WO2015183150A1 - A method and a system for performing a health test - Google Patents

A method and a system for performing a health test Download PDF

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Publication number
WO2015183150A1
WO2015183150A1 PCT/SE2015/050322 SE2015050322W WO2015183150A1 WO 2015183150 A1 WO2015183150 A1 WO 2015183150A1 SE 2015050322 W SE2015050322 W SE 2015050322W WO 2015183150 A1 WO2015183150 A1 WO 2015183150A1
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WO
WIPO (PCT)
Prior art keywords
dbs
unique
user
data
test
Prior art date
Application number
PCT/SE2015/050322
Other languages
French (fr)
Inventor
Ola BARTHOLDSSON
Original Assignee
Bodymarkers Ab
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bodymarkers Ab filed Critical Bodymarkers Ab
Publication of WO2015183150A1 publication Critical patent/WO2015183150A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00722Communications; Identification
    • G01N35/00871Communications between instruments or with remote terminals
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00722Communications; Identification
    • G01N35/00732Identification of carriers, materials or components in automatic analysers
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00029Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor provided with flat sample substrates, e.g. slides
    • G01N2035/00099Characterised by type of test elements
    • G01N2035/00108Test strips, e.g. paper
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584Control arrangements for automatic analysers
    • G01N35/00722Communications; Identification
    • G01N35/00732Identification of carriers, materials or components in automatic analysers
    • G01N2035/00742Type of codes
    • G01N2035/00752Type of codes bar codes
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood

Definitions

  • the present disclosure generally relates to a method and a system for performing a health test. More particularly, the present disclosure relates to a method and a system for performing a health test, which allows for maintaining the anonymity of a user while providing potentially sensitive information, such as the health test result, to the user. Background
  • a medical doctor or a nurse typically takes a blood test.
  • the doctor or nurse may use any suitable equipment for blood extraction, including, for example, needles, collection devices (e.g., tubes), alcohol swabs, sterile gauzes, lancets for puncturing the skin, etc.
  • the doctor or nurse may use a bandage to protect the puncture site after the blood sample has been produced.
  • a blood sample may e.g. be acquired by placing collected blood in a blood specimen collection device.
  • the blood specimen collection device is typically associated with the user via a personal identification number, such as a personal code number (a.k.a. social security number, or national identification number).
  • personal identification numbers are identification numbers that may be used by the governments of many countries as a means of tracking their citizens, permanent residents, and temporary residents for the purposes of work, taxation, government benefits, health care, and other governmentally- related functions. In Sweden, as one example, personal identification numbers typically use ten digits, YYMMDD-NNGC. The first six digits give the birth date in YYMMDD format. Digits seven to nine (NNG) are used to make the number unique, where digit nine (G) is odd for men and even for women. The seventh and eighth digit (for numbers issued before 1990) identify the county of birth or foreign born people.
  • the blood specimen collection device including the blood sample is then mailed to a testing facility for analysis. Once the testing facility has performed the relevant health test on the received blood sample, the health test results are returned (e.g. mailed) to the sender, i.e. the hospital.
  • the doctor or nurse examines the health test result and contacts the user associated with the personal identification number for making an appointment for consultation based on the health test results.
  • a method for performing a health test of a user is provided.
  • a unique disposable identifier is assigned to a User Equipment (UE), which is associated with a Dried Blood Spot (DBS) sample indicative of a health condition of said user.
  • the unique disposable identifier identifies the UE and the DBS sample taken by the user.
  • the DBS sample, together with the unique disposable identifier, are received at a Mass Spectrometry (MS) apparatus.
  • MS apparatus performs a DBS test on the received DBS sample to detect a health condition and to determine a test result.
  • the MS apparatus correlates the test result from the DBS test with the unique disposable identifier received in connection with the DBS sample.
  • the MS apparatus forms, or creates, a first data message comprising information about the test result correlated with said unique disposable identifier.
  • the MS apparatus further transmits said first data message to a server.
  • the server receives said first data message from the MS apparatus and retrieves said information about the test result correlated with said unique disposable identifier from the received first data message.
  • the server also stores said information about the test result correlated with said unique disposable identifier in a memory associated with the server.
  • the UE transmits a second data message to the server, wherein the second data message comprises a request for a test result as well as the unique disposable identifier identifying the UE.
  • the server receives said second data message from the UE.
  • the server provides the test result to said UE when the unique disposable identifier received in the first data message from the MS apparatus is the same as the unique disposable identifier received in the second data message from the UE.
  • the UE reads an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier.
  • the UE also retrieves, or otherwise identifies, the unique disposable identifier from the optically readable representation of data from the disposable test kit.
  • the UE stores the unique disposable identifier in a memory associated with the UE.
  • the optically readable representation of data may be a barcode, such as a matrix barcode.
  • a matrix barcode is sometimes referred to as a two- dimensional barcode.
  • An example of a preferred matrix code is a Quick Response (QR) code.
  • QR Quick Response
  • the disposable test kit comprises a filter paper intended for said DBS sample, wherein the optically readable representation of data is provided (e.g., pre-printed) on said filter paper.
  • the earlier-mentioned step of receiving the DBS sample may comprise receiving said filter paper including said DBS sample, wherein the DBS sample is identified by the unique disposable identifier comprised in the optically readable representation of data.
  • a system for performing a health test of a user comprises a UE, a MS apparatus and a server.
  • a unique disposable identifier is assigned to the UE, which is associated with a DBS sample indicative of a health condition of said user.
  • the unique disposable identifier identifies the UE and the DBS sample taken by the user.
  • the MS apparatus is adapted to: receive the DBS sample together with the unique disposable identifier; perform the DBS test on the received DBS sample to detect a health condition and to determine a test result; correlate the test result from the DBS test with the unique disposable identifier received in connection with the DBS sample; form a first data message comprising information about the test result correlated with said unique disposable identifier received in connection with the DBS sample; and transmit said first data message to a server.
  • the server is adapted to: receive said first data message from the MS apparatus; retrieve said information about the test result correlated with said unique identifier from said first data message; and store said information about the test result correlated with said unique identifier in a memory associated with the server.
  • the UE is adapted to transmit a second data message to the server, wherein the second data message comprises a request for a test result as well as the unique disposable identifier identifying the UE.
  • the server is further adapted to receive said second data message from the UE, wherein said second data message comprises the request for the test result as well as the unique disposable identifier identifying the UE.
  • the server is also adapted to provide the test result to said UE when the unique disposable identifier received in the first data message from the MS apparatus is the same as the unique disposable identifier received in the second data message from the UE.
  • the UE is adapted to: read an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier; retrieve the unique disposable identifier from the optically readable representation of data from the disposable test kit; and store the unique disposable identifier in a memory associated with the UE.
  • the optically readable representation of data may be a matrix barcode, such as a QR code.
  • the disposable test kit comprises a filter paper intended for said DBS sample, wherein the optically readable representation of data is provided on said filter paper.
  • the MS apparatus is adapted to receive said filter paper including said DBS sample, and the DBS sample is identified by the unique disposable identifier comprised in the optically readable representation of data.
  • the unique disposable identifier By assigning the unique disposable identifier to a UE which is associated with a DBS sample indicative of a health condition of said user it is made possible to allow for health tests without compromising the anonymity of the user.
  • the UE which is typically associated with the user (e.g., through a Subscriber Identity Module (SIM)), will be assigned the same unique disposable identifier as the DBS sample taken by the user.
  • SIM Subscriber Identity Module
  • the UE will access the test results only if, or when, the unique disposable identifier assigned to the UE matches the corresponding unique disposable identifier, which is stored in the server and which is furthermore associated with the relevant test results. This provides for a health test where the anonymity of the user can be maintained.
  • the unique identifier is a unique disposable identifier. Compared to personal identification numbers, which are typically not disposable but rather constant over time, a disposable identifier is generally less prone to fraud. This may be particularly important when providing users with sensitive information, such as health test results.
  • the DBS sample may be taken by the user at home or at any desired place. Consequently, the user does not have to visit a hospital in order to perform the health test.
  • This provides for a flexible solution, where the user himself/herself can choose where to take his or her DBS sample. Also, this may save time for the user. Still further, this may allow for saving resources at the hospital such that doctors and/or nurses may focus their time on other, potentially more important, life-saving operations or medical tests. For example, in today's society many people wishes to perform health tests for other reasons than pure medical reasons. If the purpose is medical in nature, it may be natural for the user to visit the hospital for performing the health test.
  • the embodiments of the present invention allow for relieving the pressure on hospitals by providing users with a self-test.
  • the self-test provided by the embodiments of the invention allow a user to take a DBS sample at home (or at any other desired place) and, subsequently, access the test results via the UE associated with the user.
  • a UE for use when performing a health test of a user.
  • the UE may be associated with a DBS sample indicative of a health condition of said user.
  • a unique disposable identifier is assigned to the UE, which unique disposable identifier identifies the UE and the DBS sample taken by the user.
  • the UE comprises a transmitter, a processor, and a memory.
  • the UE stores computer program code, which, when run in the processor causes the UE to transmit, by means of the transmitter, a second data message to a server, wherein the second data message comprises a request for a test result of the health test as well as the unique disposable identifier identifying the UE.
  • the UE may also comprise a receiver adapted to receive a third data message from the server, wherein said third data message comprises the requested test result.
  • the UE may also comprise a user interface adapted to display the received test result.
  • the UE may comprise a reader and the memory may store computer program code, which, when run in the processor causes the UE to: read, by means of the reader, an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier; retrieve, by means of the reader, the unique disposable identifier from the optically readable representation of data from the disposable test kit; and store the unique disposable identifier in a memory associated with the UE.
  • the optically readable representation of data may be a matrix barcode, such as a QR code.
  • a disposable test kit for use when performing a health test of a user.
  • the disposable test kit includes a DBS sample to be taken by the user, as well as an optically readable representation of data comprising a unique disposable identifier identifying the DBS sample, wherein the optically readable representation of data is readable by means of a UE according to the earlier-mentioned third aspect. Said unique disposable identifier may thus be assigned to said UE.
  • the disposable test kit comprises a filter paper intended for said DBS sample, wherein the optically readable representation of data is provided (e.g., preprinted) on said filter paper.
  • the optically readable representation of data is a matrix barcode, such as a QR code.
  • various embodiments of this disclosure allow for a user to pair his/her UE with a DBS sample to be taken by the user, e.g. at home.
  • the test results of the health test are later available at a server (after that a MS apparatus has performed its DBS test on the received DBS sample)
  • the same UE may access the test results only if, or when, the unique disposable identifier assigned to the UE matches the corresponding unique disposable identifier, which is stored in the server and which is furthermore associated with the relevant test results of the health test.
  • This provides for a health test where the anonymity of the user can be maintained.
  • the various embodiments suggested in this disclosure provides for improved flexibility.
  • the user may access the test results of the health test at any place and at any time the user finds convenient.
  • some embodiments described herein require little or no manual input by the user. This may allow for increased accuracy and/or security compared to solutions where passwords, personal identification numbers, etc. are manually entered at the UE. This may be especially important for health test results due to the potentially sensitive nature of health test results.
  • some embodiments described herein do not require skilled users. Instead, the user only has to read an optically readable representation of data, e.g. by reading a QR code by means of a QR reader of the UE, from the disposable test kit including the DBS sample to be taken by the user. This reduces the risk of errors when pairing the UE with the DBS sample.
  • FIG. 1 is schematic diagram illustrating an exemplary environment where embodiments presented herein may be applied;
  • Fig. 2A is a schematic diagram illustrating some modules of an embodiment of a UE
  • Fig. 2B schematically shows one example of a computer program product according to an embodiment
  • Fig. 3 shows a disposable test kit according to an embodiment.
  • Fig. 1 is a schematic diagram illustrating an exemplary environment where embodiments of the invention may be applied.
  • Fig. 1 depicts a system 100, which may be referred to as a health test system or a Dried Blood Spot (DBS) Selftesting System.
  • the system 100 comprises one or more User Equipments (UEs) 200.
  • UEs User Equipments
  • a UE 200 may e.g. be a mobile terminal or a wireless terminal, a mobile phone such as a smartphone, a computer such as a laptop, a Personal Digital Assistant (PDA) or a tablet computer (sometimes referred to as a surf plate).
  • PDA Personal Digital Assistant
  • a UE 200 is associated with a user (not shown), e.g. via the SIM module of the UE.
  • the system also comprises a DBS sample 300 to be taken by the user.
  • the DBS sample 300 to be taken by the user is part of a disposable test kit (not shown).
  • the system 100 further includes a Mass Spectrometry (MS) apparatus 400.
  • the MS apparatus is part of, or otherwise located in, a testing facility 401.
  • the system 100 comprises one or more servers 500.
  • the one or more UEs 200 are communicatively connectable to the one or more servers 500 through a network 600.
  • the MS apparatus 400 is communicatively connectable to the one or more servers 500 through the network 600.
  • the network 600 may, e.g., be a cellular network.
  • the cellular network 600 may thus be a wireless communication network such as LTE (Long Term Evolution), WCDMA (Wideband Code Division Multiple Access), any other cellular network standardized by the 3 Generation Partnership Project (3GPP), Wimax, or any other wireless communication network.
  • LTE Long Term Evolution
  • WCDMA Wideband Code Division Multiple
  • DBS is a form of biosampling where blood samples are blotted and dried on filter paper.
  • DBS may be particularly advantageous for self-testing, because DBS testing does not require skilled users.
  • the user does not have to take a venous blood sample. Rather, dried blood spot specimens can be collected by applying a few drops of blood, drawn by lancet or similar equipment from the finger, heel or toe, onto a specially manufactured absorbent filter paper.
  • MS mass spectrometry
  • biomarkers of DBS samples that could be analyzed by MS are, without limitation: HbAlc, glucose, Prostate-specific antigen (PSA), folate, Apo A-l, Apo B, fibrinogen, hs-CRP, HDL, LDL, homocysteine, Lipoprotein(a), Lipoprotein-associated phospholipase A2 (LpPLA2), total cholesterol, triglycerides, Cortisol, DHEA-S, estradiol, insulin, IGF-1, luteinizing hormone (LH), progesterone, sex hormone-binding globulin (SHBG), testosterone, Thyroid-stimulating hormone (TSH), B-PEth, thyroxine (T4), triiodothyronine (T3), albumin, alkaline phosphatase (ALP), ALT / SGPT, AST / SGOT, bilirubin, globulin, total protein, blood urea nitrogen (B
  • the user initially obtains, or otherwise acquires, a DBS sample 300 to be taken by the user.
  • the DBS sample 300 to be taken by the user is comprised in a disposable test kit (not shown).
  • This disposable test kit may e.g. comprise a bag including the DBS sample 300 to be taken by the user.
  • the disposable test kit including the DBS sample 300 to be taken by the user may e.g. be ordered from a test kit provider.
  • the disposable test kit may be ordered via the Internet. If the disposable test kit is ordered via the Internet, the user may use his or her UE 200 to carry out the order. This may be advantageous, since the user can place his or her order at any place and at any time the user finds convenient.
  • the disposable test kit including the DBS sample 300 may be provided at a pharmacy. Yet alternatively, the disposable test kit including the DBS sample 300 may e.g. be provided at any of the following: a fitness center, a sports store, a cosmetics store, or any other consumer goods retailer.
  • the disposable test kit typically comprises any other any suitable equipment for taking the DBS sample 300 such as: a lancet for taking a DBS blood sample e.g. from the fingertip of the user, a filter paper intended for said DBS sample, a plaster, alcohol swabs, sterile gauzes, etcetera.
  • the disposable test kit typically also comprises a unique disposable identifier identifying the DBS sample 300 of the disposable test kit.
  • the filter paper comprised in the disposable test kit comprises an optically readable representation of data (e.g. in the form of a matrix barcode, such as a QR code), wherein the optically readable representation of data comprises the unique disposable identifier.
  • the optically readable representation of data is provided on said filter paper.
  • the optically readable representation of data may be pre-printed on the filter paper. Before (or, after) the user takes his or her DBS blood sample, the user may use his or her UE 200 to read the optically readable representation of data from the filter paper.
  • the UE 200 then retrieves the unique disposable identifier from the thus read optically readable representation of data.
  • the retrieved unique disposable identifier may also be stored in a memory associated with the UE 200.
  • This memory is preferably an internal memory of the UE 200. Alternatively, this memory may be an external memory, which is accessible by the UE 200.
  • the DBS sample 300 to be taken by the user is assigned a unique disposable identifier identifying the DBS sample 300.
  • the unique disposable identifier is comprised in the optically readable representation of data (e.g. in a QR code) provided, or otherwise pre-printed, on the filter paper.
  • the UE 200 retrieve this unique disposable identifier from the optically readable representation of data and store it in the memory associated with the UE 200. It is thus possible to pair the UE 200 with the DBS sample 300 to be taken by the user who is associated with the UE 200.
  • a DBS sample 300 may be taken by the user by applying a few drops of blood, drawn by a lancet or similar equipment from the finger, heel or toe, onto the filter paper, which is typically a specially manufactured absorbent filter paper. The few drops of blood will then dry on the filter paper for about an hour, or so.
  • the DBS sample 300 taken by the user can thereafter be placed in an envelope or in a bag.
  • the envelope, or bag, including the taken DBS sample 300 is then delivered, e.g. mailed or shipped, to a MS apparatus 400 for subsequent analysis.
  • the MS apparatus 400 may preferably, but not necessarily, be part of, or otherwise located in, a testing facility 401.
  • the MS apparatus 400 receives the DBS sample 300 together with the unique disposable identifier.
  • the MS apparatus 400 may e.g. comprise a processor, a memory and a reader such as an optical reader for reading optically readable representations of data (e.g. a QR code).
  • the memory may store computer program code, which, when run in the processor causes the MS apparatus 400 to read, by means of the reader, the optically readable representation of data from the received DBS sample 300, wherein the optically readable representation of data comprises said unique disposable identifier.
  • the memory may also store computer program code, which, when run in the processor causes the MS apparatus 400 to retrieve, by means of the reader, the unique disposable identifier from the optically readable representation of data from the received DBS sample 300.
  • the retrieved unique disposable identifier may also be stored in a memory associated with the MS apparatus 400.
  • This latter memory may be an internal memory of the MS apparatus 400.
  • this memory may be an external memory, which is accessible by the MS apparatus 400.
  • the MS apparatus may thus read, retrieve and store the unique disposable identifier associated with the DBS sample 300 that will be analyzed by the MS apparatus 400.
  • the MS apparatus 400 performs a DBS test on the received DBS sample 300 to detect a health condition and to determine a test result.
  • the MS apparatus 400 thus analyses the extracted dried blood spot of the DBS sample 300.
  • the procedure for performing a DBS test using MS is, as such, known in the art and will therefore not be further detailed herein.
  • the MS apparatus 400 can subsequently correlate the test result from the DBS test with the stored unique disposable identifier. More particularly, the memory of the MS apparatus 400 may store computer program code, which, when run in the processor causes the MS apparatus 400 to correlate the test result from the DBS test with the stored unique disposable identifier.
  • the memory may store computer program code, which, when run in the processor causes the MS apparatus 400 to form, or otherwise create, a first data message comprising information about the test result correlated with said unique disposable identifier.
  • the memory of the MS apparatus 400 may also store computer program code, which, when run in the processor causes the MS apparatus 400 to transmit, by means of a transmitter of the MS apparatus 400, the first data message to a server 500.
  • the first data message may, e.g., be transmitted to the server 500 via the network 600.
  • the server 500 thus receives the first data message from the MS apparatus 400.
  • a receiver of the server 500 is configured to receive the first data message. Accordingly, the server 500 receives information about the test result correlated with said unique disposable identifier.
  • the server 500 may e.g. comprise a processor and a memory.
  • the memory may store computer program code, which, when run in the processor causes the server 500 to retrieve said information about the test result correlated with said unique disposable identifier from the received first data message.
  • the server 500 is configure to store said information about the test result correlated with said unique disposable identifier in a memory associated with the server.
  • This latter memory may be an internal memory of the server 500. Alternatively, this memory may be an external memory, which is accessible by the server 500.
  • Action 4 The UE 200 transmits a second data message to the server 500.
  • This second data message comprises a request for a test result as well as the unique disposable identifier identifying the UE.
  • the unique disposable identifier identifying the UE is the same unique disposable identifier that was assigned to the UE in action 1.
  • the server 500 thus receives the second data message from the UE 200.
  • Action 5 The server 500 is configured to compare the unique disposable identifier identifying the UE received along with the above-mentioned request in the second data message against stored unique disposable identifiers to check whether a health test result associated with the unique disposable identifier is available at the server 500.
  • the server When it is determined that the unique disposable identifier received in the first data message from the MS apparatus 400 (which is then stored in the memory of the server 500) is the same as, i.e. matches, the unique disposable identifier received in the second data message from the UE, the server will make the test result available to the UE 200. More particularly, the memory of the server 500 may store computer program code, which, when run in the processor of the server 500 causes the server 500 to provide the test result to the UE 200 when the unique disposable identifier received in the first data message from the MS apparatus 400 is the same as, i.e. matches, the unique disposable identifier received in the second data message from this UE 200.
  • Action 6 As described above, when it is determined that the unique disposable identifier received in the first data message from the MS apparatus 400 (which is then stored in the memory of the server 500) is the same as, i.e. matches, the unique disposable identifier received in the second data message from the UE 200, the server 500 will make the test result available to the requesting UE 200. Thus, the UE 200 may access the health test result from the server 500. For example, the UE 200 may receive a third data message from the server, the third data message comprising the requested test result. Once received by the UE 200, the health test result may be presented to the user through the UE 200, e.g. by means of a display of the UE 200.
  • Fig. 2A is a schematic diagram illustrating some modules of an example embodiment of a UE 200 shown in Fig. 1.
  • the UE 200 is a smart phone or a tablet computer.
  • the UE 200 comprises a processor 201, a memory 202, a transmitter (Tx) 203, a receiver (Rx) 204 and a User Interface (UI) 205.
  • the transmitter (Tx) 203 and the receiver (Rx) 204 may alternatively be provided by means of a transceiver (Tx/Rx), which combines transmission and reception capabilities.
  • the processor 201 may be provided using any suitable central processing unit (CPU), microcontroller, digital signal processor (DSP), etcetera, which is capable of executing a computer program comprising computer program code, the computer program being stored in memory 202.
  • the memory 202 may be any combination of random access memory (RAM) and read only memory (ROM).
  • the memory 202 may e.g. comprise persistent storage, which, for example, can be a single one or a combination of magnetic memory, optical memory, or solid state memory or even remotely mounted memory.
  • the UI 205 may e.g. comprise a display and input means (such as a keybord, a mouse or a touch screen display). In advantageous embodiments, the UI 205 comprises a touch screen display.
  • Touch screen displays are attractive, e.g., because they facilitate small form factor UEs (e.g. smart phones or tablet computers) on which there may be limited room to include a display as well a one or several key buttons, scroll wheels, and/or the like for allowing the user to interact with and send commands to the UE 200. Also, inputting commands to the UE 200 by touching a graphical user interface displayed on a touch screen display may be intuitive to many users, and thus touch screen displays are generally perceived as user- friendly by many users.
  • the UE 200 may also comprise a reader 206 adapted to read an optically readable representation of data, such as barcodes of different types (e.g. QR codes).
  • the reader 206 may be an optical reader.
  • the reader 206 may comprise a camera.
  • the reader 206 can be implemented as a barcode reader for reading a barcode, e.g. a matrix barcode such as a QR code.
  • the UE 200 shown in Fig. 2A is suitable for use when performing a health test of a user according to the earlier-described method discussed in connection with Fig. 1.
  • the UE 200 can be associated with a DBS sample indicative of a health condition of the user of the UE 200.
  • a unique disposable identifier can be assigned to the UE 200, which unique disposable identifier identifies the UE 200 and the DBS sample 300 taken by the user.
  • the memory 202 may store computer program code, which, when run in the processor 201 causes the UE 200 to read, by means of the reader 206, an optically readable representation of data from a disposable test kit including the DBS sample 300 to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier.
  • the memory 202 may also store computer program code, which, when run in the processor 201 causes the UE 200 to retrieve, by means of the reader, the unique disposable identifier from the optically readable representation of data from the disposable test kit.
  • the retrieved unique disposable identifier may be stored in another memory 207 associated with the UE 200.
  • the memory 202 stores computer program code, which, when run in the processor 201 causes the UE 200 to transmit, by means of the transmitter 203, a second data message to a server 500, wherein the second data message comprises a request for a test result of the health test as well as the unique disposable identifier identifying the UE 200.
  • the receiver 204 is adapted to receive a third data message from the server 500, wherein said third data message comprises the requested test result.
  • the health test result may be presented to the user by means of the UI 205 of the UE 200.
  • FIG. 2B yet another embodiment of the invention is disclosed.
  • Fig. 2B illustrates a computer program comprising instructions (or, computer program code) which, when executed on a processor 201 of a UE 200, will cause the UE 200 to transmit, by means of a transmitter of the UE 200, a second data message to a server 500, wherein the second data message comprises a request for a test result of the health test as well as the unique disposable identifier identifying the UE.
  • a receiver of the UE 200 may be adapted to receive a third data message from the server, wherein said third data message comprises the requested test result.
  • the computer program may comprise instructions which, when executed on a processor 201 of the UE 200, will cause the UE 200 to read, by means of a reader of the UE 200, an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier; retrieve, by means of the reader of the UE 200, the unique disposable identifier from the optically readable representation of data from the disposable test kit; and store the unique disposable identifier in a memory associated with the UE 200.
  • a carrier may comprise the above-mentioned computer program.
  • the carrier may be a computer readable storage medium 208.
  • the carrier may be one of an electronic signal, an optical signal, or a radio signal.
  • the carrier is embodied as a software package (also sometimes referred to as software application, application or APP) which can be distributed over a network, such as the Internet.
  • the disposable test kit is suitable for use when performing a health test of a user according to the embodiments described herein.
  • the disposable test kit comprises the DBS sample 300 to be taken by the user.
  • the disposable test kit also comprises the optically readable representation of data 301, such as a QR code, comprising the unique disposable identifier.
  • the optically readable representation of data 301 which is exemplified by a QR code in Fig. 3 is readable by means of reader of the UE 200 shown in Figs. 1 and 2A. It is hereby made possible to pair the UE 200 with the DBS sample 300 as described earlier.
  • the disposable test kit comprises a filter paper 302 for the DBS sample 300 wherein the optically readable representation of data is provided, e.g. pre-printed, on said filter paper 302 as is schematically illustrated in Fig.3.
  • various embodiments described herein allow for a user to pair his/her UE 200 with a DBS sample to be taken by the user, e.g. at home.
  • the test results of the health test are later available at a server (after that a MS apparatus has performed its DBS test on the received DBS sample)
  • the same UE 200 may access the test results only if, or when, the unique disposable identifier assigned to the UE 200 matches the corresponding unique disposable identifier, which is stored in the server 500 and which is furthermore associated with the relevant test results of the health test.
  • This provides for a health test where the anonymity of the user can be maintained.
  • the various embodiments suggested in this disclosure provides for improved flexibility.
  • the user may access the test results of the health test at any place and at any time the user finds convenient.
  • some embodiments described herein require little or no manual input by the user. This may allow for increased accuracy and/or security compared to solutions where e.g. personal identification numbers are manually entered at the UE 200. This may be especially important for health test results due to the potentially sensitive nature of health test results.
  • some embodiments described herein do not require skilled users. Instead, the user only has to read an optically readable representation of data, e.g. by reading a QR code by means of a reader of the UE 200, from the disposable test kit including the DBS sample 300 to be taken by the user. This reduces the risk of errors when pairing the UE with the DBS sample 300.
  • the various embodiments described in this disclosure may provide many advantages. For example, by assigning the unique disposable identifier to a UE 200 which is associated with a DBS sample 300 indicative of a health condition of said user it is made possible to allow for health tests without compromising the anonymity of the user.
  • the UE 200 which is typically associated with the user, will be assigned the same unique disposable identifier as the DBS sample 300 taken by the user.
  • the UE 200 will access the test results only if, or when, the unique disposable identifier assigned to the UE 200 matches the corresponding unique disposable identifier, which is stored in the server 500 and which is furthermore associated with the relevant test results.
  • This provides for a health test where the anonymity of the user can be maintained.
  • the unique identifier is disposable. Compared to personal identification number, which are typically not disposable, disposable unique identifiers are less prone to fraud.
  • the DBS sample 300 may be taken by the user at home or at any desired place. Consequently, the user does not have to visit a hospital in order to perform the health test.
  • This provides for a flexible health test, where the user himself/herself can choose where to take his or her DBS sample 300. This may save time for the user. This may also allow for saving resources at the hospital.
  • some of the embodiments described herein may allow for relieving the pressure on hospitals by providing users with a self-test.
  • the self-test provided by the embodiments described herein may allow a user to take a DBS sample at home (or at any other desired place) and, subsequently, access the test results via the UE 200 associated with the user.
  • the use of a combination of DBS testing and MS technology allow for improved self-tests, where many different biomarkers of a DBS sample can be analyzed to detect various health conditions and to determine different health test results depending on the specific purpose of the test. It is therefore foreseen that the various embodiments described in this disclosure can be used in a variety of application areas including, but not limited to, the following: general health monitoring, diet supplement monitoring, medical intake monitoring, weight loss diet monitoring, illness monitoring, anti-aging monitoring, hair loss monitoring, alcohol intake monitoring, pregnancy monitoring, allergy monitoring, etcetera.

Abstract

The present disclosure generally relates to a method and a system for performing a health test of a user. The present invention also relates to a User Equipment (UE) for use when performing a health test of a user as well as a disposable test kit, which is suitable for use when performing a health test of a user. The disposable test kit for use when performing the health test of a user may e.g. include a Dried Blood Spot (DBS) sample (300) to be taken by the user as well as a Quick Response (QR) code (301) comprising a unique disposable identifier identifying the DBS sample. The QR code (301) can be read by means of the UE for thereby assigning the unique disposable identifier to the UE.

Description

A METHOD AND A SYSTEM FOR PERFORMING A HEALTH TEST
Technical Field
The present disclosure generally relates to a method and a system for performing a health test. More particularly, the present disclosure relates to a method and a system for performing a health test, which allows for maintaining the anonymity of a user while providing potentially sensitive information, such as the health test result, to the user. Background
Generally, when a health test is carried out, a user has to visit a hospital or similar institution. When the body fluid to be tested is blood, a medical doctor or a nurse typically takes a blood test. The doctor or nurse may use any suitable equipment for blood extraction, including, for example, needles, collection devices (e.g., tubes), alcohol swabs, sterile gauzes, lancets for puncturing the skin, etc. Also, the doctor or nurse may use a bandage to protect the puncture site after the blood sample has been produced. A blood sample may e.g. be acquired by placing collected blood in a blood specimen collection device.
The blood specimen collection device is typically associated with the user via a personal identification number, such as a personal code number (a.k.a. social security number, or national identification number). Typically, personal identification numbers are identification numbers that may be used by the governments of many countries as a means of tracking their citizens, permanent residents, and temporary residents for the purposes of work, taxation, government benefits, health care, and other governmentally- related functions. In Sweden, as one example, personal identification numbers typically use ten digits, YYMMDD-NNGC. The first six digits give the birth date in YYMMDD format. Digits seven to nine (NNG) are used to make the number unique, where digit nine (G) is odd for men and even for women. The seventh and eighth digit (for numbers issued before 1990) identify the county of birth or foreign born people.
The blood specimen collection device including the blood sample is then mailed to a testing facility for analysis. Once the testing facility has performed the relevant health test on the received blood sample, the health test results are returned (e.g. mailed) to the sender, i.e. the hospital.
The doctor or nurse examines the health test result and contacts the user associated with the personal identification number for making an appointment for consultation based on the health test results.
The above described process of taking a blood test and receiving consultation based on the health test results may take unnecessarily long time. Therefore, tests have been developed and marketed that allow people to take a blood sample at home and mail it to a medical laboratory for analysis. However, these tests typically require the person taking the test to give the laboratory his or her name and address. The loss of anonymity thereby discourages people from taking the test.
Summary
It is in view of the above considerations and others that the various embodiments of the present invention have been made. It is a general object of the embodiments of the invention to allow for health tests without compromising the anonymity of the user.
This general object has therefore been addressed by the appended independent claims. Advantageous embodiments are defined in the appended dependent claims.
According to a first aspect, a method for performing a health test of a user is provided. A unique disposable identifier is assigned to a User Equipment (UE), which is associated with a Dried Blood Spot (DBS) sample indicative of a health condition of said user. The unique disposable identifier identifies the UE and the DBS sample taken by the user. The DBS sample, together with the unique disposable identifier, are received at a Mass Spectrometry (MS) apparatus. The MS apparatus performs a DBS test on the received DBS sample to detect a health condition and to determine a test result. Furthermore, the MS apparatus correlates the test result from the DBS test with the unique disposable identifier received in connection with the DBS sample. Also, the MS apparatus forms, or creates, a first data message comprising information about the test result correlated with said unique disposable identifier. The MS apparatus further transmits said first data message to a server. The server receives said first data message from the MS apparatus and retrieves said information about the test result correlated with said unique disposable identifier from the received first data message. The server also stores said information about the test result correlated with said unique disposable identifier in a memory associated with the server. The UE transmits a second data message to the server, wherein the second data message comprises a request for a test result as well as the unique disposable identifier identifying the UE. The server receives said second data message from the UE. Still further, the server provides the test result to said UE when the unique disposable identifier received in the first data message from the MS apparatus is the same as the unique disposable identifier received in the second data message from the UE.
In a particularly advantageous embodiment, the UE reads an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier. The UE also retrieves, or otherwise identifies, the unique disposable identifier from the optically readable representation of data from the disposable test kit. Furthermore, the UE stores the unique disposable identifier in a memory associated with the UE. The optically readable representation of data may be a barcode, such as a matrix barcode. A matrix barcode is sometimes referred to as a two- dimensional barcode. An example of a preferred matrix code is a Quick Response (QR) code.
In some embodiments, the disposable test kit comprises a filter paper intended for said DBS sample, wherein the optically readable representation of data is provided (e.g., pre-printed) on said filter paper. In some embodiments, the earlier-mentioned step of receiving the DBS sample may comprise receiving said filter paper including said DBS sample, wherein the DBS sample is identified by the unique disposable identifier comprised in the optically readable representation of data.
According to a second aspect, a system for performing a health test of a user is provided. The system comprises a UE, a MS apparatus and a server.
A unique disposable identifier is assigned to the UE, which is associated with a DBS sample indicative of a health condition of said user. The unique disposable identifier identifies the UE and the DBS sample taken by the user.
The MS apparatus is adapted to: receive the DBS sample together with the unique disposable identifier; perform the DBS test on the received DBS sample to detect a health condition and to determine a test result; correlate the test result from the DBS test with the unique disposable identifier received in connection with the DBS sample; form a first data message comprising information about the test result correlated with said unique disposable identifier received in connection with the DBS sample; and transmit said first data message to a server.
The server is adapted to: receive said first data message from the MS apparatus; retrieve said information about the test result correlated with said unique identifier from said first data message; and store said information about the test result correlated with said unique identifier in a memory associated with the server.
The UE is adapted to transmit a second data message to the server, wherein the second data message comprises a request for a test result as well as the unique disposable identifier identifying the UE.
The server is further adapted to receive said second data message from the UE, wherein said second data message comprises the request for the test result as well as the unique disposable identifier identifying the UE. The server is also adapted to provide the test result to said UE when the unique disposable identifier received in the first data message from the MS apparatus is the same as the unique disposable identifier received in the second data message from the UE.
In some embodiments, the UE is adapted to: read an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier; retrieve the unique disposable identifier from the optically readable representation of data from the disposable test kit; and store the unique disposable identifier in a memory associated with the UE. The optically readable representation of data may be a matrix barcode, such as a QR code. In some embodiments, the disposable test kit comprises a filter paper intended for said DBS sample, wherein the optically readable representation of data is provided on said filter paper. In some embodiments, the MS apparatus is adapted to receive said filter paper including said DBS sample, and the DBS sample is identified by the unique disposable identifier comprised in the optically readable representation of data.
By assigning the unique disposable identifier to a UE which is associated with a DBS sample indicative of a health condition of said user it is made possible to allow for health tests without compromising the anonymity of the user. The UE, which is typically associated with the user (e.g., through a Subscriber Identity Module (SIM)), will be assigned the same unique disposable identifier as the DBS sample taken by the user. When the test results are available at the server (after the MS apparatus has performed its DBS test on the received DBS sample), the UE will access the test results only if, or when, the unique disposable identifier assigned to the UE matches the corresponding unique disposable identifier, which is stored in the server and which is furthermore associated with the relevant test results. This provides for a health test where the anonymity of the user can be maintained.
It should be appreciated that it is a further advantage that the unique identifier is a unique disposable identifier. Compared to personal identification numbers, which are typically not disposable but rather constant over time, a disposable identifier is generally less prone to fraud. This may be particularly important when providing users with sensitive information, such as health test results.
It is a further advantage that the DBS sample may be taken by the user at home or at any desired place. Consequently, the user does not have to visit a hospital in order to perform the health test. This provides for a flexible solution, where the user himself/herself can choose where to take his or her DBS sample. Also, this may save time for the user. Still further, this may allow for saving resources at the hospital such that doctors and/or nurses may focus their time on other, potentially more important, life-saving operations or medical tests. For example, in today's society many people wishes to perform health tests for other reasons than pure medical reasons. If the purpose is medical in nature, it may be natural for the user to visit the hospital for performing the health test. However, if the purpose is to improve the lifestyle or just to get a health status report it may be beneficial if the user does not occupy the resources at hospitals unnecessarily much. The embodiments of the present invention allow for relieving the pressure on hospitals by providing users with a self-test. The self-test provided by the embodiments of the invention allow a user to take a DBS sample at home (or at any other desired place) and, subsequently, access the test results via the UE associated with the user.
According to a third aspect, a UE for use when performing a health test of a user is provided. The UE may be associated with a DBS sample indicative of a health condition of said user. A unique disposable identifier is assigned to the UE, which unique disposable identifier identifies the UE and the DBS sample taken by the user. More particularly, the UE comprises a transmitter, a processor, and a memory. The UE stores computer program code, which, when run in the processor causes the UE to transmit, by means of the transmitter, a second data message to a server, wherein the second data message comprises a request for a test result of the health test as well as the unique disposable identifier identifying the UE.
The UE may also comprise a receiver adapted to receive a third data message from the server, wherein said third data message comprises the requested test result. The UE may also comprise a user interface adapted to display the received test result.
In some embodiments, the UE may comprise a reader and the memory may store computer program code, which, when run in the processor causes the UE to: read, by means of the reader, an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier; retrieve, by means of the reader, the unique disposable identifier from the optically readable representation of data from the disposable test kit; and store the unique disposable identifier in a memory associated with the UE.
Typically, but not necessarily, the optically readable representation of data may be a matrix barcode, such as a QR code.
According to a fourth aspect, a disposable test kit for use when performing a health test of a user is provided. The disposable test kit includes a DBS sample to be taken by the user, as well as an optically readable representation of data comprising a unique disposable identifier identifying the DBS sample, wherein the optically readable representation of data is readable by means of a UE according to the earlier-mentioned third aspect. Said unique disposable identifier may thus be assigned to said UE. Advantageously, the disposable test kit comprises a filter paper intended for said DBS sample, wherein the optically readable representation of data is provided (e.g., preprinted) on said filter paper. Preferably, but not necessarily, the optically readable representation of data is a matrix barcode, such as a QR code.
As will be understood from the above, various embodiments of this disclosure allow for a user to pair his/her UE with a DBS sample to be taken by the user, e.g. at home. When the test results of the health test are later available at a server (after that a MS apparatus has performed its DBS test on the received DBS sample), the same UE may access the test results only if, or when, the unique disposable identifier assigned to the UE matches the corresponding unique disposable identifier, which is stored in the server and which is furthermore associated with the relevant test results of the health test. This provides for a health test where the anonymity of the user can be maintained. Also, since the user can access the health test results in his/her UE, the various embodiments suggested in this disclosure provides for improved flexibility. For example, the user may access the test results of the health test at any place and at any time the user finds convenient. Furthermore, some embodiments described herein require little or no manual input by the user. This may allow for increased accuracy and/or security compared to solutions where passwords, personal identification numbers, etc. are manually entered at the UE. This may be especially important for health test results due to the potentially sensitive nature of health test results. Moreover, some embodiments described herein do not require skilled users. Instead, the user only has to read an optically readable representation of data, e.g. by reading a QR code by means of a QR reader of the UE, from the disposable test kit including the DBS sample to be taken by the user. This reduces the risk of errors when pairing the UE with the DBS sample.
Brief Description of the Drawings
These and other aspects, features and advantages will be apparent and elucidated from the following description of various embodiments, reference being made to the accompanying drawings, in which:
Fig. 1 is schematic diagram illustrating an exemplary environment where embodiments presented herein may be applied;
Fig. 2A is a schematic diagram illustrating some modules of an embodiment of a UE;
Fig. 2B schematically shows one example of a computer program product according to an embodiment; and
Fig. 3 shows a disposable test kit according to an embodiment.
Detailed Description of Embodiments
The present invention will now be described more fully hereinafter. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided by way of example so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those persons skilled in the art. Like reference numbers refer to like elements or method steps throughout the description.
Fig. 1 is a schematic diagram illustrating an exemplary environment where embodiments of the invention may be applied. Fig. 1 depicts a system 100, which may be referred to as a health test system or a Dried Blood Spot (DBS) Selftesting System. The system 100 comprises one or more User Equipments (UEs) 200. A UE 200 may e.g. be a mobile terminal or a wireless terminal, a mobile phone such as a smartphone, a computer such as a laptop, a Personal Digital Assistant (PDA) or a tablet computer (sometimes referred to as a surf plate). Typically, a UE 200 is associated with a user (not shown), e.g. via the SIM module of the UE. The system also comprises a DBS sample 300 to be taken by the user. In preferred embodiments, the DBS sample 300 to be taken by the user is part of a disposable test kit (not shown). The system 100 further includes a Mass Spectrometry (MS) apparatus 400. In some embodiments, the MS apparatus is part of, or otherwise located in, a testing facility 401. Also, the system 100 comprises one or more servers 500. The one or more UEs 200 are communicatively connectable to the one or more servers 500 through a network 600. Similarly, the MS apparatus 400 is communicatively connectable to the one or more servers 500 through the network 600. The network 600 may, e.g., be a cellular network. The cellular network 600 may thus be a wireless communication network such as LTE (Long Term Evolution), WCDMA (Wideband Code Division Multiple Access), any other cellular network standardized by the 3 Generation Partnership Project (3GPP), Wimax, or any other wireless communication network.
With further reference to Fig. 1, a preferred embodiment of a method for performing a health test of a user will now be described. As will be appreciated, it is proposed to use DBS testing and Mass Spectrometry (MS). As is known among persons skilled in the art, DBS is a form of biosampling where blood samples are blotted and dried on filter paper. DBS may be particularly advantageous for self-testing, because DBS testing does not require skilled users. The user does not have to take a venous blood sample. Rather, dried blood spot specimens can be collected by applying a few drops of blood, drawn by lancet or similar equipment from the finger, heel or toe, onto a specially manufactured absorbent filter paper. Historically, the concept that capillary blood, obtained from pricking the heel or finger and blotted onto filter paper, can been used to screen for metabolic diseases in large populations of neonates has been used since the early 1960's. For example, neonatal screening for phenylketonuria (PKU) is common since the 1970's. Since then, so-called Guthrie card samples have been collected routinely from infants in many countries to screen for PKU and more recently for congenital hypothyroidism, sickle cell disorders and HIV infection. The limitations of sensitivity and specificity when screening such small volumes of blood has restricted the use of dried blood spots historically. However, recent advances in DBS testing have overcome many of these problems. Therefore, the inventor has realized that DBS may become particularly promising for health tests. At the same time, the use of mass spectrometry (MS) in testing facilities has increased. This development is driven by great advances in mass spectrometry in the last fifteen years. For example, MS is extensively used for analysis of metabolites from dried blood spots taken at birth. Mass spectrometry permits a rapid measurement of e.g. different metabolites in different biological specimens using e.g. filter paper spots. Because of its high sensitivity, this technique can e.g. be used for qualitative and quantitative analysis of many analytes such as purines and pyrimidines, amino acids and acylcarnitines, homocysteine, orotic acid, succinylacetone etcetera, with appropriate standards. It has therefore been realized by the inventor that the MS technology of today is already capable of carrying out qualitative and quantitative analyses of many biomarkers even from small volumes of blood, which is typically the case in DBS testing. Also, if the great advances of MS technology continue it will become possible to carry out analyses of very many biomarkers from small volumes of blood in a near future. In other words, the inventor has realized that the combined use of DBS testing and MS is particularly advantageous for the embodiments of the invention described in this disclosure. Examples of biomarkers of DBS samples that could be analyzed by MS are, without limitation: HbAlc, glucose, Prostate-specific antigen (PSA), folate, Apo A-l, Apo B, fibrinogen, hs-CRP, HDL, LDL, homocysteine, Lipoprotein(a), Lipoprotein-associated phospholipase A2 (LpPLA2), total cholesterol, triglycerides, Cortisol, DHEA-S, estradiol, insulin, IGF-1, luteinizing hormone (LH), progesterone, sex hormone-binding globulin (SHBG), testosterone, Thyroid-stimulating hormone (TSH), B-PEth, thyroxine (T4), triiodothyronine (T3), albumin, alkaline phosphatase (ALP), ALT / SGPT, AST / SGOT, bilirubin, globulin, total protein, blood urea nitrogen (BUN), creatinine, eGFR, 25 -hydroxy vitamin D, retinol, thiamine, cobalamin, folic acid, biotin, ascorbic acid, alpha tocopherol, phylloquinone, vitamin B 12, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), omega-3, omega-6.
Action 1: With continued reference to Fig. 1, the user initially obtains, or otherwise acquires, a DBS sample 300 to be taken by the user. Typically, but not necessarily, the DBS sample 300 to be taken by the user is comprised in a disposable test kit (not shown). This disposable test kit may e.g. comprise a bag including the DBS sample 300 to be taken by the user. The disposable test kit including the DBS sample 300 to be taken by the user may e.g. be ordered from a test kit provider. For example, the disposable test kit may be ordered via the Internet. If the disposable test kit is ordered via the Internet, the user may use his or her UE 200 to carry out the order. This may be advantageous, since the user can place his or her order at any place and at any time the user finds convenient. Alternatively, the disposable test kit including the DBS sample 300 may be provided at a pharmacy. Yet alternatively, the disposable test kit including the DBS sample 300 may e.g. be provided at any of the following: a fitness center, a sports store, a cosmetics store, or any other consumer goods retailer.
Furthermore, the disposable test kit typically comprises any other any suitable equipment for taking the DBS sample 300 such as: a lancet for taking a DBS blood sample e.g. from the fingertip of the user, a filter paper intended for said DBS sample, a plaster, alcohol swabs, sterile gauzes, etcetera.
The disposable test kit typically also comprises a unique disposable identifier identifying the DBS sample 300 of the disposable test kit. In preferred embodiments, the filter paper comprised in the disposable test kit comprises an optically readable representation of data (e.g. in the form of a matrix barcode, such as a QR code), wherein the optically readable representation of data comprises the unique disposable identifier. Typically, the optically readable representation of data is provided on said filter paper. For instance, the optically readable representation of data may be pre-printed on the filter paper. Before (or, after) the user takes his or her DBS blood sample, the user may use his or her UE 200 to read the optically readable representation of data from the filter paper. The UE 200 then retrieves the unique disposable identifier from the thus read optically readable representation of data. The retrieved unique disposable identifier may also be stored in a memory associated with the UE 200. This memory is preferably an internal memory of the UE 200. Alternatively, this memory may be an external memory, which is accessible by the UE 200.
From the above, it is appreciated that the DBS sample 300 to be taken by the user is assigned a unique disposable identifier identifying the DBS sample 300. In the preferred embodiment described above, the unique disposable identifier is comprised in the optically readable representation of data (e.g. in a QR code) provided, or otherwise pre-printed, on the filter paper. When the user uses his or her UE 200 to read the optically readable representation of data from the filter paper, it is possible for the UE 200 to retrieve this unique disposable identifier from the optically readable representation of data and store it in the memory associated with the UE 200. It is thus possible to pair the UE 200 with the DBS sample 300 to be taken by the user who is associated with the UE 200.
After (or, before) having paired the UE 200 with the DBS sample 300, the user takes a DBS sample 300. A DBS sample 300 may be taken by the user by applying a few drops of blood, drawn by a lancet or similar equipment from the finger, heel or toe, onto the filter paper, which is typically a specially manufactured absorbent filter paper. The few drops of blood will then dry on the filter paper for about an hour, or so. The DBS sample 300 taken by the user can thereafter be placed in an envelope or in a bag. The envelope, or bag, including the taken DBS sample 300 is then delivered, e.g. mailed or shipped, to a MS apparatus 400 for subsequent analysis.
Action 2: The MS apparatus 400 may preferably, but not necessarily, be part of, or otherwise located in, a testing facility 401. The MS apparatus 400 receives the DBS sample 300 together with the unique disposable identifier.
The MS apparatus 400 may e.g. comprise a processor, a memory and a reader such as an optical reader for reading optically readable representations of data (e.g. a QR code). The memory may store computer program code, which, when run in the processor causes the MS apparatus 400 to read, by means of the reader, the optically readable representation of data from the received DBS sample 300, wherein the optically readable representation of data comprises said unique disposable identifier. The memory may also store computer program code, which, when run in the processor causes the MS apparatus 400 to retrieve, by means of the reader, the unique disposable identifier from the optically readable representation of data from the received DBS sample 300. The retrieved unique disposable identifier may also be stored in a memory associated with the MS apparatus 400. This latter memory may be an internal memory of the MS apparatus 400. Alternatively, this memory may be an external memory, which is accessible by the MS apparatus 400. The MS apparatus may thus read, retrieve and store the unique disposable identifier associated with the DBS sample 300 that will be analyzed by the MS apparatus 400.
Next, the MS apparatus 400 performs a DBS test on the received DBS sample 300 to detect a health condition and to determine a test result. The MS apparatus 400 thus analyses the extracted dried blood spot of the DBS sample 300. The procedure for performing a DBS test using MS is, as such, known in the art and will therefore not be further detailed herein.
Since the MS apparatus 400 has stored the unique disposable identifier associated with the DBS sample 300, the MS apparatus 400 can subsequently correlate the test result from the DBS test with the stored unique disposable identifier. More particularly, the memory of the MS apparatus 400 may store computer program code, which, when run in the processor causes the MS apparatus 400 to correlate the test result from the DBS test with the stored unique disposable identifier.
Furthermore, the memory may store computer program code, which, when run in the processor causes the MS apparatus 400 to form, or otherwise create, a first data message comprising information about the test result correlated with said unique disposable identifier.
Action 3: The memory of the MS apparatus 400 may also store computer program code, which, when run in the processor causes the MS apparatus 400 to transmit, by means of a transmitter of the MS apparatus 400, the first data message to a server 500. The first data message may, e.g., be transmitted to the server 500 via the network 600.
The server 500 thus receives the first data message from the MS apparatus 400. For example, a receiver of the server 500 is configured to receive the first data message. Accordingly, the server 500 receives information about the test result correlated with said unique disposable identifier.
The server 500 may e.g. comprise a processor and a memory. The memory may store computer program code, which, when run in the processor causes the server 500 to retrieve said information about the test result correlated with said unique disposable identifier from the received first data message. Also, the server 500 is configure to store said information about the test result correlated with said unique disposable identifier in a memory associated with the server. This latter memory may be an internal memory of the server 500. Alternatively, this memory may be an external memory, which is accessible by the server 500.
Action 4: The UE 200 transmits a second data message to the server 500. This second data message comprises a request for a test result as well as the unique disposable identifier identifying the UE. The unique disposable identifier identifying the UE is the same unique disposable identifier that was assigned to the UE in action 1.
The server 500 thus receives the second data message from the UE 200. Action 5: The server 500 is configured to compare the unique disposable identifier identifying the UE received along with the above-mentioned request in the second data message against stored unique disposable identifiers to check whether a health test result associated with the unique disposable identifier is available at the server 500.
When it is determined that the unique disposable identifier received in the first data message from the MS apparatus 400 (which is then stored in the memory of the server 500) is the same as, i.e. matches, the unique disposable identifier received in the second data message from the UE, the server will make the test result available to the UE 200. More particularly, the memory of the server 500 may store computer program code, which, when run in the processor of the server 500 causes the server 500 to provide the test result to the UE 200 when the unique disposable identifier received in the first data message from the MS apparatus 400 is the same as, i.e. matches, the unique disposable identifier received in the second data message from this UE 200.
Action 6: As described above, when it is determined that the unique disposable identifier received in the first data message from the MS apparatus 400 (which is then stored in the memory of the server 500) is the same as, i.e. matches, the unique disposable identifier received in the second data message from the UE 200, the server 500 will make the test result available to the requesting UE 200. Thus, the UE 200 may access the health test result from the server 500. For example, the UE 200 may receive a third data message from the server, the third data message comprising the requested test result. Once received by the UE 200, the health test result may be presented to the user through the UE 200, e.g. by means of a display of the UE 200.
Fig. 2A is a schematic diagram illustrating some modules of an example embodiment of a UE 200 shown in Fig. 1. In an advantageous embodiment, the UE 200 is a smart phone or a tablet computer. In the illustrated embodiment, the UE 200 comprises a processor 201, a memory 202, a transmitter (Tx) 203, a receiver (Rx) 204 and a User Interface (UI) 205. The transmitter (Tx) 203 and the receiver (Rx) 204 may alternatively be provided by means of a transceiver (Tx/Rx), which combines transmission and reception capabilities. The processor 201 may be provided using any suitable central processing unit (CPU), microcontroller, digital signal processor (DSP), etcetera, which is capable of executing a computer program comprising computer program code, the computer program being stored in memory 202. The memory 202 may be any combination of random access memory (RAM) and read only memory (ROM). The memory 202 may e.g. comprise persistent storage, which, for example, can be a single one or a combination of magnetic memory, optical memory, or solid state memory or even remotely mounted memory. The UI 205 may e.g. comprise a display and input means (such as a keybord, a mouse or a touch screen display). In advantageous embodiments, the UI 205 comprises a touch screen display. Touch screen displays are attractive, e.g., because they facilitate small form factor UEs (e.g. smart phones or tablet computers) on which there may be limited room to include a display as well a one or several key buttons, scroll wheels, and/or the like for allowing the user to interact with and send commands to the UE 200. Also, inputting commands to the UE 200 by touching a graphical user interface displayed on a touch screen display may be intuitive to many users, and thus touch screen displays are generally perceived as user- friendly by many users. Optionally, the UE 200 may also comprise a reader 206 adapted to read an optically readable representation of data, such as barcodes of different types (e.g. QR codes). The reader 206 may be an optical reader. The reader 206 may comprise a camera. In some embodiments, the reader 206 can be implemented as a barcode reader for reading a barcode, e.g. a matrix barcode such as a QR code.
The UE 200 shown in Fig. 2A is suitable for use when performing a health test of a user according to the earlier-described method discussed in connection with Fig. 1. The UE 200 can be associated with a DBS sample indicative of a health condition of the user of the UE 200. Furthermore, a unique disposable identifier can be assigned to the UE 200, which unique disposable identifier identifies the UE 200 and the DBS sample 300 taken by the user. To this end, the memory 202 may store computer program code, which, when run in the processor 201 causes the UE 200 to read, by means of the reader 206, an optically readable representation of data from a disposable test kit including the DBS sample 300 to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier. The memory 202 may also store computer program code, which, when run in the processor 201 causes the UE 200 to retrieve, by means of the reader, the unique disposable identifier from the optically readable representation of data from the disposable test kit. Moreover, the retrieved unique disposable identifier may be stored in another memory 207 associated with the UE 200.
Furthermore, the memory 202 stores computer program code, which, when run in the processor 201 causes the UE 200 to transmit, by means of the transmitter 203, a second data message to a server 500, wherein the second data message comprises a request for a test result of the health test as well as the unique disposable identifier identifying the UE 200.
Still further, the receiver 204 is adapted to receive a third data message from the server 500, wherein said third data message comprises the requested test result. Once received by the receiver 204, the health test result may be presented to the user by means of the UI 205 of the UE 200.
Turning now to Fig. 2B, yet another embodiment of the invention is disclosed.
Fig. 2B illustrates a computer program comprising instructions (or, computer program code) which, when executed on a processor 201 of a UE 200, will cause the UE 200 to transmit, by means of a transmitter of the UE 200, a second data message to a server 500, wherein the second data message comprises a request for a test result of the health test as well as the unique disposable identifier identifying the UE. Also, a receiver of the UE 200 may be adapted to receive a third data message from the server, wherein said third data message comprises the requested test result. Still further, the computer program may comprise instructions which, when executed on a processor 201 of the UE 200, will cause the UE 200 to read, by means of a reader of the UE 200, an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier; retrieve, by means of the reader of the UE 200, the unique disposable identifier from the optically readable representation of data from the disposable test kit; and store the unique disposable identifier in a memory associated with the UE 200.
A carrier may comprise the above-mentioned computer program. The carrier may be a computer readable storage medium 208. Alternatively, the carrier may be one of an electronic signal, an optical signal, or a radio signal. In preferred embodiments, the carrier is embodied as a software package (also sometimes referred to as software application, application or APP) which can be distributed over a network, such as the Internet.
With reference to Fig. 3, a disposable test kit will be described. The disposable test kit is suitable for use when performing a health test of a user according to the embodiments described herein. The disposable test kit comprises the DBS sample 300 to be taken by the user. The disposable test kit also comprises the optically readable representation of data 301, such as a QR code, comprising the unique disposable identifier. The optically readable representation of data 301 which is exemplified by a QR code in Fig. 3 is readable by means of reader of the UE 200 shown in Figs. 1 and 2A. It is hereby made possible to pair the UE 200 with the DBS sample 300 as described earlier. Preferably, the disposable test kit comprises a filter paper 302 for the DBS sample 300 wherein the optically readable representation of data is provided, e.g. pre-printed, on said filter paper 302 as is schematically illustrated in Fig.3.
As will be appreciated, various embodiments described herein allow for a user to pair his/her UE 200 with a DBS sample to be taken by the user, e.g. at home. When the test results of the health test are later available at a server (after that a MS apparatus has performed its DBS test on the received DBS sample), the same UE 200 may access the test results only if, or when, the unique disposable identifier assigned to the UE 200 matches the corresponding unique disposable identifier, which is stored in the server 500 and which is furthermore associated with the relevant test results of the health test. This provides for a health test where the anonymity of the user can be maintained. Also, since the user can access the health test results in his/her UE 200, the various embodiments suggested in this disclosure provides for improved flexibility. For example, the user may access the test results of the health test at any place and at any time the user finds convenient. Furthermore, some embodiments described herein require little or no manual input by the user. This may allow for increased accuracy and/or security compared to solutions where e.g. personal identification numbers are manually entered at the UE 200. This may be especially important for health test results due to the potentially sensitive nature of health test results. Moreover, some embodiments described herein do not require skilled users. Instead, the user only has to read an optically readable representation of data, e.g. by reading a QR code by means of a reader of the UE 200, from the disposable test kit including the DBS sample 300 to be taken by the user. This reduces the risk of errors when pairing the UE with the DBS sample 300.
The various embodiments described in this disclosure may provide many advantages. For example, by assigning the unique disposable identifier to a UE 200 which is associated with a DBS sample 300 indicative of a health condition of said user it is made possible to allow for health tests without compromising the anonymity of the user. The UE 200, which is typically associated with the user, will be assigned the same unique disposable identifier as the DBS sample 300 taken by the user. When the test results are available at the server 500 (after the MS apparatus 400 has performed its DBS test on the received DBS sample 300), the UE 200 will access the test results only if, or when, the unique disposable identifier assigned to the UE 200 matches the corresponding unique disposable identifier, which is stored in the server 500 and which is furthermore associated with the relevant test results. This provides for a health test where the anonymity of the user can be maintained. It is a further advantage that the unique identifier is disposable. Compared to personal identification number, which are typically not disposable, disposable unique identifiers are less prone to fraud.
It is still another advantage that the DBS sample 300 may be taken by the user at home or at any desired place. Consequently, the user does not have to visit a hospital in order to perform the health test. This provides for a flexible health test, where the user himself/herself can choose where to take his or her DBS sample 300. This may save time for the user. This may also allow for saving resources at the hospital. In fact, some of the embodiments described herein may allow for relieving the pressure on hospitals by providing users with a self-test. The self-test provided by the embodiments described herein may allow a user to take a DBS sample at home (or at any other desired place) and, subsequently, access the test results via the UE 200 associated with the user.
Yet further, the use of a combination of DBS testing and MS technology allow for improved self-tests, where many different biomarkers of a DBS sample can be analyzed to detect various health conditions and to determine different health test results depending on the specific purpose of the test. It is therefore foreseen that the various embodiments described in this disclosure can be used in a variety of application areas including, but not limited to, the following: general health monitoring, diet supplement monitoring, medical intake monitoring, weight loss diet monitoring, illness monitoring, anti-aging monitoring, hair loss monitoring, alcohol intake monitoring, pregnancy monitoring, allergy monitoring, etcetera.
Modifications and other variants of the described embodiments will come to mind to one skilled in the art having benefit of the teachings presented in the foregoing description and associated drawings. Therefore, it is to be understood that the embodiments are not limited to the specific example embodiments disclosed and that modifications and other variants are intended to be included within the scope of this disclosure. Furthermore, although specific terms may be employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. Therefore, a person skilled in the art would recognize numerous variations to the described embodiments that would still fall within the scope of the appended claims. As used herein, the terms "comprise/comprises" or "include/includes" do not exclude the presence of other elements or steps. Furthermore, although individual features may be included in different claims, these may possibly advantageously be combined, and the inclusion of different claims does not imply that a combination of features is not feasible and/or advantageous. Also, it should be noted that in the description of embodiments, the partition of functional blocks into particular units is by no means limiting. Contrarily, these partitions are merely examples. Functional blocks described herein as one unit may be split into two or more units. In the same manner, functional blocks that are described herein as being implemented as two or more units may be implemented as a single unit without departing from the scope of the claims. Also, even if certain method steps, or actions, have been described in a certain order it should be appreciated that the described method steps, or actions, may sometimes be performed, or executed, in a different order. In addition, singular references do not exclude a plurality. Finally, reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

A method for performing a health test of a user, the method comprising:
assigning (1) a unique disposable identifier to a User Equipment, UE, associated with a Dried Blood Spot, DBS, sample indicative of a health condition of said user, wherein the unique disposable identifier identifies the UE and the DBS sample taken by the user;
receiving (2) the DBS sample together with the unique disposable identifier at a Mass Spectrometry, MS, apparatus;
performing (2), by means of the MS apparatus, a DBS test on the received DBS sample to detect a health condition and to determine a test result, correlating (2), by means of the MS apparatus, the test result from the DBS test with the unique disposable identifier received in connection with the DBS sample;
forming (2), by means of the MS apparatus, a first data message comprising information about the test result correlated with said unique disposable identifier;
transmitting (3), by means of the MS apparatus, said first data message to a server;
receiving (3), by means of the server, said first data message from the MS apparatus,
retrieving (3), by means of the server, said information about the test result correlated with said unique disposable identifier from the received first data message;
storing (3), by means of the server, said information about the test result correlated with said unique disposable identifier in a memory associated with the server;
transmitting (4), by means of the UE, a second data message to the server, wherein the second data message comprises a request for a test result as well as the unique disposable identifier identifying the UE;
receiving (4), by means of the server, said second data message from the UE; and
providing (6), by means of the server, the test result to said UE when the unique disposable identifier received in the first data message from the MS apparatus is the same as the unique disposable identifier received in the second data message from the UE.
The method according to claim 1, wherein the step of assigning (1) comprises: reading, by means of the UE, an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier;
retrieving, by means of the UE, the unique disposable identifier from the optically readable representation of data from the disposable test kit; and
storing, by means of the UE, the unique disposable identifier in a memory associated with the UE.
The method according to claim 2, wherein the optically readable representation of data is a matrix barcode, such as a Quick Response, QR, code.
The method according to claim 2 or 3, wherein the disposable test kit comprises a filter paper intended for said DBS sample and wherein the optically readable representation of data is provided on said filter paper.
The method according to claim 4, wherein the step of receiving (2) the DBS sample comprises:
receiving said filter paper including said DBS sample, wherein the DBS sample is identified by the unique disposable identifier comprised in the optically readable representation of data.
A system (100) for performing a health test of a user, in which system (100) a unique disposable identifier is assigned to a User Equipment, UE (200), associated with a Dried Blood Spot, DBS, sample (300) indicative of a health condition of said user, wherein the unique disposable identifier identifies the UE (200) and the DBS sample (300) taken by the user; the system (100) comprising the UE (200), a Mass Spectrometry, MS, apparatus (400) and a server (500), and wherein
the MS apparatus (400) is adapted to:
o receive the DBS sample (300) together with the unique disposable identifier;
o perform the DBS test on the received DBS sample (300) to detect a health condition and to determine a test result;
o correlate the test result from the DBS test with the unique disposable identifier received in connection with the DBS sample (300);
o form a first data message comprising information about the test result correlated with said unique disposable identifier received in connection with the DBS sample (300); and o transmit said first data message to the server (500);
the server (500) is adapted to: o receive said first data message from the MS apparatus (400); o retrieve said information about the test result correlated with said unique identifier from said first data message; and o store said information about the test result correlated with said unique identifier in a memory associated with the server
(400);
- the UE (200) is adapted to:
o transmit a second data message to the server (500), wherein the second data message comprises a request for a test result as well as the unique disposable identifier identifying the UE (200); wherein
the server (500) is further adapted to receive said second data message from the UE (200), wherein said second data message comprises the request for the test result as well as the unique disposable identifier identifying the UE (200) and to provide the test result to said UE (200) when the unique disposable identifier received in the first data message from the MS apparatus (400) is the same as the unique disposable identifier received in the second data message from the UE (200).
The system (100) according to claim 6, wherein the UE (200) is further adapted to:
read an optically readable representation of data from a disposable test kit including the DBS sample (300) to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier;
retrieve the unique disposable identifier from the optically readable representation of data from the disposable test kit; and
store the unique disposable identifier in a memory associated with the
UE.
The system (100) according to claim 7, wherein the optically readable representation of data is a matrix barcode, such as a Quick Response, QR, code.
The system (100) according to claim 7 or 8, wherein the disposable test kit comprises a filter paper intended for said DBS sample (300) and wherein the optically readable representation of data is provided on said filter paper.
10. The system (100) according to claim 9, wherein the MS apparatus (400) is further adapted to receive said filter paper including said DBS sample (300), and wherein the DBS sample (300) is identified by the unique disposable identifier comprised in the optically readable representation of data.
11. A User Equipment, UE (200), for use when performing a health test of a user, wherein the UE (200) is associated with a Dried Blood Spot, DBS, sample indicative of a health condition of said user and wherein a unique disposable identifier is assigned to the UE (200), which unique disposable identifier identifies the UE (200) and the DBS sample taken by the user; the UE (200) comprising:
a transmitter (203);
a processor (201); and
a memory (202) storing computer program code, which, when run in the processor (201) causes the UE (200) to transmit, by means of the transmitter (203), a second data message to a server, wherein the second data message comprises a request for a test result of the health test as well as the unique disposable identifier identifying the UE (200).
12. The UE (200) according to claim 11, further comprising:
a receiver (204) adapted to receive a third data message from the server, wherein said third data message comprises the requested test result; and
a User Interface (205) adapted to display the received test result.
13. The UE (200) according to claim 11 or 12, further comprising a reader (206) and wherein the memory (202) stores computer program code, which, when run in the processor (201) causes the UE (200) to:
read, by means of the reader (206), an optically readable representation of data from a disposable test kit including the DBS sample to be taken by the user, wherein the optically readable representation of data comprises the unique disposable identifier;
retrieve, by means of the reader (206), the unique disposable identifier from the optically readable representation of data from the disposable test kit; and
store the unique disposable identifier in another memory (207) associated with the UE (200).
14. The UE (200) according to claim 13, wherein the optically readable representation of data is a matrix barcode, such as a Quick Response, QR, code.
15. A disposable test kit for use when performing a health test of a user, wherein the disposable test kit includes:
a Dried Blood Spot, DBS, sample (300) to be taken by the user; and an optically readable representation of data (301) comprising a unique disposable identifier identifying the DBS sample (300), wherein the optically readable representation of data (301) is readable by means of a UE (200) according to any one of the claims 11-14 for assigning said unique disposable identifier to said UE (200).
16. The disposable test kit according to claim 15, wherein the disposable test kit comprises a filter paper (302) intended for said DBS sample (300) and wherein the optically readable representation of data (301) is provided on said filter paper (302).
17. The disposable test kit according to claim 15 or 16, wherein the optically readable representation of data (301) is a matrix barcode, such as a Quick Response, QR, code.
PCT/SE2015/050322 2014-05-30 2015-03-19 A method and a system for performing a health test WO2015183150A1 (en)

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