WO2016000216A1

WO2016000216A1 - Whole blood sample testing method and blood tester

Info

Publication number: WO2016000216A1
Application number: PCT/CN2014/081426
Authority: WO
Inventors: 郁琦; 谢子贤; 李朝阳; 代勇; 易秋实; 叶燚
Original assignee: 深圳迈瑞生物医疗电子股份有限公司
Priority date: 2014-07-01
Filing date: 2014-07-01
Publication date: 2016-01-07
Also published as: CN107656068A; CN107656085A; CN107656068B; CN107656085B; CN105378478B; CN113176417B; CN105378478A; CN113176417A

Abstract

A blood tester for whole blood sample testing, and whole blood sample testing method; blood routine parameters and CRP parameters of a single whole blood sample can be quickly measured on a single blood tester; a blood routine measurement module (1) and a CRP measurement module (2) are integrated on the same blood tester; in addition, the CRP measurement module (2) is provided with at least two measurement vessels (223), thus improving CRP parameter measurement efficiency, and quickly completing measurement of the blood routine parameters and CRP parameters of a plurality of whole blood samples.

Description

Whole blood sample detecting method and blood detecting instrument

The present invention relates to the field of blood detection and analysis, and particularly relates to a whole blood sample detecting method and a blood detecting instrument, which are used for supporting a single machine using a whole blood sample for routine blood cell detection and CRP detection. Background technique

Now, in the clinical diagnosis of hospitals, it is often necessary to obtain the blood routine parameters of the patient's blood and the test results of CRP (C-reactive protein) parameters.

In most existing blood testing instruments, blood routine counting and classification, blood testing and CRP testing are performed on different instruments using different types of samples. Blood cell counting and classification are generally performed on blood cell analysis using whole blood samples. CRP is measured on a biochemical analysis or a specialty protein analyzer using serum samples. Since blood routines and CRP are often used in combination in clinical practice, the hospital currently needs to collect two samples on the patient or increase the amount of blood collected, and test them on different machines. This causes great pain to the patient and needs to be detected on two machines, which is troublesome to check.

In order to solve the above problems, it is necessary to develop an instrument that uses the same whole blood sample to detect blood routine parameters and CRP parameters on one machine. Since these parameters are measured differently, multiple measurement channels are required to support measurements of different parameters.

Currently supporting single-machine products, whole blood samples can be used for blood routine parameter measurement and CRP parameter measurement, but the test speed is slow, and the maximum test speed is only 20 samples/hour, which cannot meet the efficiency requirements in clinical tests. Summary of the invention

The present application proposes a whole blood sample detecting method and a blood detecting instrument, which can use the same sample to quickly complete measurement of blood routine parameters and CRP parameters on the same machine.

According to a first aspect of the present application, the present application provides a blood tester comprising: a blood routine measurement module, a C-reactive protein measurement module, a sample collection and distribution module, a liquid path support module, and a control and information processing module;

The blood routine measurement module is configured to provide a measurement site for the assigned sample, perform measurement for the purpose of obtaining at least one blood routine parameter, and output the measurement result; c Reaction protein measurement module comprises: at least two measurement containers for providing a measurement site for the assigned sample, and at least one set of detection devices, at least one set of detection devices respectively performing samples in the measurement container to obtain C-reactive protein parameters For the purpose of measuring and outputting the measurement results;

The sample collection and distribution module is used for collecting whole blood samples, and assigning the collected samples to the blood routine measurement module and the C-reactive protein measurement module;

The liquid path support module provides liquid path support for the sample collection and distribution module and each measurement module; the control and information processing modules are respectively coupled to the sample collection and distribution module, each measurement module and the liquid path support module for controlling the sample collection And the distribution module collects the sample and the distribution sample, and the control liquid path support module performs fluid transportation, receives the measurement result output by each measurement module, and processes the measurement result.

According to a second aspect of the present application, the present application provides another blood tester comprising: a blood routine measurement module, a C-reactive protein measurement module, a sample collection and distribution module, a liquid path support module, and a control and information processing module;

The blood routine measurement module is configured to provide a measurement site for the assigned sample, perform a measurement for the purpose of obtaining at least one blood routine parameter, and output the measurement result;

The C-reactive protein measurement module is used to provide a measurement site for the assigned sample, a measurement for the purpose of obtaining the c-reactive protein parameter for the assigned sample, and a measurement result, and the C-reactive protein measurement module includes a plurality of measurement channels, each The measurement channel includes a measurement container; the sample collection and distribution module is configured to collect the whole blood sample, and distribute the collected sample to the blood routine measurement module and the C-reactive protein measurement module;

According to a third aspect of the present application, the present application provides a method for detecting a whole blood sample by a blood tester, including:

The sample collection step, the sample collection and distribution module collects the whole blood sample;

a sample distribution step of assigning the collected samples to the blood routine measurement module and the C-reactive protein measurement module; wherein, the samples assigned to the C-reactive protein measurement module are alternately allocated to the C-reactive protein measurement module according to a preset sequence One of the measuring containers;

The blood routine measurement step, the blood routine measurement module performs the assigned sample to obtain at least A blood routine parameter is the purpose of the measurement and outputs the measurement result;

The C-reactive protein measuring step, the C-reactive protein measuring module performs measurement for the purpose of obtaining c-reactive protein parameters on the assigned sample and outputs the measurement result.

According to the blood tester provided by the present application, on the one hand, since the blood tester combines the blood routine measurement module and the C-reactive protein measurement module, the measurement of the blood routine parameter and the CRP parameter can be performed on the same machine, avoiding twice. Or multiple sample collections, alleviating the patient's pain, and avoiding the blood routine parameters and CRP parameters must be measured on different machines, reducing the trouble of measurement; on the other hand, the C-reactive protein measurement module is configured with at least two measurement containers. / Multiple measurement channels, it is possible to improve the measurement efficiency of CRP parameters; Since the measurement time of CRP parameters is longer than the measurement time of blood routine parameters, the CRP parameter measurement efficiency is obtained when two measurements are continuously performed on multiple samples on a single machine. The improvement can effectively improve the overall measurement efficiency.

According to the detection method of the blood tester provided by the present application, each channel in the C-reactive protein measurement module is measured in turn, eliminating the influence of the measurement time of the CRP parameter longer than the 'J amount time of the blood routine parameter on the whole measurement efficiency. DRAWINGS

1 is a sectional view of a blood detector disclosed in Embodiment 1 of the present application; FIG. 2 is a block diagram showing the structure of a blood detector disclosed in Embodiment 1 of the present application; FIG. 3 is a C-reactive protein measurement of Embodiment 1 of the present application. Another structural block diagram of the module; FIG. 4 is a schematic diagram of a sample continuous measurement strategy according to Embodiment 1 of the present application;

5 is a schematic structural diagram of a sample collection and distribution module according to Embodiment 1 of the present application;

6a and FIG. 6b are schematic diagrams of sample allocation of a sample collection and distribution module according to Embodiment 1 of the present application;

6a is a schematic diagram of a sample size of a one-time collection of the embodiment 1 of the present application;

Figure 6b is a schematic view showing the sample size after the first allocation of the embodiment 1 of the present application;

7 is a top plan view of an automatic sample introduction module according to Embodiment 2 of the present application;

8 is a schematic diagram showing the structure of a latex reagent storage module according to Embodiment 3 of the present application;

Fig. 9 is a flow chart showing the method for detecting whole blood samples in the third embodiment of the present application. detailed description

In the embodiment of the present application, the CRP parameter measurement function and the blood routine measurement function are integrated into the same blood tester, and both the CRP measurement and the blood routine measurement use the whole blood sample, CRP measurement. The amount is obtained by first mixing a whole blood sample and a hemolytic agent, and then adding a latex reagent.这种 When using this measurement method, the measurement time of the CRP parameter is longer than the measurement time of the blood routine parameter. For example, for the same sample, the blood routine parameter measurement takes 1 minute, while the CRP parameter measurement takes 2 minutes, if the blood is completed. Waiting for CRP parameter measurement after measurement of conventional parameters will inevitably reduce the measurement speed of blood routine parameters. In order to quickly complete the measurement of the blood routine parameters and the CRP parameters on the same machine, in the embodiment of the present application, the C-reactive protein measurement module includes a plurality of measurement channels, and during the continuous measurement of the sample, the plurality of measurement channels are pre-processed. It is assumed that the samples are added in turn and measured. The present application will be described below in detail with reference to the accompanying drawings. Example 1:

Please refer to FIG. 1 and FIG. 2 for a structure of the blood tester disclosed in the embodiment. 1 is a schematic diagram of a three-dimensional structure of a blood detector, and FIG. 2 is a block diagram of a structure of a blood detector; the arrow line in FIG. 2 is an electrical signal direction, and the solid arrow line is a liquid path. The blood tester includes: a blood routine measurement module 1 (not shown in FIG. 1), a C-reactive protein measurement module (hereinafter also referred to as a CRP measurement module), a sample collection and distribution module 3, and a liquid path support module 8 ( The mark is not shown in Fig. 1 and the control and information processing module 9 (the mark is not shown in Fig. 1;). among them:

The blood routine measurement module 1 is for providing a measurement site for the assigned sample, and performing measurement for the purpose of obtaining at least one blood routine parameter for the assigned sample and outputting the measurement result. Referring to FIG. 1 , in a specific embodiment, the blood routine measurement module 1 can be further subdivided into various sub-measurement modules according to measurement needs: WBC classification measurement module 11, WBC/HGB measurement module 12, and RBC/PLT measurement module. 13. The WBC classification measurement module 11 is configured to provide a place for the assigned sample to complete the reaction, and measure the five-category result of obtaining the WBC; the WBC/HGB measurement module 12 is used to complete the measurement of the WBC (white blood cell) count and the morphological parameter. And the function of measuring HGB (hemoglobin, hemoglobin); RBC/PLT measurement module 13 is used to complete the measurement of RBC (red blood cell, red blood cell), PLT (blood platelet) and morphological parameters. It should be noted that each of the above sub-modules (11, 12, and 13) can be implemented by using existing measurement methods. In the actual blood routine measurement process, other blood routine measurement sub-modules can also be added, or the above-mentioned Some submodules.

The C-reactive protein measurement module 2 is for providing a measurement site for the assigned sample, and performing measurement for the purpose of obtaining the C-reactive protein parameter for the assigned sample and outputting the measurement result. Sample After being assigned to the C-reactive protein measurement module 2, the reaction is first carried out with the added hemolytic agent, and then the latex reagent is added to the reaction solution, and finally the photo-transmission amount or the light-scattering amount of the reaction solution added with the latex reagent is detected by photoelectric detection. And output the measurement results. In the present application, a facility for providing a sample from a reaction, a measurement to a measurement output is collectively referred to as a measurement channel, and a measurement channel generally includes: a reaction container that can provide a reaction site for the sample and the reagent, which can be realized as The reaction liquid provides a measurement container for the measurement site, and a detection device that can measure the reaction liquid in the measurement container and output the measurement result. In the specific implementation, the reaction container and the measuring container can also be combined into one, which can be used as a reaction site for samples and reagents, or as a measurement site for the reaction liquid.

In an embodiment of the present application, the C-reactive protein measurement module includes at least two measurement containers and at least one set of detection devices to implement a plurality of measurement channels, each measurement channel including a measurement container for providing the sample to be dispensed At the measurement site, the detecting device separately performs measurement for the purpose of obtaining the C-reactive protein parameter for the sample in the measuring container and outputs the measurement result. Since the C-reactive protein measurement is required, a whole blood sample, a hemolytic agent, and a latex reagent are mixed and reacted for a predetermined period of time. Thus in certain embodiments, the C-reactive protein measurement module comprises at least one reaction vessel, at least two measurement vessels, and at least one set of detection devices in communication with the measurement vessel for providing a reaction to the dispensed sample and reagent At the site, after the samples and reagents to be dispensed are reacted, they are distributed to the measuring container in a predetermined order for C-reactive protein measurement. In some embodiments, the reaction vessel and the detection device correspond to the measurement vessel, i.e., each measurement channel includes a reaction vessel, a detection device, and a measurement vessel. In a further embodiment, the reaction vessel and/or the detection device are not corresponding to the measurement vessel - for example, the number of reaction vessels and/or detection devices is less than the measurement vessel, and the reaction vessel and/or the detection device are subjected to multiple measurement channels Share. In this case, one measuring channel comprises a measuring vessel, a reaction vessel and/or a detection device shared with other measuring channels. In other specific embodiments, the C-reactive protein measurement module may also have no reaction vessel, and the measurement vessel provides both a reaction site and a measurement site.

The sample collection and distribution module 3 is used to collect whole blood samples, and distribute the collected samples to the blood routine measurement module 1 and the C reaction protein measurement module 2. When the reaction vessel includes the reaction vessel, the sample collection and distribution module 3 distributes the collected sample to the reaction vessel; when the reaction vessel is not included in the measurement channel, the sample collection and distribution module 3 assigns the collected sample to the sample Measure the valley.

The liquid path support module 8 provides fluid path support for the sample collection and distribution module and each measurement module. In a particular embodiment, the fluid path support module 8 typically includes: a valve, a pump, and/or a syringe In the blood tester, the transport function of transporting samples, reagents, and discharging waste liquid is mainly realized. The control and information processing module 9 is respectively coupled to the sample collection and distribution module 3, each measurement module and the liquid path support module 8, for controlling the sample collection and distribution module 3, collecting samples and distributing samples, and controlling the liquid path support module 8. The fluid is transported, the measurement results output by each measurement module are received, and the measurement results are processed. In this embodiment, the control and information processing module controls the sample collection and distribution module to distribute the samples collected each time to a measurement channel of the blood routine measurement module and the C-reactive protein measurement module according to a predetermined amount, and the measurement channel is based on the pre-measurement The rotation sequence is determined such that one of the plurality of measurement containers in the C-reactive protein measurement module obtains different distribution samples in a preset order of rotation.

The measurement of blood routine and C-reactive protein parameters is illustrated below by a specific structure of the C-reactive protein measurement module.

As shown in FIG. 1 , the C-reactive protein measurement module includes two measurement channels 21 and 22 , and a schematic diagram of a measurement channel of one of them is shown in FIG. 3 , and mainly includes a reaction container 221 , a sample transport line 222 , and a The measuring container 223, a detecting device, a CRP measuring cell waste liquid discharging mechanism 224, a reaction cell waste liquid discharging mechanism 225, a hemolytic agent transporting mechanism 226, the reaction container 221 and the measuring container 223 are controllably connected through the sample transporting line 222. The detecting device is a photodetector, and includes a light emitting end 227 and a light detecting end 228. In this embodiment, the light emitting end 227 is a light source for emitting light that can illuminate the reaction container, and the light detecting end 228 is a photoelectric sensor. Receiving transmitted light passing through the reaction vessel. In this embodiment, the light emitting end 227 and the light detecting end 228 are respectively disposed on opposite sides of the measuring container 223. The two measuring channels can use the same structure as described above, or different structures can be used. For example, there is no reaction vessel in the other measuring channel, and the reaction and measurement of the sample and reagent are completed in the measuring container. Those skilled in the art will appreciate that the scattered light passing through the measuring container can also be detected, and the position of the light emitting end and the light detecting end can be adjusted as needed.

The basic working principle is: After starting the measurement, the sample is placed on the sample suction position, and the sample collection and distribution module 3 is used for sample suction, and then the motion component on the sample collection and distribution module 3 is moved on each measurement module. The required samples are respectively allocated to corresponding measurement modules, such as CRP measurement module 1, WBC classification measurement module 1 1, WBC/HGB measurement module 12, and RBC/PLT measurement module 13. After each sample is assigned, the measurement module starts the measurement of the corresponding parameter. After the measurement is completed, it will be cleaned and enter the standby state, waiting for the start of the next measurement.

Since the CRP parameter measurement time of a single sample is longer than the blood routine parameter measurement time (2 minutes and 1 minute, respectively), 60 samples/hour can be achieved for simultaneous measurement of these two parameters. Test speed, this embodiment uses a dual-channel alternate measurement design of the CRP measurement module. The specific principle is as follows: The two independent CRP measurement channels, CRP first measurement channel 21 and CRP second measurement channel 22, are integrated to form a CRP measurement module 2. In the continuous measurement of the sample, each time the sample is collected, the sample of the collected sample is quantitatively distributed to all the blood conventional measurement modules and is assigned to one of the measurement channels in the CRP measurement module. For each blood measurement module, After the blood routine measurement of one sample is finished, the blood routine measurement of the next sample is started. For the two measurement channels of the C-reactive protein measurement module, the CRP measurement for each sample is alternated in sequence in two CRP measurement channels, and the CRP measurement process of the two assigned samples overlaps in time, thus enabling Each sample does not need to wait for the completion of the CRP parameter measurement of the current sample after completing the blood routine parameter measurement to initiate a blood routine measurement of the next sample. Finally, after each sample is measured by its own CRP parameters, the blood routine and CRP parameters are simultaneously output, and all the measurement results of one sample per minute are output, thereby improving the overall test speed to achieve a high test speed of 60 samples/hour. .

Please refer to Figure 4. Assume that the time taken for the CRP parameter measurement is 2 minutes, and the blood routine parameter measurement time is 1 minute. In Fig. 4, samples 1 to 8 are continuously collected samples to be measured, Omin indicates the measurement start time, and 1 min to 9 min indicates the elapsed time (min is the time unit, minute). The blood routine parameter measurements of the 8 samples were serially completed in the blood routine measurement module 1, and each sample took 1 minute. The CRP parameter measurements for samples 1 through 8 were alternated between CRP measurement channel 1 and CRP measurement channel 2, each sample taking 2 minutes. As shown in FIG. 3, the sample collection and distribution module 3 first assigns the sample 1 to the CRP first measurement channel 21 for CRP parameter measurement of the sample 1, and then the sample collection and distribution module 3 assigns the sample 2 to the CRP second. The measurement channel 22 performs the CRP parameter measurement of the sample 2, and then the sample 3 is assigned to the CRP first measurement channel 21, and then the sample 4 is assigned to the CRP second measurement channel 22 for CRP parameter measurement, and so on. The eight samples of the set are alternately assigned to the two measurement channels (the CRP first measurement channel 21 and the CRP second measurement channel 22) in a predetermined order with the distribution module 3. In the above process, the blood routine parameters of each sample are measured earlier than the CRP parameter lmin, but all the measurement results of the sample are output together when the CRP parameters are completed. Once the measurement is initiated, the entire measurement of the first sample (sample 1) is output after 2 minutes of the first sample measurement (2 minutes due to CRP parameter measurement), after which all measurements of one sample are output every 1 min. Of course, all measurements of the last sample should be output t=lmin after the blood routine parameter measurement, where t is the time taken by the CRP parameter measurement minus the time spent by the blood routine parameter measurement. It can be seen that if 60 samples are continuously measured, it can be output in about 60 minutes. The measurement results of all 60 samples were measured at a speed of approximately 60 samples/hour. It should be noted that the above examples are merely for facilitating the understanding of the technical solutions by those skilled in the art, and may not be considered as the entire content of the technical solution. For example, the measurement channel of the CRP parameter measurement may also be multiple, and the blood routine parameter measurement consumes. The time and CRP parameter measurement time can also be other time. In one embodiment, the sample collection and distribution module 3 includes a moving mechanism and a pick-up needle fixed to the moving mechanism, the moving mechanism driving the pick-up needle to move in the horizontal direction and the vertical direction. Please refer to FIG. 5 , which is a schematic structural diagram of an example of the sample collection and distribution module 3 in the embodiment. The sample collection and distribution module 3 includes: a fixed bracket 31, an X-direction guide 32, an X-direction transmission 33, a movable bracket 34, a Z-direction guide 35, a Z-direction transmission mechanism 36, a sample needle 37, and a swab 38. The fixing bracket 31 is connected to the fixing bracket of the detector. Of course, in other embodiments, the fixing bracket of the detector can be directly used instead; the movable bracket 34 passes through the X-direction guide 32, the X-direction transmission portion 33 and the fixing bracket 31. Forming a sliding connection such that the movable bracket 34 and the components mounted thereon can be moved in the X direction to form a moving mechanism, the power of which is from the X-direction transmission 33; the sampling needle 37 passes through the Z-direction guide 35, the Z-direction transmission mechanism 36 and the movable bracket 34 forms a sliding connection, so that the sampling needle 37 can move in the Z direction with respect to the movable bracket 34; the swab 38 functions to clean the outer wall of the sampling needle 37, and when the sampling needle 37 performs the Z-direction movement, the swab 38 passes through the liquid path supporting module. 8 Provide liquid cleaning of the outer wall of the sample needle while pumping away the liquid after washing.

The working principle of the sample collection and distribution module 3 is as follows:

1 sample set

The movable bracket 34 is moved to the sample suction position 49 by the driving of the X-direction transmission 33, and the sample needle 37 is moved downward through the Z-direction transmission mechanism 36 into the test tube of the sample suction position 49. At this time, the sampling needle 37 can be stored in the sample needle 37 through the power supplied by the liquid path support module 8 to take a preset quantitative sample, and the sample collection operation is completed.

2 Samples are cleaned after collection

After the sample collection is completed, a small amount of sample is inevitably adhered to the outside of the sample needle 37. When the sample needle 37 is raised, the swab 38 will clean the outer wall of the sample needle 37 to avoid the quantitative influence of the outer wall sample.

3 sample allocation

Driven by the X-direction transmission 33, the movable bracket 34 is moved above the corresponding measuring module; the pick-up needle 37 is moved downward into the measuring module by the Z-direction transmission 36. When the needle tip reaches the inside of the measurement module, the liquid path support module 8 provides power, and the sample stored inside the sample needle 37 is quantitatively pushed out, added to the measurement module, and the sample distribution is completed. Work.

It should be noted that the Z direction is a vertical direction and the X direction is a horizontal direction. In other embodiments, the horizontal direction may also be a Y direction, or an X direction and a Y direction, for example, in the X direction and Y. The direction of the drive rail is increased, and the Y-direction transmission device can be added to realize the movement of the moving mechanism (such as the movable bracket 34) in the X direction and the Y direction; for example, the X-direction transmission 33 can also be rotated by the horizontal plane. Device replacement.

In a preferred embodiment, each of the blood routine measurement module 1, the C-reactive protein measurement module 2, and the sample suction position 49 are arranged along the horizontal movement of the sample needle 37. The sample suction position 49 is preferably set at a position near the start end of the horizontal movement path of the sample needle.

In a preferred embodiment, the sample collection and distribution module 3 sample collection and distribution module collects samples once and then distributes them to each of the blood routine measurement module 1 and the C-reactive protein measurement module 2. Referring to FIG. 6a and FIG. 6b, since the sample size required for each item measurement in the blood routine measurement module 1 and the C-reactive protein measurement module 2 is determined, the sample collection and distribution module 3 can be measured according to each module. The sample size is collected once. Assume that in a clinical test, blood routine parameter measurement needs to measure two items (such as WBC classification project and WBC/HGB measurement project), respectively, the sample size is VI and V2, and the sample size required for CRP parameter measurement is V3, then the sample釆 Set and Assignment Module 3—The sample size of the secondary acquisition is greater than or equal to V1+V2 +V3, as shown in Figure 6a. Then, the sample collection and distribution module 3 is assigned to each measurement container in accordance with the sample size required for each of the blood routine measurement module 1 and the C-reactive protein measurement module 2. For example, a sample of VI is assigned to the measurement container of the WBC classification project, and the sample of V2+V3 remains in the sample collection and distribution module 3, as shown in FIG. 6b; the sample collection and distribution module 3 will remain. The two samples of the V2+V3 are assigned to the measurement containers for the WBC/HGB measurement items and CRP parameter measurements. In other embodiments, depending on the needs of the measurement item, it is also possible to divide into more segments, or to reduce the number of segments.优点 The advantage of assigning samples in this way is that it is not necessary to collect the samples in each measurement container one by one, and the method of collecting samples at one time is more time-saving than the method of collecting samples multiple times, and the measurement efficiency is improved. Further, in order to avoid cross-contamination of samples assigned to different measurement containers, there is a predetermined volume of discarded samples between the two samples. After discarding the sample that comes into contact with the reagent, the sample can be prevented from affecting the measurement result of the next measurement module, and the sample used by two adjacent measurement modules is not cross-contaminated.

When CRP is measured, the hemolytic agent is driven by the liquid path support module 8 to introduce the hemolytic agent into the CRP reaction vessel through the hemolytic agent transport mechanism, and reacts with the blood sample and the latex reagent added later in the CRP reaction vessel, and then Transport samples to CRP via sample transport lines In the measuring container, the light detecting end detects the light emitted by the light emitting end and passing through the CRP measuring container and the sample liquid; after the reaction container and the measuring container are completed, the waste liquid is respectively reacted by the liquid path supporting module. The container waste discharge mechanism and the measurement container waste discharge mechanism respectively discharge the CRP reaction container and the CRP measurement container. When the hemolytic agent is delivered to the reaction vessel, unlike the prior art sputum delivery method, the hemolytic agent is added to the reaction vessel by a special hemolytic agent transport line in the present embodiment, the purpose of which is to save The measurement time of the CRP is increased by the time taken by the sample needle to pick up and dispense the reagent, thereby further improving the overall test speed.

Each measurement module is cleaned after the measurement is completed and before the next sample measurement begins. In other embodiments, the plurality of measurement channels in the C-reactive protein measurement module can share a reaction vessel, and the reaction vessels are controllably connected to different measurement vessels through different sample transport conduits. The detecting device may also be shared. For example, a C-reactive protein measuring module is provided with an optional ring mechanism, and a plurality of measuring containers are arranged in a row on the ring mechanism.

The C-reactive protein measurement module may have only one detecting device, and the detecting device is disposed on the rotating path of the ring mechanism, and the measuring container rotates with the ring mechanism, passes through the detecting device one by one and stops for detecting, and the detecting device stops in the detecting region thereof. The reaction liquid in the measuring container is tested.

The blood detector disclosed in the embodiment can effectively use the waiting time of the C-reactive protein measurement time by using a whole blood sample for routine blood cell detection and CRP detection by setting a plurality of measurement channels in the C-reactive protein measurement module. The blood cells of the sample are routinely tested, so that the blood routine parameter measurement and the C-reactive protein measurement of each sample can work together, and the blood routine parameter measurement and the C-reactive protein measurement time are coordinated, and the measurement speed is improved. Example 2:

The embodiment of the present invention differs from the above embodiment in that the blood detector disclosed in the embodiment further includes an automatic sample introduction module 4, as shown in FIG. 1, the automatic sample introduction module 4 provides continuous samples for the sample collection and distribution module 3 and The sample loading and unloading is completed, and the autosampler module 4 is preferably disposed at the front end of the blood tester. Please refer to FIG. 7 , which is a schematic view of the auto-injection module, which mainly includes: a test tube rack transport mechanism 41 , a load position detecting mechanism 42 , a test tube rack loading mechanism 43 , a test tube rack unloading mechanism 44 , a test tube presence detecting mechanism 45 , and a test tube barcode information . Acquisition agency 46. The working process is: the test tube rack transporting portion 41 transports the test tube rack in which the test tube is placed in the X direction to the loading area 410. When the loading position detecting mechanism 42 detects that the test tube rack is in place, the test tube rack loading mechanism 43 places the test tube rack in the Y direction. The test tube rack moves the test tube in sequence according to the test tube position on the test tube rack The rack enters the test tube position 47, the sample mix check position 48 and the sample suction position 49; when each test tube placement position on the test tube rack reaches the test tube detection position 47, the test tube presence detecting mechanism 45 detects whether there is a test tube at the position, and The test tube barcode information acquisition mechanism 46 scans the barcode on the test tube; if a test tube is detected, when the test tube at the position moves to the 48 sample mixed position, the test tube is mixed by the mixing module in the device, and then moved. When the sample suction position is 49, the sample collection is performed by the sample collection and distribution module 3; when the last test tube position of the entire test tube holder is moved out of the sample suction position 49, the test tube rack unloading mechanism 44 moves the test tube holder in the opposite direction of the X direction. Pushing into the unloading zone 411 completes the unloading of the entire test tube rack sample.

In summary, the workflow of the entire autosampler module 4 is as follows:

1 Place the test tube and the test tube rack to start the automatic sample introduction procedure;

2 The test tube is transported to the loading position with the test tube rack;

3 The test tube rack is loaded, and the test tube is sequentially moved into the test tube position 47, the sample mixed position 48 and the sample suction position 49;

4 In the test tube test position 47, check whether there is a test tube. When a test tube is detected, scan the test tube barcode;

5 In the sample mixing check box 48, if there is a test tube, the sample is mixed, otherwise it will be directly moved into the sample suction position 49;

6 in the sample suction position 49: If there is a test tube, the sample is taken;

7 If the current sample is in the last tube position of the current tube rack, the tube rack is unloaded.

In a specific embodiment, the sample suction position 49 should preferably be set at the beginning of the horizontal movement path of the sampling needle.

In a preferred embodiment, the X direction of the autosampler module 4 should coincide with the X direction of the sample set and dispense module 3.

The blood detector disclosed in the embodiment improves the automation degree of the blood detector by adding the automatic sample introduction module 4, and is more conducive to the management of the sample (especially the large number of samples), thereby further improving the blood routine and CRP of the whole blood sample. The overall measurement speed of the parameter. Example 3:

The blood detector disclosed in this embodiment further includes a latex reagent storage module 5, as shown in FIG. 1, the latex reagent storage module 5 is used to provide a cryopreservation environment for the latex reagent, and a latex reagent. The storage module 5 is disposed at a position of the blood detector that is closer to the edge of the detector and away from the inside. Set the latex reagent storage module 5 away from the inspection The advantage of the position inside the tester is that it not only facilitates the replacement of the latex reagent, but also prevents the user from reaching the inside of the instrument when replacing the latex reagent, reducing the risk of bio-contamination of the user.

In a preferred embodiment, referring to FIG. 7, the latex reagent storage module 5 can be disposed between the sample loading area 410 and the sample unloading area 411 of the auto-injection module 4 to facilitate sharing the sample with the latex reagent and the sample. And simplify the movement of the needle.

In a specific embodiment, referring to FIG. 8, the latex reagent storage module 5 includes: a cooling mechanism 51 and a cold chamber door 52.

The refrigeration unit 51 has a refrigeration chamber 53 inside and an opening 54 on the side for providing a low temperature for the latex reagent.

The cold chamber door 52 is configured to close the refrigerating chamber from the side opening of the refrigerating chamber, and the side of the cold chamber door facing the refrigerating chamber is provided with a latex reagent placement position 50, and the cold chamber door can expose the latex reagent placement position under the force state. The outside of the meter or the latex reagent placement position is enclosed in the refrigeration compartment.

In a specific embodiment, the cold chamber door and the refrigerating mechanism are of a split structure, and the cold chamber door can be pushed away from the refrigerating chamber by being pushed and pulled and/or inverted, and exposed outside the measuring instrument or close to the refrigerating chamber outside the measuring instrument and closed for cooling. room. For example, the cold chamber door 52 can be away from the refrigerating chamber and exposed outside the measuring instrument under the force state. At this time, the cold chamber door 52 is in an open state, so that the user can contact the latex reagent placing position 50; the cold chamber door 52 is subjected to the opposite force. Under the action of the meter, the outside of the measuring instrument is close to the refrigerating chamber and the refrigerating chamber is closed. At this time, the latex reagent placing position 50 is located in the cavity of the refrigerating chamber.

In a preferred embodiment, the blood tester can further include an emergency sample placement position 55 disposed on a side of the cold chamber door 52 facing away from the refrigeration chamber. At this point, the emergency sample placement 55 will be exposed to the outside of the blood tester prior to the latex reagent placement 50. The starting point for this design is that in clinical testing, the frequency of adding emergency samples to the blood tester is higher. Add/replace latex reagents to the blood tester and use this design to facilitate the measurement of emergency samples.

The following is an example of measuring the blood routine parameters and CRP parameters of a whole blood sample by two consecutive samples (sample 1 and sample 2), wherein the blood routine measurement module includes a WBC classification measurement module, a WBC/HGB measurement module, and an RBC/ For example, the PLT measurement module is shown in Figure 9. The flow is as follows:

Step 1. Start the measurement, sample 1 Autosample and mix. When the measurement is started, the auto-injection module 4 completes the sample 1 injection, the presence or absence of the test, the tube barcode information acquisition, and the sample mixing according to the workflow described in the second embodiment.

Step 2. Sample 1 is taken. When the test tube reaches the sample suction position 49, the sample is collected and divided. The matching module 3 is driven by the X-direction transmission 33, moves the moving mechanism (such as the movable bracket 34) to the sample suction position 49, and moves the sample needle 37 downward through the Z-direction transmission mechanism 36 into the test tube of the sample suction position 49. The sample required for blood routine parameters and CRP parameter measurement is aspirated into the sample needle 37. The sample needle is raised to the initial height by the drive of the Z-direction transmission mechanism 36, and the swab 38 cleans the outer wall of the sample needle 37.

Step 3. Add CRP hemolytic agent to CRP measurement channel 1. The liquid path support module 8 provides power to add the CRP hemolytic agent to the CRP measurement channel 1 in the C-reactive protein measurement module 2.

Step 4. CRP measurement channel 1 blood. Driven by the X-direction transmission 33, the movable bracket 34 is moved over the CRP measuring channel 1, and the sampling needle 37 is moved downward through the Z-direction transmission mechanism 36 into the CRP measuring channel 1, and the blood sample required for CRP measurement is added. Blood samples are added to the CRP measurement channel 1 and sample hemolysis begins, ready for subsequent CRP measurements. The needle is raised to the initial height by the drive of the Z-direction transmission mechanism 36, and the swab 38 cleans the outer wall of the sampling needle 37.

Step 5. The WBC classification measurement module divides the blood. Driven by the X-direction transmission 33, the movable bracket 34 is moved over the WBC sorting measurement module 11, and the pick-up needle 37 is moved down to the WBC sorting measurement module 11 by the Z-direction transmission mechanism 36 to perform blood separation and start WBC classification measurement. . After the blood splitting is completed, the sampling needle 37 is raised to the initial height by the drive of the Z-direction transmission mechanism 36, and the swab 38 cleans the outer wall of the sample needle 37.

Step 6. The WBC/HGB measurement module divides the blood. Driven by the X-direction transmission 33, the movable bracket 34 is moved over the WBC/HGB measuring module 12, and the pick-up needle 37 is moved downward through the Z-direction transmission mechanism 36 into the WBC/HGB measuring module 12 to the module and the RBC/ The PLT measurement module 13 measures the distribution of the desired blood sample therein.

Step 7. Draw the sample diluted in the WBC/HGB measurement module 12 and assign it to the RBC/PLT measurement module 13. After the blood sample has been diluted, the fluid path support module 8 provides power to draw the partially diluted sample of the WBC/HGB measurement module 12 into the sample needle 37. The boring needle 37 is raised to the initial height by the driving of the Z-direction transmission mechanism 36, and then the X-direction transmission 33 drives the movable bracket 34 to move over the RBC/PLT measuring module 13, and the boring needle 37 is turned by the Z-direction transmission mechanism 36. Move down to the RBC/PLT measurement module 13 for blood splitting and initiate RBC and PLT measurements. After the blood separation is completed, the sample needle 37 is raised to the initial height by the driving of the Z-direction transmission mechanism 36, and the swab 38 cleans the outer wall of the sample needle 37.

Step 8. Add a hemolytic agent to the WBC/HGB measurement module 12. The fluid path support module 8 adds the hemolytic agent to the WBC/HGB measurement module 12 to initiate WBC and HGB measurements. Step 9. Pipette the latex reagent. The X-direction transmission 33 drives the movable bracket 34 to move over the latex reagent storage module 5, and moves the sample needle 37 downward into the latex reagent storage module 5 through the Z-direction transmission mechanism 36 to suck the latex reagent into the sample needle 37. . The sample needle 37 is raised to the initial height by the drive of the Z-direction transmission mechanism 36, and the swab 38 cleans the outer wall of the sample needle 37.

Step 10. Add the latex reagent to the CRP measurement channel 1. The X-direction transmission 33 drives the movable bracket 34 to move over the C-reactive protein measurement module 2, and moves the sample needle 37 down to the CRP measurement channel 1 through the Z-direction transmission mechanism 36 to add the latex reagent therein, and simultaneously initiates the CRP measurement.

Step 11. Clean the WBC classification measurement module 11, the WBC/HGB measurement module 12, and the RBC/PLT measurement module 13. After the WBC classification measurement module 11, the WBC/HGB measurement module 12, and the RBC/PLT measurement module 13 complete the respective measurements of the sample 1, the liquid path support module 8 transports the reagents to the corresponding measurement modules and completes the cleaning.

Step 12. Sample 2 Autosample and mix, sample 2 draw. Repeat steps 1 and 2 to process sample 2.

Step 13. Add CRP hemolytic agent to CRP measurement channel 2. The liquid path support module 8 provides power to add the CRP hemolytic agent to the CRP measurement channel 2 of the C-reactive protein measurement module 2.

Step 14. CRP measurement channel 2 points of blood. The X-direction transmission 33 drives the movable bracket 34 to move over the CRP measurement channel 2, and moves the sample needle 37 down to the CRP measurement channel 2 through the Z-direction transmission mechanism 36, and adds the blood sample required for CRP measurement. Sample blood hemolysis begins after the blood sample is added to the CRP measurement channel 2, ready for subsequent CRP measurements. The sample needle 37 is raised to the initial height by the Z-direction transmission mechanism 36, and the swab 38 cleans the outer wall of the sample needle 37.

Step 15. Sample 2 Blood is routinely measured and the latex reagent is aspirated. Repeat steps 5 through 9. Step 16. Add the latex reagent to the CRP measurement channel 2. The X-direction transmission 33 drives the movable bracket 34 to move over the C-reactive protein measurement module 2, and moves the sample needle 37 down to the CRP measurement channel 2 through the Z-direction transmission mechanism 36 to add the latex reagent therein, and simultaneously initiates the CRP measurement.

Step 17. Clean the WBC classification measurement module 11, the WBC/HGB measurement module 12, and the RBC/PLT measurement module 13. Repeat step 11 after completing the sample 2 blood routine measurement.

Step 18. Clean the C-reactive protein measurement module 2. Since the CRP measurement time is longer than the blood routine measurement time, after waiting for the blood of the sample 2 to complete the measurement, the sample in the CRP channel 1 This 1 completes the CRP measurement, at which time the liquid path support module 8 initiates the cleaning of the CRP measurement channel 1. After another 1 minute, the CRP measurement channel 2 completes the measurement of the sample 2, and the liquid path support module 8 initiates the cleaning of the CRP measurement channel 2.

So far, the measurement of blood routine parameters and CRP parameters of the whole blood samples of the two consecutive samples was completed.

The present application has been described with reference to specific examples, and is merely used to help the understanding of the application and is not intended to limit the application. Variations to the above-described specific embodiments may be made by those skilled in the art in light of the concept of the present application.

Claims

Rights request

A blood tester comprising:

a blood routine measurement module, configured to provide a measurement site for the assigned sample, perform a measurement for the purpose of obtaining at least one blood routine parameter, and output the measurement result;

a C-reactive protein measurement module, the C-reactive protein measurement module comprising: at least two measurement containers for providing a measurement site for the dispensed sample, and at least one set of detection devices, the at least one set of detection devices respectively for the measurement container The sample in the measurement is performed for the purpose of obtaining the c-reactive protein parameter and outputs the measurement result;

a sample collection and distribution module for collecting whole blood samples, and assigning the collected samples to a blood routine measurement module and a C-reactive protein measurement module;

The liquid path support module provides liquid path support for the sample collection and distribution module and each measurement module; the control and information processing modules are respectively coupled to the sample collection and distribution module, each measurement module and the liquid path support module for controlling the sample The collection and distribution module collects samples and allocates samples, and controls the liquid path support module to perform fluid delivery, receives measurement results output by each measurement module, and processes the measurement results.

2. The blood test apparatus according to claim 1, wherein the C-reactive protein measurement module further comprises at least one reaction container for providing a reaction site for the dispensed sample and reagent, the reaction container and the measurement container, respectively. Connected.

3. The blood test apparatus according to claim 1, wherein the number of the reaction container, the measuring container, and the detecting device are the same, each measuring container is in communication with a corresponding reaction container, and is performed by a corresponding detecting device. measuring.

The blood tester according to any one of claims 1 to 3, wherein the plurality of measuring containers in the C-reactive protein measuring module obtain different dispensing samples one by one in a preset order of rotation.

The blood detector according to any one of claims 1 to 4, wherein the control and information processing module controls the sample collection and distribution module to collect the samples after collecting the samples each time. The segment is assigned to one of the blood measurement module and the C reaction protein measurement module.

6. A blood tester, comprising:

C-reactive protein measurement module, which is used to provide a measurement site for the sample to be dispensed, and to perform measurement for the purpose of obtaining the C-reactive protein parameter of the assigned sample and output the measurement result. The c-reactive protein measurement module includes a plurality of measurement channels, each of which includes a measurement container;

7. The blood test apparatus according to claim 6, wherein the control and information processing module controls the sample collection and distribution module to distribute the samples collected each time to a blood routine measurement module and C according to a predetermined amount. A measurement channel of the reaction protein measurement module, the measurement channel being determined according to a preset sequence of rotations.

8. The blood test apparatus according to claim 7, wherein each of the measurement channels further comprises:

a reaction vessel, the reaction vessel being in communication with the measurement vessel for receiving a sample dispensed by the sample collection and distribution module;

A detecting device comprising a light emitting end for emitting light illuminable to the reaction vessel, and a light detecting end for receiving light passing through the reaction vessel.

9. A blood test apparatus according to claim 4 or claim 7 wherein the C-reactive protein measurement module has a time overlap at least during the measurement of the two dispensed samples.

The blood tester according to any one of claims 1 to 9, further comprising an automatic sample introduction module, wherein the automatic sample introduction module automatically provides continuous samples for the sample collection and distribution module and completes The sample is loaded and unloaded, and the autosampler module is disposed at the front end of the blood tester.

1 . The blood test apparatus according to claim 10, wherein the sample collection and distribution module comprises a moving mechanism and a pick-up needle fixed on the moving mechanism, and the moving mechanism drives the pick-up needle in a horizontal direction. And move in the vertical direction.

12. The blood test apparatus according to claim 1, wherein the sample suction position of each of the blood routine measurement module, the C-reactive protein measurement module, and the auto-injection module moves along a horizontal direction of the sample needle. Arrangement.

The blood tester according to any one of claims 1 to 9, wherein A latex reagent storage module is included, the latex reagent storage module is configured to provide a cryopreservation environment for the latex reagent, and the latex reagent storage module is disposed at a position of the blood detector closer to the edge of the detector and away from the interior.

14. The blood test apparatus according to claim 10, further comprising a latex reagent storage module, wherein the latex reagent storage module is configured to provide a cryopreservation environment for the latex reagent, and the latex reagent storage module is set in an automatic manner. Between the sample loading area and the sample unloading area of the injection module.

The blood tester according to claim 13 or 14, wherein the latex reagent storage module comprises:

a refrigeration mechanism having a refrigeration chamber inside and an opening on the side;

a cold chamber door for closing a refrigerating chamber from a side opening of the refrigerating chamber, wherein a side of the cold chamber door facing the refrigerating chamber is provided with a latex reagent placement position, and the cold chamber door can place the latex reagent under stress The position is exposed outside the measuring instrument or the latex reagent placement position is closed to the refrigeration chamber.

16. The blood test apparatus according to claim 15, wherein the cold chamber door and the refrigerating mechanism are of a split structure, and the cold chamber door is remote from the refrigerating chamber and exposed by means of pushing and/or flipping. The outside of the measuring instrument or the outside of the measuring instrument is close to the cooling chamber and closes the cooling chamber.

17. The blood test apparatus according to claim 16, further comprising an emergency sample placement position, the emergency sample placement position being disposed on a side of the cold chamber door facing away from the refrigeration chamber.

The blood test apparatus according to any one of claims 1 to 17, wherein the liquid path supporting module comprises a hemolytic agent delivery line, and the hemolytic agent delivery line is in communication with the C-reactive protein measuring module.

19. The method of detecting a whole blood sample by a blood tester according to claim 1 or 6, comprising:

a sample distribution step of allocating the collected samples to the blood routine measurement module and the C-reactive protein measurement module, wherein the sample assigned to the C-reactive protein measurement module is alternately allocated to the C-reactive protein measurement module according to a preset sequence One of the measuring containers;

a blood routine measurement step, the blood routine measurement module performs a measurement for the purpose of obtaining at least one blood routine parameter on the assigned sample and outputs the measurement result;

20. The method according to claim 19, wherein in the sample allocation step, The sample collection and distribution module collects the samples once and then distributes them to the blood routine measurement module and the c-reactive protein measurement module.

The method according to claim 19 or 20, wherein in the blood routine measurement step, the blood routine measurement of the next sample is started after the blood routine measurement of one sample is ended, in the C-reactive protein measurement step. There are at least two measurement processes for assigning samples that overlap in time.

22. The method of claim 21, wherein each measurement module is cleaned after the measurement is completed and before the next sample measurement begins.

23. The method according to claim 19 or 20, wherein the blood routine measurement module comprises a WBC classification measurement module, a WBC/HGB measurement module, and an RBC/PLT measurement module, and for each sample, the sample allocation step includes :

The liquid path supporting module inputs the hemolytic agent into the measuring container selected in the C-reactive protein measuring module according to the preset order;

The sample collection and distribution module allocates a quantitative sample to the selected measurement container in the C-reactive protein measurement module by alternately distributing the samples in a preset order;

The sample collection and distribution module allocates quantitative samples to the WBC classification measurement module; the sample collection and distribution module allocates quantitative samples to the WBC/HGB measurement module; the sample collection and distribution module absorbs the diluted samples of the WBC/HGB measurement module and distributes them. To the RBC/PLT measurement module;

The liquid path support module adds a hemolytic agent to the WBC/HGB measurement module;

The sample collection and distribution module draws the latex reagent;

The sample collection and distribution module adds latex reagents to the measurement vessels selected for the sequential distribution of samples in a predetermined sequence.