves backward and the barcode is recognized in the slot where the cartridge <NUM> is inserted, so that it may be determined whether lot information matches the stored item.

Next, when the sample tube <NUM> containing the sample is inserted into the apparatus through the tube holder <NUM>, the barcode of the tube holder <NUM> is identified, and information on the sample tube <NUM> mounted on the tube holder <NUM> is determined so that as many examinations as the number of samples mounted on the tube holder <NUM> can be performed. Thereafter, the examination is performed according to the programmed procedure, and the information on the sample taken from the barcode of the sample is stored. Here, when sample information is transmitted from a hospital system, a process of determining whether the sample matches the corresponding sample may be added. If the sample contained in the sample tube <NUM> is whole blood, a mixing operation may be performed in the mixing unit <NUM>. The sampling operation unit <NUM> mounts the tip <NUM>, collects a sample, and automatically performs pretreatment (mixing) and dispensing to the cartridge <NUM>. After use, the tip <NUM> is discharged to the tip collection container <NUM>.

After dispensing is completed, the cartridge <NUM> waits during a reaction waiting time according to the item information, and is moved to the optical analysis unit <NUM> so as to be optically scanned. The scanned analog signal is converted into a digital signal to be transmitted to the control/arithmetic unit <NUM>. Next, the control/arithmetic unit <NUM> analyzes it using an arithmetic formula suitable for the item, and then the examination result is output to the outside.

Claim 1:
An automatic in vitro diagnostic apparatus comprising:
a base frame (<NUM>);
a cuvette tray (<NUM>) movable back and forth on the base frame (<NUM>), for mounting cuvette holders (<NUM>) thereon, the cuvette holders (<NUM>) accommodating a plurality of cuvettes arranged alongside each other, wherein each cuvette includes at least one open chamber (<NUM>), a reagent chamber (<NUM>), a tip (<NUM>), and a cartridge (<NUM>) comprising an assay strip; and
a first driving unit (<NUM>) for moving the cuvette tray back and forth;
a sampling operation unit (<NUM>) movable left and right perpendicular to the moving direction of the cuvette tray (<NUM>) on the base frame (<NUM>);
a third driving unit (<NUM>) for moving the sampling operation unit (<NUM>) left and right;
an optical analysis unit (<NUM>) disposed at the rear end of the sampling operation unit, movable left and right on the base frame (<NUM>), for optically analyzing the assay strip of the cuvette;
wherein the term moving direction describes the front-rear direction with respect to the horizontal plane in which the cuvette tray (<NUM>) is located, and the direction perpendicular to the moving direction describes the left-right direction,
a fourth driving unit (<NUM>) for moving the optical analysis unit (<NUM>) left and right;
characterized in that the automatic in vitro diagnostic apparatus further comprises
a tube tray (<NUM>) movable back and forth in parallel with the moving direction of the cuvette tray (<NUM>) on the base frame (<NUM>), for mounting tube holders (<NUM>) thereon, the tube holders (<NUM>) accommodating a plurality of capless sample tubes (<NUM>) containing samples;
a second driving unit (<NUM>) for moving the tube tray (<NUM>) back and forth; and
a control unit (<NUM>) for controlling the automatic in vitro diagnostic apparatus and configured to cause the sampling operation unit (<NUM>) to collect a sample contained in one of said sample tubes (<NUM>) accommodated on a tube holder (<NUM>) mounted on said tube tray (<NUM>), mixing it in an open chamber (<NUM>) of a cuvette accommodated in a cuvette holder (<NUM>) mounted on said cuvette tray (<NUM>) with a reagent taken from a reagent chamber (<NUM>) of said cuvette, and dropping the mixed solution in the open chamber (<NUM>) onto the assay strip provided in said cuvette.