AUTOMATED ORDERING AND REPORTING FOR PRESCRIPTION-BASED, CUSTOMER-PERFORMED DIAGNOSTIC TESTS - Patent application

Abstract

A system and method are provided for integration of user-administered diagnostic test results with electronic health records. In one aspect, the method includes receiving a prescription specifying a user-administered test and a patient, transmitting the prescription information to a pharmacy and a test provider, generating a unique order identifier that is sent to a user application that associates the order identifier with the test results after the user administers the test, receiving the test results associated with the order identifier, storing the test results and the order identifier in a medical record database associated with a medical record number or encounter identifier, and sending a notification of the test results to the prescribing clinician.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 319,138, filed March 11, 2022, which is hereby incorporated by reference in its entirety.

[0002] The present disclosure relates generally to diagnostic testing, and more specifically to systems and methods for integration of user-administered diagnostic test results with electronic health records. [Background technology]

[0003] User-administered diagnostic tests are becoming increasingly popular because they can provide reliable, inexpensive, portable, fast, and simple diagnostic tests. Advantageously, many user-administered diagnostic tests can be minimally invasive and can be performed by a user (e.g., a patient or other non-clinician) in an environment outside of a clinical or laboratory environment, such as the user's home. However, sharing the results of user-administered diagnostic tests is typically difficult, time consuming, and inefficient in the context of existing electronic health record systems. Summary of the Invention [Means for solving the problem]

[0004] In a first aspect, a system includes one or more processors associated with at least one of a healthcare provider and a testing provider, and a user device including the one or more processors. The one or more processors associated with at least one of the healthcare provider and the testing provider are configured with computer-executable instructions to receive a prescription from a clinician computing device specifying a user-administered test and a patient, transmit prescription information corresponding to the prescription to a pharmacy interface, generate an order identifier that uniquely identifies the prescription, and cause transmission of the order identifier to a user application installed on a computing device associated with the patient. The one or more processors of the user device are configured with processor-executable instructions included in the user application to receive the order identifier, obtain test results corresponding to the user-administered test, associate the received order identifier with the test results, and send the test results in association with the order identifier to the one or more processors associated with the healthcare provider.

[0005] In some embodiments, the one or more processors associated with at least one of the healthcare provider and the testing provider are further configured to receive the test results in association with the order identifier and store the test results and the order identifier in the medical record database in association with at least one additional identifier corresponding to the patient or at least one additional identifier corresponding to the consultation corresponding to the prescription.

[0006] In some embodiments, the one or more processors associated with at least one of the healthcare provider and the testing provider are further configured to send a notification to the clinician computing device indicative of the test results.

[0007] In some embodiments, the one or more processors associated with at least one of the healthcare provider and the testing provider are further configured to cause a notification to be sent to the patient instructing the patient to install the user application on the computing device, In some embodiments, the notification comprises an email, a text message, or a push notification in a second application different from the user application.

[0008] In some embodiments, obtaining a test result corresponding to a user-performed test includes receiving an image of the test device taken following application of a sample to the test device, and automatically determining the test result based on the image data of the received image of the test device. In some embodiments, the test device includes a lateral flow assay test strip, and automatically determining the test result includes detecting one or more lines on the lateral flow assay test strip.

[0009] In some embodiments, the one or more processors associated with at least one of the healthcare provider and the test provider are further configured to cause a test type identifier corresponding to the user-administered test to be transmitted to the user application, In some embodiments, transmitting the test type identifier causes the user application to provide one or more instructions associated with the test type to the patient.

[0010] In some embodiments, the user-performed test comprises a lateral flow assay and the test result comprises one or more lines on the lateral flow assay.

[0011] In a second aspect, a computer-implemented method for providing user-administered tests in conjunction with an electronic medical record system includes, under control of one or more processors, receiving from a clinician computing device a prescription specifying a user-administered test and a patient, transmitting prescription information corresponding to the prescription to a pharmacy interface, generating an order identifier that uniquely identifies the prescription, causing the order identifier to be transmitted to a user application installed on a computing device associated with the patient and configured to associate the order identifier with test results determined at least in part by the user application, receiving test results from the user application in association with the order identifier, storing the test results and the order identifier in a medical record database in association with at least one additional identifier corresponding to the patient or at least one additional identifier corresponding to the visit corresponding to the prescription, and sending a notification associated with the test results to the clinician computing device.

[0012] In some embodiments, the method further includes sending a notification to the patient instructing the patient to install the user application on the computing device prior to causing the command identifier to be sent to the user application, in some embodiments, the notification instructing the patient to install the user application comprises an email, a text message, or a push notification in a second application distinct from the user application.

[0013] In some embodiments, the method further includes transmitting a test type identifier corresponding to the user-performed test to a user application. In some embodiments, transmitting the test type identifier causes the user application to provide one or more instructions to the patient associated with the test type. In some embodiments, the test type identifier corresponds to a lateral flow assay test.

[0014] In some embodiments, the notification associated with the test result further includes a patient identifier or a consultation identifier associated with the prescription.

[0015] In some embodiments, the user-performed test comprises a lateral flow assay test and the test result comprises one or more lines on the lateral flow assay.

[0016] In a third aspect, a computer-implemented method for providing user-administered tests in conjunction with an electronic medical record system includes, under control of one or more processors of a computing device associated with a patient, receiving from a computer system associated with a test provider or health care provider an order identifier corresponding to a prescription specifying the user-administered test and the patient, obtaining test results corresponding to the user-administered test, and transmitting the test results to the computer system associated with the test provider or health care provider in association with the order identifier.

[0017] In some embodiments, the method further includes receiving an indicator of a test type of the user-performed test, obtaining one or more instructions associated with the test type, and displaying the one or more instructions to the patient prior to obtaining the test results. In some embodiments, the one or more instructions include instructions for collecting a sample, instructions for applying a sample to a test device, instructions for determining the validity of the sample or the test results, or instructions for imaging the test device to determine the results by a computing device.

[0018] In some embodiments, obtaining test results corresponding to the user-administered test includes instructing the patient to enter the test results in a user interface of the computing device.

[0019] In some embodiments, obtaining a test result corresponding to the user-performed test includes receiving an image of a test device used for the user-performed test and automatically determining the test result based on image data of the received image of the test device. In some embodiments, the test device includes a lateral flow assay test strip, and automatically determining the test result includes detecting one or more lines on the lateral flow assay test strip. In some embodiments, the computing device includes an image capture device, and receiving the image of the test device includes displaying instructions to a user to capture an image of the test device using the image capture device, and receiving the image from the image capture device.

[0020] In some embodiments, the method further includes providing a notification to the patient in response to receiving the order identifier.

[0021] In some embodiments, the user-performed test comprises a lateral flow assay and the test result comprises one or more lines on the lateral flow assay. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 illustrates generally an exemplary system and closed-loop communication workflow for conducting a user-administered diagnostic test in conjunction with an electronic health record system. [Diagram 2] 1 is a flow chart illustrating an exemplary method for obtaining and reporting results of a user-administered diagnostic test based on a test order from a healthcare provider. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Traditionally, tests ordered, requested, or prescribed by a physician or other clinician have been performed in settings such as hospital or reference laboratories that may employ trained test administration personnel and computer-implemented workflows that allow for receiving test prescriptions and transmitting test results that can be entered into the patient record. However, the development of high-quality rapid diagnostic tests has enabled the introduction of laboratory-quality diagnostic assays in settings where it was previously not possible to process samples. For example, many tests that were traditionally performed in laboratory settings are now suitable for user administration, such as by the patient themselves in their own home. Advantageously, such user-administered tests may be simpler and more cost-effective than laboratory-administered tests. In terms of testing for the presence or absence of infectious diseases, user-administered tests may also be performed without requiring a potentially ill patient to travel to a laboratory or clinical setting and potentially spread pathogens. In some cases, user-administered tests may be desirable for tests ordered following a virtual consultation by a physician or other clinician, since hospital or laboratory tests may require an additional trip to a healthcare provider facility.

[0024] Existing medical record systems do not allow for efficient integration of the results of user-administered tests. For example, if a patient performs a home diagnostic test and wishes to share the results with their physician, the patient may need to manually send the test results by email or fax, or log into a medical record tracking application and manually enter these results into the application. Such a process may be time consuming, error prone, and rely on several manual communication steps to enter the results into the patient's medical record. In addition, because user-administered tests are often purchased over the counter, it may be difficult for users to obtain reimbursement for the cost of such tests that would otherwise be covered by insurance.

[0025] The present disclosure provides systems and workflows that can address the above-mentioned problems, for example, by enabling integration of user-performed diagnostic tests into prescriptions or into laboratory test reporting workflows, as described in more detail below. Advantageously, the systems, workflows, and methods of the present disclosure enable physicians to order or prescribe user-performed tests in substantially the same manner as they order laboratory or hospital tests, and to receive automatic notification of the results of the user-performed tests in the same manner as they receive from existing laboratory or hospital tests, thereby reducing or minimizing disruption to existing workflows employed by physicians to prescribe or order medications and tests.

[0026] Embodiments of the present disclosure relate to systems and techniques for the detection of analytes of interest that may be present in biological or non-biological samples, such as fluids. Analytes of interest may include any detectable substance, such as, but not limited to, antibodies, proteins, haptens, nucleic acids, amplicons, and hormones. Although embodiments of the present disclosure are described with respect to diagnostic tests, it will be understood that the systems, workflows, and methods of the present disclosure may be performed for user-administered non-diagnostic tests, such as for harmful or non-harmful drugs or contaminants. Although exemplary systems, devices, and methods are described below throughout this disclosure with respect to the collection, testing, and detection of samples suitable for diagnostic tests for infectious diseases, it will be understood that the present disclosure may be used to collect, test, and detect any particles, molecules, or samples of interest. Testing devices or testing systems, such as the user-administered tests described herein, may be configured for the performance of diagnostic tests and / or non-diagnostic tests. In some embodiments, embodiments of the present disclosure may be implemented in conjunction with systems such as the BD Veritor At-Home COVID-19 Test, BD Veritor System for Rapid Detection of SARS CoV-2, BD Veritor System for Rapid Detection of Flu A+B, BD Veritor System for Rapid Detection of SARS CoV-2 & Flu A+B, BD Veritor System for Rapid Detection of Respiratory Syncytial Virus (RSV), BD Veritor System for Rapid Detection of Group A Strep, BD Veritor system, the BD Veritor Plus system, and / or components or operations thereof.

[0027] 1 generally illustrates an exemplary system 100 and closed-loop communication workflow for performing user-administered diagnostic tests in conjunction with an electronic health record system. It will be understood that system 100 is exemplary and includes several optional components, and that the workflow and methods of the present disclosure may be equally implemented in other systems having more, fewer, or different components compared to system 100 of FIG.

[0028] The exemplary system 100 can include a clinician computing device 105, a patient computing device 110, and a healthcare provider (HCP) computing system 115 that can communicate with one or more network-connected resources, such as a test provider application 160 and / or a middleware application 165. The HCP computing system 115 can include components such as an electronic medical record (EMR) database 120, a middleware interface component 130, and an interface engine 125. The HCP computing system 115 can be configured to communicate with a pharmacy interface 135 associated with at least one pharmacy 140. The system 100 can further include a test provider user application 155 configured to communicate with the test provider application 160.

[0029] The clinician computing device 105 and the patient computing device 110 can be, for example, mobile devices such as smartphones or tablets, laptop or desktop computer systems, or other computing devices. The clinician computing device 105 can include functionality for audio or video conferencing to conduct a virtual consultation with a patient. The clinician computing device 105 can be further configured to communicate with an HCP computing system 115 over a network, such as to enable the clinician to order or submit a prescription for the patient following a virtual or in-person consultation. The patient computing device 110 can also include functionality for audio or video conferencing. The patient computing device 110 can be configured to communicate with the clinician computing device 105 over a network, directly, or through one or more components of the HCP computing system 115, to enable the patient to participate in a virtual consultation with the clinician using the clinician computing device 105.

[0030] The HCP computer system 115 may communicate with any or all of the clinician computer device 105, the patient computer device 110, the pharmacy interface 135, the test provider application 160, and / or the middleware application 165. Additionally, the HCP computer system 115 may communicate with a number of different clinician computer devices 105, the patient computer device 110, the pharmacy interface 135, the test provider application 160, and / or the middleware application 165. The EMR database 120 may store electronic medical records for a number of patients of the HCP. An individual patient medical record may include various information such as records of clinician visits and / or consultations, current or past prescribed treatments, medications, and tests, etc., as well as other information typically stored in connection with an electronic medical record or electronic health record. The middleware interface component 130 is configured for communication between the middleware application 165 and the HCP computer system 115. The interface engine 125 can be configured for communication between the EMR database 120, the middleware interface component 130, and one or more pharmacy interfaces 135. Some embodiments of the systems, workflows, and methods of the present disclosure can be implemented without the middleware application 165 and / or the middleware interface component 130.

[0031] The pharmacy interface 135 can be any computer system configured for interaction between a healthcare provider and a pharmacy. For example, the pharmacy interface 135 can be a computer system of a prescription provider or other health information exchange provider. The pharmacy interface 135 can be in communication with one or more pharmacies 140, which can be physical pharmacy locations where patients or other users can pick up prescribed medications, tests, etc., and / or delivery services that can provide prescribed medications, tests, etc., to patients or other users.

[0032] The test provider user application 155 can be a software program, such as a mobile device application, that can execute on a device, such as the patient computing device 110 or another computing device operable by a user, such as the patient or another user assisting the patient in performing a diagnostic test. The test provider user application 155 can perform any number of functions, including, but not limited to, providing a user with instructions for performing a test (e.g., instructions for collecting a sample, instructions for applying the sample to a testing device, instructions for determining the validity of the sample and / or test results, instructions and / or an interface for the test provider user application 155 to image the testing device to determine a result, etc.), receiving test result input from a user, optically determining a test result based on one or more images of the testing device, associating the test result with one or more identifiers, and / or communicating the test result and any associated identifiers over a network to a remote computer system, such as the test provider application 160.

[0033] An exemplary closed-loop communication workflow for performing a user-administered diagnostic test is now described below with respect to the components of system 100. It will be understood that the following workflow may be implemented in conjunction with other systems having more, fewer, or different components than those shown in FIG. 1 without departing from the scope of this disclosure.

[0034] In a first stage, the patient is examined by a clinician or other health care provider, e.g., a physician. In some embodiments, the examination may be a virtual examination in which the patient may use the patient computing device 110 to communicate with the clinician using the clinician computing device 105. As a result of the examination, the clinician may make a decision to order a user-administered test. For example, if the clinician identifies symptoms indicative of possible infection with an infectious disease, the clinician may order a user-administered test to determine whether the patient has the infectious disease.

[0035] During or after the encounter, the clinician can enter a prescription or order for a user-administered test for the patient using a prescription interface on the clinician computing device 105 or another computing device. The prescription or order is entered into the record for the patient in the EMR database 120. The prescription or order can be associated with a visit identifier (e.g., a visit identifier or visit ID) that uniquely identifies the visit or consultation for which the user-administered test was prescribed. Once the prescription or order is entered into the patient's record, the interface engine 125 can generate a pharmacy order and send the order to the pharmacy interface 135 to be executed at the pharmacy. Additionally, the interface engine 125 can replicate the order and send it to the middleware application 165 through the middleware interface component 130. The order sent to the middleware application 165 can include one or more associated identifiers, such as the order identifier, medical record number, and / or visit identifier generated for the requested test. The middleware application 165 can further send the order and any associated identifiers to the test provider application 160.

[0036] In response to receiving the order and associated identifier, the test provider application 160 may send a communication to the patient. For example, the test provider application 160 may send a notification to a test provider user application 155 running on the patient computing device 110 or another computing device, which in turn may indicate the type of user-administered test to be performed. The notification may further include the received order identifier, medical record number, and / or encounter identifier such that the identifier may later be associated with the test results. In some embodiments, the test provider application 160 may be further configured to send a notification (e.g., email, text message, push notification within an application such as a medical record access application, etc.) to the patient to download the test provider user application 155 if the patient or associated user has not already downloaded the test provider user application 155.

[0037] In response to receiving a pharmacy order from the HCP computer system 115, the pharmacy interface 135 can transmit the pharmacy order to a physical pharmacy 140, such as a pharmacy selected by the patient. The patient or authorized user can then pick up the prescribed user-administered test 150 from the pharmacy 140 and take it to a testing location 145, such as the patient's home or another location suitable for administering the test.

[0038] At the testing location 145, the patient or another user administers a user-administered test 150. The user-administered test 150 may be administered in conjunction with a test provider user application 155. For example, at 155a, a graphical user interface (GUI) of the test provider user application 155 may provide one or more instructions regarding collecting a sample from a patient, such as by displaying one or more written instructions, photographs, diagrams, videos, or animations. At 155b, the GUI may further provide one or more instructions regarding applying the sample to a test device, such as by applying the test device to a lateral flow assay or other test analysis device. At 155c, the GUI may further provide a visual output that locally indicates the results of the test to the patient and / or another user administering the test. In some embodiments, the results of the test may be determined in part or in whole by the test provider user application 155.

[0039] The test provider user application 155 can further associate the test results with identifying information corresponding to the encounter, the patient, and / or the test. For example, the test provider user application 155 can have information stored therein, such as an order identifier, a medical record number, and / or a consultation identifier. The test provider user application 155 can retrieve the stored information and send test results associated with one or more of the stored identifiers to the test provider application 160. For example, the test provider user application 155 can send a communication to the test provider application 160 that includes the test results and at least one of the order identifier, the consultation identifier, and / or the medical record number. The test provider application 160 can then send the test results and the associated identifiers to the HCP computer system 115 directly or through the middleware application 165.

[0040] The HCP computer system 115 receives the test results and associated identifiers from the test provider application 160. Upon receiving the communication, the HCP computer system 115 can process the communication to associate the test results with the patient's EMR and the particular encounter in the EMR database 120. In some embodiments, the HCP computer system 115 processes the test results using an existing processing workflow for unsolicited laboratory test results and generates an order record that can be associated with the patient and encounter corresponding to the user-performed test 150 in the EMR database 120. Following the unsolicited test results workflow or other suitable test result acceptance workflow, the HCP computer system 115 can update the patient's EMR with the test results and can also send a notification of the test results to the patient's healthcare provider and / or the individual clinician who performed the encounter. Thus, the above-described workflow efficiently enables clinicians to prescribe user-performed tests and automatically be notified of test results in a manner that reduces the probability of errors, missed test results, or other inefficiencies.

[0041] Figure 2 is a flow chart illustrating an exemplary method 200 for obtaining and reporting results of a user-administered diagnostic test based on a test order from a healthcare provider. Method 200 may be implemented by a computer system such as, for example, HCP computer system 115 and test provider application 160 in system 100 of Figure 1. Although method 200 is described below with respect to HCP computer system 115 and other components of system 100, method 200 may be equally implemented in conjunction with other computer systems without departing from the scope of the present disclosure.

[0042] Method 200 begins at block 205 when a test order is received. The test order may be received, for example, as a result of a physician or other clinician entering a prescription for a specified user-administered test using a computer prescription interface. The test order received at block 205 may be associated with an identifier for a particular type of user-administered test, a medical record number associated with the patient to be tested, and / or a visit identifier that identifies the visit or consultation for which the user-administered test is prescribed. Once a test order is received, method 200 continues to block 210.

[0043] In block 210, the HCP computer system 115 sends the prescription to the pharmacy and test provider application. The prescription may be sent to the pharmacy through a pharmacy interface, such as, for example, pharmacy interface 135 of Figure 1. Upon receiving the prescription, the pharmacy may retrieve the specified user-administered test and provide the test supplies to the patient.

[0044] In block 215, the HCP computer system 115 and / or the test provider application 160 may generate one or more test identifiers, such as, for example, an order identifier. For example, the one or more test identifiers may include identifiers that are associated with a later generated order record corresponding to the test and with the test results after the test has been administered. The one or more test identifiers may later be used as unique identifiers for the test results.

[0045] In block 220, the HCP computer system 115 and / or test provider application 160 may send one or more test identifiers to a user application associated with the patient (e.g., test provider user application 155). In some embodiments, if the patient or associated user has not yet downloaded the user application, a notification may be sent to the patient or other user through a different communication means, such as email, text, or another application, instructing the patient or user to download the application.

[0046] In block 225, the HCP computer system 115 receives the test results from the user application after the patient self-administers the user-administered test or another user administers the user-administered test to the patient in conjunction with the user application. For example, the HCP computer system 115 may receive the test results through the test provider application 160 and / or the middleware application 165. The incoming test result communication may include one or more test identifiers generated in block 215 such that the HCP computer system can accurately associate the incoming test results with the patient's electronic medical record or electronic health record in the EMR database 120.

[0047] At block 230, in response to receiving the test result communication directly or indirectly from a user application, the HCP computer system 115 generates an order using an order generation workflow. For example, in some embodiments, the order may be generated using a results workflow for an existing unsolicited test. The order may be associated with a medical record number corresponding to the patient and / or a visit identifier corresponding to the particular visit and / or consultation for which the test was prescribed.

[0048] At block 235, once the order is generated, the HCP computer system associates the received test results with the order. For example, the order record can be expanded to include an indication of whether the patient was determined to have a positive or negative test result for the presence or absence of a particular analyte or analytes of interest, which may indicate whether the patient has a specified infectious disease or other condition detectable by a particular user-administered test. After the test results are associated with the order, method 200 ends at block 240 when the test results are sent to the patient's healthcare provider. The test results can be provided, for example, as a notification to the clinician who originally performed the consultation or visit and prescribed the test. This allows the clinician to be alerted of the test results without having to follow up with the patient, rely on the patient's manual report, or manually consult the patient's electronic medical record to obtain the results of the test and take any appropriate action, such as prescribing a medication or other course of treatment associated with the test results.

[0049] terminology The analytical devices described herein may include diagnostic test tools or other testing devices, assays, and / or systems for detecting one or more analytes of interest in a sample. In the context of the present disclosure, a user-administered test may include a variety of tests configured to be performed by a user, not necessarily a physician, another clinician, a laboratory technician, or the like, on a patient or other test subject. For example, the user performing the user-administered test may be the patient or individual undergoing the test or another individual, such as a family member, caregiver, acquaintance, etc. A user-administered test may be configured to be performed in a variety of locations other than a laboratory or clinical environment. A user-administered test may be an "at-home" test suitable for administration in the user's home, workplace, or any other public or private location. For example, a user-administered test may be a packaged kit that includes all the equipment necessary to collect and test a biological or environmental sample and generate a test result. Additionally, a user-administered test may be configured to be used in conjunction with an application that executes on a computing device, such as a patient's or user's mobile device or any other computing device. In such computer-integrated testing, the application may be configured to only receive test result input by a user, or may be configured to perform at least a portion of the test result determination by taking or receiving one or more images of a testing device, e.g., a test, and optically generating the test result based on the one or more images.

[0050] The analytical devices described herein are capable of accurately measuring multiple analytes of interest in many different types of samples. Samples can include specimens or cultures obtained from any source, as well as biological and environmental samples. Biological samples can be obtained from animals (including humans) and can encompass fluids, solids, tissues, and gases. Biological samples include urine, saliva, and blood products, such as plasma, serum, and the like. Such examples should not be construed as limiting the sample types applicable to the present disclosure.

[0051] In some embodiments, the sample is an environmental sample for detecting one or more specimens in an environment. In some embodiments, the sample is a biological sample from a subject. In some embodiments, the biological sample can include peripheral blood, serum, plasma, ascites, urine, cerebrospinal fluid (CSF), sputum, saliva, bone marrow, synovial fluid, aqueous humor, amniotic fluid, earwax, breast milk, bronchoalveolar lavage fluid, semen (including prostatic fluid), cowper's fluid or pre-ejaculatory fluid, female ejaculate, sweat, fecal material, hair, tears, cyst fluid, pleural and peritoneal fluid, pericardial fluid, lymph, chyme, chyle, bile, interstitial fluid, leucorrhea, pus, sebum, vomit, vaginal secretions, mucosal secretions, stool, pancreatic juice, sinus lavage, bronchopulmonary aspirate, or other lavage fluid.

[0052] As used herein, "analyte" generally refers to a substance to be detected. For example, analytes can include antigenic substances, haptens, antibodies, and combinations thereof. Analytes include, but are not limited to, toxins, organic compounds, proteins, peptides, microorganisms, amino acids, nucleic acids, hormones, steroids, vitamins, drugs (both those administered for therapeutic purposes and those administered for nefarious purposes), drug vehicles or by-products, bacteria, virus particles, and metabolites of any of these substances or antibodies against any of them.Some specific examples of analytes include ferritin, creatine kinase MB (CK-MB), human chorionic gonadotropin (hCG), digoxin, phenytoin, phenobarbital, carbamazepine, vancomycin, gentamicin, theophylline, valproic acid, quinidine, luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol, progesterone, C-reactive protein (CRP), lipocalin, IgE antibodies, environmental kines, TNF-related apoptosis-inducing ligand (TRAIL), vitamin B2 microglobulin, interferon gamma-inducible protein 10 (IP-10), interferon-inducible GTP-binding protein (Myxovirus (influenza virus) resistance 1, MX1, MxA, IFI-78K, IFI78, MX, MX-dynamin-like GTPase 1), procalcitonin (PCT), glycated hemoglobin (Giy), and glycated hemoglobin (Giy). Hb), cortisol, digitoxin, N-acetyl-procainamide (NAPA), procainamide, rubella antibodies, such as rubella IgG and rubella IgM, toxoplasma antibodies, such as toxoplasma IgG (Toxo-IgG) and toxoplasma IgM (Toxo-IgM), testosterone, salicylate, acetaminophen, hepatitis B surface antigen (HBsAg), hepatitis B core antigen antibodies (Anti-HBC), such as anti-hepatitis B core antigen IgG and IgM, human immunodeficiency virus (HIV) These include human immunodeficiency virus types 1 and 2 (HIV1 and HIV2), human T-cell leukemia virus types 1 and 2 (HTLV), hepatitis B e antigen (HBeAg), hepatitis B e antigen antibody (Anti-HBe), influenza virus, thyroid stimulating hormone (TSH), thyroxine (T4), total triiodothyronine (TotalT), free triiodothyronine (FreeT3), carcinoembryonic antigen (CEA), lipoproteins, cholesterol, and triglycerides, and alpha-fetoprotein (AFP).Drugs of abuse and controlled substances include, but are not limited to, amphetamines, methamphetamines, barbiturates, e.g., amobarbital, secobarbital, pentobarbital, phenobarbital, and barbital, benzodiazepines, e.g., librium and valium, cannabinoids, e.g., hashish and marijuana, cocaine, fentanyl, LSD, methaqualone, opiates, e.g., heroin, morphine, codeine, hydromorphone, hydrocodone, methadone, oxycodone, oxymorphone, and opium, phencyclidine, and propoxyphene. Additional analytes of interest for biological or environmental materials can be included.

[0053] The present disclosure relates to diagnostic and / or environmental testing devices, such as, for example, lateral flow assay devices, testing systems, and methods for determining the presence and concentration of multiple analytes in a sample, including when one or more analytes of interest are present at high concentrations and one or more analytes of interest are present at low concentrations. As discussed above, as used herein, "analyte" generally refers to a substance to be detected, such as a protein. Examples of proteins that can be detected by the lateral flow assay devices, testing systems, and methods described herein include, but are not limited to, the following:

[0054] TRAIL: TNF-related apoptosis-inducing ligand (also known as Apo2L ligand, Apo-2 ligand, and CD253), with representative RefSeg DNA sequences NC_000003.12, NC_018914.2, and NT_005612.17, and with representative RefSeg protein sequence accession numbers NP_001177871.1, NP_001177872.1, and NP_003801.1. The TRAIL protein belongs to the tumor necrosis factor (TNF) ligand family.

[0055] CRP: C-reactive protein, with representative RefSeg DNA sequences NC_000001.11, NT_004487.20, and NC_018912.2, and a representative RefSeg protein sequence accession number NP_000558.2.

[0056] IP-10: chemokine (CXC motif) ligand 10, with representative RefSeg DNA alignments NC_000004.12, NC_018915.2, and NT_016354.20 and RefSeq protein alignment NP_001556.2.

[0057] PCT: Procalcitonin is a peptide precursor of the calcitonin hormone. A representative RefSeq amino acid sequence for this protein is NP_000558.2. Representative RefSeq DNA sequences include NC_000001.11, NT_004487.20, and NC_018912.2.

[0058] MX1: Interferon-inducible GTP-binding protein Mx1 (also known as interferon-inducible protein p78, interferon-regulated resistant GTP-binding protein MxA). Representative RefSeq amino acid sequences for this protein are NP_001138397.1, NM_001144925.2, NP_001171517.1, and NM_001178046.2.

[0059] The lateral flow assay devices, test systems and methods of the present disclosure can measure either soluble and / or membrane forms of TRAIL protein, hi one embodiment, only the soluble form of TRAIL is measured.

[0060] Implementations disclosed herein provide systems, methods, and devices for detecting the presence and / or amount of harmful drugs. Those skilled in the art will recognize that these embodiments may be implemented in hardware or a combination of hardware, software, and / or firmware.

[0061] The assay reading functions described herein can be stored as one or more instructions or processor readable media or computer readable media. The term "computer readable medium" refers to any available medium accessible by a computer or processor. By way of example, such media can include, but are not limited to, RAM, ROM, EEPROM, flash memory, CD-ROM, or other optical disk storage, magnetic disk storage, or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and accessible by a computer. It should be noted that computer readable media can be tangible and non-transitory. The term "computer program product" refers to a combination of a computing device or computer and code or instructions (e.g., "program") that they can execute, process, or compute. As used herein, the term "code" can refer to software, instructions, code, or data that can be executed by a computing device or processor.

[0062] The various exemplary logic blocks and modules described in connection with the embodiments disclosed herein may be implemented or performed by machines such as general purpose processors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other programmable logic devices, individual gate or transistor logic units, individual hardware components, or any combination thereof, designed to perform the functions described herein. The general purpose processor may be a microprocessor, but in variations may be a controller, microcontroller, or state machine, or combinations thereof, etc. The processor may be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a combination of multiple microprocessors, a combination of one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology, a processor may also include primarily analog components. For example, any of the signal processing algorithms described herein may be implemented in analog circuitry. The computing environment can include any type of computing system, including, but not limited to, microprocessor-based computing systems, mainframe computers, digital signal processors, portable computing devices, electronic organizers, device controllers, and computing engines within consumer electronics products.

[0063] The methods disclosed herein include one or more steps or actions for achieving the same. The method steps and / or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is required for the proper operation of the method being described, the order and / or use of specific steps and / or actions may be modified without departing from the scope of the claims.

[0064] The term "determining" encompasses a variety of actions, and thus "determining" can include calculating, computing, processing, deriving, examining, looking up (e.g., looking up in a table, database, or another data structure), and ascertaining, and the like. Similarly, "determining" can include receiving (e.g., receiving information) and accessing (e.g., accessing data in a memory), and the like. Similarly, "determining" can include resolving, selecting, choosing, establishing, and the like. The phrase "based on" does not mean "based only on" unless otherwise specified. In other words, the phrase "based on" refers to both "based only on" and "based at least on."

[0065] The foregoing description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the scope of the present invention. Thus, the present invention is not limited to the embodiments shown herein, but rather is intended to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. one or more processors associated with at least one of a health care provider and a testing provider; a user device including one or more processors; The one or more processors associated with at least one of the health care provider and the testing provider are configured to: receiving a prescription from a clinician computing device specifying a user-administered test and a patient; transmitting prescription information corresponding to the prescription to a pharmacy interface; generating an order identifier that uniquely identifies the prescription; transmitting the command identifier to a user application installed on a computing device associated with the patient. It is configured as follows: The one or more processors of the user device execute processor-executable instructions contained in the user application to: receiving the command identifier; obtaining test results corresponding to the user-administered test; Associating the received command identifier with the test result; and transmitting the test results in association with the order identifier to the one or more processors associated with the health care provider. It is configured as follows: system.

2. the one or more processors associated with at least one of the health care provider and the testing provider; receiving the test results in association with the command identifier; storing the test results and the order identifier in a medical record database in association with at least one additional identifier corresponding to the patient or at least one additional identifier corresponding to the consultation corresponding to the prescription; The system of claim 1 further configured to:

3. 3. The system of claim 2, wherein the one or more processors associated with at least one of the health care provider and the testing provider are further configured to send a notification indicative of the test results to the clinician computing device.

4. 2. The system of claim 1, wherein the one or more processors associated with at least one of the healthcare provider and the testing provider are further configured to cause a notification to be sent to the patient instructing the patient to install the user application on the computing device.

5. The system of claim 4 , wherein the notification comprises an email, a text message, or a push notification in a second application different from the user application.

6. obtaining the test results corresponding to the user-administered test; receiving an image of the testing device taken following application of a sample to the testing device; automatically determining the inspection result based on image data of the received image of the inspection device; The system of claim 1 , comprising:

7. the test device comprises a lateral flow assay test strip; and automatically determining the test result includes detecting one or more lines on the lateral flow assay test strip. The system of claim 6.

8. 2. The system of claim 1, wherein the one or more processors associated with at least one of the healthcare provider and the test provider are further configured to cause a test type identifier corresponding to the user-administered test to be transmitted to the user application.

9. The system of claim 8 , wherein the transmission of the identifier of the test type causes the user application to provide one or more instructions to the patient associated with the test type.

10. 10. The system of claim 1, wherein the user-performed test comprises a lateral flow assay and the test result comprises one or more lines on the lateral flow assay.

11. 1. A computer-implemented method for providing a user-administered test in conjunction with an electronic medical record system, comprising: Under the control of one or more processors, receiving a prescription from a clinician computing device specifying a user-administered test and a patient; transmitting prescription information corresponding to the prescription to a pharmacy interface; generating an order identifier that uniquely identifies the prescription; transmitting the command identifier to a user application installed on a computing device associated with the patient, the user application configured to associate the command identifier with test results determined at least in part by the user application; receiving the test results from the user application in association with the command identifier; storing the test results and the order identifier in a medical record database in association with at least one additional identifier corresponding to the patient or at least one additional identifier corresponding to the consultation corresponding to the prescription; sending a notification associated with the test results to the clinician computing device; The method includes:

12. 12. The computer-implemented method of claim 11, further comprising sending a notification to the patient instructing the patient to install the user application on the computing device prior to causing the user application to transmit the command identifier.

13. 13. The computer-implemented method of claim 12, wherein the notification instructing the patient to install the user application comprises an email, a text message, or a push notification in a second application different from the user application.

14. The computer-implemented method of claim 11 , further comprising causing an identifier of a test type corresponding to the user-performed test to be sent to the user application.

15. 15. The computer-implemented method of claim 14, wherein the transmission of the identifier of the test type causes the user application to provide one or more instructions to the patient associated with the test type.

16. 15. The computer-implemented method of claim 14, wherein the identifier of the test type corresponds to a lateral flow assay test.

17. The computer-implemented method of claim 11 , wherein the notification associated with the test result further comprises an identifier for the patient or a consultation associated with the prescription.

18. the user-performed test comprises a lateral flow assay test; The test result includes one or more lines on the lateral flow assay.

18. A computer-implemented method according to any one of claims 11 to 17.

19. 1. A computer-implemented method for providing a user-administered test in conjunction with an electronic medical record system, comprising: Under the control of one or more processors of a computing device associated with the patient, receiving, from a computer system associated with a test provider or health care provider, an order identifier corresponding to a prescription specifying a user-administered test and the patient; obtaining test results corresponding to the user-administered test; transmitting the test results in association with the order identifier to the computer system associated with the test provider or the health care provider; The method includes:

20. receiving an indicator of a test type of the user-administered test; obtaining one or more instructions associated with the test type; displaying the one or more instructions to the patient prior to obtaining the test results; 20. The computer-implemented method of claim 19, further comprising:

21. 21. The computer-implemented method of claim 20, wherein the one or more instructions include instructions for collecting a sample, instructions for applying a sample to a testing device, instructions for determining the validity of a sample or a test result, or instructions for imaging a testing device to determine a result by the computing device.

22. 20. The computer-implemented method of claim 19, wherein obtaining the test results corresponding to the user-administered test comprises instructing the patient to enter the test results in a user interface of the computing device.

23. The step of obtaining test results corresponding to the user-administered test comprises: receiving an image of an inspection device used in the user-performed inspection; automatically determining the inspection result based on image data of the received image of the inspection device; 20. The computer-implemented method of claim 19, comprising:

24. the test device comprises a lateral flow assay test strip; and automatically determining the test result comprises detecting one or more lines on the lateral flow assay test strip.

24. The computer-implemented method of claim 23.

25. the computing device includes an image capture device; Receiving the image of the inspection device includes: displaying instructions to the user to capture an image of the inspection device using the image capture device; receiving the image from the image capture device; Including, 24. The computer-implemented method of claim 23.

26. 20. The computer-implemented method of claim 19, further comprising providing a notification to the patient in response to receiving the order identifier.

27. 27. The computer-implemented method of any one of claims 19 to 26, wherein the user-performed test comprises a lateral flow assay and the test result comprises one or more lines on the lateral flow assay.

Images