CN116952806A

CN116952806A - Sample analyzer

Info

Publication number: CN116952806A
Application number: CN202210389623.7A
Authority: CN
Inventors: 郑文波; 叶波; 姚栋蓝; 祁欢; 叶燚
Original assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Current assignee: Shenzhen Mindray Bio Medical Electronics Co Ltd
Priority date: 2022-04-14
Filing date: 2022-04-14
Publication date: 2023-10-27

Abstract

The present application relates to a sample analyzer comprising a sample preparation device, an impedance detection device, an optical detection device, and a controller configured to: controlling the impedance detecting means to detect platelets in the first measurement sample to acquire electronic information of the first measurement sample, controlling the optical detecting means to detect platelets in the second measurement sample to acquire optical information of the second measurement sample, determining whether or not the platelet detection of the second measurement sample by the optical detecting means is abnormal and/or determining whether or not the platelet detection of the first measurement sample by the impedance detecting means is abnormal, and selectively outputting at least one of a first platelet count result obtained based on the electronic information, a second platelet count result obtained based on only the optical information, and a third platelet count result obtained based on the electronic information and the optical information, based on the determination result. Thereby enabling accurate platelet counts to be obtained quickly.

Description

Sample analyzer

Technical Field

The application relates to the field of in-vitro diagnosis, in particular to a sample analyzer.

Background

Platelet count is a clinical diagnosisAnd an important test item required for treating thrombocytopenia (PLT) caused by various reasons. When the platelet count of the patient is lower than 20 x 10 ≡ ⁹ at/L, it is traditionally thought that a platelet transfusion must be given to the patient, otherwise the patient will be at risk of fatal hemorrhage. 20 x 10 ⁹ L is a medical decision level for clinical use in preventive platelet transfusion as a platelet count threshold.

In recent years, there has been a trend in clinic to reduce preventive platelet transfusion due to the threshold value being 20X 10 ⁹ L is reduced to 10 x 10 ≡ ⁹ after/L, the risk of random bleeding is not significantly increased. Studies have shown that if the clinician has sufficient confidence in the reliability of platelet counts to assess bleeding risk, the medical decision level for preventive platelet transfusion can be reduced to 5X 10 ≡ ⁹ and/L. In order to ensure the accuracy and safety of clinical diagnosis, the platelet count is not only accurate but also accurate. Therefore, accurate counting of platelets is of great clinical importance.

The existing blood cell counting instrument adopts an impedance method (impedance method detection channel) or an optical method (optical method detection channel) to count blood platelets, the blood platelets are small in size and are generally distributed at 0-20 fL, the small size is easy to interfere, for example, the blood platelets are easy to interfere by common electric noise, substances remained in instrument pipelines and the like.

In order to cope with the influence of detection abnormality of the detection device on platelet count, it is common to ensure accuracy of platelet count by alarm or retest after abnormality elimination. However, this greatly affects the detection efficiency of the cytometer.

Disclosure of Invention

Therefore, the application aims to provide a sample analyzer, which acquires a plurality of platelet detection results of a blood sample to be detected through a plurality of different detection channels, and automatically selects and outputs corresponding undisturbed platelet counting results according to whether the detection channels are abnormal or not, so that an accurate platelet counting result can be quickly obtained, and the measurement efficiency of the sample analyzer is improved.

In order to achieve the above object, the present application proposes a sample analyzer comprising: a sample preparing section for preparing a first measurement sample containing a part of the blood sample to be measured and a diluent and a second measurement sample containing a part of the blood sample to be measured, a hemolytic agent and a first staining agent; the impedance detection device comprises a first flow chamber and a detection component, wherein the first flow chamber is used for allowing a first measurement sample to pass through, and the detection component is used for acquiring electronic information when the first measurement sample passes through the first flow chamber; an optical detection device including a second flow cell for passing a second measurement sample, a light source for irradiating the second measurement sample passing through the second flow cell with light, and a light detector for detecting optical information generated after the second measurement sample is irradiated with light while passing through the second flow cell; and a controller configured to: controlling the impedance detecting means to detect platelets in the first measurement sample to acquire electronic information of the first measurement sample, controlling the optical detecting means to detect platelets in the second measurement sample to acquire optical information of the second measurement sample, performing a judging step in which it is judged whether or not the platelet detection of the second measurement sample by the optical detecting means is abnormal and/or whether or not the platelet detection of the first measurement sample by the impedance detecting means is abnormal, and selectively outputting at least one of a first platelet count result obtained based on the electronic information of the first measurement sample, a second platelet count result obtained based on the optical information of the second measurement sample, and a third platelet count result obtained based on the electronic information of the first measurement sample and the optical information of the second measurement sample, according to a judgment result of the judging step.

Compared with the existing sample analyzer, the application can judge whether the detection of the detection device in the sample analyzer is abnormal or not, and select to output a proper platelet counting result according to whether the detection of the detection device is abnormal or not, thereby rapidly obtaining a relatively accurate platelet counting result, being beneficial to improving the measurement efficiency, reducing the sample retest times and improving the measurement accuracy.

Drawings

Fig. 1 is a schematic structural view of an embodiment of a sample analyzer provided according to the present application.

Fig. 2 is a schematic structural view of an embodiment of an impedance detection device of a sample analyzer according to the present application.

Fig. 3 is a schematic structural view of an embodiment of an optical detection device of a sample analyzer according to the present application.

Fig. 4 to 16 are flowcharts illustrating different embodiments of outputting a platelet count result by a controller of a sample analyzer according to the present application.

Fig. 17 is a graph of measured signals of non-blood sample substances that are not disturbed by noise, according to some embodiments of the application.

Fig. 18 is a graph of measured signals of noise-disturbed non-blood sample substances according to some embodiments of the application.

FIG. 19 is a schematic diagram of detecting particle counts per second according to some embodiments of the application.

Detailed Description

Embodiments of the present application will now be described more fully hereinafter with reference to the accompanying drawings, in which it is shown, however, in which some, but not all embodiments of the application are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It should be noted that, the term "first\second\third" related to the embodiment of the present application is merely to distinguish similar objects, and does not represent a specific order for the objects, it is to be understood that "first\second\third" may interchange a specific order or sequence where allowed.

As mentioned in the background art, since platelets are generally distributed at 0 to 20fL due to their small volume, the platelet count is susceptible to detection abnormality of the detection device. For example, the principle of impedance method for detecting platelets is the coulter principle, which detects the total number of particles passing through a detection aperture. Thus, when a small hole is detected to be clogged, the detected particle count may be significantly low, resulting in inaccurate platelet count. In addition, whether optical or impedance, the particles are caused to pass the detector one by the action of a fluid, so as to generate a pulse signal, and the measurement result of blood cells is obtained by counting the pulses. When the acting pressure of the fluid is unstable, the particle number passing through the detector in a fixed time is unstable, and the measurement result of blood cells is affected.

Based on the analysis, samples with abnormal platelet detection channels need to be identified, so that accurate platelet counting results reported to clinic are ensured.

To this end, the present application proposes a sample analyzer capable of solving the above-mentioned problems.

Referring to fig. 1, the sample analyzer 100 at least includes a sample preparation device 120, a detection device 130, and a controller 140. In addition, the sample analyzer 100 may further comprise a sampling device 110 for collecting a blood sample to be measured of the patient.

The sampling device 110 may have a pipette (e.g., a sampling needle) with a pipette nozzle and have a driving section for driving the pipette to quantitatively aspirate a blood sample to be measured through the pipette nozzle, for example, the sampling needle is moved into a sample container containing the blood sample to aspirate the blood sample to be measured by driving of the driving section.

Sample preparation device 120 is configured to prepare a first measurement sample comprising a portion of a blood sample to be tested and a diluent, and to prepare a second measurement sample comprising a portion of the blood sample to be tested, a hemolysis agent for lysing red blood cells, and a first stain. Alternatively, the sample preparation device 120 may also be used to prepare a third assay sample comprising a portion of the blood sample to be tested, a diluent, and a second stain.

In some embodiments, the sample preparation device 120 may have at least one reaction well and a reagent supply device (not shown). The at least one reaction cell is for receiving a blood sample to be measured sucked by the sampling device 110, and the reagent supply device supplies a processing reagent (including a diluent, a hemolyzing agent, a first staining agent, a second staining agent, etc.) to the at least one reaction cell, so that the blood sample to be measured sucked by the sampling device 110 is mixed with the processing reagent supplied by the reagent supply device in the reaction cell to prepare a measurement sample (including a first measurement sample and a second measurement sample).

In a specific example, the at least one reaction cell may include a first reaction cell and a second reaction cell, and the reagent supply device may include a first reagent supply part and a second reagent supply part. The sampling device 110 is used for partially distributing the collected blood sample to be tested to the first reaction tank and the second reaction tank respectively. The first reagent supply section is configured to supply a diluent to the first reaction cell, so that a portion of the blood sample to be measured distributed to the first reaction cell is mixed with the diluent and reacted to prepare a first measurement sample. The second reagent supply section is configured to supply the hemolysis agent and the first staining agent to the second reaction cell, so that a portion of the blood sample to be measured, which is allocated to the second reaction cell, is mixed and reacted with the hemolysis agent and the first staining agent to prepare a second measurement sample.

Here, the hemolytic agent is used to lyse erythrocytes in blood and break them into fragments, but can keep the morphology of leukocytes substantially unchanged. The first stain may be a stain for effecting the classification of leukocytes, for example, may be a stain capable of effecting the classification of leukocytes in a blood sample into at least three leukocyte subpopulations (monocytes, lymphocytes and neutrophils), or may be a stain capable of effecting the identification of basophils and/or nucleated erythrocytes in a blood sample.

In some embodiments, the hemolytic agent may include at least one of an alkyl glycoside, a triterpenoid saponin, a steroid saponin, and the first stain may include a membrane-specific dye or a mitochondrial-specific dye. Further examples of the first stain of the haemolytic agent provided by the present application may be referred to PCT patent application WO2019/206300A1 filed by applicant at 26, 4, 2019, the entire disclosure of which is incorporated herein by reference.

Optionally, the at least one reaction tank may further include a third reaction tank, and the reagent supply device may further include a third reagent supply part. The sampling device 110 is also used to partially distribute the collected blood samples to be tested to the third reaction cell, respectively. The third reagent supplying section is configured to supply the diluent and the second coloring agent to the third reaction cell, so that a portion of the blood sample to be measured distributed to the third reaction cell is mixed and reacted with the diluent and the second coloring agent to prepare a third measurement sample. Here, the diluent is used to spheroidize cells and has an effect of promoting staining, the second stain is different from the first stain and the second stain is a stain that can be used to identify platelets in a blood sample.

The detection device 130 has an optical detection device 131 for detecting the second measurement sample prepared by the sample preparation device 120 to obtain optical information of the second measurement sample (this is also referred to as a hemolysis optical detection channel) and optionally detecting the third measurement sample prepared by the sample preparation device 120 to obtain optical information of the third measurement sample (this is also referred to as an optical platelet detection channel), and an impedance detection device 132 for detecting the first measurement sample prepared by the sample preparation device 120 to obtain electronic information of the first measurement sample (this is also referred to as an impedance detection channel).

The impedance detection device 132 includes a first flow cell for the passage of the first measurement sample and a detection means for acquiring electronic information of the passage of the first measurement sample through the first flow cell.

In one embodiment of the impedance detection device 132, the impedance detection device 132 is configured as a sheath flow impedance detection device. As shown in fig. 2, the sheath flow impedance sensing device 132 includes a first flow chamber 1321 having an aperture 1322 with an electrode 1323. The sheath flow impedance detecting device 132 detects the direct current impedance generated when particles in the first measurement sample pass through the hole 1322, and outputs an electric signal (i.e., electronic information) reflecting information when the particles pass through the hole. Specifically, the sampling device 110 is driven by its driving device and moves to the first reaction cell of the sample preparation device 120 after sucking the blood sample to be tested, and a part of the sucked blood sample to be tested is injected into the first reaction cell. The transfer line 1326 transfers the first measurement sample treated with the diluent in the first reaction cell to the first flow chamber 1321. The sheath flow impedance sensing device 132 may also be provided with a sheath fluid reservoir, not shown, for providing sheath fluid to the first flow chamber 1321. In the first flow chamber 1321, the first measurement sample flows through the small hole 1322 under the sheath fluid, so that the first measurement sample becomes a trickle, and particles contained in the first measurement sample pass through the small hole 1322 one by one. The electrode 1323 is electrically connected to a dc power supply 1324, and the dc power supply 1324 supplies dc power between the pair of electrodes 1323. During the period when the dc power supply 1324 supplies dc power, the impedance between the pair of electrodes 1323 can be detected, and a resistance signal (i.e., electronic information) indicating the change in impedance is amplified by the amplifier 1325 and then supplied to the controller 140. Since the magnitude of the resistance signal corresponds to the volume (size) of the particles, a first platelet count result may be obtained by signal processing the resistance signal by the controller 140.

The optical detection device 131 includes a second flow cell for passing the second measurement sample, a light source for irradiating the second measurement sample passing through the second flow cell with light, and a light detector for detecting optical information generated after the second measurement sample is irradiated with light while passing through the second flow cell. Optionally, the third flow chamber is further configured to pass a third measurement sample, the light source is further configured to illuminate the third measurement sample passing through the second flow chamber with light, and the light detector is further configured to detect optical information generated after the third measurement sample is illuminated while passing through the second flow chamber.

In one embodiment of the optical detection device 131, as shown in FIG. 3, the optical detection device 131 has a light source 1311, a beam shaping assembly 1312, a second flow chamber 1313, and a forward scatter detector 1314 arranged in that order. On one side of the flow chamber 1313, a dichroic mirror 1316 is arranged at an angle of 45 ° to the straight line. A part of the side light emitted by blood cells in the flow cell 1313 is transmitted through the dichroic mirror 1316 and captured by the fluorescence detector 1315 arranged behind the dichroic mirror 1316 at an angle of 45 ° to the dichroic mirror 1316, while another part of the side light is reflected by the dichroic mirror 1316 and captured by the side scatter detector 1317 arranged in front of the dichroic mirror 1316 at an angle of 45 ° to the dichroic mirror 1316. Platelets in the blood sample may be counted based on optical information such as forward scattered light signals captured by forward scattered light detector 1314, side scattered light signals captured by side scattered light detector 1317, and fluorescent signals captured by fluorescent light detector 1315.

The controller 140 includes a processor and a storage medium storing a computer program. The controller 140 is configured to control the impedance detection device 132 and the optical detection device 131 to detect the first and second (and optionally also the third) measurement samples when the computer program is executed by the processor to obtain and output a platelet count result of the blood sample to be tested.

In some embodiments, as shown in fig. 1, the sample analyzer 100 may further include a display device 150, a first housing 160, and a second housing 170. The display device 150 is configured to display information related to the platelet count, such as the platelet count result. The detecting device 130 and the controller 140 are disposed inside the second housing 170, and disposed at both sides of the second housing 170, respectively. The sample preparation device 120 is disposed inside the first casing 160. The display device 150 is disposed on an outer surface of the first casing 160.

A specific flow of the controller 140 of the sample analyzer provided by the present application to acquire and output the platelet count result will be described with reference to fig. 4 to 16.

In some embodiments, as shown in fig. 4, the controller 140 may be configured to perform the following steps:

S210: controlling the impedance detecting means 200 to detect platelets in the first measurement sample to acquire electronic information of the first measurement sample;

s220: controlling the optical detection device 300 to detect platelets in the second measurement sample to obtain optical information of the second measurement sample;

s230: executing a judging step in which it is judged whether or not the platelet detection of the second measurement sample by the optical detection device is abnormal and/or whether or not the platelet detection of the first measurement sample by the impedance detection device is abnormal; and is also provided with

S240: at least one of a first platelet count result PLT-I obtained based on the electronic information of the first measurement sample, a second platelet count result PLT-W obtained based on the optical information of the second measurement sample only, and a third platelet count result PLT-H obtained based on the electronic information of the first measurement sample and the optical information of the second measurement sample is selected and outputted according to the judgment result of the judgment step.

It should be understood that step S210 and step S220 may be performed simultaneously or sequentially, which is not particularly limited in the present application.

In embodiments of the present application, the second platelet count result PLT-W or the third platelet count result PLT-H is not obtained by adding a dedicated optical platelet detection channel as in the prior art, but may be obtained using an existing hemolysis optical detection channel, such as a white blood cell sorting channel or a nucleated red blood cell detection channel. Since the blood routine tests typically include at least impedance-based platelet tests and white blood cell classification, the acquisition of the second and third platelet count results does not substantially increase the cost of the test.

In some embodiments, the controller 140 may be configured to obtain a second platelet count result PLT-W of the blood sample to be tested based only on optical information of the second assay sample, such as described in PCT patent application WO2019/206300A1 filed by applicant at 2019, month 4, 26, the entire disclosure of which is incorporated herein by reference.

In yet other alternative embodiments, the controller 140 may be configured to obtain the second platelet count result PLT-H of the blood sample to be tested based on the electronic information of the first measurement sample and the optical information of the second measurement sample. For example, in one example, a first platelet histogram is generated based on electronic information of a first measurement sample, a second platelet histogram is generated based on scattered light information in optical information of a second measurement sample, and then a second platelet count result PLT-H is calculated from the first platelet histogram and the second platelet histogram. For further embodiments and details reference is made to PCT patent application WO2019/206313A1 filed by applicant at 26, 4, 2019, the entire disclosure of which is incorporated herein by reference.

Preferably, the controller 140 may be further configured to: in the judgment step S230, it is judged whether or not the platelet detection by the optical detection device on the second measurement sample is abnormal and whether or not the platelet detection by the impedance detection device on the first measurement sample is abnormal.

In some embodiments, as shown in fig. 5, the controller 140 may be further configured to perform the following steps when performing step S230 and step S240:

s231a: judging whether the platelet detection of the second measurement sample by the optical detection device is abnormal or not;

s231b: when the optical detection device is judged to detect abnormality of the platelet of the second measurement sample, judging whether the impedance detection device is abnormal for detecting the platelet of the first measurement sample;

s241a: and outputting a second platelet count result PLT-W when the optical detection device is judged to be normal for platelet detection of the second measurement sample.

Further, as shown in fig. 6, the controller 140 is further configured to perform the following steps when performing step S240:

s241b: when it is determined that the impedance detecting device detects abnormality in platelets of the first measurement sample, at least one of the first platelet count result PLT-I and the second platelet count result PLT-W is output.

S241c: when the impedance detecting device is judged to be normal in platelet detection of the first measurement sample, a first platelet count result PLT-I is output.

Alternatively, the controller 140 may also output an alarm prompt when executing step S241b, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

Alternatively to step S241b of the embodiment shown in fig. 6, in other embodiments, as shown in fig. 7, the controller 140 is further configured to perform step 250:

when the optical detection device is judged to be abnormal in platelet detection of the second measurement sample and the impedance detection device is judged to be abnormal in platelet detection of the first measurement sample, the sample preparation device 120 is controlled to prepare a third measurement sample containing a part of the blood sample to be measured, a diluent and a second stain, and the optical detection device is controlled to detect platelets in the third measurement sample to acquire optical information of the third measurement sample.

Further, in the embodiment shown in fig. 7, the controller 140 is further configured to perform the following steps when performing step S230 and step S240:

s232: judging whether the platelet detection in the third measurement sample is abnormal or not by the optical detection device;

s242a: when it is judged that the optical detection device is normal to detect platelets in the third measurement sample, a fourth platelet count result PLT-O obtained based on the optical information of the third measurement sample is output.

Further, in the embodiment shown in fig. 7, the controller 140 may be further configured to perform step S242b when performing step S240: when it is judged that the optical detection device detects abnormality in platelets in the third measurement sample, at least one of the first platelet count result PLT-I, the second platelet count result PLT-W, and the fourth platelet count result PLT-O.

Optionally, the controller 140 may also output an alarm prompt when executing step S242b, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

Alternatively to the embodiment shown in fig. 7, in other embodiments, it is also possible to determine whether the impedance detecting device detects an abnormality in platelets of the first measurement sample, and then determine whether the optical detecting device detects an abnormality in platelets of the second measurement sample. As shown in fig. 8, the controller 140 may be further configured to perform the steps of:

s233a: judging whether the platelet detection of the first measurement sample by the impedance detection device is abnormal or not;

s233b: when judging that the impedance detection device detects abnormality of the blood platelet of the first measurement sample, judging whether the optical detection device detects abnormality of the blood platelet of the second measurement sample;

s243a: outputting a first platelet count result PLT-I when the impedance detection device is judged to be normal for platelet detection of the first measurement sample;

s243b: and outputting a second platelet count result PLT-W when the optical detection device is judged to be normal for platelet detection of the second measurement sample.

S251: when it is determined that the optical detection device detects abnormality in platelet of the second measurement sample, controlling the sample preparation device 120 to prepare a third measurement sample containing a part of the blood sample to be measured, the diluent, and the second stain, and controlling the optical detection device to detect platelet in the third measurement sample to acquire optical information of the third measurement sample;

S233c: judging whether the platelet detection in the third measurement sample is abnormal or not by the optical detection device;

s243c: when it is judged that the optical detection device is normal to detect platelets in the third measurement sample, a fourth platelet count result PLT-O obtained based on the optical information of the third measurement sample is output.

S243d: when it is judged that the optical detection device detects abnormality in platelets in the third measurement sample, at least one of the first platelet count result PLT-I, the second platelet count result PLT-W, and the fourth platelet count result PLT-O.

Alternatively, the controller 140 may also output an alarm prompt when executing step S243d, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

Since the third platelet count result PLT-H is obtained based on the electronic information of the first measurement sample and the optical information of the second measurement sample, whether or not the platelet detection of the first measurement sample by the impedance detection device is abnormal and whether or not the platelet detection of the second measurement sample by the optical detection device is abnormal affect the accuracy of the third platelet count result PLT-H. Thus, in alternative embodiments to the embodiment shown in fig. 5, in other embodiments, as shown in fig. 9, the controller 140 may be further configured to perform the following steps when performing step S240:

S244a: when the optical detection device is judged to be normal for platelet detection of the second measurement sample and the impedance detection device is judged to be normal for platelet detection of the first measurement sample, the first platelet count result PLT-I or the third platelet count result PLT-H is output.

S244b: when it is judged that the platelet detection of the second measurement sample by the optical detection device is abnormal and the platelet detection of the first measurement sample by the impedance detection device is normal, a first platelet count result PLT-I is output.

Further, in the embodiment shown in fig. 9, the controller 140 may be further configured to perform the steps of:

s252: when the optical detection device is judged to be abnormal in platelet detection of the second measurement sample and the impedance detection device is judged to be abnormal in platelet detection of the first measurement sample, controlling the sample preparation device 110 to prepare a third measurement sample containing a part of the blood sample to be measured, a diluent and a second coloring agent, and controlling the optical detection device to detect platelets in the third measurement sample so as to acquire optical information of the third measurement sample;

s234: judging whether the platelet detection in the third measurement sample is abnormal or not by the optical detection device;

S244c: outputting a fourth platelet count result PLT-O obtained based on the optical information of the third measurement sample when the optical detection device is judged to be normal for detecting platelets in the third measurement sample;

s244d: when it is judged that the optical detection device detects abnormality in platelets in the third measurement sample, at least one of the first platelet count result PLT-I, the third platelet count result PLT-H, and the fourth platelet count result PLT-O.

Optionally, the controller 140 may also output an alarm prompt when executing step S244d, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

According to some embodiments, the controller 140 may be further configured to determine in the determining step whether the platelet detection of the first assay sample by the impedance detection device is abnormal; outputting a first platelet count result PLT-I when the impedance detection device is judged to be normal for platelet detection of the first measurement sample; when it is judged that the impedance detecting device detects abnormality of platelets in the first measurement sample, the sample preparing device is controlled to prepare a third measurement sample containing a part of the blood sample to be measured, the diluent and the second stain, and the optical detecting device is controlled to detect platelets in the third measurement sample to acquire optical information of the third measurement sample.

In one specific example, as shown in fig. 10, the controller 140 is configured to perform the steps of:

in step S230, it is determined whether or not the impedance detecting device detects abnormality in platelets in the first measurement sample;

s245a: outputting a first platelet count result PLT-I when the impedance detection device is judged to be normal for platelet detection of the first measurement sample;

s253: when it is judged that the impedance detecting means detects abnormality in platelet of the first measurement sample, the sample preparing means 110 is controlled to prepare a third measurement sample containing a part of the blood sample to be measured, a diluent, and a second stain, and the optical detecting means is controlled to detect platelets in the third measurement sample to acquire optical information of the third measurement sample;

step S235, judging whether the platelet detection in the third measurement sample is abnormal or not by the optical detection device;

s245b: outputting a fourth platelet count result PLT-O obtained based on the optical information of the third measurement sample when the optical detection device is judged to be normal for detecting platelets in the third measurement sample;

s245c: when it is determined that the optical detection device detects an abnormality in platelets in the third measurement sample, at least one of the first platelet count result PLT-I and the fourth platelet count result PLT-O is output.

Optionally, the controller 140 may also output an alarm prompt when executing step S245c, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

In some alternative embodiments, as shown in fig. 11, the controller 140 may be further configured to perform the following steps when performing steps S230 and S240:

s236a, judging whether the platelet detection of the first measurement sample by the impedance detection device is abnormal;

s236b: when judging that the impedance detection device is normal to platelet detection of the first measurement sample, judging whether the platelet detection of the optical detection device is abnormal to platelet detection of the second measurement sample;

s246a: outputting a first platelet count result PLT-I or a second platelet count result PLT-W or a third platelet count result PLT-H when the optical detection device is judged to be normal for platelet detection of the second measurement sample;

s246b: when it is judged that the optical detection device detects abnormality in platelet of the second measurement sample, the first platelet count result PLT-I is outputted.

Further, on the basis of the embodiment shown in fig. 11, as shown in fig. 12, the controller 140 may be further configured to perform the following steps:

s254: when the impedance detection device is judged to be abnormal in platelet detection of the first measurement sample, controlling the sample preparation device to prepare a third measurement sample containing a part of blood sample to be detected, diluent and a second staining agent, and controlling the optical detection device to detect platelets in the third measurement sample so as to acquire optical information of the third measurement sample;

S236c, judging whether the platelet detection in the third measurement sample is abnormal or not by the optical detection device;

s246c: when it is judged that the optical detection device is normal to detect platelets in the third measurement sample, a fourth platelet count result PLT-O obtained based on the optical information of the third measurement sample is output.

S246d: when it is determined that the optical detection device detects an abnormality in platelets in the third measurement sample, at least one of the first platelet count result PLT-I, the second platelet count result PLT-W, the third platelet count result PLT-H, and the fourth platelet count result PLT-O is output.

Optionally, the controller 140 may also output an alarm prompt when executing step S246d, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

Alternatively to the embodiment shown in fig. 12, based on the embodiment shown in fig. 11, as shown in fig. 13, the controller 140 may be further configured to perform the following steps:

s236d: when judging that the impedance detection device detects abnormality of the blood platelet of the first measurement sample, judging whether the optical detection device detects abnormality of the blood platelet of the second measurement sample;

s246e: outputting a second platelet count result PLT-W when the optical detection device is judged to be normal for platelet detection of the second measurement sample;

S255: when the optical detection device is judged to detect abnormal platelet of the second measurement sample, controlling the sample preparation device to prepare a third measurement sample containing a part of blood sample to be detected, diluent and second coloring agent, and controlling the optical detection device to detect platelet in the third measurement sample so as to acquire optical information of the third measurement sample;

s236d, judging whether the platelet detection in the third measurement sample is abnormal or not by the optical detection device;

s246f: when it is judged that the optical detection device is normal to detect platelets in the third measurement sample, a fourth platelet count result PLT-O obtained based on the optical information of the third measurement sample is output.

S246g: when it is determined that the optical detection device detects an abnormality in platelets in the third measurement sample, at least one of the first platelet count result PLT-I, the second platelet count result PLT-W, and the fourth platelet count result PLT-O is output.

Optionally, the controller 140 may also output an alarm prompt when executing step S246g, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

In some embodiments, the optical platelet channel of the sample analyzer may be a normally open channel, that is, the platelet detection of the third assay sample by the optical detection device may be activated, i.e., the detection mode of the blood sample to be measured comprises the detection of the optical platelet channel. Accordingly, as shown in fig. 14, the controller 140 may also be configured to perform the following steps:

S260: controlling the optical detection device to detect platelets in the third measurement sample so as to acquire optical information of the third measurement sample;

in the determination step S230, it is also determined whether or not the platelet detection of the third measurement sample by the optical detection device is abnormal; and is also provided with

In step S240, at least one of a first platelet count result PLT-I obtained based on the electronic information of the first measurement sample, a second platelet count result PLT-W obtained based on the optical information of the second measurement sample alone, a third platelet count result PLT-H obtained based on the electronic information of the first measurement sample and the optical information of the second measurement sample, and a fourth platelet count result PLT-O obtained based on the optical information of the third measurement sample is selected and outputted according to the judgment result of the judgment step.

Further, the controller 140 may be further configured to perform the following steps when performing steps S230 and S240:

when the optical detection device is judged to be abnormal in platelet detection of the third measurement sample, judging whether the impedance detection device is abnormal in platelet detection of the first measurement sample and/or the optical detection device is abnormal in platelet detection of the second measurement sample; and is also provided with

And outputting a fourth platelet count result PLT-O when the optical detection device is judged to be normal for detecting the third measurement sample.

In one example, as shown in fig. 15, the controller 140 may be configured to perform the following steps when performing steps S230 and S240:

s237a: judging whether the platelet detection of the third measurement sample by the optical detection device is abnormal or not;

s237b: when the optical detection device is judged to be abnormal in platelet detection of the third measurement sample, judging whether the optical detection device is abnormal in platelet detection of the second measurement sample;

s237c: when the optical detection device is judged to detect abnormality of the platelet of the second measurement sample, judging whether the impedance detection device is abnormal for detecting the platelet of the first measurement sample; and is also provided with

S247a: and outputting a second platelet count result PLT-W when the optical detection device is judged to be normal for platelet detection of the second measurement sample.

Further, in the embodiment shown in fig. 15, the controller 140 may be further configured to perform the following steps when performing step S240:

s247b: outputting at least one of a first platelet count result PLT-I, a second platelet count result PLT-W, and a fourth platelet count result PLT-O when it is determined that the impedance detecting device detects abnormality in platelets of the first measurement sample; and is also provided with

S247c: when the impedance detecting device is judged to be normal in platelet detection of the first measurement sample, a first platelet count result PLT-I is output.

Alternatively, the controller 140 may also output an alarm prompt when executing step S247b, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

According to some embodiments, the controller 140 may be further configured to: when the optical detection device is judged to detect abnormality of the platelet of the third measurement sample, judging whether the impedance detection device and/or the optical detection device is abnormal or not based on the integrated platelet information obtained by the electronic information of the first measurement sample and the optical information of the second measurement sample; judging whether the platelet detection of the first measurement sample by the impedance detection device is abnormal or not when judging that the impedance detection device and/or the optical detection device is abnormal based on the comprehensive platelets; outputting a third platelet count result when the impedance detection device and/or the optical detection device are/is judged to be normal based on the integrated platelets; and outputting a fourth platelet count result when the optical detection device is judged to be normal to detect the third measurement sample.

In a specific example, as shown in fig. 16, the controller 140 may be further configured to perform the following steps when performing steps S230 and S240:

S238a: judging whether the platelet detection of the third measurement sample by the optical detection device is abnormal or not;

s238b: when it is judged that the optical detection device detects abnormality of platelets of the third measurement sample, judging whether or not the impedance detection device and/or the optical detection device is abnormal based on integrated platelet information obtained from the electronic information of the first measurement sample and the optical information of the second measurement sample;

s238c: judging whether the platelet detection of the first measurement sample by the impedance detection device is abnormal or not when the impedance detection device and/or the optical detection device are/is abnormal based on the integrated platelets;

s248a: outputting a third platelet count result PLT-H when the impedance detection device and/or the optical detection device are/is judged to be normal based on the integrated platelets;

s248b: outputting a fourth platelet count result PLT-O when the optical detection device is judged to be normal for detecting the third measurement sample;

s248c: outputting at least one of a first platelet count result PLT-I, a third platelet count result PLT-H, and a fourth platelet count result PLT-O when it is determined that the impedance detecting device detects abnormality in platelets of the first measurement sample; and is also provided with

S248d: when the impedance detecting device is judged to be normal in platelet detection of the first measurement sample, a first platelet count result PLT-I is output.

Optionally, the controller 140 may also output an alarm prompt when executing step S248c, so as to prompt the user that the detection of the optical detection device and the impedance detection device is abnormal.

In some embodiments, when the sample analyzer is configured to obtain the first platelet count result PLT-I (impedance detection channel), the third platelet count result PLT-H (impedance detection channel combined with the hemolysis optical detection channel), and the fourth platelet count result PLT-O (optical platelet detection channel) simultaneously, the corresponding platelet count results may be output through table 1, where Y represents that the channel measurement is normal, and N represents that the channel measurement is faulty.

TABLE 1

In other embodiments, when the sample analyzer is configured to obtain the first platelet count result PLT-I (impedance detection channel), the second platelet count result PLT-W (hemolysis optical detection channel), and the fourth platelet count result PLT-O (optical platelet detection channel) simultaneously, the corresponding platelet count results may be output through table 2, where Y represents that the channel measurement is normal and N represents that the channel measurement is faulty.

TABLE 2

In an embodiment of the present application, the second platelet count result PLT-H or PLT-W is calculated based on the optical information of the second measurement sample subjected to the hemolysis and staining process. Based on this, in some embodiments, the controller 140 may be further configured to: and acquiring a leukocyte classification result and/or a leukocyte count result and/or a naive granulocyte detection result of the blood sample to be tested based on the optical information of the second measurement sample. For example, in one example, the controller 140 may classify the leukocytes into at least neutrophils, lymphocytes, and monocytes based on the optical information of the second assay sample.

Alternatively, in other embodiments, the controller 140 may be further configured to: basophil information and/or nucleated red blood cells of the blood sample to be measured are identified based on the optical information of the second measurement sample.

In an embodiment of the present application, the impedance detection device performs platelet detection of the first measurement sample through the impedance detection channel, the optical detection device performs platelet detection of the second measurement sample through the hemolysis optical detection channel, and the optical detection device performs platelet detection of the third measurement sample through the platelet optical detection channel. In the detection process, the conditions of unstable liquid flow, noise interference and the like of each detection channel can occur, so that abnormal platelet detection is caused.

For example, platelet detection by the impedance detection channel is abnormal due to clogging, flow instability, noise interference; platelet detection by the hemolysis optical detection channel is abnormal due to unstable flow and noise interference; platelet detection by the platelet optical detection channel is abnormal due to unstable flow and noise interference.

Thus, according to some embodiments, the controller 140 may be further configured to determine whether the platelet detection process of the impedance detection device on the first assay sample is abnormal by identifying the presence or absence of a plugged hole, unstable flow, and/or noise disturbance in the impedance detection device.

In addition, the controller 140 may be further configured to determine whether platelet detection of the second measurement sample and/or the third measurement sample by the optical detection device is abnormal by identifying whether flow instability and/or noise interference is present in the optical detection device.

The method for determining noise disturbance and instability of the liquid flow is described below.

In some embodiments, it may be determined whether platelet detection is disturbed based on the detection signal of a non-blood sample, typically a blood cell-free material directly drawn by a sample analyzer, such as: dilution, air, and the like. FIG. 17 is a graph of detection signals of non-blood sample substances that are not disturbed by noise, according to some embodiments of the application. FIG. 18 is a graph of detection signals of noise-disturbed non-blood sample substances according to some embodiments of the application.

In one specific example, if the number of particles of the identified non-blood sample material is greater than a fixed threshold, then noise interference is considered.

In another specific example, if the non-blood sample material measurement signal is not stationary over time, then a noisy disturbance is considered.

The method for judging the signal stability can be, for example, the following method: the detection signal is noted as x= [ X1, X2, X3, ], xn ], the standard deviation of the detection signal is calculated according to the following formula, and if the standard deviation is greater than a set threshold, the signal is considered to be unstable.

Alternatively, the coefficient of variation of the measurement signal may also be calculated according to the following formula, and if the coefficient of variation is greater than a set threshold, the signal is considered to be unstable, i.e. noisy.

Alternatively, the total number of measurement signals greater than a certain threshold may be denoted as P, and the total number of measurement signals may be denoted as T ifThe signal is considered to be not stationary, i.e. noisy.

Alternatively or additionally, in other embodiments, it may be determined whether platelet detection is disturbed based on the stability of the fluid flow of particles individually through the detection device. This applies to impedance detection channels, hemolysis optical detection channels and optical platelet detection channels.

Fig. 19 is a schematic diagram of detecting a number of particles per second (i.e., a number of particles detected per second that pass through a detection region) in a detection apparatus according to some embodiments of the application. The left side of fig. 19 shows the number of particles detected per second when the flow is stable, and the right side of fig. 19 shows the number of particles detected per second when the flow is unstable.

The method for determining the stability of the liquid flow is similar to the method for determining the stability of the signal, and will not be described herein.

The features or combinations of features mentioned above in the description, in the drawings and in the claims may be used in any combination with one another or individually, as long as they are significant and do not contradict one another within the scope of the application.

The foregoing description is only of the preferred embodiments of the present application and is not intended to limit the scope of the application, and all equivalent modifications made by the present application and the accompanying drawings, or direct/indirect application in other related technical fields are included in the scope of the present application.

Claims

1. A sample analyzer, comprising:

a sample preparing unit for preparing a first measurement sample containing a part of a blood sample to be measured and a diluent, and a second measurement sample containing a part of the blood sample to be measured, a hemolytic agent for lysing red blood cells, and a first staining agent;

an impedance detection device comprising a first flow chamber for the passage of the first measurement sample and a detection means for acquiring electronic information of the passage of the first measurement sample through the first flow chamber;

an optical detection device including a second flow cell for passing the second measurement sample, a light source for irradiating the second measurement sample passing through the second flow cell with light, and a light detector for detecting optical information generated after the second measurement sample is irradiated with light while passing through the second flow cell; and

A controller configured to:

controlling the impedance detection device to detect platelets in the first measurement sample to acquire electronic information of the first measurement sample,

controlling the optical detection device to detect platelets in the second measurement sample to obtain optical information of the second measurement sample,

a judging step of judging whether or not the platelet detection of the second measurement sample by the optical detection device is abnormal and/or judging whether or not the platelet detection of the first measurement sample by the impedance detection device is abnormal, and

and selecting and outputting at least one of a first platelet count result obtained based on the electronic information of the first measurement sample, a second platelet count result obtained based on the optical information of the second measurement sample only, and a third platelet count result obtained based on the electronic information of the first measurement sample and the optical information of the second measurement sample according to the judgment result of the judgment step.

2. The sample analyzer of claim 1, wherein the controller is further configured to:

in the judging step, it is judged whether or not the platelet detection by the optical detection device on the second measurement sample is abnormal and whether or not the platelet detection by the impedance detection device on the first measurement sample is abnormal.

3. The sample analyzer of claim 2, wherein the controller is further configured to:

when the optical detection device is judged to be abnormal in platelet detection of the second measurement sample, judging whether the impedance detection device is abnormal in platelet detection of the first measurement sample;

and outputting the second platelet count result when the optical detection device is judged to be normal in platelet detection of the second measurement sample.

4. The sample analyzer of claim 3, wherein the controller is further configured to:

outputting at least one of the first platelet count result and the second platelet count result when it is determined that the impedance detecting device detects an abnormality in platelets of the first measurement sample;

and outputting the first platelet count result when the impedance detection device is judged to be normal for platelet detection of the first measurement sample.

5. The sample analyzer of claim 2, wherein the controller is further configured to:

outputting the first platelet count result or the third platelet count result when it is judged that the platelet detection of the second measurement sample by the optical detection device is normal and the platelet detection of the first measurement sample by the impedance detection device is normal; and

Outputting the first platelet count result when it is judged that the optical detection device detects abnormal platelets of the second measurement sample and it is judged that the impedance detection device detects normal platelets of the first measurement sample.

6. The sample analyzer of claim 2, 3 or 5, wherein the controller is further configured to:

when it is judged that the optical detection device detects abnormality of platelets in the second measurement sample and it is judged that the impedance detection device detects abnormality of platelets in the first measurement sample, the sample preparation device is controlled to prepare a third measurement sample containing a part of the blood sample to be measured, a diluent, and a second stain, and the optical detection device is controlled to detect platelets in the third measurement sample to acquire optical information of the third measurement sample.

7. The sample analyzer of claim 1, wherein the controller is further configured to:

in the judging step, judging whether or not the impedance detecting device detects an abnormality in platelets of the first measurement sample;

outputting the first platelet count result when the impedance detection device is judged to be normal for platelet detection of the first measurement sample;

When it is judged that the impedance detecting device detects abnormality in platelets of the first measurement sample, the sample preparing device is controlled to prepare a third measurement sample containing a part of the blood sample to be measured, a diluent and a second stain, and the optical detecting device is controlled to detect platelets in the third measurement sample to acquire optical information of the third measurement sample.

8. The sample analyzer of claim 2, wherein the controller is further configured to:

when the impedance detection device is judged to be normal in platelet detection of the first measurement sample, judging whether the optical detection device is abnormal in platelet detection of the second measurement sample;

outputting the first platelet count result or the second platelet count result or the third platelet count result when the optical detection device is judged to be normal for platelet detection of the second measurement sample;

and outputting the first platelet count result when the optical detection device judges that the platelet of the second measurement sample is abnormal in detection.

9. The sample analyzer of claim 8, wherein the controller is further configured to:

10. The sample analyzer of claim 8, wherein the controller is further configured to:

when judging that the impedance detection device detects abnormality of the platelet of the first measurement sample, judging whether the platelet detection of the optical detection device of the second measurement sample is abnormal or not;

outputting the second platelet count result when the optical detection device is judged to be normal for platelet detection of the second measurement sample;

when it is judged that the optical detection device detects the platelet of the second measurement sample abnormally, the sample preparation device is controlled to prepare a third measurement sample containing a part of the blood sample to be measured, a diluent and a second staining agent, and the optical detection device is controlled to detect the platelet in the third measurement sample so as to acquire the optical information of the third measurement sample.

11. The sample analyzer of any of claims 6-7 and 9-10, wherein the controller is further configured to:

in the judging step, it is further judged whether or not the optical detection device detects abnormality in platelets in the third measurement sample;

and outputting a fourth platelet count result obtained based on the optical information of the third measurement sample when the optical detection device is judged to be normal for detecting platelets in the third measurement sample.

12. The sample analyzer of claim 1, wherein the sample preparation device is further configured to prepare a third assay sample comprising a portion of the blood sample to be tested, a diluent, and a second stain;

the second flow cell is further configured to pass the third measurement sample, the light source is further configured to irradiate the third measurement sample passing through the second flow cell with light, and the photodetector is further configured to detect optical information generated after the third measurement sample is irradiated with light while passing through the second flow cell; and

the controller is further configured to:

controlling the optical detection device to detect platelets in the third measurement sample to obtain optical information of the third measurement sample,

In the judging step, it is also judged whether or not the platelet detection of the third measurement sample by the optical detection device is abnormal, and

and selecting and outputting at least one of the first platelet count result obtained based on the electronic information of the first measurement sample, the second platelet count result obtained based on the optical information of the second measurement sample only, the third platelet count result obtained based on the electronic information of the first measurement sample and the optical information of the second measurement sample, and the fourth platelet count result obtained based on the optical information of the third measurement sample, according to the judgment result of the judging step.

13. The sample analyzer of claim 12, wherein the controller is further configured to:

And outputting the fourth platelet count result when the optical detection device is judged to be normal to detect the third measurement sample.

14. The sample analyzer of claim 13, wherein the controller is further configured to:

when the optical detection device is judged to be abnormal in platelet detection of the third measurement sample, judging whether the optical detection device is abnormal in platelet detection of the second measurement sample;

15. The sample analyzer of claim 14, wherein the controller is further configured to:

outputting at least one of the first platelet count result, the second platelet count result, and the fourth platelet count result when it is determined that the impedance detection device detects an abnormality in platelets of the first measurement sample; and is also provided with

16. The sample analyzer of claim 12, wherein the controller is further configured to:

when it is determined that the optical detection device detects abnormality in platelets of the third measurement sample, determining whether the impedance detection device and/or the optical detection device is abnormal based on integrated platelet information obtained from the electronic information of the first measurement sample and the optical information of the second measurement sample;

judging whether or not the impedance detecting device detects the platelet of the first measurement sample as abnormal, when judging that the impedance detecting device and/or the optical detecting device are abnormal based on the integrated platelet;

outputting the third platelet count result when the impedance detection device and/or the optical detection device are/is judged to be normal based on the integrated platelets;

17. The sample analyzer of claim 16, wherein the controller is further configured to:

outputting at least one of the first platelet count result, the third platelet count result, and the fourth platelet count result when it is determined that the impedance detection device detects an abnormality in platelets of the first measurement sample;

And outputting the first platelet count result when the impedance detection device is judged to be normal to platelet detection of the first measurement sample.

18. The sample analyzer of any one of claims 11-17, wherein the controller is further configured to:

in the judging step, it is judged whether or not the platelet detection of the third measurement sample by the optical detection device is abnormal by recognizing whether or not there is a flow instability and/or noise interference in the optical detection device.

19. The sample analyzer of any one of claims 1-18, wherein the controller is further configured to:

judging whether the platelet detection process of the impedance detection device on the first measurement sample is abnormal or not by identifying whether a hole blockage, unstable liquid flow and/or noise interference exists in the impedance detection device; and/or

Determining whether platelet detection of the second measurement sample by the optical detection device is abnormal by identifying whether flow instability and/or noise interference is present in the optical detection device.

20. The sample analyzer of any one of claims 1-19, wherein the controller is further configured to:

And acquiring a leukocyte classification result and/or a leukocyte count result and/or a naive granulocyte detection result of the blood sample to be tested based on the optical information of the second measurement sample.