CN110892245A - Sample analyzer and sampling monitoring method - Google Patents
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Abstract
A sampling unit (100) of the sample analyzer comprises a sample suction needle (10), a pipeline (20) and a pressure sensor (40), wherein the sample suction needle (10) sucks a sample, the pipeline (20) is communicated with the sample suction needle (10), and the pressure sensor (40) is communicated with the pipeline (20) and used for monitoring the pressure of the pipeline (20) in the sampling process. The pressure of the pipeline (20) in the sampling process is monitored through the pressure sensor (40), and whether abnormity occurs in the sampling process is judged.
Description
The invention relates to the field of medical instruments, in particular to a sample analyzer and a sampling monitoring method.
A sample analyzer such as a blood cell analyzer is widely known, which includes a sampling device for sampling a blood sample from a test tube container, and an analyzing device for analyzing the sampled blood sample. Typically, the sampling device also has the function of monitoring whether a blood sample is being drawn properly.
In a conventional sampling device, a first liquid sensor and a second liquid sensor are provided on both sides of a sampling and sorting valve of a quantitative pipette, and whether or not a sample is normally sampled is monitored by whether or not the sensor detects the sample after the pipette has sampled the sample. However, the sampling device must use a sampling valve to measure the sample. The sampling and sample dividing valve is suitable for dividing a sample into a plurality of equal parts at the same time, is expensive, and has a flow path from the pipette to the sampling and sample dividing valve, so that a large amount of sample (self consumption) which is not used for analysis is wasted.
In another sampling device, a light-transmitting portion and a light-blocking portion are alternately provided at regular intervals in the longitudinal direction of a pipette to check the liquid amount. The pipette for liquid amount confirmation is made of a transparent material such as quartz glass or hard transparent glass, and has a surface on which aluminum foil or the like is sprayed at a predetermined interval in the longitudinal direction, and a light receiving device receives light emitted from a light emitting device transmitted through the pipette to confirm the liquid amount. However, materials such as quartz glass and hard transparent glass are difficult to be precisely machined, and it is difficult to meet the pipette machining accuracy requirement.
Disclosure of Invention
In view of the above, it is necessary to provide a sample analyzer and a sampling monitoring method with low cost, high precision and high reliability, in order to overcome the above-mentioned shortcomings in the prior art.
A sample analyzer comprising a sampling unit, the sampling unit comprising:
a sample sucking needle having a needle head and a needle tail, the needle head being inserted into the sealed container to draw a sample; the pipeline is communicated with the needle tail of the sample sucking needle; and
and the pressure sensor is communicated with the pipeline and used for monitoring the pressure of the pipeline in the sampling process.
In one embodiment, the sample sucking device further comprises a power source which is communicated with the pipeline and provides power for the sample sucking needle to suck a sample.
In one embodiment, the pressure sensor is located at the power source.
In one embodiment, the pressure sensor is located at the sample aspirating needle.
In one embodiment, the sample analyzer further comprises a first switching piece and a second switching piece, the pipeline comprises a first pipeline and a second pipeline, the first pipeline is connected between the needle tail of the sample suction needle and the first switching piece, the second pipeline is connected between the first switching piece and the second switching piece, the first switching piece is used for communicating or cutting off the first pipeline and the second pipeline, and the second pipeline is connected to a negative pressure source or the atmosphere through the second switching piece.
In one embodiment, the second switching member includes a first port, a second port, and a third port, the first port is connected to the second pipeline, the second port is connected to the negative pressure source, the third port is connected to the atmosphere, and the second switching member is capable of communicating the first port with the second port or communicating the first port with the third port.
In one embodiment, the second switch includes:
the two ends of the first sub-switching piece are respectively connected with the second pipeline and the negative pressure source, and the first sub-switching piece is used for communicating or cutting off the second pipeline and the negative pressure source; and
and two ends of the second sub-switching piece are respectively connected with the second pipeline and the atmosphere, and the second sub-switching piece is used for communicating or cutting off the second pipeline and the atmosphere.
In one embodiment, the sample sucking needle is provided with a gas release channel, and the gas release channel is used for communicating the sealed container with the atmosphere.
In one embodiment, the air release channel is an air release groove arranged on the outer side wall of the sample suction needle. In one embodiment, the device further comprises a sample preparation unit, a detection unit and a control unit, wherein the sampling unit sucks a sample and provides the sample to the sample preparation unit, the sample preparation unit reacts the sample with a reagent to generate a sample, the detection unit measures the sample and obtains a detection result, and the control unit controls the sampling unit, the sample preparation unit and the detection unit.
In one embodiment, the control unit comprises a storage module, a comparison module and an execution module, wherein the storage module stores a threshold pressure range of the pipeline in the sampling process, the comparison module compares whether the pressure in the pipeline monitored by the pressure sensor in the sampling process is within the threshold pressure range, and the execution module controls the sampling unit, the sample preparation unit and the detection unit according to a comparison result of the comparison module.
In one embodiment, the control unit controls the sample sucking needle to puncture the closed container to deflate the closed container, and if the pressure of the pipeline after puncture is within a threshold pressure range, the control unit controls the sampling unit to sample, controls the sample preparation unit to prepare a sample, and controls the detection unit to measure and output a detection result.
In one embodiment, if the pressure of the pipeline after puncture is not within the threshold pressure range, the control unit controls the sample sucking needle to puncture the closed container for the second time to deflate the closed container for the second time;
if the pressure of the pipeline is within the threshold pressure range after the secondary puncture, the control unit controls the sampling unit to sample, controls the sample preparation unit to prepare a sample and controls the detection unit to measure and output a detection result;
and if the pressure of the pipeline is not in the threshold pressure range after the secondary puncture, the control unit controls the sampling unit, the sample preparation unit and the detection unit not to perform sampling, sample preparation and measurement actions, or alarms to prompt that the pressure is abnormal although sampling, sample preparation, measurement and detection results are output.
In one embodiment, if the pressure of the pipeline is not in the threshold pressure range in the sampling process, the control unit controls the sampling unit to perform needle washing and secondary sampling;
if the pressure of the pipeline is within the threshold pressure range in the secondary sampling process, the control unit controls the sample preparation unit to prepare a sample and controls the detection unit to measure and output a detection result;
if the pressure of the pipeline is not in the threshold pressure range in the secondary sampling process, the control unit controls the sample preparation unit and the detection unit not to perform sample preparation and measurement actions, or performs sample preparation, measurement and detection result output, but gives an alarm to prompt that the pressure is abnormal.
In one embodiment, the alarm prompting pressure abnormity comprises any one of sampling needle blockage abnormity, undersampling abnormity, sampling impurity abnormity and non-sampling abnormity.
In one embodiment, the control unit records the pressure of the pipeline in the sampling process to form a pressure characteristic curve, and identifies the sampling needle blockage abnormality, undersampling abnormality, sampling impurity abnormality or non-sampling abnormality according to the pressure characteristic curve in the sampling process.
In one embodiment, in the process that the sampling unit samples the sample to the sample preparation unit, the control unit controls the pressure sensor to record the pressure of the pipeline, and if the pressure of the pipeline is not within the threshold pressure range, the control unit controls the detection unit to output an alarm to prompt that the pressure is abnormal.
A sampling monitoring method comprises the following steps:
providing a sample analyzer, wherein the sample analyzer comprises a sampling unit, a sample preparation unit, a detection unit and a control unit, the sampling unit sucks a sample from a closed container and provides the sample to the sample preparation unit, the sample preparation unit reacts the sample with a reagent to generate a sample, the detection unit measures the sample and obtains a detection result, and the control unit controls the sampling unit, the sample preparation unit and the detection unit; the sampling unit comprises a sample sucking needle, a pipeline communicated with the sample sucking needle and a pressure sensor communicated with the pipeline;
in the sampling process of the sampling unit, the pressure sensor monitors the pressure of the pipeline, and whether the sampling process is abnormal or not is judged according to the obtained pressure.
In one embodiment, the sample sucking needle is provided with an air release channel, the sample sucking needle punctures the closed container to release air of the closed container, and if the pressure of the pipeline after puncturing is within a threshold pressure range, sampling, sample preparation, measurement and detection result output are carried out.
In one embodiment, if the pressure of the pipeline after puncture is not within the threshold pressure range, the sample sucking needle punctures the closed container for the second time to deflate the closed container for the second time;
if the pressure of the pipeline is within the threshold pressure range after the secondary puncture, sampling, sample preparation, measurement and output of a detection result are carried out;
and if the pressure of the pipeline is not in the threshold pressure range after the secondary puncture, the sampling, sample preparation and measurement actions are not executed, or the sampling, sample preparation, measurement and detection result output are carried out, but an alarm is given to prompt that the pressure is abnormal. In one embodiment, if the pressure of the pipeline is not in the threshold pressure range in the sampling process, needle washing and secondary sampling are carried out;
if the pressure of the pipeline is within the threshold pressure range in the secondary sampling process, sample preparation, measurement and detection result output are carried out;
if the pressure of the pipeline is not within the threshold pressure range in the secondary sampling process, sample preparation and measurement actions are not executed; or executing sample preparation and measurement actions, and alarming to prompt pressure abnormity; or after sample preparation and measurement actions are executed, a detection result is output, and the result abnormity is prompted.
In one embodiment, the alarm prompting pressure abnormity comprises any one of sampling needle blockage abnormity, undersampling abnormity, sampling impurity abnormity and non-sampling abnormity.
In one embodiment, the method further comprises the steps of forming a pressure characteristic curve of the pressure of the pipeline obtained by monitoring in the sampling process, and identifying whether the alarm prompting pressure abnormality is sampling needle blockage abnormality, undersampling abnormality, sampling impurity abnormality or non-sampling abnormality according to the pressure characteristic curve.
In one embodiment, in the process that the sample sucking needle divides the sucked sample into samples to the sample preparation unit, the pressure sensor monitors the pressure of the pipeline in real time, and if the pressure of the pipeline is not within the threshold pressure range, an alarm is given to prompt that the pressure is abnormal.
Compared with the prior art, the sample analyzer and the sampling monitoring method have the following advantages: firstly, a sealed container deflation monitoring mode is provided, the sealed container deflation effect can be effectively monitored, the alarm prompt can be given when the sealed container deflation does not meet the requirement, the shielding result processing is carried out, and the clinical risk can be effectively avoided; secondly, the pressure monitoring sampling and sample dividing process is used, the unnecessary sample amount and reagent amount are not increased, and compared with other monitoring methods, the method saves samples and reagents; thirdly, the pressure monitoring can obtain a pressure value range according to comparison of different abnormal modes, so that possibility is provided for distinguishing various abnormal modes, wherein the abnormal modes comprise puncture abnormity, sampling needle blockage, insufficient sampling, sampling impurities, sample non-suction abnormality, sample separation abnormality and the like, the reliability of sampling and sample separation monitoring is improved to a greater extent, and the clinical detection risk is avoided to a greater extent.
FIG. 1 is a schematic block diagram of a sample analyzer according to an embodiment of the present invention;
FIG. 2 is a schematic diagram of a sampling unit of the sample analyzer of FIG. 1;
FIG. 3 is another schematic diagram of a sampling unit in the sample analyzer of FIG. 1;
FIG. 4 is a schematic view of another configuration of a sampling unit in the sample analyzer of FIG. 1;
FIG. 5 is a flow chart of a sample sampling and sample splitting monitoring method for a sample analyzer according to an embodiment of the present invention;
FIG. 6 is a flow chart of a sample sampling and sample splitting monitoring method for a sample analyzer according to another embodiment of the present invention;
FIG. 7 shows a pressure profile for a normal draw;
FIG. 8 shows a pressure characteristic curve of a sample-aspirating needle-plugging in an abnormal mode;
FIG. 9 shows a pressure profile for an abnormal pattern of undersampling;
FIG. 10 shows a pressure characteristic curve in which the abnormal pattern is a sample sucking foreign matter;
fig. 11 shows a pressure characteristic curve in which the abnormal pattern is an unstripped sample.
As shown in fig. 1, a sample analyzer according to an embodiment of the present invention may be a blood cell analyzer or a blood clotting meter. The sample analyzer includes a sampling unit 100, a sample preparation unit 101, a detection unit 102, and a control unit 103. The sampling unit 100 sucks a blood sample to be tested from a sealed container (e.g., a closed tube vessel) and supplies the blood sample to the sample preparation unit 101. The sample preparation unit 101 reacts a reagent with a sample provided by the sampling unit 100 to generate a sample required for detection. The detection unit 102 measures the sample supplied from the sample preparation unit 101 and obtains a detection result. The control unit 103 is communicatively connected to the sampling unit 100, the sample preparation unit 101, and the detection unit 102, and controls the sampling unit 100, the sample preparation unit 101, and the detection unit 102 to perform operations such as sampling, sample preparation, and detection, respectively, on the sampling unit 100, the sample preparation unit 101, and the detection unit 102.
Referring also to fig. 2, in one possible embodiment of the present invention, the sampling unit 100 includes a sample-aspirating needle 10, a conduit 20, a power source 30, and a pressure sensor 40.
The pipette tip 10 includes a tip and a tail. The tip of the pipette tip 10 is adapted to be inserted into a sealed container (not shown) to extract a sample. The sample sucking needle 10 is provided with an air discharging channel 11. The air release passage 11 is used for communicating the sealed container with the atmosphere. In one embodiment, the air release channel 11 is an air release groove disposed on the outer side wall of the sample suction needle 10. In another embodiment, the sample aspirating needle 10 may be provided with a deflation tube, and the deflation channel 11 is formed in the deflation tube.
The pipeline 20 is communicated with the needle tail of the sample suction needle 10. The power source 30 is communicated with the pipeline 20 and provides power for the sample suction needle 10 to draw a sample. The power source 30 may be an automatic type injector that is automatically controlled by a power mechanism. The power source 30 is communicatively connected to the control unit 103 and controlled by the control unit 103.
After the sample is sucked by the sample sucking needle 10, the sample may partially enter the pipeline 20 depending on the sucked amount, but the sample should be prevented from entering the power source 30 so as not to affect the normal operation of the power source 30.
The pressure sensor 40 is installed in the pipeline 20 and communicated with the pipeline 20, and is used for monitoring the pressure of the pipeline 20 in the sampling process and recording the measured pressure value in real time. Pressure sensor 40 may be remote from needle 10, for example at power source 30. Since the pressure sensor 40 is disposed at the power source 30 without being contaminated by the sample, the biocompatibility of the sampling unit 100 can be improved, and different kinds of samples can be sucked without frequent replacement or cleaning of the pressure sensor 40. Considering that the detected pressure can reflect the pressure of the pipeline 20 during sampling more truly near the sample-sucking needle 10, the pressure sensor 40 can also be arranged at the sample-sucking needle 10 to improve the pressure sensitivity of the pressure sensor 40.
According to the invention, the pressure sensor 40 is arranged to monitor whether the pressure of the pipeline 20 is in the threshold range in the sampling process in real time, so that whether the sampling process is in a normal state or an abnormal state can be judged, and an abnormal detection result is screened out, so that the clinical risk is avoided. Further, the pressure sensor 40 can also monitor whether the pressure in the pipeline 20 is within a threshold range during the process of sampling the sample into the sample preparation unit 101 by the sampling unit 100, thereby determining whether the sampling process is normal or not, so as to further avoid clinical risks.
Wherein the sampling process refers to a time period from the time when the sample sucking needle 10 penetrates into the sealed container to the time when the sample sucking needle 10 sucks the sample and exits from the sealed container; the sample separation process is a period of time from when the sample sucking needle 10 is withdrawn from the sealed container to when the sample is discharged to the reaction cell of the sample preparation unit 101. The pressure sensor 40 may record the line 20 pressure in real time for any unit of time during the sampling and sample splitting processes described above.
In this embodiment, the puncturing process may be further defined as a process before the pipette tip 10 punctures into the sealed container until the pipette tip 10 contacts the sample in the sealed container. Before the sample suction needle 10 punctures the sealed container, the pressure in the sealed container can be positive pressure or negative pressure relative to the external environment. Experiments show that the pressure in the sealed container influences the accuracy of sampling and detection results, so that the pressure in the sealed container is monitored in the sampling process, the detection results corresponding to the sampling when the pressure in the sealed container is in an abnormal state are eliminated, and the clinical risk can be reduced. When the sample suction needle 10 is inserted into the sealed container, the air release channel 11 communicates the sealed container with the external environment, and the pressure in the sealed container can be released. When the pipette needle 10 is inserted into the sealed container, the sealed container is communicated with the pipeline 20, so that the pressure sensor 40 monitors the pressure in the pipeline 20, namely, the pressure in the sealed container, thereby monitoring the deflation effect of the sealed container.
Specifically, the average pressure in the sealed container during the puncturing process can be calculated according to the pressure value in each unit time monitored by the pressure sensor 40 in real time, and compared with the threshold pressure range, whether the deflation effect in the puncturing process is abnormal or not can be judged. If abnormal, the sealed container may be subjected to other processing such as secondary puncture deflation, as will be further described below with reference to the sampling monitoring method. The threshold pressure range of the puncture process can be determined by counting pressure abnormity values appearing in the puncture process, and can also be obtained by boundary test experiments. Further, the pressure monitored per unit time during the puncturing process can be used for forming a pressure characteristic curve. And judging whether the deflation effect is abnormal in the puncturing process by judging whether each point in the pressure characteristic curve of the puncturing process is in the threshold pressure range of the corresponding point.
The invention can also form a pressure characteristic curve by the pressure of the pipeline 20 in each unit time monitored in the process of completing the suction of the sample after the sample suction needle 10 contacts the sample and withdrawing the sealed container, and compare the pressure characteristic curve formed by the monitored pressure with the preset pressure characteristic curve in the normal state to judge whether the pressure difference in each unit time is in the threshold pressure range, thereby judging whether the sampling process is abnormal. Furthermore, pressure characteristic curves under various abnormal modes can be preset, and the pressure characteristic curves under the abnormal modes comprise sampling needle blockage abnormality, undersampling abnormality, sampling impurity abnormality and non-sampling abnormality. When the sample suction process is judged to be abnormal, a specific abnormal mode can be identified according to the comparison result of the pressure characteristic curve formed by the monitoring pressure and the pressure characteristic curves under the abnormal modes. For example, when the pressure characteristic curve formed according to the monitoring pressure is matched with the pressure characteristic curve in the sampling impurity abnormal mode, it can be determined that the sampling impurity is abnormal in the sample sucking process. The threshold pressure range of the sampling process can be determined by counting the abnormal pressure values in the sampling process, and can also be obtained by a boundary test experiment. The pressure characteristic curves in the different modes during sampling can also be obtained by means of statistics or boundary tests.
The present invention can also form a pressure characteristic curve for the pressure of the pipeline 20 in each unit time monitored in the sample separation process, compare the pressure characteristic curve with the pressure characteristic curve in the preset normal state, and judge whether the pressure difference in each unit time is within the threshold pressure range, thereby judging whether the sample separation process is abnormal. The threshold pressure range in the sample separation process can be determined by counting pressure abnormal values in the sample separation process, and can also be obtained by a boundary test experiment.
In another possible embodiment of the present invention, as shown in fig. 3, the sampling unit 100 includes a sample suction needle 21, a pipeline 22, a power source 23, a pressure sensor 24, a first switching member 25, and a second switching member 26. The line 22 includes a first line 221 and a second line 222. The first line 221 is connected between the pipette tip 21 and the first switching member 25. The second pipe 222 is connected between the first switching member 25 and the second switching member 26. The first switching member 25 is used to connect or disconnect the first pipe 221 and the second pipe 222. The second pipe 222 is connected to the negative pressure source 7 and the atmosphere through the second switching member 26. It will be appreciated that the second line 222 is also connected between the first switch member 25 and the power source 23.
The pressure sensor 24 is used to monitor the pressure in the line 22 during sampling and to record the measured pressure value in real time. The pressure monitoring process in the sampling process in this embodiment is slightly different from that in the above embodiment, and the sample separation process and the sample preparation process are substantially the same as those in the previous embodiment. Specifically, in the present embodiment, the pressure sensor 24 can record and measure in real time that the first switching member 25 connects the first pipeline 221 and the second pipeline 222 (i.e. connects the sample suction needle 21 to the power source 23 for sample suction); the pressure value during the sample sucking process is the pressure value until the sample sucking needle 21 exits the sealed container (i.e. the suction of the sample is completed, and the first switching member 25 cuts off the communication between the first pipeline 221 and the second pipeline 222). In this embodiment, a process from the insertion of the closed vessel into the pipette needle 21 to the removal of the closed vessel from the pipette needle 21 is defined as a sampling process. It will be appreciated that the pressure sensor 24 may also monitor the pressure during the entire sampling process in real time and screen the pressure changes during the above-described sampling process for analysis.
Specifically, the pressure sensor 24 may be located away from the pipetting needle 21, for example at the power source 23. Since the pressure sensor 24 is disposed at the power source 23 without being contaminated by the sample, the biocompatibility of the sampling unit 100 can be improved, and different kinds of samples can be sucked without frequently replacing or cleaning the pressure sensor 24. Considering that the detected pressure can reflect the pressure of the pipeline 22 during sampling more truly near the sample-sucking needle 21, the pressure sensor 24 can also be arranged at the sample-sucking needle 21 to improve the pressure sensitivity of the pressure sensor 40.
In this embodiment, the sampling unit 100 can control the pressure environment of the first pipeline 221 through the actions of the first switching element 25 and the second switching element 26, so as to eliminate adverse effects of the pressure in the closed test tube on the sampling accuracy, and therefore, when the sampling unit 100 is used for sampling, the sampling can be completed only by puncturing the sample suction needle 21 once, and procedures of puncturing pretreatment (the time consumed by puncturing pretreatment is usually more than several seconds) and cleaning the sample suction needle 21 after puncturing pretreatment are not required, so that the sampling time is shortened, and the sampling speed is increased. Since the sampling process is a critical path for the measurement of the sample analyzer, the sampling by the sampling unit 100 shortens the measurement time of the sample analyzer, and increases the measurement speed of the sample analyzer. Meanwhile, the sample suction needle 21 can be worn down by only one puncture for sampling by using the sampling unit 100, and the service life of the sample suction needle 21 is prolonged.
In one embodiment, as shown in fig. 3, the second switch 26 includes a first interface 261, a second interface 262, and a third interface 263. The first port 261 is connected to the second pipe 222, the second port 262 is connected to the negative pressure source 7, the third port 263 is connected to the atmosphere, and the second switching member 26 can communicate the first port 261 with the second port 262 or communicate the first port 261 with the third port 263. The second switch 26 may be a valve, such as a two-position three-way solenoid valve.
In another embodiment, as shown in fig. 4, the second switch 26 includes a first sub-switch 264 and a second sub-switch 265. Both ends of the first sub-switching member 264 are respectively connected to the second pipe 222 and the negative pressure source 7, and the first sub-switching member 264 is used for connecting or disconnecting the second pipe 222 and the negative pressure source 7. The first sub-switch 264 may be a valve, such as a shutoff valve or the like. Both ends of the second sub-switch 265 are respectively connected to the second pipe 222 and the atmosphere, and the second sub-switch 265 is used for connecting or disconnecting the second pipe 222 and the atmosphere. The second sub-switch 265 may be a valve, such as a shutoff valve or the like.
Optionally, the negative pressure source 7 includes an air storage tank 71, negative pressure is formed in the air storage tank 71, and the air storage tank 71 is communicated with the second pipeline 222 so as to enable the second pipeline 222 to be in a negative pressure state. The negative pressure source 7 may further include an air pump 72, and the air pump 72 is used for communicating with the air storage tank 71 to establish the negative pressure in the air storage tank 71.
The pressure value of the negative pressure in the air storage tank 71 is less than or equal to-30 kPa. When the second pipeline 222 is communicated with the air storage tank 71, the pressure of the second pipeline 222 is the same as that of the air storage tank 71, so that the pressure of the second pipeline 222 is lower than the negative pressure in the test tube.
In one embodiment, the control unit 103 includes a storage module 104, a comparison module 105, and an execution module 106.
The memory module 104 stores threshold pressure ranges for the pipeline 20 during sampling. The memory module 104 may also store a threshold pressure range for the circuit 20 during the lancing process. The storage module 104 may also store a threshold pressure range for the circuit 20 during the sample splitting process. Further, the storage module 104 can also store the pressure characteristic curves of the pipeline 20 in the normal state during the puncturing process, the sampling process and the sample separating process, and store typical pressure characteristic curves of the pipeline 20 in various abnormal modes during the sampling process, such as a sampling needle plugging pressure characteristic curve, an under-sampling pressure characteristic curve, a sampling impurity pressure characteristic curve and an un-sampling pressure characteristic curve.
The comparison module 105 is configured to determine whether the pressure of the pipeline 20 during the real-time monitoring of the puncturing, sampling, and sample splitting is within a threshold pressure range. The comparing module 105 may also be configured to determine whether a pressure difference between the pressure in each unit time in the pressure characteristic curve formed by monitoring the pressure and the pressure in the corresponding unit time in the pre-stored corresponding pressure characteristic curve is within a threshold pressure range. Further, the comparing module 105 may be further configured to determine whether a pressure characteristic curve formed by identifying the monitored pressure is consistent with pressure characteristic curves in the pre-stored abnormal modes, and further identify a specific abnormal mode.
The execution module 106 is communicatively connected to the sampling unit 100, the sample preparation unit 101, and the detection unit 102, and controls the sampling unit 100, the sample preparation unit 101, and the detection unit 102 to execute corresponding operations such as puncturing, sampling, sample preparation, and detection according to the determination result of the comparison module 105.
Two sampling monitoring methods provided by the present invention will be described below with reference to fig. 5 and 6. Both methods include: providing a sample analyzer, wherein the sample analyzer comprises a sampling unit, a sample preparation unit, a detection unit and a control unit, the sampling unit sucks a sample from a closed container and provides the sample to the sample preparation unit, the sample preparation unit reacts the sample with a reagent to generate a sample, the detection unit measures the sample and obtains a detection result, and the control unit controls the sampling unit, the sample preparation unit and the detection unit; the sampling unit comprises a sample sucking needle, a pipeline communicated with the sample sucking needle and a pressure sensor communicated with the pipeline; in the sampling process of the sampling unit, the pressure sensor monitors the pressure of the pipeline in real time, and whether the sampling process is abnormal or not is judged according to the obtained pressure.
Specifically, as shown in fig. 5, in a middle sampling method of the present invention, step S1 is a puncturing step, i.e., a process before the pipette needle is inserted into the sealed container until it contacts the sample in the sealed container. The sample suction needle is provided with an air release channel, and the sample suction needle can release air to the closed container after puncturing the closed container. The puncturing step can be completed by the control unit controlling and driving the sample sucking needle in the sampling unit.
Step S2 is a step of determining the air bleeding effect, that is, whether or not the pressure in the tube path after the puncturing step S1 is within the threshold pressure range. After the puncturing step S1, the puncturing needle enters the sealed container, the pressure sensor is communicated with the sealed container via the pipeline, and the pressure in the pipeline, that is, the pressure in the sealed container, is monitored, so that the pressure sensor can be used for determining whether the pressure in the sealed container is within the threshold pressure range. If the pressure in the sealed container is judged to be in the threshold pressure range, the subsequent sampling step S3, sample preparation step S5 and measurement and output normal result step S7 are carried out. Because of the pressure in the sealed container will influence the accuracy of sample and testing result, through monitoring the pressure in the sealed container at the sampling in-process, and the testing result that the sample that the pressure in the sealed container is in the abnormal condition corresponds is excluded, can reduce clinical risk.
If it is determined in step S2 that the pressure in the sealed container is not within the threshold pressure range, a secondary piercing step S21 is performed to deflate the sealed container again. After the secondary puncture step S21, a secondary deflation effect determination step S22 is performed to determine whether or not the pressure in the tube path is within the threshold pressure range after the puncture step S21. If the pressure in the sealed container is judged to be in the threshold pressure range, the subsequent sampling step S3, sample preparation step S5 and measurement and output normal result step S7 are carried out.
In the actual sampling process, the pressure in the sealed container after the secondary puncture is still not satisfactory may occur. Thus, when it is judged that the pressure in the line is not within the threshold pressure range after the puncturing step S21, the sampling step S23, the sample preparation step S24, and the measurement and output detection result step S8 may be performed. Wherein, the pressure abnormity can be warned when the detection result is output, and the possibility of inaccurate measurement result is prompted. Further, this alarm prompt pressure anomaly may be embodied as a puncture pressure anomaly. The alarm mode can be a mode of making a mark on an output detection result, and the like. In step S8, the output of the detection result may be to display the detection result normally, but to make a warning mark that is not referred to, or to mask the detection result with characters or patterns that have no readable meaning. Or, the detection result is only to output an alarm to indicate that the pressure is abnormal.
When the pressure in the pipeline is judged not to be in the threshold pressure range after the puncture step S21, the subsequent sampling, sample preparation and measurement actions can not be executed, the sampling process is directly terminated, and an alarm prompt for abnormal sampling is given.
In one embodiment, after the sampling step S3, a step S4 is performed to determine whether the sampling is normal. The pressure characteristic curve is formed by the pipeline pressure in each unit time monitored in the process of completing the suction of the sample to the time of withdrawing the sealed container after the sample suction needle is contacted with the sample, and the pressure characteristic curve formed by the monitored pressure is compared with the prestored pressure characteristic curve in a normal state to judge whether the pressure difference in each unit time is in a threshold pressure range, so that whether the sampling is abnormal or not is judged. If the step S4 is judged to be normal, the subsequent sample preparation step S5 and the step S7 of measuring and outputting a normal result are carried out. If the step S4 is abnormal, a needle wash and sub-sampling step S41 is performed. After the secondary sampling step S41, a determination step S42 is performed to determine whether the sampling is normal. The determination process in step S42 may be the same as the determination process in step S4, and the pressure characteristic curve may be formed by the line pressures in each unit time monitored in the process of completing the suction of the sample after the sample suction needle contacts the sample and withdrawing the sealed container, and the pressure characteristic curve formed by the monitored pressure may be compared with the pre-stored pressure characteristic curve in the normal state to determine whether the pressure difference in each unit time is within the threshold pressure range, thereby determining whether the sampling is abnormal. If the step S42 is judged to be normal, the subsequent sample preparation step S5 and the step S7 of measuring and outputting a normal result are carried out. If the step S42 judges it to be abnormal, the following sample preparation step S43, measurement and test result output step S8 are performed.
In step S8, the output of the detection result may be to display the detection result normally, but to make a warning mark that is not referred to, or to mask the detection result with characters or patterns that have no readable meaning. Furthermore, the invention can also preset pressure characteristic curves under various abnormal modes, wherein the pressure characteristic curves under the abnormal modes comprise abnormal sampling needle blockage, abnormal undersampling, abnormal sampling impurities and abnormal non-sampling. When the step S42 determines that the abnormal pressure is detected, the pressure characteristic curve formed by the monitored pressure and the pressure characteristic curves in the abnormal modes can be compared to identify specific abnormal modes, and in step S8, the alarm prompt pressure abnormality is embodied as a specific sampling pressure abnormality. For example, when the pressure characteristic curve formed by comparing the monitored pressure is matched with the abnormal pressure characteristic curve of the sampling impurities, an alarm can be given to prompt the abnormal mode of the sampling impurities.
Fig. 6 illustrates a second sampling monitoring method provided by the present invention. Step S11 is a sampling step, and the process from the insertion of the pipette needle into the closed container to the removal of the closed container from the pipette needle is defined as a sampling process. The sampling step can be completed by the control unit controlling and driving the sample sucking needle in the sampling unit. Specifically, after the first switching piece cuts off the first pipeline and the second pipeline, the sampling needle pierces the test tube cap and extends into the test tube, so that the influence of the deformation of the second pipeline on the isolation gas column in the first pipeline can be shielded. Then, the second switching member communicates the second pipe with the negative pressure source. The negative pressure source enables the second pipeline to be in a negative pressure state, so that the influence of the negative pressure existing in the test tube on the isolation air column can be offset. Then, after the second switching member disconnects the second pipeline from the negative pressure source, the first switching member communicates the first pipeline with the second pipeline. Then, the power source draws the biological sample in the test tube into the sample suction needle. And finally, after the first pipeline and the second pipeline are cut off again by the first switching piece, the sample sucking needle leaves the test tube. The sampling process is completed. The pressure sensor can record the pressure change of the pipeline in each unit time in the sampling process and form a pressure characteristic curve.
Step S12 is a step of determining the sampling process. Specifically, the pressure characteristic curve formed by the monitoring pressure may be compared with a pre-stored pressure characteristic curve in a normal state to determine whether the pressure difference in each unit time is within a threshold pressure range, so as to determine whether the sampling is abnormal.
If the step S12 is judged to be normal, the subsequent sample preparation step S13 and the step S15 of measuring and outputting a normal result are carried out.
If step S12 determines that it is abnormal, a needle wash and sub-sampling step S121 is performed. After the secondary sampling step S121, a determination step S122 is performed to determine whether the sampling is normal. The determination process in step S122 may be the same as the determination process in step S12, and the pressure characteristic curve may be formed by the line pressure in each unit time monitored in the process of completing the suction of the sample to the time of withdrawing the sealed container after the sample suction needle contacts the sample, and the pressure characteristic curve formed by the monitored pressure may be compared with the pre-stored pressure characteristic curve in the normal state to determine whether the pressure difference in each unit time is within the threshold pressure range, thereby determining whether the sampling is abnormal. If the step S122 is judged to be normal, the subsequent sample preparation step S13 and the step S15 of measuring and outputting a normal result are carried out. If the step S122 determines that the detection result is abnormal, the following sample preparation step S123 and the measurement and output detection result step S124 are performed.
In step S124, the output of the detection result may be to normally display the detection result, but make a warning mark that is not referred to (i.e., the warning result is abnormal), or to mask the detection result with a character or a pattern that does not have a readable meaning.
Furthermore, the invention can also preset pressure characteristic curves under various abnormal modes, wherein the pressure characteristic curves under the abnormal modes comprise abnormal sampling needle blockage, abnormal undersampling, abnormal sampling impurities and abnormal non-sampling. When the step S122 determines that the abnormal pressure is detected, the pressure characteristic curve formed by the monitoring pressure and the pressure characteristic curves in the abnormal modes may be compared to identify specific abnormal modes, and in step S124, the alarm prompt pressure abnormality is embodied as a specific sampling pressure abnormality. For example, when the pressure characteristic curve formed by comparing the monitored pressure is matched with the abnormal pressure characteristic curve of the sampling impurities, an alarm can be given to prompt the abnormal mode of the sampling impurities.
According to the method, the pressure in the sealed container is monitored in the sampling process, and the detection result corresponding to the sampling when the pressure in the sealed container is in an abnormal state is eliminated, so that the clinical risk can be reduced.
FIG. 7 shows a typical pressure profile for a normal draw. FIG. 8 shows a pressure profile of a typical sample blocking needle; FIG. 9 shows a typical undersampling pressure profile; FIG. 10 shows a pressure profile of a typical sample pick-up contaminant; FIG. 11 shows a typical unstripped pressure profile. As an example, when the difference between the pressure value corresponding to each unit time on a certain pressure characteristic curve formed by monitoring the pipeline pressure during the sampling process and the pressure value corresponding to the unit time on the normal sample suction pressure characteristic curve shown in fig. 7 is outside the threshold pressure range, it can be determined that the certain pressure characteristic curve is not consistent with the normal sample suction pressure characteristic curve, and it is determined that the sampling process is abnormal.
As an example, when the difference between the pressure value corresponding to each unit time on a certain pressure characteristic curve formed by monitoring the pipeline pressure during the sampling process and the pressure value corresponding to each unit time on the pressure characteristic curve in the specific abnormal mode shown in fig. 8 to 11 is within the threshold pressure range, it can be determined that the certain pressure characteristic curve is consistent with the pressure characteristic curve in the specific abnormal mode, and the specific abnormality exists in the sampling process.
As a further embodiment of the present invention, the step of judging whether the sample is normal or not S6/S14 is also performed after the step of preparing the sample S5/S13. In the process that the sample sucking needle divides the sucked sample into the sample preparation unit, the pressure sensor monitors the pressure of the pipeline in real time, if the pipeline pressure is within the threshold pressure range in the process, the step S7/S15 of measuring and outputting a normal result is executed, and if the pipeline pressure is not within the threshold pressure range in the process, the step S8/S124 of measuring and outputting a detection result is executed. In step S8/124, an alarm may be given to indicate the pressure abnormality. Further, this alarm prompt pressure anomaly may be embodied as a sample-divided pressure anomaly. The alarm mode can be a mode of making a mark on an output detection result, and the like. In the above step S8/124, the output of the detection result may be to display the detection result normally, but to make a warning mark that is not referred to, or to mask the detection result with a character or a pattern that has no readable meaning.
The sample separation judging step S6/S14 is used as the secondary verification of the sampling judging step, so that the sample separation reliability can be further improved, and the clinical detection risk can be reduced.
Compared with the prior art, the sample analyzer and the sampling monitoring method have the following advantages: firstly, a sealed container deflation monitoring mode is provided, the sealed container deflation effect can be effectively monitored, the alarm prompt can be given when the sealed container deflation does not meet the requirement, the shielding result processing is carried out, and the clinical detection risk can be effectively avoided; secondly, the pressure monitoring sampling and sample dividing process is used, so that the unnecessary amount of the sample and the reagent is not increased, and compared with other monitoring methods, the method saves the reagent and the sample; thirdly, the pressure monitoring can obtain a pressure value range according to comparison of different abnormal modes, so that possibility is provided for distinguishing various abnormal modes, wherein the abnormal modes comprise puncture abnormity, sampling needle blockage, insufficient sampling, sampling impurities, sample non-suction abnormality, sample separation abnormality and the like, the reliability of sampling and sample separation monitoring is improved to a greater extent, and the clinical detection risk is avoided to a greater extent.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (23)
- A sample analyzer comprising a sampling unit, wherein the sampling unit comprises:a sample sucking needle having a needle head and a needle tail, the needle head being inserted into the sealed container to draw a sample; the pipeline is communicated with the needle tail of the sample sucking needle; andand the pressure sensor is communicated with the pipeline and used for monitoring the pressure of the pipeline in the sampling process.
- The sample analyzer of claim 1 further comprising a power source in communication with the conduit and providing power to the draw needle to draw the sample.
- The sample analyzer of claim 2, wherein the pressure sensor is located at a power source.
- The sample analyzer of claim 1 wherein the pressure sensor is located at the pipette tip.
- The sample analyzer of claim 1, further comprising a first switch and a second switch, the conduit comprising a first conduit and a second conduit, the first conduit being connected between the needle tail of the sample-aspirating needle and the first switch, the second conduit being connected between the first switch and the second switch, the first switch being adapted to communicate or disconnect the first conduit with the second conduit, the second conduit being connected to a source of negative pressure or atmosphere through the second switch.
- The sample analyzer of claim 5, wherein the second switch includes a first port connected to the second conduit, a second port connected to the negative pressure source, and a third port connected to the atmosphere, the second switch being capable of communicating the first port with the second port or the first port with the third port.
- The sampling assembly of claim 5, wherein the second switch comprises:the two ends of the first sub-switching piece are respectively connected with the second pipeline and the negative pressure source, and the first sub-switching piece is used for communicating or cutting off the second pipeline and the negative pressure source; andand two ends of the second sub-switching piece are respectively connected with the second pipeline and the atmosphere, and the second sub-switching piece is used for communicating or cutting off the second pipeline and the atmosphere.
- The sample analyzer of claim 1 wherein the pipette tip has a vent channel disposed therein for communicating the sealed container with the atmosphere.
- The sample analyzer of claim 8 wherein the vent channel is a vent groove disposed on an exterior sidewall of the pipette tip.
- The sample analyzer as claimed in claim 1, further comprising a sampling unit, a detecting unit and a control unit, wherein the sampling unit sucks the sample and supplies the sample to the sampling unit, the sampling unit reacts the sample with the reagent to generate a sample, the detecting unit measures the sample and obtains a detection result, and the control unit controls the sampling unit, the sampling unit and the detecting unit.
- The sample analyzer as claimed in claim 10, wherein the control unit comprises a storage module storing a threshold pressure range of the pipeline during sampling, a comparison module comparing whether the pressure in the pipeline monitored by the pressure sensor during sampling is within the threshold pressure range, and an execution module controlling the sampling unit, the sample preparation unit, and the detection unit according to the comparison result of the comparison module.
- The sample analyzer as claimed in claim 11, wherein the control unit controls the sample suction needle to puncture the closed container to deflate the closed container, and if the pressure of the pipeline after puncture is within a threshold pressure range, the control unit controls the sampling unit to sample, controls the sample preparation unit to prepare a sample, and controls the detection unit to measure and output a detection result.
- The sample analyzer of claim 11, wherein if the pressure of the pipeline is not within the threshold pressure range during sampling, the control unit controls the sampling unit to perform needle washing and secondary sampling;if the pressure of the pipeline is within the threshold pressure range in the secondary sampling process, the control unit controls the sample preparation unit to prepare a sample and controls the detection unit to measure and output a detection result;if the pressure of the pipeline is not in the threshold pressure range in the secondary sampling process, the control unit controls the sample preparation unit and the detection unit not to perform sample preparation and measurement actions, or performs sample preparation and measurement, and gives an alarm to prompt that the pressure is abnormal.
- The sample analyzer of claim 13, wherein the alarm-prompted pressure anomaly comprises any one of a sample-stuck-needle anomaly, an under-sampling anomaly, a sample-impurity anomaly, and an under-sampling anomaly.
- The sample analyzer of claim 10, wherein the control unit records the pressure of the pipeline during sampling to form a pressure characteristic curve, and identifies a sampling needle blockage abnormality, an undersampling abnormality, a sampling impurity abnormality or an un-sampling abnormality during the sampling according to the pressure characteristic curve.
- The sample analyzer of claim 11, wherein in the process of sampling the sample to the sample preparation unit by the sampling unit, the control unit controls the pressure sensor to record the pressure of the pipeline, and if the pipeline pressure is not within the threshold pressure range, the control unit controls the detection unit to output an alarm to prompt that the pressure is abnormal.
- A sampling monitoring method is characterized by comprising the following steps:providing a sample analyzer, wherein the sample analyzer comprises a sampling unit, a sample preparation unit, a detection unit and a control unit, the sampling unit sucks a sample from a closed container and provides the sample to the sample preparation unit, the sample preparation unit reacts the sample with a reagent to generate a sample, the detection unit measures the sample and obtains a detection result, and the control unit controls the sampling unit, the sample preparation unit and the detection unit; the sampling unit comprises a sample sucking needle, a pipeline communicated with the sample sucking needle and a pressure sensor communicated with the pipeline;in the sampling process of the sampling unit, the pressure sensor monitors the pressure of the pipeline, and whether the sampling process is abnormal or not is judged according to the obtained pressure.
- The sampling monitoring method according to claim 17, wherein the sample suction needle is provided with an air release channel, the sample suction needle punctures the closed container to release air from the closed container, and if the pressure of the pipeline after puncturing is within a threshold pressure range, sampling, sample preparation, measurement and detection result output are performed.
- The sampling monitoring method of claim 18, wherein if the pressure of the line after piercing is not within a threshold pressure range, the pipette needle pierces the closed container a second time to deflate the closed container a second time;if the pressure of the pipeline is within the threshold pressure range after the secondary puncture, sampling, sample preparation, measurement and output of a detection result are carried out;and if the pressure of the pipeline is not in the threshold pressure range after the secondary puncture, the sampling, sample preparation and measurement actions are not executed, or the sampling, sample preparation and measurement actions are executed, but an alarm is given to prompt that the pressure is abnormal.
- A sampling monitoring method according to claim 17, wherein if the pressure of the pipeline is not within the threshold pressure range during sampling, needle washing, secondary sampling are performed;if the pressure of the pipeline is within the threshold pressure range in the secondary sampling process, sample preparation, measurement and detection result output are carried out;if the pressure of the pipeline is not within the threshold pressure range in the secondary sampling process, sample preparation and measurement actions are not executed; or executing sample preparation and measurement actions, and alarming to prompt pressure abnormity; or after sample preparation and measurement actions are executed, a detection result is output, and the result abnormity is prompted.
- A sampling monitoring method according to claim 20, wherein the alarm prompt pressure abnormality includes any one of sampling needle blockage abnormality, undersampling abnormality, sampling impurity abnormality, and non-sampling abnormality.
- A sampling monitoring method according to claim 21, further comprising forming a pressure characteristic curve from the pressure of the pipeline monitored during sampling, and identifying the alarm prompt pressure abnormality as sampling needle blockage abnormality, under-sampling abnormality, sampling impurity abnormality, and non-sampling abnormality according to the pressure characteristic curve.
- The sampling monitoring method according to claim 17, wherein in the process that the sample sucking needle divides the sucked sample into samples to the sample preparation unit, the pressure sensor monitors the pressure of the pipeline in real time, and if the pressure of the pipeline is not within the threshold pressure range, an alarm is given to prompt that the pressure is abnormal.
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| PCT/CN2017/093927 WO2019014942A1 (en) | 2017-07-21 | 2017-07-21 | Sample analyzer and sample monitoring method |
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