System for biological sample collection, examination and reading in quick biochemical tests and data management

Abstract

The present invention relates to a system used in remote laboratory assays, having cartridge (C) with a reagent strip (TR) a reader (L) with a dedicated hardware (HDL) and a dedicated software (SDL), a local remote hardware (HRL) with a dedicated software (SDHL), an external served hardware (HES) with a data base (BD) and a dedicated software (SDS) and an external hardware with an access interface (HEIA) with an interface software connected to the Internet (SICI) and dedicated software (SDIA), which reads the parameters of the cartridge for collecting various types of biological samples and transmits data, allowing the data to be accessed remotely, with the advantages of being easy to use, of optimizing workflows, of being easy for users to learn, of allowing new exams to be easily and conveniently recorded, of being modular, compact, smaller, portable, ergonomic, user-friendly, intuitive, more practical and less expensive.

Claims

1. A system for biological sample collection, examination and reading in biochemical tests and data management, comprising a cartridge (C) equipped with a reagent strip (TR) that reproduces results based on color variation, with a code identifier (IC) which stores all parameters for performing the examination and which enables the system to perform a new exam by only including protocol information in the code identifier (IC) and unidirectionally connected to a reader (L); with the reader (L) that transmits test result data comprising a test result to local remote hardware (HRL) from reading information and interpreting results of the cartridge (C) together with sample data and the code identifier (IC) and unidirectionally connected to the local remote hardware (HRL) and to the cartridge (C); the local remote hardware (HRL), comprising dedicated software (SDHL) that receives the test result data and transmits the test result data to external server hardware (HES) or makes available on a screen the test result data, the test result, the sample data, the code identifier (IC), and patient data and bi-directionally connected to the external server hardware (HES) and unilaterally to the reader (L); the external server hardware (HES) comprising an application server with minimum features of: a Gigabit network interface, 1.2 GHz processor, 4 GBytes RAM, storage with 512 GBytes memory, and with a database (BD) and dedicated software (SDS) that receives and stores the test result data, the test result, the sample data, and code identifier (IC), and the patient data in the database (BD) and is bi-directionally connected to external access interface hardware (HEIA) and to the local remote hardware (HRL); and the external access interface hardware (HEIA), comprising minimum features of: a 700 MHz processor, 512 MBytes RAM, 512 MBytes of storage memory and endowed with Internet connection software (SICI) of Wi-Fi type and dedicated software (SDIA) which makes possible for a user to consult the test result data, the test results, the sample data, the code identifier, and the patient data and bidirectionally connected to the external server hardware (HES).

2. The system for biological sample collection, examination and reading in biochemical tests and data management according to claim 1, wherein all the parameters for performing the examination comprise: a name, reaction time, limits, and calibration points to enable the system to perform the new exam.

3. The system for biological sample collection, examination and reading in biochemical tests and data management according to claim 1, wherein the test result data comprises: a serial number, lot and expiration date for the cartridge containing the reagent strip being stored on the external server hardware and saved together with the test result, allowing to know an origin and if cartridge data are true, since the test result data must be in the system.

4. The system for biological sample collection, examination and reading in biochemical tests and data management according to claim 1, wherein the new exam is performed in the following sequence: A. START; B. Adapt the cartridge from desired sample cartridges; C. Place a sample in a region indicated on the cartridge; D. Insert the cartridge with the sample into a desired reader slot of the reader, wherein the following complementary sequence is performed: E. Read and interpret the code identifier by the reader; F. Send, by the reader exam information associated with the cartridge to the local remote hardware; G. Does the local remote hardware have a connection to the external server hardware? If yes go to I, if not, go to H; H. Schedule cartridge validation for connection and go to J; I. Validate cartridge information associated with the cartridge; J. Is the cartridge valid? If yes go to K, if not go to V; K. Start the new exam; L. Identify a patient on the local remote hardware; M. Wait for time to finish the new exam; N. Capture, by the reader, chemical variations on the reagent strip; O. Interpret, by the reader, the test result and sends to the local remote hardware; P. Assign, by the local remote hardware, the test result to the patient; Q. Display, by the local remote hardware, the test result and saves the test result to the local database; R. Does the local remote hardware have a server connection to the external server hardware? If yes go to T, if not go to S; S. Schedule, by the local remote hardware, an exam submission to the external server hardware and go to W; T. Send, by the local remote hardware, a scan result to the external server hardware; U. Test result is available for external access and go to W; V. Show the user that the cartridge is not valid; and W. END.

Description

(1) For a better understanding of this patent the following figures are attached:

(2) FIG. 1. showing the block diagram of interconnections between the components of the system from the present patent;

(3) FIG. 2. showing the block diagram of the performed process, including those executed by the dedicated software of the system from the present patent; and

(4) FIG. 3. showing the block diagram of the operation of the system from the present patent.

(5) The system of the present invention is comprised of a cartridge assembly (C) having a reagent strip (TR) which produces color-based result, with code identifier (IC) which stores all basic parameters for performing the examination, and which enables the system to perform a new exam type by only including the protocol information in the code identifier (IC) and unidirectionally connected to the reader (L); with reader (L) endowed with dedicated hardware (HDL) and dedicated software (SDL) that transmits the test result data to the local remote hardware (HRL) from the reading of the information and interpreting of the cartridge (C) results together with the sample data and cartridge code and unidirectionally connected to the local remote hardware (HRL) and to the cartridge (C); local remote hardware (HRL), such as a tablet or mobile phone, with dedicated software (SDHL) that receives the exams data and transmits it to the external server hardware (HES) or makes available on the screen the exam result, the data from the sample and cartridge code and patient data and bi-directionally connected to external server hardware (HES) and unilaterally to reader (L); external server hardware (HES) with application server with minimum features of: Gigabit network interface, 1.2 GHz processor, 4 GBytes RAM, storage with 512 GBytes memory, and with database (BD) and dedicated software (SDS) that receives the test result, sample data and cartridge code and patient data and stores it in the database (BD) and is bi-directionally connected to external access interface hardware (HEIA) and to the local remote hardware (HRL); and external hardware with access interface (HEIA), such as mobile phone, tablet or computer with minimum features of: 700 MHz processor, 512MBytes RAM, 512 MBytes of storage memory and endowed with internet connection software (SICI) of Wi-Fi type and dedicated software (SDIA) which makes possible for the user to consult the test result, sample data and cartridge code and patient data and bidirectionally connected to external server hardware (HES).

(6) The process performed including the dedicated software of this system is as follows:

(7) A. START;

(8) B. Adapt the desired sample cartridge;

(9) C. Place the sample in the region indicated on the cartridge;

(10) D. Insert cartridge into desired reader slot;

(11) E. Cartridge code identifier is read and interpreted by the reader;

(12) F. Reader sends exam information to local remote hardware;

(13) G. Does local remote hardware have connection to external server hardware? If yes go to I, if not, go to H;

(14) H. Schedule cartridge validation for connection and go to J;

(15) I. Validates cartridge information;

(16) J. Is cartridge valid? If yes go to K, if not go to V;

(17) K. Starts the exam;

(18) L. Identifies the patient on local remote hardware;

(19) M. Waits for time to finish the exam;

(20) N. Reader captures chemical variations on cartridge test strip;

(21) O. Reader interprets cartridge result and sends to local remote hardware;

(22) P. Local remote hardware assigns test result to patient;

(23) Q. Local remote hardware displays the result and saves it to the local database;

(24) R. Does local remote hardware have server connection? If yes go to T, if not go to S;

(25) S. Local remote hardware schedules exam submission to server and goes to W;

(26) T. Local remote hardware sends scan result to external server hardware;

(27) U. Does exam result available for external access and go to W;

(28) V. Shows the user that the cartridge is not valid; and

(29) W. END.

(30) The operation of the system of the present invention is as follows:

(31) a. START;

(32) b. Connect reader and local remote hardware;

(33) c. Is it the first use? If yes go to d, but go to f;

(34) d. Register establishment in the software of the local remote hardware;

(35) e. Activate Bluetooth®;

(36) f. Enter username and password in the software of the local remote hardware;

(37) g. Connect local remote hardware to the desired reader;

(38) h. Place the biological sample in the cartridge for the chosen examination;

(39) i. Insert the cartridge into the reader;

(40) j. Local remote hardware software displays exam data;

(41) k. Is the cartridge valid for exam? If yes go to m, if not go to l;

(42) l. local remote hardware reports invalid cartridge and go to q;

(43) m. Reader LEDs flash, press the cartridge all the way down;

(44) n. Identify patient data in local remote hardware software;

(45) O. Await for finalization of the exam;

(46) P. Software on local remote hardware displays scan result; and

(47) q. THE END.