An automated blood culture system calibration device

Abstract

The present invention discloses an automated blood culture system calibration device, comprising a data receiving terminal and a plurality of calibration units; the calibration unit comprises an upper shell, a lower shell, a charging interface, an optical sensor, a temperature sensor and a calibration circuit; the data receiving terminal comprises a display module, a control button and a receiving circuit. The automated blood culture system calibration device of the present invention can replace the standard strain as the automated blood culture system calibration medium, has stable and reliable performance, does not require the preparation of standard strain positive culture fluid and a large number of blood culture bottles during the calibration operation, has low use cost, can effectively discover the cause of false negatives in the blood culture system, can realize the synchronous calibration of optical parameters and temperature parameters, saves calibration time, and has a wide range of applications.

Description

Technical Field

[0001] The invention belongs to the technical field of quality control of automated blood culture systems, and in particular relates to a calibration device for an automated blood culture system. Background Art

[0002] The automated blood culture system (hereinafter referred to as the blood culture system) is a system that uses the principle of fluorescence or photoelectric colorimetry and is used in clinical laboratories to continuously culture, automatically detect and judge the culture results (positive or negative) of microorganisms in human blood or other sterile body fluids in vitro. The system includes a blood culture instrument and a matching culture medium. Due to the wide application of blood culture systems in the field of clinical microbiological analysis and the frequent provision of test data to the outside world, it is necessary to calibrate them.

[0003] Although the current calibration of the blood culture system can refer to YY / T 0656-2008 "Automated Blood Culture System" to calibrate the temperature accuracy and fluctuation using temperature sensors and conduct positive tests using standard strains, it is unable to detect possible false negatives and lacks a performance evaluation method for the temperature difference between the internal wells of the blood culture system incubation module and the optical system, so the calibration method is very imperfect. At the same time, CNAS-GL028 "Guidelines for Validation of Clinical Microbiology Testing Procedures" requires evaluation and functional verification of the incubation system, optical system and software of the blood culture system to see if they are operating in accordance with the manufacturer's regulations, but there is currently a lack of corresponding dedicated equipment in the clinic to carry out this. Summary of the invention

[0004] The object of the present invention is to provide an automated blood culture system calibration device, which uses the integration of optical sensors and temperature sensors to monitor the changes in optical and temperature parameters during the operation of the automated blood culture system in real time to simultaneously calibrate the temperature parameters and optical parameters of the automated blood culture system; it solves the problems of complex positive test procedures using standard strains and inability to detect false negatives, and the inability to calibrate the temperature system synchronously with the positive test of the standard strain, as well as the lack of an optical system calibration method.

[0005] To achieve the above object, the present invention adopts the following technical solution:

[0006] An automated blood culture system calibration device comprises a data receiving terminal and a plurality of calibration units;

[0007] The calibration unit includes an upper housing, a lower housing, a charging interface, an optical sensor, a temperature sensor and a calibration circuit;

[0008] The upper shell and the lower shell are assembled into a calibration unit shell, the bottom of the calibration unit shell is concave, used to protect the internal structure of the calibration unit; the charging interface is used to charge the calibration unit; the optical sensor is arranged at the center of the concave bottom of the calibration unit shell, used to monitor optical data; the temperature sensor is arranged at one side of the bottom of the calibration unit, used to monitor temperature data; the calibration circuit is used to calibrate temperature data and optical data;

[0009] The data receiving terminal includes a display module, a control button and a receiving circuit;

[0010] The receiving circuit is used to receive and process the temperature data and optical data of the calibration unit; the display module is used to display the processing result of the receiving circuit; and the control button is used to control the switch of the data receiving terminal and adjust the display result of the display module.

[0011] Preferably, the calibration units are symmetrically distributed during testing.

[0012] Preferably, the calibration unit shell is a bottle-shaped structure with a minimum length of 100.5 mm and a diameter of 34.8 mm, which is consistent with the size of clinical blood culture bottles, and is equipped with inlay sleeves of different sizes for inlaying the sleeves into the outside of the calibration unit so that it can be matched with the holes for placing blood culture bottles inside automated blood culture systems of different manufacturers and models during calibration.

[0013] Preferably, the optical sensor comprises one or more silicon photocells for monitoring the emitted light from the bottom of the recessed hole for placing the blood culture bottle in the automated blood culture system, and the emitted light generated from the bottom of the recessed hole for placing the blood culture bottle is emitted in the direction of the optical sensor.

[0014] Preferably, the optical sensor is provided with a cosine corrector for collecting radiation within a 180° solid angle, thereby eliminating optical interface problems in the calibration unit light collection sampling geometry.

[0015] Preferably, the calibration unit further includes a storage chip, a battery and an antenna;

[0016] The storage chip is used to store the optical and temperature data collected by the optical sensor and the temperature sensor;

[0017] The battery is used to provide the energy required for the normal endurance of the calibration unit;

[0018] The antenna is arranged on the upper part of the calibration unit, coupled with the storage chip, and is used for wirelessly transmitting the optical data and temperature data stored in the storage chip to the data receiving terminal.

[0019] Preferably, the calibration circuit comprises a signal conditioning module A, a signal conditioning module B, an analog / digital conversion module, a zigbee main controller, a wireless signal power amplification module, and a lithium battery and charging module;

[0020] The signal conditioning module A and the signal conditioning module B are used to condition the data collected by the temperature sensor and the optical sensor respectively;

[0021] The analog / digital conversion module is used for analog-to-digital conversion processing of collected data;

[0022] The zigbee main controller and the wireless signal power amplifier module are used to control the sending of commands and the transmission of data;

[0023] The lithium battery and the charging module are used for charging the calibration circuit.

[0024] Preferably, the receiving circuit comprises a transceiver module, a data processing module, a lithium battery and a charging module;

[0025] The zigbee communication module and the wireless signal power amplification module are used to receive data transmitted from the terminal node and send control commands to the terminal node;

[0026] The Bluetooth communication module is used to send the data processed by the main controller to the terminal device connected to the Bluetooth communication module;

[0027] The main controller is used to receive and process data sent by the ZigBee communication module;

[0028] The lithium battery and charging module are used to realize power conversion of the lithium battery and supply power to the main controller module, the ZigBee module, the wireless signal power module and the Bluetooth communication module.

[0029] Preferably, the above-mentioned receiving circuit also includes a data interface for transmitting parameters stored in the data receiving terminal for subsequent evaluation of the calibration result.

[0030] Preferably, the above-mentioned automated blood culture system calibration device also includes a special containing box for shielding mechanical shock, pressure or humidity; the special containing box is provided with a protrusion that matches the recess at the bottom of the calibration unit shell, and the protrusion is provided with a male charging interface, and the female charging interface is arranged in the recessed part at the bottom of the calibration unit shell for integrated charging of the calibration unit.

[0031] The present invention has the following advantages:

[0032] The automated blood culture system calibration device of the present invention can replace standard strains as the automated blood culture system calibration medium, has stable and reliable performance, does not require the preparation of standard strain positive culture fluid and a large number of blood culture bottles during the calibration operation, has low use costs, can effectively discover the cause of false negatives in the blood culture system, can achieve synchronous calibration of optical parameters and temperature parameters, saves calibration time, and has a wide range of applications. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 This is a schematic diagram of the principle structure of an embodiment of an automated blood culture system calibration device of the present invention;

[0034] Figure 2 A schematic diagram of a calibration unit model of an embodiment of an automated blood culture system calibration device of the present invention;

[0035] Figure 2 In the middle, 1-upper shell, 2-lower shell, 3-charging interface female head, 4-optical sensor, 5-temperature sensor;

[0036] Figure 3 It is a schematic diagram of a data receiving terminal model of an embodiment of an automated blood culture system calibration device of the present invention;

[0037] Figure 3 In the middle, 6-display module, 7-control buttons;

[0038] Figure 4 A calibration circuit structure diagram of an embodiment of an automated blood culture system calibration device of the present invention;

[0039] Figure 5 This is a structural diagram of a receiving circuit of an embodiment of an automated blood culture system calibration device of the present invention. DETAILED DESCRIPTION

[0040] The following is a description of the implementation of the present invention by means of specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0041] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change in the proportional relationship, or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the effects and purposes that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle", etc. cited in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0042] Example 1

[0043] like Figure 1 As shown, considering that temperature and optical parameters are the main calibration parameters of the automated blood culture system, this embodiment provides an automated blood culture system calibration device, including 1 data receiving terminal and 9 calibration units;

[0044] During testing, the calibration units are arranged symmetrically. Calibration units should be arranged at the edge and central areas of the automated blood culture system. Calibration does not affect the normal working state of the automated blood culture system. The received calibration data is analyzed and processed through the data receiving terminal.

[0045] The measurement range of the temperature sensor 4 is (0-50)°C, and the maximum allowable error is ±0.1°C; the wavelength range of the optical sensor 3 is (360-720)nm, the illumination is (0-200000)lx, and the maximum allowable error is ±5%.

[0046] In an embodiment, the automated blood culture system calibration device also includes a dedicated containing box to shield the calibration unit, data receiving terminal, embedded sleeve and external power cord of the automated blood culture system calibration device from factors such as mechanical shock, pressure or humidity.

[0047] like Figure 2 As shown, the calibration unit includes an upper shell 1, a lower shell 2, a charging interface 3, an optical sensor 4, a temperature sensor 5 and a calibration circuit;

[0048] The upper shell 1 and the lower shell 2 are assembled into a calibration unit shell, and the material thereof is mainly composed of polyetheretherketone (PEEK) resin. The bottom of the calibration unit shell is concave, which is used to protect the internal structure of the calibration unit;

[0049] In the embodiment, the calibration unit shell is a bottle-shaped structure with a minimum length of 100.5 mm and a diameter of 34.8 mm, which is consistent with the size of clinical blood culture bottles, and is equipped with inlay sleeves of different sizes for inlaying the sleeves into the outside of the calibration unit so that it can be matched with the holes for placing blood culture bottles inside automated blood culture systems of different manufacturers and models during calibration. When in use, the calibration unit can be increased or decreased and automatically networked.

[0050] The female head of the charging interface 3 is located in the recessed part at the bottom of the calibration unit, and matches with the male head of the charging interface 3 protruding at the bottom of the calibration unit slot inside the dedicated containing box. When the calibration unit is not in use, it can be inserted into the calibration unit slot for integrated charging.

[0051] The optical sensor 4 is arranged at the center of the depression at the bottom of the calibration unit housing, and the exposed surface of the probe is a circular hole with a diameter of 4 mmd, which is used to monitor the optical data;

[0052] In an embodiment, the optical sensor 4 comprises one or more silicon photocells for monitoring the emitted light from the bottom of the recessed hole for placing the blood culture bottle in the automated blood culture system. The emitted light generated by the bottom of the recessed hole for placing the blood culture bottle is emitted in the direction of the optical sensor.

[0053] The temperature sensor 5 is arranged at one side of the bottom of the calibration unit and is used to monitor temperature data;

[0054] In an embodiment, the optical sensor 5 is provided with a cosine corrector, which can be used to collect radiation (light) within a 180° solid angle by the calibration unit of the automated blood culture system calibration device, thereby eliminating the optical interface problem in the light collection sampling geometry of the calibration unit.

[0055] The calibration circuit is used to calibrate temperature data and optical data;

[0056] In an embodiment, the calibration unit further includes a storage chip, a battery and an antenna;

[0057] The storage chip is used to store the optical and temperature data collected by the optical sensor and the temperature sensor;

[0058] The battery is used to provide the energy required for the normal endurance of the calibration unit;

[0059] The antenna is arranged on the upper part of the calibration unit, coupled with the storage chip, and is used for wirelessly transmitting the optical data and temperature data stored in the storage chip to the data receiving terminal.

[0060] like Figure 4As shown, in the embodiment, the calibration circuit includes a signal conditioning module A, a signal conditioning module B, an analog / digital conversion module, a zigbee main controller, a wireless signal power amplification module, and a lithium battery and charging module;

[0061] The signal conditioning module A and the signal conditioning module B are used to condition the data collected by the temperature sensor and the optical sensor respectively;

[0062] The analog / digital conversion module is used for analog-to-digital conversion processing of collected data;

[0063] The zigbee main controller and the wireless signal power amplifier module are used to control the sending of commands and the transmission of data;

[0064] The lithium battery and the charging module are used for charging the calibration circuit.

[0065] When the automated blood culture system calibration device is working, 9 calibration units monitor in real time the temperature and optical parameters in 9 different recessed holes for placing blood culture bottles in the automated blood culture system. During the operation of this blood culture system, the temperature of the incubation module needs to be kept constant, and the system's light source output signal changes periodically.

[0066] like Figure 3 As shown, the data receiving terminal includes a display module 6, a control button 7 and a receiving circuit;

[0067] The display module 6 is used to display the calibration results of multiple calibration unit temperature parameters and optical parameters after being processed and analyzed by the data processing module, and the display methods include digital display and curve display;

[0068] The control button 7 is used to control the switch of the data receiving terminal and adjust the display result of the viewing display module 6;

[0069] The receiving circuit is used to receive and process the temperature data and optical data of the calibration unit;

[0070] like Figure 5 As shown, in the embodiment, the receiving circuit includes a zigbee communication module, a wireless signal power amplification module, a Bluetooth communication module, a main controller, a lithium battery and a charging module;

[0071] The zigbee communication module and the wireless signal power amplification module are used to receive data transmitted from the terminal node and send control commands to the terminal node;

[0072] The Bluetooth communication module is used to send the data processed by the main controller to the terminal device connected to the Bluetooth communication module;

[0073] The main controller is used to receive and process data sent by the ZigBee communication module;

[0074] The processed data is displayed on the LCD screen;

[0075] The lithium battery and charging module are used to realize power conversion of the lithium battery and supply power to the main controller module, the ZigBee module, the wireless signal power module and the Bluetooth communication module.

[0076] In an embodiment, the receiving circuit further comprises a data interface for transmitting parameters stored in the data receiving terminal, and the interface may comprise an electrical connection, which may be suitable for communication and connected to an electronic component of an external computer or an AAP terminal.

[0077] During implementation, the optical parameters and temperature parameters displayed by the data receiving terminal can be transmitted to an external device such as a computer or an AAP terminal, and the transmitted information can be used for subsequent evaluation of the calibration results.

[0078] Although the present invention has been described in detail above by general description and specific embodiments, it is obvious to those skilled in the art that some modifications or improvements can be made to the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all belong to the scope of protection claimed by the present invention.

Claims

1. An automated blood culture system calibration device, characterized in that: It comprises a data receiving terminal and a plurality of calibration units; the calibration units comprise an upper housing (1), a lower housing (2), a charging interface (3), an optical sensor (4), a temperature sensor (5) and a calibration circuit; The upper shell (1) and the lower shell (2) are assembled into a calibration unit shell, the bottom of the calibration unit shell is recessed, and is used to protect the internal structure of the calibration unit; the charging interface (3) is used to charge the calibration unit; the optical sensor (4) is arranged at the center of the recessed bottom of the calibration unit shell, and is used to monitor optical data; the optical sensor (4) is provided with a cosine corrector, and the cosine corrector is used to collect radiation within a 180° solid angle, thereby eliminating the optical interface problem in the calibration unit light collection sampling geometry; the temperature sensor (5) is arranged at one side of the bottom of the calibration unit, and is used to monitor the temperature data The calibration circuit is used to calibrate temperature data and optical data, and mainly includes a signal conditioning module A, a signal conditioning module B, an analog / digital conversion module, a zigbee main controller, a wireless signal power amplification module, a lithium battery and a charging module. The signal conditioning module A and the signal conditioning module B are used to condition the data collected by the temperature sensor and the optical sensor respectively, the analog / digital conversion module is used for analog-to-digital conversion processing of the collected data, the zigbee main controller and the wireless signal power amplification module are used for sending control commands and transmitting data, and the lithium battery and the charging module are used for charging the calibration circuit; The data receiving terminal comprises a display module (6), a control button (7) and a receiving circuit; the receiving circuit is used to receive and process the temperature data and optical data of the calibration unit; the display module (6) is used to display the processing result of the receiving circuit; the control button (7) is used to control the switch of the data receiving terminal and adjust the display result of the display module (6).

2. An automated blood culture system calibration device according to claim 1, characterized in that: The calibration units are symmetrically distributed during testing.

3. The automated blood culture system calibration device according to claim 1, characterized in that: The calibration unit shell is a bottle-shaped structure with a minimum length of 100.5 mm and a diameter of 34.8 mm, which is consistent with the size of clinical blood culture bottles, and is equipped with inlay sleeves of different sizes for inlaying the sleeves into the outside of the calibration unit so that they can be matched and placed in the holes for placing blood culture bottles inside automated blood culture systems of different manufacturers and models during calibration.

4. The automated blood culture system calibration device according to claim 1, characterized in that: The optical sensor (4) comprises one or more silicon photocells for monitoring the emitted light at the bottom of the recessed hole in which the blood culture bottle is placed in the automated blood culture system.

5. The automated blood culture system calibration device according to claim 1, characterized in that: The calibration unit further includes a storage chip, a battery and an antenna; the storage chip is used to store the optical and temperature data collected by the optical sensor and the temperature sensor; the battery is used to provide the energy required for the normal endurance of the calibration unit; The antenna is arranged on the upper part of the calibration unit, coupled with the storage chip, and is used for wirelessly transmitting the optical data and temperature data stored in the storage chip to the data receiving terminal.

6. The automated blood culture system calibration device according to claim 1, characterized in that: The receiving circuit includes a zigbee communication module, a wireless signal power amplification module, a Bluetooth communication module, a main controller, a lithium battery and a charging module; the zigbee communication module and the wireless signal power amplification module are used to receive data transmitted from the terminal node and send control commands to the terminal node; the Bluetooth communication module is used to send the data processed by the main controller to the terminal device connected to the Bluetooth communication module; the main controller is used to receive and process the data sent by the zigbee communication module; the lithium battery and the charging module are used to realize the power conversion of the lithium battery and supply power to the main controller module, the zigbee module, the wireless signal power module and the Bluetooth communication module.

7. The automated blood culture system calibration device according to claim 1, characterized in that: The receiving circuit also includes a data interface for transmitting parameters stored in a data receiving terminal for subsequent evaluation of the calibration results.

8. An automated blood culture system calibration device according to any one of claims 1 to 7, characterized in that: The automated blood culture system calibration device also includes a dedicated containing box for shielding mechanical shock, pressure or humidity; at the same time, the dedicated containing box is provided with a protrusion that matches the bottom depression of the calibration unit shell, and the protrusion is provided with a male charging interface (3), and the female charging interface (3) is arranged in the bottom depression of the calibration unit shell for integrated charging of the calibration unit.

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