JP2022548289A - Apparatus for dispensing and analyzing biological fluids - Google Patents

Abstract

The present disclosure relates to devices for dispensing and analyzing biological fluids. The dispensing device (100) comprises a cartridge (102) having a receiving chamber (104) for receiving a bulk sample of biological fluid and a metering chamber (106) in which fluid flows between the receiving chamber (104). , each metering chamber (106) configured to hold a predetermined volume of a sample of biological fluid (110) dispensed from a bulk sample of biological fluid, each metering chamber (106) containing a sample of each biological fluid. An outlet (108) is provided for dispensing the sample (110), and a dispensing filter (12) is provided for filtering each biological fluid sample (100) upon dispensing. A sample of biological fluid (110) in metering chamber (106) is dispensable through outlet (108) by applying vacuum pressure in cartridge (102), and dispensing filter (112) is subjected to vacuum pressure. Prevent dispensing of the biological fluid sample (110) if not. [Selection drawing] Fig. 2A

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This disclosure claims the benefit of Greek Patent Application No. 20190100403, filed September 18, 2019, which is hereby incorporated by reference in its entirety. join.

The present disclosure relates generally to devices for dispensing and analyzing biological fluids. More particularly, the present disclosure describes various embodiments of dispensing devices for dispensing samples of biological fluids and analyzer devices for analyzing samples of biological fluids.

An assay is a research or analytical procedure in the medical and/or ecological context for qualitatively assessing or quantitatively determining the presence or amount or functional activity of an analyte in a sample of biological fluid. A subject, or patient, provides a sample of biological fluid to detect the presence or extent of a disease. Samples of biological fluids can be provided in the form of excretions or secretions from living individuals, including serum, interstitial fluid, urine, blood, saliva, intravascular fluid, cytosol, and intracellular fluid.

As an example, a urinalysis is a type of analysis performed on a sample of biological fluid from an individual, particularly a urine sample, that provides a source of information regarding the anatomy and function of the individual's kidney and urinary tract. . Urinalysis provides insight into the status of systemic diseases such as chronic kidney disease and/or diabetes. Urinary albumin is one of the important markers tested in urine samples to gather information to establish an individual's status of renal and urinary tract function. It is widely accepted that urinary albumin is used as an absolute standard for diagnosis of chronic kidney disease. Creatinine is another primary indicator tested in urine specimens. WO 2015/130225 describes a test for diagnosing chronic kidney disease by determining urinary albumin and creatinine concentrations and corresponding albumin/creatinine ratios.

Albumin and creatinine concentrations are measured at different times or in different steps, which takes longer and requires more manual steps, so they should be analyzed simultaneously to reduce measurement time. is desirable. However, manual processes are prone to human error resulting in inconsistent and unreliable results. Measurement of albumin and creatinine requires chemical reaction of urine with reagents and adequate reaction time to obtain accurate and consistent results. Manual operation may result in albumin and creatinine measurements being taken too early or too late. That is, reaction times may be inconsistent or inaccurate. To improve the process of urinalysis analysis, trained personnel and ancillary laboratory equipment are required. However, in remote areas with limited access to medical care, trained personnel and/or appropriate equipment are rare.

WO 2017/078630 describes a point of care analysis system for home or clinical use. The analysis system uses a dispensing device to dispense a sample of biological fluid into a cuvette, and the analysis device then analyzes the sample of biological fluid. A separate actuator is used to actuate the piston assembly, thereby dispensing the biological fluid sample into the cuvette. The cuvette containing the sample of biological fluid is then placed into the analyzer for analysis. There is some delay between loading the biological fluid sample into the cuvette and loading the cuvette into the analyzer. This can also affect the reaction time between the sample of biological fluid in the cuvette and the reagents, compromising analytical results and even erroneous diagnoses.

Accordingly, to address or alleviate at least one of the problems and/or disadvantages described above, there is a need to provide improved apparatus for dispensing and analyzing samples of biological fluids.

According to a first aspect of the present disclosure, there is a dispensing device for dispensing biological fluid, the dispensing device comprising a cartridge. The cartridge comprises a receiving chamber for receiving a bulk sample of biological fluid, a set of metering chambers in fluid communication with the receiving chamber, each metering chamber for a sample of biological fluid dispensed from the bulk sample of biological fluid. and each metering chamber comprises an outlet for dispensing a sample of the respective biological fluid, further comprising a dispensing filter for filtering the sample of the respective biological fluid upon dispensing; A sample can be dispensed through the outlet by applying a vacuum pressure within the cartridge, the dispensing filter preventing dispensing of the biological fluid sample in the absence of vacuum pressure.

According to a second aspect of the present disclosure, there is an analyzer for analyzing biological fluids. The analyzer removably houses a dispensing device consisting of a set of cuvettes and a set of biological fluid samples, the cuvettes containing a vacuum chamber containing a set of reagents, a vacuum cover sealing the dispensing device within the vacuum chamber, and a biofluid sample. A vacuum device that applies a vacuum pressure to the vacuum chamber to dispense a sample of the biological fluid into the cuvette such that the sample of the biological fluid reacts with the reagents to form an analytical sample, and a vacuum device that controls the vacuum device to perform the analysis process. A set of analysis control systems is provided, the analysis process including applying vacuum pressure to dispense a sample of the biological fluid and analyzing the analysis sample in the cuvette.

According to a third aspect of the present disclosure, there is a method of analyzing biological fluid. The method comprises the steps of deploying an analyzer comprising a vacuum chamber, a vacuum cover and a vacuum device, and mounting a dispensing device within the vacuum chamber, the dispensing device receiving a set of cuvettes and a set of samples of biological fluid. the cuvette containing a set of reagents; sealing the analyzer within the vacuum chamber with a vacuum cover; activating the vacuum device to dispense the sample of the biological fluid into the cuvette into the vacuum chamber. applying a vacuum pressure to cause the sample of biological fluid to react with reagents to form an analytical sample; and activating a set of analytical control systems to control the vacuum device to perform the analytical process, comprising: The analysis process includes applying a vacuum pressure to dispense a sample of biological fluid and analyze the analysis sample in the cuvette.

According to a fourth aspect of the present disclosure is an analysis system for analyzing biological fluids. The analysis system comprises a base station and a plurality of inspection stations communicatively connected to the base station and each comprising an analysis device. The analyzer removably houses a dispensing device containing a set of cuvettes and a set of biological fluid samples, the cuvettes containing a vacuum chamber containing a set of reagents, a vacuum cover sealing the dispensing device within the vacuum chamber; and a set of analytical control systems for performing analytical processes. The analytical system further comprises a set of vacuum devices for applying vacuum pressure within the vacuum chamber of the laboratory, the vacuum pressure dispensing the sample of biological fluid into the cuvette, the sample of biological fluid reacting with the reagent to forming an analysis sample, each analysis step including applying a vacuum pressure to dispense the sample of the biological fluid, and analyzing the analysis sample in the cuvette, the base station controlling the laboratory to perform the analysis step; is configured to run

According to a fifth aspect of the present disclosure, there is an identification system for supporting an analytical process performed on a sample of a patient's biological fluid. The identification system is a first identification label permanently disposed on a dispensing device that collects and dispenses biological fluid for analysis and includes encoded first identification data associated with the dispensing device. A first identification label and a second identification label permanently located on the dispensing device and containing encoded second identification data relating to reagents contained in cuvettes of the dispensing device. and a third identification label removably attached to the dispensing device, the third identification label including encoded third identification data for patient access to the analysis results. , the first identification data and/or the second identification data are verifiable against reference identification data for verifying the dispensing device and/or the reagent, and the third identification data allows the patient to identify the patient's electronic It will be possible to access the analysis results using the device.

According to a sixth aspect of the present disclosure, a computerized method is disclosed for utilizing analytical results from an analytical process performed on a biological fluid sample of a patient. The computerized method comprises receiving a request from the patient from the first electronic device to access the online interface to initiate the analysis process, the request from the patient including a device identifier and identification data associated with a dispensing device for collecting a sample of biological fluid; associating the identification data with the device identifier; receiving a request containing identification data and analysis results from the online interface to enter the analysis results; associating the analysis results with the identification data; and sending a message of the results to the first electronic device. The sending step, wherein the resulting message indicates that the analysis results are available on the online interface accessed by the first electronic device.

Accordingly, an apparatus for dispensing and analyzing samples of biological fluids according to the present disclosure is disclosed herein. Various features, aspects and advantages of the present disclosure will become more apparent from the following detailed description of embodiments of the present disclosure, by way of non-limiting example only, together with the accompanying drawings.
1A-1D illustrate various examples of dispensing devices for dispensing biological fluids. 1A-1D illustrate various examples of dispensing devices for dispensing biological fluids. 1A-1D illustrate various examples of dispensing devices for dispensing biological fluids. 1A-1D illustrate various examples of dispensing devices for dispensing biological fluids. Fig. 3 is a cross-sectional view of a dispensing device containing a series of cuvettes; Fig. 2 is an exploded view of a dispensing device including cuvettes; FIG. 3 is a cross-sectional view of the dispensing device during dispensing of a sample of biological fluid; FIG. 3 is a cross-sectional view of the dispensing device during dispensing of a sample of biological fluid; 4A and 4B are various views of another dispensing device; 4A and 4B are various views of another dispensing device; 4A and 4B are various views of another dispensing device; 4A and 4B are various views of another dispensing device; 4A and 4B are various views of the metering chamber of the dispensing device; 4A and 4B are various views of the metering chamber of the dispensing device; 4A and 4B are various views of the metering chamber of the dispensing device; 4A and 4B are various views of the metering chamber of the dispensing device; 4A-4D are various views of the piston assembly of the dispensing device. 4A-4D are various views of the piston assembly of the dispensing device. 4A-4D are various views of the piston assembly of the dispensing device. Fig. 3 is a view of the cartridge lid of the dispensing device; 4A-4D are various views of a cuvette and a cuvette case for holding the cuvette. 4A-4D are various views of a cuvette and a cuvette case for holding the cuvette. 1A and 1B are various views of an analyzer for analyzing biological fluids; FIG. 1A and 1B are various views of an analyzer for analyzing biological fluids; FIG. 1A and 1B are various views of an analyzer for analyzing biological fluids; FIG. 4 is a flow chart of a biological fluid analysis method using an analyzer. Figures 4A and 4B are various views of the vacuum cover of the analyzer; Figures 4A and 4B are various views of the vacuum cover of the analyzer; 1 is a diagram of a vacuum device of an analyzer and a vacuum control system for controlling the vacuum device; FIG. 1 is a diagram of a vacuum device of an analyzer and a vacuum control system for controlling the vacuum device; FIG. 4A-4D are various views of the vacuum actuator of the analyzer. 4A-4D are various views of the vacuum actuator of the analyzer. It is an example of an electromagnetic mixing system for an analyzer. 4A and 4B are various examples of optical measurement systems of analyzers; 4A and 4B are various examples of optical measurement systems of analyzers; 4A and 4B are various examples of optical measurement systems of analyzers; FIG. 4 is an illustration of a time schedule for operating the optical measurement system; 1A and 1B are various views of an analysis system for analyzing biological fluids; FIG. 1A and 1B are various views of an analysis system for analyzing biological fluids; FIG. Fig. 3 shows various configurations of the inspection station of the analysis system; Fig. 3 shows various configurations of the inspection station of the analysis system; Fig. 3 shows various configurations of the inspection station of the analysis system; FIG. 3 shows an example of an identification system used in a dispensing device to assist the analytical process; Fig. 3 is a flow chart of a computerized method for utilizing analysis results from an analysis step;

For brevity and clarity, descriptions of embodiments of the present disclosure are directed to apparatus for dispensing and analyzing samples of biological fluids according to the drawings. While aspects of the present disclosure will be described in conjunction with the embodiments provided in this document, it will be understood that they are not intended to limit the present disclosure to those embodiments. On the contrary, this disclosure covers alternatives, modifications and equivalents to the embodiments described herein, which fall within the scope of this disclosure as defined by the appended claims. Additionally, in the detailed description that follows, specific details are set forth in order to provide a thorough understanding of the present disclosure. However, one of ordinary skill in the art, i.e., one of ordinary skill in the art, may practice the present disclosure without specific details and/or may result from combining aspects of certain embodiments. It will be appreciated that it accompanies the details of In many instances, well-known systems, methods, procedures, and components have not been described in detail to avoid unnecessarily obscuring aspects of the disclosed embodiments.

In embodiments of the present disclosure, any discussion or use of a given element or particular element in a particular figure, or reference to a particular element in corresponding descriptive material, is identified in another figure or descriptive material to which it is associated. Including the same elements, identical elements or similar elements or element numbers.

References to “an embodiment/example,” “another embodiment/example,” “some embodiments/examples,” “some other embodiments/examples,” etc. refer to the implementations thus described. Forms/examples may include particular features, structures, characteristics, properties, elements, or limitations, but not all embodiments/examples necessarily include particular features, structures, characteristics, properties, elements, or limitations. indicates that it is not Moreover, repeated use of the phrases "in an embodiment/example" or "in another embodiment/example" do not necessarily refer to the same embodiment/example.

The terms "configuration," "including," "having," etc. do not exclude the presence of features/elements/steps other than those stated in the embodiments. The description of particular features/elements/steps in different embodiments does not indicate that combinations of these features/elements/steps cannot be used in the embodiments.

The terms "a" and "an" herein are defined as one or more. The use of "/" in figures or related text is understood to mean "and/or" unless indicated otherwise. The term "set" is defined, according to known mathematical definitions, as a nonempty finite organization of elements that mathematically exhibit at least one cardinality (e.g., a set as defined herein may be a unit, a single, or a can correspond to a single set of elements, or a set of multiple elements). It is understood that the recitations of specific numerical values or ranges of values herein include or are recitations of approximate numerical values or ranges of values. The terms "first", "second", "third", etc. are used merely as labels or identifiers and are not intended to impose numerical requirements on the associated terms. The term "reciprocal" denotes an interrelationship between two or more elements.

Distributor 100
A representative embodiment of the present disclosure, with reference to FIGS. 1A-1D, includes a dispensing device 100 for dispensing a sample 110 of biological fluid. Biological fluids are defined as biological or bioorganic fluids produced by living organisms. A sample of biological fluid 110 may be used to screen, monitor, and/or diagnose early stages of diabetes including its evolutionary stage, chronic kidney disease, kidney-related diseases such as acute kidney disease, or other diseases for which a urine sample may be used. , includes a sample of urine discharged from a living person (ie, subject or patient).
A bulk sample of biological fluid is transferred to the dispensing device 100 from a collection device such as a cup, pipette or other type of container. Dispensing device 100 comprises a cartridge 102 having a receiving chamber 104 and a set of one or more metering chambers 106 in fluid communication with receiving chamber 104 . Receiving chamber 104 is configured to receive a bulk sample of biological fluid and distribute the bulk sample of biological fluid to metering chamber 106 .

Each metering chamber 106 is configured to hold a predetermined amount of sample 110 of biological fluid dispensed from a bulk sample of biological fluid. Depending on the configuration/dimensions of metering chamber 106, the predetermined volumes within metering chamber 106 may be equal to each other or different. Still referring to FIG. 2A, each metering chamber 106 includes an outlet 108 for dispensing a respective biological fluid sample 110 and a dispensing filter 112 for filtering each biological fluid sample 110 as it is dispensed. . Preferably, a distribution filter 112 is positioned at one end of each metering chamber 106 just prior to each outlet 108 . Outlet 108 may be in the form of a nozzle, and distribution filter 112 is configured to filter particulate matter of a certain size such that no particulate matter is expelled through outlet 108 .

A filtered biological fluid sample 110 is dispensed from the cartridge 102 into a set of one or more cuvettes 200, as shown in FIG. 2A. In some embodiments, the dispensing device 100 includes a cuvette case 202 for removably receiving a set of cuvettes 200 and protecting the cuvettes 200 . Cartridge 102 and cuvette case 202 are removably connectable to each other, such that each cuvette 200 joins a respective one of respective metering chambers 106 for receiving a respective filtered biological fluid sample 110 . be done. For example, the bottom portion of cartridge 102 includes a fastening mechanism 114 that removably couples to cuvette 200 . Non-limiting examples of fastening mechanisms 114 include latches, snap clips, threads, and step clips. The middle portion of the cartridge 102, remote from the fastening mechanism 114, includes a set of aligners 105 configured to align the cuvette case 202 so that the cuvette 200 is properly positioned for analysis. The bottom portion includes structural elements such as stiffening ribs to strengthen the weighing chamber 106 . FIG. 2B shows an exploded view of how the various parts of dispensing device 100, including cuvette 200 and cuvette case 202, are assembled together.

A sample 110 of biological fluid in metering chamber 106 can be dispensed into cuvette 200 through outlet 108 by applying a vacuum pressure to cartridge 102 , ie, by pressing cartridge 102 . As shown in FIG. 3A, a sample of biological fluid 110 is dispensed into metering chamber 106 prior to dispensing. A sample of biological fluid 110 is dispensed into a cuvette 200, as shown in FIG. 3B. As described further below, the cuvette 200 contains reagents 210 and a biological fluid sample 110 that are mixed together for analysis.

Furthermore, the distribution filter 112 prevents distribution of the biological fluid sample 110 in the absence of vacuum pressure. Cartridge 102 includes a cartridge lid 116 on top to seal cartridge 102 and facilitate decompression or creation of a vacuum environment in cartridge 102 . It will be appreciated that any suitable method can be used to achieve the above sealing, such as ultrasonic welding to prevent air leakage. Cartridge lid 116 includes fill port 118 for transferring a bulk sample of biological fluid from the collection device to receiving chamber 104 .

Receiving chamber 104 may include a set of intermediate fluid conduits or channels 117 that facilitate transfer of a bulk sample of biological fluid to metering chamber 106 . Intermediate fluid conduits or channels 117 are in fluid communication with receiving chamber 104 and metering chamber 106 to further facilitate distribution or dispensing of a bulk sample of biological fluid from receiving chamber 104 to metering chamber 106. are placed.
Intermediate fluid conduits or channels 117 have a plurality of voids evenly distributed throughout and corresponding to metering chamber 106 to convey sample of biological fluid 110 to metering chamber 106 . Cartridge lid 116 can include an intermediate container in fluid communication with fill port 118 . The intermediate container has a plurality of voids evenly distributed throughout and corresponding to metering chambers 106 to convey a bulk sample of biological fluid received via filling port 118 to receiving chamber 104, and thereafter, Communicate to weighing room 106 .

Cartridge lid 116 includes a cap 120 that recloses fill port 118 after transferring a bulk sample of biological fluid. FIGS. 4A and 4B show an embodiment of cartridge 102 in which fill port 118 is closed after transferring a bulk sample of biological fluid to cartridge 102 . 5A and 5B show another embodiment of cartridge 102. FIG. Cap 120 may be flexibly joined or hinged to cartridge lid 116 or separately screwed onto fill port 118 . Cartridge lid 116 may include a vacuum port 122 for receiving an external actuator operable by application of vacuum pressure. This external actuator is actuated by vacuum pressure and is called a vacuum actuator. Cartridge lid 116 may include a set of pores 124 that allow air to vent during application of vacuum pressure, thus preventing pressure build-up inside cartridge 102 . Pores 124 may include filters or absorbent membranes to vent air and prevent liquid leakage. In the absence of vacuum pressure, the pores 124 prevent air within the cartridge 102 from escaping and prevent ambient air from entering the cartridge 102 .

Each distribution filter 112 includes a set of frit filters and/or a set of semi-permeable membranes. For example, fritted filters include fritted glass and/or sintered frit, and semi-permeable membranes are made of hydrophobic materials. The frit filter/semi-permeable membrane has pores sized to allow each biological fluid sample 110 to pass through each outlet 108 during application of vacuum pressure, while permitting distribution of the biological fluid sample 110. prevent and seal to their respective metering chambers 106 in the absence of vacuum pressure. The pore size is sized to retain or remove particulate matter between about 1 μm and 5 μm. The pores are preferably sized to retain particulate matter of at least 2 μm, and particulate matter of less than 2 μm is still contained in the biological fluid sample 110 and passes through the distribution filter 112 . The distribution filter 112 can also help prevent reagents 210 in the cuvette 200 from entering the metering chamber 106 that may be displaced during mixing of the biological fluid with the sample 110 .

Cartridge lid 116 may include a fill filter engageable with fill port 118 . The fill filter is separable from the fill port 118 so that it can be removed, especially after the fill filter becomes clogged with particulate matter. In this example, if insufficient biofluid sample 110 has passed through fill port 118 into receiving chamber 104, a new fill filter is installed in fill port 118 before dispensing device 100 is reused. , a sufficient biological fluid sample 110 is dispensed into the receiving chamber 104 . Similar to the distribution filter 112, the fill filter can include a set of fritted filters and/or semi-permeable membranes formed from hydrophobic materials. The loading filter performs pre-filtration of the bulk sample of biological fluid during transfer to the receiving chamber 104 of the bulk sample of biological fluid, which pre-filters the sample of biological fluid 110 before flowing into the metering chamber 106. Remove some particulate matter. The distribution filter 112 then performs a second filtration of the biological fluid sample 110 during distribution.
The fill filter and the distribution filter 112 cooperate for two-stage filtration of the biological fluid sample 110 . The fill filter and distribution filter 112 have diameters sized appropriately to control the two stages of filtration. For example, a loading filter may have larger pores to remove larger particles from a bulk sample of biological fluid, and a dispensing filter 112 may displace the biological fluid during dispensing of the biological fluid sample 110 into the cuvette 200 . It may have finer pores for filtering and purifying the sample 110 . The fill filter thus provides the user of dispensing device 100 the flexibility to pre-filter a bulk sample of biological fluid. The user may be a patient attempting to fill the cartridge 102 with his or her biological fluid, or an operator (e.g., a clinical doctor).

In some embodiments, each metering chamber 106 includes at least one rib 126 or set of raised supports to support and/or properly position each distribution filter 112 . Further, ribs 126 prevent distribution filter 112 from collapsing or deforming under pressure from sample of biological fluid 110 as sample of biological fluid 110 is dispensed through distribution filter 112 and outlet 108, thus , allowing the biological fluid sample 110 to be properly filtered and dispensed into the cuvette 200 .

In some embodiments, each metering chamber 106 includes a plurality of sets of ribs 126 centrally located with respect to each other. For example, the first set of ribs 126 may be positioned furthest from the center of the outlet 108, the third set of ribs 126 may be positioned closest to the center of the outlet 108, and the second set of ribs 126 may be positioned furthest from the center of the outlet 108. It can be located between the first set of ribs and the third set of ribs 126 . One set of ribs 126 may have the same or a different depth than the other set of ribs 126 . For example, the first set of ribs 126 is shorter than the second set of ribs 126, and the second set of ribs 126 is shorter than the third set of ribs. This configuration creates an angled or sloped space across the ribs 126 . The sloped space is shaped and angled toward the center of the outlet 108 to facilitate the transfer of the biofluid sample 110 in the metering chamber 106 during dispensing to the center of the outlet 108. there is Thus, the sloped space allows the biofluid sample 110 to flow uninterrupted toward the outlet 108 without gravitational hindrance. Although various examples of rib 126 configurations are shown in FIGS. 6A-6D, other configurations are possible and/or the weighing chamber 106 can include any number of sets of ribs 126. will be understood.

In some embodiments, the perimeter of distribution filter 112 resides within at least one of the sets of ribs 126 . A peripheral edge or portion of the peripheral edge of the distribution filter 112 engages the outermost ribs 126 to form a seal that prevents flow of the biological fluid sample 110 around the peripheral edge of the distribution filter 112, which allows the biological fluid sample 110 to be properly filtered through the distribution filter 112 . The perimeter may be molded or folded inwardly into a vertical shape to lie between ribs 126 . Alternatively, the rim can be glued and/or ultrasonically glued to the inner surface of the metering chamber 106 so that the biological fluid sample 110 does not flow back into the metering chamber 106 . The engagement between distribution filter 112 and ribs 126 adds rigidity to distribution filter 112 and prevents distribution filter 112 from displacing during application of vacuum pressure. Alternatively, however, metering chamber 106 includes a retaining ring 128 positioned over distribution filter 112 . Specifically, a retaining ring 128 is press fit onto distribution filter 112 to secure distribution filter 112 on ribs 126 and prevent backflow of biological fluid sample 110 .

As described above, vacuum pressure is applied to the cartridge 102 to dispense the biological fluid sample 110 through the outlet 108 into the cuvette 200 by a combination of vacuum pressure and gravity. Upon dispensing upon application of vacuum pressure, the biological fluid sample 110 is filtered through a dispensing filter 112 to remove particulate matter of at least a particular size, such as 2 microns. Each outlet 108 may be configured to allow a predetermined amount of filtered biological fluid sample 110 to flow in response to vacuum pressure.

In some embodiments, dispensing device 100 includes cover 130 that covers cartridge 102 and cuvette case 202 when coupled together. Cover 130 may include a window 132 or visible portion disposed on its surface to allow viewing of receiving chamber 104 . A window 132 allows the level of the volume of the biological fluid sample 110 in the cartridge 102 to be viewed to allow checking that the metering chamber 106 contains the desired predetermined volume of the biological fluid sample 110 . Window 132 contains indicators that inform the user as to how much to fill cartridge 102 with the bulk sample of the biofluid from the collection device. As shown in FIG. 5B, window 132 includes lower indicator 134 and upper indicator 135 . If the volume level of biological fluid sample 110 viewed through window 132 is lower than lower indicator 344 , this means that insufficient biological fluid sample 110 is contained within metering chamber 106 . If the volume level is above the upper indicator 135, this means that the amount of the biological fluid sample 110 is too large.
Accordingly, lower indicator 134 and upper indicator 135 increase the amount of bulk sample of biological fluid filling cartridge 102 to an appropriate level to achieve the desired amount of sample 110 of biological fluid in metering chamber 106. It depends.
A visual baffle may be placed behind the window 132 through which the biological fluid sample 110 can interact to provide a visual background. In this manner, window 132 is configured to provide visual feedback to the user to determine whether a predetermined amount of sample 110 of biological fluid has been reached. The user can rely on the visual feedback to increase the volume of the biological fluid sample 110 accordingly.

In some embodiments, cover 130 includes two or more windows 132 positioned on the surface of cover 130 to allow viewing of receiving chamber 104 . For example, a first window 132 is located on one side of the cartridge 102, a second window 132 is located on the opposite side of the cartridge 102, and both windows 132 are aligned horizontally with respect to each other. Both windows 132 allow the user to view the level of the volume of the biological fluid sample 110 within the cartridge 102 from both sides of the cartridge 102 to see if the biological fluid sample 110 is evenly distributed within the metering chamber 106 . can be visually confirmed. If one window 132 shows the level of volume of lower indicator 134 and the other window 132 shows the level of volume of upper indicator 135, this indicates that sample of biological fluid 110 is evenly distributed in metering chamber 106. means no. This can occur because the fill port 118 is located near one side of the cartridge 102 and biological fluid may not flow smoothly to the farthest metering chamber 106 . The user can then make appropriate adjustments to add more biofluid so that the biofluid sample 110 is evenly distributed. If both windows 132 show approximately the same volume level between lower indicator 134 and upper indicator 135, this means that biological fluid sample 110 is evenly distributed in metering chamber . This allows a precise volume of the biological fluid sample 110 to be dispensed into the cuvette 200 to react with the reagents 210 and obtain useful analytical results in order to diagnose a medical condition.

In some embodiments, such as those shown in FIGS. 2A and 2B, dispensing device 100 includes a set of gaskets 136 or retaining seals positioned between cartridge 102 and cuvette case 202 . Gasket 136 creates a biasing effect to secure the coupling between cartridge 102 and cuvette case 202, thus maintaining a tight fit therebetween and providing a tight fit between cartridge 102 and cuvette 200. Provides a sealing engagement. The number of gaskets 136 corresponds to the number of cuvettes 200 such that each gasket 136 is configured to engage a respective one of the cuvettes 200 . Those skilled in the art will readily appreciate that the placement of gasket 136 can be set to match cuvette 200 . Gasket 136 may include a series of voids that are appropriately sized and shaped and positioned accordingly to facilitate distribution of filtered biological fluid sample 110 from outlet 108 into cuvette 200 .

piston assembly 150
A sample of biological fluid 110 is dispensed from cartridge 102 into cuvette 200 by applying vacuum pressure. In some embodiments, the vacuum pressure acts directly on a sample of biological fluid 110 contained in metering chamber 106 and forces sample of biological fluid 110 through outlet 108 and distribution filter 112 . In some embodiments, the dispensing device 100 includes a piston assembly 150 disposed in the cartridge 102 and vacuum pressure actuates the piston assembly 150 to dispense the sample of biological fluid.

As shown in FIGS. 7A-7C, piston assembly 150 includes a set of pistons/plungers/rods 152 that operate within metering chamber 106 to dispense sample 110 of the biological fluid. Piston assembly 150 further includes a spindle 153 joined to piston 152, which spindle 153 is received within vacuum port 122 of cartridge lid 116, as shown in FIG. 7D. Each piston 152 corresponds to one of the metering chambers 106 into which the respective biological fluid sample 110 is dispensed. Specifically, the piston 152 is actuated or displaced from a first position to a second position to force the biological fluid sample 110 out through the distribution filter 112 and into the cuvette 200 and expelled. be able to. Additionally, to allow positive displacement of the piston assembly 150, pores are placed at appropriate locations on the dispensing device 100 to transport airflow beyond the confinement of the dispensing device 100. FIG. For example, the cartridge lid 116 includes pores 124 through which air can escape, allowing pressure displacement within the cartridge 102 and preventing pressure build-up. Thus, in this manner, piston 152 can stroke downward into metering chamber 106 .

A piston assembly 150 is positioned in the cartridge 102 and application of vacuum pressure causes the piston assembly 150 to be displaced downward, thereby dispensing the biological fluid sample 110 through the dispensing filter 112 and the outlet 108 . In some embodiments, the application of vacuum pressure actuates an external or vacuum actuator, which in turn displaces piston assembly 150 . Vacuum actuation of the vacuum actuator is avoided to allow manual actuation to manually displace the piston assembly 150, such as in situations where the application of vacuum pressure would malfunction.

In some embodiments, dispensing device 100 includes a set of intermediate fluid conduits or channels 117 for transferring bulk samples of biological fluid from receiving chamber 104 to metering chamber 106 . Before piston assembly 150 is displaced into metering chamber 106, intermediate fluid conduit or channel 117 holds a first portion of the bulk sample of biological fluid. As piston assembly 150 is displaced into metering chamber 106 , a second portion of the bulk sample of biological fluid or excess biological fluid exits metering chamber 106 . When piston assembly 150 is fully displaced into metering chamber 106 , a second portion of the bulk sample of biological fluid resides in intermediate fluid conduit or channel 117 leaving sample of biological fluid 110 in metering chamber 106 .

Piston assembly 150 includes suitable structural elements, such as ribs and trusses, which align and guide piston 152 during displacement along the height of metering chamber 106 and when vacuum pressure is applied. Piston 152 is sometimes reinforced to maintain structural integrity. An example of truss structure 158 within piston assembly 150 is shown in FIGS. 7A and 7B.
Similarly, as shown in FIG. 7D, the vacuum port 122 is paired with a primary structural element 137 such as a retaining rib that aligns the piston assembly 150 and constrains the piston assembly 150 from torsion or rotation during the application of vacuum pressure. of support structure elements 138. Structural elements 137, 138 also increase strength and maintain structural integrity under vacuum pressure. Truss structure 158 may include at least one raised portion 155 for vertically engaging an end of main structural element 137 . Additionally, the piston assembly 150 may include an orientation device 157, such as a poka-yoke mechanism, to prevent misorientation of the piston assembly 150 during assembly to the vacuum port 122.

Each metering chamber 106 may include a set of piston stops 154 positioned at a height above outlet 108 . A piston stop 154 cooperates with each piston 152 to prevent excessive movement of the piston 152 and precisely dispense a predetermined volume of the biological fluid sample 110 into each cuvette 200 . The piston stopper 154 may be differently sized to hold or contain another predetermined volume of the biological fluid sample 110 within the metering chamber 106 . Piston stop 154 may also be configured to drain an amount of biological fluid in excess of a predetermined volume of each metering chamber 106 .

In one embodiment, piston assembly 150 includes first, second, and third pistons 152 . In one example, the first and third pistons 152 have the same length, which is longer than the length of the second piston 152 . In another example, the first and third pistons 152 have the same length, which is shorter than the second piston 152 . It will be appreciated that the first, second and third pistons 152 can vary in length. By varying the length, the accuracy of the amount of biological fluid sample 110 dispensed from metering chamber 106 can be controlled. For example, a first piston 152 with a shorter length displaces a smaller amount than a second piston 152 with a longer length because the first piston 152 can displace along a longer distance. can be distributed.

Each piston 152 further includes a resilient piston seal 156, such as a rubber or silicone toric joint, located at one end of the piston and engaging each metering chamber 106 such that the piston seal 156 is coaxial with the metering chamber 106. become. The outer diameter of piston seal 156 is concentric with the inner diameter of metering chamber 106 , and during operation vacuum pressure displaces piston 152 and piston seal 156 remains tightly fitted in metering chamber 106 .

Each metering chamber 106 may include structural elements, such as stiffening ribs, that cooperate with piston 152 to prevent unwanted collapse or deformation when vacuum pressure is applied. Each metering chamber 106 controls a pre-defined volume of the sample of biological fluid 110 and has an appropriate amount to reduce the formation of air bubbles in the sample of biological fluid 110, thus ensuring the accuracy of the dispensed amount. Size. The applied vacuum pressure also facilitates the evacuation of air in the cartridge 102 containing the metering chamber 106, mitigating the formation of air bubbles in the biological fluid sample 110 so that a precise amount of the biological fluid sample 110 is dispensed. ensure that Preferably, the biological fluid samples 110 contained in each metering chamber 106 can be dispensed through the outlets 108 over approximately the same period of time. Depending on the desired duration and length of the piston 152, each cuvette 200 can receive the dispensed biological fluid sample 110 for approximately the same duration or for different durations.

cuvette 200
As described above, the filtered biological fluid sample 110 is dispensed from the cartridge 102 into one or more sets of cuvettes 200 . In some embodiments, such as shown in FIG. 2A, the dispensing device 100 includes a cuvette case 202 removably coupled to the cartridge 102 and a metering chamber for receiving the sample 110 of filtered biological fluid. Includes cuvette 200 coupled to 106 . Cartridge 102 and cuvette case 202 are removably coupled to each other, and cartridge 102 can be removed to view cuvette 200 received within cuvette case 202 . As shown in FIG. 8A, each cuvette 200 can include a fastening mechanism 204 that removably couples to a corresponding fastening mechanism 114 at the bottom of cartridge 102 . Non-limiting examples of fastening mechanisms 204 include latches, snap clips, threads, and step clips.

As shown in FIG. 8B, cuvette case 202 includes a set of cuvette orienters 205 that align cuvette 200 so that cuvette 200 is properly positioned for analysis. As shown in FIG. 8C, cuvette orienter 205 can include one or more stepped portions 207 positioned at the bottom of cuvette case 202 .
The cuvette case 202 can further include a set of cartridge aligners 209 that align the cuvette case 202 for coupling to the cartridge 102 . The bottom of cuvette case 202 includes a space or gap 206 such that the bottom of cuvette 200 does not physically contact cuvette case 202 when cuvette 200 is received in cuvette case 202 .

Each cuvette 200 may contain a reagent 210, such as a dry or wet reagent, for reacting with a sample of biological fluid 110 dispensed therein. Reagents 210 may include bromocresol green (BCG) to detect 3,5-dinitrobenzoic acid (DNBA) (or picric acid) to detect albumin and/or creatinine. As shown in FIG. 1D, the cartridge 102/cuvette case 202 can contain a set of indicators 208 for identifying the reagents 210 and/or purpose of each cuvette 200. As shown in FIG. In many embodiments, three cuvettes 200 are used in dispensing device 100, a BCG reference cuvette 200, a DNBA cuvette 200, and a BCG sample cuvette 200. A person skilled in the art can arrange the indicators 208 in any desired order. Additionally, the indicator 208 informs the operator to properly place the cuvette 200 within the cuvette case 202 prior to coupling the cuvette case 202 to the cartridge 102 . The indicia 208 can be embossed or attached to the surface of the cartridge 102/cuvette case 202 (such as by using a representative sticker).

As shown in FIG. 2A, each cuvette 200 includes at least one magnetic body 212, which may be in the form of beads or spherical bodies. Magnetic body 212 is made of neodymium or ferrite material and can be moved under the influence of a magnetic field. More specifically, the core of the magnetic body 212 may be made of a neodymium/ferrite material and the magnetic body 212 and externally coated with an inert material. The inert material is non-reactive with the sample of biological fluid 110/reagent 210 to prevent contamination of the sample of biological fluid 110 that could affect the analytical results. The magnetic material 212 should be small enough to fit inside the cuvette 200 with enough room to move around to agitate and mix the biological fluid sample 110 with the reagents 210 . Each cuvette 200 may include a cuboidal space to facilitate agitation or mixing of the biological fluid sample 110 and reagents 210 . For example, the top and bottom of cuvette 200 may be rectangular in shape, and the top may be dimensionally equal to or larger than the bottom.

As shown in FIG. 2B, dispensing device 100 may include gasket 136 that provides a sealing engagement between cartridge 102 and the top of cuvette 200 . Gasket 136 includes a series of holes of suitable size and shape that facilitate dispensing of filtered biological fluid sample 110 from outlet 108 into cuvette 200 . The holes also facilitate air bubble elimination of the cuvette 200, especially after a mixing step that can form air bubbles, depending at least on the type of reagent 210 and the mixing speed. Air bubbles are evacuated through holes in gasket 136 when vacuum pressure is applied. The holes can be arranged in the gasket 136 in a suitable arrangement to debub only certain cuvettes 200 . For example, this hole may be located only in the DNBA cuvette 200 to debub only this cuvette 200 . Optionally, each cuvette 200 can include at least one vent 214 to facilitate evacuation of air bubbles when vacuum pressure is applied. Vent 214 includes a hydrophobic membrane that vents air and prevents leakage of sample 110 of biological fluid.

Once the cuvette 200 is received in the cuvette case 202, the cuvette 200 is properly aligned for analysis, such as using a light beam. Each cuvette 200 is made of a substantially transparent material that allows the efficient passage of a light beam to analyze the mixture of biological fluid sample 110 and reagent 210 . A transparent cuvette 200 also provides the possibility to observe the reagents 210 within the cuvettes 200 during manufacturing, thus ensuring that the correct reagents 210 are present in the correct cuvettes 200 . The cuvette case 202 includes a group of windows 216 to allow a light beam to propagate through the cuvette 200 for analyzing the biological fluid sample 110 . More specifically, the windows 216 are positioned on at least two sides of the cuvette case 202 and positioned at a suitable height so that the light beams do not cross or interfere with each other. This allows the mixed biological fluid sample 110 (or analysis sample 310) to be analyzed by the light beam without interference. Window 216 may be of various shapes and sizes, such as circular (as shown in FIGS. 4A and 4B) and elongated/elliptical (as shown in FIGS. 5A and 5B).

Analyzer 300
In an exemplary embodiment of the present disclosure with reference to Figures 9A-9C, there is an analyzer 300 for analyzing biological fluids. In particular, analyzer 300 is configured to analyze or analyze sample 110 of biological fluid mixed with reagent 210 in cuvette 200 . The mixture of biological fluid sample 110 and reagent 210 can be referred to as an analytical sample 310 . Analysis results of analysis sample 310 can be used for screening, monitoring, and/or diagnosis of diseases or conditions such as diabetes or chronic kidney disease.

The analyzer 300 includes a vacuum chamber 400 that removably houses the dispensing device 100 as described above. In particular, dispensing device 100 includes a set of cuvettes 200 and a set of biological fluid samples 110 , cuvettes 200 including a set of reagents 210 . The cuvette 200 is housed in a cuvette case 202, and the base of the cuvette case 202 may be configured such that there is a space or gap 206 that prevents the cuvette 200 from physically contacting the base. Gap 206 reduces vibration during agitation or mixing of biological fluid sample 110 and reagent 210, and the reduced vibration minimizes movement of cuvette 200 to precisely focus the light beam through window 216. can do. The cuvette case 202 can have a base aligner 218 positioned at a distance from the base of the cuvette case 202 and can be further aligned with the vacuum chamber 400, e.g. It facilitates housing the dispensing device 100 within the vacuum chamber 400 so that it can only be inserted in one direction.

Analysis device 300 further includes a vacuum cover 450 for sealing dispensing device 100 to vacuum chamber 400 . Preferably, the vacuum cover 450 is movably connected to the vacuum chamber 400, such as by hinges, to facilitate opening and closing of the vacuum cover 450. FIG. 9B shows vacuum cover 450 hinged to vacuum chamber 400 and in an open position. However, it will be appreciated that the vacuum cover 450 is removably attached to the vacuum chamber 400 and is removable such that the vacuum cover 450 can be physically removed/replaced. The vacuum cover 450 may include a bottom coupling portion 452 and the vacuum chamber 400 may include a top coupling portion 402, the bottom and top coupling portions 452, 402 being engageable with each other and the vacuum cover 450 and the vacuum chamber 400.

The analyzer 300 includes a vacuum device 500 for applying a vacuum pressure to the vacuum chamber 400 to dispense the vacuum liquid sample 110 into the cuvette 200 . In other words, vacuum device 500 evacuates vacuum chamber 400 and dispensing apparatus 100 sealed within vacuum chamber 400, with closed vacuum cover 450 containing metering chamber 106 containing sample 110 of biological fluid. , the vacuum causes the biological fluid sample 110 to be dispensed from the metering chamber 106 into the cuvette 200 . The analyzer 300 has an actuator 550 operable against the piston assembly 150 of the dispensing device 100 as a result of the vacuum pressure, thereby dispensing the biological fluid sample 110 from the metering chamber 106 .

The analyzer 300 includes a set of analytical control systems 320 for controlling the vacuum device 500 to perform analytical processes including applying vacuum pressure to dispense a sample of biological fluid 110 and extract a sample of biological fluid 110 . and reagents 210 to form an assay sample 310 , and the assay sample 310 is analyzed in the cuvette 200 . Specifically, the analytical control system 320 controls the vacuum device 500 to apply vacuum pressure and the vacuum chamber 400, as well as many other analytical control systems 320 that perform and control portions of the analytical process. It includes a vacuum control system 330 configured to reduce the pressure.
A non-limiting example of such an analytical control system 320 is configured to use electromagnetism to perform a mixing process to mix the biological fluid sample 110 with the reagents 210 in the cuvette 200 to obtain the analytical sample 310. an electromagnetic mixing system 600 , an optical measurement system 700 configured to perform spectroscopy on an analytical sample 310 , and a temperature control system 800 configured to monitor and/or control the temperature within the analytical device 300 . The set of analytical control systems 320 can further include a master control system 350 configured to control the analytical control systems 320 and automate the analytical process.

The analyzer 300 is operated by an operator to perform analytical processing. Workers may be clinicians, laboratory assistants, or skilled technicians (collectively referred to as "workers") who can perform analytical steps.

Analysis device 300 may include several mounting portions for mounting various components, including any one or more of analysis control system 320 or portions thereof, for example. The mounting portions are arranged such that these components are mounted in a preset manner to ensure alignment with other components. For example, the optical measurement system 700 must be properly aligned with the vacuum chamber 400 to accurately analyze the analysis sample 310 in the dispensing device 100 contained in the vacuum chamber 400. Some of the mounting portions may be suitable for mounting fans or similar cooling units for air ventilation of the analyzer 300 to facilitate heat dissipation. The body of the analyzer 300 may be formed of a network of fluid conduits, eg, flow channels in fluid communication with fans directed to conductive and/or convective heat flow.

Using pre-positioned mounting portions to mount the various elements within the analyzer 300 facilitates control of the assembly as the elements can be easily repositioned to other mounting portions. . The elements can be rearranged to optimize space within the analyzer 300, optimize airflow for better air circulation, and then provide better heat dissipation. The elements are rearranged to optimize space within the analyzer 300 and optimize airflow to improve air circulation and, as a result, improve heat dissipation. Rearranging the elements also helps redistribute the overall weight of the analyzer 300 more evenly, stabilizing the analyzer 300 during the analysis process. The analyzer 300 includes a tilt sensor to feed back positional information about the analyzer so that the operator can check whether the analyzer 300 is in the proper position and orientation, such as a planar position. In particular, the tilt sensor checks whether the analyzer 300 is maintained in a flat position during the analysis process so as not to corrupt the analysis results.

When dispensing device 100 is first housed or loaded into vacuum chamber 400, as shown in FIG. exposed to ambient atmospheric pressure. Closure of the vacuum cover 450 can create a sealing engagement and create a vacuum environment for the dispensing device 100 sealed therein. Additionally, vacuum cover 450 and vacuum chamber 400 may include a series of interlocking members and/or interlock detectors configured to check the sealing engagement between the vacuum cover and the vacuum chamber. The vacuum chamber 400 is thereby properly sealed by a closed vacuum cover 450 and the vacuum chamber 400 is pressed by a vacuum device 500 for dispensing the sample 110 of biological fluid.

The analysis process includes applying vacuum pressure to dispense a sample of biological fluid 110 and analyzing the analysis sample 310 , such as by using an optical measurement system 700 . The analysis process further includes mixing the sample of biological fluid 110 with the reagent 210 using the electromagnetic mixing system 600 prior to analyzing the analysis sample 310 . The analysis results are then used to derive information about the analysis sample 310, such as for screening, monitoring, and/or diagnosis of diseases or conditions. After the analysis process is complete, vacuum cover 450 is opened and dispensing device 100 is removed from vacuum chamber 400 . In particular, the vacuum chamber 400 may be pressurized, ie returned to ambient atmospheric pressure, prior to opening the vacuum cover 450 .

Analysis method 900
In a representative embodiment or example of the present disclosure with reference to FIG. 10, there is a method 900 of analyzing biological fluids using, among other things, the analytical device 300 . Method 900 includes step 902 of providing analytical apparatus 300 including vacuum chamber 400 , vacuum cover 450 and vacuum device 500 . Method 900 includes step 904 of loading dispensing device 100 into vacuum chamber 400, dispensing device 100 including a set of cuvettes 200 and a set of biological fluid samples 110, cuvettes 200 containing a set of reagents 210. including. Method 900 includes sealing 906 dispensing device 100 within vacuum chamber 400 with vacuum cover 450 . The method 900 includes operating 908 the vacuum device 500 to apply a vacuum pressure to the vacuum chamber 400, the vacuum pressure to dispense the sample of biological fluid 110 into the cuvette 200, and Sample 110 reacts with reagent 210 to form analytical sample 310 . The method 900 includes operating the set of analysis control systems 320 to control the vacuum device 500, apply vacuum pressure to dispense the sample of biological fluid 110, and analyze the analysis sample 310 in the cuvette 200. It includes step 910 of performing the process.

In some embodiments, analytical control system 320 includes electromagnetic mixing system 600 . The analysis process includes a mixing process using the electromagnetic mixing system 600 to mix the biological fluid sample 110 with the reagents 210 in the cuvette 200 . In some embodiments, analytical control system 320 includes optical measurement system 700 . The analysis process includes spectroscopy on the analysis sample 310 within the cuvette 200 . In some embodiments, analytical control system 320 includes temperature control system 800 . The analysis process can include monitoring and/or controlling the temperature within the analysis device 300 .

After the analysis process is completed and the analysis results are obtained, the vacuum cover 450 is opened and the used dispensing device 100 is unloaded from the vacuum chamber 400 . A fresh or previously unused dispensing device 100 containing a sample of biological fluid 110 and a new batch of reagents 210 can be loaded into the vacuum chamber 400 for performing another analytical step. Preferably, the dispensing device 100 is disposable for sanitary purposes and the used dispensing device 100 is disposed of in a manner that biohazardous waste is disposed of after the analytical process is completed. However, it will be appreciated that the dispensing device 100 may be manufactured to be reusable after cleaning and sterilization.

Various embodiments of the present disclosure provide improved dispensing devices 100, 300 for dispensing and analyzing samples 110 of biological fluids. Dispensing the sample of biological fluid 110 also includes filtering the sample of biological fluid 110 to remove particulate matter, resulting in a filtered sample of biological fluid 110 that is less contaminated and provides more accurate analytical results. allows to obtain For example, the biological fluid sample 110 is a urine sample and the reagents 210 used are BCG and DNBA. The analytical results can be used to diagnose diseases or conditions such as chronic kidney disease by measuring urinary albumin and creatinine concentrations and the corresponding albumin/creatinine ratios.

By automating the analysis process using the analysis control system 320, the analysis process can be performed with greater accuracy and reliability than conventional measurements by the human eye. Conventional or manual measurements may measure albumin and creatinine too early or too late, i.e., inconsistent reaction times between the sample of biological fluid 110 and the reagent 210, or It is wrong and prone to human error which contributes to unreliable results. The automated analysis process ensures consistency of reaction time and steps from dispensing a sample of biological fluid 110 to mixing the sample of biological fluid 110 with reagents 210 and analyzing the analytical sample 310 . In particular, the dispensing and reactions occur only after the dispensing device 100 is loaded into the analytical device 300, eliminating the risk of delays that would otherwise occur had the reactions been initiated prior to loading. Skilled or trained personnel may not be required to evaluate the analytical results. Using dispensing device 100 and analyzer 300 to obtain accurate analytical results and medical diagnoses more quickly, especially in remote locations where access to trained personnel and medical facilities is limited. can be done.

Although various embodiments are described herein with respect to urine, such as using BCG and DNBA as exemplary reagents 210 in diagnosing medical conditions such as chronic kidney disease, other reagents 210 may be used in other medical conditions. It will be appreciated that it can be used for the diagnosis of Samples 110 of other forms of biological fluids, such as saliva and blood samples, are placed in the dispensing device 100 and analysis device 300 described herein for analysis and, consequently, diagnosis of medical conditions. It is also understood that they can be used as well.

vacuum chamber 400
As shown in FIG. 9C, the vacuum chamber 400 is configured to removably receive a dispensing device 100 containing a set of cuvettes 200 and a set of biological fluid samples 110 . Vacuum chamber 400 can include suitable alignment/guiding elements for receiving and mounting dispensing device 100 . Alternatively, the vacuum chamber 400 may be configured such that the dispensing device 100 can only enter the vacuum chamber 400 in one direction. For example, dispensing device 100 and vacuum chamber 400 may have corresponding alignment/guiding elements, such as base aligner 218 of cuvette case 202, which prevent vacuum chamber 400 from receiving dispensing device 100 in other orientations. hinder

The alignment of the cuvette case 202 within the vacuum chamber 400 ensures accuracy and uninterrupted channeling of the light beam from the optical measurement system 700 for analysis (charged particles are bound between crystal planes and only in one specific direction). ongoing phenomenon). Vacuum chamber 400 may include a set of windows or spaces 408 that allow the light beam for analysis to propagate through cuvette case 202 and cuvette 200 (as shown in FIG. 15A). More specifically, windows or spaces 408 are located on at least two sides or opposing sides of the vacuum chamber 400 and are aligned with the windows 216 of the cuvette case 202 so that the light beams do not cross or interfere with each other.

In one embodiment, vacuum chamber 400 is integrally formed within the body of analytical device 300 . In another embodiment, vacuum chamber 400 is formed separately and coupled to the body of analyzer 300 by a suitable coupling mechanism. For example, the vacuum chamber 400 may have a series of coupling holes that correspond to the body of the analytical device 300 . Vacuum chamber 400 is coupled to analyzer 300 via coupling holes, such as by using fasteners such as screws and bolts.

Vacuum chamber 400 is supported on its base by several structural elements. Structural elements are arranged to maintain the vacuum chamber 400 in a desired position to minimize alignment errors due to vibrations caused by vacuum pressure. The structural elements are further arranged to structurally support vacuum chamber 400 by vacuum actuator 550 during loading of dispensing device 100 so that vacuum chamber 400 maintains its desired position. Vacuum chamber 400 is supported by a series of anti-vibration isolators for controlling the amount of vibrational translation or resonance. The anti-vibration isolator may be placed on the base of the vacuum chamber 400 and may be lined with a non-slip material to prevent slipping. An additional anti-vibration isolator is positioned at the base of the analyzer 300 and cooperates with a series of adjustable fasteners to adjust the orientation of the analyzer 300 and minimize tilting of the analyzer 300. good too.

Vacuum chamber 400 includes a top mating portion 402 engageable with a bottom mating portion 452 of vacuum cover 450 . Upper mating portion 402 may include grooves 404 for retaining a series of sealing elements for creating sealing engagement with vacuum cover 450 . Sealing elements include O-rings, toric joints, gaskets, and/or radial seals. The groove 404 has a cross-section in the form of a dovetail or partial dovetail and can include a pinch at one or more sections of the groove 404 .

Vacuum chamber 400 may include a set of vacuum chamber interlocking members 406 configured to lock engagement between vacuum cover 450 and vacuum chamber 400 . Vacuum chamber interlock members 406 may include one or more lock receivers 406 for receiving corresponding vacuum cover interlock members 456 , such as lock pins 456 receivable on vacuum cover 450 . Lock pin 456 is engageable with lock receiver 406 to ensure that closed vacuum cover 450 is properly locked in place with respect to vacuum chamber 400 . The mating locking pin 456 also prevents an operator from accidentally opening the vacuum cover 450 during the analysis process, which could compromise the analysis results.

Vacuum chamber 400 may include a series of vacuum chamber interlock detectors configured to detect when vacuum cover 450 closes to seal vacuum chamber 400 . The analysis process begins after or in response to the vacuum chamber interlock detector detecting that the vacuum cover 450 is properly closed. A vacuum chamber interlock detector may include a magnetic sensor, such as a Hall effect sensor, configured to detect magnetic elements of the vacuum cover 450 . Specifically, when the vacuum cover 450 is closed, the magnetic element is sufficiently close to the magnetic sensor to interact and be detected. The magnetic sensor can optionally create visual and/or audible warnings to notify the operator that the vacuum cover 450 is properly closed.

Proper closure of the vacuum cover 450 ensures that the sealing engagement is intact and the vacuum chamber 400 is ready for depressurization. Also, the sealed vacuum chamber 400 is impervious to external atmospheric light that can interfere with the optical measurement system 700 and compromise analytical results. In some situations, such as due to misalignment of the components of optical measurement system 700, light from optical measurement system 700, such as laser light, that should normally be contained within vacuum chamber 400 is instead directed to vacuum chamber 400. may be scattered away from By ensuring that the sealing engagement is intact, the laser light remains contained within the sealed vacuum chamber 400 and the operator is directly exposed to laser light that is harmful to the operator's eyes. prevent it from being done. Another way to mitigate this risk is to include a shield within the vacuum chamber 400 to block the laser from operator exposure during the analysis process. This shield is sometimes made from a dark/light absorbing material such as black acetal.

After the analytical process is completed, the vacuum device 500 is pressurized to return the vacuum chamber 400 to ambient atmospheric pressure. Vacuum chamber 400 may include a series of pores for neutralizing ambient atmospheric pressure. It should be noted that the pores are closed during depressurization and opened after the analysis step is completed.

vacuum cover 450
9A, 11A, and 11B, vacuum cover 450 is configured to seal dispensing device 100 within vacuum chamber 400 . As described above for vacuum chamber 400, vacuum cover 450 includes a bottom mating portion 452 engageable with top mating portion 402 of vacuum chamber 400 to create a sealing engagement therebetween.
Vacuum cover 450 may include a series of vacuum cover interlocking members 456 configured to lock engagement between vacuum cover 450 and vacuum chamber 400 . Vacuum cover interlock member 456 includes one or more receptacles engageable with lock receptacle 406 of vacuum chamber 400 to lock vacuum cover 450 and prevent an operator from accidentally opening it. A possible locking pin 456 may be included. The locking pin 456 is snap fit to provide tactile and/or audible feedback to the operator when the vacuum cover 450 is closed. Vacuum cover 450 and/or locking pin 456 may be configured with areas of suitable elasticity to prevent sudden slamming of vacuum cover 450 and mitigate the risk of damage to analyzer 300 . Locking pin 456 is retracted or disengaged to open vacuum cover 450 after the analysis process is complete.

Vacuum cover 450 may include a set of vacuum cover interlock detectors configured to detect when vacuum cover 450 is closed to seal vacuum chamber 400 . A vacuum cover interlock detector may include a magnetic element positioned to be detected by a magnetic sensor in the vacuum chamber 400 when the vacuum cover 450 is closed. The vacuum cover interlock detector may further include an optical isolator 454 to detect when the vacuum cover 450 is closed. Light blocker 454 operates to detect the light beam when the light source emits the light beam directly onto the photodetector and the light beam is not blocked. Light blocker 454 is normally positioned so that it does not intersect the light beam when vacuum cover 450 is open. Closing the vacuum cover 450 moves the light interrupter to a position that blocks the light beam, and the blocked light beam is not detected by the photodetector. No detection of blocked light beams means that the vacuum cover 450 is properly closed.

The vacuum cover 450 may include one or both types of vacuum cover interlocking detectors—magnetic-based and optical-based—that detect when the vacuum cover 450 is properly closed. Implementing both types of interlocking detectors would be redundant measures to avoid one type of failure point or one type of single fault tolerant safety system. This dual safety approach further adds worker safety, especially for workers who are untrained and/or remotely located where the analyzer 300 is being used. For example, if the magnetic sensor fails to detect the magnetic element, the optoisolator can still act to ensure that the vacuum cover 450 is closed. If one or both types fail, the optical metrology system 700 is shut down, preventing the analysis process from running. The analysis process involves laser light that is harmful to the operator's eyes when exposed to it, especially if the vacuum cover 450 is not closed properly resulting in one or both types of vacuum cover interlock detection. Contains laser light that can be harmful to the eyes of workers if any of the equipment fails.

Vacuum cover 450 may be movably coupled to vacuum chamber 400 , such as by hinge mechanism 404 . The hinge mechanism 404 may include a set of torsion springs 458 configured to move the vacuum cover 450 between open and closed states. A torsion spring 458 is configured to bias the vacuum cover 450 toward the closed condition. Torsion springs 458 may be placed on either side of the vacuum cover 450 to prevent the vacuum cover 450 from deforming or being damaged when the vacuum cover 450 is opened and closed.

The torque applied by torsion spring 458 reinforces the sealing engagement between vacuum cover 450 and vacuum chamber 400 . Torsion spring 458 may be configured such that the amount of force required to exceed the torque of the torsion spring and move vacuum cover 450 to the open state is manageable by the operator. This allows the operator to comfortably open the vacuum cover 450 and make appropriate adjustments to the vacuum cover 450 and/or the vacuum chamber 400 as needed.

Torsion spring 458 may be configured to dampen movement of vacuum cover 450, particularly when vacuum cover 450 is closed. For example, hinge mechanism 404 may include a set of dampening elements that cooperate with torsion spring 458 .
The dampening element prevents the vacuum cover 450 from being accidentally forced closed, reducing the risk of damage to the analyzer 300. Additionally, the damping element reduces or prevents external forces from causing misalignment and/or vibration on the vacuum cover 450 so that the sealing engagement remains unaffected and intact. be.

Vacuum cover 450 may include a vacuum cover handle 460 for handling by an operator to open and close vacuum cover 450 . Vacuum cover handle 460 is movable between a closed state and an open state. The vacuum cover 450 can be opened when the vacuum cover handle 460 is in the open state.
For example, when the operator moves the vacuum cover handle 460 to the open state, the lock pin 456 of the vacuum cover 450 is released from the lock receiver 406 of the vacuum chamber 400 . This unlocks the vacuum cover 450 from the vacuum chamber 400 and allows the vacuum cover 450 to be opened by an operator. Vacuum cover handle 460 may be connected to vacuum cover 450 by a set of springs that bias vacuum cover handle 460 toward the closed condition.

Vacuum cover 450 may include a vacuum cover actuator, such as a solenoid actuator or latch, engageable with vacuum cover handle 460 . The solenoid actuator is actuated in response to initiation of the analysis process or after the analysis process has been initiated.
Specifically, once the analysis process is initiated, the vacuum cover 450 is already closed and the solenoid actuator is activated to engage the vacuum cover handle 460 . An activated solenoid actuator locks the vacuum cover handle 460 in the closed state. An actuated solenoid actuator creates an additional locking force on the vacuum chamber 400 to limit movement of the closed vacuum cover 450 and prevent the vacuum cover 450 from being accidentally opened by an operator. After the analysis process is completed, the solenoid actuator is deactivated so that it disengages from the vacuum cover handle 460 . A deactivated solenoid actuator frees the vacuum cover handle 460 to be moved to the open position by an operator, thereby opening the vacuum cover 450 . The solenoid actuator may be spring loaded so as to be biased toward the non-actuated state.

To open the vacuum cover 450, the operator first partially opens the vacuum cover handle 460 by tilting or lifting it to an intermediate or partially open position. Vacuum cover interlock member 456 may be configured to retract from vacuum chamber interlock member 406 in conjunction with lifting of vacuum cover handle 460 . The operator continues to open the vacuum cover handle 460 by tilting it from the intermediate position to the open position or pulling it up. In the open state, an interlock detector, such as a Hall effect sensor or photoisolator 454 is triggered to deactivate the optical measurement system 700 . This disables the light beam and prevents unwanted or stray laser beams from escaping or jumping out of the analyzer 300 . An open vacuum cover handle 460 unlocks the vacuum cover 450 and allows the vacuum cover 450 to be opened.

vacuum device 500
12A and 12B, vacuum device 500 is controlled by vacuum control system 330 to evacuate vacuum chamber 400 and dispense biological fluid sample 110 into cuvette 200 . The vacuum device 500 may be or include a vacuum pump to apply a vacuum pressure and thus reduce the vacuum chamber 400 from ambient atmospheric pressure, typically around 1 bar. The vacuum pump may rotate at about 2000-3000 RPM, preferably 2400 RPM to apply the vacuum pressure. The vacuum or negative pressure applied to vacuum chamber 400 is typically in the range of -20 kPa to -160 kPa relative to ambient atmospheric pressure. The vacuum pressure is preferably in the range -70 kPa to -100 kPa, or alternatively in the range -11 kPa to -15 kPa absolute relative to an atmospheric pressure of 1 bar. In some embodiments, there may be a number of pre-defined settings for selecting a pre-defined range of vacuum pressures. The predefined ranges are -45 kPa to 50 kPa, -75 kPa to -85 kPa, -86 kPa to -95 kPa, -65 kPa to -74 kPa, -96 kPa to -105 kPa, -106 kPa to -115 kPa.
The pre-defined range allows the analyzer 300 to account for a variety of atmospheric conditions, especially when the analyzer 300 is deployed in low to high altitude environments and various locations with varying pressures. Advantageous. It will be appreciated that the increments between each pre-defined range may vary to account for the life cycle of use of the vacuum device 500 .

Vacuum device 500 may be supported on a vacuum fixture within analyzer 300 . The vacuum fixture is configured to transmit or transmit vibrational forces from the vacuum device 500 towards the base of the analyzer 300. Vacuum device 500 may be attached to a vacuum fixture such that the center of mass of vacuum device 500 is near the bottom of analyzer 300 to improve vibration damping. For example, vacuum pumps or motors are heavy and should be placed close to the bottom.

As shown in FIG. 12B, vacuum device 500 may be fluidly connected to a set of valves 502, such as solenoid valves, to facilitate depressurization and pressurization of vacuum chamber 400. As shown in FIG. Valve 502 may include a check valve to prevent backflow of air into vacuum chamber 400 after vacuum chamber 400 has been depressurized to the desired vacuum pressure or when vacuum device 500 is in an inactive state. good. The check valve may be configured to allow air to flow back into the vacuum chamber 400 in order to pressurize the vacuum chamber 400 after the analysis process is completed. It will be appreciated that any number of valves 502 may be used and the construction and connection of valves 502 to vacuum device 500 are well known to those skilled in the art. The vacuum device 500 may also be fluidly connected to a carbon filter 504 for cleaning air exchange between the vacuum device 500 and the vacuum chamber 400 . This prevents odors from escaping into the surrounding environment. Carbon filter 504 uses activated carbon to remove airborne impurities using adsorption. However, it will be appreciated that other types of filters, such as non-carbon filters, may be used to remove impurities.

After the vacuum chamber 400 is depressurized and the sample of biological fluid 110 is dispensed into the cuvette 200 , the sample of biological fluid 110 is mixed with reagents 210 into an analytical sample 310 . Vacuum pressure is reduced to facilitate debubbling of analytical sample 310 within cuvette 200 . Debubbling removes residual air bubbles in the analytical sample 310 to increase the accuracy of analysis by the optical measurement system 700 and improve results. A pressure sensor 506 is provided or connected to the vacuum chamber 400 to provide feedback of the current pressure to the vacuum device 500, which can control the application of vacuum pressure in response to the feedback.

vacuum actuator 550
As shown in FIG. 11B, the vacuum cover 450 includes a housing 470 for a vacuum actuator 550 configured to be actuated on the dispensing device 100 to pump the biological fluid sample 110 into the cuvette 200 by the vacuum actuator 550 . can be distributed. Vacuum device 500 applies vacuum pressure to cause actuation of vacuum actuator 550 housed within vacuum cover 450 . Vacuum actuator housing 470 is in fluid communication with vacuum chamber 400 , and vacuum actuator housing 470 is depressurized to actuate vacuum actuator 550 when vacuum pressure is applied to vacuum chamber 400 . . Alternatively, vacuum device 500 may apply vacuum pressure directly to both vacuum actuator housing 470 and vacuum chamber 400 .

13A and 13B, when vacuum device 500 applies vacuum pressure, lower portion 552 of vacuum actuator 550 is exposed to vacuum pressure and upper portion 554 of vacuum actuator 550 is exposed to ambient atmospheric pressure. The pressure differential between the ambient atmospheric pressure and the vacuum pressure actuates the vacuum actuator 550 downwardly and toward the dispensing device 100 from the disengaged position. In the disengaged position as shown in FIG. 13A, the vacuum actuator 550 may be completely contained within the vacuum actuator housing 470 . Vacuum actuator 550 is actuated to a first engaged position for engaging piston assembly 150 of dispensing device 100 . In the first engaged position, vacuum actuator 550 continues to operate to the second engaged position to displace piston assembly 150 downward, as shown in FIG. 13B. In the second engaged position, piston assembly 150 is displaced into metering chamber 106 and sample of biological fluid 110 contained within receiving chamber 104 and metering chamber 106 is dispensed into cuvette 200 . Vacuum actuator 550 may be configured to actuate a limit switch to stop further actuation of vacuum actuator 550 in the second engaged position. The pressure differential thus activates the vacuum actuator 550 and ultimately dispenses the sample 110 of biological fluid.

The vacuum actuator 550 may include a spring 556 or other biasing element positioned to bias the vacuum actuator 550 to the disengaged position, as shown in Figure 13A. Spring 556 is configured such that the pressure differential is sufficient to compress spring 556 and actuate vacuum actuator 550 . After the analysis process is complete, vacuum device 500 pressurizes vacuum chamber 400 and vacuum actuator housing 470 back to ambient atmospheric pressure. The pressure differential is removed and spring 556 returns vacuum actuator 550 to the disengaged position. Vacuum actuator housing 470 may include a set of pores 472 for neutralizing to ambient atmospheric pressure. Notably, the pores 472 are closed during depressurization and opened after completing the analysis process.

Due to the low pressure differential required to actuate the vacuum actuator, the vacuum actuator 550 can be sealed within the vacuum actuator housing 470 in a manner similar to a piston seal that can achieve good sealing characteristics and low frictional forces. be accommodated. Vacuum actuator 550 may include peripheral grooves 558 to retain o-rings, toric joints, or gaskets to reduce or minimize frictional forces during actuation. Vacuum actuator 550 may be cushioned with an elastic material, such as foam, within vacuum actuator housing 470 to protect against external forces.

electromagnetic mixing system 600
Referring to Figure 14, an electromagnetic mixing system 600 is configured for performing a mixing process in or as part of an analytical process. The electromagnetic mixing system 600 includes a set of electromagnetic units 602 for generating magnetic fields within a vacuum chamber 400 , more specifically within a cuvette 200 received within the vacuum chamber 400 . Each cuvette 200 can be paired with a respective set of electromagnetic units 602 . The electromagnetic units 602 may be arranged in a rectangle around each cuvette 200 and the magnetic field thus generated is directed towards the cuvette 200 . Each electromagnetic unit 602 includes at least one electromagnetic element or electromagnet that generates a magnetic field.

The magnetic field facilitates mixing of the biological fluid sample 110 with the reagents 210 in the cuvettes 200 by causing movement of the magnetic material 212 in each cuvette 200 . Movement of magnetic material 212 within cuvette 200 physically agitates and mixes sample 110 of biological fluid with reagent 210 . Metering chamber 106 is formed by the cooperation of distribution filter 112 and ribs 126 to prevent backflow or osmosis of analytical sample 310 contained in cuvette 200 and potentially displaced during contamination toward metering chamber 106 . to prevent

The power input to electromagnetic unit 602 is controlled to control the generation of the magnetic field. By generating a controlled magnetic field, the magnetic material 212 within the cuvette 200 can be constrained to move along a predetermined path. For example, the magnetic material 212 can move according to a predefined or variable pattern defined or selected by an operator. The predefined pattern may be in the form of a u-shaped pattern or an n-shaped pattern, although it is understood that there are other patterns or paths along which the magnetic material 212 can move within the cuvette 200. right. The generation of the magnetic field is temporally controlled such that the sample 110 of biological fluid and the reagent 210 are homogeneously mixed within a certain duration to form an analytical sample 310 useful for analysis. In particular, homogenous mixing or agitation means that there is minimal to no residual or unmixed biological fluid sample 110 or reagent 210 in the cuvette 200 .

During the mixing process, vacuum pressure is continuously applied to maintain a vacuum environment within the cuvette 200 , thereby reducing the tendency of air bubbles to form within the cuvette 200 . After mixing with the magnetic material 212 , the vacuum pressure is maintained or reduced to facilitate debubbling the analytical sample 310 to remove residual air bubbles in the analytical sample 310 .

Thus, by operating the electromagnetic mixing system 600 to generate a magnetic field within the vacuum chamber 400 and the cuvette 200 , the biological fluid sample 110 and the reagent 210 within the cuvette 200 can be physically mixed by the magnetic material 212 . can. The magnetic material 212 can be controlled by a magnetic field to move at a desired timing, speed and direction to physically mix the sample 110 of biological fluid and the reagent 210 together. This allows the sample of biological fluid 110 and the reagent 210 to be mixed consistently, avoiding over-mixing or under-mixing that would result in an unprofitable analysis sample 310 and compromise the analytical results. Moreover, mixing occurs without any contact with external components, such as glass stir bars, and without continuous inversion. Without the need to use a glass stirrer to mix the biological fluid sample 110, the analyzer 300 can be used to safely analyze potentially biologically hazardous analytical samples 310. can be done.

Optical measuring system 700
Referring to FIG. 15A, optical metrology system 700 is configured to perform spectroscopic or photochemical inspections in or as part of an analytical process. After the sample of biological fluid 110 and the reagent 210 are mixed using the electromagnetic mixing system 600, the spectroscopy studies the interaction between the sample of biological fluid 110 and the reagent 210 electromagnetically, such as by using a light beam. Analyze or study using targeted radiation. For example, spectroscopy may use the BCG reagent 210 to determine the presence of albumin in the sample 110 of biological fluid and the DNBA reagent 210 to determine the presence of creatinine. The spectroscopic examination can be performed upon completion of the mixing process performed by the electromagnetic mixing system 600 or after a predetermined amount of time has elapsed after completing the mixing process. In this way, the mixing of the biological fluid sample 110 and the reagent 210 and the spectroscopic examination on the resulting analytical sample 310 are performed in an automated manner with reduced or minimal manual intervention by an operator. can do.

Optical measurement system 700 includes at least one light source 702 and at least one photodetector 704 . Each cuvette 200 can be paired with a respective set of collinear light sources 702 and photodetectors 704 .
Specifically, a light source 702 is positioned on one side of the cuvette 200 and a photodetector 704 is positioned on the opposite side of the cuvette 200, as shown in FIG. 15A. The light source 702 and photodetector 704 are arranged such that the light beams do not cross or interfere so that the analysis sample 310 is analyzed without interference. The cuvette case 202 aligns and holds the cuvettes 200 so that each cuvette 200 is properly aligned within the path of the respective light beam between the respective light source 702 and photodetector 704 . Cuvette 200 is made from a substantially transparent material to allow light to pass through efficiently. An optically transparent window or space 408 of the vacuum chamber 400 and an optically transparent window 216 of the cuvette case 202 are aligned to allow the analytical light beam to pass through the analytical sample 310 . Cuvette 200 is preferably shaped like a cube to reduce reflection/refraction effects, thus reducing loss of laser information.

Optical measurement system 700 includes a series of optical elements 706 positioned between light source 702 and photodetector 704 to condition the light beam to improve analytical results. For example, optical element 706 may include a converging lens, a diverging lens, and/or a Fresnel lens positioned to collimate/redirect the light beam and to focus the light beam at cuvette 200 . Optical element 706 may include a light guide for directing a beam of light emitted from light source 702 through cuvette 200 to photodetector 704 . Optical element 706 includes a light filter, such as a light blocker, to allow positive emission of light through cuvette 200 toward photodetector 704 . Other optical elements 706 that can be used are mirrors and prisms or other reflective/refractive elements, but are not limited to such.

In one embodiment, a light beam diverges from light source 702 and the diverged light beam propagates through cuvette 200 toward photodetector 704 . In one embodiment, a light beam emanates from light source 702 and optical element 706 conditions, collimates, or focuses the light beam. The collimated light beam then propagates through cuvette 200 towards photodetector 704 . In one embodiment, a light beam emanates from light source 702 and optical element 706 focuses the light beam into cuvette 200 . In one embodiment, as shown in FIG. 15B, a light beam diverges from light source 702 and collimating lens 706 collimates the divergent light beam. The collimated light beam propagates through cuvette 200 towards photodetector 704 . A focusing lens focuses the collimated light beam onto the photodetector 704 .

The optical measurement system 700 may include multiple baffles 708 surrounding each light source 702 and/or each photodetector 704 . Baffle 708 is positioned to prevent light scattered from light source 702 from leaking into vacuum chamber 400 and restricts the light beam to analysis sample 310 . For example, an aperture or aperture 718 may be positioned between collimating lens 706 and window or space 408, as shown in FIG. 15A. A baffle 708 is arranged with the aperture 718 to reduce stray light from the light beam and allow substantially all of the light beam to propagate toward the window or space 408 . A baffle 708 is also positioned to prevent external airglow from reaching the photodetector 704, which could compromise the analytical results. Baffle 708 may be made of a dark/light-absorbing material, such as black acetal, which encompasses light scattered from light source 702 as well as ambient light. In addition, the black acetal material can operate at high temperatures of at least 80° C., allowing optical measurement system 700 to continue to function despite thermal radiation from light source 702 .

Optical measurement system 700 may include a set of heat sinks 710 for light source 702 . As shown in FIG. 15C, each light source 702 may be placed on a respective one of the heat sinks 710 to facilitate absorption/dissipation of heat generated by the light source 702 during light emission. . For example, the light source 702 can be attached to the heat sink 710 by a set of source leads 712, such as by soldering, and an adhesive/adhesive material 714 can be applied between the attachment portions to stabilize the attachment. Adhesive/adhesive material 714 may be a thermal paste or other similar thermal composite for optimum thermal conductivity. The heat sink 710 can be made of thermally conductive material such as metallic materials including aluminum and copper. It will be appreciated that the structure of heat sink 710 may include heat dissipation elements, such as fins, to increase the overall surface area for heat dissipation. Dissipating heat from the light source 702 helps prevent damage to the light source 702 . The heat sink 710 also reduces unwanted heat transfer to the cuvette 200, mitigating thermal factors that can compromise analytical results.

Light source 702 may be a light emitting diode (LED) or a laser diode that emits a laser. This laser diode achieves higher light efficiency than LEDs, consuming less power while emitting a more powerful laser. This laser diode can provide high power conversion efficiency, high spectral resolution, and high optical coupling. The laser beam is better collimated and focused and can travel some distance without guidance. Thus, the vacuum chamber 400 of the dispensing device 100 containing the cuvette 200 can be made larger to facilitate access for maintenance, such as cleaning. A laser diode can have an integrated sensor for measuring the intensity of the emitted laser beam. The narrower spectral bandwidth of laser diodes provides greater specificity for a single absorption coefficient than LEDs.

Photodetector 704 may be a photodiode for detecting light by analytical sample 310 in cuvette 200 and measuring changes in light absorption. The photodiodes can be made of silicon or silicon-based materials, for example for measuring light beams in the wavelength range of 400-900 nm.
The optical measurement system 700 includes a set of transimpedance amplifiers, such as a 20-bit delta-sigma converter, connected to a photodiode and configured to suppress noise and improve the performance of the photodiode. and an analog-to-digital converter. Improved performance allows for longer linear dynamic measurement range and increased measurement of attenuated light by a factor of about 1000 (or 3 absorption units), allowing for more accurate measurement of compounds within the analytical sample 310 become.

In some embodiments, optical measurement system 700 is configured to perform a calibration process to improve the accuracy of analytical results. For example, calibration can compensate for laser intensity drift that can be affected by high temperatures.
In one embodiment, light source 702 emits a first light beam and a second light beam. A first light beam is propagated to be detected by a first photodetector 704 and a second light beam is propagated to be detected by a second photodetector 704 . In another embodiment, the light source 702 emits a light beam and an optical element 706, such as a mirror/prism, to split the light beam into a first light beam and a second light beam. Specifically, a first light beam is reflected by a mirror/prism and enters a first photodetector 704 , and a second light beam propagates through the mirror/prism to a second photodetector 704 . Incident. The first photodetector 704 may be referred to as a feedback photodetector because the first light beam is hardly attenuated.

In the calibration process, the baseline optical attenuation of optical element 706 of optical measurement system 700 is first calculated prior to loading vacuum chamber 400 into dispensing device 100 . The baseline optical attenuation represents the rate at which light intensity decreases through optical element 706 when vacuum chamber 400 is not loaded. The power produced by light emitted from light source ₇₀₂ is denoted PL. The first light beam is reflected by optical element 706 to first photodetector 704 and is not significantly attenuated by optical element 706 . The second light beam is propagated through optical element 706 to second photodetector 704 and is attenuated by optical element 706 . The power of the first light detected by the first photodetector 704 is labeled _P1b . The power of the second light detected by the second photodetector 704 is indicated as _P2b . The responsivity of the _first photodetector 704 is denoted as r1. The responsivity of the _second photodetector 704 is denoted as r2. The reference optical attenuation is denoted a _b and can be calculated using equations (1) and (2).
(1) Formula P _1b =r ₁ P _L
(2) Equation P _2b = a _b r ₂ P _L

Vacuum chamber 400 is then loaded into dispensing device 100 containing cuvettes 200 containing reagents 210 . A sample of biological fluid 110 is dispensed into cuvette 200 and mixed with reagent 210 . A mixed biological fluid sample 110 or assay sample 310 in the cuvette 200 is tested to obtain an assay result. Analytical optical attenuation, which represents the rate at which light intensity decreases through a cuvette 200 containing an analytical sample 310 , is calculated to measure the optical absorbance of the cuvette 200 and the analytical sample 310 . A light beam is emitted in a manner similar to the calibration process described above. The first light beam is reflected by the optical element 706 to the first photodetector 704 and does not propagate through the cuvette 200, so it is substantially attenuated. The second light beam is propagated through optical element 706 and cuvette 200 to second photodetector 704 and is attenuated by them. The power of the first light detected by the first photodetector 704 is labeled _P1a . The power of the second light detected by the second photodetector 704 is indicated as _P2a . The analytical optical attenuation is denoted a _a and can be calculated using equations (3) and (4).
(3) Equation P _1a =r ₁ P _L
(4) Formula P _2a = a _a a _b r ₂ P _L

To further improve the accuracy of analytical results, light attenuation through the material of cuvette 200 should be accounted for in light absorption measurements, even though cuvette 200 is substantially transparent. The analytical optical attenuation is the combination of the cuvette optical attenuation (a _c ) and the sample optical attenuation (a _s ), as shown in equation (5). Cuvette optical attenuation represents the rate at which light intensity decreases through an empty cuvette 200 . Thus, it is the transparent material of the cuvette 200 that causes the optical attenuation of the cuvette. The sample optical attenuation represents the rate at which light intensity is reduced through the analytical sample 310 itself without being affected by the transparent material of the cuvette 200 .
(5) Formula a _a = a _c a _s

To calculate the optical attenuation of the cuvette, the vacuum chamber 400 is loaded into the dispensing device 100 containing the cuvette 200, but the cuvette 200 does not contain the biological fluid sample 110 or the reagent 210, i.e. the cuvette 200 is empty. . A light beam is emitted in a manner similar to the calibration process described above. The first light beam is reflected by the optical element 706 to the first photodetector 704 and does not propagate through the empty cuvette 200 and is therefore attenuated substantially. The second light beam is propagated through optical element 706 and empty cuvette 200 to second photodetector 704 and is attenuated by them. The power of the first light detected by the first photodetector 704 is labeled _P1c . The power of the second light detected by the second photodetector 704 is indicated as _P2c . The cuvette light attenuation can be calculated using equations [6] and [7].
(6) Formula P _{1C =} r ₂ PL
₍ 7 ₎ Formula _{P2C = acabr2PL}

With known values for the reference optical attenuation, analytical optical attenuation, and cuvette optical attenuation, the sample optical attenuation can be calculated to measure the optical absorption of the analytical sample 310 . This measured light absorption is not affected by the cuvette material and is therefore more accurate. Accordingly, the optical measurement system 700 is calibrated to account for and compensate for noise effects due to the optical element 706 and cuvette material, and to isolate optical attenuation caused by the analytical sample 310 alone. This results in more accurate and consistent analytical results and aids in diagnosing medical conditions.

In many embodiments, there are three cuvettes 200 containing three analytical samples 310 to be analyzed: a BCG reference cuvette 200, a DNBA cuvette 200, and a BCG sample cuvette 200. For the BCG cuvette 200, the photodetector 704 is configured to measure the absorption of the albumin BCG target and non-activating BCG reaction to estimate the albumin concentration in the sample 110 of biological fluid mixed with the BCG reagent 210. It is For the DNBA cuvette 200 , the photodetector 704 is configured to measure kinetic measurements of the creatinine response to estimate the creatinine concentration in the sample 110 of biological fluid mixed with the DNBA reagent 210 . In one embodiment, all three analytical samples 310 are analyzed simultaneously. In one embodiment, analysis samples 310 are analyzed in sequence and the time gap between each analysis may be the same or different.

For example, as shown in the time schedule 716 of FIG. 16 for operating the optical measurement system 700, the photodetector 704 can measure the optical absorbance of the analytical sample 310 sequentially in each period. . Specifically, the first photodetector 704 may measure the optical absorbance of the assay sample 310 in the BCG sample cuvette 200 during a first period of time, and the second photodetector 704 measures the second and a third photodetector 704 measures the optical absorbance of the analytical sample 310 in the BCG reference cuvette 200 during a third period of time. may be measured. In this configuration, only light source 702 for one cuvette 200 is active at any given time, reducing overall heat generation by optical measurement system 700 and improving photodetector 704 performance.

When a biological fluid sample 110 reacts with a reagent 210, such as BCG or DNBA, a colored chemical reaction occurs that causes an absorption change. The different colored light or different wavelength light is preset to match the absorption wavelength of the reacted biological fluid sample 110 , which is the analytical sample 310 . In one example, the light source 702 paired with the DNBA cuvette 200 is configured to emit green light in the wavelength range of 495 nm to 570 nm, and more preferably in the wavelength range of 510 nm to 530 nm. If creatinine is present in the biological fluid sample 110 , it will react with the DNBA reagent 210 to form a purple and red composite color in the analytical sample 310 . The rate of complex formation is directly proportional to the concentration of creatinine. The concentration of creatinine was determined by measuring the change in absorbance under the effect of combined green light over a period of time, calculating the rate of change in combined absorbance over a period of time, and calculating the calculated rate of change. is determined by comparing to a calibration curve of pre-determined creatinine concentrations.

In another example, light source 702 for BCG cuvette 200 is configured to emit red light in the wavelength range of 620 nm to 750 nm, and preferably in the wavelength range of 630 nm to 640 nm. A BCG sample cuvette 200 contains a sample 110 of biological fluid mixed with a BCG reagent 210 . The BCG reference cuvette 200 contains a sample of biological fluid 110 mixed with a BCG reagent 210 and another reagent 210 for denaturing the sample of biological fluid 110 . A BCG reference cuvette 200 was used as a control or reference for the BCG sample cuvette 200 for comparison. If albumin is present in the sample of biological fluid 110 , albumin reacts with the BCG reagent 210 to form a colored complex in the analytical sample 310 . A colored complex forms in the BCG sample cuvette 200, but this formation is blocked in the BCG reference cuvette 200 because the biological fluid sample 110 is denatured. The intensity of the complex color is directly proportional to the concentration of albumin in urine. The concentration of albumin is determined by measuring the absorption spectrum of the analysis sample 310 in the BCG cuvette 200 under the effect of red light, calculating the difference between the absorption spectra of the two analysis samples 310, and calculating the absorption amount of the difference. can be determined by comparison with a predetermined calibration curve of .

The optical measurement system 700 performs spectroscopy in which the sample to be analyzed 310 absorbs electromagnetic radiation, such as visible light, of predetermined wavelengths, for example, transmission spectroscopy, reflection spectroscopy, and spectroscopy. Other forms of spectroscopic measurements can be performed, such as dispersive spectroscopy. Other optical elements 706, such as mirrors for reflection spectroscopy, and configurations of light source 702, photodetector 704, and optical element 706 can be readily understood by those skilled in the art to implement other forms of spectroscopy. As such, it varies.

Temperature control system 800
The temperature control system 800 is configured for monitoring and/or controlling an analytical process, or part of an analytical process, in the analytical device 300 . The chemical reaction between the biological fluid sample 110 and the reagent 210 is typically affected by the environment or ambient temperature. In particular, an increase in ambient air temperature can accelerate reaction rates, which is sometimes undesirable. In one embodiment, the temperature control system 800 monitors temperature changes in the analytical device 300 prior to initiation of analysis or during use to prevent the analytical device 300 from continuing or causing unnecessary thermal shock to the analytical sample 310. It is configured to provide feedback as to whether or not it is possible to cool so as not to give By monitoring the temperature before starting the analysis, erroneous results can be eliminated and reliable analytical results can be returned. In another embodiment, temperature control system 800 is configured to compensate for temperature changes of chemical reactions in cuvette 200 . Specifically, reaction results provide feedback to compensate for higher reaction rates at higher temperatures. For example, for the creatinine response, feedback can compensate for higher response rates at higher temperatures in creatinine responses where dynamic measurements are used. Controlling the temperature of the chemical reaction can increase the reliability of the analytical results. This provides a consistent environment for the cuvette 200 and ensures that the analytical sample 310 is analyzed near the same temperature.

Temperature control system 800 may include a set of HVAC (heating, ventilation, and air conditioning) elements located on or integrated on analyzer 300 . The air conditioning element is configured to control the temperature of the analyzer 300 within a desired operating temperature range. In some cases, analyzer 300 is deployed in an air-conditioned environment that reduces the need for such temperature control. However, in some other cases, analyzer 300 may be deployed in more hostile environments such as remote or rural areas where analyzer 300 is exposed to weather elements.

The air conditioning element may include one or more ventilation outlets and/or one or more fans for exchanging air between the analyzer and the outside environment. The air-conditioning element includes a series of heating and/or cooling units, such as heat sinks and cooling coils, to heat and/or cool the analyzer 300 within a predetermined predetermined operating temperature range, the operating temperature range being 30°C. °C to 80 °C, and more preferably less than 50 °C. If the operating temperature exceeds the desired range, the efficiency of the light source 702 may be reduced, resulting in inaccurate analytical results.

The temperature control system 800 can include a series of temperature sensors for measuring the temperature of various components of the analyzer 300 and provide temperature feedback. The temperature control system 800 can send temperature feedback and thereby adjust various conditions of the analyzer 300 based on the temperature feedback. Among these conditions are the cooling time, the laser settling time, the temperature of the laser, the laser driving current, the analytical The operating temperature of the device 300 and the temperature of the vacuum chamber 400 are included. For example, one or more temperature sensors are configured to measure a series of laser calibration temperatures for determining operating temperature conditions. Each laser diode 702 is activated to laser through a respective cuvette 200 to a respective laser detector 704 and feed back a respective calibration temperature. If the laser calibration temperature exceeds the temperature range of 15°C to 40°C, such as above 40°C, an error message is sent to the operator, potentially jeopardizing the current and previous analysis results. , so decide whether to disable them.

The temperature sensor includes a thermistor sensor configured to measure ambient temperature and provide feedback regarding the current ambient temperature. A thermistor sensor may be exposed outside the analyzer 300 . Alternatively, the thermistor sensor may be enclosed within a case to prevent any mishandling or tampering. Ambient air temperature can be measured continuously or periodically. The ambient temperature measured by the thermistor sensor can further constrain the desired operating temperature range of the analyzer 300, such as between 20°C and 40°C. Preferably, the desired operating temperature range may be in the range of 20°C to 30°C. Using a thermistor sensor, the analyzer 300 can account for any deviations at any given time and provide an accurate assessment of operating conditions before proceeding with the analysis process. If the thermistor sensor measures the ambient temperature beyond the desired operating temperature range, the operator is alerted and prompted to consider terminating the analysis process.

Main control system 350
Main control system 350 is configured for overall control of analytical control system 320 , including vacuum device 500 , electromagnetic mixing system 600 , optical measurement system 700 and temperature control system 800 . Main control system 350 includes a processor or central processing unit (CPU) configured to perform the various steps of the analysis process. The processor may take the form of a printed wiring board and may include suitable algorithms, logic, circuits and/or interfaces for performing such steps, as will be readily appreciated by those skilled in the art. . The main control system 350 includes a set of memory devices or modules containing stored information relating to the performance of the analytical process. This information is pre-stored in the memory device at the manufacturing level and is not operable at the operator level.

The main control system 350 includes an operator control interface 352 for providing operator input for controlling the analysis process and displaying dynamic information regarding the analysis process, such as progress and updates. The operator must enter login details such as a username and password before the main control system 350 allows the operator to control the analysis process. This prevents unauthorized personnel from accessing the main control system 350 . After accessing the main control system 350 , the operator can initiate the analysis process by interacting with the operator control interface 352 .

Operator control interface 352 can include, for example, a set of input devices for the operator to provide input to make appropriate adjustments to the analytical process. Some of these adjustments include the operating temperature, the vacuum force, the path followed by the magnetic material 212 within the cuvette 200, and the alignment of the light source 702/photodetector 704 of the optical measurement system 700. is not limited to These adjustments ensure that the analytical process is performing within tolerances or parameters. Input devices may include, but are not limited to, keyboards (physical and/or virtual), buttons, switches, knobs, joysticks, mice, trackballs, and the like.

The operator control interface 352 may include a display panel for displaying information to the operator, such as responding to operator input. For example, the displayed information may include temperature feedback to inform the operator of the current operating temperature, keeping the operator informed whether the current operating temperature is within the desired operating temperature range. This temperature feedback helps prevent erroneous analytical results that could be compromised due to overheating.

The display panel can optionally include a graphical user interface (GUI) for displaying information and receiving operator input. For example, the display panel may include a touch screen panel that accepts capacitive input, which may be contact based or non-contact based. Main control system 350 may include lighting and/or sound devices configured to generate visual/audible alerts. These alerts relate to information displayed on the GUI or to errors during the analysis process. For example, depending on whether the vacuum cover 450 is in the locked or unlocked state, the GUI may display symbols reflecting that state. This provides visual feedback to the operator and prevents the operator from forcing the vacuum cover 450 open.

Main control system 350 includes a set of communication ports, such as CPU ports, that can be connected to many other electronic devices. These other electronic devices may include printers, scanners, data storage devices, and adapters for connecting with the facility's information system. For example, the adapter may be based on the RS-232 communication protocol and configured for connection with a hospital information system (HIS) or laboratory information system (LIS). Main control system 350 may include communication devices for wireless communication, such as those based on Wi-Fi™, Bluetooth™, and/or cellular network communication protocols. The communication device can communicate with an external electronic device such as a computer, laptop, tablet or mobile phone to provide access to analysis results on the fly. This provides additional flexibility for the operator to coordinate and perform other tests for the patient. The main control system 350 also includes a power switch 354, such as a rocker switch, for switching the analyzer 300 on and off, and a power input socket, such as a 24V DC socket, for hard-wiring to a power source. include.

The main control system 350 may be programmed with a power management system set to switch the analyzer 300 to a sleep or sleep mode after a predetermined period of inactivity. The power management system is also configured to safely shut down the analyzer 300 in the event of an emergency power outage, ensuring data integrity, especially for recent analysis results that are not backed up elsewhere. can. As a power redundancy measure, the main control system 350 may include or be connected to a backup power source, such as an uninterruptible power supply (UPS). The main control system 350 may program a schedule management program that periodically causes operators to perform cleaning and inspection steps for maintenance of the analyzer 300, thereby improving the quality and quality of future analysis results. Ensure validity.

Analysis system 1000
17A and 17B, an exemplary embodiment of the present disclosure includes an analysis system 1000 for analyzing or analyzing an analysis sample 310 made from a sample 110 of biological fluid mixed with a reagent 210. FIG. Analysis system 1000 includes a base station 1010 and a plurality of inspection stations 1020 communicatively coupled to base station 1010 . Base station 1010 is configured to control inspection stations 1020 to perform respective analysis processes on each inspection station 1020 . Base station 1010 may be integrated with one of inspection stations 1020 . Alternatively, base station 1010 is communicatively connected to inspection stations 1020 but is not integrated with any inspection stations 1020 .

The base station 1010 includes a main control system 350 (base control system 1012) configured to provide overall control over the inspection station 1020 that performs analytical processing. Each laboratory 1020 includes a respective analyzer 300 including at least a vacuum chamber 400, a vacuum cover 450, and a series of assay control systems 320 for performing each assay process. Each analysis apparatus 300 may comprise a respective vacuum device 500 or, alternatively, the analysis system 1000 may comprise a series of vacuum devices 500 for applying vacuum pressure to the vacuum chamber 400. The vacuum pressures applied to each vacuum chamber 400 may be substantially equal to or different from each other. The vacuum pressure applied to any one of the vacuum chambers 400 may be substantially the same as or different from any of the other vacuum chambers 400. It will be appreciated that the various aspects of analyzer 300 described herein apply in the same or analogous fashion to laboratory 1020 and have not been further detailed for the sake of brevity. .

Each analyzer 300 in each laboratory 1020 includes a main control system 350 (laboratory control system 1022) configured for local control of each analytical control system 320 set. In some cases, an operator may operate each inspection control system 1022 of each inspection station 1020 to perform each inspection station's 1020 analysis process. For example, each of the inspection control systems 1022 may include an operator control interface 352 or GUI. In other cases, an operator may operate the base control system 1012 of base station 1010 to exercise overall control over inspection station 1020 . The station control system 1012 may also include an operator control interface 352 or GUI that may not be present on the inspection control system 1022 .

Base control system 1012 may include a set of base control programs for overall control management/administration. Similarly, each test control system 1022 can include a set of test control programs for managing/operating each local control. These control programs allow various administrative/administrative functions to be performed. Non-limiting examples of these functions include operator access management, operator control interface management, output management, memory management, data storage management, external device management, data communication management, maintenance and quality. There is one related to the management of check schedules. It will be appreciated that other programs can be installed to facilitate management/operation of the base station 1010, inspection station 1020.

In some embodiments, such as those shown in Figures 17A and 17B, inspection stations 1020 are physically connected to base stations 1010 in a series arrangement, such as a daisy chain network topology. Figures 18A and 18B show various examples of such serial arrangements. In one example shown in FIG. 18A, a base station 1010 and an inspection station 1020 are interconnected using a cable 1016 for CPU. In another example shown in Figures 17B and 18B, a base station 1010 and an inspection station 1020 are integrally connected together in a monolithic arrangement. Specifically, each station 1010,1020 includes at least one connection interface or port 1014,1024 (as shown in FIGS. 9A and 17A) to couple directly to at least one other station 1010,1020. Coupling in this monolithic arrangement may be temporary or permanent and may be performed at the manufacturing facility or by a qualified service technician.

In some embodiments, inspection stations 1020 are physically connected to base stations 1010 in a parallel fashion, such as a star network topology. In one example, base station 1010 and inspection station 1020 are interconnected using communication cable 1016 . In another example, base station 1010 and inspection station 1020 are connected to a common network device that routes network traffic through stations 1010,1020. Network appliances can provide network security features, such as firewalls, to protect analysis system 1000 from malicious exploits. Notably, each station 1010, 1020 may include similar network security features that collectively protect the analysis system 1000. FIG.

In some embodiments, inspection station 1020 is wirelessly connected to base station 1010 using various wireless communication protocols such as Wi-Fi™. Base station 1010 and test station 1020 may be connected to a common network device that implements wireless communication. Additionally, the network appliance may similarly provide the network security features described above.

Only some examples of network topologies for connecting the base station 1010 and the inspection station 1020 are described, but they may be connected by other arrangements/topologies and the base station 1010 may be the inspection station. It will be appreciated that the 1020 can be communicated with. Additionally, each station 1010, 1020 may be powered by a separate or independent power source. Alternatively, base station 1010 is powered by a power source and inspection station 1020 receives power from base station 1010 .

In some embodiments, inspection stations 1020 are physically connected to base stations 1010 in a monolithic daisy chain network topology. Specifically, a first inspection station 1020 is integrated with the base station 1010, a second inspection station 1020 is connected to the base station 1010, a third inspection station 1020 is connected to the second inspection station 1020, A fourth inspection station 1020 is connected to a third inspection station 1020, and so on, depending on the number of inspection stations.

Base station 1010 includes communication equipment for transmitting instructions to inspection station 1020 . Specifically, the base station 1010 is a first laboratory station containing a first batch of biological fluid samples 110 mixed with a first batch of reagents 210 (i.e., a first batch of analytical samples 310). Send 1020 a first set of instructions to a second batch containing a second batch of biological fluid samples 110 mixed with a second batch of reagents 210 (i.e., a second batch of analytical samples 310). A second set of instructions is sent to the laboratory 1020 to include a third batch of biological fluid samples 110 mixed with a third batch of reagents 210 (i.e., a third batch of analytical samples 310). Sending a third set of instructions to three laboratories 1020 for a fourth batch of biological fluid samples 110 mixed with a fourth batch of reagents 210 (i.e., a fourth batch of analytical samples 310). A fourth set of instructions may be sent to a fourth inspection station 1020 including: The batches of reagents 210 may be the same or different from each other between batches or within each batch, allowing different reagent tests to be performed in the analytical process for diagnosis of different medical conditions, thereby providing a comprehensive picture of the patient. establish medical records; For example, a first batch of reagents 210 may differ from a second batch of reagents 210 to allow for different analytical tests, establishing a broader set of diagnoses for a patient. Further, the first laboratory 1020 may be configured differently than the second laboratory 1020 to fill different lots of reagents 210 .

For each laboratory 1020, a respective set of instructions may be provided at the respective laboratory 1020, such as to calibrate the optical measurement system 700 according to the respective batch of reagents 210, or to check the operational status of the respective analyzer 300. It may include a request to perform a preliminary test. Each instruction set can include a request to perform a live test, ie, an analysis process, on a respective analytical sample 310 batch. The base station 1010 can determine the number of iterations of preliminary tests to be performed on the test station 1020 before performing a live test. The sets of instructions may be sent in any order so that the inspection stations 1020 can perform the analysis steps independently of each other. Alternatively, the base station 1010 may send a common set of instructions to all inspection stations 1020 to perform the analysis process on each batch of analysis samples 310 simultaneously.

After the first analysis step is completed, the first analysis results are returned from the first inspection station 1020 to the base station 1010 for storage and communication to the operator. Similarly, after the second analysis process and the third analysis process are completed, the second analysis result and the third analysis result are sent from the second inspection station and the third inspection station 1020 to the base station 1010, respectively. returned. Analysis results include event logs and/or error records. The event log contains data associated with each analytical step, such as date/time stamps and identification data for each reagent batch 210 . The error record may contain data regarding any errors or problems that may have occurred during each analytical step.

The combination of base station 1010 and first inspection station 1020 is sometimes referred to as first inspection system 1030 . The combination with the second inspection station 1020 may be called the second inspection system 1032, the combination with the third inspection station 1020 may be called the third inspection system 1034, and the fourth inspection station 1020 may be called the third inspection system 1034. inspection station 1020 may be referred to as a fourth inspection system 1036 . As shown in FIGS. 17B and 18C, a first inspection system 1030 is integrally housed in a common body or first housing 1040 and a second inspection system 1032 is housed in a second housing 1042. , a third inspection system 1034 is housed in the third housing 1044 and a fourth inspection system 1036 is housed in the fourth housing 1046 . It will be appreciated that the operator may rely on any one or more of the inspection systems 1030, 1032, 1034, 1036.

In one embodiment of the present configuration, each inspection station 1020 of inspection systems 1030, 1032, 1034, 1036 includes a respective vacuum device 500 for evacuating a respective vacuum chamber 400. FIG. The vacuum devices 500 are not fluidly connected to each other and each vacuum device 500 may be operated independently of the others. In another embodiment, there is a common vacuum device 500 within the first inspection station 1020 configured to depressurize the vacuum chamber within the first inspection station 1020 . Common vacuum device 500 is fluidly connected to vacuum chambers 400 in all inspection stations 1020 and is further configured to depressurize all vacuum chambers 400 . Therefore, all vacuum chambers 400 can be collectively evacuated by a common vacuum device 500 .

In this configuration of inspection systems 1030, 1032, 1034, 1036, each inspection station 1020 can receive at least one dispensing device 100 for each analytical step. Each inspection station 1020 can perform analytical processing independently of other inspection stations. Additional inspection stations 1020 can be connected and installed in a plug-and-play approach to expand analysis system 1000 . Operators can connect additional inspection stations 1020 on demand to increase, among other things, the number of analysis steps performed by the analysis system 1000 in order to increase overall throughput. For example, analysis system 1000 may be deployed in remote locations with limited access to medical care. Analysis system 1000 enables samples of biological fluid 110 taken from the remote patient to be analyzed for rapid screening, monitoring, and/or diagnosis of medical conditions. By adding more laboratories 1020 to the analysis system 1000, more analysis processes can be performed simultaneously, providing better medical assistance to patients in the area.

This analysis system 1000 can quickly and efficiently perform multiple tests for many patients at a central location. Expansion of the analysis system 1000 advantageously allows more patients to be screened, monitored, and/or diagnosed more quickly in any medical condition. With a growing population, and especially with more people suffering from diseases such as diabetes and chronic kidney disease, such tests are needed to understand a person's physical health as quickly as possible. Individual medical costs are also increasing, and unless these medical conditions are screened, monitored and diagnosed soon, there will be a direct impact on the economy as governments seek to build up reserve funds. .

Identification system 1100
In a representative or exemplary embodiment of the present disclosure, referring to FIG. 19, there is an identification system 1100 for assisting analytical processes performed on a sample 110 of a patient's biological fluid. In particular, identification system 1100 helps patients identify and obtain their analysis results after the analysis process is completed. Identification system 1100 includes at least three identification labels 1110 : first identification label 1112 , second identification label 1114 , and third identification label 1116 . A first identifying label and a second identifying label 1112, 1114 are permanently disposed on a dispensing device 100 configured to dispense a sample 110 of biological fluid collected from a patient. The first and second identification labels 1112, 1114 may be formed directly on the dispensing device 100 by printing/scribing/embossing, etc. on its surface, or may be provided separately on its surface. It may be provided by a later fastener, adhesive, other bonding means, or the like. It is understood that the first and second identification labels 1112, 1114 can be positioned differently by reversing their positions, as shown in FIG. Will.

A third identification label 1116 is removably attached to the dispensing device 100 . The third identifying label 1116 is separated or removed by the patient or an operator such as a clinician assisting the patient and thereafter identifies the analysis result after the analysis process on the sample 110 of the patient's biological fluid is completed, used to obtain. A third identification label 1116 can be attached such that it cannot be adhered after it is removed. Attachment of the third identification label 1116 may include tamper-proof/tamper-proof features readily known to those skilled in the art. The identification label 1110 may be placed and attached to any surface or portion of the dispensing device 100 , such as the cartridge 102 . For example, first and second identification labels 1112 , 1114 are located on opposite sides of cartridge 102 and third identification label 1116 is located in window 132 of cartridge 102 .

This analysis device 300 is configured to receive the dispensing device 100 . The analyzer 300 further includes a set of reading devices configured to read or scan at least the first identification label and the second identification label 1112,1114. In one embodiment, a common reading device is arranged to read both the first identification label and the second identification label 1112,1114. In other embodiments, a first reading device is arranged to read the first identification label 1112 and a second reading device is arranged to read the second identification label 1114 . A reading device is placed in the vacuum chamber 400 and the dispensing apparatus 100 is placed in the vacuum chamber 400 in only one orientation to facilitate reading of the first and second identification labels 1112,1114. preferably The first and second identification labels 1112, 1114 are readable after the vacuum cover 450 is closed.

In other embodiments, the first identification label 1112 and/or the second identification label 1114 are placed on the cartridge lid 116 so that the operator can access an external reading device not connected to the analyzer 300, such as a barcode. A reader is used to scan first identification label 1112 and/or second identification label 1114 . Scanning with this external device provides a secondary safety approach in case the reading device of analyzer 300 cannot read first identification label 1112 and/or second identification label 1114 .

Vacuum chamber 400 may include a reader mount for mounting a reading device and may include a window for covering the reading device. The window is sealed onto the reading device, such as by adhesive or fasteners, while the reading device is able to read the first identification label and the second identification label 1112,1114. When the dispensing apparatus 100 is housed within the vacuum chamber 400, the reading device is placed a distance away from the first and second identification labels 1112, 1114 for quick and reliable reading. may A reflective element can be placed on the inner surface of the reader mount to provide off-axis illumination to the first and second identification labels 1112, 1114 through the windows without reflecting back to the reading device. The reflective element may be a thin piece of aluminum foil.

The reading device can employ any suitable technique to read the first identification label and the second identification label 1112,1114. For example, each of the first identification label and the second identification label 1112, 1114 may be in the form of a barcode or other optical code, and the reading device may include a laser for reading or scanning the barcode. Scanner and/or camera-based readers may be included. The barcode may be a linear barcode such as GS1-128 or GS1DataBar. The barcode may be a matrix barcode such as GS1QRCode™ or GS1DataMatrix™. The use of barcodes based on the GS1 standard ensures that products such as the dispensing device 100 and associated information are smoothly, efficiently and securely transported for proper interactive use from the manufacturing facility to the deployment site. can move. For example, GS1 barcodes encode information such as product numbers, serial numbers, batch numbers, and the like.

In some embodiments, dispensing device 100 is disposable and manufactured with pre-connected cartridge 102 and cuvette 200 at the manufacturing facility. Cuvette 200 is also preloaded with reagents 210 . Disposable dispensing device 100 can comprise a BCG sample cuvette 200, a BCG reference cuvette 200, and a DNBA cuvette 200 containing either BCG reagent or DNBA reagent 210 accordingly. A reading device reads the first and second identification labels 1112, 1114 to retrieve identification data about the dispensing device 100 and the reagents 210, which calibrates the analyzer 300 to perform the analytical process. used to

A reading device reads the first identification label 1112 to detect the presence of the dispensing device 100 and retrieve first identification data about or associated with the dispensing device 100 . The first identification data is encoded in the GS1 barcode of the first identification label 1112 and stored in the memory or storage device of the analyzer 300 upon retrieval. The first identification data may include identifiers of dispensing device 100 or portions thereof, such as cartridge 102, batch identifiers, lot identifiers, serial identifiers, product codes, and the like.

The reading device reads the second identification label 1114 to retrieve second identification data relating to or relating to the reagents 210 contained in the cuvettes 200 of the dispensing device 100 . The second identification data can be encoded in the GS1 barcode of the second identification label 1114 and can be stored in the memory or storage device of the analyzer 300 upon collection. The second identification data can include reagent 210 identifiers, manufacturing dates, expiration dates, batch identifiers, lot identifiers, serial identifiers, product codes, and the like.
After retrieving and storing the first identification data and the second identification data, reference identification data is retrieved from a pre-established library or database and compared to the first identification data and the second identification data.

In one embodiment, the database resides locally within the analyzer 300, such as a memory device or storage device. A local database may be part of a closed intranet system that does not interface with the Internet. The intranet system can receive and store reference identification data in a local database only from licensed manufacturers of dispensing devices 100 and reagents 210 . The local database can be pre-loaded with reference identification data during scheduled upgrade or maintenance activities authorized by the licensed manufacturer to mitigate the risk of tampering, and the upgrade or maintenance. Activities are permitted by licensed manufacturers to reduce the risk of tampering.

In another embodiment, the analyzer 300 is communicatively connected to the facility's integrated system where the analyzer 300 is located, such as a HIS or LIS, and the database resides in the facility's integrated system. Although the analysis device 300 can extract the reference identification data from the facility database, due to data privacy issues, the analysis device 300 not only stores the analysis results but also the first identification data and the second identification data in the facility database. May not be shared with database. The first identification data and the second identification data and analysis results remain stored in the local memory or storage device of the analyzer 300 . This configuration provides an additional layer of security to protect the patient's identity.

Also, in another embodiment, the analysis device 300 is communicably connected to a remote server, such as a cloud server, where the database resides. A verification step between the analytical device 300 and the cloud server may be required before the analytical device 300 can receive the reference identification data from the cloud server. The verification step includes verifying the identifiers of the analysis device 300 and the cloud server with each other prior to mating the analysis device 300 and the cloud server to open at least one communication channel for communicating reference identification data. The reference identification data may be encrypted by the cloud server to add another layer of security, and the encrypted reference identification data is later decrypted by the analysis device 300 using a predetermined security key. It is understood that data security features, specifically pairing/bonding, encryption/decryption, etc., are readily understood by those skilled in the art and have not been described in further detail for the sake of brevity. be.

When a new or updated version of the reference identification data is installed or loaded into the database, the installation simultaneously deletes the old version of the reference identification data still stored in the database. That is, the new or updated version of the reference identification data overwrites the old version of the reference identification data in the database. These older versions of the reference identification data may have become obsolete or become invalid over time and are no longer applicable for future analysis. This prevents the analysis device 300 from analyzing an old/outdated/invalid dispensing device 100. FIG.

The authenticity of the recovered first and second identification data, i.e., that dispensing device 100 and reagent 210 are genuine or legitimate products from a licensed manufacturer, by comparison with reference identification data. It can be verified whether or not A failed verification may indicate that the dispensing device 100 and/or reagents 210 contained therein may be counterfeit from an unlicensed or unauthorized supplier.
Also, the dispensing device 100 and/or reagents 210 may be genuine but later found to be defective or contaminated during quality checks, indicating that the manufacturer has already rejected or recalled the product. . This verification step can be used to identify fraudulent or invalid products and can add integrity to the analysis results.

Comparison with reference identification data can also be used for other checks and verifications. For example, first identification data and second identification data may indicate that dispensing device 100/reagent 210 is intended for use in a particular country or region. If the dispensing device 100 is loaded into an analyzer 300 located in another country or region, the analyzer 300 will generate an error alert that rejects the dispensing device 100 and the analysis process will not begin. Error alerts may be in the form of display messages, visual indications, audio alerts, or a combination thereof. This check provides some protection against the use of dispensing devices 100 that are parallel imported from other regions. In another example, the reference identification data can indicate that the analytical device 300 can only be used with a predetermined set of dispensing devices 100 and/or reagents 210 . If the first identification data and the second identification data of a dispensing device 100 matching the predetermined set are obtained, the analysis device 300 generates an error alarm rejecting the dispensing device 100 and the analysis process begins. not.

After matching the first identification data and the second identification data with the reference identification data, analyzer 300 retrieves one or more algorithms or programs for calibration before beginning the analysis process. Algorithms or programs may be stored in the local database of the analysis device 300 or may be stored on a cloud server. Algorithms or programs are customized for a particular batch of reagents 210 in dispensing device 100 and used to calibrate analyzer 300, particularly optical measurement system 700, to optimize the analytical process. In this way, the appropriate algorithm or program can be safely retrieved for analyzing the analysis sample 310 without knowing the patient's identity.

The third identification label may similarly be in the form of a bar code or other optical code and includes third identification data encoded therein. The third identification data is unique to dispensing device 100 and suitable for one-time use only. An external electronic device or reading device can be used to read the third identification data to access the analysis results after the analysis process on the sample of patient biological fluid 110 is completed. An external electronic device or reading device can be connected to the analyzer 300 or an external computer system. In some embodiments, referring to FIG. 20, there is a computerized method 1150 for making available analytical results from an analytical process performed on a sample 110 of a patient's biological fluid. The computerized method 1150 is implemented on a computer system such as a remote server or cloud server where the database resides. The computer system includes a processor and various modules/components for performing various steps of the present method 1150, including suitable logic, circuits and/or components for performing such steps. or in response to non-transitory instructions operated or executed by a processor including an interface.

The operator first removes or cuts off the third identification label 1116 from the dispensing device 100 before providing the dispensing device 100 to the patient. A detached third identifying label 1116 is placed on the patient's medical record document, which contains sensitive patient data that is available only to a selected group of people, including workers.
The patient picks up the dispensing device 100 without the third identifying label 1116 and proceeds to transfer the bulk sample of biological fluid through the collection device. The patient then returns the dispensing device 100, now containing the sample 110 of biological fluid, to the operator.

After returning the dispensing device 100, the patient uses a first electronic device, such as an integrated camera phone, to read the third identification label 1116 on the medical record document. In an alternative embodiment, the patient takes the dispensing device 100 with the third identifying label 1116 left untreated and collects the sample 110 of biological fluid. This dispensing device 100 is returned to the operator and the third identifying label 1116 is cut off and placed on the medical record document. The patient uses the first electronic device to read the third identifying label 1116 before and after it is detached. In yet another embodiment, dispensing device 100 can further include a fourth identification label removably attached to dispensing device 100 . The fourth identification label includes encoded third identification data therein. One of the third identification label and the fourth identification label can be cut away and placed on the medical record document, while the rest remain on the dispensing device 100 . It will be appreciated that additional identifying labels may be removably attached to dispensing device 100 .

To minimize time spent within the facility, such as a clinic or hospital, where analyzer 300 is deployed, the patient later remotely accesses the analysis results through an online interface, such as via an application or website. be able to. The method 1150 includes receiving 1152 a request from the patient to access the online interface from the first electronic device and initiating the analysis process. The patient's request includes third identification data and further includes a device identifier for the first electronic device. In one example, the first electronic device reads the third identifying label 1116 (or fourth identifying label) and retrieves third identifying data including an address or URL to the online interface. In another example, a first electronic device executes an application to access an online interface. The first electronic device captures an image of the third identification label 1116 (or the fourth identification label), obtains third identification data, and sends the patient's request.

Thus step 1152 activates the third identification data, which remains valid until the analysis results are received. Additionally, the method 1150 can include verifying the third identification data in comparison to the reference identification data. By comparison with the reference identification data, it can be verified whether the third identification data is separate from the authenticity (dispensing device 100) and/or whether it is valid. For example, a failed verification has already been used in a previous analytical step for another patient, and dispensing device 100 is intended for one-time use only. is defective or the third identification data has already been neutralized. A verification message can be sent to the first electronic device to inform the patient of the verification status.

The device identifier may be a network address, such as a media access control (MAC) address of the first electronic device. Method 1150 includes step 1154 of associating the third identification data with the device identifier. This provides third identification data unique to the first electronic device and thus to the patient. This also prevents other patients from accessing the patient's analysis results.

After receiving the dispensing device 100 containing the biological fluid sample 110, the operator loads the dispensing device 100 into the analysis device 300 and performs the analysis process. After completing the analysis process, the operator prepares to input the analysis results into the computer system. Specifically, the operator uses a second electronic device such as a computer integrated with a camera or connected to the camera, returns the dispensing apparatus 100, and the patient uses the first electronic device, 3 identification label 1116 (or the fourth identification label). The method 1150 includes receiving 1156 a request from the operator to access the online interface and enter the analysis results from the second electronic device.
The operator's request includes third identification data and analysis results. In one example, the second electronic device reads third identifying label 1116 (or fourth identifying label) to retrieve third identifying data, including an address or URL to an online interface. In another example, a second electronic device executes an application to access an online interface. The first electronic device captures an image of the third identification label 1116 (or the fourth identification label), obtains third identification data, and sends the operator's request along with the analysis results.

Additionally, the method 1150 can include verifying the third identification data in comparison to the reference identification data, as described above. A verification message can be sent to the second electronic device to inform the operator of the verification status.

Method 1150 includes step 1158 of associating the analysis result with the third identification data. This creates an analysis unique to the third identification data, which is unique to the first electronic device and thus to the patient. Therefore, other patients would not be able to access the analysis results. The method 1150 includes sending 1160 the result message to the first electronic device. The results message indicates that analysis results are available on the online interface accessed by the first electronic device. Thereafter, the patient continues to access the analysis results using the first electronic device with an online interface, such as via an application or website.

In the illustrated situation, there is a first dispensing device 100 with a first "third identification data" and a second dispensing device 100 with a second "third identification data". Although the patient can use the first dispensing device 100 to collect a sample 110 of biological fluid, the step of verifying the first "third identification data" is performed only when the first dispensing device 100 May indicate invalid. Nevertheless, the patient can still return the first dispensing device 100 to the operator who transfers the biological fluid sample 110 to the second dispensing device 100 . Confirming the second "third identification data" indicates that the second dispensing device 100 is valid and the operator proceeds with the analysis process. The analysis result is associated with the second "third identification data", but a further association is made between the second "third identification data" and the first "third identification data" There is This allows the patient to use the first "third identification data" to access the analysis results. Alternatively, the operator can transfer the data from the first dispensing device 100 to the second dispensing device so that the patient can obtain the analysis results, usually using a second "third identification data" as described above. After transferring the biological fluid sample 110 to 100, the patient may be required to validate a second "third identification data".

As another example, a patient collects his biological fluid into a collection device and transfers the biological fluid from the collection device to the first dispensing device 100 . The patient then hands the first dispensing device 100 and the collection device with the remaining biological fluid to the operator. After that, the operator carries out the analysis process. In an unlikely scenario, dispensing an insufficient sample of biological fluid 110 into the cuvette 200 could invalidate the analytical results.
To prevent the patient from dispensing another batch of biological fluid, the operator can use the collection device with the patient's remaining biological fluid and dispense it into the second dispensing apparatus 100 . Prior to performing the analysis step on the second dispensing device 100, the operator uses an external device or reading device to read the third identification label 1116 of both the first and second dispensing devices 100. Hundreds of dispensing devices can be scanned for traceability. Instead, the reading device of the analyzer 300 reads the first dispensing device 100 and the second dispensing device 100 in series, reflecting the same patient usage of the first dispensing device and the second dispensing device 100. be able to.

Additionally, the method 1150 can include disabling the third identification data in response to the first electronic device accessing the analysis results on the online interface. This is because the dispensing device 100 with the third identifying label 1116 (or the fourth identifying label) removed may not be suitable for subsequent use, especially if the dispensing device 100 is disposable and intended for one-time use only. Prevent it from being used in the analytical process. The method 1150 can include disabling the third identification data if the analysis results have not been accessed after a predetermined expiration date has passed. This reduces wastage of computational resources because the analysis results are not hosted indefinitely on the computer system while waiting for the patient to access the analysis results.

Optionally, method 1150 includes initiating a predetermined waiting period for the third identification data in response to receiving the patient's request. This predetermined waiting period is between 10 and 30 minutes, but is not so limited. The method 1150 may further include sending a wait message to the first electronic device responsive to initiation of the predetermined wait period. This waiting message informs the patient of an estimated waiting period before he expects to receive the analysis results. From the perspective of the operator performing the analysis process, this predetermined waiting period also prompts the operator to enter analysis results within the waiting period. The method 1150 can further include disabling the third identification data if no analysis results have been received after a predetermined waiting period has elapsed.
If the analysis process is not completed within the waiting period, the analytical results may be inaccurate because the biological/chemical profile of the biological fluid sample 110 may have changed during the waiting period. Overriding the third identification data may inform the patient that the analysis results are not expected because they are not accurate.

Throughout the patient's journey from receiving the dispensing device 100 to taking the biological fluid sample 110 and accessing the analysis results, the patient relies on the third identification data to initiate the analysis process on the online interface. , to later access the analysis results. Patients are not required to reveal their personal identities, allowing patients to test biofluid samples and receive analytical results anonymously. In this manner, the identification system 1100 and computerized method 1150 help protect patient privacy throughout the analysis process.

After that, based on the analysis results, it is possible to decide whether or not to continue the consultation at the clinic or hospital. For example, the analysis results may reveal to the patient a quantitative number of compounds or substances in the sample of biological fluid 110 that pose little or no risk to the patient, and in such cases, at least short-term In reality, it may not be necessary to arrange follow-up visits. However, as pathogens such as viruses become more prominent and widespread, remote or non-central hospital and clinic screening and surveillance becomes even more important for patients to check their medical profile. Become.

In some embodiments, there is an analysis system 1000 that includes a base station 1010 and multiple inspection stations 1020, each inspection station including an analyzer 300. FIG. Using two laboratories 1020 as an example, a first laboratory 1020 with a first analyzer 300 receives a first dispensing device 100 containing a first batch of reagents 210 and performs a second assay. A second laboratory 1020 with apparatus 300 receives a second dispensing apparatus 100 containing a second lot of reagents 210 .
In one embodiment, each inspection station 1020 compares its respective first identification data and second identification data to respective reference identification data. In another embodiment, both the first identification data and the second set of identification data are sent from inspection station 1020 to base station 1010 . The base station then compares both the first identification data and the second set of identification data with the respective reference identification data. Comparison results are returned from base station 1010 to inspection station 1020 . Comparison results can be sent along with appropriate algorithms or programs for the analysis process to be performed by inspection station 1020 . Alternatively, inspection station 1020 can retrieve the appropriate algorithm or program from local analyzer 300 .

The identification label 1110 may be in the form of a GS1 QR Code™, and the identification data is encoded in the GS1 QR Code™. However, due to the limited data capacity of the GS1 QR Code™, it may not be sufficient to encode all of the required identification data. It is understood that additional identification labels 1110 are included in the identification system and thus all identification labels 1110 enable retrieval of all necessary identification data associated with dispensing device 100 and reagents 210. right. Alternatively, instead of encoding the identifying data within the identifying label 1110, the identifying label 1110 may encode an address or URL to the online location. A reading device reads the identification label 1110 and accesses the address to retrieve identification data remotely stored at the online location. This can be accomplished when the analysis device 300 is connected to an intranet system or the Internet.

In one embodiment, the identification label 1110 may be placed on a set of printed seal labels. A set of printed seal labels can be placed on one or more surface portions of dispensing device 100 , such as on cartridge 102 and/or on cuvette case 202 . Each of the printed seal labels can include any one or more of the identification labels 1110 in any combination. For example, smaller labels 1110 are printed together in a single printed seal label, while larger labels 1110 are printed individually.

Materials and Manufacturing The various components of the dispensing device 100/analytical device 300 may be made from any of the following materials - polypropylene/polypropene (PP), high density polyethylene (HDPE), silicone, butyl rubber, nitrate rubber, and poly(methacrylic) ( PMMA), or a combination of materials - styrene acrylonitrile resin (SAN) - but not limited to these. The material PMMA is alternatively known as acrylic or acrylic glass and under the trade names Plexiglas™, Acrylite™, Lucite™, and Perspex™. Where appropriate, various components of dispensing device 100/analyzer 300 are assembled with sealing elements to prevent or at least mitigate leakage of biological fluids. Such sealing elements include O-rings made of resilient materials, toric joints or gaskets, rubber/silicon tight-fit connections, ultrasonic bonding, ultrasonic bonding, adhesive glue, latches, cantilever levers, etc. including but not limited to.

The dispense device 100/analyzer 300 or such components may be manufactured by molding or other known manufacturing methods. In particular, they may be formed by manufacturing processes that include additive manufacturing steps. Three-dimensional (3D) printing is common, but other additive manufacturing methods are available. Rapid prototyping and rapid manufacturing are also terms used to describe additive manufacturing processes.

As used herein, "additive manufacturing" generally refers to a manufacturing process in which successive layers of material are provided to each other, layer by layer, 3D building blocks, "stacks," or as "additive products." . This is compared to some subtractive manufacturing methods (milling or drilling) in which parts are continuously removed and machined. Successive layers are generally fused to form a unitary component having various integral sub-components. In particular, the manufacturing process allows examples of the present disclosure to be integrally formed and to include various features not possible using conventional manufacturing methods.

The additive manufacturing methods described herein allow suitable sizes and shapes to be manufactured with various characteristics not possible using conventional manufacturing methods. Additive manufacturing can create complex geometries without any tools, molds, or fixtures, and with little or no wasted material. Rather than fabricating the part from a solid billet of plastic or metal, much of which is scrapped and discarded, all that is needed to shape the part is the material used in additive manufacturing.

Suitable additive manufacturing techniques according to the present disclosure include, for example, fused deposition modeling, selective laser sintering, 3D printing such as by inkjet and laser jet, stereolithography (SLA), direct selective laser sintering (DSLS), e-beam Melting (EBM), Laser Engineered Net Shaping (EBM), Laser Net Shape Manufacturing (LNSM), Direct Metal Deposition (DMD), Continuous Digital Light Processing (CDLP), Direct Selective Laser Melting (DSLM), Direct Metal Laser Melting ( DMLS), material jet (MJ), drop on demand (DOD), binder jet (BJ), laminated object manufacturing (LOM), and other known processes.

The additive manufacturing processes described herein can be used to form the elements using any suitable material. For example, the materials are metals, plastics, polymers, composites, or other suitable materials that can be solids, liquids, powders, sheet materials, wires, or any suitable form or combination thereof. More specifically, according to exemplary embodiments of the present disclosure, the additively manufactured components described herein may be used partially, wholly, or in an additive manufacturing process. and may be formed of any combination of materials suitable for and suitable for the exemplary fabrication described herein.

As noted above, the additive manufacturing processes disclosed herein allow a single component to be formed from multiple materials. Accordingly, the examples described herein can be formed from any suitable mixture of the above materials. For example, a component may include multiple layers, segments or parts formed on different materials, processes, and/or different additive manufacturing equipment. In this way, components can be constructed with different material and material properties to meet the needs of any particular application. Further, although the parts described herein are constructed entirely through additive manufacturing processes, in alternative embodiments all or a portion of these parts are cast, machined, and/or otherwise manufactured. It should be understood that it may be formed by any suitable manufacturing process. In fact, any suitable combination of materials and manufacturing methods can be used to form these components.

Additive manufacturing processes typically manufacture parts based on three-dimensional information, eg, a three-dimensional computer model (or design file) of the part. Accordingly, the examples described herein include not only the products or components described herein, but also the use of such products or components through additive manufacturing and computer software, firmware or hardware. Including methods for controlling.

A product's structure may be represented digitally in the form of a design file. A design file, or computer-aided design (CAD) file, is a configuration file that encodes one or more of the surface or volumetric features of a product's shape. That is, the design file represents the geometric layout or shape of the product.

Design files can be in any file format now known or recently developed. For example, a design file can be in stereolithography or stereomosaic processing language (.stl) format created for a 3D system's stereolithography CAD program, or the shape and configuration of any 3D object on any additive manufacturing printer. The Additive Manufacturing File (.amf) format, which is the American Society of Mechanical Engineers (ASME) standard, which is an extensible markup language (XML) based format that allows any CAD software to be manufactured.
Other examples of design file formats include AutoCAD(TM) (.dwg) files, Blender(TM) (.blend) files, Parasolid(TM) (.x_t) files, 3D ManufacturingFormat(TM) (.3mf) files, There are many other file formats, including Autodesk (3ds) files, Collada(TM) (.dae) files, and Wavefront(TM) (.obj) files.

The design file is created using modeling (eg, CAD modeling) software and/or by scanning the surface of the product to measure the surface configuration of the product. Once obtained, the design file is converted by the processor into a set of computer-executable instructions that, once executed by the processor, control an additive manufacturing device that produces a product according to the geometric shapes specified in the design file. can be Conversion allows the design file to be converted into slices or layers that are sequentially formed by additive manufacturing equipment. Instructions (known as geometry codes or "G-codes") can be calibrated to specific additive manufacturing equipment to specify the precise location and amount of material to be formed at each stage of the manufacturing process. As noted above, formation can be by vapor deposition, firing, or other forms of additive manufacturing methods.

Code or instructions may be translated between different formats, converted into a series of data signals for transmission, received as a series of data signals, converted to code as appropriate, and stored. Instructions are inputs to the additive manufacturing system and may come from a component designer, intellectual property (IP) provider, design firm, operator or owner of the additive manufacturing system, or other source. . An additive manufacturing system can execute instructions to manufacture a product using any of the techniques or methods disclosed herein.

The design file or computer-executable instructions are stored in a (transitory or non-transitory) computer-readable storage medium (e.g., memory, storage system, etc.) that stores the code or computer-readable instructions representing the product to be manufactured. may As previously mentioned, the code or computer readable instructions define the product used to physically create the object upon execution of the code or instructions by the additive manufacturing system. For example, the instructions may include a precisely defined 3D model of the product to be generated from any of a wide variety of well-known CAD software systems such as AutoCAD™, TurboCAD™, DesignCAD3DMax™. can be done. Alternatively, a model or prototype of the product can be scanned to determine the 3D information of the product. Thus, by controlling the additive manufacturing device according to computer-executable instructions, the additive manufacturing device can be commanded to print out a product.

In view of the above, embodiments include methods of manufacturing by additive manufacturing. This includes obtaining a design file representing the product and instructing the additive manufacturing equipment to manufacture the product according to the design file. The additive manufacturing device can include a processor configured to automatically convert the design file into computer-executable instructions for controlling manufacturing of the product. In these embodiments, once the design file itself is input into the additive manufacturing device, it can automatically trigger manufacturing of the product. Thus, in this embodiment, the design file itself can be thought of as computer-executable instructions that cause the additive manufacturing device to manufacture the product. Alternatively, the design file is converted to instructions by an external computing system and the resulting computer-executable instructions are provided to the additive manufacturing equipment.

In view of the above, the construction and manufacture of implementations of the subject matter and operations described herein can be accomplished using digital electronic circuitry or using computer software, firmware, or hardware, including , structures disclosed herein and structural equivalents thereof, or combinations of one or more thereof. For example, hardware includes processors, microprocessors, electronic circuits, electronic components, integrated circuits, and the like. Implementation of the subject matter described herein involves one or more computer programs, i.e., one or more modules of computer program instructions, for execution by or for controlling the operation of a data processing apparatus. It can be implemented using something encoded on a computer storage medium. Alternatively or additionally, the program instructions may be mechanically generated to encode information for transmission suitable for a receiving device to be executed by an artificially generated propagating signal, e.g. can be encoded in an electrical, optical, or electromagnetic signal generated in the A computer storage medium may be or be included in a computer readable storage device, a computer readable storage substrate, a random or serial access memory array or device, or a combination of one or more thereof. can. Moreover, although a computer storage medium is not a propagated signal, a computer storage medium can be the source or destination of computer program instructions encoded in an artificially generated signal. A computer storage medium may also be or be contained within one or more separate physical components or media (eg, multiple CDs, disks, or other storage devices).

Although additive manufacturing techniques are described herein as enabling the manufacture of complex objects, here by building the object point-by-point, layer-by-layer, typically vertically. , other manufacturing methods are possible and within the scope of the present subject matter. For example, although the discussion herein refers to the addition of materials to form successive layers, those skilled in the art will appreciate that the methods and structures disclosed herein can be applied to any additive or other manufacturing technique. You will understand that it can be implemented.

In the foregoing detailed description, embodiments of the present disclosure relating to apparatus for dispensing and analyzing samples of biological fluids are described with reference to the presented figures. The description of various embodiments in this document is not intended to be limited to specific or particular representations of the disclosure, but is merely intended to describe non-limiting examples of the disclosure. The present disclosure helps address at least one of the aforementioned problems and problems associated with the prior art. Although only some embodiments of the present disclosure are disclosed in this document, various changes and/or modifications can be made to the disclosed embodiments without departing from the scope of the present disclosure. It will be apparent to those of ordinary skill in the art in view of the present disclosure. Accordingly, the scope of the disclosure, as well as the scope of the following claims, is not limited to the embodiments described herein.

Claims (95)

A dispensing device for dispensing a biological fluid, comprising:
The dispensing device comprises a cartridge, the cartridge comprising:
a receiving chamber for receiving a bulk sample of the biological fluid;
a set of metering chambers in fluid communication with the receiving chamber, each metering chamber configured to hold a predetermined volume of the sample of biological fluid dispensed from the bulk sample of biological fluid;
each metering chamber comprising an outlet for dispensing each biological fluid sample and further comprising a dispensing filter for filtering each biological fluid sample upon dispensing;
A sample of biological fluid within the metering chamber is dispensable through the outlet by applying vacuum pressure within the cartridge, wherein the distribution filter prevents dispensing of the sample of biological fluid in the absence of vacuum pressure. , a dispensing device. 2. The dispensing device of claim 1, wherein the dispensing filter comprises a set of fritted filters and/or a set of semi-permeable membranes. 3. The dispensing device of claim 2, wherein the fritted filter comprises fritted glass and/or sintered frit. 4. A dispensing device according to claim 2 or 3, wherein said semi-permeable membrane is made of a hydrophobic material. 5. A dispensing device according to any preceding claim, wherein the dispensing filter is configured to retain particulate matter of at least 2[mu]m. Further provided is a cuvette case that removably receives a set of cuvettes, the cartridge and the cuvette case being removably coupled to each other, and each cuvette being coupled to a respective weighing chamber for receiving a respective filtered biological fluid sample. 6. A dispensing device as claimed in any one of claims 1 to 5. 7. The dispensing device of claim 6, further comprising a cuvette within the cuvette case, the cartridge and cuvette case being removably coupled to each other and the cuvette being removably coupled to the weighing chamber. 8. The dispensing device of claim 7, wherein each cuvette includes a magnetic material to facilitate physical mixing of the biological fluid sample and reagents within the cuvette. 9. A dispensing device according to claim 7 or 8, wherein each cuvette comprises pores to facilitate evacuation of air bubbles when vacuum pressure is applied. 10. The dispensing device of claim 9, wherein said pores are composed of a hydrophobic membrane. 11. A dispensing device according to any of claims 6-10, further comprising a set of gaskets disposed between the cartridge and the cuvette case to seal engagement between the cartridge and the cuvette case. 12. The dispensing device of claim 11, wherein the gasket comprises a set of holes to facilitate dispensing of the filtered biological fluid sample into the cuvette. 13. A dispensing device according to any preceding claim, further comprising a cartridge lid for sealing the cartridge. 14. The dispensing device of Claim 13, wherein the cartridge lid includes a vacuum port for receiving a vacuum actuator operable by application of vacuum pressure. 15. A dispensing device according to claim 13 or 14, wherein the cartridge lid comprises a series of pores for evacuating air during application of vacuum pressure. 16. The dispensing device of any of claims 13-15, wherein the cartridge lid comprises a fill port for transferring a bulk sample of biological fluid to the receiving chamber. 17. The dispensing device of claim 16, wherein the cartridge lid includes a fill filter engageable with a fill port for pre-filtration of a bulk sample of biological fluid. 18. The dispensing device of claim 17, wherein the packed filter comprises a set of fritted filters and/or a set of semi-permeable membranes. 19. A dispensing device as claimed in any preceding claim, wherein each metering chamber comprises a series of ribs for supporting the respective dispensing filter. 20. The dispensing device of claim 19, wherein the ribs are arranged to facilitate communication of the biological fluid sample to the center of the outlet. 21. A dispensing device according to any preceding claim, wherein each metering chamber comprises a retaining ring attached to each dispensing filter to prevent backflow of the biological fluid sample. 22. A dispensing device according to any preceding claim, further comprising a piston assembly disposed within the cartridge, the piston assembly operable by application of vacuum pressure to dispense the sample of biological fluid. . 23. The dispensing device of claim 22, wherein the piston assembly includes a set of pistons, each piston displaceable into a respective one of the metering chambers to dispense a respective biological fluid sample. 24. A dispensing device according to claim 22 or 23, wherein the piston assembly is displaced by a vacuum actuator actuated by the application of vacuum pressure. 25. A dispensing device according to any preceding claim, further comprising a series of identification labels containing identification data relating to the dispensing device and/or reagents. 10. The identification label comprises a first identification label, the first identification label being permanently located on the dispensing device and comprising first identification data encoded in association with the dispensing device. 26. Distributor according to 25. The identification label comprises a second identification label permanently disposed on the dispensing device and containing encoded second identification data associated with reagents contained in the cuvette. 27. A dispensing device according to claim 26. The identification label comprises a third identification label removably attached to the dispensing device and a code for accessing analytical results from an analytical process performed on the sample of biological fluid. 28. The dispensing device of claim 27, comprising third identification data encoded. 29. Dispensing device according to claim 27 or 28, wherein the first identification data and/or the second identification data are verifiable against reference identification data for verifying the dispensing device and/or the reagent. 30. A dispensing device according to any of claims 25-29, wherein each identification label comprises a matrix barcode. 31. A computer program product comprising computer executable instructions which, when executed by a processor, cause the processor to control an additive manufacturing device to manufacture a dispensing device according to any preceding claim. A method of manufacturing a product via additive manufacturing, comprising:
obtaining an electronic file representing the shape of a product, said product being a dispensing device according to any one of claims 1 to 30;
and C. controlling an additive manufacturing device to manufacture a product in one or more additive manufacturing steps according to the geometry specified in the electronic file. An analyzer for analyzing a biological fluid,
a vacuum chamber removably housing a dispensing device containing a set of cuvettes and a set of biological fluid samples, the cuvettes containing a set of reagents;
a vacuum cover that seals the dispensing device within the vacuum chamber;
a vacuum device for applying a vacuum pressure to the vacuum chamber to dispense a sample of the biological fluid into the cuvette such that the sample of the biological fluid reacts with the reagents to form an analytical sample;
Equipped with a set of analytical control systems that control vacuum devices to carry out analytical processes,
An analytical device, wherein the analyzing step includes applying a vacuum pressure to dispense a sample of the biological fluid and analyzing the analytical sample in the cuvette. 34. The analyzer of claim 33, wherein the vacuum chamber and vacuum cover are provided with a set of interlocking detectors for detecting when the vacuum cover is closed. 35. The analyzer of Claim 34, wherein said interlocking detector comprises a magnetic element and a magnetic sensor. 36. An analyzer according to claim 34 or 35, wherein the vacuum cover comprises an optical isolator for detecting when the vacuum cover is closed. 37. The analyzer of any of claims 33-36, wherein the vacuum cover comprises a vacuum cover handle for handling the vacuum cover. 38. The analyzer of claim 37, wherein the vacuum cover handle is movable between a closed state and an open state, and wherein the vacuum cover can be opened from the vacuum chamber when the vacuum cover handle is in the open state. 39. The analyzer of claim 38, wherein the vacuum cover comprises a vacuum cover actuator engageable with the vacuum cover handle to lock the vacuum cover handle closed. 40. The vacuum cover handle of claim 38 or 39, wherein the vacuum cover handle has an intermediate state between a closed state and an open state, and wherein the vacuum cover is unlocked while the vacuum cover handle moves from the intermediate state to the open state. The analyzer described. 41. The analyzer of any of claims 38-40, wherein the optical measurement system of the analyzer is inactive when the vacuum cover handle is open. 40. An analysis apparatus according to any of claims 33-39, further comprising a set of valves fluidly connected to the vacuum device for facilitating the application of vacuum pressure. 42. The analyzer of any of claims 33-41, further comprising a carbon filter fluidly connected to the vacuum device for cleaning the air exchange between the vacuum device and the vacuum chamber. 44. An analytical device according to any of claims 33-43, further comprising a vacuum actuator operable by applying vacuum pressure. 45. The analyzer of Claim 44, wherein the vacuum cover comprises a vacuum actuator housing for a vacuum actuator. 46. The analyzer of claims 44 or 45, wherein the vacuum actuator is operable to displace a piston assembly of a dispensing device, thereby dispensing a sample of biological fluid. 47. The analyzer of any of claims 44-46, wherein the vacuum actuator comprises a spring biasing the vacuum actuator to the disengaged position. 48. The analyzer of any of claims 33-47, wherein the analytical control system comprises an electromagnetic mixing system for mixing a sample of biological fluid with reagents in a cuvette. 49. The analyzer of claim 48, wherein the electromagnetic mixing system comprises a set of electromagnetic mixing units that generate magnetic fields within cuvettes. 50. The analyzer of claim 49, wherein the magnetic field causes movement of magnetic material within each cuvette to facilitate mixing. 51. The analyzer of any of claims 33-50, wherein the analytical control system comprises an optical measurement system for performing spectroscopy on the analytical sample. 52. The analyzer of claim 51, wherein said optical measurement system includes at least one light source and at least one photodetector. 53. The analyzer of claim 52, wherein for each cuvette, a set of light sources and photodetectors are collinear and paired with the cuvette. 54. An analyzer according to claim 52 or 53, wherein the optical measurement system comprises a number of baffles surrounding the light source and/or photodetector to prevent light scattering. 54. An analysis device according to claim 52 or 53, further comprising a set of heat sinks, each light source being arranged on a respective one of the heat sinks. 56. An analysis device according to any of claims 52-55, wherein each light source comprises a light emitting diode (LED) or a laser diode. 57. The analyzer of any of claims 53-56, further comprising a set of optical elements positioned between the light source and the photodetector. 58. The analyzer of claim 57, wherein the optical measurement system is configured to perform a calibration process to compensate for light attenuation caused by optical elements and cuvettes. 59. The analyzer of any of claims 33-58, wherein the analytical control system comprises a temperature control system for monitoring and/or controlling the temperature within the analyzer. 60. The analytical device of claim 59, wherein the temperature control system comprises a set of heating and/or cooling units for heating and/or cooling the analytical device within a predefined operating temperature range. 61. The analyzer of any of claims 33-60, wherein the analysis control system includes a master control system for controlling the analysis control system and automating the analysis process. 62. The analyzer of Claim 61, wherein the main control system is configured to provide feedback that a vacuum cover is closed. 63. The analytical device of any of claims 33-62, further comprising a connection interface for coupling to another analytical device. 64. The set of claims 33 to 63, further comprising a set of reading devices, said reading device reading the set of identification labels disposed on the dispensing device, thereby retrieving the set of identification data encoded in the identification labels. Analytical device according to any one of the above. 65. The analysis device of Claim 64, wherein the analysis device is configured to receive reference identification data for comparison with a set of identification data. 66. The analyzer of claim 65, wherein the comparison allows verification of the dispensing device and/or reagents. A method of analyzing a biological fluid, comprising:
deploying an analyzer comprising a vacuum chamber, a vacuum cover and a vacuum device;
mounting a dispensing device in the vacuum chamber, the dispensing device having a set of cuvettes and a set of biological fluid samples, the cuvettes having a set of reagents;
sealing the analyzer in the vacuum chamber with a vacuum cover;
activating the vacuum device to apply a vacuum pressure to the vacuum chamber to dispense the sample of the biological fluid into the cuvette and react the sample of the biological fluid with the reagents to form the analytical sample;
activating a set of analysis control systems to control the vacuum device to perform an analysis process, wherein the analysis process applies vacuum pressure to dispense a sample of the biological fluid and to disperse the analysis sample in the cuvette; A method of analyzing a biological fluid comprising the step of analyzing. 68. The method of claim 67, wherein the analyzing step comprises actuating a vacuum actuator by applying vacuum pressure. 69. The method of claim 68, wherein the analyzing step comprises actuating a vacuum actuator to move a piston assembly of an analytical device to thereby dispense a sample of the biological fluid. 70. Any of claims 67-69, wherein the analysis control system includes an electromagnetic mixing system, and wherein the analyzing step includes using the electromagnetic mixing system to mix a sample of biological fluid with reagents in a cuvette. the method of. 71. The method of any of claims 67-70, wherein the analysis control system comprises an optical measurement system and analyzing comprises performing spectroscopy on the analysis sample using the optical measurement system. 72. The method of claim 71, wherein the analyzing step comprises using an optical measurement system to perform a calibration step to compensate for optical attenuation caused by the cuvette and optical elements of the optical measurement system. 73. Any one of claims 67 to 72, wherein the analysis control system comprises a temperature control system and the analysis step comprises monitoring and/or controlling the temperature within the analysis device using the temperature control system. Method. 74. The method of any of claims 67-73, wherein the analysis control system comprises a master control system for controlling the analysis control system and automating the analysis process. the analysis apparatus includes a set of reading devices; and
using a reading device to read a set of identification labels located on the dispensing apparatus;
75. A method according to any of claims 67-74, comprising obtaining a set of identification data encoded in an identification label. 76. The method of claim 75, further comprising receiving reference identification data from a pre-established database. 77. The method of claim 76, further comprising comparing the set of identification data to reference identification data for validation of dispensing devices and/or reagents. An analysis system for analyzing biological fluids, comprising:
a base station;
a plurality of inspection stations communicatively connected to the base station and each comprising an analysis device;
The analyzer is
a vacuum chamber removably housing a dispensing device containing a set of cuvettes and a set of biological fluid samples, the cuvettes containing a set of reagents;
a vacuum cover that seals the dispensing device within the vacuum chamber;
a set of analytical control systems for performing analytical steps;
The analytical system further comprises a set of vacuum devices for applying vacuum pressure within the vacuum chamber of the laboratory, the vacuum pressure dispensing the sample of biological fluid into the cuvette, the sample of biological fluid reacting with the reagent to forming an analytical sample,
each analysis step includes applying a vacuum pressure to dispense a sample of the biological fluid and analyzing the analysis sample in the cuvette;
The analysis system, wherein the base station is configured to control an inspection station to perform the analysis process. 79. The analysis system of Claim 78, wherein the base station is integrated with one of the inspection stations. 80. Claim 78 or claim 79, wherein the analysis equipment of each laboratory includes one of the respective vacuum devices, each vacuum device being configured to apply a vacuum pressure within the vacuum chamber of the respective laboratory. analysis system. Claim 78 or, comprising a common vacuum device fluidly connected to the vacuum chambers of all inspection stations, the common vacuum device being configured to apply vacuum pressure to all the vacuum chambers. Analysis system according to 79. 82. The analysis system of any of claims 78-81, wherein the inspection stations are arranged in series and physically connected to the base station. 83. The analysis system of Claim 82, wherein the base station and inspection station are integrally connected to each other in a monolithic arrangement. For each inspection station, the base station:
sending a respective set of instructions to the inspection station to perform a respective analytical step;
and/or Analytical system according to any one of claims 78 to 83, adapted to send a common set of commands to all laboratories in order to carry out the analytical steps simultaneously. 81. The analytical system of Claim 80, wherein the vacuum pressures applied to each vacuum chamber are substantially equal to each other. 81. The analytical system of Claim 80, wherein the vacuum pressures applied to each vacuum chamber are different from each other. 87. The analysis system of any of claims 78-86, wherein the base station comprises a communication device for transmitting instructions to an inspection station to carry out the analysis process. An identification system for supporting an analytical process performed on a sample of a patient's biological fluid, comprising:
A first identification label permanently disposed on a dispensing device for collecting and dispensing biological fluid for analysis, the first identification label including encoded first identification data associated with the dispensing device. When,
a second identification label permanently located on the dispensing device, the second identification label including encoded second identification data relating to reagents contained in cuvettes of the dispensing device;
a third identification label removably attached to the dispensing device, the third identification label including encoded third identification data for patient access to the analysis results;
the first identification data and/or the second identification data are verifiable against reference identification data for verifying the dispensing device and/or the reagent;
The identification system, wherein the third identification data allows the patient to access the analysis results using the patient's electronic device. 89. The identification system of Claim 88, wherein each identification label comprises a matrix barcode. A computerized method for utilizing analytical results from an analytical process performed on a patient biological fluid sample, comprising:
receiving a request from a patient from a first electronic device to access the online interface and initiate an analysis process, the request from the patient comprising the device identifier of the first electronic device and the biofluid; identification data associated with the dispensing device for collecting the sample;
associating identification data with a device identifier;
receiving, from the second electronic device, a request containing identification data and analysis results from an operator performing an analysis process and accessing an online interface to enter the analysis results;
associating the results of the analysis with identification data;
A computerized method, sending a result message to a first electronic device, the result message indicating that analysis results are available on an online interface accessed by the first electronic device. . 91. The computerized method of Claim 90, further comprising disabling the identification data in response to the first electronic device accessing the analysis results on the online interface. further initiating a predefined identification data waiting period in response to receiving the patient's request;
91. A computerized method according to claim 89 or 90, comprising invalidating the identification data if no analysis results have been received after a predefined waiting period has elapsed. 93. The computerized method of Claim 92, further comprising transmitting a waiting message to the first electronic device in response to initiation of the predefined waiting period. 94. The computerized method of any of claims 90-93, comprising disabling the third identification data if the analysis results are not accessed after a predefined expiration date. 95. The computerized method of any of claims 90-94, further comprising verifying the identification data against reference identification data.

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