Automated order and outcome reporting of prescription-based user-performed diagnostic tests

Abstract

Systems and methods for integrating diagnostic test results performed by a user with electronic health records are provided. In one aspect, a method includes receiving a prescription specifying a test performed by a user and a patient, transmitting prescription information to a pharmacy and a test provider, generating a unique order identifier, the order identifier being sent to a user application, the user application associating the order identifier with a test result after the test performed by the user, and transmitting the order identifier to the user application. A test result is received in association with the order identifier, the test result and the order identifier are stored in a medical record database in association with the medical record number or the consultation identifier, and a notification of the test result is sent to a clinician who makes a prescription.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 319,138, filed on March 11, 2022, which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to diagnostic testing, and more particularly to systems and methods for integrating user-administered diagnostic test results with electronic health records. Background Art

[0004] User-administered diagnostic tests are becoming increasingly popular because they can provide reliable, inexpensive, portable, rapid, 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) outside of a clinical or laboratory setting (e.g., a user's home). However, sharing user-administered diagnostic test results in conjunction with existing electronic health record systems is often difficult, time-consuming, and inefficient. Summary of the invention

[0005] In a first aspect, a system includes one or more processors associated with at least one of a healthcare provider and a test 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 test provider are configured with computer-executable instructions to: receive a prescription for a test performed by a designated user and a patient from a clinician computing device; transmit prescription information corresponding to the prescription to a pharmacy interface; generate an order identifier that uniquely identifies the prescription; and cause the order identifier to be transmitted 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 a test result corresponding to the test performed by the user; associate the received order identifier with the test result; and send the test result in association with the order identifier to the one or more processors associated with the healthcare provider.

[0006] In some embodiments, 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 a medical records database in association with at least one additional identifier corresponding to the patient or the consultation, wherein the consultation corresponds to a prescription.

[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 send a notification indicating the test result to the clinician computing device.

[0008] 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 transmitted 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.

[0009] In some embodiments, obtaining a test result corresponding to a test performed by a user includes: receiving an image of the test device taken after applying the specimen to the test device; 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.

[0010] 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 transmission to the user application of an identifier of a test type corresponding to the test administered by the user. In some embodiments, transmission of the identifier of the test type causes the user application to provide one or more instructions associated with the test type to the patient.

[0011] In some embodiments, the user-administered test comprises a lateral flow assay, and the test result comprises one or more lines on the lateral flow assay.

[0012] In a second aspect, a computer-implemented method for providing user-performed tests in conjunction with an electronic medical record system includes performing the following operations under the control of one or more processors: receiving a prescription from a clinician computing device, the prescription specifying a user-performed 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, which is installed on a computing device associated with a patient and is configured to associate the order identifier with a test result determined at least in part by the user application; receiving the test result from the user application in association with the order identifier; storing the test result and the order identifier in a medical record database in association with at least one additional identifier corresponding to the patient or consultation, wherein the consultation corresponds to the prescription; and sending a notification associated with the test result to the clinician computing device.

[0013] In some embodiments, the method further comprises sending a notification prior to causing the order identifier to be transmitted to the user application, the notification instructing the patient to install the user application on the computing device. 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 different from the user application.

[0014] In some embodiments, the method further comprises causing transmission to the user application of an identifier of a test type corresponding to the test performed by the user. In some embodiments, transmission of the identifier of the test type causes the user application to provide one or more instructions associated with the test type to the patient. In some embodiments, the identifier of the test type corresponds to a lateral flow assay test.

[0015] In some embodiments, the notification associated with the test result also includes an identifier of the patient or an identifier of the consultation associated with the prescription.

[0016] In some embodiments, the user-administered test comprises a lateral flow assay test, and the test results comprise one or more lines on the lateral flow assay.

[0017] In a third aspect, a computer-implemented method for providing a user-administered test in conjunction with an electronic medical record system includes performing the following operations under the control of one or more processors of a computing device associated with a patient: receiving an order identifier corresponding to a specified user-administered test and the patient's prescription from a computing system associated with a test provider or a healthcare provider; obtaining a test result corresponding to the user-administered test; and sending the test result in association with the order identifier to a computing system associated with the test provider or the healthcare provider.

[0018] In some embodiments, the method further comprises: receiving an indicator of a test type of a test to be administered by a user; obtaining one or more instructions associated with the test type; and displaying the one or more instructions to the patient before obtaining the test result. 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 adequacy of a sample or a test result, or instructions for imaging a test device to determine a result by a computing device.

[0019] In some embodiments, obtaining a test result corresponding to a user-administered test includes prompting the patient to enter the test result at a user interface of the computing device.

[0020] In some embodiments, obtaining a test result corresponding to a test performed by a user includes: receiving an image of a test device for the test performed by the user; 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.

[0021] In some embodiments, the method further includes providing a notification to the patient in response to receiving the order identifier.

[0022] In some embodiments, the user-administered 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

[0023] Figure 1 An example system and closed-loop communication workflow for implementing user-administered diagnostic tests in conjunction with an electronic health record system is schematically illustrated.

[0024] Figure 2 is a flow chart illustrating an example method for obtaining and reporting results of a user-administered diagnostic test based on a test order from a healthcare provider. DETAILED DESCRIPTION

[0025] Traditionally, the test ordered, required or stipulated by a physician or other clinician has been performed in a setting such as a hospital laboratory or reference laboratory, which may employ a trained test executor and a computer-implemented workflow that allows the receipt of a test prescription and the transmission of a test result that can be entered into a patient record. However, the development of high-quality rapid diagnostic tests has enabled laboratory-quality diagnostic assays to be deployed in environments that historically could not process samples. For example, more and more tests that were traditionally performed in laboratory settings are now suitable for user implementation, such as performed by patients in their own homes. Advantageously, the test implemented by this user may be easier and more cost-effective than the test implemented in a laboratory. In the context of testing for the presence of infectious diseases, the test implemented by the user can also be performed without requiring the patient who may be ill to go to a laboratory or clinical setting where pathogens may be spread. In some cases, for the test ordered after a virtual consultation with a physician or other clinician, the test implemented by the user may be desirable because the hospital or laboratory test may require additional travel to the health care provider's facility.

[0026] Existing medical record systems fail to provide effective 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, they may need to manually send the test results via email or fax, or may need to log into a medical record tracking application and manually enter the results in the application. Such processes can be time consuming and error prone, and rely on several manual communication steps in order 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 be reimbursed for the cost of these tests, which would otherwise be covered by insurance.

[0027] The present disclosure provides systems and workflows that can address these challenges (e.g., by allowing user-administered diagnostic tests to be integrated into prescription or laboratory test reporting workflows, as described in more detail below). Advantageously, the systems, workflows, and methods of the present disclosure can reduce or minimize disruption to existing workflows that physicians employ when prescribing or ordering medications and tests because they allow physicians to order or prescribe user-administered tests in substantially the same manner as they would otherwise order laboratory or hospital tests, and receive automatic notification of the results of user-administered tests in the same manner as they would otherwise receive from existing laboratory or hospital tests.

[0028] Embodiments of the present disclosure relate to systems and techniques for detecting 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. Reference diagnostic tests describe embodiments of the present disclosure, but it should be understood that the systems, workflows, and methods of the present disclosure may be implemented in non-diagnostic tests performed by users (e.g., tests for dangerous or non-dangerous drugs or pollutants). Throughout the present disclosure, example systems, devices, and methods will be described with reference to the collection, testing, and detection of analytes (e.g., those analytes associated with diagnostic tests involving infectious diseases), but it should be understood that the present disclosure may be used to collect, test, and detect any particles, molecules, or analytes of interest. Test equipment or systems (such as tests performed by users as described herein) may be configured to perform 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, the BD Veritor System for Rapid Detection of SARS CoV-2, the BD Veritor System for Rapid Detection of Influenza A+B, the BD Veritor System for Rapid Detection of SARS CoV-2 and Influenza A+B, the BD Veritor System for Rapid Detection of Respiratory Syncytial Virus (RSV), the BD Veritor System for Rapid Detection of Group A Streptococcus, the BD Veritor System, the BD Veritor Plus System, and / or components or operations thereof.

[0029] Figure 1 An example system 100 and closed-loop communication workflow for implementing user-administered diagnostic tests in conjunction with an electronic health record system is schematically illustrated. The system 100 is exemplary and includes a number of optional components; it should be understood that the workflow and method of the present disclosure may also be used in conjunction with an electronic health record system. Figure 1 The system 100 may be implemented in other systems having more, fewer, or different components.

[0030] The example system 100 may include a clinician computing device 105, a patient computing device 110, and a healthcare provider (HCP) computing system 115, which may communicate with one or more networked resources, such as a test provider application 160 and / or a middleware application 165. The HCP computing system 115 may 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 may be configured to communicate with a pharmacy interface 135 associated with at least one pharmacy 140. The system 100 may also include a test provider user application 155, which is configured to communicate with the test provider application 160.

[0031] The clinician computing device 105 and the patient computing device 110 can be, for example, mobile devices such as smartphones, tablet computers, laptops or desktop computing systems, or any other computing device. The clinician computing device 105 may include functionality for audio or video conferencing (e.g., for virtual consultations with patients). The clinician computing device 105 may also be configured to communicate with the HCP computing system 115 via a network, for example, to allow a clinician to order or submit a prescription for a patient after a virtual or face-to-face consultation. The patient computing device 110 may similarly include functionality for audio or video conferencing. The patient computing device 110 may be configured to communicate with the clinician computing device 105 via a network, directly or through one or more components of the HCP computing system 115, for example, to enable a patient to participate in a virtual consultation with a clinician using the clinician computing device 105.

[0032] The HCP computing system 115 can communicate with any or all of the clinician computing device 105, the patient computing device 110, the pharmacy interface 135, the test provider application 160, and / or the middleware application 165. In addition, the HCP computing system 115 can communicate with multiple different clinician computing devices 105, patient computing devices 110, pharmacy interfaces 135, test provider applications 160, and / or middleware applications 165. The EMR database 120 can store electronic medical records of multiple patients of the HCP. Individual patient medical records may include various information, such as records of clinician visits and / or consultations, current or previous prescribed treatments, medications, tests, etc., as well as any other information typically stored in association with electronic medical records or electronic health records. The middleware interface component 130 is configured for communication between the middleware application 165 and the HCP computing 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 may be implemented without the middleware application 165 and / or the middleware interface component 130 .

[0033] The pharmacy interface 135 may be any computing system configured for interaction between a healthcare provider and a pharmacy. For example, the pharmacy interface 135 may be a computing system of an electronic prescription provider or any other health information exchange provider. The pharmacy interface 135 may communicate with one or more pharmacies 140, which may be physical pharmacy locations where patients or other users can pick up prescribed medications, tests, etc., and / or may provide delivery services for prescribed medications, tests, etc. to patients or other users.

[0034] The test provider user application 155 may be a software program, such as a mobile device application, that may be executed on a device, such as the patient computing device 110 or another computing device operable by a user (e.g., the patient or another user assisting the patient in performing diagnostic tests). The test provider user application 155 may perform any number of functions, including, but not limited to, providing instructions to a user for performing a test (e.g., instructions for collecting a sample, instructions for applying a sample to a test device, instructions for determining the adequacy of a sample and / or a test result, instructions and / or an interface for imaging the test device for determining a result by the test provider user application 155, etc.), receiving an input test result from a user, optically determining a result of the test result based on one or more images of the test device, associating the test result with one or more identifiers, and / or transmitting the test result and any associated identifiers to a remote computing system (e.g., the test provider application 160) via a network.

[0035] An example closed-loop communication workflow for implementing a user-administered diagnostic test will now be described with reference to the components of system 100. It should be understood that the following workflow may be combined with other workflows having more than one embodiment without departing from the scope of the present disclosure. Figure 1 More, less, or the same as those shown Figure 1 Other systems that have different components than those shown may be implemented.

[0036] In a first step, the patient has a consultation with a clinician or other healthcare provider (e.g., a physician). In some embodiments, the consultation may be a virtual consultation, in which the patient may use the patient computing device 105 to communicate with the clinician using the clinician computing device 110. As a result of the consultation, the clinician may decide to order a user-administered test. For example, if the clinician identifies symptoms that indicate possible infection with an infectious disease, the clinician may order a user-administered test to determine whether the patient has an infectious disease.

[0037] During or after the consultation, the clinician can use the prescription interface on the clinician computing device 105 or another computing device to enter a prescription or order for the test performed by the user for the patient. The prescription or order is entered into the patient record in the EMR database 120. The prescription or order can also be associated with a consultation identifier (e.g., a visit identifier or visit ID), which uniquely identifies the consultation or visit when the test performed by the user is prescribed. When the prescription or order has been entered into the patient's record, the interface engine 125 can generate a pharmacy order, which can be sent to the pharmacy interface 135 to be completed at the pharmacy. In addition, the interface engine 125 can copy the order and send the copied order to the middleware application 165 via the middleware interface component 130. The order sent to the middleware application 165 may include one or more associated identifiers, such as the generated order identifier, medical record number and / or consultation identifier associated with the requested test. The middleware application 165 can send the order and any associated identifiers to the test provider application 160.

[0038] 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 executed on the patient computing device 110 or another computing device, which may indicate the type of user-performed test to be performed in conjunction with the application. The notification may also include the received order identifier, medical record number, and / or consultation identifier, so that any such identifier may be associated with the test results later. In some embodiments, if the patient or associated user has not yet downloaded the test provider user application 155, the test provider application 160 may also be configured to send a notification to the patient (e.g., an email, a text message, a push notification in an application such as a medical record access application, etc.) to download the test provider user application 155.

[0039] In response to receiving the pharmacy order from the HCP computing 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 an authorized user can then obtain the prescribed user-administered test 150 from the pharmacy 140, and the user-administered test 150 can be shipped to a testing location 145, such as the patient's home or another suitable location for testing.

[0040] At the test location 145, the patient or another user performs a user-performed test 150. The user-performed test 150 can be performed 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 can provide one or more instructions for collecting a sample from a patient (e.g., by displaying one or more written instructions, photos, charts, videos, animations, etc.). At 155b, the GUI can also provide one or more instructions for applying the sample to the test (e.g., by applying the test to a lateral flow assay or other test analysis device). At 155c, the GUI can also provide a visual output indicating the result of the test locally to the patient and / or other user performing the test. In some embodiments, the result of the test can be determined in part or in whole by the test provider user application 155.

[0041] The test provider user application 155 may also associate the test results with identification information corresponding to the consultation, patient, and / or test. For example, the test provider user application 155 may have stored information such as an order identifier, a medical record number, and / or a consultation identifier. The test provider user application 155 may retrieve the stored information and transmit the test results to the test provider application 160 in association with one or more of the stored identifiers. For example, the test provider user application 155 may transmit 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 may then transmit the test results and any associated identifiers to the HCP computing system 115 directly or via the middleware application 165.

[0042] The HCP computing system 115 receives the test result and the associated identifier from the test provider application 160. Upon receiving the communication, the HCP computing system 115 may process the communication to associate the test result with the patient's EMR and a specific consultation in the EMR database 120. In some embodiments, the HCP computing system 115 uses an existing processing workflow for unsolicited laboratory test results to process the test result and generate an order record, which may be associated with the patient and consultation corresponding to the test 150 performed by the user in the EMR database 120. According to the unsolicited test result workflow or any other suitable test result receiving workflow, the HCP computing system 115 may update the patient's EMR based on the test result, and may also send a notification of the test result to the patient's healthcare provider and / or the individual clinician performing the consultation. Therefore, the above workflow may effectively allow clinicians to prescribe tests performed by the user and automatically notify the test results in a manner that reduces the probability of errors, lost test results, or other inefficiencies.

[0043] Figure 2 2 is a flow chart illustrating an example method 200 for obtaining and reporting the results of a user-performed diagnostic test based on a test order from a healthcare provider. The method 200 may be performed by a computing system such as, for example, Figure 1 The method 200 is performed by the HCP computing system 115 and the test provider application 160 in the system 100. Although the method 200 will be described with reference to the HCP computing system 115 and other components of the system 100, the method 200 may also be performed in conjunction with other computing systems without departing from the scope of the present disclosure.

[0044] When a test order is received, the method 200 begins at block 205. For example, the test order may be received 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 of a particular type of user-administered test, a medical record number associated with the patient to be tested, and / or a consultation identifier identifying the visit or consultation when the user-administered test was prescribed. When a test order has been received, the method 200 proceeds to block 210.

[0045] At block 210, the HCP computing system 115 sends the prescription to the pharmacy and the test provider application. The prescription may be sent, for example, via a pharmacy interface such as Figure 1 The pharmacy interface 135 of the pharmacy is sent to the pharmacy. After receiving the prescription, the pharmacy can retrieve the test performed by the specified user and provide the test to the patient.

[0046] At block 215, the HCP computing system 115 and / or the test provider application 160 may generate one or more test identifiers (e.g., order identifiers). For example, the one or more test identifiers may include an identifier to be associated with a subsequently created order record corresponding to the test and its results (once the test is performed). The one or more test identifiers may then be used as a unique identifier for the results of the test.

[0047] At block 220, the HCP computing system 115 and / or the test provider application 160 may send the one or more test identifiers to a user application associated with the patient (e.g., the 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 via a different communication means (such as email, text, or via another application) instructing the patient or user to download the application.

[0048] At block 225, after the patient has self-administered the user-administered test or another user has administered the user-administered test to the patient in conjunction with the user application, the HCP computing system 115 receives the test results from the user application. For example, the HCP computing system 115 may receive the test results via the test provider application 160 and / or the middleware application 165. The received test result communication may include one or more test identifiers generated at block 215 so that the HCP computing system can accurately associate the received test results with the patient's electronic medical record or electronic health record in the EMR database 120.

[0049] At block 230, in response to receiving the test result communication directly or indirectly from the user application, the HCP computing system 115 creates an order using an order creation workflow. For example, in some embodiments, an order may be created for a patient using an existing unsolicited test result workflow. The order may be associated with a medical record number corresponding to the patient and / or with a consultation identifier corresponding to a specific visit or consultation when the test was prescribed.

[0050] At block 235, when the order has been created, the HCP computing system associates the received test result with the order. For example, the order record may be enhanced to include an indication of whether the patient was determined to have a positive or negative test result for the presence of a particular analyte or analytes of interest, which may indicate whether the patient suffers from a specified infectious disease or has other conditions detectable by a test performed by a specified user. After the test result is associated with the order, the method 200 terminates at block 240 when the test result is sent to the patient's healthcare provider. For example, the test result may be provided as a notification to a clinician who performed the initial consultation or visit and prescribed the test, so that the clinician is alerted to the test result without having to follow up with the patient, without having to rely on a manual report from the patient, or without having to manually check the patient's electronic medical record to retrieve the result of the test and take any indicated action (e.g., prescribe a medication or other treatment regimen associated with the test result).

[0051] the term

[0052] The analytical equipment described herein may include a diagnostic test or any other test equipment, a test and / or a system for detecting one or more analytes of interest in a sample. In the context of the present disclosure, the test performed by the user may include various tests, which are configured to be performed by a user who is not necessarily a physician, another clinician, a laboratory technician, etc., on a patient or other individual to be tested. For example, the user who performs the test performed by the user may be a patient or individual to be tested, or another person (such as a family member, a caregiver, an acquaintance, etc.). The test performed by the user may also be configured to be performed in various locations outside a laboratory or clinical setting. The test performed by the user may be a "home" test suitable for performing in a user's home, a workplace, or any other public or private location. For example, the test performed by the user may be a packaged kit, which includes collecting and testing biological or environmental samples to generate all the equipment required for a test result. In addition, the test performed by the user may be configured to be used in conjunction with an application program executed on a computing device (such as a mobile device of a patient or user or any other computing device). In such computer-integrated testing, the application may be configured only to receive user-input test results, or may be configured to perform at least a portion of the determination of the test results (e.g., by capturing or receiving one or more images of a test device (such as a test device) and optically generating a test result based on the one or more images).

[0053] The analytical equipment described herein can accurately measure a variety of analytes of interest in many different types of samples. Samples can include specimens or cultures obtained from any source, as well as biological samples and environmental samples. Biological samples can be obtained from animals (including humans) and cover fluids, solids, tissues and gases. Biological samples include urine, saliva and blood products (such as plasma, serum, etc.). However, these examples should not be interpreted as limiting the sample types applicable to the present disclosure.

[0054] In some embodiments, the sample is an environmental sample for detecting one or more analytes in the 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, cerumen, breast milk, bronchoalveolar lavage fluid, semen (including prostatic fluid), Cowper's fluid or pre-ejaculatory fluid, female ejaculation, sweat, feces, hair, tears, cyst fluid, pleural and peritoneal fluid, pericardial fluid, lymph, chyme, chyle, bile, interstitial fluid, menstruation, pus, sebum, vomitus, vaginal secretions, mucosal secretions, fecal water, pancreatic juice, lavage fluids from sinus cavities, bronchopulmonary aspirates or other lavage fluids.

[0055] As used herein, "analyte" generally refers to a substance to be detected. For example, analytes may 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 (including those administered for therapeutic purposes and those administered for illicit purposes), drug intermediates or byproducts, bacteria, viral particles, and metabolites or antibodies to any of the above. Specific examples of some 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; cytokines; TNF-related apoptosis-inducing ligand (TRAIL); vitamin B2 microglobulin; interferon gamma-induced protein 10 (IP-10); interferon-induced GTP-binding protein (also known as myxovirus (influenza virus) resistance 1, MX1, MxA, IFI-78K, IFI78, MX, MX motor protein, such as GTPase 1); procalcitonin (PCT); glycosylated hemoglobin (Gly Hb); cortisol; digitoxin; N-acetylprocainamide (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; salicylates; acetaminophen; Hepatitis B virus surface antigen (HBsAg); Hepatitis B core antigen antibodies, such as anti-hepatitis B core antigen IgG and IgM (Anti-HBC); Human immunodeficiency virus 1 and 2 (HIV 1 and 2); human T-cell leukemia virus 1 and 2 (HTLV); hepatitis B e antigen (HBeAg); antibody to hepatitis B e antigen (Anti-HBe); influenza virus; thyroid stimulating hormone (TSH); thyroxine (T4); total triiodothyronine (total T3); free triiodothyronine (free T3); carcinoembryonic antigen (CEA); lipoproteins, cholesterol, and triglycerides; and alpha-fetoprotein (AFP). Drugs of abuse and controlled substances include, but are not intended to be limited to: amphetamines; methamphetamine; barbiturates, such as amobarbital, secobarbital, pentobarbital, phenobarbital, and parbital; benzodiazepines, such as chlordiazepoxide and diazepam; cannabinoids, such as hashish and marijuana; cocaine; fentanyl; LSD; methaqualone; opioids, such as heroin, morphine, codeine, hydromorphone, hydrocodone, methadone, oxycodone, oxymorphone, and opium; phencyclidine; and propoxyhene.Additional analytes may be included for biological or environmental substances of interest.

[0056] The present disclosure relates to diagnostic and / or environmental testing devices, such as, for example, lateral flow assay devices, test 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 described 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, test systems, and methods described herein include, but are not limited to:

[0057] TRAIL: TNF-related apoptosis-inducing ligand (also known as Apo2L, Apo-2 ligand, and CD253); representative RefSeq DNA sequences are NC_000003.12; NC_018914.2; and NT_005612.17, and representative RefSeq protein sequence accession numbers are NP_001177871.1; NP_001177872.1; and NP_003801.1. The TRAIL protein belongs to the tumor necrosis factor (TNF) ligand family.

[0058] CRP: C-reactive protein; representative RefSeq DNA sequences are NC_000001.11; NT_004487.20; and NC_018912.2, and a representative RefSeq protein sequence accession number is NP_000558.2.

[0059] IP-10: Chemokine (CXC motif) ligand 10; representative RefSeq DNA sequences are NC_000004.12; NC_018915.2; and NT_016354.20, and the RefSeq protein sequence is NP_001556.2.

[0060] PCT: Procalcitonin is the peptide precursor of the hormone calcitonin. 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.

[0061] MX1: Interferon-induced GTP-binding protein Mx1 (also known as interferon-induced protein p78, interferon-regulated resistance GTP-binding protein, MxA). Representative RefSeq amino acid sequences of this protein are NP_001138397.1; NM_001144925.2; NP_001171517.1; and NM_001178046.2.

[0062] The lateral flow assay devices, test systems and methods according to the present disclosure can measure the soluble form and / or the membrane form of the TRAIL protein. In one embodiment, only the soluble form of TRAIL is measured.

[0063] The embodiments disclosed herein provide systems, methods and devices for detecting the presence and / or amount of hazardous drugs.One skilled in the art will recognize that these embodiments can be implemented in hardware or a combination of hardware and software and / or firmware.

[0064] The test read function described herein can be stored as one or more instructions on a processor-readable medium or a computer-readable medium. The term "computer-readable medium" refers to any available medium that can be accessed by a computer or a processor. As an example and not limitation, such a medium may include RAM, ROM, EEPROM, flash memory, CD-ROM or other optical disk storage devices, disk storage devices or other magnetic storage devices, or any other medium that can be used to store the required program code in the form of an instruction or data structure and can be accessed by a computer. It should be noted that the computer-readable medium can be tangible and non-temporary. The term "computer program product" refers to a computing device or processor in combination with a code or instruction (e.g., a "program") that can be executed, processed or calculated by a computing device or processor. As used herein, the term "code" may refer to software, instructions, code or data that can be executed by a computing device or a processor.

[0065] The various illustrative logic blocks and modules described in conjunction with the embodiments disclosed herein may be implemented or executed by a machine (e.g., a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof, which are designed to perform the functions described herein). A general purpose processor may be a microprocessor, but in an alternative, the processor may be a controller, a microcontroller, or a state machine, a combination thereof, or the like. The processor may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in combination with a DSP core, or any other such configuration. Although primarily described herein with respect to digital technology, the processor may also primarily include analog components. For example, any signal processing algorithm described herein may be implemented in an analog circuit system. The computing environment may include any type of computer system, including but not limited to a microprocessor-based computer system, a mainframe computer, a digital signal processor, a portable computing device, a personal organizer, a device controller, and a computing engine within an appliance, to name a few.

[0066] The method disclosed herein includes one or more steps or actions for implementing the method. Without departing from the scope of the claims, the method steps and / or actions can be interchangeable with each other. In other words, unless the correct operation of the described method requires a specific sequence of steps or actions, the order and / or use of specific steps and / or actions can be modified without departing from the scope of the claims.

[0067] The term "determining" encompasses a wide variety of actions, and thus "determining" may include computing, calculating, processing, deriving, investigating, looking up (e.g., looking up in a table, a database, or another data structure), ascertaining, etc. In addition, "determining" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), etc. In addition, "determining" may include resolving, selecting, choosing, establishing, etc. Unless expressly specified otherwise, the term "based on" does not mean "based only on." In other words, the term "based on" describes both "based only on" and "based at least on."

[0068] The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be applied to other embodiments without departing from the scope of the invention. Therefore, the present invention is not intended to be limited to the embodiments shown herein, but should be consistent with the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A system comprising: one or more processors associated with at least one of a healthcare provider and a testing provider, the one or more processors configured with computer executable instructions to: receiving from a clinician computing device a test administered by a designated user and a patient's prescription; transmitting prescription information corresponding to the prescription to a pharmacy interface; generating an order identifier that uniquely identifies the prescription; and causing transmission of the order identifier to a user application installed on a computing device associated with the patient; as well as A user device comprising one or more processors configured with processor-executable instructions included in the user application to: receiving the order identifier; obtaining a test result corresponding to a test performed by the user; associating the received order identifier with the test result; and The test results are sent in association with the order identifier to the one or more processors associated with the healthcare provider.

2. The system according to 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: receiving the test result in association with the order identifier; and The test result and the order identifier are stored in a medical records database in association with at least one additional identifier corresponding to the patient or a consultation, wherein the consultation corresponds to the prescription.

3. The system according to claim 2, wherein: 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 indicating the test result.

4. The system according to 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 transmission of a notification instructing the patient to install the user application on the computing device.

5. The system according to claim 4, wherein: The notification includes an email, a text message, or a push notification in a second application different from the user application.

6. The system according to claim 1, wherein: Obtaining the test result corresponding to the test performed by the user comprises: receiving an image of the test device taken after the specimen is applied to the test device; and The test result is automatically determined based on image data of the received image of the test device.

7. The system according to claim 6, wherein: The testing device comprises a lateral flow assay test strip, and wherein automatically determining the test result comprises detecting one or more lines on the lateral flow assay test strip.

8. The system according to 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 transmission to the user application of an identifier of a test type corresponding to a test administered by the user.

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

10. The system according to any one of claims 1 to 9, wherein: The user-administered test comprises a lateral flow assay, and the test result comprises one or more lines on the lateral flow assay.

11. A computer-implemented method for providing a user-administered test in conjunction with an electronic medical record system, the method comprising, under the control of one or more processors: receiving a prescription from a clinician computing device, the prescription specifying a test to be performed by a user and a patient; transmitting prescription information corresponding to the prescription to a pharmacy interface; generating an order identifier that uniquely identifies the prescription; causing transmission of the order identifier to a user application installed on a computing device associated with the patient and configured to associate the order identifier with a test result determined at least in part by the user application; receiving the test result from the user application in association with the order identifier; storing the test result and the order identifier in a medical records database in association with at least one additional identifier corresponding to the patient or the consultation, wherein the consultation corresponds to the prescription; as well as A notification associated with the test result is sent to the clinician computing device.

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

13. The computer-implemented method of claim 12, wherein: The notification instructing the patient to install the user application includes 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 transmission to the user application of an identifier of a test type corresponding to the test administered by the user.

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 associated with the test type to the patient.

16. 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 also includes an identifier of the patient or an identifier of a consultation associated with the prescription.

18. The computer-implemented method according to any one of claims 11 to 17, wherein: The user-administered test comprises a lateral flow assay test, and wherein the test result comprises one or more lines on the lateral flow assay.

19. A computer-implemented method for providing a user-administered test in conjunction with an electronic medical record system, the method comprising, under the control of one or more processors of a computing device associated with a patient: receiving, from a computing system associated with a testing provider or a healthcare provider, an order identifier corresponding to a test to be performed by a designated user and a prescription for said patient; obtaining a test result corresponding to a test performed by the user; as well as The test result is sent in association with the order identifier to the computing system associated with the testing provider or the healthcare provider.

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

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 test device, instructions for determining the adequacy of a sample or a test result, or instructions for imaging a test device to determine a result by the computing device.

22. The computer-implemented method of claim 19, wherein: Obtaining the test result corresponding to the test administered by the user includes prompting the patient to enter the test result at a user interface of the computing device.

23. The computer-implemented method of claim 19, wherein: Obtaining the test result corresponding to the test performed by the user comprises: receiving an image of a test device used for a test to be administered by the user; and The test result is automatically determined based on image data of the received image of the test device.

24. The computer-implemented method of claim 23, wherein: The testing device comprises a lateral flow assay test strip, and wherein automatically determining the test result comprises detecting one or more lines on the lateral flow assay test strip.

25. The computer-implemented method of claim 23, wherein: The computing device comprises an image capture device, and wherein receiving the image of the test device comprises: displaying instructions to the user to capture an image of the test device using the image capture device; and The image is received from the image capture device.

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

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

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