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    US2021132035A1 Original Document 20220119075425

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    Cesar Gabriel Zapata Casariego
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    ca») United States US 20210132035A1 c2) Patent Application Publication co) Pub. No: US 2021/0132035 Al Adelman (43) Pub. Date: May 6, 2021 (54) MODULAR HANDAIELD POINT OF CARE usw 40 (2006.01) TESTING SYSTEM Hosw 1202 (2006.01) uw 12033200601) (71). Applicant: iAssay, Ine, San Diego, CA (US) A6IB 52052006001) GOIN 2125 (2006 01) (72) Inventor: Lonnie W. Adelman, San Diego, CA GOIN 21768 (Go0801) (us) GOIN 33497 (2006.01) 21 . (2) US.cL 21) Appl. Now 17/001,069 cc GOIN 33/48785 (2013.01); HOSW 12/08 22) Filed: Aug, 24, 2020 Related US. Application Data (68) Continuation-in-part of application No. 16°380,861, filed on Apr: 10, 2019, now Pat. No, 10,753.92 which is a continuation of application No. 14/6 167, filed on Jun. 10,2015, now Pat, No, 10:309,954, filed as application No, PCT/US2013/074209 on Dee 10, 2013. (60) Provisional application No. 61/797,69, filed on Dee 12, 2012, provisional application No. 63/012,228, filed on Apr. 19, 2020, provisional application No. 62/908.477, fled on Sep. 30, 2019 Publication Classification (51) Int. Cl GOIN 33487 HOAW 1208 (2006.01) (2006.01), 105 (2013.01); HoaW 80 (2018.02), HOS 1202 (2013.01): HosW 12/033 (2021.01), ‘ABIB 5/6898 (2013.01); GOIN 21728 (2013.01); GOIN 21/6486 (2013.01); GOIN 33/487 (2013.01); GOIN 344497 (2013.01) ABIB 5702055 (201301) ABSTRACT A hand-held point of eare monitoring system that includes a plurality of assay modules configured to receive different assay devioes that perform assays on one oF more samples. Atleast to ofthe assay modules or at least wo of the assay ‘vices have different identifiers that identify the assays. The system also includes an apparatus having 2 portable {frame configured to interchangeably receive the plurality of assay modules in 2 same port: a means for decoding the fereat identifiers when received by the frame; nd a means or wading assay result, Patent Application Publication May 6,2021 Sheet 1 of 15 US 2021/0132035 Al 100 412 102, 108 _ 104, 111B 106, 106B 104, 111A 106, 106A FIG. 1 Patent Application Publication May 6,2021 Sheet 2 of 15 US 2021/0132035 Al 104 103A 103B 103C 103D ©) ° fil 111A FIG. 2A 104 103C 103D c LIE) Ae oO FIG. 2B Patent Application Publication May 6,2021 Sheet 3 of 15 US 2021/0132035 Al 104 Lo 105 —_ = = od 119A 119A, 1198 129 FIG. 2C Patent Application Publication May 6,2021 Sheet 4 of 15 US 2021/0132035 Al 109A 1098 | tt Ow 1 1091 109C t+ 109D 4 109E 109F | — 1096 109H | } 1095 —— FIG. 3A Patent Application Publication May 6,2021 Sheet Sof 15 US 2021/0132035 Al 100 / 108 1091 a 105 105, 109A FIG. 3B Patent Application Publication May 6,2021 Sheet 6 of 15 US 2021/0132035 Al 104,a11a 4 1048 106 106 Patent Application Publication May 6,2021 Sheet 70f 15 US 2021/0132035 Al 104, 1118 Ye & =) =) 114, 114A 107A —> eT 114, 1148 106 FIG. 4C 104, 1114 > 114, 1148 107A —> 114, 1148 106 FIG. 4D Patent Application Publication May 6,2021 Sheet 8 of 15 US 2021/0132035 Al 106 FIG. 4E Patent Application Publication May 6,2021 Sheet 9 of 15 US 2021/0132035 Al 106 FIG. 5A Patent Application Publication May 6, 2021 Sheet 10 of 15 US 2021/0132035 Al FIG. 5C Patent Application Publication May 6, 2021 Sheet 11 of 15 US 2021/0132035 Al 106 106 Patent Application Publication May 6, 2021 Sheet 12 of 15 US 2021/0132035 Al FIG.7 Patent Application Publication May 6,2021 Sheet 13 of 15 US 2021/0132035 Al 102 113¢ 113H 1136 ° }~ 1131 113F > O j_ 136 ° 113A He) 1130 113) 1138 —|-4 113K 113 FIG. 8 Patent Application Publication May 6, 2021 Sheet 14 of 15 US 2021/0132035 Al FIG. 9A Patent Application Publication May 6,2021 Sheet 15 of 15 US 2021/0132035 Al 502, 516 502, 516 502, 519 502, 517 FIG. 10 US 2021/0132035 Al MODULAR HAND-HELD POINT OF CARE, ‘TESTING SYSTEM CROSS REFERENCE TO RELATED "APPLICATIONS. [0001] This is continuation in part of U.S. patent app cation Sr. no. 16/380,861, filed Apr. 10,2019, now US. Pat No, 10,753,921, which is a continuation of US. pateat application Ser. No. 14/651,167, fled Jun. 10, 2015, now US. Pat, No, 10,309,954, which is a U.S. national phase application of PCT/US2013/074208, filed Dec. 10, 2013, now expired, whieh claims benefit of priority to US. pro visional patent application no, 61/797,691, filed Dee. 12, 2012, now expired. Fach patent application referred to in this paragraph is herein incorporated by reference in its entire [0002] This application also claims benefit of priority to US. provisional patent application no. 6M012,228, filed Apr. 19, 2020 and U.S, provisional patent application no. 621908477, filed Sep. 30, 2019. Fach patent application refecred 10 in this paragraph is herein incoeporated by reference in its entirety ‘TECHNICAL FIELD 10003] ‘The invention relates to the field of medical devices ‘and more specifically o a handheld point of care system, ‘which includes an apparatus having interchangeable mod. ules, which themselves are configured to conduc a plurality ‘of different assays, and which communicates with external devices to collet additional assay data, displays assay resus, and communicates results with remote providers ‘over computer networks, BACKGROUND OF THE INVENTION [0004] Point of care testing is an important way for healthcare providers to effectively and ellicently provide care to individuals. In pancular, point of care testing allows for testing and monitoring of individuals in a plurality of Settings including a hospital, clini, remote reference Jab testing ficilty, doctor's office, home of individual being tested, or anywhere in which an individual may be tested or ‘monitored, Point of care testing, or the carrying out of laboratory tests outside of a traditional laboratory setting, has grown and expanded asa practice over the pas 20 years dlriven at least in part by improvements in technology as well 48a marked increase in at-home patient care. 10005] _ While its use has increased greatly over the past 20, ‘yeas, point of care testing has long been and remains highly inefficient for both the point of care testing provider as well, as the patient. For instance, while it is common for test results tobe displayed by portable test deviews, such devices do aot typically save test data as electronic files that can be transferred or aggregated with other test result data files for subsequent processing or analysis. Rather, test results are usually displayed tothe provider, then reconded or inputted ‘manually into patient files or databases, where they can be printed in worksheets for later comparison with other tests [0006] ‘The ineficiency of point of care testing is also due to the physical cumbersomeness ofthe point of care testing technology as well as its use. For example, a point of care testing. provider, using traditional technology, fiequently ust utilize either multiple point of eare readers, where each reader is configured to perform a single assay or a single May 6, 2021 reader configured to read! more than one assay but only one assay at a time, which itself is selected from a prepro- grammed test menu. Thus, conducting tests with dillerent ‘components atthe bedside or ata walk-in site convention ally requires multiple readers oat least multiple steps. [0007] However, multiple readers are physically cumber- some fo carry from test site to test site and also take up critical heach space at @ physician's oflie, lab or a phat- macy. A a esul, a point of care testing provider is typically unable to add additional tests, either ordered by the physi- cian or requested by the patient while they are atthe site ‘because the provider does not typically have all testing tools available on hand. Thus, additional testing requires the provider leave and return to the site with the additional testing tools an obvious source of inelicieney atthe point, of care SUMMARY OF THE INVENTION [0008] The invention addresses the above deficiencies and provides related embodiments. In particular, described herein are hand-held modular point of care testing systems ‘and methods for testing individuals, which permit multiple tests to be performed using a single handheld appara, Moreover, the systems and methods also permit receiving test resuls or data from other testing devices or systems, and securely pairing, analyzing and/or communicating test result tiles [0009] The systems and methods described herein are licen in numerous ways including how assay results and data are collocted from multiple data sources: and how results and data are transmitted to a network oF networks andlor server of servers that are accessible to healtheare providers and laboratory personnel. In addition, the systems ‘and methods address fong felt but unmet need with respect ‘o traditional point of care testing technology for reducing the cumbersomeness and inllcieney in existing technology in that the instant systems and methods, for example: (1) cfliciently collet and transmit data from multiple different types of input sources; and 2) provide multiplex analysis for rutile different assays and sample types, [0010] The above is accomplished in one aspect of the invention by a modular hand-held point of care testing system, which includes a plurality of assay modules con- figured to receive different assay devices to perform assays, on one of mote samples, such a8 a biological sample or environmental sample, and where at least two of the assay ‘modules or atleast two of the assay devices have different identifies; an apparatus having a portable frame configured ‘o interchangeably reeeve the plurality of assay modules in 1 sume port; a means for decoding the diferent identifiers when received by the frame; and a means for reading assay results, [0011] Iasonse embodiments, the assay module isa single ‘component that is inserted into the frame of the assay device; however, in preferred embodiments the assay” module includes an assay adapter configured to receive the assay vice and a door that receives the adapter. In further embodiments, the door is shared between diflerent assay adapters for different assay devices. {0012} In some embodiments ata distal end of the assay adapter can be a slot positioned transverse to the longitudi- nalextent ofthe assay module anda movable Nap configured to reversibly cover the slot and extend parallel 19 the longitudinal extent of the assay module US 2021/0132035 Al [0013] In some embodiments, at a proximal end of the door can be a handle, optionally configured as a proximal knob, for removing the assay module from the frame, and at distal end ofthe assay adapter can he distal fingers sot for removing the assay adapter fram the door 10014] Preferably, the apparatus is configured for mult pilex testing by conducting a plurality of tess. In some embodiments, the apparatus reads test results from a plural- ity of assays conducted on a single test device. In other ‘embodiments, the apparatus eads test results fom a plural- ity of assays conducted on to or more test devices. In some ‘embodiments, the apparatus receives more than one assay module or assay device, thereby performing more than one assay. In some embodiments, two oF more assays are pet= formed simultaneously. Nonlimiting examples of assays that ‘can be performed include one or more asiay selected from the group consisting of a Sodium assay, Potassium assay, Chloride assay, BUN/Urea assay, Glucose assay, Hematocrit assay, lonized Caleium assay, PO2 assay, pl assay, PCO2 assay, Creatinine assay, Lactate assay, Celite ACT assay, Prothrombin Time PT/INR assay, Kaolin ACT assay. Car- diac Troponin Lie/Tal assay, Total Carbon Dioxide/TCO2 assay, Creatine Kinase MBICK-MB assay. B-Type Natri- ‘uetic Peptide/BNP assay, an immunodiagnostic assay, a DNA sequencing assay, bioluminescent assay, a cell, cytometry assay, a lateral flow assay, and an HbAle assay, 10015] In some embodiments, at least one assay is an immunodiagnostic assay, optionally an enzyme-linked imnosorbent assay (ELISA), In some embodiments at least one assay’ is lateral flow immunoassay, which option= ally includes analysis of line presence or absence intensity, Tine colo, ora combination thereof. At least one assay can bbe a DNA soquencing assay based on DNA sequencing chip(). At least one assay can include polymerase chain reaction (PCR). At least one assay can be a miceoluidic assay. Atleast one assay ean detect or measure ina change in electic charge or pF, such as to detect of measure cell ‘growth oF metabolism. [0016] In some embodimeats at least one assay device includes an immunoassay test strip. The assay deviee can be ‘ cartridge or container. The assay device can be a closed ‘container with an electronic interface that uses nanoparticle ‘technology internally to perform the assy. In sonic embod ‘meats the assay device includes an image capture device and LCD display, which can be inserted into the apparatus and the image captured. Optical character recognition software ccan then identify the text or other identifying indicia to ‘automatically identify the assay so that any required settings ‘or programming can be initiated or followed andlor so that ‘2 grophical user interface is populated with proper control ‘option oF display. 10017] Identifiers can be used to distinguish one assay fiom another In some embodiments, the identifier ison the assay device itself (eg. manufacturers printd information}; and in other embodiments, the identifier is on the assay ‘module. In some embodiments the identifies inlude inl such a, but not limited to a bar code, a QR code, an ‘alphanumeric code, and a color code and where the means for decoding the indica includes an indicia reader (e.g. bar code, QR code, alphanumeric code andlor color code reader). In other embodiments, the identifiers include an RF tag of NFC circuit, and the means for decoding the RF tag ‘or NPC circuit includes an RE tag reader or NFC reader. In ‘ther embodiments, the identifier includes structural features May 6, 2021 that distinguish the assay device from others, which can be decoded using optical imaging or optical scattering analysis in conjunction with optical character recognition software. In some embodiments, the identifiers include diferently ordered teeth, nd the means for decoding the differently ordered teth includes a photoinerrupte. Contol teeth may also be provided to confirm proper insertion of the assay into the frame, {0018} In some embodiments, the apparatus includes an imaging module, such as a camera circuit, for optically capturing the identifier andor assay results, Assay results can then be analyzed using the apparatus. In some embodi- ments, the apparatus itself has a user interface, micropro cessor and memory fo read and optionally analyze assay results, {0019} In other embodiments, the portable frame has a keeper adapted to receive and keep smart device (c., smartphone or tablet computer) or independent touch sereen, In embodiments inchuding a smart device (e. smaeiphone or tablet computer) oF embodiments that funetonally eon nected to a smart deviee, the invention can also include downloadable software for the smart device for reading andor analyzing assay results In some embodiments, the portable frame is adapted to receive (or the portable appa ‘tus inludes) one or more single board computers, such 28 but no limited o a Raspberry Bi, optionally running Linux, [0020] In some embodiments, the apparatus or smart device includes optical stabilization software for stabilizing optical reading or results. In other embodiments the system includes a stabilization structure, optionally configured as a gimbal, tht improves stability of the apparatus, assay mod tule andlor or assay device during shock or movement. In some embodiments, stabilization is accomplished eletroni- cally via @ gravitational sensor that simultaneously sends positon data to the apparatus so that image shaking can be corrected. In related embodiments, the stabilization is ‘accomplished optically andlor electronically, such as by detecting positioning or movement of one or move bubble levelers ot colored iguids/polymers that shift when moved inne or more directions, then adjusting for the movement [0021] In some embodiments, the apparatus includes a collimator. In some embodiments, the apparatus includes fone or more ofa light pipe, lens, prism, signal guiding, or amplification device lined-up with a camera, imaging modalities, oF detection deview [0022] In some embodiments, the means for reading assay results includes a luminescence recorder adapted to record luminescence. Nonlimiting examples of Inminesoence recorders include a camer, « Auorescent light reconder, a LUV recorder, a diodelamplifier type receiver, and a combi- nation thereof. In some embodiments, the luminescence recorder is a buil-in eamera ofa portable computing device. [0023] The systom can also include a bright field light source white light) andlor an excitaion light source config- ured to delivera wavelength to the assay device that excites, fluorescent molecules and a fluorescence detector for detect- ing fluorescence. In some embodiments, the light source is, positioned on the assay module. In other embodiments, the light source is positioned within the portable frame, Non Timiting examples of ight sources include one or more laser diodes or ight exiting diodes (LEDs), optionally selected from the group consisting of white light, an ultraviolet light, 1 violet light, a blue light, a green light, a yellow light, an US 2021/0132035 Al orange light, anda relight. Lighting ean be contolled by independent circuit boards, device processor or smart 10024) In some embodiments the system is configured to conductor communicate with vital sign detector confia- ured to Sense one oF more vital signs ofan individ. Now Timiting examples include stethoscopes, blood presse cl, and heat rate monitors. The system ean also comm- nicate with biological sensors inching insulin sensors. ‘Communication can be one-way or two-way, and ths the system can inclode suitable pons, such as USB pors or a transceiver configured to tansmit and reeeive data. The ‘wansceiver can operate on one oe mare tansmission teche nologss, including but not limited to 3G eommenication protacols 4G communication protocols 5 communication proineols GSM standards, CDMA protocols, IEEE 802.11 Standards, hutooihproocls, Wf proweos, and satelite ‘communications. Communication can be by visible light ‘communications, infrared communications, @ hardwired connection, or near field communication, ln some embodi- ment, the system communicates with ther asays devices. [0025] In some embodiments, the system includes a uni- ‘veal interoperability coupler for coupling diferent assay modules to a same port. The universal operability coupler «an include adjustment bars with exteal handles that allow the user to preset the extemal handles to positions that hold the assay ole in pee 0026] ‘The system caa also include a fanetional module that performs an electrical operation to supplement the testigg system. Preferably, the functional module is conig- ‘une fr interchangeable insertion int the same prt as the plurality of assay modules. In some embodiments, the system includes universal interopebilty coupler far coupling different funetional modules toa same port as assay ‘modules. In some embodiments, the assay modules and funetional modules. share similér dimensions for inter- ‘changeable connection within a same por of the apparatus 10027] In some embodiments, the functional mexule includes a transceiver. In some embodiments, one or more fuetional modules include one oF more of a battery, wireless data transmission device, a wired data transmission device, a microprocessor, an nterfave for receiving and recording signals fom at least one vital sian detector, a luminescence recorder, a display device, a portable comput ing devie. a data storage device, anda hu for eletcally ccoecting one or more assay modules to the apparats 0028] In some embodiments, the funetonal module includes a wireless data transmission device, optionally ‘operating on one or more transmission technologies, includ- ing of 3G communication protocols, 4G communication proincols, 5G communication proiocos, GSM standards, CDMA protocols, IEEE 802.11 standads, Bhetooth proto. cols, satellite communications, visible light communica: tins, infrared communications, and near fe eommuniea- tions. In some embodiments the functional module transmits data to a focal area network or the Internet. In some ‘embodimens, the functional module includes an adapter for powering an exeml device (eg. powered USB). [0029] In view ofthe above, also diselosed is # modular hhand-beld point of care testing sytem, which includes an assay module configured to receive an assay deviee 10 periorm an assay on a biologie sample: functional module that pecforms an eletical operation to supplement the testing system; and an apparatus With porable fume having May 6, 2021 f plurality of ports, where at Jeast two ports are each configured to interchangeably reeive the assay module and the functional module, and where, the apparatus includes or is configured to functionally connect toa means for reading assay rel [0030] Also in view ofthe above, a modular point of care testing system is provided, which includes an assay module configured to rooeive an assay device that performs an assay ‘ona sample, such as a biological or environmental sample, ‘lone or in combination withthe assay module; an apparatus ‘ith portable frame configured to receive the assay module and read assay results fom the assay device; a wansmitier configured to transmit data from the assay module or appa- ratus to a mobile computing device or a remote server; and ‘8 universal interoperability, coupler configured to opeeably couple a plurality of diferent assay modules and optionally functional modules with the portable frame. BRIEF DESCRIPTION OF THE DRAWINGS {0031] The novel features of the invention are set forh ‘with particularity inthe appended claims. A beter under- Standing of the features and advantages of the present invention will be obtained by reference tothe following detailed description that es fork ilsrative embodiments, in which the principles ofthe invention are uilized, and the accompanying dawings of which {0032} FIG. 1 shows an exemplary embodiment of a ‘modular hand-beld point of ear testing system 100, show ing an exemplary apparates 102 receiving functional mod ules 154, 1058 and assay modules 1068, 1068 and having a graphical user nteiace M12 fo displaying and istrocting transmission of data ies. 10033] FIG. 24 is an exemplary lateral flow test device 104 for use with the invention that i conigued t est for four diferent analytes 103A-103D on a single tet stip IIA. FIG. 28 is another exemplary lateral ow test device 104, which ests fr fve analytes 1034-103E (and conta 10) on separate test eps TILA, FIG, 2C is atest deve 104 inthe form ofa container 105 having elecrodes 19, 1108 for measuring clei properties ofthe sample (119A) an electric properties af solution (119B) within which the Sample is incubated. {0034] FIG. 3A isa schematic of an exemplary mulipu- pose funetonal device 105, {0035} FIG. 38 is a schematic ofan exemplary apparatus 102 showing an integrated camera 1091 and single board computer 109 {0036] FIGS. 44-4F show exemplary configurations of various assay deviees 104 fom different manufacturers being received by assay modules 106, defined generally by dillrea assay adapters HOTA that fits into @ same door 1078 [0037] FIGS. $A-SC show an exemplary method of opera tin, which includes inserting an assay device 104 ino its comesponding assay module 106, then inserting the assay module 106 ito the apparatus 102 {0038} FIGS. 6A-68 depict an exemplary assay module 106 identifiable by tvth T14A and inca TAB. [0039] FIG. 7 depicts an exemplary means for automating assy ideation, {0040] FIG. 8 is a schematic of an assay apparatus 102 Configured to peforn a plurality of diferent asseys. [0041] FIGS. 94.98 depict an embodiment ofan assy Spparsts 102 that couples to & starsphone 117 US 2021/0132035 Al [0042] FIG. 10 shows an example of eaviconment $00 that «can be employed to interact withthe testing system. DETAILED DESCRIPTION OF THE INVENTION [0043] The preseat disclosure is described in greater detail below, This description is not intended to be a detailed catalog ofall the dillereat ways in which the invention may be implemented, oral the features that may be added tothe instant invention. For example, features iustrated with respect to one embodiment may be incorporated into other embodiments, and features illustrated with respect 10 a particular embodiment may be deleted from that embocl- ‘ment. In aition, numerous variations and additions to the various embodiments suggested herein will be apparent to those skilled in the art in light of the instant disclosure, Which do not depart from the instant invention. Hence, the following specification is intended to illustrate profeered ‘embodiments of the invention, and not to exhaustively specify all permutations, combinations and variations thereof, [0044] As an introduction, described herein are modular hand-held point of care testing and monitoring systems ‘configured to carzy out tests and measurements including, but not limited to, biologic sample testing. and physical parameter (eg. vital sign) measurement. Assays performed by the systems generally include healtheare assays and veterinary assays for detecting and monitoring: medical conditions of individuals but ean also be adapted for food product assays and environmental assays. [0045] As used herein, the term “point of care” means any location where @ hand-held testing system may be utilized and/or any locaton at which healthcare may be delivered to an individual. Non-imiting examples of a point of care includes a home of a patent, a health clinic or doctor's office, a mobile clinic or other field clinic ste, a nursing ‘home, a rehabilitation Facility, oF hospital [0046] As used herein “biologic sample” or “biological sample” means a sample obiained from an individual Examples include bodily Aids such as blood, serum, plasma, saliva, urine, ocular Hid, semea, and spinal uid Samples can be suspensions made from solid, semi-solid or highly viseous materials, such a soils, fecal mater, tissues, ‘onzans or other samples: that are not fluid in nature. For ‘example, these solid or semi-solid samples can be mixed with an appropriate solution, such as a bulfer (eg. a diluent ‘or extraction buffer). The sample can be macerated, frozen ‘and thawed, or otherwise extracted to form a id sample or suspension sample. Residual particulates ean be removed or reduced using conventional methods, such as filation or centrifugation. “Biological samples” can include cells, ‘microbes, organelles, nveleie acids (DNA, RN). polypep- tides, analytes, and biochemical complexes. As used herein, the team “individual” means any human or animal [0047] The term “environmental sample” means a ‘men taken from surroundings such as water, sil, municipal ‘waste, hazardous waste, potential pollutants and others. Environmental samples can be used to assess water quality, soil quality air quality, pollution, ecology, fisheries, forestry ‘and othe? eaviroamestal studies, In some embodiments, ‘environmental assays test forthe presence or abundance of ‘one or more inorganic eompounel or metal [0048] Turing now to FIG. 1, modular hand-held point ‘of care testing system 100 is depicted, which is configured May 6, 2021 to runa varia of laboratory tests on one of more biologic samples. More specifically, system 100 includes apparatus 102, which is configured to read test results from a plurality of differnt assay dovices 104. Jumping briefly to FIG. 10, test resulls can then be communicated tothe operator or ea be transmitted over « computer network 810 for remote analysis and monitoring, [0049] Moving on to FIGS. 2A-2C, which will be escribed in more detail in passages that follow, assay device 104 isa strcture upoa or within which a biological assay is performed, To this end assay device 104 can include any suitable container 108 or receptacle for receiv- ing and holding a sample during testing. Thus, a container 108 refers to an assay device 104 having a receptacle for receiving and holding a sample during testing, [0050] In some embodiments, the biological assay ean be conducted solely using the assay device 104, such as where all components of the assay are positioned in or on assay device 104, An example is shown in FIG. 24, where test vice 104 includes atest stip IITA that conducts a lateral flow assay able to capture and thus display the presence or abundance of different analytes 108-103D using antibody capture techniques known in the immunodiagnostic arts. IG, 2B depicts a similar configuration, where a single test, device 104 inchudes four separate est strips 111. configured to detect or measure five analytes 103A-103E plus control 103F. However, as depicted in FIG. 2C, in other embod sents the assay’ is conducted within assay deviee 104 but requires further input from apparatus 102 such as delivering electricity to electrodes 1194-1193 via electric contacts 129 or by inducing fluorescence using LEDs 113F positioned Within apparatus 102 (see FIG. 8) [0051] Tuning now to FIGS. 1-10 collectively, assay device 104s preferably held using assay module 106, which itself is configured for insertion into portable frame 108 of apparatus 102. That is, assay module 106 is adapted for coupling assay device 104 with portable frame 108 so that, apparatus 102 can read assay results fom assay device 104, AS nonlimiting examples, assay module 106 may be con- figured to couple with assay devices 104 embodied a8 a sample container 105 (eg. a cartridge, housing. or cuvette IIIB) or atest strip IITA Tacking a surrounding cartidge oF housing. In embodiments where assay module 106 receives assay device 104 configured as a sample container 108, assay module 106 can electronically couple assay device 104 to apparatus 102 such as using suitable electronic connectors and circuitry for conducting an assay within the container (eg. to provide power to an elecirde-based assay) Likewise, assay module 106 may be configured as an terface to transfer daa (e.g electrical test data) from assay ddovice 104 to apparatus 102. Moreover as best seen in FIG, 1, apparatus 102 can conduct different tests simultancously, ‘which can be monitored using graphical usr interface 112 In particular, assay module 106A is shown ready for receiv- ing cuvette TH1B for insertion into apparatus 102 for con ducting a first test, and assay module 106B is shown with test stip ILA ready for insertion into available port 10 of apparatus 102 to conduct a second test on a same sample, ‘Test results are then communicated or transmitted through a network to healthcare providers, [0052] FIG. 1 also shows apparatus 102 with two already received functional modules 105A, 10SB, which are sized to share 8 same port 110 as assay modules 106, 106B within, frame 108, Functional module 108 is « componest that US 2021/0132035 Al peeforms an operation to supplement or assist apparatus 102 ‘but does not itself conduct biological assay’ nor does it physically receive an assay device 104 for insertion into frame 108 for reaing assay ress. Funetonal mode 105, nay however, ceive assay esuls from another device (eg themometer, pulse and blood oxygen monitor) for pairing with pint dats. Moving. on to FIG. 3, a funtonal ‘module 105 canbe o can include one or more of: a battery 1094, a wired or wireless data transmission device 109B, a microprocessor 109C, an interface fr zeeiving and recoed- ing signals from at feast one vital sign detector 109D, a Tuminescence recorder 1095, a display device 109F, a por table computing device 1096, a data storage device 109H, ‘camera 1081 and others. In some embodiment fnetonal rmodile 108 receives. data from a thied-pary assay for pairing with patient dats obtained hy apparas 102, thea ‘commisicates or tansmits paired data to healthcare provide en. 100S3]_In view of the above, one ofthe benefits of the system 100 is that i is modola By “modula” its meant thatthe system 100 inludes one ce more interchangeable components or pats. Typically, two interchangeable mod ‘les may be emaved and inserted into a same pot 110 af the apparatis 102 thereby decreasing the numberof required pots 10 to perform multiple assays and function. Prefer- ably, the system 100 is modular in that two oF more assay nodules 106 canbe interchanged witina same port 10nd ‘wo oF more functional modules 108 can be iterchanged within a same port 110, The sytem 100i also preferably ‘modular in that assay modules 106 and functional modules 105 may be interchanged within a same pon 110. 10088] Best shown in FIGS. 1, $4-SC and 94-98, snp ratus 102 is preferably portable so that system 100 is capability of being operated while being hed inthe hands of fan operator AS such, fame 108 of apparatus 102 is prefer ably sized and configured to be eomforably held inthe hand ofa typical user. In some embodiments, fame 108 inches 8 strap configured to securey or comfortably holt frame 108 within as operator's and. In addition, frame 108 is primar ily formed of generally lightweight polymer components that ean be comfortably held and cared when used. Pref= erably apparatus 12 is also capable of being operated while ‘being support by o esting onan inanimate sure, such ‘8 ona patient's bed. ona desk or chai, on a utility ea, or any sch surfaces located ato else to the ste where testing takes place 10085] Retuming collectively to FIG. 110, assay modile 106 properly postions assay device 104 in apparatus 102 for reading assy rests. As wil be explained in more detail in sections that fll. when assay edule 106 is inserted ito pot 110, preferably apparatus 102 idetitos the asay otha pparatus 102 iates required programming o condvet the sey ead assy ress, andlor communicate with network 510 (F1G. 10) to receive assay information. As such, assay ‘dependent programming canbe identified and stated auto- matically in response to an automated assay identification step. Though not prefered cause its more prone to user ceror, the artisan will appreciate that a user could also perform one or more steps suchas entiying the assay and inputting one or more patent or assay parameters into apparatus 102 using conventional input cont [00S6) Moving on to FIGS. 4A-4E a plurality of eitlreat sssay modules 106 configured to recive a plurality of diferent assay devices 104 are depicted. Dilereat mani May 6, 2021 turers of assay devices 104 tend to use dtferent sizes and shapes to distinguish their assay devices 104 from others. “Thus, conventional assay readers are typically limited to a single assay and its genetic copes, One solution to reading ifferent sized assay devices 104 in single apparatus 102 is to have a plrality of diferent sized ports 110, which is encompassed by the disclosure herein. Another i to have agjutably sized ports 110, which s also encompassed bythe disclosure herein, The solution depicted in FIGS. 44-SC is the development ofa plurality of assay modules 106 that ean be interchanged within a same port 110. In particular, each assay module 106 is configured to receive an assay device 104 that performs an assay (€.. on a biologie sample), and Where atleast two assay modules 106 and/or atleast two assay devices 104 have different identifiers 114, Apparatus 102 is configured to receive each different asay module 106 in a same port 110 and includes a means for decoding identifiers 114 such that when received, identifiers 114 idemify the paicuar assay or assay settings forthe appa- ratus 102 as needed (eg. qualitative or quantitative assess- ‘ment) and thus apparatus 102 can initiate programming or setting instrctions to perform or read say results. An example is depicted in FIGS. 64-7, in which identifiers 114 are embodied as dilferently ordered teeth II4A. In such embodiments, reading and distinguishing between diferent assay modules 106 by the apparatus 102 can be by way of 4 phovointermpter 116 (see FIG. 7) that distinguishes beteen sets of diferent ondered teth I14A. Also shown is contol tooth 115 that ensures assay module 106 is flly inserted into frame 108 {00S7] A photointerupter 116 is a photosensor, which ‘ypically inchs Fight emitting elements and fight eeeving elements aligned fecing each othe in a single package that work by detecting igh blockage when a target object comes between both elements, acting as an optical switch. To this end, different arrays of teeth LIMA on different assay mod- ules 106 can be aligned to selectively block diferent com- binations of emitters and receivers for identification. Using this approach, a plurality of assay modules 106 can be adapted to fit in a same port 110; yet be distinguished from ‘one another by the predefined array of teeth 1144, These differnt arays of teeth I14A provide the identity of the test device 104 or subgroup of test devices 104 and thus permit te apparatus 102 to automatically proceed with conducting any required steps or adjustments for proper testing or reading, {00S8] In another embodiment, identifiers 114 include indicia 1148 printed on assay module 106 and/or assay device 104 (See F1G. 44). In such embodiments, the means for decoding the identifier 114 ean be embadied as camera 1134 (FIG. 8) configured to capture one or more images of the indicia 14B for assay identification. As shown in the schematic of FIG. 8 the camera HI3A ean have its own separate and dedicated circuit controled by a device pro- cessor 113B within apparatus 102. Altematively, camera 1091 can be provided as a functional module 108 (see FIG. 3A) orean be by way of asmart device et. smartphone 117 or tablet computer) (see FIG. 9), Accordingly, refering {0 FIGS. 110, a plraliy of assay modules 106 can be adapted oft a plurality of different assay devices 104 and fit ina same port 110, and by proviing distinguishable indicia 148 that can be decoded by system 100, test device 104 can be identified for proper reading or analysis. In a Variation ofthis approach, test device 104 includes printed US 2021/0132035 Al indicia L148, which can be captured by apparatus 102 oF smariphone 117. Nonlimiting examples of indicia 148. include a barcode, « QR code, an alphanumeric code, and a colar code. [0059] In some embodiments, assay module 106 includes, fan RF tag IAC, and the apparatus 102 includes an RF tag electronic reader 113C. Accordingly, a plurality of assay modules 106 can. be adapted to fit a plurality of different assay devices 104 and fit in a same port 110, yet be distinguished from one another by their corresponding RF tag 114C that can be detected by the apparatus 102, which informs the apparatus 102 the identity of the test device 104, ‘and thus the type and sensitivity of the assay tor proper reading and/or analysis. 10060] In some embodiments, the system 100 uses 0 oF ‘more means for decoding identifies 14, This approach can be preferred when a manuficturer offers different assays Within a same cartidge footprint or when different mani facturers rely on a substantially similar catidge footprint. Inthese instances, assay module 106, which is identified by 2 specific array of teeth 114A, can be paired with one or more assay device 104. Decoding the aay of teeth 1144, ‘can be performed by photointerrupter 16 (FIG. 7), which can initiate a means for decoding a second identifer 114 (FIGS. 44-46), sued as using a laser scanner or camera 113A to optically scan the assay device 104 for distinguish able indicia 148 (eg. alphanumeric characters, colors, dlistnguishing surface characteristics, QR code) or using RF tug electronic reader I13C to read RC tag IAC, One of ‘ordinary skill in the art will recognize thatthe means for decoding a secondary identifier 114 can also be used as a cconfimation checkpoint, to confiam the assay device 104 prior fo reading asay results [0061] In view ofthe above, the artisan will appreciate thot identifiers 114 may be used to adjust apparatus 102 settings, assay identification, sample identification, patient identi cation, and others. Moreover, identifies 114 canalso be used to track patient or sample information throughout the testing and analysis process 10062] In addition to the above, assay modules 106 have ‘heen developed to address particular requirements for dif- fereat assay devices 104, For example, returning 0 FIG. 4A, some assay devices 104 have elongated end portions 118, ‘which in some embodiments can be a sample application ‘pad. To account for this elongated portion 118, assay module 106 in FIG. 4A is slotted 120 so that elongated portion 118, ‘can be bent and fed through slot 120, However, one chal- lenge with bending portions of test device 104 is that ia some instances, test devie 104 applies a counter force, This ‘counter force ean potentially cause additional challenges in ‘capturing test results. As such, an assay module 106 has been developed having ata slo 120 positioned transverse to the longitudinal extent of the assay’ module 106 for accepting and bending portions of a assay device 104 and a movable flap 121 configured to reversibly cover the slot 120 and ‘extend parallel to the longitudinal extent of the module 106. ‘This fap 121, when extending longitudinally, partially cov- cers assay device 104 and provides a suficient retaining force to prevent the assay device 104 from substantial movement, thereby permiting test results to be effectively capture. [0063] Assay modules 106 have also been further improved for manipulation by users. For example, in FIG. AE, assay module 106 has two separable parts, such as assay adapter 107A for holding assay device 104, and door 107 May 6, 2021 for receiving one of more assay adapters 107A. Assay module 196, atthe proximal end of door 107B can inl proximal kab 122 (soe also FIG. 8C) and atthe distal end of assay adapter 107A can inclnde distal fingers slots 128 (oe NG. AE}. As such, the user can use knob 122 to asist ‘with insertion or removal of assay module 106 tof port 110; ad finger sos 124 can assist the emovainsertion of assay adapter 107A when paced with door 10TB. [0064] Ina rete embodiment, door 107B olds an assy adapter 107A, which has a means for heating andor cooling one or more assay devies 104 (eg. a Pelier cooler or heater) In further embodiments, door 107B holds an assay adapter 117. configured asa heating andr cooling block adapted to receive assay devices 104 configured as tubes or microbes, which hold the sample: for testing. In some cmbodimeas the assay module 106 or assay adapter 107A, includes block foruse asa thermoeyeler whe inserted into fpparts 102 for conbiting polymerase chain reaction (PCR) in assay devices 104 configured as microbes. In oer embodiments the assay moxle 196 or assy adapter 107s configured for conducting isothemal amplification, including loop-medited amplification (LAMP) and whole genome ampliation (WGA), stand displacement ampli fiction (SDA), helicase dependent amplification (HAD), recombinase polymerase amplification (RPA), nile aid sequences based amplification (NASBA), and others. In Some embodiments the door 117B hols a complete blood count (CBC) unt to measure the amount r oncentraton of White hlood cell. The atin will appreciate hat door 1078, nay also house eagents for delivery to assay devices 104, such as trough micrfuiie or perisatic pumps integrated into adaper 107A, [0065] In some embextiments system 100 includes a sta bilzation structure, optionally configured asa gimbal, that Improves stability of apparatus 162, assy module 106 antior assy device 104 during shock or movement, In related embodiments, stabilization is accomplished elee- teonically via @ gravitational sensor that simultaneously sends position data to apparatus 102 so that image shaking can be corrected. In related embodiments, the stblization is accomplished optically andor electronically, such as by deteting pestoning or movement of one or move bubble levelrs or colored ligucs’polymers that shift when moved in one or more directions, then adjusting forthe movement In some embodiments, apparatus 102 andor assay module 106 further inches shroud or shield conigured to block ambient noise andr interference, whether by caused. by Tih, electrical signal, or magmatic fores. In ome emboui- ments, there is @ shroud configured 1o’at least partially surround apparatus 102 1 block noise andlor interference [0066] Among the fare achievements, assay mexles 106 have also been specifically developed for Muoreseenee assays. In particu, an assay mole 106 as boen devel- oped, which inches an excitation ight sources configured 10 deliver wavelength tothe assy device 104 that excites Alvorescent molecules, which when coupled to an apparatus 102 that includes a Mooresence detector 13D, permits the ue of fluorescent testing. In prefrrd embodiments, the excitation light source is one or more light emitting diodes (LEDs) 131, In exemplary embodiments, the LEDs 131 Include one or more ofan ultavioet Hight violet fight, Due gt a aren pt a yellow ight an range Fight, and ard igh, which are powered when inserted nto apparatus 102 Bright field illumination ean also be perlormed using a US 2021/0132035 Al ‘white light, such as using a white LED 13 included in an ray of nonewhite LEDS or separately. 10067] Taming now to the variety of assays that can be performed, the system 100 is configured to perform a variety ‘of assays which include, but are not nite to one or more of immunodignostc assays, tera flow assays, DNA Sequencing asoys, biotuminescentassys, metabolic assys, call proliferation assay, cel eytometry assays and others, {0068} In some embodiments, the assay i one oF more ‘assay selected from the group consisting ofa Sodium assay, Potassium asa, Chloride assay, BUN Ure assay Glucose assay, Hematocrit assay, Ionized Caleium assay, P2 assay, pll.assay, PCO2 assay, Creatinine aay Lactate assay, Celts ACT assy, Potombin Time PTUINR assay, Kaolin ACT assy, Caiae Troponin Veil assay, Total Carbon Diox- ie/ICO2 assay, Creatine Kinase MB/CK-MB assay, BBType Natriuretic PeptidelBNP assay, an iamunodignos- tic assay. a DNA soqucncing assay, a bioluminescent assay, 2 call cytometry assay, Jatral low assay, and an HbAle assays. [0069] Non-timiting examples of additonal asays that ‘an be carted out using the system 100 include detection af Virus or antibodies against virus (eg. severe acute respi tory syndrome (SARS); Covid-19), ABO Grouping (Blood Typing), Acrenocoricotropic Hormone level, Aldosterone level, Alpha 1 Antinypsin level Alpha Fetoprotein level, Aluminum level, Amylase level, Antinclear Antibody (ANA) Screen, Apolipoprotein AI (Apo Al) level, Anenic level, B 12 level, Beta Carotene level, Beta HCG level, Bone-Speciic Allaline Phosphatase love, Baype nate ‘uri poptide level, Calsitonin, serum level, Caen, lon- ized level, Cancer Antigen 125 level, Caneee Antigen 15-3 level, Cancer antigen 2729 level, Candida Antibodies level, Carboyrate Antigen 199 level, Careinoembrvonic Antigen level Camitine Catecholamine level, Celiac Disease Ant ‘ody Screen, Cerulolasmin level, Chemisiry Panel & Com- plete Blood Count (C1), Chromi,plasina level, Chro- ‘mograin A level, Complement C3 level, Complement C4 level, Copper leva, CoQ 10 (Coeazyme QIO) level, Crti- sol level, Consol 24 Hour level, Cortisol AM/PM level, Coxsackie Group B Antibodies, C-Peptide level, C-Reactive Protein level. Creatine Kinase level, C-Telopeptide, seria level, Cystatin © Cytokine Pane level, Cytomegaloviss (CMV) Antibodies, iG, Cytomegalovis (CMV) Antbod ies, IeM, D-Dimer level, Delytoepiandosterone Sulit level, Dihydrotestosterone level, Epstein Bat Virus, ESR, Estadio! level, Total Estrogen level, Estrone level, F24s0- prostae level, Fator VIII Activity, Ferritin level, Fibrino- gen love, Folate level, Frucosamine level, Glostin-3 eve, Gamma Giutamy! Transfrase level, Glutathione evel, Glu- ten Jvel, Helocobacter Pylori, gG, Hemoglobin AIC level, Hepatitis B surface Antibody, Hepatitis C Virus Antibody, Homocysteine level, Human Herpes Virus Antibodies, lnsi- lin-Like Growth Facior Binding Protein 3(TGFBP-), Insc, [N-Terminal Propeptie of Type I Procollagen (PINP), Inter leukin 6 (IL.6),Inerteokin 8 (IL-8), Interleukin theta (L~ Theta), Todine level, loized Caleium level, Iron & Tota Inoa-Binding Capacity (TIBC), Lactate Dehydrogenase (LD) Isenzymes, Leptin level, Lipase level Lipoprotein (a) level, Lithium level, Magnesium level, Mercury level, Myeloperoxidase kvel, Oslecalein level, Parathyroid Hor ‘mone level, Reticuloeyte Count, Serotonin level, Sex Hor mone Binding Globulin level, Transferrin level, Troponin 1 level, Tumor Necrosis Fator-Alpha level, Vita. level, May 6, 2021 Vitamin BI evel, Vitamin B 12 level, Vitamin B6 level, Vitamin € level, Vitamin D Vitamin Ki level, Zine level, Adrenocortcotrpic Hormone level, Alkaline Phosphatase level, Aluminum level, Ammonia level, Antiiuretic Hor. ‘mone level, Antinuoleer Antibody, Arsenic level, B Type Naturotic Peptide level, Total Estrogen level, Progesterone level, Testosterone level, Prostate Specific Antigen level (PSA), C-Reactive Protein (High Sensitivity Cardia) level, Cadmium level, Calcium, Tonized (Serum) Test, Candida Antigen | Antibody Profile, Ceniloplasmin levels, Chla- riydia Paeunomonia level, Complete Metaboli Panel, Cop- perlevel, Consol level, C-Pepide level, Dehydroepiandios- terone level, Dihydeoestosteone level, Epstein-Barr Virus level, Erythrocyte Sedimentation Rate, Estadio! level, Est rio! evel, Eston level, Ferritin level, Folate level, Follicle Stimulating Hormene level, Luteinizing Hormone level, Glucose-6-Phosphate Dehydrogenase level, Glutathione level, Growth Hormone evel, Hemoglobin Al € level Homocysteine level, Ig Immonoglobin level, IgE Immu- noglobin evel, Insulin evel, Insulin Growth Factor (GF, Iron level, Lactic Acid Dehydrogenase level, Lead level, Leptin level, Lipid level, Magnesium level, Manganese, ‘Methylmalonic Acid level, Microalbumin level, Parathyroid Hormone level, Prolactin level, Prothrombin Time (PT), Partial Thromboplastin (PTT) Prothrombin Time INR, Reverse Teliodothyronine level, Selenium level, Sex Hor- ‘mone-Binding Globulin level, 3 Uptake, Testosterone Free and Total, Thyroalobulin, Tayroid Antibody level, Thyroid Stimolating Hormone level, Thyroxine (T4), Thyroxine Binding Globulin level, Tamor Necrosis Fatoe-Alpha, Unie Acid level, Total Cholesterol, HDL Cholesterol level, LDL. Cholesterol level, Urine Spevtic Gravity (SG), Urine pl, Urine Protein level, Urine Gincose level, Urine Ketones, Urine Blood (hemoglobin) and Myoglobin, Urine Leukocyte Esterase, Urine Nitrite, Urine Bilirbin, Urobilinogen, and Fecal Occult Blood {0070} In some embodiments, the immunodisenostic assays are enzyme-tinked immunosorbent assays (ELISA), ‘The ELISA (sometimes also called an EIA) is a sensitive, inexpensive assay technique involving the use of antibodies (or other binding. moieties) coupled 10 indicators (eg. enzymes like horseradish peroxidase and alkaline phos- plistase) used to detect the presence or amount of an alte of interest, While there are several diferent types, basically ELISAs are ereted by coating a suitable plastic (he solid phase) with an antibody. To complete the reaction, a sample believed to contain the antigen of interest is added t0 the solid phase. Then a second antibody coupled with an enzyme is used followed by washing unbound secondary, then addition of a color-forming subseate forthe enzyme. in some embodiments, the ELISA assay is based on compari son of eolor type, color intensity, ora combination thereof to one or more references. In some embodiments, the assay device 104 includes one or more wells in which the ELISA assay can be performed and the apparatus 102 includes an optical reader for reading colorimetric changes due tothe ELISA reaction. {0071] In some embodiments, the immunodiagnosic assays ar lateral low assay. Lateral low tests also known as Lateral Flow Immonochromatographic Assays are simple devices intended 10 detect the presence (or absence) of target analyte in sample (matrix) without the need for specialized and costly equipment, though many Tab based applications exist that are supported by reading equipment US 2021/0132035 Al ‘Typically, these assays are used for medical diagnostics either for home testing, point of eare testing, oF laboratory use. A widely spread and wellknown application is the Thome pregnancy test. The lteral flow assay is based on a series of capillary beds, such as pices of porous paper sintered polymer Each ofthese elements has the capacity to transport id (eg, urine) spontaneously. The frst element (the sample pad) acts 28 a sponge and holds an excess of Sample id. Once soaked, the aid migrates to the seeond clement (conjugate pad) in which the mannfocturer has stored the so-aled conjugate a dried format of biostive particles (See below) in @saltsugar matrix that contains everything to guarantee an optimized chemical reaction ‘rwcen the target molecule (en antiga) and its chemsi- cal prize € antibody) that hs been immobilized onthe particle's surface. While the sample Mid dissolves the saltsugar mati, it albo dissolves the particles and in one combined transport action the sample and conjugate mix ‘wile owing through the porous structure. In this way, the analyte binds othe particles while migrating fer through ‘te third capillary bed. This material has one oF moze areas (often called stipes) where a third molecule has been immobilized by the manufacture. By the ime the sample conjugate mix reaches these stips, analyte has been bound fon the ptcle and the third “copie’ molecule binds the complex. Aer a while, when more and moze Hid has passed the stipes, patcles accurate and the stipearea changes color. Typieally, there are at est two stipes: one {abe contro) that captures any parle and thereby shows that reaction conditions and technology worked fine, the secon contains a specific capture molecule and only cap- tures those particles onto which an analyte molecule has boon immobilized. After passing these reaction zones the fhid enters the final porous material hat acts a a waste container (aso called a “sink”, Lateral Plow Assays ean ‘operat as ethor competitive or sandwich assays. In some ‘embodiments, the later How assay based on comparison af line intensity, ine col, or a combination thereat one or ‘more reference lines, There can also be sample and negative contol lines. To this en, the assay device 104 can be a Tater flow test strip and results ean be ead optically using the apparatus 192, the color and inteasty can be assessed, and the results displayed or trnsmited as desir 10072] The systems and methods aso include nucleic acid Sequencing essays. In particular an assay device 104 canbe «embodied as a DNA sequencing chip ora nuclei acid array that works withthe apparanis 102 to conduct DNA sequene ing analysis [0073] The systems and methods can aso include meta- boli asays ad cell proliferation assay. In such embol ‘ment, the assay device 104 canbe configured asa container 108 with elecirdes 9A-11913 that sense changes in analyte concentration or pH, which s indicative of metabo- lism and thus cell growth (se FIG. 2C) [0074]. Non-limiting examples of bioluminescent (or chemiluminescent assays performed fll or in pat by the assay device 14 and optionally assay module 196 include luciferase asays In biological research, luciease is com rool used as reporter to assess the trascrptonal activity in cols that are transfected with genetic construct con- taining the leiferase gene user the contol of a promoter of interest. Additionally, proluminesceat molecules that are converted to Tucifrin upon activity ofa paicular enzyme ‘ean be used to detect enzyme activity in coupled oe wo-step May 6, 2021 Juciferase asays. Such substrates have been used to detect caspuse activity and eytochrome P4S0 atvity, among ot- {0075} Luciferase can aso be used to detect the level of cellular ATP in cll viability assays oe for kinase activity assays. Luciferase can act as an ATP sensor protein through biotinylation. Bitinylason will immobilize luiferse on the eell-suriae by binding toa steptavidin-bitin comple. This allows luciferase to detect the efflux of ATP from the cell and will eflectively display the real-time release of AIP through bioluminescence, Luciferase can additionally be made more sensitive for AIP detection by increasing the fuminescence intensity through genetic mexificatons {0076] An example ofa bioluminescence ATP assay is the ATP Bioluminescence Assay Kit CLS I! by Roche Applied Science, whichis specially developed for applications in ‘which constant ight signal are required for Kinatic stds of enzymes and metabolic studies, or if coupled enzymatic assays are applied. If ATP deteminations are manvaly stared, the CLS Kit provides high reproducibility duet the constant signal generation. However, the sensitivity of the Kit is lower by a factor of 10 as compared to the ATP Bioluminescence Assay Kit HS I, which is recommended fr determinations in the high-sensitivity range. The ATP Bioluminescence Assay Kit HS I also contains an effiient cell Isis eagent and can be used forthe detection of ATP in microorganisms or animal cells. The ATP Biolumines- cence Assay Kit CLS Il has « Detection lint of 10-11 M ATP (10-18 moles), using a fuminometer {0077} Ia some embodiments, an asiay module 106 is configured to perform a cel eytometey assay, and where the assay module 106 or apparatus 102 (Gee FG. 8) includes pump 11, laser diode 113F, microcomputer 1136, and fn optical Sensor H13H. Cell eyiometry is a laser-based biophysical technology’ employed in cell counting, cell sorting, biomarker deietion and protein engineering, by suspending cells ina steam of tid and passing them by an clectonie detection apparatus. I allows simultaneous mul- tiparametic analysis of the physical and chemical charac- testes of upto thousands of panicles per second. Flow cytomety $8 routinely used in the diagnosis of health disorders, especially blood cancers, hut has many other applications in basic research, clinical practice and elinical teas. A commen variation i to physically sort panicles based on their propertcs, so as to purify populations of interest, {0078] _Asa non-limiting example, a beam of light (usually laser light (e.lser diode 113F) ofa single wavelength is directed onto a hycrodynamiclly focus stream of liguid. Anumber of detectors (e.g optical sensors 13H) are aimed atthe point where the stam passes throug the ight beam: ‘one inne wit the ight beam (Forward Seater or FSC) and several perpendicular to it (Sie Seater o SSC) and one or more fluorescence detectors Bach suspended particle from (0210150 micrometers passing trough the beam seater the ray, and fluorescent chemicals found in the particle or atiehed to the porte may be excited ino emiting light at ‘longer wavelenth than the ight source. This combination of seattered and fhorescent iti picked up by the detee- tors, and, by analyzing Auctuations in brighiness at each detector (one fo each uorescent emission peak) iti then possible to derive various types of information about the pliysical and chemical structure of each ingividual particle FSC correlates withthe ell volume and SSC depends onthe US 2021/0132035 Al inner complexity ofthe panicle (shape of the nucleus, the amount and type of eytoplasmie granules or the me ‘yane oughes), Tiss because the lights sattered lf of the intemal components ofthe eel. Some flow eytometes ‘onthe market have eliminated the need foe huorescence and use only light scatter for measurement. Other flow eytom fers form images ofeach el’ fluorescence, scattered light, and transite light [0079] Detection methodologies used by the appara 192 depend t least in part, on the asuy being performed Insonic embodiment, the apparatus 102 includes an imag ing module and/or detector tat detects optical wavelengts. ‘One of oxinary sil in the art will ecognze that apparatus 102 can include imaging component, such as lenses (ea dichroic lens, half ball lens, concave lens, convex lenses, collimator), fits (e. bandpass fillers), CCD sensors, ‘CMOS sensors and the lke to selectively collect wave. lengths for testing. Further. the apparatus 102 can iaelude character recognition software for decoding indicia 4B. 10080] In some embodiments, the apparatus 102 detects colorimetric changes that occur ina cuvette IIIB. As such, the apparatus 102 or assay moxle 196 may be configured to, for example, tansmit a beam of enerey (eg. light, radiation) through the ewvette IAB where it maybe detected by a detector (eoptical sensor 131) witha the apparatus 102. In some embodiments, the beam of light interacts with the ewette 1B and the apparatus 102 uses Ransan seat- tering to conduct the assay. In ther embodiments, the beam flight ioteracts withthe ewette IIE andthe apparatus 102 detets, measures or calculates light absorbance. In some mbosiments the beam of energy is from an excitation light source configured 10 deliver a wavelength to the assay device 104 that excites one or more ooreseent molecules, such that a fluorescence detector within the apparatus 102, can detect Maoresence fom the vette HII. {0081} In some embodiments, the apparatus 102 uses imaging wo detemaine qualitatively or quantitatively the amount of analyte 108-103D captured on atest strp HLA. “To this ead, FIGS. 44-4E exemplify the nonlimiting diver sity of test strips IITA that eam he used withthe assay modules 106 [0082] In some embodiment, the apparatus 12 includes electronic components and eieuity, soch as hut not imited {o 2 microprocesor 1131, memory 13, and tanseeiver 113K (r, altematvely, separate transmit and receiver) In some embodiments, the microprocessors H131 ae solo core, dual-core, quadhcore, Score, I6-ore, 32core, Gore microprocessors. The microprocessors 1131 may be graphic processors with ane core oF more than one cor. In some ceases, the mivroproceses 1131 are microconoles and Single processors, Alematively, the microprocessor 1131 may be an electronic circuitry designed specifically to process the data described in this subject matter. Inadition, non-transitory memory includes software that is configured to cause the processor fo cary out various processes described herein 10083] In some embodiments, the apparatus 102 incudes ‘one oF more cameras 113A, detectors (electronic HISD, radiation), or other imaging modalities. Cameras 188 or detectors can be controled by processors 1138, Altea tively, cameras 113A and detectors can be configured (0 ‘uansnit signals wielessy, such as 10 smariphones 117, tablets andor one or more single board computers 109), such 2s but no limited to a Raspberry Pi optionally eaning May 6, 2021 Lynx. In some embodiments, the apparatus 102 includes a Juminescence recorder 113K (including. chemilumines- cence) adapted to record luminescence generated by the assay device 104 as it tests a sample using a luminescence technique. In some embodiments the luminescence reconler T13K is selected from a camera, a fluorescent light recorder, 1 UV recorder, or combinations thereof. In some embodi- ments, the luminescence recorder isa built-in camera of portable computing deviee. In some embodiment, the lumi- rescence recorder includes a light source and a light receiver, such as a pin diodefamplifer type receiver tuned to 1 specific wavelength, [084] In some embodiments, the frame 108 is configured to operably couple with a smariphone 117, tablet or other computing device so that one or more of the elect components of the computing device are utilized as the electronic components of the system 100, For example, 2s shown in FIGS, 9.98, some embodiments, the frame 108. is adapled to receive a smartphone 117 or computer tablet such tat the smartphone 117 or tablet eamersalign withthe assay device 104 to read assay results In other embodiment, the apparatus 102, which may include an imaging circuit, a CCD sensor or CMOS senso, is configured to couple with, a computing device so that the computing device is opera- tively integrated with the apparatus 102 to collect and analyze the data, The imaging eireuit ean include a detection nay. In some embodiments, the portable computing device is selected from a smartphone 117 or a tablet compute. In some embodiments, the computing device includes a down loadable software module configured to provide step-by- step guidance for coupling, collecting and analyzing data, In some embodiments, the computing device includes a down- loadable software module configured to collet, process ans ‘organize data from the apparatus 102, assay device 104, assay module 106, or a combination thereof. In some embodiments, the computing device inchudes a download- able software module configured to communicate data to a user, where the data is acquired from the assay module 106, the apparatus 102, or combination thereol. Ia some embodiments the asay information is securely communi- cated fo the user through a serve. In some embodiments, the servers an Internet server r a local access network server In some embodiments, the user is a patient, a doctor, ora ruse. Computing devices suitable for use in the present isclosure inelude, but are not Fimited t0, mobile phones, mobile computing devices, smartphones, portable comput- er, tablet computers, and mobile computers. [0085] In some embodiments, images formed by indi- vidual cameras or other imaging modalities o detectors are assembled to create a single image with a wider feld of view. In some embodiments, images formed create an image captured with natural light. The embodiments are to artili= cially increase the field of view with two cameras {0086} Instill another improvement, stabilization has been improved such as to improve assay reading while the apparatus 102 undergoes shock. In some embodiments, the smartphones, tablets or optical processing includes optical stabilization software for stabilizing optical reading or results, [0087] In some embodiments, the apparatus 102 includes ‘a means for wireless communication configured to transfer data with a corresponding means for wieless communica tion on a module as would a mechanical coupler (c-. a proag-based system). Now-limiting examples of wireless US 2021/0132035 Al ‘transmission technologies suitable for use as universal oper= able coupler in the apparatus 102 include 3G transceivers, 4G transceivers, SG transceivers, Bluetooth transceivers, visible light signal transceivers, inffared transceivers, RF ransceivers, and neue field transceivers, [0088] As previously described, the apparatus 102, in some embodiments, is configured to receive functional ‘module 105 andor assay module 102 within any one of its pons 110, In general, a funetional module 108 provides a finetionaity without condueting a biological assay, For ‘example, 2 functional module 105 may couple with the apparatus 102 by way of the por 110 and provide a reader, processor, or memory that is operably coupled with the

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