CN117783561A - Quality management system of high-flux sample analysis equipment - Google Patents

Abstract

The invention relates to the technical field of biological sample detection and analysis, in particular to a quality management system of high-flux sample analysis equipment, which adopts a hardware structure frame of an upper computer, a middle computer and a lower computer, and comprises the following components: the quality monitoring module is used for outputting control signals, collecting quality data of all devices of the high-flux sample analysis equipment in operation and judging the quality data according to a quality control limit range; the data receiving and quality control module is connected with the quality monitoring module and is used for receiving the quality data uploaded by the quality monitoring module and establishing a corresponding quality control limit range for each quality monitoring point according to the quality data; and the data output module is connected with the data receiving and quality control module and is used for uploading the quality data to the inter-cloud system, outputting the quality data and generating and outputting a quality report. The invention realizes the automation and real-time monitoring of the quality data, and improves the management efficiency, the service life and the reliability of the equipment.

Description

Quality management system of high-flux sample analysis equipment

Technical Field

The invention relates to the technical field of biological sample detection and analysis, in particular to a quality management system of high-flux sample analysis equipment.

Background

The commonly used biological sample analysis devices include biochemical analyzers, hemoglobin analyzers, immunoassay analyzers, coagulation analyzers, and the like, are used for analyzing the composition of substance components of a biological sample to be measured, and are widely used in analysis research in clinical detection and biological fields. For example, the coagulation analyzer clinically performs coagulation and anticoagulation, fibrinolysis and antifibrinolysis analysis on a blood sample of a patient, has important diagnostic value on hemorrhagic diseases, thrombotic diseases, DIC and liver and kidney diseases, and plays an important role in preoperative inspection and anticoagulation quality detection.

Such sample analysis devices typically add biological samples to a reaction cuvette, add detection reagents to aid in incubation, washing, or/and mixing, and measure parameters such as concentration and chemical properties of each component by a physical detection method. The biological sample analysis device can well complete the detection task of daily biological samples, and simultaneously, a laboratory operator can also perform quality control test on the sample analysis device through a biomass control product, and the quality control test result directly feeds back the detection quality of a test system consisting of the analysis device and the reagent. If the quality control result accords with the quality control limit range, the sample analysis device is in a good control state; if the quality control result exceeds the quality control limit range, the detection quality is poor due to the fact that some fault reasons exist. An operator can find whether the sample analysis equipment has quality control loss or not in advance to a certain extent through the quality control test, and judge whether the sample analysis equipment needs to be used in advance, so that the subsequent medical dispute is avoided.

However, the above-mentioned quality control test by means of the biomass control further judges whether the sample analysis device is out of control has the following drawbacks: firstly, performing quality control test through a biomass control product is to test and evaluate test results, and whether the test results are out of control and are caused by poor sample analysis equipment or poor matched reagents cannot be rapidly and accurately distinguished; secondly, quality control testing of the biomass control product cannot set quality control points for equipment in the detection process, and when the quality control testing result shows that the quality is out of control, a maintenance engineer is required to spend effort to analyze the cause of the out of control equipment and locate fault points, and the technical level requirements of the maintenance engineer are high; third, quality control testing of biomass control cannot accurately feed back the tendency of mass attenuation and the cause of mass attenuation of the sample analysis device.

The integration level of the existing sample analysis device is higher, such as high-throughput sample analysis devices with parts number of up to thousands, and the variables affecting the quality of the device become more, so that the quality of the sample analysis device is far from being monitored by only the quality control test of the biomass control. If the quality problem of the sample analysis device is not monitored and maintained in time, abnormal test results may be caused, and even accelerated deterioration of the quality of the sample analysis device may be caused, resulting in medical accidents.

Disclosure of Invention

Therefore, the technical problem to be solved by the invention is to solve the problem that the running quality and trend of the high-flux sample analysis equipment cannot be monitored in real time in the prior art.

In order to solve the technical problems, the invention provides a quality management system of high-throughput sample analysis equipment, which adopts a hardware structure framework of an upper computer, a middle computer and a lower computer, and comprises:

the quality monitoring module adopts distributed control boards, and each control board independently controls a plurality of stepping motors, a plurality of sensor signal input ports, a plurality of level output ports, a plurality of bidirectional input and output ports, an analog AD acquisition port and an RS485 communication port; the device is used for receiving control signals output by the upper computer and the middle computer, collecting quality data of all devices of the high-flux sample analysis equipment in operation, judging the quality data according to a quality control limit range, and outputting early warning information when the quality data exceeds the quality control limit range;

the host computer, with quality monitoring module communication connection, include:

the data receiving and quality control module is connected with the quality monitoring module and is used for receiving the quality data uploaded by the quality monitoring module, establishing corresponding quality control limit ranges for all quality monitoring points according to the quality data, and sending the quality control limit ranges of all the quality monitoring points to the quality monitoring module so that the quality monitoring module can judge the quality data according to the quality control limit ranges;

And the data output module is connected with the data receiving and quality control module and is used for uploading the quality data to the inter-cloud system, outputting the quality data and generating and outputting a quality report.

In one embodiment of the invention, the quality monitoring module comprises:

the motion quality monitoring unit is arranged on the mechanical arm of the high-flux sample analysis equipment and comprises a plurality of stepping motors, wherein each stepping motor is connected with a zero position sensor through a sensor signal input port; the motion quality monitoring unit is used for executing one-time automatic calibration of the stepping motor through the zero position sensor in each motion cycle process of the mechanical arm, acquiring the regression step number of the stepping motor, and taking the deviation of the actual regression step number and the theoretical step number as the quality data of the mechanical arm;

the characteristic bit quality monitoring unit is arranged on the mechanical arm of the high-flux sample analysis equipment and is used for automatically adjusting characteristic bits of the mechanical arm, taking adjusting parameters as quality data of the characteristic bits of the mechanical arm, establishing an adjusting parameter database and monitoring the change trend of the adjusting parameters;

the liquid path quality monitoring unit is arranged on a liquid path system of the high-flux sample analysis equipment and is used for monitoring liquid path pressure of each liquid path control point by using the needle blocking sensor and counting the running time of vulnerable parts in the liquid path system to be used as quality data of the liquid path system;

The refrigerating system quality monitoring unit is arranged on the refrigerating system of the high-flux sample analysis equipment and comprises a plurality of temperature sensors, wherein the temperature sensors are used for monitoring the temperature of the refrigerant liquid and the cooling fins and the reagent refrigerating temperature in real time;

the thermal system quality monitoring unit is arranged on the thermal system of the high-flux sample analysis equipment and is used for monitoring and automatically adjusting the temperature of the working area inside the high-flux sample analysis equipment;

the detection system quality monitoring unit comprises a reference channel, wherein the reference channel is connected with a detection channel of a detection system of the high-flux sample analysis equipment in parallel and comprises an independent optical fiber branch and an independent photoelectric detector silicon diode which are arranged on the detection system, and the reference channel is used for correcting an optical path AD value of the detection system;

the power supply system quality monitoring unit comprises an output voltage monitoring subunit arranged on each switching power supply of the high-flux sample analysis equipment and a voltage monitoring subunit arranged on the optical path detection system, and is used for converting the power supply voltage value of each shunt in the power supply system from analog quantity to digital quantity and monitoring the voltage of the power supply system.

In one embodiment of the present invention, the detection system quality monitoring unit corrects an optical path AD value of a detection system, including:

The detection system quality monitoring unit acquires an AD data set of a light source lamp of a test channel in test time at a time interval of 0.1s to obtain three sets of data under a certain wavelength lambda: { AD _i } _λ 、{ADd _i } _λ And ADr _i } _λ The method comprises the steps of carrying out a first treatment on the surface of the Wherein { AD } _i } _λ Represents the ith AD value of the test specimen light source lamp at wavelength λ, { ADd _i } _λ An ith AD value representing the dark value of the test channel at wavelength λ, { ADr _i } _λ An ith AD value of the reference channel light source lamp at the wavelength lambda;

according to the smoothing parameter pair { AD _i } _λ 、{ADd _i } _λ Sum { ADr } _i } _λ Smoothing to obtain smoothed data setAnd->

Data set smoothed by reference channelCalculating to obtain reference value S of reference channel _λ ；

Calculating a data set { ADc { of AD values of the light source lamp after calibration of the test channel _i } _λ ：

In one embodiment of the invention, the light source lamp AD value data set { ADc after calculating the test channel calibration _i } _λ The formula is:

wherein the correction factor

In one embodiment of the invention, the characteristic bit quality monitoring unit comprises:

the characteristic position adjustment subunit is arranged on the mechanical arm and is used for automatically adjusting the characteristic position of the mechanical arm in a mode that one surface is determined by three points and one line is determined by two points;

the characteristic position automatic calibration subunit is arranged on the mechanical arm with the sampling needle and is used for automatically calibrating the characteristic position of the mechanical arm by utilizing the principle of capacitance change detected by the liquid level of the sampling needle;

The characteristic position adjustment parameter checking subunit is arranged on the mechanical arm needing manual adjustment of the characteristic position and is used for checking the parameter rationality of the adjustment parameter of the characteristic position of the mechanical arm;

the characteristic bit adjustment parameter statistical analysis subunit is used for recording specific numerical values and update dates of the characteristic bit adjustment parameters of the characteristic bit adjustment subunit, the characteristic bit automatic calibration subunit and the characteristic bit adjustment parameter checking subunit, establishing a database for the characteristic bit adjustment parameters, and monitoring the change trend of the adjustment parameters.

In one embodiment of the present invention, the quality monitoring unit of the refrigeration system further includes a peltier driving current monitoring circuit disposed on the peltier for monitoring the magnitude of the peltier driving current and analyzing whether the peltier is damaged and its aging trend.

In one embodiment of the invention, the refrigeration system quality monitoring unit further comprises:

the fan rotating speed monitoring subunit is arranged on a fan of the refrigeration system and used for monitoring the rotating speed of the fan and analyzing the quality trend of the fan;

the circulating pump monitoring subunit is arranged on a refrigerant circulating pump of the refrigerating system and used for monitoring the total running duration and the rotating speed of the refrigerant circulating pump and analyzing the quality trend of the refrigerant circulating pump.

In one embodiment of the invention, the thermal system quality monitoring unit comprises:

the temperature sensor is arranged above a testing area, an incubation area, a heating needle, a reaction cup arranging mechanism, a replenishing mechanism and an equipment internal working area of the high-flux sample analysis equipment and is used for monitoring the temperature of each area of the thermal system;

the heating subunit is arranged on the reaction cup arranging mechanism and the replenishing mechanism and is used for preheating the reaction cup;

the air inlet fan is arranged on the lower cabinet of the high-flux sample analysis equipment and used for adjusting the temperature of the working area inside the high-flux sample analysis equipment.

In one embodiment of the present invention, the data receiving and quality control module includes:

the data receiving unit is connected with the quality monitoring module and is used for receiving the quality data uploaded by the quality monitoring module; the quality data comprises initialization quality data, test initialization quality data, periodic test quality data and daily maintenance quality data;

the data quality control unit is connected with the data receiving unit and is used for establishing a corresponding quality control limit range for each quality monitoring point according to the quality data and sending the quality control limit range of each quality monitoring point to the quality monitoring module so that the quality monitoring module can judge the quality data according to the quality control limit range; the data quality control unit comprises:

The quality control limit range establishing subunit is used for establishing the quality control limit range of the quality data by adopting a level-Jennings and Westgard multi-rule quality control method according to the reference value level and the fluctuation level of the quality data of the motion quality monitoring unit, the liquid path quality monitoring unit and the power supply system quality monitoring unit in the quality monitoring module;

the operation diary monitoring subunit is used for receiving the quality data of the characteristic bit quality monitoring unit in the quality monitoring module and the operation data of each device in the high-flux sample analysis equipment and constructing a database;

and the wearing part operation data statistics subunit is used for counting the total operation duration of wearing parts in the liquid path system and the operation mileage of the transmission mechanism component, and generating time nodes of normal working condition period, wearing fatigue period and out-of-service operation of each wearing part and the quality index of each wearing part.

In one embodiment of the present invention, the data output module includes:

the quality data output unit is used for outputting quality data by adopting a billboard;

a quality report printing unit for generating and outputting a stage quality report of the high throughput sample analysis apparatus in a printed manner;

the quality data pushing inter-cloud unit is used for pushing the quality data of the high-flux sample analysis equipment to an inter-cloud system through a GPRS wireless network by utilizing the wireless data transmission terminal.

Compared with the prior art, the technical scheme of the invention has the following advantages:

according to the quality management system of the high-flux sample analysis equipment, quality monitoring points are established in each system of the high-flux sample analysis equipment through the quality monitoring module, real-time monitoring is carried out on devices or mechanical operation processes which possibly have quality problems, and a quality control limit range is established for each quality monitoring point in a self-adaptive mode through the data receiving and quality control module. The quality monitoring module automatically identifies abnormal or unqualified quality data according to the quality control limit range, timely outputs early warning information, helps maintenance engineers to locate fault points, and facilitates operators to take corresponding corrective measures. The data output module uploads the quality data to the inter-cloud system, the inter-cloud system performs further data analysis and pushes the analysis result to the maintenance engineer, and the maintenance engineer can conveniently intervene in advance to maintain the equipment. The invention realizes the automation and real-time monitoring of quality data in multiple dimensions, greatly improves the management efficiency of the high-flux sample analysis equipment, reduces the conditions of manual intervention and equipment maintenance delay, effectively slows down the quality deterioration of the high-flux sample analysis equipment, and improves the operation life and reliability of the equipment.

Drawings

In order that the invention may be more readily understood, a more particular description of the invention will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings.

FIG. 1 is a block diagram of a mass management system of a high throughput sample analysis apparatus of the present invention;

FIG. 2 is a schematic diagram of a high throughput sample analysis apparatus in accordance with an embodiment of the present invention;

FIG. 3 is an electrical block diagram of a quality monitoring module of the present invention;

FIG. 4 is a diagram showing the motion quality monitoring of CTH1Y of a lot number 1 device according to an embodiment of the present invention;

FIG. 5 is a diagram showing the motion quality monitoring of CTH1Y of a lot number 2 device in an embodiment of the present invention;

FIG. 6 is a diagram for monitoring the motion quality of a plunger motor with a lot number S1 in an embodiment of the invention;

FIG. 7 is a schematic of a refrigeration system of a high throughput sample analysis apparatus in accordance with an embodiment of the present invention;

FIG. 8 is a schematic block diagram of a detection system quality monitoring unit of the present invention;

FIG. 9 is a graph of the optical path AD of a detection system unused detection system quality monitoring unit of a high throughput sample analysis device in an embodiment of the invention;

FIG. 10 is a graph of the optical path AD of a detection system of a high-throughput sample analysis apparatus using a detection system quality monitoring unit according to an embodiment of the present invention;

FIG. 11 is a flowchart of a data output module pushing quality data between clouds in an embodiment of the present invention;

FIG. 12 is a schematic diagram of a quality data sign interface in accordance with an embodiment of the present invention;

FIG. 13 is a schematic diagram of a quality report in an embodiment of the invention;

fig. 14 is a flow chart of a method of quality management of a high throughput sample analysis apparatus of the present invention.

Description of the specification reference numerals: 1. a light source lamp module; 2. a light spot processing module; 3. a light source lamp module; 4. a detection channel; 5. and (3) a reference channel.

Detailed Description

The present invention will be further described with reference to the accompanying drawings and specific examples, which are not intended to be limiting, so that those skilled in the art will better understand the invention and practice it.

Example 1

Referring to fig. 1, the present embodiment provides a quality management system of a high-throughput sample analysis device, which adopts a hardware structure framework of an upper computer, a middle computer and a lower computer, and includes a quality monitoring module and an upper computer. The upper computer is in communication connection with the quality monitoring module and comprises a data receiving and quality control module and a data output module. A schematic structural diagram of the high throughput sample analysis apparatus is shown in fig. 2. Each module of the quality management system is described in detail below.

Referring to the electrical structure block diagram of the quality monitoring module shown in fig. 3, the quality monitoring module adopts a distributed control board, each control board independently controls a plurality of stepping motors, a plurality of sensor signal input ports, a plurality of level output ports, a plurality of bidirectional input and output ports, an analog AD acquisition port and an RS485 communication port, and is used for receiving control signals output by an upper computer and a middle computer, acquiring quality data of each device of the high-throughput sample analysis equipment in operation, judging the quality data according to a quality control limit range, and outputting early warning information when the quality data exceeds the quality control limit range. The quality monitoring module comprises a motion quality monitoring unit, a characteristic bit quality monitoring unit, a liquid path quality monitoring unit, a refrigerating system quality monitoring unit, a thermal system quality monitoring unit, a detection system quality monitoring unit and a power supply system quality monitoring unit.

The motion quality monitoring unit is mounted on a mechanical arm of the high-flux sample analysis device and comprises a plurality of stepping motors, wherein each stepping motor comprises a plurality of sensor signal input ports.

Typically, one sensor signal input port of the stepper motor is connected to the zero position sensor and one sensor signal input port is connected to the encoder. If the application scene contains a plurality of characteristic positions, each characteristic position needs to occupy one sensor signal input port of the stepping motor. When the electric stepper is connected with the encoder, the encoder and the stepper motor form a closed-loop control system, and if the stepper motor is out of step or the movement mechanism is blocked, the running quality of the movement mechanism can be recorded in real time through the pulse count of the encoder, and the quality data is reported in real time. However, if a high throughput sample analysis apparatus requires several tens of stepper motors, if each stepper motor is connected to an encoder, the overall analysis apparatus is cost prohibitive and the encoder is sized, resulting in a more compact movement mechanism lacking space to deploy the encoder.

Therefore, in this embodiment, the encoder is not configured in the motion quality monitoring unit, and the stepper motor is connected to a zero position sensor only through the sensor signal input port, so that the stepper motor and the zero position sensor form an open loop system. In each motion cycle process, the motion quality monitoring unit executes one-time automatic calibration of the stepping motor, acquires the regression step number of the stepping motor, obtains the deviation between the actual regression step number and the theoretical step number, takes the deviation between the actual regression step number and the theoretical step number as motion quality data of the motion quality monitoring unit, and directly feeds back the quality of the circulating motion.

Referring to fig. 4 and 5, fig. 4 is a CTH1Y motion quality monitoring diagram of a lot number 1 device, and fig. 5 is a CTH1Y motion quality monitoring diagram of a lot number 2 device. The CTH1Y motor is not provided with an encoder, is connected with a zero position sensor only through a sensor signal input port, and records the motion pulse deviation of the CTH1Y motor by executing an automatic calibration method.

By comparison analysis, the motion pulse deviation of the CTH1Y motor of the equipment with the number 1 exceeds 30 pulse steps, the pulse deviation of the CTH1Y motor of the equipment with the number 2 is smaller than 5 pulse steps, and a certain deviation exists in the motion quality of the CTH1Y motor of the equipment with the number 1, so that the CTH1Y motion mechanism of the equipment with the number 1 is analyzed. The 30 pulse step number deviation is converted to have a motion error of about 0.1mm, and further analysis finds that a certain gap exists between a linear guide rail and a guide rail sliding block, which are configured by a CTH1Y motion mechanism of the equipment with the number of 1, so that a certain tiny shaking amount exists in the motion mechanism, thereby causing motion quality deviation, and the individual quality deviation of the batch of linear guide rails is determined through the comparison of the motion quality data.

As described with reference to fig. 6, fig. 6 is a diagram of monitoring the motion quality of a plunger motor with a lot number S1. As can be seen from fig. 6, there is a certain sporadic motion error exceeding 600 pulse steps before date 08 months 20. The number S1 plunger motor is also connected with a zero position sensor only through a sensor signal input port, and in the period test process, each control cycle executes automatic calibration. By analyzing the transmission mechanism of the number S1 plunger motor, a certain reverse gap exists between the screw rod and the screw rod nut, and the material has a certain batch-to-batch difference, which is expressed as the motion quality difference of the number S1 plunger motor of different equipment, so that the motion quality deviation is caused sporadically. Therefore, after the date is numbered 08-21, the reverse gap influence is eliminated by revising the motion control method, the motion quality deviation of the plunger motor numbered S1 is returned to be within 5 pulse steps, and the individual reverse gap deviation of the batch materials can be determined by analyzing the motion quality data.

In summary, the motion quality monitoring unit can monitor and determine whether the mechanical arm is out of step due to a motor in the motion process, for example, the mechanical arm is out of position due to serious clamping stagnation of the linear guide rail, so that the test result of the analysis equipment is affected. When the motion quality monitoring unit monitors that the motion position of the mechanical arm is out of alignment, reminding or alarming information is output in real time, meanwhile, the related biological sample testing result is marked as an abnormal condition result, an operator is reminded of needing to intervene and check, corresponding special treatment is carried out, for example, the operator is reminded of needing to repeat testing of the sample or manual checking of a reaction curve and the like. The motion quality monitoring unit can also monitor whether the mechanical arm has trend quality deterioration in the motion process, and when the motion quality monitoring unit recognizes the trend quality deterioration, the motion quality monitoring unit outputs a prompt in real time or pushes an abnormal condition to an operator or a maintenance engineer so as to help the operator or the maintenance engineer to make the equipment maintenance.

The characteristic bit quality monitoring unit is arranged on a mechanical arm of the high-throughput sample analysis equipment and comprises a characteristic bit adjustment subunit, a characteristic bit automatic calibration subunit, a characteristic bit adjustment parameter checking subunit and a characteristic bit adjustment parameter statistical analysis subunit.

The characteristic position adjustment subunit automatically adjusts the characteristic position of the mechanical arm in a mode that one surface is determined by three points and one line is determined by two points. If the movement area of the mechanical arm is one surface, three stroke limit positions are selected as characteristic positions. The coordinates of the middle position are obtained through automatic conversion of the three characteristic positions, so that the setting of too many characteristic positions which need manual adjustment is avoided, and the risk of human errors is reduced.

The characteristic position automatic calibration subunit is arranged on the mechanical arm with the sampling needle, and realizes the automatic calibration of the mechanical arm at the characteristic position by utilizing the principle of capacitance change of the liquid level detection of the sampling needle. When the needle tip of the sampling needle contacts an object with conductive characteristics, the capacitance value of the detection sampling needle can change obviously. The characteristic position automatic calibration subunit utilizes the characteristic of the capacitance value of the sampling needle to place an object with conductive characteristic or a container with liquid on the characteristic position to be calibrated, and circularly executes liquid level detection. In the area of the object with the conductive characteristic, the characteristic bit automatic calibration subunit can normally trigger the capacitance value change of the sampling needle when the liquid level detection is executed; outside the area of the object with the conductive characteristic, the characteristic bit automatic calibration subunit cannot normally trigger the capacitance value change of the sampling needle when the liquid level detection is performed. The sampling needle circularly detects the object with the conductive characteristic according to the budget stepping progress, so that the object region coordinate with the conductive characteristic is scanned, and the central coordinate of the characteristic bit is obtained through calculation of a computer program. The characteristic position automatic calibration subunit realizes the characteristic position automatic calibration of the sampling needle mechanical arm, effectively reduces the human calibration error and improves the accuracy of the characteristic position calibration.

The feature bit adjustment parameter checking subunit is mounted to a robotic arm that is unable to automatically calibrate the feature bit by a computer program. Because the mechanical arm can only be adjusted manually, parameter rationality checking is required for adjusting parameters of characteristic positions of the mechanical arm. Every feature bit of the mechanical arm which needs manual adjustment is provided with a reasonable interval value, when the feature bit is manually adjusted every time, the feature bit adjustment parameter checking subunit performs checking on the adjusted feature bit parameter, and if the adjusted feature bit parameter exceeds a preset reasonable interval range, the feature bit adjustment parameter checking subunit outputs an alarm prompt, so that bad adjustment quality caused by the influence of human subjective factors is avoided.

The characteristic bit adjustment parameter statistical analysis subunit is used for recording specific numerical values and update dates of the characteristic bit adjustment parameters of the characteristic bit adjustment subunit, the characteristic bit automatic calibration subunit and the characteristic bit adjustment parameter checking subunit, establishing a database for the characteristic bit adjustment parameters, archiving, analyzing adjustment frequency and adjustment difference of each characteristic bit adjustment parameter, and monitoring the change trend of the adjustment parameters.

If a feature bit is subjected to multiple times of adjustment in a short time, the feature bit adjustment parameter statistical analysis subunit outputs corresponding reminding information. For example, during one or more days, an operator or a maintenance engineer does not notice a previous feature bit adjustment record, but a plurality of times of adjustment for a certain feature bit occurs, and then the feature bit adjustment parameter statistical analysis subunit outputs reminding information. The reminding information comprises the phenomenon that whether a mechanical arm is not firmly fixed or the operation mechanism is obviously blocked or not is checked.

And the characteristic bit adjustment parameter statistical analysis subunit executes quality control analysis of each adjustment parameter according to the database of the characteristic bit adjustment parameters. If a certain characteristic bit adjustment parameter value has larger deviation with the historical data of the characteristic bit adjustment parameter in the database, the characteristic bit adjustment parameter statistical analysis subunit outputs reminding information.

And the characteristic bit adjustment parameter statistical analysis subunit further draws a quality control trend graph according to the database of characteristic bit adjustment parameters, outputs the change trend of each characteristic bit adjustment parameter, and analyzes whether the moving device of the high-flux sample analysis equipment has a deterioration trend or a wear trend.

In summary, the feature position quality monitoring unit realizes the automatic feature position adjustment function of the mechanical arm, avoids the feature position difference caused by the manual adjustment mechanical arm, and causes the quality difference of the high-throughput sample analysis equipment. And the characteristic bit quality monitoring unit can analyze the variation trend of each characteristic bit adjustment parameter within a certain time span range, so as to analyze whether the mechanical mechanism of the high-flux sample analysis equipment has quality abnormality or quality deterioration trend, and prompt a maintenance engineer to intervene in maintenance.

The liquid path quality monitoring unit is arranged on a liquid path system of the high-flux sample analysis equipment and comprises needle blocking sensors, wherein the needle blocking sensors are used for monitoring liquid path pressure of each liquid path control point and counting operation time and circulation times of liquid path easy-to-damage parts to be used as quality data of the liquid path system.

In the sampling needle liquid path system, a needle blocking sensor of the liquid path quality monitoring unit is used for monitoring the pressure of the sampling needle and checking whether a needle point is blocked by a fibrinogen condensation block in a biological sample. And if the sampling needle is blocked, the liquid path quality monitoring unit triggers an alarm.

When the pressure pump quality in the liquid path system is poor, the working pressure of the flushing liquid path is insufficient, so that the inner wall and the outer wall of the sampling needle cannot be effectively flushed, and the problem that the sampling needle is polluted in a carrying way or the precision of the biological samples distributed is poor is caused. The liquid path quality monitoring unit monitors the working pressure of the flushing liquid path by using the needle blocking sensor, and if the pressure of the flushing liquid path is lower than the effective range, the liquid path quality monitoring unit triggers an alarm and makes a risk mark on the result of a biological sample detection project to remind an operator of the need of equipment checking or retesting and other operations.

The liquid path quality monitoring unit also performs operation time statistics on the liquid path device. If the operation time of the liquid path device exceeds a certain period, the liquid path quality monitoring unit reminds an operator of liquid path maintenance, such as filter replacement and liquid path vulnerable part replacement, so that equipment is prevented from running with diseases.

The liquid path quality monitoring unit also monitors the negative pressure of the liquid path for discharging the liquid, so that the problems that when the negative pressure of the liquid path for discharging the liquid is insufficient, the liquid generated by the high-flux sample analysis equipment cannot be discharged out of the machine in time, the liquid is diffused in the machine, equipment short circuit, device damage or sampling needle carrying pollution are caused by serious problems.

In summary, the liquid path quality monitoring unit monitors the pressure of the sampling needle, the working pressure of the flushing liquid path and the negative pressure of the waste liquid path, performs operation time statistics on the liquid path device, evaluates the quality condition of the liquid path system of the high-flux sample analysis equipment, monitors the damage position and aging trend of the device in the liquid path system, and can prompt a maintenance engineer to intervene in maintaining the liquid path system in time.

Referring to fig. 7, because the high-throughput sample analysis device has high integration level, the assembly maintenance is difficult, the refrigeration module is externally arranged in the easy-maintenance area, and the refrigerant liquid is conveyed to the reagent tray through the pipeline and the circulating liquid path to cool the reagent tray. The high-flux sample analysis equipment uses the peltier to cool the refrigeration module, heat generated by the peltier is transferred to the cooling fin, and the cooling fin is cooled rapidly through the fan. The liquid flow channel design is arranged in the refrigerating plate in the refrigerating module, after the refrigerant liquid is conveyed into the refrigerating plate, temperature exchange is carried out in the refrigerating plate, so that the temperature of the refrigerant liquid is reduced, the cooled refrigerant liquid is output into the reagent disk module from the refrigerating plate, temperature heat exchange is carried out in the reagent disk module again, heat of the reagent disk is taken away, cooling of the reagent disk is realized, and the reagent disk is sequentially circulated.

The refrigeration system quality monitoring unit is arranged on the refrigeration system of the high-flux sample analysis device and comprises a plurality of temperature sensors. The specific positions of the plurality of temperature sensors include: a temperature sensor is arranged in the refrigeration module and used for monitoring the temperature of the refrigerant liquid; the radiating fin is provided with a temperature sensor for monitoring the temperature of the radiating fin; the inside temperature sensor that sets up of reagent dish is used for monitoring reagent refrigeration temperature. The cooling fin temperature sensor and the refrigerant liquid temperature sensor in the refrigerating module are combined to analyze whether excessive dust is accumulated on the filter cotton of the fan, so that the cooling fin is poor in cooling effect and the temperature of the refrigerant liquid is affected.

The refrigerating system quality monitoring unit further comprises a Peltier driving current monitoring circuit arranged on the Peltier and used for monitoring the size of the Peltier driving current and analyzing whether the Peltier is damaged and the aging trend of the Peltier.

The refrigerating system quality monitoring unit further comprises a fan rotating speed monitoring subunit arranged on the fan and a circulating pump monitoring subunit arranged on the refrigerant circulating pump. The fan rotating speed monitoring subunit is used for monitoring the rotating speed of the fan, judging whether the fan is damaged or not and analyzing whether the quality of the fan has a deterioration trend or not. The circulating pump monitoring subunit is used for monitoring the total operation duration and the rotation speed of the refrigerant circulating pump and analyzing whether the circulating pump has the trend of exceeding the effective period and deteriorating the quality.

If the high temperature of the heat sink is transferred to the refrigeration module, it can cause the temperature inside the reagent tray to be too high, causing reagent failure inside the reagent tray. In this embodiment, the refrigeration system quality monitoring unit further includes a thermal fuse disposed on the heat sink. When the temperature of the radiating fin reaches the early warning temperature, for example, 56 ℃, the thermal fuse is triggered to fuse, the power supply of the Peltier is automatically disconnected, the temperature of the radiating fin is prevented from being too high after the system is out of control, and the ageing of devices in the refrigerating system is accelerated.

The refrigerating system quality monitoring unit utilizes a plurality of temperature sensors, a Peltier drive current monitoring circuit, a rotating speed detection subunit and a thermal fuse, and realizes the positioning of faults in the refrigerating system through combination logic judgment, thereby avoiding the accelerated deterioration of the refrigerating system quality or more serious quality accidents caused by single faults. The refrigerating system quality monitoring unit also records and tracks devices in the refrigerating system, such as a circulating pump, a Peltier, a fan and dust filtering cotton of the fan, through detection data of a plurality of temperature sensors, a Peltier driving current monitoring circuit, a rotating speed monitoring subunit and a thermal fuse, and outputs a data trend chart, so that a maintenance engineer or an operator can conveniently know the ageing condition of the devices in the refrigerating system.

The thermal system quality monitoring unit is arranged on the thermal system of the high-flux sample analysis equipment and specifically comprises temperature sensors respectively arranged in a test area, an incubation area and a heating needle, a heating subunit of a reaction cup arranging mechanism and a replenishing mechanism, the temperature sensors above the inner working area of the high-flux sample analysis equipment and an air inlet fan of a lower cabinet.

The temperature sensors arranged in the test area, the incubation area and the heating needle are respectively used for monitoring whether the temperatures of the test area, the incubation area and the heating needle are abnormal or not.

Considering that the preheating temperature of the reaction cup in the high-flux sample analysis equipment has potential influence on the detection result of the biological sample in advance, the thermal system quality monitoring unit is provided with a heating subunit and a temperature sensor in the cup arranging mechanism and the replenishing mechanism of the reaction cup, and is used for preheating the reaction cup in advance and monitoring whether the preheating temperature of the reaction cup is abnormal or not. In this example, the pre-heated target temperature is 37 ℃.

The thermal system quality monitoring unit is provided with a temperature sensor above the internal working area of the high-flux sample analysis equipment, and three air inlet fans are arranged on the lower cabinet of the high-flux sample analysis equipment and used for adjusting the temperature of the internal working area of the high-flux sample analysis equipment. When the temperature is high in summer, as a plurality of heating devices are arranged in the high-flux sample analysis equipment and a plurality of mechanical arm stepping motors generate a large amount of heat, the temperature of a working area is increased and exceeds the target incubation temperature of the biological sample by 37 ℃. The thermal system quality monitoring unit increases the air inlet quantity of the three air inlet fans, and cools the working area, so that the incubation temperature of the biological sample can be controlled at the target incubation temperature. When the air temperature is lower in winter, the temperature deviation between the temperature of a working area and the temperature is larger when the air temperature is higher, the quality monitoring unit of the thermal system reduces the air inlet quantity of the three air inlet fans, and the internal temperature of the high-flux sample analysis equipment is maintained by utilizing the heat generated in the high-flux sample analysis equipment, so that when the air temperature is larger in deviation, the internal temperature of the high-flux sample analysis equipment is always kept in a stable range. The thermal system quality monitoring unit utilizes the self heat of the high-flux sample analysis equipment, automatically adjusts the temperature in the space of the working area by controlling the air inlet quantity of the air inlet fan, stabilizes the temperature in the machine, and reduces the quality deviation of the test result caused by the temperature deviation.

Referring to fig. 8, the detection system quality monitoring unit includes a separate fiber branch and a separate photodetector silicon diode disposed in a detection system of a high-throughput sample analysis apparatus. The independent optical fiber branches and the independent photoelectric detector silicon diodes form an independent channel which is parallel to each detection channel in the detection system and is called a reference channel and used for correcting the AD value of the optical path of the detection system.

Due to the LED lamp, a certain temperature drift effect exists, so that the traditional optical measuring device has a certain optical signal change trend, and the testing precision of the optical measuring device is affected. And the lack of standard channels in conventional optical measurement devices results in the inability to calibrate each test channel of the measurement system. When the test channels are affected by the environment, such as chips or flying dust of the reaction cup enter the optical measurement window, so that the light intensity value of the test channels is affected, all the test channels have the same AD curve change trend due to the temperature drift effect of the LED lamp. Therefore, the detection system quality monitoring unit regards errors with the same trend among the test channels as system errors, a reference channel is additionally arranged on the basis of the traditional optical measuring device, and AD values of the test channels are corrected by identifying and eliminating the system errors.

Specifically, the reference channel recognizes the variation trend of the AD curve, calculates the relative variation of the test channel, and then deducts the relative variation of the test period in the test channel to eliminate the influence of the light source lamp.

The relation among the AD value of the light source lamp at the moment i of the test channel, the AD value of the light source lamp at the moment i of the reference channel, the reference value of the reference channel and the AD value of the light source lamp at the moment i after the test channel is calibrated is as follows:

ADc _i ＝AD _i -ADr _i +S

wherein AD is _i AD value of light source lamp at certain moment i of test channel is represented by ADr _i AD value of the light source lamp at reference channel i, S represents reference value of the reference channel, ADc _i The AD value of the light source lamp at the time i after the calibration of the test channel is shown.

Thus, the detection system quality monitoring unit calculates ADc _i Calibrating a light source lamp of a test channel, wherein the specific steps comprise:

the detection system quality monitoring unit acquires an AD data set of a light source lamp of a test channel in test time at a time interval of 0.1s to obtain three sets of data under a certain wavelength lambda: { AD _i } _λ 、{ADd _i } _λ And ADr _i } _λ . Wherein { AD } _i } _λ Represents the ith AD value of the test specimen light source lamp at wavelength λ, { ADd _i } _λ An ith AD value representing the dark value of the test channel at wavelength λ, { ADr _i } _λ The ith AD value of the reference channel light source lamp at wavelength lambda is shown.

The detection system quality monitoring unit performs the detection according to the smoothing parameter pair { AD } _i } _λ 、{ADd _i } _λ Sum { ADr } _i } _λ Smoothing to obtain smoothed data setAnd->

Data set smoothed by reference channelCalculating to obtain reference value S of reference channel _λ . In this embodiment, the reference value of the reference channel is the data set +.>Mean of the first 16 points, or data set +.>AD values of the intermediate segment after linear fitting.

The AD value data set of the light source lamp after the calibration of the test channel is calculated as follows:

in this embodiment, considering the attenuation of the test sample to the signal, adding the correction factor Fact on the basis of calculation, the formula is:

wherein the correction factor

Using the AD value data set { ADc } of the calibrated test channel light source lamp _i } _λ And (3) performing clinical result calculation such as coagulation or a rate method and the like, so as to obtain more accurate test results.

Referring to fig. 9 and 10, fig. 9 shows a trend of the AD value of the conventional optical measuring device without using the quality monitoring unit of the detection system, i.e., the reference channel, with a significant trend of decreasing the AD curve. Fig. 10 is an AD curve after calibration by the quality monitoring unit of the detection system, and it can be seen that the calibrated AD curve is flat, and the quality is improved.

The power supply system quality monitoring unit comprises an output voltage monitoring subunit arranged on each switching power supply of the high-flux sample analysis equipment and a voltage monitoring subunit arranged on the optical path detection system, and is used for converting the power supply voltage value of each shunt in the power supply system from analog quantity to digital quantity and monitoring the voltage of the power supply system. When the quality monitoring unit of the power supply system monitors unstable voltage or out of control voltage in the power supply system, an alarm is triggered in real time, a current execution project is marked, an operator is informed of the need of retesting the current execution project or checking a reaction curve of the current execution project, and the operator is prevented from outputting a report of low detection quality.

In summary, the quality monitoring module automatically calibrates each system by analyzing the quality condition of the device in real time when the high-throughput sample analysis device executes biological sample test, and notifies operators and maintenance engineers when deviation occurs, so as to avoid unqualified sample detection caused by quality problem of the device.

The data receiving and quality control module is connected with the quality monitoring module and comprises a data receiving unit and a data quality control unit, wherein the data receiving and quality control unit is used for receiving the quality data uploaded by the quality monitoring module, establishing corresponding quality control limit ranges for all quality monitoring points according to the quality data, and sending the quality control limit ranges of all the quality monitoring points to the quality monitoring module so that the quality monitoring module can judge the quality data according to the quality control limit ranges.

The data receiving unit is connected with the quality monitoring module and is used for receiving the quality data uploaded by the quality monitoring module. The quality data received by the data receiving unit comprises initialization quality data, test initialization quality data, periodic test quality data and daily maintenance quality data.

The data quality control unit is connected with the data receiving unit and is used for establishing corresponding quality control limit ranges for all the quality monitoring points according to the quality data received by the data receiving unit and sending the quality control limit ranges of all the quality monitoring points to the quality monitoring module so that the quality monitoring module can judge the quality data according to the quality control limit ranges. The data quality control unit comprises a quality control limit range establishment subunit, an operation diary monitoring subunit and a wearing part operation data statistics subunit.

The quality control limit range establishing subunit is configured to establish a quality control limit range of the quality data, such as a control range and an out-of-control range, by using a level-Jennings and Westgard multi-rule quality control method according to a reference value level and a fluctuation level of quality data of the motion quality monitoring unit, the liquid path quality monitoring unit and the power supply system quality monitoring unit in the quality monitoring module.

In this embodiment, the quality control limit range establishing subunit establishes an acceptable range of the quality data, a device operation quality in-control range, a quality early warning range and a runaway warning range by adopting a level-Jennings and Westgard multi-rule quality control method.

The quality control limit range establishment subunit can monitor the running quality change trend of the high-flux sample analysis equipment, reduce the occurrence of quality runaway condition of each monitoring point and improve the deviation detection capability of the monitoring points. And the transverse quality control of quality data among different equipment and among different material batches can be realized, the material batch quality monitoring is established, and the batch material quality is identified.

The operation diary monitoring subunit is used for receiving the quality data of the characteristic bit quality monitoring unit in the quality monitoring module and the operation data of each device in the high-flux sample analysis equipment, constructing a database, analyzing whether the high-flux sample analysis equipment has characteristic bit change or device function failure recently, leading to the change of the operation state of the high-flux sample analysis equipment, and outputting early warning information when the quality data exceeds a quality control limit range. For example, analyzing the fluid path pressure values of each monitoring point of the fluid path system, including but not limited to the pressure of the needle blocking sensor, the circulating fluid path pressure, and the waste fluid discharge fluid path pressure; and analyzing the AD value of the Peltier drive current, the rotating speed of the refrigerant pump, the motion precision deviation of each motor and the change condition of the adjustment data of the position coordinates of each characteristic bit.

The wearing part operation data statistics subunit is used for counting the total operation duration of wearing parts and the operation mileage of a transmission mechanism in the liquid path system, and generating time nodes of normal working condition period, wearing fatigue period and out-of-period operation of each wearing part and the quality index of each wearing part according to the characteristics of each wearing part. The longer the total duration of operation of the wearing parts, the greater the operating mileage of the driving machine components, and the lower the quality index thereof. The total operation time of the vulnerable parts in the liquid path system comprises, but is not limited to, the total operation time of the diaphragm pump and the circulating pump and the service time of the filter. The operating mileage of the driving machine component includes, but is not limited to, the total operating mileage of the linear guide rail, the total number of rotations of the collecting ring, and the total operating cycle number of the plunger pump.

The data output module is connected with the data receiving and quality control module and comprises a quality data output unit, a quality report printing unit and a quality data pushing inter-cloud unit. Fig. 11 is a flowchart of the data output module pushing quality data between clouds.

The quality data output unit outputs quality data in a billboard mode. Referring to FIG. 12, the signage output is a software interface signage output of several types of critical information, including but not limited to daily operational data statistics, recent maintenance and planning, instrument usage, and today's equipment index.

The daily operation data statistics comprise the number of daily operation samples, the number of projects, the number of daily use reaction cups and the like. The recent service conditions and plans include a previous service time and a service type, a next service time and a service type, wherein the service type includes regular service, quarterly service, and annual service. The instrument use condition comprises the total running time of equipment, total test items, total consumption of reaction cups and the like. The today's device index includes a quality index of the current high-throughput sample analysis device, a number of samples tested by the high-throughput sample analysis device on the day, a duration of on-time of the high-throughput sample analysis device on the day, and the like. The mass index of the current high-flux sample analysis device is a weighted average of the mass data of each mass monitoring point, the operation data of the current high-flux sample analysis device, the maintenance condition and the like, and the calculation formula is as follows:

Q＝Q ₁ P ₁ +Q ₂ P ₂ +…+Q _n P _n

wherein Q is the quality index of the high-throughput sample analysis device, Q _i For each quality monitoring pointQuality data, P _i For the weighting coefficients, i=1, 2, …, n, n is the total number of quality monitoring points.

The quality report printing unit is used for generating and outputting a stage quality report of the high-throughput sample analysis device in a printing mode, as shown in fig. 13, the quality report adopts conclusion type to illustrate the quality index of the device, the quality result of the device, the maintenance advice of the device and various quality indexes, and an operator or a maintenance engineer can quickly and comprehensively know the quality condition of the device and make a maintenance plan through the quality report.

The quality data pushing inter-cloud unit utilizes a wireless data transmission terminal to push the quality data of the high-flux sample analysis equipment to an inter-cloud system through a GPRS wireless network or an Internet public network. The quality data can be further analyzed by the inter-cloud system, and the transverse comparison analysis of the quality data among a plurality of analysis devices can be realized to analyze the batch quality difference of the high-flux sample analysis devices. Analyzing the quality data reported by each analysis device through a computer program of the inter-cloud system to rank the quality data of the device, and timely pushing the ranked device information to a maintenance engineer. The computer program of the inter-cloud system can also carry out batch management on high-flux sample analysis equipment, analyze whether obvious quality data differences exist among different batch equipment, and if the quality differences exist among batches, timely push relevant information to quality engineers or research and development engineers.

The quality data pushing inter-cloud unit can timely and effectively feed back the running state and maintenance advice of the equipment after the inter-cloud system processes the quality data through an analysis algorithm by pushing the quality data to the inter-cloud system, and the quality data is pushed to a maintenance engineer or a manufacturer to timely maintain the equipment, so that the running life of the high-flux sample analysis equipment is prolonged, or the manufacturer can timely find out the quality difference of material batches and timely formulate improvement measures.

Example two

Referring to fig. 14, based on the quality management system of the high-throughput sample analysis apparatus in the first embodiment, the present embodiment provides a quality management method of the high-throughput sample analysis apparatus, including the steps of:

when the high-flux sample analysis equipment operates, the quality monitoring module collects quality data of quality monitoring points;

the data receiving and quality control module receives the quality data of each quality monitoring point acquired by the quality monitoring module, establishes a quality control limit range corresponding to each quality monitoring point according to the quality data, and outputs a quality control chart of each quality monitoring point;

the quality monitoring module judges the quality data according to the quality control limit range established by the data receiving and quality control module, and outputs early warning information when the quality data exceeds the quality control limit range;

the data output module uploads the quality data to the inter-cloud system, the inter-cloud system analyzes the data, and the analysis result is pushed to the equipment maintenance engineer;

the maintenance engineer intervenes in advance to maintain the equipment;

the equipment reaches a good running state, and a quality report of the equipment is output by utilizing the data output module in the running process.

It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations and modifications of the present invention will be apparent to those of ordinary skill in the art in light of the foregoing description. It is not necessary here nor is it exhaustive of all embodiments. And obvious variations or modifications thereof are contemplated as falling within the scope of the present invention.

Claims (10)

1. A quality management system of a high throughput sample analysis apparatus, characterized in that a hardware architecture framework of an upper, middle and lower computer is adopted, comprising:

the quality monitoring module adopts distributed control boards, and each control board independently controls a plurality of stepping motors, a plurality of sensor signal input ports, a plurality of level output ports, a plurality of bidirectional input and output ports, an analog AD acquisition port and an RS485 communication port; the device is used for receiving control signals output by the upper computer and the middle computer, collecting quality data of all devices of the high-flux sample analysis equipment in operation, judging the quality data according to a quality control limit range, and outputting early warning information when the quality data exceeds the quality control limit range;

the host computer, with quality monitoring module communication connection, include:

the data receiving and quality control module is connected with the quality monitoring module and is used for receiving the quality data uploaded by the quality monitoring module, establishing corresponding quality control limit ranges for all quality monitoring points according to the quality data, and sending the quality control limit ranges of all the quality monitoring points to the quality monitoring module so that the quality monitoring module can judge the quality data according to the quality control limit ranges;

And the data output module is connected with the data receiving and quality control module and is used for uploading the quality data to the inter-cloud system, outputting the quality data and generating and outputting a quality report.

2. The quality management system of a high throughput sample analysis apparatus of claim 1, wherein said quality monitoring module comprises:

the motion quality monitoring unit is arranged on the mechanical arm of the high-flux sample analysis equipment and comprises a plurality of stepping motors, wherein each stepping motor is connected with a zero position sensor through a sensor signal input port; the motion quality monitoring unit is used for executing one-time automatic calibration of the stepping motor through the zero position sensor in each motion cycle process of the mechanical arm, obtaining the regression step number of the stepping motor,

taking the deviation of the actual regression step number and the theoretical step number as the quality data of the mechanical arm;

the characteristic bit quality monitoring unit is arranged on the mechanical arm of the high-flux sample analysis equipment and is used for automatically adjusting characteristic bits of the mechanical arm, taking adjusting parameters as quality data of the characteristic bits of the mechanical arm, establishing an adjusting parameter database and monitoring the change trend of the adjusting parameters;

The liquid path quality monitoring unit is arranged on a liquid path system of the high-flux sample analysis equipment and is used for monitoring liquid path pressure of each liquid path control point by using the needle blocking sensor and counting the running time of vulnerable parts in the liquid path system to be used as quality data of the liquid path system;

the refrigerating system quality monitoring unit is arranged on the refrigerating system of the high-flux sample analysis equipment and comprises a plurality of temperature sensors, wherein the temperature sensors are used for monitoring the temperature of the refrigerant liquid and the cooling fins and the reagent refrigerating temperature in real time;

the thermal system quality monitoring unit is arranged on the thermal system of the high-flux sample analysis equipment and is used for monitoring and automatically adjusting the temperature of the working area inside the high-flux sample analysis equipment;

the detection system quality monitoring unit comprises a reference channel, wherein the reference channel is connected with a detection channel of a detection system of the high-flux sample analysis equipment in parallel and comprises an independent optical fiber branch and an independent photoelectric detector silicon diode which are arranged on the detection system, and the reference channel is used for correcting an optical path AD value of the detection system;

the power supply system quality monitoring unit comprises an output voltage monitoring subunit arranged on each switching power supply of the high-flux sample analysis equipment and a voltage monitoring subunit arranged on the optical path detection system, and is used for converting the power supply voltage value of each shunt in the power supply system from analog quantity to digital quantity and monitoring the voltage of the power supply system.

3. The quality control system of a high-throughput sample analysis apparatus according to claim 2, wherein the detection system quality monitoring unit corrects an optical path AD value of a detection system, comprising:

the detection system quality monitoring unit acquires an AD data set of a light source lamp of a test channel in test time at a time interval of 0.1s to obtain three sets of data under a certain wavelength lambda: { AD _i } _λ 、{ADd _i } _λ Sum { ADr } _i } _λ The method comprises the steps of carrying out a first treatment on the surface of the Wherein { AD } _i } _λ Represents the ith AD value of the test specimen light source lamp at wavelength λ, { ADd _i } _λ An ith AD value representing the dark value of the test channel at wavelength λ, { ADr _i } _λ Reference channel light source lamp with wavelength lambdai AD values;

according to the smoothing parameter pair { AD _i } _λ 、{ADd _i } _λ Sum { ADr } _i } _λ Smoothing to obtain smoothed data setAnd->

Data set smoothed by reference channelCalculating to obtain reference value S of reference channel _λ ；

Calculating a data set { ADc { of AD values of the light source lamp after calibration of the test channel _i } _λ ：

4. A quality control system for a high throughput sample analysis apparatus according to claim 3, wherein the light source lamp AD value data set { ADc after calculation of test channel calibration _i } _λ The formula is:

wherein the correction factor

5. The quality management system of a high throughput sample analysis apparatus of claim 2, wherein said characteristic bit quality monitoring unit comprises:

The characteristic position adjustment subunit is arranged on the mechanical arm and is used for automatically adjusting the characteristic position of the mechanical arm in a mode that one surface is determined by three points and one line is determined by two points;

the characteristic position automatic calibration subunit is arranged on the mechanical arm with the sampling needle and is used for automatically calibrating the characteristic position of the mechanical arm by utilizing the principle of capacitance change detected by the liquid level of the sampling needle;

the characteristic position adjustment parameter checking subunit is arranged on the mechanical arm needing manual adjustment of the characteristic position and is used for checking the parameter rationality of the adjustment parameter of the characteristic position of the mechanical arm;

the characteristic bit adjustment parameter statistical analysis subunit is used for recording specific numerical values and update dates of the characteristic bit adjustment parameters of the characteristic bit adjustment subunit, the characteristic bit automatic calibration subunit and the characteristic bit adjustment parameter checking subunit, establishing a database for the characteristic bit adjustment parameters, and monitoring the change trend of the adjustment parameters.

6. The quality control system of a high-throughput sample analysis apparatus according to claim 2, wherein the refrigeration system quality monitoring unit further comprises a peltier driving current monitoring circuit disposed on the peltier for monitoring the magnitude of the peltier driving current and analyzing whether the peltier is damaged and its aging tendency.

7. The quality management system of a high throughput sample analysis apparatus of claim 2, wherein said refrigeration system quality monitoring unit further comprises:

a fan rotation speed monitoring subunit, which is arranged on a fan of the refrigeration system and used for monitoring the rotation speed of the fan,

and analyzing the quality trend of the fan;

the circulating pump monitoring subunit is arranged on a refrigerant circulating pump of the refrigerating system and used for monitoring the total running duration and the rotating speed of the refrigerant circulating pump and analyzing the quality trend of the refrigerant circulating pump.

8. The quality control system of a high throughput sample analysis apparatus of claim 2, wherein said thermal system quality monitoring unit comprises:

the temperature sensor is arranged above a testing area, an incubation area, a heating needle, a reaction cup arranging mechanism, a replenishing mechanism and an equipment internal working area of the high-flux sample analysis equipment and is used for monitoring the temperature of each area of the thermal system;

the heating subunit is arranged on the reaction cup arranging mechanism and the replenishing mechanism and is used for preheating the reaction cup;

the air inlet fan is arranged on the lower cabinet of the high-flux sample analysis equipment and used for adjusting the temperature of the working area inside the high-flux sample analysis equipment.

9. The quality management system of a high throughput sample analysis apparatus of claim 1, wherein said data receiving and quality control module comprises:

the data receiving unit is connected with the quality monitoring module and is used for receiving the quality data uploaded by the quality monitoring module; the quality data comprises initialization quality data, test initialization quality data, periodic test quality data and daily maintenance quality data;

the data quality control unit is connected with the data receiving unit and is used for establishing a corresponding quality control limit range for each quality monitoring point according to the quality data and sending the quality control limit range of each quality monitoring point to the quality monitoring module so that the quality monitoring module can judge the quality data according to the quality control limit range; the data quality control unit comprises:

the quality control limit range establishing subunit is used for establishing the quality control limit range of the quality data by adopting a level-Jennings and Westgard multi-rule quality control method according to the reference value level and the fluctuation level of the quality data of the motion quality monitoring unit, the liquid path quality monitoring unit and the power supply system quality monitoring unit in the quality monitoring module;

The operation diary monitoring subunit is used for receiving the quality data of the characteristic bit quality monitoring unit in the quality monitoring module and the operation data of each device in the high-flux sample analysis equipment and constructing a database;

and the wearing part operation data statistics subunit is used for counting the total operation duration of wearing parts in the liquid path system and the operation mileage of the transmission mechanism component, and generating time nodes of normal working condition period, wearing fatigue period and out-of-service operation of each wearing part and the quality index of each wearing part.

10. The quality management system of a high throughput sample analysis apparatus of claim 1, wherein said data output module comprises:

the quality data output unit is used for outputting quality data by adopting a billboard;

a quality report printing unit for generating and outputting a stage quality report of the high throughput sample analysis apparatus in a printed manner;

the quality data pushing inter-cloud unit is used for pushing the quality data of the high-flux sample analysis equipment to an inter-cloud system through a GPRS wireless network by utilizing the wireless data transmission terminal.