Devices and methods for immunoassay analysis of biological samples

Abstract

A device and method for analyzing a sample fluid is disclosed. The device comprises a base, a spindle rotatably coupled to the base; a motor that rotates a disc disposed on the spindle, the disc receives a volume of a fluid that has one or more components of the sample fluid; at least one actuator coupled to the base, the actuator mixes the fluid in the disc; at least one sensor coupled to the base, the sensor collects data of the sample fluid in the disc; and a controller that controls each of the spindle, motor, actuator and sensor.

Description

TITLE

[0001] Devices and Methods for Immunoassay Analysis of Biological SamplesCROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U. S. Provisional Patent Application No. 63 / 514,973 filed July 21 , 2023 entitled “Devices and Method for Immunoassay Analysis of Biological Samples”, which is incorporated by reference herein in its entirety.TECHNICAL FIELD

[0003] The present disclosure generally relates to devices and methods for handling fluids and, in some embodiments, to devices and methods for immunoassay analysis of biological samples.SUMMARY

[0004] Devices and Methods for analyzing a sample fluid is disclosed. In certain embodiments, the device comprises: a base; a spindle rotatably coupled to the base; a motor configured to rotate a disc disposed on the spindle, the disc configured to receive a volume of a fluid having one or more components of the sample fluid; at least one actuator coupled to the base, the actuator configured to mix the fluid in the disc; at least one sensor coupled to the base, the sensor configured to collect data of the sample fluid in the disc; and a controller configured to control each of the spindle, motor, actuator and sensor.

[0005] In certain embodiments, the actuator is movably coupled to the base. In certain embodiments, the actuator is movable between a disengaged position and an engaged position. In certain embodiments, an emitting end of the actuator is a first distance from the disc in the disengaged position and a second distance from the disc in the engaged position. In certain embodiments, the first distance is greater than the second distance.

[0006] In certain embodiments, the device further comprising: the disc. In certain embodiments, wherein the disc has one or more wells at a first common radius relative to a rotation axis of the disc, wherein each of the one or more wells is configured to receive a volume of a fluid including one or more components of the sample fluid. In certain embodiments, the disc further comprises a plurality of testing chambers, and in certain embodiment each of the plurality of testing chambers comprises: a sample chamber for receiving the sample fluid; a buffer chamber for receiving a buffer; and one of the one or more wells.

[0007] In certain embodiments, each of the plurality of testing chambers is configured to measure one or more of vitamin Bl 2, free thyroxine hormone (T4), parathyroid hormone (PTH), free triiodothyronine hormone (T3), thyroid stimulating hormone (TSH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), N-terminal pro b-type natriuretic peptide (NT-proBNP), C- Reactive Protein (CRP), vitamin D (Vit D), estradiol, prostate-specific antigen (PSA), beta human chorionic gonadotropin (HCG), ferritin, D-dimmer, testosterone, progesterone, and troponin, or a combination thereof in the sample fluid.

[0008] In certain embodiments, the at least one actuator homogenizes the fluid in the disc. In certain embodiments, the at least one actuator emits vibrations into the fluid in the disc. In certain embodiments, the at least one actuator emits pulsing vibrations into the fluid in the disc. In certain embodiments, the at least one actuator comprises three actuators. In certain embodiments, each of the three actuators are at a first common radius relative to a rotational axis of the spindle. In certain embodiments, each of the three actuators are different radii relative to a rotational axis of the spindle.

[0009] In certain embodiments, the device further comprising: a homing mechanism disposed proximate the disc configured to detect a position of the disc relative to the at least one sensor. In certain embodiments, the homing mechanism includes a homing signal emitter emitting a homing signal and a homing signal receiver configured to receive the homing signal. In certain embodiments, the controller recognizes a location of the disc relative to a home location when the homing signal reaches the homing signal receiver. In certain embodiments, the at least one actuator includes a spring cushioning the actuator. In certain embodiments, the device further comprising: at least one magnet coupled to the base, the magnet configured to attract one or more magnetic particles within the disc.

[0010] In certain embodiments, a device for analyzing a sample fluid is disclosed. In certain embodiments, the device comprising: a base; a spindle rotatably coupled to the base; a motor configured to rotate a disc disposed on the spindle, the disc configured to receive a volume of a fluid having one or more components of the sample fluid; at least one magnet coupled to the base, the magnet configured to attract one or more magnetic particles within the disc; at least one sensor coupled to the base, the sensor configured to collect data of the sample fluid in the disc; and a controller configured to control each of the spindle, motor, magnet and sensor.

[0011] In certain embodiments, the device further comprising: at least one actuator coupled to the base, the actuator configured to mix the fluid in the disc. In certain embodiments, the at least on actuator is moveable relative to the disc between an initial position where the at least one actuator isspaced apart from the disc and an engaged position where the at least one actuator contacts the disc. In certain embodiments, the controller moves the at least one actuator from the initial position to the engaged position. In certain embodiments, the controller applies a DC voltage to the at least one actuator to move from the initial position to the engaged position. In certain embodiments, the controller moves the at least one actuator independent of the spindle, motor, magnet and sensor.

[0012] In certain embodiments, the magnet includes a pair of submagnets. In certain embodiments, the pair of submagnets are coupled to a magnetically conductive plate. In certain embodiments, the pair of submagnets coupled to the magnetically conductive plate produces field lines at a pole of each of the pair of submagnets. In certain embodiments, a plurality of magnets are coupled to the base. In certain embodiments, each of the plurality of magnets are at a first common radius relative to a rotational axis of the spindle. In certain embodiments, the plurality of magnets are spaced apart from each other about the first common radius.

[0013] In certain embodiments, the device further comprising: the disc. In certain embodiments, the disc having one or more wells at a first common radius relative to a rotation axis of the disc, wherein each of the one or more wells is configured to receive a volume of a fluid including one or more components of the sample fluid. In certain embodiments, the disc further comprises a plurality of testing chambers, and in certain embodiments each of the plurality of testing chambers comprises: a sample chamber for receiving the sample fluid; a buffer chamber for receiving a buffer; and one of the one or more wells.

[0014] In certain embodiments, each of the plurality of testing chambers is configured to measure one or more of vitamin Bl 2, free thyroxine hormone (T4), parathyroid hormone (PTH), free triiodothyronine hormone (T3), thyroid stimulating hormone (TSH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), N-terminal pro b-type natriuretic peptide (NT-proBNP), C- Reactive Protein (CRP), vitamin D (Vit D), estradiol, prostate-specific antigen (PSA), beta human chorionic gonadotropin (HCG), ferritin, D-dimmer, testosterone, progesterone, and troponin, or a combination thereof in the sample fluid.

[0015] In certain embodiments, a device for analyzing a sample fluid is disclosed. In certain embodiments, the device comprising: a base; a spindle rotatably coupled to the base; a motor configured to rotate a disc disposed on the spindle, the disc configured to receive a volume of a fluid having one or more components of the sample fluid; at least one actuator movably coupled to the base, the actuator configured to mix the fluid in the disc; at least one magnet coupled to the base, the magnetconfigured to attract one or more magnetic particles within the disc; at least one sensor coupled to the base, the sensor configured to collect data of the sample fluid in the disc; and a controller configured to control each of the spindle, motor, actuator, magnet and sensor. In certain embodiments, the actuator is movable between a disengaged position and an engaged position. In certain embodiments, the magnet includes a pair of submagnets coupled to a magnetically conductive plate.

[0016] In certain embodiments, a method of analyzing a sample fluid is disclosed. In certain embodiments,, the method comprising: operating a motor of a device for analyzing a sample fluid to rotate a spindle and a disc disposed on the spindle, wherein the disc receives a volume of a fluid having one or more components of the sample fluid; mixing, using at least one actuator, the volume of the fluid having one or more components of the sample fluid to mix the fluid in the disc; attracting, using at least one magnet, one or more magnetic particles within the disc; collecting, using one or more sensors, data of the sample fluid in the disc; and controlling, using the controller, each of the motor, spindle, actuator, magnet and sensor.

[0017] In certain embodiments, the disc further comprises a plurality of testing chambers. In certain embodiments, each of the plurality of testing chambers receives about 63 pL of a buffer into a buffer chamber and about 13 pL of the sample into a sample chamber. In certain embodiments, the buffer comprises tris-buffered saline. In certain embodiments, the sample fluid comprises blood. In certain embodiments, the disc is rotated in a first direction at a rotational speed of at least 6000 rpm to separate blood plasma from red cell matter in the sample fluid. In certain embodiments, the disc is rotated in the first direction at a rotational speed of between about 5000 and 8500 rpm to move the blood plasma and the buffer into a mixing chamber. In certain embodiments, excess air is released by a vent when the blood plasma is moved into the mixing chamber. In certain embodiments, the disc is repeatedly rotated in the first direction at a first rotational speed of between about 2000 to 3000 rpm followed by a second rotational speed of about 6000 to 8000 rpm to mix the blood plasma and the buffer in the mixing chamber. In certain embodiments, the first rotational speed is greater than the second rotational speed.

[0018] In certain embodiments, the disc is rotated in a second direction at a rotational speed of at least 1500 rpm to move the blood plasma and the buffer into a reaction chamber containing one or more reagents and one or more magnetic particles disposed therein. In certain embodiments, the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the actuator. In certain embodiments, the actuator homogenizes and incubates the mixed blood plasma and buffer, the reagent and the magnetic particles within the reaction chamber. In certainembodiments, the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the magnet. In certain embodiments, the magnet moves the magnetic particles into an annex in fluid communication with the reaction chamber.

[0019] In certain embodiments, each of the plurality of testing chambers receives about 50 pL of a wash buffer into a wash buffer chamber. In certain embodiments, the disc is rotated in one of the first direction or the second direction to move a first volume of the wash buffer from the wash buffer chamber through the reaction chamber and into a waste chamber in fluid communication with the reaction chamber. In certain embodiments, the disc is rotated in one of the first direction or the second direction to move a second volume of the wash buffer from the wash buffer chamber through the reaction chamber and into the waste chamber in fluid communication with the reaction chamber.

[0020] In certain embodiments, each of the plurality of testing chambers receives about 42 pL of the buffer into a secondary buffer chamber including a reporter particle. In certain embodiments, the disc is rotated in one of the first direction or the second direction to move the buffer and the reporter particles from the reporter chamber from the secondary buffer chamber into a holding chamber. In certain embodiments, the disc is rotated in one of the first direction or the second direction to move any fluid in the reaction chamber into the waste chamber in fluid communication with the reaction chamber. In certain embodiments, the disc is rotated in one of the first direction or the second direction to move the buffer and the reporter particles from the holding chamber into the reaction chamber.

[0021] In certain embodiments, the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the magnet. In certain embodiments, the magnet moves the magnetic particles from the annex to the reaction chamber. In certain embodiments, the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the actuator. In certain embodiments, the actuator homogenizes and incubates the magnetic particles and the reporter particles within the reaction chamber. In certain embodiments, the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the magnet. In certain embodiments, the magnet moves the magnetic particles into the annex.

[0022] In certain embodiments, the disc is rotated in one of the first direction or the second direction to move the wash buffer from the wash buffer chamber through the reaction chamber and into the waste chamber. In certain embodiments, the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the magnet. In certain embodiments, the magnet moves the magnetic particles from the annex to the reaction chamber. In certain embodiments, thedisc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the actuator. In certain embodiments, the actuator homogenizes and incubates the magnetic particles and the buffer within the reaction chamber.

[0023] In certain embodiments, the disc is rotated in one of the first direction. In certain embodiments, the sensor detects photoluminescent absorption of the magnetic particles during a detection period. In certain embodiments, the motor is configured to continue rotation of the disc during the detection period. In certain embodiments, the sensor measures a baseline photoluminescent absorption of the reaction chamber prior to the detection period. In certain embodiments, the baseline photoluminescent absorption of the reaction chamber is separated from the photoluminescent absorption measured during the detection period.BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The foregoing summary, as well as the following detailed description of embodiments of the device for testing a microfluidic sample, will be better understood when read in conjunction with the appended drawings of the exemplary embodiments. It should be understood, however, that the invention is not limited to the precise arrangements and instrumentalities shown.

[0025] In the drawings:

[0026] Fig. 1 is a top perspective view of a device for analyzing a sample fluid in accordance with a first exemplary embodiment of the present invention;

[0027] Fig. 2 is an exploded view of the device of Fig. 1;

[0028] Fig. 3 is a bottom view of a disc of the device of Fig. 1;

[0029] Fig. 4 is a top view of a testing chamber of the disc of the device of Fig. 1;

[0030] Fig. 5A is a top view of a testing chamber of the disc of the device of Fig. 1;

[0031] Fig. 5B is a magnified top view of a portion of a testing chamber of the disc of the device of Fig. 1;

[0032] Fig. 6 is a top view of a testing chamber of the disc of the device of Fig. 1;

[0033] Fig. 7 is a top view of a testing chamber of the disc of the device of Fig. 1;

[0034] Fig. 8 is a magnified top view of a portion of a testing chamber of the disc of the device of Fig. 1;

[0035] Fig. 9 is a top view of a testing chamber of the disc of the device of Fig. 1;

[0036] Fig. 10 is a magnified top view of a portion of a testing chamber of the disc of the device of Fig. 1;

[0037] Fig. 11 is a top view of a testing chamber of the disc of the device of Fig. 1;

[0038] Fig. 12 is a magnified top view of a portion of a testing chamber of the disc of the device ofFig. 1;

[0039] Fig. 13 is a top view of a testing chamber of the disc of the device of Fig. 1;

[0040] Fig. 14 is a magnified top view of a portion of a testing chamber of the disc of the device ofFig. 1;

[0041] Fig. 15 is a top view of a testing chamber of the disc of the device of Fig. 1;

[0042] Fig. 16 is a magnified top view of a portion of a testing chamber of the disc of the device ofFig. 1;

[0001] Fig. 17 is a top view of a testing chamber of the disc of the device of Fig. 1;

[0002] Fig. 18 is a top perspective view of a spindle of the device of Fig. 1;

[0043] Fig. 19 is a side cross-section view of the spindle of the device of Fig. 1;

[0044] Fig. 20 is a top perspective view of the magnet and magnetically conductive plate of the device ofFig. 1;

[0045] Fig. 21a is a cross-sectional view of the actuator of the device of Fig. 1 in an initial position;

[0046] Fig. 21b is a cross-sectional view of the actuator of the device ofFig. 1 in an engaged position;

[0047] Fig. 22 is a side view of the homing PCBA of the device ofFig. 1;

[0048] Fig. 23 is a side view of the Homing PCBA of the device ofFig. 1 with a disc disposed in the device;

[0049] Fig. 24 is a top view of a testing chamber of a disc of a device for analyzing a sample fluid in accordance with a second exemplary embodiment of the present invention;

[0050] Fig. 25 is a top view of the testing chamber of claim 24; and

[0051] Fig. 26 is a top view of the testing chamber of claim 24.DETAILED DESCRIPTION

[0052] Currently, about 70% of all medical decisions rely on lab-based diagnostics. However, as it stands today, the diagnostic process is disjointed from how care is delivered. The primary care system requires patients to travel to external phlebotomy sites to draw blood, which is sent to labs via courier, and subsequently processed. This means that lab results reach health care professionals long after the patient has left. This friction in care delivery and disease management leads to tremendous waste in the healthcare system, including: (i) patients delay getting lab tests or fail to adhere to lab testing, or subsequent care recommendations; (ii) the gap in the diagnostic process leads to missed tests, missed diagnosis, a lack of intervention, and ultimately poor outcomes; and (iii) healthcare professionals waste time tracing lab orders to patient encounter notes. When intervention is needed, more time is wasted in reaching out to patients and driving subsequent steps in the patient’s care pathway.

[0001] These problems are even more acute when caring for rural populations or patients belonging to groups facing adverse social determinants of health, where there are many challenges in ensuring successful follow ups from an initial patient encounter. Several point-of-care instruments have been developed to bridge this divide. However, these instruments are limited to single types of tests and fail to completely meet the workflow needs of primary care providers. As such, there is a need for a single system that produces simple, comprehensive, and fast test results. This is achieved through a highly automated workflow and through the use of centrifugal microfluidics discs.

[0053] Centrifugal microfluidics applications often require metering, transferring, mixing fluids and / or other steps and processes. Many of these applications use an unvented chamber connected to a siphon channel to work as an air pressure-dependent valve. The pressure change in such a valve, however, depends on the radial position of the siphon inlet at the chamber. In addition, many of these applications require stopping the cartridge during certain workflows to accommodate multiple washing requirements. However, existing valve designs, such as conventional pneumatic siphons, simple siphon metering valves and capillary siphon valves, are unsatisfactory for these applications. Accordingly, there remains a need for improved devices and methods in centrifugal microfluidics to address these and other needs in the art.

[0054] Referring to the drawings in detail, wherein like reference numerals indicate like elements throughout, there is shown in Figs. 1-23 a device, generally designated 10, in accordance with an exemplary embodiment of the present invention.

[0055] As shown in Figs. 1-2, the device 10 may be used for analyzing a sample fluid. The device 10 may include a base, a spindle, a motor, a disc, an actuator, a sensor or the like for sample handling or processing, as described below in more detail. The device 10 may include a base 12 to which one or more features may be coupled. The base may be a generally rectangular shape and include a hole 11 extending therethrough. The hole 11 may be generally central to the base. The base 12 may include a top plate 13 coupled thereto. The base 12 and the top plate 13 may be generally the same shape. The base 12 and the top plate 13 may include a plurality of holes and apertures configured to receive one or more other components or features to couple the one or more other features thereto.

[0056] The top plate 13 may include a lens mount 26 fixed thereon. The lens mount 26 may be fixed to a side of the top plate 13 opposite the side of the top plate 13 that couples to the base 12. The lens mount 26 may include a lens aperture 28 extending therethrough. The lens aperture 28 may extend through the lens mount 26 and the top plate 13. The lens mount 26 may have a generally crescent shape extending around a portion of the top plate 13. In one embodiment, the lens mount 26 extends fully around the top plate 13.

[0057] The lens aperture 28 may be shaped and sized to receive an emitter lens 30. The emitter lens 30 may include a lens and a filter. In some embodiments, the emitter lens 30 includes a plurality of lenses and filters. The emitter lens 30 may be a generally cylindrical shape. The lens aperture 28 may receive a portion of the emitter lens 30. In some embodiments, the lens aperture 28 receives the entire emitter lens 30.

[0058] The lens mount 26 may include a plurality of lens apertures 28. The lens mount 26 may include at least six lens apertures 28. The lens mount 26 may include at least five lens apertures 28. The lens mount 26 may include at least four lens apertures 28. The lens mount 26 may include at least three lens apertures 28. The lens mount 26 may include at least two lens apertures 28. Each of the one or more lens apertures 28 may be at a common radius relative to the rotational axis As of the spindle 14.

[0059] The top plate 13 may further include a top printed circuit board assembly (PCBA) 32 coupled thereto. The lens mount 26 may be disposed between the top plate 13 and the top PCBA 32. The top PCBA 32 may include a light source 34 configured to emit a light through the emitter lens 30. The top PCBA 32 may include a plurality of light sources 34, each providing an illumination at a corresponding wavelength in the plurality of wavelengths. In some embodiments, the plurality of light sources 34 is disposed circumferentially at a common radius corresponding to the common radius relative to the rotational axis As of the spindle 14. This allows for each light source 34 to illuminateeach of the one or more wells 84. Each of the plurality of light sources 34 may align with an emitter lens 30 disposed in each of the plurality of lens apertures 28. The top PCBA 32 may have a generally elbow shape with two elongate lengths extending from an angled junction. The two elongate lengths of the top PCBA 32 may extend from each other at a 90-degree angle. The top PCBA 32 may cover substantially all of two sides of the top plate 13.

[0060] The light source 34 can be any suitable light sources or a combination of different types of light sources. For instance, in some embodiments, the light source 34 may include one or more lightemitting diodes (LEDs), one or more superluminescent diodes (SLEDs), one or more narrowband light sources, one or more broadband light sources, or any combination thereof. In some embodiments, the light source 34 may provide illumination at one or more wavelengths from about 280 nm to about 1000 nm. In some embodiments, the light source 34 provides illumination at a plurality of wavelengths. Examples of wavelengths include but are not limited to 340 nm, 405 nm, 456 nm, 505 nm, 545 nm, 580 nm, 600 nm, 610 nm, 645 nm, 660 nm, 720 nm, or any combination thereof. As used herein, a wavelength generally refers to a wavelength range having a central wavelength and a spectral bandwidth, e.g., a full width at half maximum (FWHM). For instance, a wavelength of 340 nm refers to a wavelength range having a central wavelength of 340 nm and a spectral FWHM. Similarly, a wavelength of 405 nm refers to a wavelength range having a central wavelength of 405 nm and a spectral FWHM. The spectral FWHM may be about ± 5 nm, about ± 10 nm, about ± 15 nm, about ± 20 nm, about ± 25 nm, about ± 30 nm, about ± 35 nm, about ± 40 nm, or more. The spectral FWHM of one wavelength may be the same as or different from the spectral FWHM of another wavelength. An illumination at a wavelength (e.g., with a central wavelength and a spectral FWHM) may be selected to target a particular assay or assays, to reduce the chance of capturing a low-response part of the absorption spectrum of the assay chromophore, to increase the target assay sensitivity, or any combination thereof.

[0061] To facilitate a uniform temperature of the sample fluid in the disc 18, heat may be provided to the disc 18. As shown in Figs. 1-2, the device 10 may include a heater 36. The heater 36 may provide radiant heat to the disc 18 when the disc 18 is disposed on the spindle 14. The heater 36 may bring the fluid sample to a desired temperature through constant heat. In some embodiments, the heater 36 may bring the fluid sample to a desired temperature through pulsing heat. In some embodiments, rotation of the disc 18 relative to the heater may generate air circulation between the heater 36 and the disc 18 thereby lowering the temperature of the fluid sample in the disc 18. When the heater 36 is off, the air movement and circulation averages any difference in cooling across the heater 36 and the disc18. This results in very uniform heating or cooling and keeping the temperature of the disc 18 in a tight window around a desired temperature. Because the air movement and circulation may be generated by rotation of the disc 18, there is no need for any air circulation. This reduces the complexity of the device 10 and the manufacturing cost of the device 10.

[0062] In some embodiments, the desired temperature may be a targeted temperature range between about 34 °C and about 40 °C, between about 35 °C and about 39 °C, between about 36 °C and about 38 °C, or about 37 °C. In some embodiments, the desired temperature may be a particular range of 37°C ± 1°C or 37°C ± 0.5°C. In some embodiments, the desired temperature may be a particular range of 36°C ± 1°C or 36°C ± 0.5°C. In some embodiments, the heater 36 is configured such that it takes no longer than about 60 seconds, about 50 seconds, about 40 seconds, about 30 seconds or less from the time of introduction of the disc 18 into the device 10 to reach the target temperature range. In some embodiments, the heater 36 is configured such that it takes no longer than about 60 seconds, about 50 seconds, about 40 seconds, about 30 seconds or less from the time of introduction of fluid sample (e.g., buffer and / or sample) in the disc 18 to the time when the fluid sample reaches the desired temperature. The disc 18 and / or fluid sample may be refrigerated before the time of introduction.

[0063] The heater 36 may include a number of voids 37 extending therethrough. The voids 37 may be positioned, shaped and sized to allow function the movement of other components of the device 10. The voids 37 may be positioned, shaped and sized to allow the emitter 54 of the actuator 20 to pass therethrough. The voids 37 may be positioned, shaped and sized to allow the submagnets 72a, 72b of the magnet 70 to pass therethrough. The voids 37 may be positioned, shaped and sized to allow the sensor 22 to pass through.

[0064] The heater 36 may be coupled to the base 12. The heater 36 may be disposed between the base 12 and the disc 18. In some embodiments, the disc 18 is disposed between the base 12 and the heater 36. In some embodiments, the heater 36 is disposed within the base 12. The heater 36 may be a generally circular shape. The heater 36 may be integrated on a heater PCBA 38. The heater 36 may define an opening 40 in a center thereof. The opening 40 may be shaped and sized as to fit around the spindle 14. In some embodiments, the heater 36 is a PCBA including at least one heating element (not shown). The at least one heating element may extend circumferentially around the opening 40. In some embodiments, there may be at least 2 heating elements. In some embodiments, there may be at least 3 heating elements. In some embodiments, there may be at least 3 heating elements. In some embodiments, there may be at least 5 heating elements. In some embodiments, there may be at least 6 heating elements. In some embodiments, there may be at least 7 heating elements. In someembodiments, there may be at least 8 heating elements. In some embodiments, there may be at least9 heating elements. In some embodiments, there may be at least 10 heating elements.

[0065] The base 12 may include a recess 42 defined therein. The recess 42 may have a depth of approximately 15.3 mm. The recess 42 may have a depth of at least 5 mm. The recess 42 may have a depth of at least 10 mm. The recess 42 may have a depth of at least 15 mm. The recess 42 may have a depth of at least 20 mm. The recess 42 may have a depth of at least 25 mm. The recess 42 may have a depth of at least 30 mm. The recess 42 may have a depth of at least 35 mm. The recess 42 may have a depth between 5 to 35 mm. The recess 42 may have a depth between 10 to 30 mm. The recess 42 may have a depth between 15 to 25 mm. The recess 42 may have a depth between 10 to 20 mm.

[0066] The recess 42 may have a generally circular shape and extend around a portion of the base 12. The recess 42 may be shaped and sized to receive a portion of the heater 36 therein. The recess 42 may be shaped and sized to receive the heater 36 and the disc 18 therein. The recess 42 may be defined around the spindle 14 extending through the hole 11 of the base 12. The heater PCBA 38 may include a tab 44 extending therefrom. The tab 44 may be received in a cutout 46 of the base 12 to prevent rotation of the heater PCBA 38 relative to the base 12. The base 12 may include a door 43 coupled to an outer edge thereof. The door 43 may extend over the recess 42. The door 43 may pivot relative to the base between an open position and a closed position. The disc 18 may be disposed in the recess 42 when the door 43 is in the open position. The disc 18 may be prevented from being removed from the recess 42 when the door 43 is in the closed position. The door 43 may have a length substantially similar to the base 12.

[0067] The base 12 may be coupled to a plate 78. The plate 78 may be configured to couple the device10 to a separate device of structure. The plate 78 may include a number of apertures configured to receive hardware therethrough to couple the device 10 to another device or structure. The device 10 may include a spacer 80. The spacer 80 may be coupled to the plate 78 and the base 12. The spacer 80 may be a vibration isolator configured to reduce the transmission of vibrations between the plate 78 and the base 12. The spacer 80 may maintain a predetermined distance between the plate 78 and the base 12. There may be a plurality of spacers 80. There may be a spacer 80 at each corner of the plate 78. In some embodiments, there are four spacers 80.

[0068] As shown in Figs. 1-2, the device 10 may include a spindle 14 rotatably coupled to the base 12. The spindle 14 may extend through the hole 11 of the base 12. The spindle 14 may extend fromthe base 12. The disc 18, described below in more detail, may include an aperture 48 extending therethrough. The spindle 14 may extend through the aperture 48 thereby coupling the disc 18 to the base 12.

[0069] As shown in Figs. 1-2, the device 10 may include the motor 16 configured to rotate the disc 18 disposed on the spindle 14. The motor 16 may include a rotating member 51 extending therefrom. The rotating member 51 may couple the motor 16 to the spindle 14. The spindle 14 may be prevented from rotating relative to the rotating member 51 when the spindle 14 is coupled thereto. The motor 16 may be a brushless DC motor. In one embodiment, the motor 16 is a precision stepped motor. The motor 16 may rotate the disc 18 at rotational speeds between 10-8500 rpm.

[0070] The motor 16 may rotate the disc 18 at a speed of at least about 10 revolutions per minute (rpm). The motor 16 may rotate the disc 18 at a speed of at least about 20 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 30 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 40 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 50 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 100 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 200 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 300 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 400 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 500 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 600 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 700 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 800 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 900 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 1000 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 1200 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 1400 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 1600 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 1800 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 2000 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 2200 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 2400 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 2600 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 2800 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 2900 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 3000 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 3500 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 4000 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 4500 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 5000 rpm. The motor 16 may rotate the disc 18 ata speed of at least about 5500 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 6000 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 6500 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 7000 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 7500 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 8000 rpm. The motor 16 may rotate the disc 18 at a speed of at least about 8500 rpm.

[0071] In some embodiments, the device 10 or the motor 16 is configured to enable control of rotational speed of the disc 18 with a resolution, including but not limited to a resolution of about 50 rpm, about 40 rpm, about 30 rpm, about 25 rpm, about 20 rpm or better. In some embodiments, the device 10 is configured to enable control of rotational speed of the disc 18 with an accuracy, including but not limited to an accuracy of about + / - 25 rpm, about + / - 20 rpm, about + / - 15 rpm, about + / - 10 rpm or better. In some embodiments, the device 10 is configured to enable control of acceleration and deceleration of the disc 18 rotational movement in a range, including but not limited to a range of about 10 rpm / s to about 4000 rpm / s, about 15 rpm / s to about 4500 rpm / s, about 20 rpm / s to about 5000 rpm / s, about 25 rpm / s to about 5500 rpm / s, about 30 rpm / s to about 6000 rpm / s, about 35 rpm / s to about 6500 rpm / s, or about 40 rpm / s to about 7000 rpm / s

[0072] In some embodiments, the device 10 or the motor 16 is configured to enable control of rotational speed of the disc 18 such that a commanded change in speed is achieved within about + / - 1 second, about + / - 0.9 second, about + / - 0.8 second, about + / - 0.7 second, about + / - 0.6 second, about + / - 0.5 second, or less of the nominal time period. In some embodiments where a protocol specifies a ramp up from about 0 rpm to about 600 rpm at 50 rpm / s, the device 10 achieves a speed of about 590 rpm to about 610 rpm within 11.5 to 12.5 seconds.

[0073] As shown in Figs. 1-2, the device 10 may include at least one actuator 20 coupled to the base 12. In some embodiments, the actuator 20 may alternatively be referred to as a sonicator. The actuator 20 may be configured to mix the fluid in the disc 18. In some embodiments, the actuator 20 may homogenize the fluid in the disc 18. The actuator 20 may have a housing 180 configured to contain the components of the actuator 20 described herein. The housing 180 may be generally cylindrical. In some embodiments, the housing 180 is polygonal. The housing 180 may be comprised of a metal or material configured to prevent magnetic fields from passing therethrough and to keep magnetic fields in, as described in more detail below. The housing 180 may have at least one housing slot 182 extending therethrough configured to allow air to pass into the housing 180. The housing slot 182 may extend along an axis parallel to the axis As. In some embodiments, the housing slot 182 is generally circular or polygonal.

[0074] The actuator 20 may include an emitter 54 extending along an axis parallel to the axis As. The emitter 54 may be a generally cylindrical member with a tip 184 disposed at an end thereof. In some embodiments, the emitter 54 has a square or polygonal cross-section. The tip 184 may be generally rounded and may comprise a rubber material to soften engagement with the disc. In some embodiments, the emitter 54 and the tip 184 are integrally formed of the same material. At least a portion of the emitter 54 may extend from the housing 180. The emitter 54 may include a magnet 186 disposed on an end opposite the tip 184. The magnet 186 may have the same cross section as the emitter 54. The magnet 186 may be fixed to the emitter 54. The emitter 54 may be moveable between a retracted position where the tip 184 is proximate the housing 180 and an engaged position where the tip 184 is spaced apart from the housing 180. The tip 184 may engage the disc 18 in the engaged position.

[0075] The actuator 20 may include an actuator source 56 disposed within the housing 180. The actuator source 56 may be configured to move the emitter 54 between the retracted position and the extended position. The actuator source 56 may include a source body 157 and a coil 158 that extends around the source body 157. The coil 158 may wrap around the source body 157 at least once. In some embodiments, the coil 158 wraps around the source body 157 at least 5 times, at least 10 times, at least 20 times, at least 50 times. The magnet 186 may be disposed within the coil 158 when the emitter 54 is in the retracted position. The magnet 186 may be at least half-way from an end of the coil 158 when the emitter 54 is in the retracted position. In some embodiments, the magnet 186 is above the end of the coil 158 when the emitter 54 is in the retracted position.

[0076] The magnetic field produced by the current in the coil 158 may interact with the magnet 186 to move the emitter 54 from the retracted position to the engaged position. The application of current to the actuator 20 may be controlled and initiated by the controller 24 independent of all other mechanisms of the device 10. An electric current may be supplied to the coil 158 to generate a magnet field emitting from the coil 158. The current may have a frequency of approximately 250 Hz. In some embodiments, the current has a frequency of approximately 220 Hz, approximately 230 Hz, approximately 240 Hz, approximately 250 Hz, approximately 260 Hz, approximately 270 Hz, or approximately 280 Hz. In some embodiments, the current has a frequency of at least 220 Hz, at least 230 Hz, at least 240 Hz, at least 250 Hz, at least 260 Hz, at least 270 Hz, or at least 280 Hz. The amount of current required to move the emitter 54 may vary slightly for each magnet 186. The actuator 20 may be calibrated prior to installation into the device 10 to ensure a sufficient amount of current is being provided to the coil 158.

[0077] The current may be modulated to control the movement of the emitter 54. The current may be supplied to slowly move the emitter 54 into the engaged position so as to not damage or disrupt the disc 18. Once in the engaged position, the current may be varied (increased and decreased) to produce a vibration or other repeated contact between the tip 184 and the disc 18. The emitter 54 may move from the engaged position to the retracted position when the current has been lowered or completely removed. Gravity may be utilized to return the emitter 54 to the retracted position.

[0078] The actuator source 56 may supply a vibration or other noise to the emitter 54. The actuator 20 may be configured to emit vibrations into the fluid in the disc 18 using the emitter 54. In some embodiments, the actuator 20 emits pulsing vibrations into the fluid in the disc 18. In some embodiments, the actuator 20 emits constant vibrations into the fluid in the disc 18. The emitter 54 may be located proximate the disc 18. The disc 18 may rotate relative to the emitter 54.

[0079] The device 10 may include two actuators 20. In some embodiments, the device 10 includes at least three actuators 20. In some embodiments, the device 10 includes at least four actuators 20. Each of the three actuators 20 may be at a common radius relative to the rotational axis As of the spindle. In some embodiments, each of the three actuators 20 are at different radii relative to the rotational axis As of the spindle. The three actuators 20 may be spaced apart from each other. The three actuators may be fixed relative to each other by a actuator mount 58. The actuator mount 58 may be shaped and sized to receive the emitter 54 therethrough. The actuator source 56 may be coupled to the actuator mount 58.

[0080] The actuator 20 may be movably coupled to the base 12. In some embodiments, the actuator 20 may be fixed relative to the base 12. The actuator 20 may be movable between a disengaged position and an engaged position. The emitter 54 may be a first distance from the disc 18 in the disengaged position and a second distance from the disc 18 in the engaged position. The first distance may be greater than the second distance. The first distance may be between approximately 2 mm and 10 mm. The first distance may be at least 1 mm. The first distance may be at least 2 mm. The first distance may be at least 4 mm. The first distance may be at least 6 mm. The first distance may be at least 8 mm. The first distance may be at least 10 mm. The first distance may be at least 12 mm. The second distance may be approximately 0 mm. The second distance may be at least 1 mm. The second distance may be at least 2 mm. The second distance may be at least 3 mm. The second distance may be at least 4 mm. The second distance may be at least 5 mm. The second distance may be at least 6 mm.

[0081] The actuator 20 may be in contact with the disc 18 in the engaged position. The actuator 20 being brought into contact with the disc 18 may apply a force on the disc 18. If the force deforms the disc 18, the integrity of the disc 18 may be compromised or a test of the sample fluid in the disc 18 may be inaccurate. As such, it may be necessary to cushion the force exerted on the disc 18 by the actuator 20. In some embodiments, the actuator 20 may include a spring 21. The spring 21 may be disposed within the actuator source 56. In some embodiments, the spring 21 is coupled to the actuator 20. The spring 21 may ensure that there the force produced by the actuator 20 on the disc 18 is dampened when the actuator 20 contacts the disc 18.

[0082] As shown in Figs. 1-2, the device 10 may include a sensor 22 coupled to the base 12. The sensor 22 may be configured to collect data of the sample fluid in the disc 18. The sensor 22 may be a receiver lens. The sensor 22 may include a lens and a filter. In some embodiments, the sensor 22 includes a plurality of lenses and filters. The sensor 22 may be coupled to a receiver mount 60. The receiver mount 60 may be a generally crescent shape. The receiver mount 60 may include an arm 62 extending therefrom. The arm may include a receiver port 64 configured to receive the sensor 22. The receiver port 64 may receive a portion of the sensor 22. In some embodiments, the receiver port 64 received the entire sensor 22.

[0083] In some embodiments, the device 10 has a plurality of sensors 22, each configured to detect an optical signal indicative of a corresponding wavelength in the plurality of wavelengths. In some embodiments, the plurality of sensors 22 is disposed circumferentially at a common radius relative to the rotational axis As of the spindle 14. In some embodiments, each of the plurality of sensors 22 is optically aligned with a corresponding light source 34 in the plurality of light sources 34. In some embodiments, each of the plurality of sensors 22 includes an optic element 23 (e.g., lens and / or filter) and a receiver 25. In some embodiments, the receiver 25 includes one or more photodiodes.

[0084] The receiver mount 60 may include a plurality of arms 62. In some embodiments, the receiver mount 60 has at least two arms 62. In some embodiments, the receiver mount 60 has at least three arms 62. In some embodiments, the receiver mount 60 has at least four arms 62. In some embodiments, the receiver mount 60 has at least five arms 62. In some embodiments, the receiver mount 60 has at least six arms 62. Each arm 62 may have a receiver port 64. The arms 62 and receiver ports 64 may be shaped and sized to align the sensor 22 with the emitter lens 30. The plurality of arms 62 and receiver ports 64 may be shaped and sized to align each of the plurality of sensors 22 with each of the plurality of emitter lenses 30.

[0085] The device 10 may include a controller 24 configured to control each of the spindle, motor, actuator, and sensor. The controller 27 may be integrated into one or more PCBAs. The controller 24 may be integrated into and control the heater PCBA 38. The controller 24 may be integrated into and control the top PCBA 32. The controller 24 may be integrated into and control a homing PCBA 66 used to track the rotation of the disc 18 relative to the base 12. As shown in Fig. 1, the controller 24 may include a wire 82 extending from at least one of the PCBAs to transmit information. The controller 24 may be configured to transmit the collected sample data to a processor 68. The processor 68 may identify at least one of vitamin Bl 2, free thyroxine hormone (T4), parathyroid hormone (PTH), free triiodothyronine hormone (T3), thyroid stimulating hormone (TSH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), N-terminal pro b-type natriuretic peptide (NT-proBNP), C-Reactive Protein (CRP), vitamin D (Vit D), estradiol, prostate-specific antigen (PSA), beta human chorionic gonadotropin (HCG), ferritin, D-dimmer, testosterone, progesterone, and troponin, or a combination thereof in the sample fluid.. The processor 68 may transmit the collected sample data to a graphic user interface (not shown).

[0086] The device 10 may include a magnet 70 coupled to the base 12. The magnet 70 may be configured to attract one or more magnetic particles within the disc 18, as described below in more detail. As shown in Fig. 20, the magnet 70 may include a pair of submagnets 72a, 72b. Each submagnet 72a, 72b may be generally cylindrical, conical, or cuboid shaped. Each submagnet 72a, 72b may be the same shape and size. In some embodiments, each submagnet 72a, 72b can be a different shape and size than the others. Each submagnet 72a, 72b may include a positive pole and a negative pole. The pair of submagnets 72a, 72b may be coupled to a magnetically conductive plate 74. Coupling the pair of submagnets 72a, 72b to the magnetically conductive plate 74 may produce magnetic field lines at the positive pole and the negative pole of each of the submagnets 72a, 72b.

[0087] The magnetically conductive plate 74 may be generally circular shaped. The magnetically conductive plate 74 may include a plurality of magnets 70 spaced around a circumference thereof. Each of the plurality of magnets 70 may be at a common radius relative to the rotational axis As of the spindle 14. Each of the plurality of magnets 70 may be evenly spaced apart from an adjacent magnet 70. The magnetically conductive plate 74 may include a cavity 76 between magnets 70 of the plurality of magnets 70. The cavity may extend from an outer edge toward an inner edge of the magnetically conductive plate 74. The cavity 76 may not extend from the outer edge to the inner edge of the magnetically conductive plate 74. The magnetically conductive plate 74 may include a plurality of cavities 76. The cavities 76 may align with the emitter 54 and the sensor 22. The cavities 76 maybe shaped and sized to allow the emitter 54 of the actuator 20 to pass therethrough. The cavities 76 may be shaped and sized to allow the sensor 22 to pass therethrough. The magnetically conductive plate 74 may include at least eight cavities 76. In some embodiments, the magnetically conductive plate 74 includes at least ten cavities 76.

[0088] As shown in Fig. 3, the disc 18 may be configured to receive a volume of a fluid comprising one or more components of the sample fluid. The disc 18 may include one or more wells 84. Each of the one or more wells 84 may be at a first common radius relative to a rotation of the disc along the axis As. Each of the one or more wells 84 may be configured to receive a volume of a fluid including one or more components of the sample fluid. Each of the one or more wells 84 may be configured to receive at least one volume of a fluid including one or more components of the sample fluid.

[0089] The disc 18 may include a plurality of testing chambers 86. As shown in Fig. 3, the disc 18 may include five testing chambers. In some embodiments, the disc 18 may include one testing chamber. In some embodiments, the disc 18 may include up to two testing chambers. In some embodiments, the disc 18 may include up to three testing chambers. In some embodiments, the disc 18 may include up to four testing chambers. In some embodiments, the disc 18 may include up to six testing chambers. In some embodiments, the disc 18 may include up to ten testing chambers.

[0090] The homing PCBA 66 may be disposed at or adjacent to the base 12 and configured for determining a location of the disc 18 relative to a home location. In some embodiments, the home location may correspond to the sensor 22, the emitter lens 30, the actuator 20, the magnet 70, or any combination thereof. As shown in Figs. 22 and 23, the homing PCBA 66 may contain a homing signal emitter 190 and a homing signal receiver 192. The homing signal emitter 190 and homing signal receiver 192 may be maintained at a set orientation on the homing PCBA 66. The homing signal emitter 190 may be disposed at least partially above the disc 18 when the disc 18 is disposed in the device 10. The homing signal receiver 192 may be disposed at least partially under the disc 18 when the disc 18 is disposed in the device 10. In some embodiments, the homing signal emitter 190 is disposed under the disc 18. The homing signal emitter 190 may emit a signal 194 that is detected by the homing signal receiver 192. The signal 194 may be prevented from reaching the homing signal receiver 192 by an outer edge of the disc 18, thereby scattering the signal 194.

[0091] The homing PCBA 66 may be configured to detect a location of a positioning structure 47 of the disc 18 (e.g., the positioning structure 47 of the disc 18 in Fig. 3). The location of the positioning structure 47 may be referred to herein as the zero position on the disc 18. When the positioningstructure 47 of the disc 18 aligns between the homing signal emitter 190 and the homing signal receiver 192, the signal 194 is received by the homing signal receiver 192. In some embodiments, the homing PCBA 66 includes both the homing signal emitter 190 and the homing signal receiver 192 above or below the disc 18 and the signal 194 may reflect off of a surface of the disc 18. A textured, projecting, angled, or other signal scattering portion of the surface may prevent the signal 194 from reaching the homing signal receiver 192 to detect a position of the disc 18. This allows for resetting the disc 18 relative to the positioning structure 47. In some embodiments, the homing PCBA 66 is configured for performing this location process with a repeatability of about <0.25, about <0.20, about <0.15, or about <0.1 degree from run to run on a standardized disc 18.

[0092] In some embodiments, the device 10 is configured to enable positioning of the disc 18 such that any point on the disc 18 is within about + / -200 pm, about + / -180 pm, about + / -160 pm, about + / - 140 pm, about + / -120 pm, about + / -100 pm, or less of its nominal position. This ensures that the sample fluid, buffer, or reagents can be introduced into the disc 18. So, for example, a pipette tip can reliably mate with the disc 18.

[0093] As shown in Fig. 4, the testing chamber 86 may include a sample chamber 88, a buffer chamber 90 and one of the one or more wells 84. The sample chamber 88 may be configured to receive the sample fluid (S). The buffer chamber 90 may be configured to receive a buffer (B). Each of the sample chamber 88, the buffer chamber 90 and the well 84 may be in fluid communication.

[0094] A method for analyzing the sample fluid may be disclosed herein. As shown in Figs. 4-17, the method may include the steps of (i) operating the motor 16 of the device 10 for analyzing a sample fluid to rotate the spindle 14 and the disc 18 disposed on the spindle 14, wherein the disc 18 may receive a volume of a fluid having one or more components of the sample fluid; (ii) mixing, using at least one actuator 20, the volume of the fluid having one or more components of the sample fluid to mix the fluid in the disc 18; attracting, using at least one magnet 70, one or more magnetic particles within the disc 18; collecting, using one or more sensors 22, data of the sample fluid in the disc 18; and controlling, using the controller 24, each of the motor 16, spindle 14, actuator 20, magnet 70 and sensor 22.

[0095] As shown in Fig. 3, the disc 18 may comprise a plurality of testing chambers 86. As shown in Fig. 4, the method may include each of the plurality of testing chamber 86 receiving a volume of a fluid. Each of the plurality of testing chambers 86 may receive about 63 pL of a buffer into the buffer chamber 90 and about 13.5 pL of the sample into the sample chamber 88. In some embodiments, theplurality of testing chambers 86 receive the entire volume of the buffer into the buffer chamber 90. The buffer may comprise tris-buffered saline. The sample may comprise blood. Each of the plurality of testing chambers 86 may receive at least 10 pL of the buffer into the buffer chamber 90. Each of the plurality of testing chambers 86 may receive at least 25 pL of the buffer into the buffer chamber 90. Each of the plurality of testing chambers 86 may receive at least 50 pL of the buffer into the buffer chamber 90. Each of the plurality of testing chambers 86 may receive at least 75 pL of the buffer into the buffer chamber 90. Each of the plurality of testing chambers 86 may receive at least 100 pL of the buffer into the buffer chamber 90. Each of the plurality of testing chambers 86 may receive at least 125 pL of the buffer into the buffer chamber 90. Each of the plurality of testing chambers 86 may receive at least 5 pL of the sample into the sample chamber 88. Each of the plurality of testing chambers 86 may receive at least 7.5 pL of the sample into the sample chamber 88. Each of the plurality of testing chambers 86 may receive at least 10 pL of the sample into the sample chamber 88. Each of the plurality of testing chambers 86 may receive at least 12.5 pL of the sample into the sample chamber 88. Each of the plurality of testing chambers 86 may receive at least 15 pL of the sample into the sample chamber 88. Each of the plurality of testing chambers 86 may receive at least 17.5 pL of the sample into the sample chamber 88. Each of the plurality of testing chambers 86 may receive at least 20 pL of the sample into the sample chamber 88.

[0096] As shown in Fig. 5, the method may include rotating the disc 18 in the first direction to move the sample and the buffer out of the sample chamber 88 and the buffer chamber 90, respectively. The sample may be moved into a separation chamber 92. The disc 18 may be rotated to separate blood plasma (P) from cell matter in the sample. The disc 18 may be rotated at a speed of at least 6000 rpm to separate blood plasma from cell matter in the sample. The disc 18 may be rotated at a speed of at least 6500 rpm to separate blood plasma from cell matter in the sample. The disc 18 may be rotated at a speed of at least 7000 rpm to separate blood plasma from cell matter in the sample. The disc 18 may be rotated at a speed of at least 7500 rpm to separate blood plasma from cell matter in the sample. The disc 18 may be rotated at a speed of at least 8000 rpm to separate blood plasma from cell matter in the sample. The disc 18 may be rotated at a speed of at least 8500 rpm to separate blood plasma from cell matter in the sample. The volume of the sample may be metered in this step. Excess sample may remain in an excess sample chamber 94. The buffer may be moved to a buffer metering chamber 96. The volume of the buffer may be metered at this step. Excess buffer may be moved into an excess buffer chamber 98.

[0097] As shown in Fig. 6, the method may include rotating the disc 18 in the first direction to move the sample and the buffer out of the separation chamber 92 and the buffer metering chamber 96, respectively. The sample may be moved into a plasma metering chamber 100. The sample, now primarily plasma, may be metered in this step. Excess sample may be moved into an excess plasma chamber 102. The buffer may be moved into a mixing chamber 104. Pneumatic pressure within the testing chamber 86 may cause the buffer to move from the buffer metering chamber 96 into the mixing chamber 104. The separation chamber 92 may have two outlets in fluid communication therewith. As shown in Fig. 6, a vent channel 101 and a plasma channel 103 may extend from the separation chamber 92. In some embodiments, the separation chamber 92 may have more than one vent channel 101. The vent channel 101 may regulate the amount of pressure that builds in the separation chamber 92 as the disc 18 is rotated to control the volume and flow rate of the sample from the separation chamber 92 into the buffer metering chamber 96. The vented air may be configured to be released into the environment outside of the device 10.

[0098] The disc 18 may be rotated in the first direction at a speed of at least 1800 rpm. The disc 18 may be rotated in the first direction at a speed of at least 2000 rpm. The disc 18 may be rotated in the first direction at a speed of at least 2200 rpm. The disc 18 may be rotated in the first direction at a speed of at least 2400 rpm. The disc 18 may be rotated in the first direction at a speed of at least 2600 rpm. The disc 18 may be rotated in the first direction at a speed of at least 2800 rpm. The disc 18 may be rotated in the first direction at a speed of at least 3000 rpm. The disc 18 may be rotated in the first direction at a speed of at least 3200 rpm. The disc 18 may be rotated in the first direction at a speed of at least 3400 rpm. The disc 18 may be rotated in the first direction at a speed of at least 3600 rpm. The disc 18 may be rotated in the first direction at a speed of at least 3800 rpm. The disc 18 may be rotated in the first direction at a speed of at least 4000 rpm.

[0099] As shown in Fig. 7, the method may include rotating the disc 18 in the first direction to move the sample out of the plasma metering chamber 100. The sample may be moved into the mixing chamber 104. The disc 18 may be rotated in the first direction at a rotational speed of between about 5000 and 8500 rpm to move the sample into the mixing chamber 104. The disc 18 may be rotated in the first direction at a speed of at least 5000 rpm. The disc 18 may be rotated in the first direction at a speed of at least 5500 rpm. The disc 18 may be rotated in the first direction at a speed of at least 6000 rpm. The disc 18 may be rotated in the first direction at a speed of at least 6500 rpm. The disc 18 may be rotated in the first direction at a speed of at least 7000 rpm. The disc 18 may be rotated in the first direction at a speed of at least 7500 rpm. The disc 18 may be rotated in the first direction at 1a speed of at least 8000 rpm. The disc 18 may be rotated in the first direction at a speed of at least 8500 rpm. Rotating the disc 18 in the first direction and the sample entering the mixing chamber 104 may move the buffer into the buffer metering chamber 96.

[0100] As shown in Fig. 8, the disc 18 may be repeatedly rotated in the first direction at a first rotational speed of between about 2000 to 3000 rpm followed by a second rotational speed of between about 6000 to 8000 rpm to mix the sample and the buffer in the mixing chamber 104 and the buffer metering chamber 96. The first rotational speed may be greater than the second rotational speed.

[0101] As shown in Fig. 9, the method may include rotating the disc 18 in a second direction to move the mixed sample and buffer out of the buffer metering chamber 96 and the mixing chamber 104 into a reaction chamber 106. The disc 18 may be rotated in the second direction at a speed of at least 1500 rpm. The disc 18 may be rotated in the second direction at a speed of at least 1750 rpm. The disc 18 may be rotated in the second direction at a speed of at least 2000 rpm. The disc 18 may be rotated in the second direction at a speed of at least 2250 rpm. The disc 18 may be rotated in the second direction at a speed of at least 2500 rpm. As shown in Fig. 7, the reaction chamber 106 may contain one or more reagents 108 and one or more magnetic particle 110 disposed therein. The one or more magnetic particle may be a ferromagnetic particle, a paramagnetic particle, a superparamagnetic particle, or any combination thereof.

[0102] The method may include rotating the disc 18 in one of the first direction or the second direction to position the reaction chamber 106 proximate the actuator 20. The actuator 20 may homogenize and incubate the mixed sample and buffer, the reagent and the magnetic particles within the reaction chamber. The disc 18 may then be rotated in one of the first direction or the second direction to position the reaction chamber 106 proximate the magnet 70. As shown in Fig. 10, the magnet 70 may move the magnetic particles into an annex 112 separated from the reaction chamber 106. The annex 112 may include an inlet portion 114 and a collection portion 116. The magnet 70 may attract the magnetic particles 110 from within the reaction chamber 106. The disc 18 may then rotate to pull the magnetic particles 110 into the annex 112 through the collection portion 116. When the disc 18 has moved the annex to a sufficient distance from the magnet, the magnet 70 may no longer attract the magnetic particles 110. As the disc 18 continues to spin, the magnetic particles 110 may settle in the collection portion 116.

[0103] As shown in Figs. 11-12, the reaction chamber 106 may be flushed to remove any contents thereof. The testing chambers 86 may receive about 50 pL of a wash buffer into a washbuffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 10 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 20 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 30 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 40 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 50 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 60 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 70 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 80 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 90 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 100 pL of a wash buffer into the wash buffer chamber 118.

[0104] The method may include rotating the disc 18 in one of the first direction or the second direction to move the wash buffer from the wash buffer chamber 118 into the reaction chamber 106. In some embodiments, rotating the disc 18 in one of the first direction or the second direction moves a first volume of the wash buffer from the wash buffer chamber 118 through a first wash channel 119 into the reaction chamber 106. The disc 18 may then be rotated in one of the first direction or the second direction to move the first volume of the wash buffer through the reaction chamber 106 and into a waste chamber 120 in fluid communication with the reaction chamber 106. The disc 18 may then be rotated in one of the first direction or the second direction to move a second volume of the wash buffer from the wash buffer chamber 118 through a second wash channel 121 into the reaction chamber 106. The disc 18 may then be rotated in one of the first direction or the second direction to move the second volume of the wash buffer through the reaction chamber 106 and into a waste chamber 120 in fluid communication with the reaction chamber 106. The second volume of the wash buffer may be greater than the first volume of wash buffer.

[0105] The first volume may be between approximately 5 pL to 20 pL. In some embodiments, the first volume is approximately 5 pL, approximately 6 pL, approximately 7 pL, approximately 8 pL, approximately 9 pL, approximately 10 pL, approximately 11 pL, approximately 12 pL, approximately 13 pL, approximately 14 pL, approximately 15 pL, approximately 16 pL, approximately 17 pL, approximately 18 pL, approximately 19 pL, or approximately 20 pL. In some embodiments, the first volume is at least 5 pL, at least 6 pL, at least 7 pL, at least 8 pL, at least 9 pL, at least 10 pL, at least11 pL, at least 12 pL, at least 13 pL, at least 14 pL, at least 15 pL, at least 16 pL, at least 17 pL, at least 18 pL, at least 19 pL, or at least 20 pL.

[0106] The second volume may be between approximately 40 pL to 100 pL. In some embodiments, the second volume is approximately 40 pL, approximately 45 pL, approximately 50 pL, approximately 55 pL, approximately 60 pL, approximately 65 pL, approximately 70 pL, approximately 75 pL, approximately 80 pL, approximately 85 pL, approximately 90 pL, approximately 95 pL, or approximately 100 pL. In some embodiments, the second volume is at least 40 pL, at least 45 pL, at least 50 pL, at least 55 pL, at least 60 pL, at least 65 pL, at least 70 pL, at least 75 pL, at least 80 pL, at least 85 pL, at least 90 pL, at least 95 pL, or at least 100 pL.

[0107] While the first volume of the wash buffer is moved from the wash buffer chamber 118 to the reaction chamber 106, a valve 123 (e.g., a pneumatic valve or similar) may prevent the second volume of the wash buffer from moving from the wash buffer chamber 118 into the reaction chamber 106.

[0108] The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 1000 rpm, approximately 1200 rpm, approximately 1400 rpm, approximately 1600 rpm, approximately 1800 rpm, approximately 2000 rpm, approximately 2200 rpm, approximately 2400 rpm, approximately 2600 rpm, approximately 2800 rpm, or approximately 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1000 rpm, at least 1200 rpm, at least 1400 rpm, at least 1600 rpm, at least 1800 rpm, at least 2000 rpm, at least 2200 rpm, at least 2400 rpm, at least 2600 rpm, at least 2800 rpm, or at least 3000 rpm.

[0109] The disc 18 may be rotated at a higher rotation speed when the second volume of the wash buffer is moved from the wash buffer chamber 118 into the reaction chamber 106 to overcome the resistance of the valve 123. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 3000 rpm, approximately 3200 rpm, approximately 3400 rpm, approximately 3600 rpm, approximately 3800 rpm, approximately 4000 rpm, approximately 4200 rpm, approximately 4400 rpm, approximately 4600 rpm, approximately 4800 rpm, approximately 5000 rpm, approximately 5200 rpm, approximately 5400 rpm, approximately 5600 rpm,approximately 5800 rpm, or approximately 6000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3000 rpm, at least 3200 rpm, at least 3400 rpm, at least 3600 rpm, at least 3800 rpm, at least 4000 rpm, at least 4200 rpm, at least 4400 rpm, at least 4600 rpm, at least 4800 rpm, at least 5000 rpm, at least 5200 rpm, at least 5400 rpm, at least 5600 rpm, at least 5800 rpm, or at least 6000 rpm.

[0110] The rotational speed may then be decreased when the valve 123 has been overcome and the wash buffer is allowed to flow therethrough. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 1000 rpm, approximately 1200 rpm, approximately 1400 rpm, approximately 1600 rpm, approximately 1800 rpm, approximately 2000 rpm, approximately 2200 rpm, approximately 2400 rpm, approximately 2600 rpm, approximately 2800 rpm, or approximately 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1000 rpm, at least 1200 rpm, at least 1400 rpm, at least 1600 rpm, at least 1800 rpm, at least 2000 rpm, at least 2200 rpm, at least 2400 rpm, at least 2600 rpm, at least 2800 rpm, or at least 3000 rpm.

[0111] In some embodiments, the volume in the wash buffer chamber 118 and the rotational speed of the disc 18 can build pressure within the valve 123 to activate the valve 123. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3000 rpm to build the pressure. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 3000 rpm, approximately 3200 rpm, approximately 3400 rpm, approximately 3600 rpm, approximately 3800 rpm, or approximately 4000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3000 rpm, at least 3200 rpm, at least 3400 rpm, at least 3600 rpm, at least 3800 rpm, at least 4000 rpm, at least 4200 rpm, at least 4400 rpm, at least 4600 rpm, at least 4800 rpm, or at least 5000 rpm.

[0112] The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3000 rpm to activate the valve 123. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 1000 rpm, approximately 1200 rpm, approximately 1400 rpm, approximately 1600 rpm, approximately 1800 rpm, approximately 2000 rpm, approximately 2200 rpm, approximately 2400 rpm, approximately 2600 rpm, approximately 2800rpm, or approximately 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1000 rpm, at least 1200 rpm, at least 1400 rpm, at least 1600 rpm, at least 1800 rpm, at least 2000 rpm, at least 2200 rpm, at least 2400 rpm, at least 2600 rpm, at least 2800 rpm, or at least 3000 rpm.

[0113] The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2500 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2750 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3500 rpm. The magnetic particles 110 may remain in the annex while the wash buffer is flushed through the reaction chamber 106. The waste chamber 120 may include an absorbent material 122 disposed therein. The absorbent material 122 may prevent any fluid in the waste chamber 120 from returning and contaminating the reaction chamber 106.

[0114] As shown in Figs. 13, the method may include the testing chamber 86 receiving about 42 pL of the buffer into a secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 20 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 25 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 30 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 35 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 40 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 45 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 50 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 55 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 60 pL of a wash buffer into the secondary buffer chamber 124. In some embodiments, the testing chamber 86 may receive at least 65 pL of a wash buffer into the secondary buffer chamber 124. In someembodiments, the testing chamber 86 may receive at least 70 pL of a wash buffer into the secondary buffer chamber 124.

[0115] The secondary buffer chamber 124 may be configured to receive or contain one or more reagents 128 disposed therein. For instance, in some embodiments, the secondary buffer chamber 124 is configured to contain one or more reagents 128 disposed therein during manufacturing of the disc 18. The one or more reagents 128 may be lyophilized, and may be in bead form. In some embodiments, the disc 18 or at least a portion of the disc 18 may be made of an injection molded thermoplastic piece with one or more cavities as the secondary buffer chamber 124, where the one or more reagents 128 (e.g., lyophilized beads) are placed. The secondary buffer chamber 124 may include a reagent 128 with a reporter particle (R) disposed therein. The reporter particle may bind to a specifically targeted analyte in the sample fluid. Introduction of the buffer into the secondary buffer chamber 124 may hydrate and reconstitute the reagent 128 with the reporter particle disposed therein. The disc 18 may then be rotated in one of the first direction or the second direction to move the buffer and reconstituted reagent 128 from the secondary buffer chamber 124 into a holding chamber 126.

[0116] The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1500 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1750 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2500 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2750 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3500 rpm.

[0117] The holding chamber 126 may prevent the buffer and reconstituted reagent 128 from moving into the reaction chamber 106. The method may include rotating the disc 18 in one of the first direction or the second direction to move any fluid in the reaction chamber 106 into the waste chamber 120 before the buffer and reconstituted reagent 128 are moved from the holding chamber 126 into the reaction chamber 106. This may prevent the volume buffer and the reporter particle from being accidentally moved into the waste chamber 120. This may also reduce contaminated samplesand enhance the accuracy of test readings. The disc 18 may then be rotated in one of the first direction or the second direction to move the buffer and the reporter particle from the holding chamber 126 into the reaction chamber 106.

[0118] The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1500 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 1750 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2500 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2750 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3500 rpm.

[0119] As shown in Fig. 14, the method may include pulling the magnetic particles 110 back into the reaction chamber 106. The disc 18 may be rotated in one of the first direction or the second direction to position the annex 112 proximate the magnet 70. The magnet 70 may move the magnetic particles from the annex 112 into the reaction chamber 106. The magnet 70 may attract the magnetic particles 110 from within the collection portion 116. The disc 18 may then rotate to pull the magnetic particles 110 into the reaction chamber 106 through the inlet portion 114. The method may include rotating the disc 18 in one of the first direction or the second direction to position the reaction chamber 106 proximate to the actuator 20. The actuator 20 may homogenize and incubate the reporter and the magnetic particles 110 within the reaction chamber.

[0120] In some embodiments, the disc 18 may be rotated in one of the first direction or the second direction to position the annex 112 proximate the actuator 20. The actuator 20 may be a actuator or similar configured to contact, directly or indirectly, the disc 18. The actuator 20 may direct vibrations into the annex 112 such that the magnetic particles 110 move into the reaction chamber 106. The actuator 20 may vibrate the annex 112 thereby adding energy to the magnetic particles 110 therein. Instead of homogenizing and incubating the magnetic particles 110, since the annex 112 has a boundary wall, the magnetic particles 110 move into the reaction chamber 106. The disc 18 may then be rotated in one of the first direction or the second direction to position the reaction chamber106 proximate the actuator 20. The actuator 20 may homogenize and incubate the reporter and the magnetic particles 110 within the reaction chamber 106.

[0121] In some embodiments, the disc 18 may be rotated in one of the first direction or the second direction to position the annex 112 proximate the actuator 20. The actuator 20 may direct vibrations into the annex 112 such that the magnetic particles 110 move into the reaction chamber 106. The actuator 20 may homogenize and incubate the reporter and the magnetic particles 110 within the annex 112.

[0122] As shown in Fig. 15, the method may include pulling the magnetic particles 110 back into the annex 112, as discussed in more detail above. The disc 18 may be rotated in one of the first direction or the second direction to position the reaction chamber 106 proximate the magnet 70. The magnet 70 may move the magnetic particles 110 into an annex 112 separated from the reaction chamber 106.

[0123] As shown in Figs. 15-16, the reaction chamber 106 may be flushed to remove any contents thereof. The testing chambers 86 may receive about 50 pL of a wash buffer into a wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 40 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 50 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 60 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 70 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 80 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 90 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 100 pL of a wash buffer into the wash buffer chamber 118.

[0124] The method may include rotating the disc 18 in one of the first direction or the second direction to move the wash buffer from the wash buffer chamber 118 into the reaction chamber 106. The disc 18 may then be rotated in one of the first direction or the second direction to move the wash buffer through the reaction chamber 106 and into a waste chamber 120 in fluid communication with the reaction chamber 106. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 2500 rpm. The disc 18 may be rotated in the first direction or the second directionat a speed of at least 2750 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3250 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of at least 3500 rpm. The magnetic particles 110 may remain in the annex while the wash buffer is flushed through the reaction chamber 106 and into the waste chamber 120.

[0125] As shown in Fig. 17, the method may include the testing chamber 86 receiving about 42 pL of the buffer into a wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 20 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 25 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 30 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 35 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 40 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 45 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 50 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 55 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 60 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 65 pL of a wash buffer into the wash buffer chamber 118. In some embodiments, the testing chamber 86 may receive at least 70 pL of a wash buffer into the wash buffer chamber 118.

[0126] The method may include rotating the disc 18 in one of the first direction or the second direction to move the wash buffer from the wash buffer chamber 118 into the reaction chamber 106. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of approximately 1000 rpm, approximately 1200 rpm, approximately 1400 rpm, approximately 1600 rpm, approximately 1800 rpm, approximately 2000 rpm, approximately 2200 rpm, approximately 2400 rpm, approximately 2600 rpm, approximately 2800 rpm, or approximately 3000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of less than 1000 rpm. The disc 18 may be rotated in the first direction or the second direction at a speed of less than 1000 rpm, less than 1200 rpm, less than 1400 rpm, less than 1600 rpm, less than 1800 rpm, less than 2000 rpm,less than 2200 rpm, less than 2400 rpm, less than 2600 rpm, less than 2800 rpm, or less than 3000 rpm.

[0127] The method may include pulling the magnetic particles 110 back into the reaction chamber 106, as discussed in more detail above. The disc 18 may be rotated in one of the first direction or the second direction to position the annex 112 proximate the magnet 70. The magnet 70 may move the magnetic particles from the annex 112 into the reaction chamber 106. The method may include rotating the disc 18 in one of the first direction or the second direction to position the reaction chamber 106 proximate the actuator 20. The actuator 20 may homogenize the buffer and the magnetic particles 110 within the reaction chamber.

[0128] The method may include rotating the disc 18 in one of the first direction or the second direction to position the reaction chamber 106 proximate the sensor 22. The motor 16 may be configured to continue rotation of the disc 18 during a detection period. In some embodiments, the motor 16 may be configured to stop rotation of the disc 18 during the detection period. The sensor 22 may detect photoluminescent absorption of the magnetic particles 110 during the detection period. After imaging, the disc 18 may be replaced with another disc 18a to perform the steps as outline above to perform testing on the disc 18a. The sensor 22 may measure a baseline photoluminescent absorption of the reaction chamber 106 prior to the detection period. In some embodiments, the baseline photoluminescent absorption of the reaction chamber 106 is separated from the photoluminescent absorption measured during the detection period.

[0129] In some embodiments, for each reaction chamber 106, the sensor 22 produces at least two readings (e.g., the reading includes at least two data points), at least three readings, at least four readings, at least five readings, at least six readings, at least seven readings, at least eight readings, at least nine readings, at least ten readings, at least fifteen readings, or at least twenty readings during the detection period. In some embodiments, for each reaction chamber 106, the sensor 22 produces a minimal of at least two readings, at least three readings, at least four readings, at least five readings, at least six readings, at least seven readings, at least eight readings, at least nine readings, or at least ten readings during the detection period. In some embodiments, for each reaction chamber 106, the sensor 22 produces from two to ten readings, from three to twelve readings, or from four to fifteen readings during the detection period.

[0130] In various embodiments, the sensor 22 may be configured to enable measurement, e.g., measuring detect photoluminescent absorption from or through the reaction chamber 106 on the disc18. For instance, in some embodiments, the sensor 22 is configured to measure photoluminescent absorption through one or more first wells on the disc 18. The measurement can be performed while the disc is stationary or spinning. Examples of acquisition devices and methods include those disclosed in U.S. Patent Application Publication No. 2019 / 0082961 Al, U.S. Patent No. 10,761,019 B2, and International Application Publication No. 2019 / 058308 Al, the content of each application is hereby incorporated by reference in its entirety for all purposes.

[0131] In some embodiments, the sensor 22 is configured to enable signal acquirement in a continuous, semi-continuous or episodic fashion. For instance, in some embodiments, the sensor 22 is operable to start or restart data acquisition about every 60 seconds, about every 55 seconds, about every 50 seconds, about every 45 seconds, about every 40 seconds, about every 35 seconds, about every 30 seconds, about every 25 seconds, about every 20 seconds, about every 15 seconds, about every 10 seconds, or less.

[0132] As shown in Figs. 18-19, the spindle 14 may comprise a locking element 50 configured to prevent the disc 18 from rotating relative to the spindle 14. The locking element 50 may include at least one protrusion 53 extending radially therefrom. The locking element 50 may include at least two protrusions 53 extending radially therefrom. The locking element 50 may include at least four protrusions 53 extending radially therefrom. The locking element 50 may include at least six protrusions 53 extending radially therefrom. The locking element 50 may include at least ten protrusions 53 extending radially therefrom.

[0133] The spindle 14 may include a collar 52 extending radially therefrom. The collar 52 may be a generally circular shape. The collar 52 may have a diameter greater than that of the aperture 48 to prevent the disc 18 from passing over the collar 52. The collar 52 may include a deformable ring 61 disposed thereon. The deformable ring 61 may be comprised of a rubber or other deformable material. The deformable ring 61 may extend around at least a portion of the collar 52. In some embodiments, the deformable ring extends around only a portion of the collar 52. The deformable ring 61 may provide friction between the spindle 14 and the disc 18 and ensure that the disc 18 remains level during operation of the device 10. The deformable ring 61 may extend from the collar 52 to engage the disc 18 when the disc 18 is disposed on the spindle 14.

[0134] The locking element 50 may include at least one locking pin 57 extending therefrom. The locking element 50 may include at least two locking pins 57 extending therefrom. The locking element 50 may include at least five locking pins 57 extending therefrom. The locking element 50may include at least ten locking pins 57 extending therefrom. The locking pin 57 may extend from the locking element 50 proximate the collar 52. The locking pin 57 may be received in a detent 59 of the disc 18. The bottom of the disc 18 may include at least as many detents 59 as the spindle 14 has locking pins 57. The detent 59 may extend into the disc 18 from the aperture 48. The detent 59 may be shaped and sized to receive at least a portion of the locking pin 57. The locking pin 57 may prevent the disc 18 from moving relative to the spindle 14 during operation of the device 10. In a case where more than one locking pin 57 is included on the spindle 14, the locking pins 57 may be unevenly spaced apart to ensure only one possible orientation of the disc 18 on the spindle 14. This orientation may ensure the disc 18 accurately receives the fluid into the sample chamber 88 and the buffer chamber 90.

[0135] To ensure the locking pin 57 is aligned with the detent 59 when the disc 18 is received in the device 10, a spindle setting mechanism may be used. The spindle 14 may be coupled to the motor 16 with a fastener 63. The spindle 14 may be fixed to the motor 16. The motor 16 may have a starting position, which corresponds to the position of the locking pin 57. The starting position may be electrically programmed into the controller 24 which moves the motor 16 into the starting position before the disc 18 is received in the device 10.

[0136] As shown in Figs. 18-19, the spindle 14 may include a disc lock 65 spaced apart from the collar 52. The disc lock 65 may be spaced apart from the collar 52 such that the disc 18 can fit therebetween. The disc lock 65 may be a ball pin disposed at an end of the locking element 50. The spindle 14 may include as many disc locks 65 as it includes locking pins 57. In some embodiments, there are more disc locks 65 than locking pins 57. In some embodiments, there are less disc locks 65 than locking pins 57. The disc lock 65 may include a ball 67 and a spring 69. The ball 67 and spring 69 may be received in a cavity 71 of the locking element 50. The cavity 71 may be a generally cylindrical space defined by the locking element 50 and a lock top 73 coupled to the end of the locking element 50. The lock top 73 may be fixed to the locking element 50 by, for example, a screw. The spring 69 may urge the ball 67 out of the cavity 71. The cavity 71 may include an opening 75 that has a smaller diameter than the ball 67 to prevent the ball 67 from moving out of the cavity 71. The ball 67 may retract in response to a force by, for example, the disc 18 being disposed on the spindle 14. The ball 67 may extend when the force is released, for example, the disc 18 has been received on the spindle 14. The ball 67 may enact a force on the disc 18 when the disc is received on the spindle 14.The ball 67 may urge the disc 18 toward the collar 52. The lock may prevent the disc 18 from moving relative to the collar 52 along the axis As during operation of the device 10.

[0137] Referring to Figs. 24-26, there is shown a second embodiment of the testing chamber, generally designated 86’. As shown in Fig. 24, the testing chamber 86’ is similar to the first embodiment of the testing chamber 86 except that the separation chamber 92’ may have a single outlet (e.g., plasma channel 103’) in fluid communication therewith. The plasma channel 103’ may be a dual-purpose channel configured to facilitate the flow of both the sample and air out of the separation chamber 92’ when the disc 18 is rotated in the first direction to move the sample out of the separation chamber 92’. The plasma channel 103’ may allow for a buildup of pressure within the separation chamber 92’ while the disc 18 is rotated to move the sample and air out of the separation chamber 92’.

[0138] As shown in Fig. 25, the testing chamber 86’ is similar to the first embodiment of the testing chamber 86 except that the testing chamber 86’ may be configured to receive multiple volumes of the wash buffer in separate chambers to flush the contents of the reaction chamber 106’. The testing chambers 86’ may receive about 50 pL of a wash buffer into a wash buffer chamber 118’ and about 8 pL of the wash buffer into the reaction chamber 106’. The disc 18’ may then be rotated in one of the first direction or the second direction to move the volume of the wash buffer in the reaction chamber 106’ into a waste chamber 120’ in fluid communication with the reaction chamber 106’. The disc 18’ may then be rotated in one of the first direction or the second direction to move the volume of the wash buffer in the wash buffer chamber 118’ into the reaction chamber 106’ . The disc 18’ may then be rotated in one of the first direction or the second direction to move the volume of the wash buffer through the reaction chamber 106’ and into the waste chamber 120’ in fluid communication with the reaction chamber 106. The magnetic particles 110’ may remain in the annex while the wash buffer is flushed through the reaction chamber 106.

[0139] In some embodiments, the testing chamber 86’ may receive at least 10 pL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 20 pL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 30 pL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 40 pL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 50 pL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receiveat least 60 gL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 70 gL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 80 gL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 90 gL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 100 gL of a wash buffer into the wash buffer chamber 118’. In some embodiments, the testing chamber 86’ may receive at least 4 gL of a wash buffer into the reaction chamber 106’. In some embodiments, the testing chamber 86’ may receive at least 5 gL of a wash buffer into the reaction chamber 106’. In some embodiments, the testing chamber 86’ may receive at least 6 gL of a wash buffer into the reaction chamber 106’. In some embodiments, the testing chamber 86’ may receive at least 7 gL of a wash buffer into the reaction chamber 106’. In some embodiments, the testing chamber 86’ may receive at least 8 gL of a wash buffer into the reaction chamber 106’. In some embodiments, the testing chamber 86’ may receive at least 9 gL of a wash buffer into the reaction chamber 106’. In some embodiments, the testing chamber 86’ may receive at least 10 gL of a wash buffer into the reaction chamber 106’. In some embodiments, the testing chamber 86’ may receive at least 11 gL of a wash buffer into the reaction chamber 106’. In some embodiments, the testing chamber 86’ may receive at least 12 gL of a wash buffer into the reaction chamber 106’.

[0140] As shown in Fig. 26, the testing chamber 86’ is similar to the first embodiment of the testing chamber 86 except that the testing chamber 86’ may include a secondary buffer chamber 124’ configured to receive a volume of the buffer and a reporter chamber 126’ configured to receive or contain one or more reagents 128’ disposed therein. The disc 18’ may then be rotated in one of the first direction or the second direction to move the buffer from the secondary buffer chamber 124’ into reporter chamber 126’. Introduction of the buffer into the reporter chamber 126’ may hydrate and reconstitute the reagent 128’ with the reporter particle disposed therein. The disc 18’ may then be rotated in one of the first direction or the second direction to move the buffer and reconstituted reagent 128’ from the reporter chamber 126’ into the reaction chamber 106’.

[0141] In some embodiments, the testing chamber 86’ may receive at least 20 gL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 25 gL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 30 gL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 35 gL of a wash buffer intothe secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 40 pL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 45 pL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 50 pL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 55 pL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 60 pL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 65 pL of a wash buffer into the secondary buffer chamber 124’. In some embodiments, the testing chamber 86’ may receive at least 70 pL of a wash buffer into the secondary buffer chamber 124’.

[0142] In one embodiment, the device includes one or more computers having one or more processors and memory (e.g., one or more nonvolatile storage devices). In some embodiments, memory or computer readable storage medium of memory stores programs, modules and data structures, or a subset thereof for a processor to control and run the various systems and methods disclosed herein. In one embodiment, a non-transitory computer readable storage medium having stored thereon computer-executable instructions which, when executed by a processor, perform one or more of the methods disclosed herein.

[0143] The term “about” or “approximately” is used herein to provide literal support for the exact number that it precedes, as well as a number that is near to or approximately the number that the term precedes. In determining whether a number is near to or approximately a specifically recited number, the near or approximating unrecited number may be a number, which, in the context in which it is presented, provides the substantial equivalent of the specifically recited number. It should be appreciated that all numerical values and ranges disclosed herein are approximate values and ranges, whether “about” is used in conjunction therewith. It should also be appreciated that the term “about,” as used herein, in conjunction with a numeral refers to a value that may be ±0.01% (inclusive), ±0.1% (inclusive), ±0.5% (inclusive), ±1% (inclusive) of that numeral, ±2% (inclusive) of that numeral, ±3% (inclusive) of that numeral, ±5% (inclusive) of that numeral, ±10% (inclusive) of that numeral, or ±15% (inclusive) of that numeral. It should further be appreciated that when a numerical range is disclosed herein, any numerical value falling within the range is also specifically disclosed.

[0144] It will be appreciated by those skilled in the art that changes could be made to the exemplary embodiments shown and described above without departing from the broad inventiveconcepts thereof. It is to be understood that the embodiments and claims disclosed herein are not limited in their application to the details of construction and arrangement of the components set forth in the description and illustrated in the drawings. Rather, the description and the drawings provide examples of the embodiments envisioned. The embodiments and claims disclosed herein are further capable of other embodiments and of being practiced and carried out in various ways.

[0145] Specific features of the exemplary embodiments may or may not be part of the claimed invention and various features of the disclosed embodiments may be combined. Unless specifically set forth herein, the terms “a”, “an” and “the” are not limited to one element but instead should be read as meaning “at least one”. Finally, unless specifically set forth herein, a disclosed or claimed method should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the steps may be performed in any practical order.

Claims

CLAIMSWhat is claimed is:

1. A device for analyzing a sample fluid, the device comprising: a base; a spindle rotatably coupled to the base; a motor configured to rotate a disc disposed on the spindle, the disc configured to receive a volume of a fluid having one or more components of the sample fluid; at least one actuator coupled to the base, the actuator configured to mix the fluid in the disc; at least one sensor coupled to the base, the sensor configured to collect data of the sample fluid in the disc; and a controller configured to control each of the spindle, motor, actuator and sensor.

2. The device of claim 1 , wherein the actuator is movably coupled to the base.

3. The device of claim 2, wherein the actuator is movable between a disengaged position and an engaged position.

4. The device of claim 3, wherein an emitting end of the actuator is a first distance from the disc in the disengaged position and a second distance from the disc in the engaged position.

5. The device of claim 4, wherein the first distance is greater than the second distance.

6. The device of claim 1 further comprising: the disc.

7. The device of claim 6, where in the disc has one or more wells at a first common radius relative to a rotation axis of the disc, wherein each of the one or more wells is configured to receive a volume of a fluid including one or more components of the sample fluid.

8. The device of claim 7, wherein the disc further comprises a plurality of testing chambers, and wherein each of the plurality of testing chambers comprises:a sample chamber for receiving the sample fluid; a buffer chamber for receiving a buffer; and one of the one or more wells.

9. The device of claim 8, wherein each of the plurality of testing chambers is configured to measure one or more of vitamin Bl 2, free thyroxine hormone (T4), parathyroid hormone (PTH), free triiodothyronine hormone (T3), thyroid stimulating hormone (TSH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), N-terminal pro b-type natriuretic peptide (NT-proBNP), C-Reactive Protein (CRP), vitamin D (Vit D), estradiol, prostate-specific antigen (PSA), beta human chorionic gonadotropin (HCG), ferritin, D-dimmer, testosterone, progesterone, and troponin, or a combination thereof in the sample fluid.

10. The device of claim 1, wherein the at least one actuator homogenizes the fluid in the disc.

11. The device of claim 10, wherein the at least one actuator emits vibrations into the fluid in the disc.

12. The device of claim 11, wherein the at least one actuator emits pulsing vibrations into the fluid in the disc.

13. The device of claim 1, wherein the at least one actuator comprises three actuators.

14. The device of claim 13, wherein each of the three actuators are at a first common radius relative to a rotational axis of the spindle.

15. The device of claim 13, wherein each of the three actuators are different radii relative to a rotational axis of the spindle.

16. The device of claim 1 further comprising: a homing mechanism disposed proximate the disc configured to detect a position of the disc relative to the at least one sensor, wherein the homing mechanism includes a homing signal emitter emitting a homing signal and a homing signal receiver configured to receive the homing signal.

17. The device of claim 16, wherein the controller recognizes a location of the disc relative to a home location when the homing signal reaches the homing signal receiver.

18. The device of claim 1, wherein the at least one actuator includes a spring cushioning the actuator.

19. The device of claim 1 further comprising: at least one magnet coupled to the base, the magnet configured to attract one or more magnetic particles within the disc.

20. A device for analyzing a sample fluid, the device comprising: a base; a spindle rotatably coupled to the base; a motor configured to rotate a disc disposed on the spindle, the disc configured to receive a volume of a fluid having one or more components of the sample fluid; at least one magnet coupled to the base, the magnet configured to attract one or more magnetic particles within the disc; at least one sensor coupled to the base, the sensor configured to collect data of the sample fluid in the disc; and a controller configured to control each of the spindle, motor, magnet and sensor.

21. The device of claim 20 further comprising: at least one actuator coupled to the base, the actuator configured to mix the fluid in the disc.

22. The device of claim 21, wherein the at least on actuator is moveable relative to the disc between an initial position where the at least one actuator is spaced apart from the disc and an engaged position where the at least one actuator contacts the disc.

23. The device of claim 22, wherein the controller moves the at least one actuator from the initial position to the engaged position.

24. The device of claim 23, wherein the controller applies a DC voltage to the at least one actuator to move from the initial position to the engaged position.

25. The device of claim 24, wherein the controller moves the at least one actuator independent of the spindle, motor, magnet and sensor.

26. The device of claim 20, wherein the magnet includes a pair of submagnets.

27. The device of claim 26, wherein the pair of submagnets are coupled to a magnetically conductive plate.

28. The device of claim 27, wherein the pair of submagnets coupled to the magnetically conductive plate produces field lines at a pole of each of the pair of submagnets.

29. The device of claim 21, wherein a plurality of magnets are coupled to the base.

30. The device of claim 29, wherein each of the plurality of magnets are at a first common radius relative to a rotational axis of the spindle.

31. The device of claim 30, wherein the plurality of magnets are spaced apart from each other about the first common radius.

32. The device of claim 20 further comprising: the disc.

33. The device of claim 32, where the disc has one or more wells at a first common radius relative to a rotation axis of the disc, wherein each of the one or more wells is configured to receive a volume of a fluid including one or more components of the sample fluid.

34. The device of claim 33, wherein the disc further comprises a plurality of testing chambers, and wherein each of the plurality of testing chambers comprises: a sample chamber for receiving the sample fluid;a buffer chamber for receiving a buffer; and one of the one or more wells.

35. The device of claim 34, wherein each of the plurality of testing chambers is configured to measure one or more of vitamin Bl 2, free thyroxine hormone (T4), parathyroid hormone (PTH), free triiodothyronine hormone (T3), thyroid stimulating hormone (TSH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), N-terminal pro b-type natriuretic peptide (NT-proBNP), C-Reactive Protein (CRP), vitamin D (Vit D), estradiol, prostate-specific antigen (PSA), beta human chorionic gonadotropin (HCG), ferritin, D-dimmer, testosterone, progesterone, and troponin, or a combination thereof in the sample fluid.

36. A device for analyzing a sample fluid, the device comprising: a base; a spindle rotatably coupled to the base; a motor configured to rotate a disc disposed on the spindle, the disc configured to receive a volume of a fluid having one or more components of the sample fluid; at least one actuator movably coupled to the base, the actuator configured to mix the fluid in the disc; at least one magnet coupled to the base, the magnet configured to attract one or more magnetic particles within the disc; at least one sensor coupled to the base, the sensor configured to collect data of the sample fluid in the disc; and a controller configured to control each of the spindle, motor, actuator, magnet and sensor, wherein the actuator is movable between a disengaged position and an engaged position, and wherein the magnet includes a pair of submagnets coupled to a magnetically conductive plate.

37. A method of analyzing a sample fluid, the method comprising: operating a motor of a device for analyzing a sample fluid to rotate a spindle and a disc disposed on the spindle, wherein the disc receives a volume of a fluid having one or more components of the sample fluid; mixing, using at least one actuator, the volume of the fluid having one or more components of the sample fluid to mix the fluid in the disc;attracting, using at least one magnet, one or more magnetic particles within the disc; collecting, using one or more sensors, data of the sample fluid in the disc; and controlling, using the controller, each of the motor, spindle, actuator, magnet and sensor.

38. The method of claim 37, wherein the disc further comprises a plurality of testing chambers, wherein each of the plurality of testing chambers receives about 63 pL of a buffer into a buffer chamber and about 13 pL of the sample into a sample chamber, wherein the buffer comprises tris-buffered saline, and wherein the sample fluid comprises blood.

39. The method of claim 38, wherein the disc is rotated in a first direction at a rotational speed of at least 6000 rpm to separate blood plasma from red cell matter in the sample fluid.

40. The method of claim 39, wherein the disc is rotated in the first direction at a rotational speed of between about 5000 and 8500 rpm to move the blood plasma and the buffer into a mixing chamber, wherein excess air is released by a vent when the blood plasma is moved into the mixing chamber, wherein the disc is repeatedly rotated in the first direction at a first rotational speed of between about 2000 to 3000 rpm followed by a second rotational speed of about 6000 to 8000 rpm to mix the blood plasma and the buffer in the mixing chamber, and wherein the first rotational speed is greater than the second rotational speed.

41. The method of claim 40, wherein the disc is rotated in a second direction at a rotational speed of at least 1500 rpm to move the blood plasma and the buffer into a reaction chamber containing one or more reagents and one or more magnetic particles disposed therein.

42. The method of claim 41, wherein the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the actuator, and wherein the actuator homogenizes and incubates the mixed blood plasma and buffer, the reagent and the magnetic particles within the reaction chamber.

43. The method of claim 42, wherein the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the magnet, and wherein the magnet moves the magnetic particles into an annex in fluid communication with the reaction chamber.

44. The method of claim 43, wherein each of the plurality of testing chambers receives about 50 pL of a wash buffer into a wash buffer chamber, and wherein the disc is rotated in one of the first direction or the second direction to move a first volume of the wash buffer from the wash buffer chamber through the reaction chamber and into a waste chamber in fluid communication with the reaction chamber, and wherein the disc is rotated in one of the first direction or the second direction to move a second volume of the wash buffer from the wash buffer chamber through the reaction chamber and into the waste chamber in fluid communication with the reaction chamber.

45. The method of claim 44, wherein each of the plurality of testing chambers receives about 42 pL of the buffer into a secondary buffer chamber including a reporter particle, and wherein the disc is rotated in one of the first direction or the second direction to move the buffer and the reporter particles from the reporter chamber from the secondary buffer chamber into a holding chamber, wherein the disc is rotated in one of the first direction or the second direction to move any fluid in the reaction chamber into the waste chamber in fluid communication with the reaction chamber, and wherein the disc is rotated in one of the first direction or the second direction to move the buffer and the reporter particles from the holding chamber into the reaction chamber.

46. The method of claim 45, wherein the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the magnet, and wherein the magnet moves the magnetic particles from the annex to the reaction chamber.

47. The method of claim 46, wherein the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the actuator, wherein the actuator homogenizes and incubates the magnetic particles and the reporter particles within the reaction chamber.

48. The method of claim 47, wherein the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the magnet, and wherein the magnet moves the magnetic particles into the annex.

49. The method of claim 48, wherein the disc is rotated in one of the first direction or the second direction to move the wash buffer from the wash buffer chamber through the reaction chamber and into the waste chamber.

50. The method of claim 49, wherein the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the magnet, and wherein the magnet moves the magnetic particles from the annex to the reaction chamber.

51. The method of claim 50, wherein the disc is rotated in one of the first direction or the second direction to position the reaction chamber proximate the actuator, and wherein the actuator homogenizes and incubates the magnetic particles and the buffer within the reaction chamber.

52. The method of claim 51, wherein the disc is rotated in one of the first direction, and wherein the sensor detects photoluminescent absorption of the magnetic particles during a detection period.

53. The method of claim 52, wherein the motor is configured to continue rotation of the disc during the detection period.

54. The method of claim 53, wherein the sensor measures a baseline photoluminescent absorption of the reaction chamber prior to the detection period.

55. The method of claim 54, wherein the baseline photoluminescent absorption of the reaction chamber is separated from the photoluminescent absorption measured during the detection period.

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