Point-of-birth system and instrument, biochemical cartridge, and methods for newborn screening

Abstract

To provide a point-of-birth system for performing newborn screening using single dried blood spot (DBS) specimen analysis, auditory brainstem response and pulse oximetry.SOLUTION: Provided is a point-of-birth system 100 that includes a point-of-birth instrument 105 for receiving and processing a biochemical cartridge for performing newborn screening. A portable smart device 190, such as a smartphone or tablet, is in communication with the point-of-birth instrument 105, and includes a newborn screening (NBS) mobile app 192. In one example, the point-of-birth system 100 supports newborn biological screening only. However, in another example, the point-of-birth system supports both newborn biological screening and newborn physiological screening.SELECTED DRAWING: Figure 59

Description

Cross-reference to related art

[0001] The subject matter of this disclosure is "Point-of-Birth No. 62 / 329,591, entitled "A Novel Electromagnetic Compatibility Test Instrument" and is incorporated herein by reference in its entirety. [Technical field]

[0002] The subject matter of the present disclosure relates generally to the processing of biological materials, and more specifically to the processing of biological materials. -of-birth systems and instruments, biochemistry cartridges, and neonatal screening This relates to a method of [Background technology]

[0003] Newborn screening (NBS) is used to identify genetic disorders that are best treated immediately after birth. It is being used in the United States as a public health measure to screen for phenylketonuria, a metabolic disorder. It was introduced in 2011 and has since expanded globally to include many more treatable conditions. The BS field screens over 30 conditions from a single dried blood spot (DBS) specimen. The introduction of mass spectrometry as a multiplexing technique for analyzing However, typical public health research labs for high-throughput applications Mass spectrometry and other techniques used in laboratories require extensive liquid handling and specialized technology. Furthermore, the traditional paradigm for newborn screening is the DBS method. The DBS specimens were then sent to a public health or reference laboratory for analysis within a few days. This processing time can result in delays in the diagnosis of some deadly diseases. can occur within hours of birth before devastating and often irreversible health effects occur. Some of these disorders require immediate diagnosis and initiation of treatment. Hypertension, galactosemia, medium-chain acyl-CoA dehydrogenase (MCAD) deficiency, hypercalcemia moniasis, congenital hypothyroidism (CH), and congenital adrenal hyperplasia (CAH) include.

[0004] Screening for hearing impairment is done at birth using the auditory brainstem response and is congenital. Pulse oximetry is used to screen for chronic heart failure, but currently biopsy data are not available. There is no point-of-birth newborn test panel available for genomic screening. Summary of the Invention

[0005] The present invention relates to a point-of-birth inspection system, a point-of-birth instrument, and The present invention further relates to a method for newborn screening and Learn how to use point-of-birth newborn screening systems.

[0006] In one aspect of the present invention, a point-of-birth testing system for newborn screening is provided. The point-of-birth testing system includes a fluid sampler for measuring the amount of fluid in the newborn. Point-of-birth equipment for controlling and communication with point-of-birth equipment The combined system provides a user interface for smart point-of-birth instrument operation. a display; and a biochemistry cartridge for receiving the sample fluid to be treated. The biochemistry cartridge is a point-of-bath cartridge for processing sample fluids. The smart display can be inserted into the instrument and can display the processed sample fluid. The results can be communicated.

[0007] The biochemistry cartridge of the point-of-birth testing system of the present invention is portable. Furthermore, the point-of-birth inspection system of the present invention may The point-of-birth system of the present invention may be a smart device. The display may be a handheld smart device. Alternatively, a point-of-sale The bath system's smart display may be a laptop computer. In a further alternative embodiment, the smart display is integrated into a point-of-birth appliance. It is a display that is embedded in the screen.

[0008] In one embodiment, the point-of-birth testing system of the present invention comprises a biological Screening alone may be supported. Alternatively, the present invention may be used as a point of sale. The screening system is used for biological screening of newborns and physiological screening of newborns. In one embodiment of the present invention, the point-of-birth The testing system may include a pulse oximetry mechanism. Point-of-birth testing systems may include hearing screening mechanisms. In a further embodiment of the present invention, the point-of-birth testing system includes a pulse oscillator. Both symmetry and hearing screening mechanisms may be included.

[0009] The point-of-birth testing system of the present invention can support multiplexed testing. Furthermore, the point-of-birth testing system of the present invention uses a single A single sample fluid can be used to test for multiple analytes.

[0010] In one embodiment of the present invention, the point-of-birth inspection system is Chemical tests can be performed. For example, the point-of-birth testing system of the present invention The test includes multiple types of tests, such as enzyme tests, colorimetric tests, immunoassay tests, and / or nucleic acid tests. The point-of-birth testing system of the present invention can perform various types of biochemical tests. In one embodiment of the system, the system is capable of screening for biological markers. For example, the point-of-birth testing system of the present invention can measure total bilirubin, ammonia, and / or screen for biological markers such as medium-chain acyl-CoA dehydrogenase It is possible to lean.

[0011] In one embodiment of the present invention, the smart display of the point-of-birth inspection system The device interfaces with the user and / or operates the point-of-birth instrument. The present application may include a newborn screening mobile application for

[0012] In one embodiment of the biochemistry cartridge of the point-of-birth testing system of the present invention, The biochemistry cartridge may include a horizontal reservoir module for holding a liquid. Additionally, in one embodiment, the horizontal reservoir module may be inclined. For example, The horizontal reservoir module may be inclined by 13 to 17 degrees. In the biochemistry cartridge, the biochemistry cartridge includes an optical interface region. The biochemistry interface area is where the biochemistry cartridge is inserted into the point-of-birth instrument. When this occurs, it can be matched to the optical detector of the point-of-birth instrument.

[0013] In another aspect of the invention, a point-of-bath device for processing a sample fluid is provided. A point-of-birth instrument is disclosed, the point-of-birth instrument comprising a housing and a biochemical sampler having a sample fluid. The loading deck receives the scientific cartridges and the smart device interfaces with the user. A biochemical test model including a display, an input reader, and a processor for a test assay. and smart displays for point-of-birth appliances. can provide results from the test assay, e.g., to a user.

[0014] In one embodiment of the present invention, the housing of the point-of-birth instrument is a base plate. The base plate is attached to the first and second side rails, and the side rails are and a circuit board disposed between the device and the point-of-birth instrument that controls operation of the point-of-birth instrument. In addition, the housing of the point-of-birth device is located between the side rails. A cam, a cartridge engaging stepper motor, a cam belt and pulley assembly, and a motor assembly for actuating the dispensing of sample fluid in the chemistry cartridge. Further, the motor assembly includes a stepper motor on a stepper motor support and a spring-loaded A power adapter, a motor shaft, and a motor engagement member may be included.

[0015] In one embodiment, the housing of the point-of-birth device of the present invention includes a power input port. Additionally, the housing of the point-of-birth device may include a power supply. The power supply assembly may include a power supply assembly disposed on the backplate.

[0016] In one embodiment of the present invention, the smart display of the point-of-birth instrument The point-of-birth device of the present invention may be a smart device or a laptop. The device is a docking station that electronically connects to a smart device or laptop. In another embodiment, the point-of-birth instrument may include a smart device. In yet another embodiment, the point-and-shoot device can communicate wirelessly with a mobile device such as a smartphone, a tablet, or a laptop. To-of-Birth instruments simply connect electronically to a smart device or laptop. have the option to communicate wirelessly with a smart device or laptop instead of Smart displays on point-of-birth instruments can also be used to communicate with users and and / or allow users to communicate results to interested parties, provide tracking information, and monitor instrument usage. provide training on the use of the drug, perform clinical calculations, and / or epidemiological tracking of the disease; The present invention can include a software application that enables

[0017] In one embodiment of the point-of-birth device, the input reader is a barcode reader. In addition, input readers, such as bar code readers, can be used to scan the newborn's identification information. It is possible.

[0018] In one embodiment of the present invention, the point-of-birth instrument is a fluorometer and / or optical Further, the point-of-birth instrument of the present invention may include an optical detector. The point-of-birth device may include a pulse oximetry module and and / or a hearing screening module. In one embodiment of the B-Bath device, the device may be portable.

[0019] In one aspect of the present invention, a biochemistry cartridge for newborn screening is disclosed. The biochemical cartridge of the present invention comprises a bottom substrate and an upper substrate spaced apart from the bottom substrate by a gap. A substrate, a cover disposed adjacent to the upper substrate, and a loading port and a loading die. a sample input well having a well cap assembly for opening and closing the port; The sample input well is for collecting neonatal test fluid. Further, the biochemistry cartridge may be inserted into a newborn screening instrument for testing. This may be done.

[0020] In one embodiment of the biochemical cartridge of the present invention, the sample input well is integrated into the cover. The cover of the biochemistry cartridge may include a relief area. In one embodiment of the disclosed biochemistry cartridge, the gap between the upper and lower substrates is It may also be an Ichamba.

[0021] In one embodiment of the biochemical cartridge of the present invention, the sample input well is a horizontal reservoir. The biochemistry cartridge may further include a cover gasket and a horizontal rib. The reservoir module mounting plate and mounting posts for fixing the horizontal reservoir module In one embodiment of the invention, the well cap assembly further comprises: The horizontal reservoir module may include a foil strip for sealing the fluid inside. Additionally, the biochemistry cartridge can be unwound from the horizontal reservoir module using a foil strip. a take-up reel for winding the film; and a reel engagement feature secured to the upper substrate; and / or or a reservoir module capture feature.

[0022] In one embodiment of the biochemical cartridge of the present invention, the horizontal reservoir module includes a first sample. a first reservoir for holding a pull fluid and a second reservoir for holding a second sample fluid. In one embodiment of the biochemistry cartridge of the present invention, the reservoir includes For example, the reservoir may be angled at 13 to 17 degrees.

[0023] In one embodiment of the biochemistry cartridge of the present invention, the cartridge is a digital microfluidic Alternatively, the biochemistry cartridge of the present invention supports digital microfluidics. In one embodiment of the biochemistry cartridge of the present invention, the newborn test The fluid may be urine and / or blood. In an embodiment, the bottom substrate may include a printed circuit board. In one embodiment of the cartridge, the gap between the bottom substrate and the top substrate contains a filler fluid. can be done.

[0024] In yet another alternative aspect of the present invention, a method for newborn screening is disclosed. In one embodiment, a method for newborn screening includes: (1) treating a sample fluid; (2) a point-of-birth device and an in-line (3) a smart display to interface with the device and a touch screen to receive sample fluid for processing. A point-of-birth testing system having a biochemistry cartridge and a reservoir for Further, the method for newborn screening includes providing a testing system. providing identification information to the system; and dispensing sample fluid into a reservoir of the biochemistry cartridge. Loading and sealing the reservoir of the biochemical cartridge after loading with sample fluid and loading the biochemistry cartridge into the point-of-birth instrument. and a step of discharging the sample fluid into an assay in a biochemistry cartridge for processing. and processing the sample fluid by a point-of-birth instrument. A smart display that interfaces with the processed sample fluid results The method may include a step of: determining whether or not a result has been received; and / or a step of communicating the result.

[0025] In one embodiment of the method for newborn screening, the method further comprises: providing a foil strip for sealing the reservoir of the biochemistry cartridge after loading and attaching a foil wrapper to secure a portion of the foil strip onto the biochemistry cartridge. providing a take-up reel; and providing a stepper motor that engages the foil take-up reel. Providing steps for loading biochemistry cartridges into point-of-birth instruments and / or operating the stepper motor after the stepping motor is turned on. After actuation, the sample fluid can be released by unscrewing the foil strip from the reservoir. and

[0026] In one embodiment of the method for newborn screening, a reservoir of biochemical cartridges is The reservoir may include a first reservoir and a second reservoir. Further, the method may include After the reservoir is loaded with the first sample fluid and the second sample fluid, A stamper providing a foil strip for sealing the first and second reservoirs of the cartridge. The foil strip is secured to the foil take-up ribbon, which secures a portion of the foil strip onto the biochemistry cartridge. providing a stepper motor that engages the foil take-up reel. Steps and after loading the biochemistry cartridge into the point-of-birth instrument activating a stepper motor; and the stepper motor is activated to move the first sample fluid. and then removing the foil strip from the first reservoir. and / or the first reservoir is opened to allow the second sample fluid to be introduced into the second reservoir. unsealing the foil strip from the second reservoir after allowing the foil strip to be releasable to the second reservoir; may include.

[0027] Another aspect of the present invention is the use of a point-of-birth newborn screening system. In one embodiment, a method for administering a point-of-birth neonatal scaffold to a patient is disclosed. Methods for using the Leaning System for point-of-birth neonatal screening providing a smart display having a display software application; This smart display includes a point-of-sale (POB) for handling sample fluids. and a biochemistry cartridge for receiving the sample fluid for processing. The point-of-birth inspection system of the present invention can communicate with the point-of-birth inspection system. Methods for using a first-of-birth newborn screening system Steps to log in to Spray's software application and open orders and interfacing the smart display with the selection of the biochemistry cartridge. scanning a sample fluid identifier on the cartridge; and inserting the biochemistry cartridge into a point-of-birth testing device; interfacing with the smart display to initialize processing of the Steps for confirming a suitable fluid sample for processing on a point-of-care cartridge; and processing the sample fluid by a BB-Bass testing instrument; and a smart display. and / or monitoring the sample fluid to determine the status of the processing of the sample fluid. and viewing test results of the sample fluid.

[0028] One Implementation of a Method for Using a Point-of-Birth Newborn Screening System In this form, the step of logging in to the smart display is to enter a user ID and password. By manually entering the credentials and / or using a barcode reader This can be done by scanning the information. In one embodiment of a method for using an infant screening system, a sample fluid identifier may be a bar code reader.

[0029] One Implementation of a Method for Using a Point-of-Birth Newborn Screening System In an embodiment, the method further comprises inputting sample fluid identification information to display a smart display. creating an open order in the software application. In addition, the use of point-of-birth newborn screening systems The method includes the steps of collecting a sample fluid from the neonate using a biochemistry cartridge. In one embodiment of the method of the present invention, a biochemistry cartridge is used to detect nascent The step of collecting a sample fluid from the infant includes identifying a sample fluid identifier on a biochemistry cartridge. After the step of scanning the sample, a biochemical cartridge containing the sample fluid is This may be performed prior to the step of inserting the device into a point-of-birth testing device. The step of collecting sample fluid from the neonate in the method of the invention comprises: removing a cover of the well and inserting a quantity of sample fluid; and sealing the input well.

[0030] One Implementation of a Method for Using a Point-of-Birth Newborn Screening System In some embodiments, the method may further include distributing the test results. One embodiment of a method for using an in-of-birth newborn screening system The method includes interfacing a software application with a smart display. The step of reviewing previously performed tests can include searching the test results to review the results of previously performed tests.

[0031] Having described the subject matter of this disclosure in general terms, reference will now be made to the accompanying drawings, which are not necessarily to scale. Refer to the surface. [Brief description of the drawings]

[0032] [Figure 1] FIG. 1 is a block diagram of an example point-of-birth platform supporting both newborn biological screening and newborn physiological screening in accordance with the present invention. [Figure 2A]FIG. 1 is a perspective exploded view of an example of the disclosed point-of-birth system and instrumentation, and biochemistry cartridge, for newborn screening. [Figure 2B] FIG. 1 is a perspective exploded view of an example of the disclosed point-of-birth system and instrumentation, and biochemistry cartridge, for newborn screening. [Figure 3A] FIG. 2B is a front view of the point-of-birth appliance shown in FIG. [Figure 3B] FIG. 2B is a rear view of the point-of-birth appliance shown in FIG. [Figure 3C] Figure 2A is a top view of the point-of-birth instrument. [Figure 3D] Figure 2A is a bottom view of the point-of-birth appliance. [Figure 3E] FIG. 2B is a left side view of the point-of-birth appliance shown in FIG. [Figure 3F] FIG. 2B is a right side view of the point-of-birth appliance shown in FIG. [Figure 4] FIG. 2C is an illustration of the point-of-birth device of FIGS. 2A and 2B with the housing removed to reveal more detail of its components. [Diagram 5] FIG. 2C is an illustration of the point-of-birth device of FIGS. 2A and 2B with the housing removed to reveal more detail of its components. [Figure 6] FIG. 2C is an illustration of the point-of-birth device of FIGS. 2A and 2B with the housing removed to reveal more detail of its components. [Figure 7] FIG. 2C is an illustration of the point-of-birth device of FIGS. 2A and 2B with the housing removed to reveal more detail of its components. [Figure 8A] FIG. 13 is a perspective view of another example of the disclosed point-of-birth system and instrumentation, and biochemistry cartridge, for newborn screening. [Figure 8B]FIG. 13 is an exploded view of another example of the disclosed point-of-birth system and instrumentation, and biochemistry cartridge, for newborn screening. [Figure 9A] FIG. 13 is a perspective view of yet another example of the disclosed point-of-birth system and instrumentation and biochemistry cartridge for newborn screening. [Figure 9B] FIG. 13 is an exploded view of yet another example of the disclosed point-of-birth system and instrumentation, and biochemistry cartridge, for newborn screening. [Figure 10A] FIG. 13 is a perspective view of yet another example of the disclosed point-of-birth system and instrumentation and biochemistry cartridge for newborn screening. [Figure 10B] FIG. 13 is an exploded view of yet another example of the disclosed point-of-birth system and instrumentation, and biochemistry cartridge, for newborn screening. [Figure 11] FIG. 1 is a front perspective view of an example of a biochemistry cartridge of the present disclosure including digital fluidics capabilities for newborn screening. [Figure 12] FIG. 1 is a rear perspective view of an example of a biochemistry cartridge of the present disclosure including digital fluidics capabilities for newborn screening. [Figure 13] FIG. 13 is a side view of the biochemistry cartridge shown in FIGS. 11 and 12. [Figure 14] FIG. 13 is a rear view of the biochemistry cartridge shown in FIGS. 11 and 12. [Figure 15] FIG. 13 is a top view of the biochemistry cartridge shown in FIGS. 11 and 12. [Figure 16] FIG. 13 is a bottom view of the biochemistry cartridge shown in FIGS. 11 and 12. [Figure 17] 13A-13C are various diagrams showing further details of the biochemistry cartridge shown in FIGS. 11 and 12 with the cover removed to reveal more detail; [Figure 18]13A-13C are various views showing further details of the biochemistry cartridge shown in FIGS. 11 and 12 with the cover removed to reveal more detail; [Figure 19] 13A-13C are various views showing further details of the biochemistry cartridge shown in FIGS. 11 and 12 with the cover removed to reveal more detail; [Figure 20] 13A-13C are various views showing further details of the biochemistry cartridge shown in FIGS. 11 and 12 with the cover removed to reveal more detail; [Figure 21] FIG. 13 is a perspective view of the underside of the cover of the biochemistry cartridge shown in FIGS. 11 and 12. [Figure 22A] FIG. 13 is a perspective view of the underside of the biochemistry cartridge shown in FIGS. 11 and 12, without the cover. [Figure 22B] FIG. 13 is a perspective view of the underside of the biochemistry cartridge shown in FIGS. 11 and 12, further without the bottom substrate. [Figure 23A] FIG. 13 is a perspective view of the top substrate relative to the bottom substrate of the biochemistry cartridge shown in FIGS. 11 and 12. [Figure 23B] FIG. 13 is a perspective view of only the bottom substrate of the biochemistry cartridge shown in FIGS. 11 and 12. [Figure 24A] FIG. 13 is an exploded view of the motor of the point-of-birth instrument associated with the biochemistry cartridge shown in Figures 11 and 12. [Figure 24B] FIG. 13 is a perspective view of the motor of the point-of-birth instrument associated with the biochemistry cartridge shown in FIGS. 11 and 12. [Diagram 25] FIG. 13 is a perspective view of an alternative configuration of the motor of the point-of-birth instrument relative to the biochemistry cartridge. [Figure 26] FIG. 1 is a perspective view of an example of a biochemistry cartridge of the present disclosure lacking digital fluidics capabilities for newborn screening. [Figure 27] FIG. 13 is a perspective view of another example of a biochemistry cartridge of the present disclosure lacking digital fluidics capabilities for newborn screening. [Figure 28] FIG. 13 is a top view of another example of a biochemistry cartridge of the present disclosure, lacking digital fluidics capabilities, for newborn screening. [Figure 29A] FIG. 13 is a perspective view of an example of a top and bottom substrate of a biochemistry cartridge that does not support digital fluidics. [Figure 29B] FIG. 13 is a perspective view of only the bottom substrate of the biochemistry cartridge, without supporting the digital fluidics. [Figure 30A] 13 is a perspective view of another example of a cover assembly that can be used with the biochemistry cartridge of the present disclosure for newborn screening. FIG. [Figure 30B] 13 is a perspective view of another example of a cover assembly that can be used with the biochemistry cartridge of the present disclosure for newborn screening. FIG. [Figure 31A] 13 is a perspective view of another example of a cover assembly that can be used with the biochemistry cartridge of the present disclosure for newborn screening. FIG. [Figure 31B] 13 is a perspective view of another example of a cover assembly that can be used with the biochemistry cartridge of the present disclosure for newborn screening. FIG. [Figure 32A] 13 is a perspective view of another example of a cover assembly that can be used with the biochemistry cartridge of the present disclosure for newborn screening. FIG. [Figure 32B] 13 is a perspective view of another example of a cover assembly that can be used with the biochemistry cartridge of the present disclosure for newborn screening. FIG. [Figure 33A] 1A-1D are various illustrations of an example horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Figure 33B] 1A-1D are various illustrations of an example horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Figure 34A] FIG. 1 is a front perspective view of the horizontal reservoir module showing the front sealing surface of the horizontal reservoir module. [Figure 34B]FIG. 13 is a cross-sectional view of a horizontal reservoir module showing the dispensing angle of the horizontal reservoir module. [Figure 35A] FIG. 13 is an explanatory diagram showing an example of a process for deploying a horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Figure 35B] FIG. 13 is an explanatory diagram showing an example of a process for deploying a horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Figure 35C] FIG. 13 is an explanatory diagram showing an example of a process for deploying a horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Figure 35D] FIG. 13 is an explanatory diagram showing an example of a process for deploying a horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Figure 35E] FIG. 13 is an explanatory diagram showing an example of a process for deploying a horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Fig. 35F] FIG. 13 is an explanatory diagram showing an example of a process for deploying a horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Figure 35G] FIG. 13 is an explanatory diagram showing an example of a process for deploying a horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Fig. 35H] FIG. 13 is an explanatory diagram showing an example of a process for deploying a horizontal reservoir module of the biochemistry cartridge of the present disclosure for newborn screening. [Diagram 36] FIG. 3 is an explanatory diagram showing an example of a functional block diagram of the point-of-birth device of FIG. 2A and FIG. 2B. [Figure 37] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Figure 38]FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Figure 39] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Diagram 40] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Diagram 41] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Diagram 42] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Diagram 43] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Diagram 44] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Diagram 45] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Figure 46] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrument, as well as a biochemistry cartridge, for newborn screening. [Figure 47] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrumentation, as well as a biochemistry cartridge, for newborn screening. [Figure 48] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrumentation, as well as a biochemistry cartridge, for newborn screening. [Figure 49] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrumentation, as well as a biochemistry cartridge, for newborn screening. [Figure 50] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrumentation, as well as a biochemistry cartridge, for newborn screening. [Figure 51] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrumentation, as well as a biochemistry cartridge, for newborn screening. [Figure 52] FIG. 1 is an explanatory diagram showing an example of a graphical user interface (GUI) of the disclosed point-of-birth system and instrumentation, as well as a biochemistry cartridge, for newborn screening. [Diagram 53] FIG. 1 is a front view of an example of a point-of-birth instrument including an integrated display. [Figure 54] FIG. 1 is a flow diagram of an example of a method of using the disclosed point-of-birth system and instrumentation, and biochemistry cartridge, for newborn screening. [Figure 55] FIG. 1 is an illustrative diagram showing an example of a point-of-birth system of the present disclosure including a laptop computer. [Figure 56] FIG. 1 is an illustration showing an example of a point-of-birth system of the present disclosure supporting physiological screening in combination with biochemical screening. [Figure 57] FIG. 1 is an illustration showing an example of a point-of-birth system of the present disclosure supporting physiological screening in combination with biochemical screening. [Figure 58] FIG. 1 is an illustration showing an example of a point-of-birth system of the present disclosure supporting physiological screening in combination with biochemical screening. [Figure 59] FIG. 1 is an illustration showing an example of a point-of-birth system of the present disclosure supporting physiological screening in combination with biochemical screening. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] The subject matter of this disclosure is illustrated in the accompanying drawings, in which some, but not all, embodiments of the invention are shown. These and other features are described in more detail below with reference to the accompanying drawings, in which like numbers refer to like elements throughout. The subject matter of the present disclosure may be embodied in many different forms and may be, for example, The present invention should not be construed as being limited to the embodiments of the present invention; rather, these embodiments are This disclosure is provided to satisfy applicable legal requirements. Indeed, the disclosure described herein Many modifications and other embodiments of the subject matter set forth in the foregoing description and the associated drawings. Such changes will occur to those skilled in the art to which the subject matter of this disclosure pertains having the benefit of the teachings. Therefore, it is to be understood that the subject matter of this disclosure is not limited to the particular embodiments disclosed, but rather that modifications and variations may be made thereto. It is understood that other embodiments are intended to be within the scope of the following claims. I want to be understood.

[0034] In some embodiments, the presently disclosed subject matter includes point-of-birth systems and devices. The present invention provides a device, a biochemistry cartridge, and a method for newborn screening, A point of sale for receiving and processing biochemistry cartridges for newborn screening. A point-of-birth system is provided that includes a point-of-birth device. Smart displays such as mobile smart devices (i.e., smartphones or tablets) Ray communicates with point-of-birth fixtures and the smart display The newborn screen is a user interface for operating the birth-of-birth system. It also includes a mobile app for point-of-birth screening. A method of using the stem is provided.

[0035] In one embodiment, a point-of-birth system and a point-of-birth appliance supports only biological screening of newborns. However, in other embodiments Point-of-birth systems and point-of-birth devices are used to Clinical and neonatal physiological screening (e.g., neonatal pulse oximetry) Supports both symmetrical and neonatal hearing screening.

[0036] The present disclosure relates to a point-of-birth system and an instrument, a biochemistry cartridge, and a novel One aspect of the live birth screening method is highly portable and easy to use.

[0037] The present disclosure relates to a point-of-birth system and an instrument, a biochemistry cartridge, and a novel In another aspect of the method for live birth screening, the liquid delivery system of the biochemistry cartridge The system is fitted with a tilted or angled water dispenser for reliable dispensing of liquids by gravity. It features a flat reservoir module (HRM).

[0038] Next, FIG. 1 shows the biological screening of newborns and the physiological screening of newborns according to the present invention. One example of a point-of-birth platform that supports both screening and For example, the point-of-birth platform 10 is a block diagram of Both the screen 20 and the physiological screen 30 are supported.

[0039] The biological screen 20 may utilize multiplexed tests 22. In a screening program, multiplexing studies22 refer to the ability to simultaneously discriminate between multiple compounds. In the point-of-birth platform, biological screening is Exemplary biological markers include screening for high Total bilirubin (TSB), glucose-6-phosphate dehydrogenase (G-PDE) for detecting bilirubinemia Glycogenase deficiency (G6PD), ammonia to detect hyperammonemia, GAL Galactose-1-phosphate uridyltransferase (GAL) for detecting T deficiency T), and medium-chain acyl-CoA dehydrogenase (MCD) to detect MCAD deficiency. AD), but are not limited to these.

[0040] Physiological screening30 includes neonatal pulse oximetry32 and neonatal hearing screening. These may include, but are not limited to, neonatal pulse oximetry. The Ri-32 test is an accepted test that improves the detection of severe congenital heart disease (CCHD). Early Hearing Screening 34 (Early Detection and Treatment of Hearing Impairments) Also known as Examination Detection and Intervention (EHDI) (2014) recommends screening all newborns for hearing loss before discharge from the hospital. For example, auditory brainstem response (ABR) and otoacoustic emission (OAE) tests are are appropriate physiological measures for screening the live birth population. ABR testing provides information about the inner ear (cochlea) and the brain pathways for hearing. The AE test detects blockage of the ear canal, the presence of middle ear fluid, and damage to the outer hair cells of the cochlea. This can be done.

[0041] The Point-of-Birth Platform 10 (1) processes small amounts of blood samples; (2) the ability to have two samples on the same cartridge and platform; (3) the ability to test for different types of biochemical samples on one platform; Ability to perform tests (enzymatic, colorimetric, immunoassay, and nucleic acid tests); and (4) provide the ability to perform more complete disease or disease risk characterization of newborns prior to discharge from the hospital. Point-of-birth platforms offer advantages over laboratory-based techniques. Room 10 also features neonatal-related testing with an assay menu focused on neonatal diseases. Therefore, traditional point-of-care biochemistry assay platforms are focused solely on It is distinguished from a team.

[0042] Point-of-birth Platform 10 is a point-of-birth system, For point-of-birth instruments, biochemistry cartridges, and newborn screening The point-of-birth platform 10 can be exemplified through the following methods: , not only in the United States but also in developing countries where the infrastructure for such testing does not exist. Potential to revolutionize newborn screening. Little user training required. Additionally, point-of-birth devices can be installed via remote guidance within an hour. An exemplary point-of-birth system, Further details of the instrument, biochemistry cartridge, and method of newborn screening are shown in Figure 1. 2A to 59 as shown and described below.

[0043] Next, FIG. 2A and FIG. 2B show the point-of-view of the present disclosure for newborn screening. The point-of-birth system 100, the point-of-birth instrument 105, and the biochemistry cartridge 1 is a perspective exploded view of an example of a point-of-birth system 200. The point-of-birth platform is based on the structure shown in .

[0044] That is, the point-of-birth system 100 is a portable smart device 190. A point-of-sale device that can be mechanically and communicatively coupled to such a smart display. The smart device 190 includes a point-of-birth appliance 105. 05 may be a user interface and network connection device. The device 190 may be, for example, a smartphone or a tablet device. The point-of-birth system 100 further includes a biochemistry cartridge 200 . The biochemistry cartridge 200 receives the sample fluid to be treated, which is taken from the neonatal subject. The biochemistry cartridge 200 is a disposable cartridge for collecting biochemical samples. A biochemistry cartridge 200 that can be plugged into the point-of-birth instrument 105 More details of this example are shown and described below with reference to Figures 11-35H.

[0045] The point-of-birth device 105 includes a housing (or body) 110 and a biochemical A cartridge loading deck 112 for receiving a cartridge 200 and a smart cartridge 202 for storing a smart cartridge. a docking station 114 for receiving a remote device 190 and an operator ID Point-of-birth system information, cartridge ID information, and sample ID information and an input such as a barcode reader 116 for scanning any information related to the system 100. In one example, the smart device 190 includes a point-of-birth device. A docking station is provided for electrically connecting (e.g., for power and communication) to the device 105. However, in another example, The smart device 190 may be separate from the point-of-birth appliance 105. It is possible to wirelessly communicate with the point-of-birth device 105 without any electrical connection. In addition, newborn screening (NBS) mobile apps192 are available at point-of-care A device that can be present on the smart device 190 to operate the birth system 100. Cut.

[0046] The point-of-birth system 100 may, for example, be used to: (1) deliver a single baby or multiple babies; (2) biochemical assays (enzymatic, colorimetric, and immunoassays) (3) conduct hearing screening (using auditory brainstem response or otoacoustic emissions); (4) perform a pulse oximetry test (see Figures 56 and 57). 58 and 59) can be used to Again, the test menu includes total bilirubin (TSB), glucose-6-riboflavin (GlcNAc), and erythrocyte sedimentation (ECS). Glycoprotein dehydrogenase deficiency (G6PD), hyperammonemia, galactosemia, and other These may include, but are not limited to, newborn screening for disorders.

[0047] The point-of-birth device 105 is a lightweight and portable device. The housing (or body) 110 of the bath device 105 may include, but is not limited to, Lightweight, sturdy, and durable, such as molded plastic and metal (e.g., aluminum) The point-of-birth device 105 may be made of any suitable material. Width: about 7 inches (17.78 cm) to about 9 inches (22.86 cm), (17.78cm) to about 10 inches (25.4cm) tall, and about 10 inches (25 The depth can range from 0.4 cm (0.4 inches) to about 12 inches (30.48 cm). The Ob-Birth fixture 105 is approximately 8 inches (20.32 cm) wide and 9 inches (2 2.86 cm) and approximately 11 inches (27.94 cm) deep. However, Any variation in characteristics is possible. For example, FIG. 2A shows a 2B shows an example of a point-of-birth device 105 that is An example of a point-of-birth device 105 having a physical form is shown. In addition to this example, 3A to 3F are front views of the point-of-birth device 105 shown in FIG. , rear view, top view, bottom view, left side view, and right side view are shown.

[0048] The point-of-birth instrument 105 may be electrically or battery powered. Again, the point-of-birth device 105 can be operated by a smart A smart device such as a smart phone or tablet device (e.g., smart device 190) It has the ability to interface with displays and can perform biochemical tests, pulse oximetry and hearing tests. The NBS Mobile App 19 can have a module for HIV screening. 2 can be used, for example, to email results to interested parties and provide a list of follow-up physicians. provide training, perform clinical calculations such as nomograms for bilirubin measurement, and In addition, it is possible to carry out epidemiological tracking of patients. 5 is a fluorescent light for one or two sets of wavelengths, and a UV light for about 400 nm to about 800 nm. ) absorbance over a range of .

[0049] The biochemistry cartridge 200 can be used with any physiological fluid, including urine and whole blood samples. For biochemical testing, two major processing steps are required: (1) sample preparation and (2) loading a sample into the biochemistry cartridge 200; and loading the point-of-birth device 105 with the 00. The to-be-born instrument 105 is used to manage the operation of the instrument, i.e., to perform the assay. A processor or controller for: The time from sample input to result output can be approximately 15 minutes. 05 preferably includes all the software necessary to perform each type of test. The Point of Birth Instrument 105 is also robust and requires no maintenance. It is preferable that the point-of-birth device 105 is designed to be More details are shown and described below with reference to FIGS. 4, 5, 6 and 7.

[0050] Next, FIG. 4, FIG. 5, FIG. 6, and FIG. 7 show the housing (or body) 110 being eliminated. The points in Figures 2A and 2B reveal more details of the components. 1 is a schematic diagram of a point-of-birth appliance 105. 5 includes a barcode reader 116 and two sensors mounted on a base plate 122. A side rail 120, a main circuit board 124 disposed between the two side rails 120, and and a lower circuit board 126 and a power input port 128 disposed on a power mounting plate 132. and a power supply assembly 130, a cartridge deck plate 134, and a fluorometer mounting One or more fluorometers 136 on a board 138, a spectrometer 140, and two side rails 120 A cam 142 disposed between the cartridge engaging stepper motor 144 and a cam belt and and pulley assembly 146, and a stepper motor 150 on a stepper motor support 152. , a spring-loaded adapter 154, a motor shaft 156, and a motor engagement member 158. nothing.

[0051] The barcode reader 116 can be any standard barcode technology. During the inspection of the in-of-birth instrument 105, a barcode reader 116 is used Obtain information such as operator ID information, cartridge ID information, and sample ID information do.

[0052] Side rail 120, base plate 122, and cartridge deck plate 13 4 can be any strong rigid member such as a plastic or metal member.

[0053] The main circuit board 124 and the lower circuit board 126 are It contains electronics for controlling the overall operation. The main circuit board 124 and the lower circuit board 1 For examples of functionality that may be implemented on 26, see FIG.

[0054] The point-of-birth instrument 105 can be electrically or battery powered. In one example, the point-of-birth instrument 105 is battery powered (battery not shown). and therefore does not use the power input port 128. The tool 105 is powered using a DC adapter. In this case, the power input port 128 is Accepts a C adapter plug. You can use either battery power or a DC adapter. Therefore, a DC power source is required to power the active components of the point-of-birth instrument 105. In yet another example, a power supply assembly 130 is provided that regulates the DC input in response to the The to-of-birth fixture 105 is powered using standard household AC voltage. In this case, the power input port 128 receives an AC plug and the power supply assembly 130 receives an additional AC The NI 8111 performs a DC to DC conversion function.

[0055] As is well known, a fluorometer is a device for measuring the intensity of fluorescence, and is used to measure the intensity of biochemical As is well known, optical spectrometers measure the characteristics of the electromagnetic spectrum. It is used to measure the properties of light over a certain area and is used in spectroscopy to identify materials. Therefore, the fluorometer 136 and the spectrometer 140 are instruments commonly used in the The optical detection in the first-of-birth instrument 105 is used.

[0056] In the point-of-birth instrument 105, a biochemistry cartridge 200 is inserted into the cartridge locomotive. When inserted into the loading deck 112, the bottom substrate 210 of the biochemistry cartridge 200 The edge is engaged with a cam 142. The cartridge engagement stepper motor 144 is then used cam 142 is rotated to pull biochemistry cartridge 200 into a fixed position. The cartridge engagement stepper motor 144 may be, for example, an Oriental Mot or PKP available from USACorp, Charlotte, North Carolina It can be one of the series 2-phase single axis stepper motors (1.8°). Cart A ridge-engaging stepper motor 144 drives the cam belt and pulley assembly 146 It is rotatably connected to the cam 142 .

[0057] The stepper motor 150 drives the biochemical cartridge 200 (see Figures 24A and 24B). and is used to actuate the liquid dispensing mechanism within the biochemistry cartridge 200. The stepper motor 150 may also be, for example, manufactured by Oriental Motor USA C. orp.'s PKP series two-phase single-axis stepper motor (1.8°) good

[0058] The preceding components are not a complete list of components as a whole, but are a few points of interest. A sampling of the main components of the Bath Instrument 105. Point of Bath Instrument 1 For more details on the functions that can be supported by the 05 components, see below with reference to FIG. 36. are shown and explained in.

[0059] Next, FIG. 8A and FIG. 8B respectively show the points of the present disclosure for newborn screening. FIG. 1 is a perspective view of another example of a graft-of-birth system and device, and a biochemistry cartridge; In this example, the point-of-birth system 100 includes a point-of-birth The bath instrument 305, the smart device 190, and the biochemistry cartridge 200 The point-of-birth device 305 includes a housing (or body) 310 and a biocompatible a cartridge loading deck 312 for receiving the optical cartridge 200; and a docking station 314 for receiving the smart device 190. The point-of-birth device 305 is the point-of-birth device shown in FIG. 2A or FIG. 2B. As compared to tool 105, it may have slightly different dimensions, functions, and aesthetic features.

[0060] Next, FIG. 9A and FIG. 9B each show the points of the present disclosure for newborn screening. FIG. 1 is a perspective view of yet another example of a to-be-born system and device, and a biochemistry cartridge. In this example, the point-of-birth system 100 includes a point of-birth instruments 405, smart devices 190, and biochemistry cartridges 200 The point-of-birth device 405 includes a housing (or body) 410, a biocompatible material, and a cartridge loading deck 412 for receiving the optical cartridge 200; and a docking station 414 for receiving the smart device 190. The point-of-birth device 405 is the point-of-birth device shown in FIG. 2A or FIG. 2B. It has slightly different dimensions, functions, and aesthetic features compared to tool 105.

[0061] Next, FIG. 10A and FIG. 10B respectively show a po-

[0023] Fig. 1 shows yet another example of an in-of-birth system and device, and a biochemistry cartridge. In this example, the point-of-birth system 100 is 505 in-the-bath instruments, 190 smart devices, and 2 biochemistry cartridges 00. The point-of-birth device 505 includes a housing (or body) 510, a cartridge loading deck 512 for receiving a biochemistry cartridge 200; , and a docking station 514 for receiving the smart device 190. The point-of-birth instrument 505 is a point-of-birth instrument shown in FIG. 2A or FIG. 2B. The device has slightly different dimensions, functions, and aesthetic features compared to the device 105.

[0062] Next, FIG. 11 and FIG. 12 respectively show the biochemical card of the present disclosure for newborn screening. 2A and 2B are front and rear perspective views of an example of a biochemistry cartridge 200. includes digital fluidics capabilities. Further, Figs. 13, 14, 15, and 16 11 and 12 are side, rear, top and bottom views of the biochemical cartridge 200. 1A and 1B show a top view and a bottom view, respectively.

[0063] The terms "front," "back," "top," "bottom," "over," "under," and " "On" refers to the relative positions of components of the biochemistry cartridge 200, e.g., the biochemistry The relative position of the top and bottom or front and rear substrates of the cartridge 200 The term "position" is used throughout this specification in reference to the biochemistry cartridge 200. It will be appreciated that the present invention will function regardless of its orientation in relation to the optical axis.

[0064] In this example, the biochemistry cartridge 200 includes a bottom plate separated by a gap (not shown). A substrate 210 (e.g., a printed circuit board (PCB)) and a top substrate 212 (e.g., a The gap may include, but is not limited to, silicone oil. or a low viscosity oil such as hexadecane filler fluid. During a newborn screening procedure, a chemical reaction or assay can be performed on the bottom substrate 210 and the top The semiconductor laser 202 may be implemented in a gap between the semiconductor laser 202 and the external substrate 212.

[0065] A cover 214 (eg, a plastic cover) is provided over the upper substrate 212 . The sample input well 216 is integrated into the cover 214. 16 is a loading port 218 and a weld for opening and closing the loading port 218. The cover 214 has a predetermined recessed or undulating area. The recessed or undulated area 222 may also include a recessed or undulated area 222. The layout of the components and / or elements within the device may be adjusted accordingly.

[0066] In relation to the upper substrate 212 of the biochemistry cartridge 200, the optical interface region 22 4 (see FIG. 12). A biochemistry cartridge 200 is provided as a point-of-birth device. When installed in the point-of-birth instrument 105, the optical detection components of the point-of-birth instrument 105 The positions of the two fluorometers 136 and the spectrometer 140 are determined by the optical arrangement of the upper substrate 212. It corresponds to the interface region 224 .

[0067] Reel attachment features 226 (see FIG. 16) are provided on the upper substrate 212. The wheel attachment feature 226 is adapted to attach to the foil take-up reel 245 (see Figures 17 and 19). It is a through hole for receiving the

[0068] Next, FIGS. 17 to 20 show various alternatives to the biochemistry cartridge 200 of FIGS. 1, where the biochemistry cartridge 200 is shown without the cover 214. The details are becoming clearer. That is, Figures 17, 18, 19, and 20 show 2A, 2B, and 2C are a perspective view, a top view, a rear view, and a top view of the biochemistry cartridge 200 with the cover 214 removed, respectively. The biochemistry cartridge 200 further includes a cover gasket 228 and a HR Horizontal Reservoir Module (HRM) 230 further including a mounting plate 239; and HRM 23 0 and a pair of mounting posts 242 for holding the HRM 230 and a pair of mounting posts 242 for sealing the fluid inside the HRM 230. foil strip 244 for winding the foil strip 244 from the HRM 230 and a foil take-up reel 245 for winding the foil, and a reel attachment for the upper substrate 212 (see FIG. 16). A reel engagement feature 246 that can be snapped into the reservoir module 226. and a module capture feature 254 (see FIG. 18 and FIG. 23A). Further details of M230 are shown and described below with reference to Figures 33A-35H.

[0069] Next, FIG. 21 shows the cover 214 of the biochemical cartridge 200 shown in FIGS. The cover 214 further includes a cover rim 248 and a sample input well 246. 216 and the top of the foil take-up reel 245. and a reel capture feature 252 for capturing the reel.

[0070] Next, FIG. 22A shows the biochemistry cartridge shown in FIGS. 11 and 12 without the cover 214. FIG. 22B is a perspective view of the underside of the biochemical card 200 with the bottom substrate 210 further removed. The underside of the cartridge 200 is shown in FIG. 2. In this view, the substrate gasket 256 and the reactant (or a Reaction (or assay) chamber area 258 is shown. Area 258 is the gap between bottom substrate 210 and top substrate 212 .

[0071] Next, FIG. 23A shows the bottom substrate 2 of the biochemical cartridge 200 shown in FIGS. 23B is a perspective view of the upper substrate 212 of the biochemistry cartridge 200. Only the bottom substrate 210 is shown. In this figure, the digital fluidics capabilities (i.e., electrochemical Electrode configuration 260 and electrical I / O contacts 262 for supporting laser wetting are shown. In this example, a biochemistry cartridge 200 is attached to a point-of-birth instrument 105. When installed in the electrical I / O contacts 262, the electrical I / O contacts 262 are connected to the main circuit of the point-of-birth fixture 105. 2. In some examples, the dry reagent is electrically connected to the electrode configuration 260. A reaction lane can be provided.

[0072] Next, FIG. 24A and FIG. 24B are diagrams showing the biochemical cartridges shown in FIG. 11 and FIG. 12, respectively. Disassembly of the stepper motor 150 of the point-of-birth instrument 105 associated with the edge 200 That is, the stepper motor 150 includes a motor shaft 156 and a A spring biased adapter 154 is mounted on the motor shaft 156. The distal tip of 154 is a reel of a foil take-up reel 245 that protrudes from the upper base plate 212. 246. In this manner, the step of the point-of-birth appliance 105 The motor 150 is used to rotate the foil take-up reel 245 of the biochemistry cartridge 200. Activate the HRM230 by rotating it.

[0073] 24A and 24B show a stepper motor engaging the underside of the biochemistry cartridge. The configuration is shown in Figure 25, while the stepper motor of the point-of-birth instrument is animated. Another arrangement is shown that engages through the top surface of the optical cartridge. In this example, the reel engagement The mating feature 246 is located on the top side of the foil take-up reel 245 and is connected to the reel engagement feature 246. The stepper motor 150 is mounted on a spring-loaded adapter. 154. A motor engagement member 158 is then attached to the distal end of the spring-loaded adapter 154. The distal end of the motor engagement member 158 is then attached to the It engages with the reel engagement feature 246. For another example, see Figure 35H.

[0074] 11-23B show a biochemistry cartridge 200 that supports digital fluidics. While one example is shown, FIGS. 26-29B show a neonatal An example of a biochemical cartridge 200 for screening is shown. "Lack of switching capability" refers to any electrode configuration for performing an electrowetting operation. Without digital fluidics capabilities, biochemistry cartridges are The edge 200 may be, for example, a flow cell. 2 shows a perspective view of a biochemistry cartridge 200 lacking idics capabilities. The cartridge 200 includes a bottom substrate 210, a top substrate 212, a cover 214, a sample input wall 216, and a sample The well 216, the well cap assembly 220, and the recessed or undulated area 222 are It can include.

[0075] In another example, Figures 27 and 28 each show a biomedical device lacking digital fluidics capabilities. A perspective view and a top view of the chemistry cartridge 200 are shown. 00 includes a bottom substrate 210, a top substrate 212, a cover 214, a sample input well 216, The well cap assembly 220 may include a recessed or undulating region 222. FIG. 29A shows a biochemistry cartridge 200 that does not support digital fluidics. 29B shows the bottom substrate 210 and the top substrate 212 of the digital fluidic device. Only the bottom substrate 210 of the biochemistry cartridge 200 is shown, without the support of the cartridge. The bottom substrate 210 can be configured to support any electrode configuration (e.g., electrode configuration 260 of FIG. 23A) and / or Or electrical I / O contacts (e.g., electrical I / O contacts 262 in FIG. 23A). In this example, the dry reagents are provided on the surface of the bottom substrate 210 and / or the top substrate 212. This may also be the case.

[0076] Next, FIG. 30A to FIG. 32B show a biochemistry cartridge according to the present disclosure for newborn screening. 10A and 10B are perspective views of three other examples of cover assemblies that can be used with the edge 200. . The sample input well 216, the loading port 218, and the well cap The assembly 220, the recessed or undulated area 222, and the cover gasket 228 are further In these three examples, the overall coverage area as well as the recessed areas Alternatively, the shape and arrangement of the undulating regions 222 may vary.

[0077] Next, FIG. 33A and FIG. 33B show various examples of the HRM 230 of the biochemistry cartridge 200. FIG. 2 is a diagram of a typical HRM 230 that holds a particular fluid and subsequently transfers it to a biochemistry cartridge 20. The HRM 230 is provided to distribute a first fluid 234 into the a first reservoir 232 for holding a second fluid 238; 36, both of which are mounted on the HRM mounting plate 239. M230 is a peripheral area around the openings of the first reservoir 232 and the second reservoir 236. The front surface 240 is sealed when the HRM 230 is filled with fluid. Further, the HRM 230 is not limited to only two reservoirs. The HRM 230 may include any number of reservoirs.

[0078] In this example, the first reservoir 232 is larger than the second reservoir 236. The second reservoir 232 can hold approximately 2 mL of fluid, while the second reservoir 236 can hold approximately 1 mL. L of fluid. Further, in this example, the HRM 230 can have a depth of, e.g. It may be about 15 mm, about 16 mm in height, and about 46 mm in length.

[0079] In the example biochemistry cartridge 200 with digital fluidics capabilities, the first reservoir The first fluid 234 in the bath 232 is a silicone oil or a hexadecane filler fluid. The second reservoir may be a filler fluid such as, but not limited to, a low viscosity oil. The second fluid 238 in the reservoir 236 may be, for example, a buffer solution, a liquid reagent, or a diluent such as water. However, biochemistry cartridges that do not have digital fluidics capabilities may be In the example of the 200, oil is not required. Therefore, the first reservoir 232 and the second reservoir Both the reservoir 236 and the reservoir 238 can be filled with a buffer solution, liquid reagent, or diluent such as water. .

[0080] Next, FIG. 34A is a front perspective view of another example of the HRM 230. In this example, the HRM 230 is the HRM shown in FIGS. 230. That is, in this example, the first reservoir 232 is still smaller than the second reservoir. 236. However, the first reservoir 232 holds approximately 1.2 mL of fluid. while the second reservoir 236 can hold approximately 0.8 mL of fluid. Further, in this example, the HRM 230 has a depth of, for example, about 24 mm and a height of, for example, about 14 mm. It may be approximately 33 mm in length.

[0081] Further, in the HRM 230 shown in FIG. 34A, for example, the circumference of the second reservoir 236 is approximately 6.325 inches (15.84 cm), and the front 240 is approximately 0.279 square inches (1 The width (i.e., wall thickness) of any portion of the front surface 240 may be, for example, 1.5 mm. For example, the thickness can be approximately 2 mm (78.7 mils). Optionally, a ferrule may be provided to increase the surface area for bonding the foil strips 244. A lip (not shown) may be provided around the edge of the front surface 240 for ease of use.

[0082] For any HRM230, the HRM230 will rotate at the optimum speed by gravity alone. For example, FIG. 34B shows a cross-sectional view of the HRM 230. The distribution angle α is, in one example, about 13° to about 17°, and in another example, In the case of the 1000 series, the 15° angle is about 15°. Again, the HRM230 is not limited to only two reservoirs. Furthermore, the distribution angles α of the reservoirs in the HRM 230 may be the same or different. It may be so.

[0083] The HRM 230 may be formed, for example, from molded plastic. 230 is made of high density polyethylene (HDPE), cyclic olefin polymer (COP), and cyclic olefin It can be made of olefin copolymer (COC) or polypropylene (PP). Additionally, to assist with gravity flow from the HRM230 and / or (1) in the first reservoir 232 and the second reservoir 236 (2) the surfaces of the first reservoir 232 and the second reservoir 233 may be coated with a hydrophobic material; 2. The inner surface of the reservoir 236 has a texture (e.g., a 110 μm textured structure). and / or (3) a small amount of oil (e.g., silicone oil) (e.g., For example, 50 μL of oil for 200 μL of diluent can be added to the diluent. .

[0084] Next, FIG. 35A to FIG. 35H show the biochemistry cartridge of the present disclosure for newborn screening. FIG. 35A is an example of a process for deploying the HRM 230 of the bridge 200. RM 230 is provided. Referring now to FIG. 35B, the first reservoir 232 is The first reservoir 232 is filled with a fluid 234 and the second reservoir 236 is filled with a second fluid 238. Referring to FIG. 35C, the HRM 230 is sealed with a foil strip 244. That is, the foil strip 244 is adhered to the front surface 240 of the HRM 230. The trip 244 is installed with the extra length or tail extending to one side. 35D, the excess length or tail of the foil strip 244 may be attached to itself. Then, referring to FIG. 35E, the wheel The excess length or tail of the foil strip 244 is attached to the foil take-up reel 245. Continuing with reference to FIG. 35F, the HRM 230 and the foil strip 244 and The combination of the foil take-up reel 245 is attached to the upper substrate 212. Next, referring to FIG. 35G, an O-ring 247 is placed on the foil take-up reel 245. 35H, a cover 214 is placed on top of the upper substrate 212. 245, thereby capturing and securing the foil take-up reel 245. The IlStrip 244 keeps the HRM230 sealed for a long time without loss of insulation. For example, aluminum foil strips having a low moisture vapor transmission rate (MVTR) can be used so that the Additionally, the foil strips 244 may be made of polyester for added strength. It can be a polyethylene terephthalate (PET) backed foil. In one example, HRM2 The adhesive retaining foil strip 244 to 30 is PE250 adhesive.

[0085] HRM 230 together with its foil strip 244 and foil take-up reel 245 Together they form the liquid delivery system of the biochemistry cartridge 200. Next, referring again to FIG. 4A, 24B, 25 and 35A-35H, the liquid from the HRM 230 The operation of the biochemistry cartridge 200 with respect to dispensing of the body is as follows. When the edge 200 is inserted into the point-of-birth instrument 105, the stepper motor 150 The HRM 230 engages the foil take-up reel 245 of the biochemistry cartridge 200. The HRM230 is then used to dispense the liquid. The motor 150 is activated and the foil strip 244 is wound onto the foil take-up reel 245. At this time, the foil strip 244 on the first reservoir 232 slowly peels off. The first fluid 234 is then slowly released, and the first fluid 234 is then absorbed by the biochemical The reaction (assay) chamber portion of the cartridge 200 is then driven by a stepper motor. As 150 continues to operate, the foil strip 244 on the second reservoir 236 also slowly The second fluid 238 is then slowly released, and the second fluid 238 is then released into the biochemical It flows into the reaction (or assay) chamber portion of the cartridge 200 .

[0086] Using the stepper motor 150, after the liquid is released from the first reservoir 232 The timing of the release of liquid from the second reservoir 236 can be controlled. For example, It is desirable to allow the oil to fully develop before dispensing the diluent. 232 and the second reservoir 236 are essentially mounted to the side, allowing for ventilation and opening. The aperture is achieved using the same foil strip 244. Additionally, the design of the HRM 230 is It reduces or completely eliminates the risk of air bubbles forming during dispensing. The design of 30 reduces or completely eliminates the dead volume due to the reservoir.

[0087] Optimal pulling force (e.g. , minimum torque), the excess length or tail of the foil strip 244 may be removed by removing the foil wrap. The path to the take-up reel 245 is approximately parallel to the plane of the front surface 240 of the HRM 230. This aligns the outer surface of the foil take-up reel 245 substantially with the plane of the front surface 240 of the HRM 230. This can be achieved by placing the electrodes so that they are in close contact with each other.

[0088] Next, FIG. 36 shows, for example, the point-of-birth device 105 of FIGS. 2A and 2B. 1 is an example of a functional block diagram. The point-of-birth device 105 includes a main circuit board 124. The main circuit board 124 includes a microcontroller 610, a USB port 612, a CA N-Port 614, Accel MEMS, LED 618, Power I / O 128 (e.g., power input input port 128), impedance detector 620, interlock and timer 622 (e.g. interlock circuits and watchdog timers), FPGA624, SD Biochemistry Cart with RAM 626, EEPROM 628, and Digital Fluidics Capabilities Electrowetting control 630, thermal control 632, H for driving the ridge 200 Motor 1 control 634 for controlling the RM stepper motor 150, cartridge engagement stepper 1 includes a motor 2 control for controlling the upper motor 144.

[0089] Certain other functions, such as but not limited to, a lighting fixture 638 associated with the spectrometer 140, One fluorometer 136, another LED 640, certain sensors and heaters 642, and certain The position switches 646 etc. communicate with the main circuit board 124. The bar code reader 116 is also The barcode reader 116 also communicates with the main circuit board 124. 48 and a USB port 650. Additionally, a power supply 130 (e.g., a power supply assembly 13 0) provides power to the main circuit board 124 and all other active components. Device 190 (not shown) may be coupled to main circuit board 124 using any wired or wireless means. can communicate with.

[0090] Next, FIG. 37 to FIG. 52 show the point of view of the present disclosure for newborn screening. Bath System 100, Point-of-Birth Instrument 105, and Biochemistry Cartridge 200. FIG. 200 is an example of a graphical user interface (GUI) 700. 00, for example, includes an upper display panel 710 and a lower display panel 715. panel 710 is used to present more global information and control to the user, while The lower display panel 715 is used to present more specific selected information and controls to the user. The GUI 700 can be implemented using any standard user interface control and display format. The GUI 700 may be displayed on a smart display such as the smart device 190. That is, the NBS mobile app on the smart device 190 can display the The GUI 700 can be launched using the controller 192.

[0091] The GUI 700 in Figure 37 allows the user to manually log in by entering a user ID and password. Alternatively, the user can log in to a point-of-birth instrument. 105 by scanning your ID badge using the barcode reader 116 You can log in by doing so.

[0092] The GUI 700 of FIG. 38 displays open and closed orders in the lower display panel 715. The Home Page with the Select Orders tab is shown in Figure 38. The Open Orders tab is selected. A list showing the patient's name, ordered assays, and order date appears. is presented.

[0093] GUI 700 in Figure 39 shows the Home Page with the Closed Orders tab selected. Again, there is a link showing the patient's name, the assay ordered, and the order date. A strike is presented.

[0094] You can start and run an inspection by selecting its name from a list of open orders. For example, the GUI 700 of FIG. 40 may be used to The barcode reader 114 is used to read the barcode on the selected biochemistry cartridge 200. The present invention takes the user through the first step of performing a newborn screening test: scanning the Additionally, patient information may be displayed in either a collapsed or expanded view.

[0095] The GUI 700 of FIG. 41 is used to insert the biochemistry cartridge 200 into the point-of-bath instrument 1 05, which will guide the user to the next step of performing a newborn screening test. Again, patient information is displayed.

[0096] When the biochemistry cartridge 200 is inserted into the point-of-birth device 105, an initial The initialization process begins. The GUI 700 in FIG. 42 shows the status of the initialization process. But again, patient information is displayed.

[0097] The GUI 700 of FIG. 43 is a barcode reader 105 for a point-of-birth instrument 105. 16 to scan the barcode on the container holding the selected patient's sample. This will prompt the user for the next step of performing a newborn screening test. Again, The patient information is displayed in a reduced view. Figure 44 shows an expanded view of the patient information.

[0098] The GUI 700 of FIG. 45 is a flow chart for adding a volume of a patient sample to a biochemistry cartridge 200. Add a newborn screening test and then select the "Run Test" button to start the test. The user is presented with the next step to perform: Again, patient information is displayed.

[0099] The GUI 700 of FIG. 46 guides the user through the steps to confirm the amount of sample added. .

[0100] The GUI 700 of FIG. 47 indicates to the user that a test is being performed and displays the status. For example, the amount of test time remaining can be shown along with the percentage completed. Again, patient information is displayed.

[0101] The GUI 700 of FIG. 48 illustrates another way of showing the status of a running test. The GUI 700 can display the patient's progress via a percentage sign next to the patient's name and / or via the bottom display A home page is shown where progress can be indicated via a bar along the bottom of panel 715.

[0102] By selecting a patient from the Completed Orders list, the GUI 700 in Figure 49 The results are presented to the user. In one example, a visual is provided to indicate the level of the detected marker. In addition, the user can choose to view more detailed information or print the information. can be selected.

[0103] When performing newborn screening tests, certain error conditions may occur. In one example, the GUI 700 of FIG. 50 displays the status of a sample loaded into the biochemistry cartridge 200. This shows the warning that can occur if the amount is insufficient to perform the test. In this example, The UI700 will display a "sampling volume insufficient" warning and the test will be cancelled.

[0104] GUI 700 in Figure 51 shows that warnings can be displayed in other ways, for example Global warnings can then be displayed in the top display panel 710. The user can select a warning You can select multiple global warnings to get more information. For example, the GUI 700 in FIG. 52 displays and reviews global warnings. Here is an example to reconsider.

[0105] The GUI 700 of the point-of-birth system 100 of the present disclosure is shown in FIGS. The illustrations, designs and information shown are for illustrative purposes only. The GUI 700 can include any depiction, design, and information.

[0106] Next, FIG. 53 shows a point-and-shoot display including a smart display, which is a built-in display 132. FIG. 1 is a front view of an example of a point-of-birth device 105. The operation of the point-of-birth instrument 105, and more particularly the operation of the point-of-birth instrument 105, is controlled by a smart device. The use of the NBS mobile app 192 on any smartphone 190 is not limited to the above. For example, in another embodiment, The point-of-birth instrument 105 may have a built-in display, which may be, for example, a touch screen. The display 132 is used to display the GUI 700 shown in FIGS. Thus, in this example, the point There is no need for a smart device 190 to be present in the birth system 100.

[0107] Next, FIG. 54 shows the point-of-birth system of the present disclosure for newborn screening. FIG. 8 is a flow diagram of an example of a method 800 for using the system 100. It may, but is not limited to, include the following steps:

[0108] In step 810, the point-of-birth application is launched and the user For example, the NBS mobile app 192 on the smart device 190 is started. Subsequently, using the GUI 700, the user may select, for example, the Log in as follows.

[0109] At step 815, the user may select open and / or completed orders. For example, using GUI 700, a user may access the home page shown in FIG. and Figure 39, open and / or completed orders. Please refer to the.

[0110] At step 820, the user selects a patient of interest from a display of open orders. For example, using GUI 700, a user may, for example, select a desired item from the list of items as shown and described in FIG. ,Select patients to be screened from the open orders display.

[0111] At step 825, the user obtains the appropriate biochemistry cartridge for the selected patient. For example, the user may select a biochemistry cartridge 200 appropriate for the selected patient. Then, as prompted by the GUI 700 as shown in FIG. The user uses the barcode reader 116 of the point-of-birth instrument 105 to The bar code on the biochemistry cartridge 200 is scanned.

[0112] At step 830, the user selects a biochemistry cartridge for use at the point of sale. For example, the device may be prompted by a GUI 700 such as that shown in FIG. Thus, the user may insert the selected biochemistry cartridge 200 into the point-of-bath instrument. Insert into 105.

[0113] In step 835, the user waits until the biochemistry cartridge is initialized. For example, as prompted by the GUI 700 shown in FIG. Wait for the chemical cartridge 200 to initialize.

[0114] At step 840, the user obtains a container of sample fluid for the selected patient and skips the For example, a user obtains a container of sample fluid for a selected patient. 43 and / or 44, as prompted by the GUI 700 instructions. The user then uses the barcode reader 116 of the point-of-birth instrument 105 to In one example, the sample container is a pipette. do.

[0115] At step 845, the user loads the selected patient's sample fluid onto the biochemistry cartridge. For example, as prompted by the GUI 700 shown in FIG. , the user can remove the biochemical cartridge by opening the well cap assembly 220. The user then opens the sample input well 216 of the sampler 200. The sample is pipetted into the loading port 218 of the sample input well 216. For example, the user may close the well cap assembly 220 to remove the biochemistry cartridge. The input well 216 of the edge 200 is closed.

[0116] At decision step 850, it is determined whether sufficient sample fluid is present in the biochemistry cartridge 200. For example, the analysis is performed by an instrument in the point-of-birth instrument 105. The amount of sample fluid present in the biochemistry cartridge 200 is determined. If pulling fluid is present, the method 800 proceeds to step 855. However, if the sample If the amount of fluid is insufficient, the method 800 ends and a GUI such as that shown in FIG. As shown at 700, the test is cancelled.

[0117] In step 855, the newborn screening test is performed using the point-of-birth device 105 It starts within.

[0118] At step 860, the user monitors the progress of the newborn screening test. For example, The progress of the test can be viewed in the GUI 700 as shown in Figures 47 and 48. Cut.

[0119] In step 865, the user views the results of the newborn screening test. For example, For any completed exam, the user may, for example, select In addition, the test results can be viewed on the NBS Mobile app on the smart device 190. Use App 192 to record and distribute any test results to any authorized party Therefore, using the NBS mobile app 192 on the smart device 190 and provide the test results to the user (by viewing the results on the smart device 190). The results can be communicated and shared using the smart device 190. to other authorized parties).

[0120] Next, FIG. 55 illustrates the present disclosure including a laptop computer as a smart display. 1 is an example of a point-of-birth system 100. For example, a smart device 19 Instead of 0, the point-of-birth system 100 can be used with any wired or wireless means. A laptop computer communicating with the point-of-birth instrument 105 using In this example, the laptop computer 195 can be used Use the NBS Desktop Application 192 instead of the S Mobile App 192 Similar to the smart device 190, a laptop computer 195 may be used. This allows the point-of-birth system 100 to be portable.

[0121] Up to now, the point-of-birth system 100 has been described with reference to FIGS. Although only biochemical screening for point-of-birth systems has been described above, The system 100 may include physiological screening in addition to biochemical screening. For example, referring to Figures 56-59, physiological and biochemical screening An example of a point-of-birth system 100 of the present disclosure is provided that supports both In one example, FIG. 56 shows a point-of-birth device 105 as previously described. 1. A point-of-care device including a biochemical cartridge 200. The point-of-birth system 100 is shown in FIG. In this example, the neonatal pulse oximetry mechanism 900 The NBS mobile app 192 communicates directly with the smart device 190. , from / to the neonatal pulse oximetry system 900 In another example, FIG. 57 illustrates a neonatal pulse o The stimulating mechanism 900 is a point-of-birth sensor instead of a smart device 190. The configuration shown is physically connected to the instrument 105. In this example, the point-of-birth The instrument 105 receives information from the neonatal pulse oximetry mechanism 900 and uses a smart The NBS mobile app 192 on the host device 190.

[0122] In yet another example, FIG. 58 shows a point-of-birth device 105, as previously described. Point-of-Birth Devices 190 and Biochemistry Cartridges 200 The system 100 is shown in FIG. 1. Additionally, the point-of-birth system 100 is a newborn hearing aid. In this example, the newborn hearing screening mechanism 910 includes: It communicates directly with smart devices 190. The NBS mobile app 192 has the following features: Information from / to Newborn Hearing Screening Organization 910 In yet another example, FIG. The leaning mechanism 910 is a point-of-birth device instead of the smart device 190. In this example, the point-of-birth device is physically connected to the The device 105 receives information from the newborn hearing screening mechanism 910 and uses a smart The NBS mobile app 192 on the client device 190.

[0123] In accordance with long-standing patent law practice, the terms "a," "an," and "the" are used interchangeably in As used herein, including in the present application, the term "one or more" refers to one or more of the above. A reference to "subjects" should be construed as including multiple subjects unless the context clearly indicates otherwise (e.g., multiple subjects). Includes test subjects.

[0124] Throughout this specification and the claims, the terms "comprise", "comprise", "compound", "compound" and "compounds" are used interchangeably. "Comprising" and "Comprising" may be interpreted differently where the context requires. Similarly, the word "include" is used in a non-exclusive sense, except where ) and grammatical variations thereof are not limiting and the enumeration of items in a list is not intended to be limiting unless otherwise stated. It does not exclude other similar items that may be substituted or added to the item.

[0125] For purposes of this specification and the appended claims, unless otherwise indicated, amounts, sizes and Size, dimensions, proportions, shapes, recipes, parameters, percentages, amounts, characteristics, and descriptions All numbers expressing values, quantities or other numerical values ​​used in the claims are expressly defined by the term "about." is modified in all instances by the term "about" even if not explicitly stated with a range. Accordingly, unless indicated to the contrary, the following specification and The numerical parameters set forth in the appended claims are not necessarily precise and need not be precise. However, the values ​​may be approximate and / or larger or smaller as desired. Depending on the desired properties sought to be obtained by the subject matter shown, tolerances, conversion factors, These may reflect rounding, measurement error, and other factors known to those of ordinary skill in the art. For example, the term "About" when referring to a value, in some embodiments, is ±100%, and in some embodiments, ±50%, in some embodiments ±20%, in some embodiments ±10%, In some embodiments, ±5%, in some embodiments, ±1%, in some embodiments, ±0. 0.5%, and in some embodiments, ±0.1% variation from the specified amount. Such variations may be indicative of variations that may be required to practice the disclosed methods or to use the disclosed combinations. It is suitable for use in the composition.

[0126] Additionally, the term "about" when used in conjunction with one or more numbers or numerical ranges, generally refers to the range. It should be understood to refer to all such numbers, including all numbers within the range of the numerical values ​​described. Modifies a range by extending its upper and lower bounds. A sequence of numeric ranges by endpoints The range includes all numbers, e.g., all integers, including their decimals, that are included in the range (e.g., The enumeration 1-5 includes 1, 2, 3, 4 and 5, as well as decimals thereof, e.g., 1.5, 2. 25, 3.75, 4.1, etc.) and any range therein.

[0127] The foregoing subject matter has been described in some detail by way of illustration and example for purposes of clarity of understanding. However, it will be apparent to those skilled in the art that certain changes and modifications may be implemented within the scope of the appended claims. It will be understood that

Claims

1. 1. A point-of-birth testing system for newborn screening, comprising: a point-of-birth device for processing a fluid sample from a neonate; a user interface connected to the point-of-birth device; A smart display that provides a user with a point-of-birth device and operates the point-of-birth device; a biochemical cartridge for receiving a sample fluid to be treated; the biochemistry cartridge includes a point A sample fluid inserted into the Obverse Instrument and processed by the smart display. A point-of-birth testing system that communicates results.

2. 10. The point-of-care device of claim 1, wherein the biochemistry cartridge is disposable. Inspection system.

3. The point-of-birth device of claim 1, wherein the point-of-birth device is portable. - Birth inspection system.

4. The smart display may be a portable smart device or a laptop computer.

2. The point-of-birth inspection system of claim 1, wherein the point-of-birth inspection system is a

5. The system of claim 1 supports only newborn biological screening. Point-of-birth testing system.

6. The system includes a newborn biological screening and a newborn physiological screening.

10. The point-of-birth inspection system of claim 1, further comprising:

7. The point-and-shoot system of claim 6 further comprises a pulse oximetry mechanism. Ob-birth testing system.

8. The system according to claim 6 or 7 further comprises a hearing screening mechanism. Into-birth testing system.

9. The point-of-birth testing system of claim 1 , wherein the system supports multiplexed testing. Inspection system.

10. The system tests for multiple analytes in a single sample fluid on the biochemistry cartridge.

2. The point-of-birth inspection system of claim 1,

11. 13. The method of claim 1, wherein the point-of-birth device performs multiple types of biochemical tests.

2. A point-of-birth inspection system as described in claim 1.

12. The multiple types of biochemical tests include enzyme tests, colorimetric tests, immunoassay tests, and / or or a nucleic acid test.

13. The system of claim 1 performs screening of biological markers. Into-birth testing system.

14. The biological markers include total bilirubin, ammonia, and / or medium chain acyl-C 14. The point-of-birth testing system of claim 13, comprising oA dehydrogenase. 。

15. The smart display interfaces with a user and displays the point of view. The present invention relates to a newborn screening mobile application for operating a newborn screening device.

2. The point-of-birth testing system according to claim 1.

16. The smart display is a display integrated into the point-of-birth device.

10. The point-of-birth inspection system of claim 1 which is a prey.

17. The biochemical cartridge includes a horizontal reservoir module for holding a tilted liquid.

2. The point-of-birth inspection system of claim 1, comprising:

18. The biochemistry cartridge is a point-of-birth device. When inserted into the instrument, the optical indicator matches an optical detector of the point-of-birth instrument.

10. The point-of-birth inspection system of claim 1, further comprising an interface area.

19. 1. A point-of-birth device for processing a sample fluid, comprising: Housing and a loading deck for receiving a biochemistry cartridge having a sample fluid; A smart display that interfaces with a user; An input reader; a biochemistry testing module including a processor for a testing assay; wherein the smart display provides results from a test assay. Of birth appliance.

20. The housing includes a base plate and first and second electrodes mounted on the base plate. and a second side rail, the point of bar being disposed between the side rails. A circuit board for controlling the operation of the device, a cam disposed between the side rails, and a cart. Ridge-engaging stepper motor, cam belt and pulley assembly, and biochemical cart a motor assembly for actuating the dispensing of sample fluid on the ridges. The point-of-birth device described in.

21. The motor assembly further includes a stepper motor on a stepper motor support and a spring-loaded 21. The point of claim 20, comprising a power adapter, a motor shaft, and a motor engagement member. To-of-birth fixture.

22. The housing includes a power input port and a power assembly disposed on a power mounting plate.

20. The point-of-birth appliance of claim 19, comprising a stent assembly.

23. 20. The point of view of claim 19, further comprising a fluorometer and / or an optical spectrometer. Bath equipment.

24. The smart display is a smart device, and the point-of-birth device The apparatus further includes a docking station electrically connected to the smart device.

20. The point-of-birth appliance of claim 19.

25. The smart display is a smart device, and the point-of-birth device 20. The point-of-birth device of claim 19, wherein the appliance communicates wirelessly with the smart device. Equipment.

26. The smart display interfaces with the user to display results to interested parties. communicate, provide tracking information, provide training for use of said device, and provide clinical calculations. and / or a software application capable of epidemiological tracking of the disease.

20. The point-of-birth appliance of claim 19, further comprising a

27. 20. The point of view of claim 19, wherein the input reader is a barcode reader. Bath equipment.

28. 20. The point-and-shoot system of claim 19, wherein the input reader scans for newborn identification information. To-of-birth fixture.

29. 20. The point-of-birth instrument of claim 19, further comprising an optical detector.

30. 20. The point-of-birth appliance of claim 19, wherein the appliance is portable.

31. 20. The point of claim 19, wherein the device further comprises a pulse oximetry module. of birth appliance.

32. 20. The point of claim 19, wherein the apparatus further comprises a hearing screening module. of birth appliance.

33. 1. A biochemistry cartridge for newborn screening comprising: A bottom substrate; a top substrate spaced from the bottom substrate by a gap; a cover disposed adjacent to the upper substrate; A loading port and a well cap assembly for opening and closing the loading port. a sample input well having a sample assembly; the sample input well is for collecting a test fluid from a neonate; The biochemistry cartridge is intended for insertion into a newborn screening instrument for testing. That is, the biochemical cartridge.

34. 34. The biochemical apparatus of claim 33, wherein the sample input well is integrated within the cover. School cartridge.

35. 34. The biochemical cartridge of claim 33, wherein the cover includes a raised area.

36. The biochemical cartridge of claim 33, wherein the gap is an assay chamber.

37. The sample input well is a horizontal reservoir module, and the biochemical cartridge is A cover gasket, a horizontal reservoir module mounting plate, and a horizontal reservoir module mounting plate are also included. and a mounting post for holding the reservoir module. cartridge.

38. The well cap assembly is adapted to contain fluid within the horizontal reservoir module. and the biochemistry cartridge further comprises a foil strip for inserting the biochemistry cartridge into the foil strip. a take-up reel for taking up the cap from the horizontal reservoir module; and a reservoir module capture feature secured to said reel engagement feature. The biochemical cartridge according to claim 1.

39. The horizontal reservoir module includes a first reservoir for holding a first sample fluid; and a second reservoir for holding a second sample fluid. Cartridge.

40. 40. The biochemical cartridge of claim 39, wherein the reservoir is sloped.

41. The biochemical cartridge of claim 40, wherein the reservoir is angled at between 13 and 17 degrees.

42. 34. The cartridge of claim 33, wherein the cartridge supports digital microfluidics. Biochemistry cartridge.

43. 34. The method of claim 33, wherein the cartridge does not support digital microfluidics. Biochemistry cartridge included.

44. 34. The biochemistry cart of claim 33, wherein the neonatal testing fluid is urine and / or blood. ridge.

45. 34. The biochemical cartridge of claim 33, wherein the bottom substrate is a printed circuit board.

46. 34. The method of claim 33, wherein a gap between the bottom substrate and the top substrate includes a filler fluid. Biochemistry cartridge.

47. 1. A method for newborn screening comprising: a point-of-bath device for processing a sample fluid; a smart display that interfaces with the point-of-birth appliance; a biochemistry cartridge having a reservoir for receiving a sample fluid for processing; providing a point-of-birth testing system comprising: providing identification information to the inspection system; loading a sample fluid into a reservoir of the biochemistry cartridge; sealing the reservoirs of the biochemical cartridge after filling them with sample fluid; 、 loading said biochemistry cartridge into said point-of-birth device. P and A step of discharging the sample fluid into the assay of the biochemical cartridge for processing. Top and processing a sample fluid with the point-of-birth device; Smart display and interface to obtain results of processed sample fluids and communicating said results; 1. A method for newborn screening comprising:

48. Furthermore, a sealing device is provided for sealing the reservoir of the biochemical cartridge after filling it with a sample fluid. providing a foil strip for aligning said biochemistry cartridge with said foil strip; providing a foil take-up reel for securing a portion of the trip; providing a stepper motor for engaging a take-up reel; and After loading the point-of-birth instrument, actuating the stepper motor and actuating the stepper motor to allow the sample fluid to be expelled. and removing the foil strip from the reservoir. The method for newborn screening described herein is

49. The reservoir of the biochemical cartridge includes a first reservoir and a second reservoir.

48. The method for newborn screening according to claim 47.

50. Further, after loading both reservoirs with the first and second sample fluids, the biochemical A strip of foil is provided for sealing the first and second reservoirs of the cartridge. a foil wrapper for securing a portion of the foil strip onto the biochemistry cartridge; providing a take-up reel; and a stepper motor engaging said take-up reel. and attaching the biochemistry cartridge to the point-of-birth device. after loading, activating the stepper motor; and activating the heater to allow a first sample fluid to be released into the first reservoir. removing the strip from the first reservoir; and and allowing the second sample fluid to be released into the second reservoir, after which the foil sample is and removing the cap from the second reservoir. Methods for cleaning.

51. A method for using a point-of-birth newborn screening system. 、 Point-of-birth newborn screening software application A point-of-birth device for processing a sample fluid, and a method for processing said sample and a biochemistry cartridge for receiving the pull fluid. providing a smart display in communication with the system; logging into a software application of the smart display; 、 Interface with the Smart Display by selecting an open order and scanning a sample fluid identifier on the biochemistry cartridge; The biochemistry cartridge containing the sample fluid is then placed in the point-of-birth testing device. Inserting; Interface with the smart display to initiate processing of the biochemistry cartridge. and identifying a suitable fluid sample for processing said biochemistry cartridge; processing the sample fluid with the point-of-birth testing device; 、 monitoring the smart display to determine a processing status of the sample fluid; P and viewing test results of the processed sample fluid; 23. A method for using a point-of-birth newborn screening system, comprising:

52. The step of logging in to the smart display includes: Credentials can be entered manually and / or using a barcode reader The point-of-birth method of claim 51, wherein the point-of-birth method is performed by scanning a Methods for using a live birth screening system.

53. 52. The point of claim 51, wherein the sample fluid identifier is a barcode reader. Methods for using the of-birth newborn screening system.

54. Additionally, sample fluid identification information may be input to the software of the smart display.

52. The method of claim 51, further comprising the step of creating an open order in the application. Methods for using the described point-of-birth newborn screening systems.

55. and collecting a sample fluid from the neonate using the biochemistry cartridge. The point-of-birth newborn screening system according to claim 51 is used to Method for using.

56. The step of collecting a sample fluid from a neonate using the biochemistry cartridge includes: After the step of scanning the sample fluid identifier on the biochemistry cartridge, and attaching the biochemical cartridge containing the sample fluid to the point-of-birth testing device.

56. The method of claim 55, wherein the step of inserting the point-of-birth nephrectomy into the Methods for using the infant screening system.

57. The step of collecting a sample fluid from the neonate includes inserting an input well in the biochemistry cartridge. removing the cover of the flask; inserting a quantity of sample fluid; and sealing the power well. Methods for using a live birth screening system.

58. 52. The method of claim 51 further comprising the step of distributing the test results. Methods for using the Bath Newborn Screening System.

59. Further, the smart display software application is interfaced with The point of claim 51 further comprises a step of reviewing the results of a previously performed test. -A method for using the of-birth newborn screening system.

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