Patent Description:
A hematology analyzer, a smear preparation apparatus (also referred to as a smearing and staining machine), a cell image analysis apparatus, and the like are often used in blood analysis. Regular quality control is required to ensure proper function and performance of instruments such as the smearing and staining machine and the cell image analysis apparatus. In the prior art, quality control for the smearing and staining machine and the cell image analysis apparatus is performed manually, which involves complex and cumbersome operations and consumes a lot of time and labor, resulting in low efficiency.

The <CIT> discloses that, hematology analyzers typically utilize blood-like control materials ("QC materials" or "controls") for daily verification of the calibration and operation of the instruments.

In the document of "Digital morphology analyzers in hematology: ICSH review and recommendation)", DI-<NUM> system is described, which includes two hematology analyzers, a slide making/staining device and an automated digital image analyzer. Thus, a single sample placed on this system can provide a complete blood count result, perform a blood smear preparation, and also determine cell location and identification. For quality control of the identification of cell location, cell location slides (recently drawn and freshly stained blood sample with normal WBC counts) are analyzed at regular intervals and after changes in staining procedures or staining solutions.

In the document of "Standard H26-A2: Validation, Verification and Quality of Automated Hematology Analyzers; Approved Standard-second Edition", it is described that, manual microscopic differentials are part of overall QC. Collect manual and analyzer values for an appropriate number of days and determine the mean differences and SDs for each cell type, comparing them with laboratory-established target values.

In the document of "Hematology without the numbers: In-clinic Blood Film Evaluation", it is disclosed that, evaluation of the blood film is an important quality control means, and systematic blood film review is essential to confirm the number being reported by the hematology instrument.

The present invention is defined by the method of claim <NUM> and the system of claim <NUM>, which are further specified in the dependent claims. The description of the following aspects is meant as support.

According to a first aspect, a precision management method for a sample analysis system is provided in an embodiment, and includes the following steps:.

In the method, the preset condition for triggering quality control includes at least one of: completion of testing of Nth sample after the hematology analyzer initially starts testing in each cycle, a preset time, a preset load, and a preset test result, wherein N is a natural number not less than <NUM>.

In the method, comparing the first test result with the second test result of the quality control sample includes:.

Before testing samples to be analyzed by a hematology analyzer, the method further includes: performing quality control on the hematology analyzer; and if the hematology analyzer passes the quality control, testing the samples to obtain the first test results of the samples.

The method further includes: if the deviation between the first test result value and the second test result value of the preset type of cells in the quality control sample is outside the preset range, outputting prompt information indicating that the cell image analysis apparatus fails to pass quality control.

In the method, the first test result of the quality control sample includes abnormality information, and comparing the first test result with the second result of the quality control sample includes:.

In the method, the abnormality information includes at least one of malaria parasites, platelet aggregation, red blood cell aggregation, hematocrit exceeding a preset threshold, uneven size of red blood cells, and abnormal white blood cells.

The method further includes: determining quality of smearing and/or staining of the quality control blood smear based on test information related to smearing and/or staining of the quality control blood smear in the second test result.

In the method, the test information related to smearing in the second test result includes at least one of blood film morphology and cell distribution of the quality control blood smear that are obtained by the cell image analysis apparatus.

In the method, the test information related to staining in the second test result includes at least one of blood film color and color shade of the quality control blood smear that are obtained by the cell image analysis apparatus.

In the method, comparing the first test result with the second test result of the quality control sample includes:
comparing the first test result with the second test result of the quality control sample after the smearing quality and the staining quality are determined to be satisfactory.

In the method, selecting a quality control sample based on the sample test results obtained by the hematology analyzer includes: selecting a sample, which has a first test result containing a test value of a preset type of cells that falls within a preset range, as the quality control sample.

In the method, the test value of the preset type of cells in the first test result that falls within a preset range includes at least one of: a white blood cell count that falls within a preset first range, a red blood cell count that falls within a preset second range, and a mean corpuscular volume that falls within a preset third range.

In the method, selecting a quality control sample based on the sample test results obtained by the hematology analyzer includes: selecting a sample having a first test result containing abnormality information as the quality control sample, wherein preferably the abnormality information includes at least one of malaria parasites, platelet aggregation, red blood cell aggregation, hematocrit exceeding a preset threshold, uneven size of red blood cells, and abnormal white blood cells.

The method further includes: if a deviation between corresponding results in the first test result and in the second test result of the quality control sample is outside a preset range, reselecting a quality control sample from the samples to be analyzed that have been tested.

The method further includes:
printing a quality control marker on the quality control sample, and the cell image analysis apparatus switches to a quality control mode to image and analyze the quality control sample when identifying the quality control marker.

According to a second aspect, a sample analysis system is provided in an embodiment and includes:.

In the sample analysis system, the smear preparation apparatus includes:.

In the sample analysis system, the cell image analysis apparatus includes an identification apparatus configured to identify the quality control marker on the blood smear of the quality control sample.

In the sample analysis system, the second test result includes test information based on cell imaging and analysis, and test information related to quality of smearing and/or staining of the cell image analysis apparatus.

In the sample analysis system, the controller is further configured to determine quality of smearing and/or staining of the smear preparation apparatus based on the test information related to quality of smearing and/or staining of the cell image analysis apparatus in the second test result.

In the sample analysis system, the hematology analyzer is further configured to tests the sample to obtain the first test result of the sample, only after being subjected to and passing quality control.

In the sample analysis system, the controller is further configured to: if a deviation between the second test result and the first test result of the quality control sample is outside a preset range, control the display apparatus to output quality control prompt information of the cell image analysis apparatus.

According to a third aspect, an automated precision management method for a sample analysis system is provided in an embodiment and includes the following steps:.

The method further includes:
providing an automated quality control option on a display interface for selection by a user, and after an instruction for selecting the automated quality control option is received, performing the automated quality control start step.

According to a fourth aspect, a sample analysis system is provided in an embodiment and includes:.

In the system, the smear preparation apparatus includes a printing apparatus configured to print sample information on the blood smear of the quality control sample, wherein the sample information includes a quality control marker.

In the system, the controller is configured to: identify blood film morphology and/or cell distribution of the quality control blood smear based on the test information related to smearing in the second test result; and determine smearing quality of the smearing machine based on the blood film morphology and/or cell distribution of the quality control blood smear;
wherein the test information related to smearing in the second test result includes at least one of blood film morphology and cell distribution of the quality control blood smear that are obtained by the cell image analysis apparatus.

In the system, the controller is further configured to: identify at least one of blood film color and color shade of the quality control blood smear based on test information related to staining in the second test result; and determine staining quality of the smear preparation apparatus based on at least one of the blood film color and the color shade of the quality control blood smear, wherein the test information related to staining in the second test result includes at least one of blood film color and color shade of the quality control blood smear that are obtained by the cell image analysis apparatus.

In the system, the controller is further configured to: compare corresponding result information in the first test result of the quality control sample with that in the second test result of the quality control sample; and control a display apparatus to output a result of the comparison.

According to a fifth aspect, a sample analysis system is provided in an embodiment and includes:.

According to a sixth aspect, a computer-readable storage medium is provided in an embodiment and includes a program, wherein the program is capable of being executed by a processor to implement the foregoing methods.

According to the sample analysis system and the precision management method therefor in the foregoing embodiments, after the sample analysis system starts sample testing, a quality control sample may be automatically selected, the quality control sample is prepared into a quality control blood smear, and then a cell image analysis apparatus images and analyzes the quality control blood smear to obtain a test result based on the imaging and analysis. The test result of the cell image analysis apparatus is compared with a test result of a hematology analyzer, and a comparison result is output, thereby automatically completing precision management for instruments such as the cell image analysis apparatus or the hematology analyzer.

The disclosure is further described in detail below by using specific embodiments with reference to the accompanying drawings. Herein, similar elements in different embodiments are identified by similar reference numerals that are associated. In the following embodiments, many details are described to facilitate better understanding of the disclosure. However, those skilled in the art may readily understand that some features may be omitted in a different case, or may be replaced by another element, material, or method. In some cases, some operations related to the disclosure are not shown or described in this specification, this is intended to prevent excessive descriptions from dominating the core part of the disclosure, and for those skilled in the art, it is inessential to describe these related operations in detail, and they can fully understand the related operations based on the descriptions in this specification and general technical knowledge in the art.

In addition, features, operations, or characteristics described in this specification may be combined into various embodiments in any proper manner. In addition, a sequence of steps or actions in method descriptions may also be changed or adjusted in a manner obvious to those skilled in the art. Therefore, various sequences in this specification and accompanying drawings only aim to clearly describe a specific embodiment and do not indicate mandatory sequences unless it is specified that a specific sequence is mandatory.

Serial numbers of components such as "first", "second", and the like herein are only used to distinguish the described objects, and do not have any sequential or technical meaning. Unless otherwise specified, "connection" or "coupling" mentioned in the disclosure includes both direct connection and indirect connection (coupling).

<FIG> is a schematic structural diagram of a sample analysis system <NUM> according to an embodiment of the disclosure. The sample analysis system <NUM> may be a blood analysis pipeline system, which includes at least one hematology analyzer <NUM>, at least one smear preparation apparatus <NUM>, at least one cell image analysis apparatus <NUM>, and a control apparatus <NUM>.

The hematology analyzer <NUM> is configured to perform blood routine examination on a sample to be analyzed, the smear preparation apparatus <NUM> is configured to prepare a smear of the sample to be analyzed, the cell image analysis apparatus <NUM> is configured to image and analyze cells in the smear, and the control apparatus <NUM> is communicatively connected to the hematology analyzer <NUM>, the smear preparation apparatus <NUM>, and the cell image analysis apparatus <NUM>.

The sample analysis system <NUM> further includes a first transfer track <NUM> and a second transfer track <NUM>. The first transfer track <NUM> is configured to transfer a test tube rack <NUM> capable of holding a plurality of tubes <NUM> containing samples to be analyzed from the hematology analyzer <NUM> to the smear preparation apparatus <NUM>. The second transfer track <NUM> is configured to transfer a slide basket <NUM> capable of holding a plurality of prepared smears <NUM> from the smear preparation apparatus <NUM> to the cell image analysis apparatus <NUM>.

The control apparatus <NUM> is electrically connected to the first transfer track <NUM> and the second transfer track <NUM> and controls actions thereof.

The sample analysis system <NUM> further includes feeding mechanisms <NUM> and <NUM> that respectively corresponds to the hematology analyzer <NUM> and the smear preparation apparatus <NUM>. The feeding mechanisms <NUM> and <NUM> respectively include loading buffer regions <NUM> and <NUM>, feeding test regions <NUM> and <NUM>, and unloading buffer regions <NUM> and <NUM>.

When a sample to be analyzed on the test tube rack <NUM> needs to be transferred to the hematology analyzer <NUM> for testing, the test tube rack <NUM> is first transferred from the first transfer track <NUM> to the loading buffer region <NUM>, and is then transferred from the loading buffer region <NUM> to the feeding test region <NUM> for testing by the hematology analyzer <NUM>. After the test is completed, the test tube rack is unloaded from the feeding test region <NUM> to the unloading buffer region <NUM>, and finally enters the first transfer track <NUM> from the unloading buffer region <NUM>.

Likewise, when a sample to be analyzed on the test tube rack <NUM> needs to be examined via microscopy, the test tube rack <NUM> needs to be transferred to the smear preparation apparatus <NUM> for smear preparation. The test tube rack <NUM> is first transferred from the first transfer track <NUM> to the loading buffer region <NUM>, and is then transferred from the loading buffer region <NUM> to the feeding test region <NUM>, so that the smear preparation apparatus <NUM> prepares a smear. After smear preparation is completed, the test tube rack is unloaded from the feeding test region <NUM> to the unloading buffer region <NUM>, and finally enters the first transfer track <NUM> from the unloading buffer region <NUM>. The smear preparation apparatus <NUM> places the prepared smear in the slide basket <NUM>, and transfers the slide basket <NUM> containing the smear to be analyzed to the cell image analysis apparatus <NUM> via the second transfer track <NUM>, and the cell image analysis apparatus <NUM> images and analyzes cells in the sample on the smear to be analyzed.

The sample analysis system <NUM> also includes a display apparatus (not shown) configured to display a sample test result and an input apparatus configured to provide input. The display apparatus may be a liquid crystal screen, a touchscreen, an LED screen, or the like. The control apparatus <NUM> may output processed data as image display data such as analysis data and instrument operating parameters to the display apparatus for display. The input apparatus may be a mouse, a keyboard, various keys, a trackball, or the like, to facilitate input operations of a user. The display apparatus may be disposed on the hematology analyzer <NUM>, the cell image analysis apparatus <NUM>, the control apparatus <NUM>, or elsewhere.

The smear preparation apparatus <NUM> may be configured for smear preparation for blood, body fluid, and the like. As shown in <FIG>, the smear preparation apparatus <NUM> includes a smearing machine <NUM>, a staining machine <NUM>, and a printing apparatus <NUM>.

The smearing machine <NUM> is configured to smear a sample based on a preset smearing parameter. A smearing process includes dispensing the sample to a slide and spreading the sample on the slide into a blood film. The smearing machine <NUM> includes a sampling mechanism for drawing a sample, a slide loading mechanism for moving a slide to a working line, a sample adding mechanism for adding the sample onto the slide, a smearing mechanism for smearing the sample on the slide, and a drying mechanism for drying a blood film on the slide.

When drawing the sample, the sampling mechanism first mixes the sample, and then aspirates the sample by using a sampling apparatus (such as a sampling needle) in the sampling mechanism. For different the sample containers, sample aspiration may be puncture aspiration (a sample container has a lid, and the sampling apparatus passes through the lid of the sample container) or may be open aspiration (a sample container is open, and the sampling apparatus directly aspirates the sample from an opening). When necessary, blood sample information may be detected to obtain information and compare the information. In some embodiments, a micro sample feeding mechanism is also included. The micro sample feeding mechanism may directly move a test tube placed by an operator toward the sampling apparatus, or the sampling apparatus may move toward a test tube placed by an operator. In another implementation, the micro sample feeding mechanism may alternatively move a test tube toward the sample adding mechanism directly, or the sample adding mechanism may move toward a test tube placed by an operator and directly adds the sample after the sample adding mechanism (such as a blood-dropping needle) aspirates the blood sample, without drawing blood via the sampling mechanism, thereby reducing the need of blood sample and further realizing micro sample feeding and priority sample feeding. When the sampling is completed, the sample adding mechanism prepares to drop the blood onto the slide.

Correspondingly, the slide loading mechanism extracts a slide and loads the slide into a corresponding position to facilitate blood dropping operation. In some embodiments, after the slide has been extracted, operations such as detection of left and right sides of the slide and cleaning of the slide may be further performed, and then the slide is loaded. The loaded slide may be printed with related information, and operations such as detection of front and back of the slide may also be performed.

A blood-dropping needle of the sample adding mechanism drops the sample onto the slide and then smearing operation is performed. The smearing mechanism smears the blood on the slide into a shape of a blood film. Generally, after the smearing operation is completed, the blood film on the slide may be dried to maintain morphology of the blood film. The slide is shown in <FIG>. In some embodiments, the slide may be driven to turn over before drying the blood film, so as to satisfy a corresponding need. In some embodiments, the dried blood smear may further be subjected to drying examination to determine a drying effect of the blood film. In some embodiments, the dried blood smear may further be subjected to blood film spreading examination to determine whether the blood film is spread and whether a spreading state is satisfactory.

The staining machine <NUM> is configured to stain the slide, and specifically, stain the blood film on the slide based on a preset staining parameter.

The printing apparatus <NUM> is configured to print sample information on the blood smear of the sample. As shown in <FIG>, a label region is provided on the blood smear, and the sample information is printed on the label region of the blood smear. The sample information printed on the label region may include information such as a sample number, a barcode, and a quality control marker.

As shown in <FIG>, the cell image analysis apparatus <NUM>, such as a cell image analyzer, at least includes an imaging apparatus <NUM>, a smear moving apparatus <NUM>, and an image analysis apparatus <NUM>. The imaging apparatus <NUM> includes a camera <NUM> and a lens group <NUM>, and is configured to image cells in the sample smeared on the smear. The smear moving apparatus <NUM> is configured to move the smear relative to the imaging apparatus <NUM>, so that the imaging apparatus <NUM> captures cell images in a specific region of the smear. The image analysis apparatus <NUM> is configured to analyze the cell images of the smear.

As shown in <FIG>, the lens group <NUM> may include a first objective lens, a second objective lens, and an ocular lens. The first objective lens may be, for example, a 10x objective lens, and the second objective lens may be, for example, a 100x objective lens. The lens group <NUM> may further include a third objective lens, which may be, for example, a 40x objective lens.

The cell image analysis apparatus <NUM> further includes an identification apparatus <NUM>, a slide gripping apparatus <NUM>, and a smear recycle apparatus <NUM>. The identification apparatus <NUM> is configured to identify identity information of the smear. The slide gripping apparatus <NUM> is configured to grip the smear from the identification apparatus <NUM> to the smear moving apparatus <NUM> for testing. The smear recycle apparatus <NUM> is configured to hold a smear that has been subjected to testing.

The cell image analysis apparatus <NUM> further includes a slide basket loading apparatus <NUM> configured to load a slide basket containing smears to be analyzed. The slide gripping apparatus <NUM> is further configured to grip a smear to be analyzed in the slide basket loaded on the slide basket loading apparatus <NUM> to the identification apparatus <NUM> for identification of identity information. The slide basket loading apparatus <NUM> is connected to the first transfer track <NUM>, so that the smear prepared by the smear preparation apparatus <NUM> can be transferred to the cell image analysis apparatus <NUM>.

The blood analysis pipeline system provided in the disclosure includes one, two or more hematology analyzers <NUM>, and one, two or more cell image analysis apparatuses <NUM>. In an embodiment, as shown in <FIG>, an example in which the blood analysis pipeline system includes two hematology analyzers <NUM> and two cell image analysis apparatuses <NUM> is used for description. <FIG> is only used as an example, and does not limit the number of instruments and apparatuses. In the blood analysis pipeline system shown in <FIG>, the hematology analyzers <NUM>, the cell image analysis apparatuses <NUM>, and the smear preparation apparatus have been described above, and therefore are not further described herein.

The dispatching apparatus is configured to dispatch the sample and the blood smear, and includes the foregoing first transfer track <NUM>, second transfer track <NUM>, feeding mechanism <NUM>, and feeding mechanism <NUM>.

The foregoing display apparatus includes a display, and the display is disposed on the control apparatus <NUM>. The control apparatus <NUM> further includes a controller <NUM> and a memory <NUM>. The memory <NUM> is configured to store various data, such as computer programs, test results of the hematology analyzer, test results of the cell image analysis apparatus, and data generated by the smear preparation apparatus. The controller <NUM> includes a processor, which may be configured to execute a program to perform precision management on the blood analysis pipeline system. The precision management may include, for example, determination of accuracy and quality of a result provided by an instrument, and may be also referred to as quality control.

As shown in <FIG>, in an embodiment, an automated precision management method in which the sample analysis system <NUM> is a blood analysis pipeline system includes the following steps:
Step <NUM>: A sample for quality control is obtained. There is a plurality of methods of obtaining the sample for quality control, one of which is shown in <FIG>, including the following steps:.

The preset condition for triggering quality control includes at least one of: completion of testing of Nth sample after the hematology analyzer initially starts testing in each cycle, a preset time, a preset load and a preset test result , wherein N is a natural number not less than <NUM>. For example, the controller selects a quality control sample every day after the first sample has been tested, or the controller selects a quality control sample at <NUM>:<NUM> a. every day, or the controller selects a quality control sample when a load of the sample analysis system is below a preset value, or the controller determines whether the first test results of the samples obtained by the hematology analyzer <NUM> are test results that satisfy a preset condition, and if yes, the controller selects a quality control sample. The test result that satisfies the preset condition may be that various blood routine examination result values all fall within normal ranges, or may be a test result including abnormality information. The former may be used for determining whether result values of a normal sample tested by the hematology analyzer and those of the normal sample tested by the cell image analysis apparatus are consistent, and the latter may be used for determining whether abnormality information of a sample tested by the hematology analyzer and that of the sample tested by the cell image analysis apparatus is consistent. The foregoing trigger condition may be set by a user, and after the preset condition for triggering quality control is satisfied, a quality control process may be automatically performed.

The controller selects a quality control sample based on the sample test results obtained by the hematology analyzer <NUM>, wherein the selected quality control sample may be a sample with a normal result. Specifically, the controller selects a sample with a test value of a preset type of cells in the first test result that falls within a preset range, as a quality control sample. For example, a sample with a white blood cell count (WBC) that falls within a first preset range is selected as a quality control sample, a sample with a red blood cell count (RBC) that falls within a second preset range is selected as a quality control sample, or a sample with a mean corpuscular volume (MCV) that falls within a third range preset is selected as a quality control sample. Because one or more quality control samples may be selected, at least one of the three types of samples may be selected as the quality control sample, which may be specifically determined based on a quality control need. Herein, the first range, the second range, and the third range may be set based on a quality control need. For example, the first range is from <NUM> × <NUM><NUM> to <NUM> × <NUM><NUM>/L, the second range is from <NUM> × <NUM><NUM> to <NUM> × <NUM><NUM>/L, and the third range is from <NUM> to <NUM> fL. Certainly, the selected quality control sample may alternatively be a sample with an abnormal result. Specifically, the controller selects a sample having a first test result containing abnormality information as a quality control sample. Preferably, the abnormality information includes at least one of malaria parasites, platelet aggregation, red blood cell aggregation, hematocrit (HCT) exceeding a preset threshold, uneven size of red blood cells, and abnormal white blood cells. Certainly, selected samples may include both a sample with a normal result and a sample with an abnormal result, so that quality control can be performed from two perspectives, thereby satisfying various quality control needs.

Step <NUM>: The controller controls the dispatching apparatus, for example, the first track <NUM>, to transfer the quality control sample to the smearing machine of the smear preparation apparatus <NUM>.

Another method of obtaining a sample for quality control includes the following steps:.

Still another method of obtaining a sample for quality control includes the following steps:.

Regardless of the method adopted in step <NUM>, before step <NUM>, the automated precision management method may further include: providing, by the controller, an automated quality control option on a display interface of the display apparatus for selection by a user, and after an instruction for selecting the automated quality control option is received, performing the automated quality control start step, that is, step <NUM>, step <NUM>', or step <NUM>". In this way, the automated precision management method in the disclosure may be enabled or disabled by the user. If disabled, the user may manually perform the quality control operation.

Step <NUM>: The controller controls the smearing machine of the smear preparation apparatus <NUM> to prepare a blood smear from the quality control sample. Specifically, the controller controls the smearing machine to smear the quality control sample based on a preset smearing parameter, wherein a smearing process includes dispensing the quality control sample onto a slide and spreading the sample on the slide into a blood film. The smearing parameter may include width, length, tail shape, and the like of the blood film, and the smearing machine may perform smearing based on the preset smearing parameter, to prepare a blood smear that satisfies the preset smearing parameter. The prepared blood smear is shown in <FIG>. One or more blood smears may be prepared from a same sample, and the specific number of blood smears depends on a quality control need, thereby satisfying various quality control needs.

During preparation of the blood smear, the controller further controls the printing apparatus to provide sample information on the blood smear of the quality control sample, wherein the sample information includes a quality control marker. For example, the printing apparatus prints, sprays, attaches, writes, or draws the quality control marker on the label region shown in <FIG>, so that the quality control blood smear has the quality control marker, which facilitates identification. Because the quality control marker is provided, in subsequent staining and imaging, the quality control blood smear is treated differently from regular samples, and corresponding staining and imaging may be performed for the quality control blood smear based on quality control needs, to realize better quality control.

Step <NUM>: The controller controls the staining machine to stain the quality control blood smear, for example, the controls the staining machine to stain the blood film on the slide based on a preset staining parameter or a preset staining mode. The preset staining parameter may be a parameter corresponding to a characteristic (blood or body fluid) of the sample, or may be a parameter corresponding to a staining mode of the cell image analysis apparatus <NUM>. In an embodiment, the smearing machine and the staining machine both select a preset parameter or a preset mode for smearing and staining for the quality control sample, thereby preparing a blood smear matching the preset parameter or the preset mode. After the cell image analysis apparatus <NUM> subsequently analyzes the blood smear, its test result may be used for determining quality of smearing and staining of the cell image analysis apparatus <NUM>. It can be seen that sample selection, blood smear preparation and staining in the disclosure may all be performed based on quality control needs, so that quality control can be completed quickly.

After the staining machine stains the quality control blood smear, the quality control blood smear is cleaned and dried. Then the controller controls the dispatching apparatus, for example, the second transfer track <NUM>, to transfer the quality control blood smear to the cell image analysis apparatus <NUM>.

Step <NUM>: The controller controls the cell image analysis apparatus <NUM> to image and analyze the quality control blood smear to obtain a second test result. Specifically, the controller controls working of the cell image analysis apparatus <NUM>, the identification apparatus of the cell image analysis apparatus <NUM> identifies the quality control marker on the blood smear of the quality control sample, and therefore the cell image analysis apparatus <NUM> learns that this blood smear is a blood smear of the quality control sample, and then switches to a quality control mode and images and analyzes the quality control blood smear in the quality control mode to obtain the second test result. The cell image analysis apparatus <NUM> may use a slide scanner, an image captured in the quality control mode of the slide scanner is more comprehensive than an image captured in a regular mode, and a second test result obtained through analysis in the quality control mode is also more comprehensive than that obtained for a regular sample, thereby satisfying quality control needs. That is, the cell image analysis apparatus <NUM> can perform imaging and analysis based on quality control needs. For example, working modes of the cell image analysis apparatus <NUM> include a white blood cell analysis mode, a red blood cell analysis mode, a platelet analysis mode, and the like, which may be used to specifically analyze and test white blood cells, red blood cells, and platelets respectively. The quality control mode may be a combination of these three modes, and can be used to image and analyze various types of cells more comprehensively.

Step <NUM>: The controller obtains the second test result of the quality control blood smear from the cell image analysis apparatus <NUM>, compares the first test result and the second test result of the quality control sample, and controls the display apparatus to output a result of the comparison. When comparing the first test result with the second test result, if the first test result is used as a baseline, then it can be determined through the comparison whether the second test result is accurate, so as to perform quality control on the cell image analysis apparatus <NUM>; if the second test result is used as a baseline, it can be determined through the comparison whether the first test result is accurate, so as to perform quality control on the hematology analyzer <NUM>. Details are described below.

In the method shown in <FIG>, before the hematology analyzer <NUM> tests the samples to be analyzed, quality control is further performed on the hematology analyzer <NUM>; and if the hematology analyzer <NUM> passes quality control, the samples are tested to obtain the first test results of the samples. In other words, step <NUM> may be started after the hematology analyzer <NUM> passes quality control. In this way, in step <NUM>, quality control may be performed on the cell image analysis apparatus <NUM> by using the first test result obtained by the hematology analyzer <NUM> as a baseline. The quality control for the hematology analyzer <NUM> may include quality control performed on the hematology analyzer by using a standard control product, or quality control performed by comparing results of a plurality of hematology analyzers. If a test result obtained by the hematology analyzer <NUM> for the standard control product is within a preset range, or if a test result obtained by the hematology analyzer <NUM> and a test result obtained by another analyzer for a same sample are consistent, the hematology analyzer <NUM> is deemed to pass quality control.

Comparing the first test result with the second test result of the quality control sample may specifically include: comparing a first test result value of a preset type of cells in the quality control sample in the first test result with a second test result value of the preset type of cells in the second test result, for example, comparing result values of lymphocytes and neutrophils in the first test result with those in the second test result; if a deviation between the first test result value and the second test result value of the preset type of cells of the quality control sample is outside a preset range, outputting prompt information. For example, if a lymphocyte ratio of the quality control sample in the first test result is <NUM>%, a lymphocyte ratio of the quality control sample in the second test result is <NUM>%, and a preset deviation range of lymphocytes is from -<NUM>% to <NUM>%, then a deviation between the lymphocyte ratios in the first test result and the second test result is outside the preset range, and a display interface may display the deviation of <NUM>% between the lymphocyte ratios, or may prompt that the deviation between the lymphocyte ratios is outside the preset range, which indicates that at least one of the results of the hematology analyzer and the cell image analysis apparatus is inaccurate, and at least one of the hematology analyzer and the cell image analysis apparatus fails to pass quality control.

In an embodiment, if the selected quality control sample is a normal sample, which, for example, has a WBC (white blood cell) count between <NUM> × <NUM><NUM>/L and <NUM> × <NUM><NUM>/L, an RBC (red blood cell) count between <NUM> × <NUM><NUM>/L and <NUM> × <NUM><NUM>/L, and an MCV (mean corpuscular volume) between <NUM> fL and <NUM> fL, the controller compares a white blood cell count of the quality control sample in the first test result with that in the second test result, and if a deviation between the two white blood cell counts is not outside the preset range, it indicates that the test of the white blood cell count conducted by the cell image analysis apparatus <NUM> satisfies a precision requirement. The controller compares a red blood cell count of the quality control sample in the first test result and that in the second test result, and if a deviation between the two red blood cell counts is not outside the preset range, it indicates that the test of the red blood cell count conducted by the cell image analysis apparatus <NUM> satisfies a precision requirement. The controller compares a mean corpuscular volume of red blood cells in the quality control sample in the first test result and that in the second test result, if a deviation between the two mean corpuscular volumes is not outside the preset range, it indicates that the test of the mean corpuscular volume conducted by the cell image analysis apparatus <NUM> satisfies a precision requirement.

If the hematology analyzer has been subjected to quality control before testing samples, and has passed quality control, in this embodiment, a deviation between a result of a preset parameter in the first test result and a result of the preset parameter in the second test result may be obtained through comparison to determine whether the test conducted by the cell image analysis apparatus <NUM> satisfies requirements, and if the deviation is outside the preset range, prompt information indicating that the cell image analysis apparatus <NUM> fails to pass quality control is output. Certainly, a ratio of the deviation between the result of the preset parameter in the first test result and the result of the preset parameter in the second test result may further be obtained through comparison to determine whether the test conducted by the cell image analysis apparatus <NUM> satisfies requirements. Specifically, the controller obtains a ration or percentage of deviation between the second test result and the first test result of the quality control sample through comparison. For example, the ratio of deviation may be obtained by multiplying by <NUM>% a quotient of dividing the deviation by the first test result value. If the ratio of deviation between the second test result and the first test result of the quality control sample is outside a corresponding preset range, the controller outputs, via the display apparatus, prompt information indicating that the cell image analysis apparatus <NUM> fails to pass quality control. Certainly, the prompt information may be more specific, for example, prompt information indicating that a test result of a specific type of cells obtained by the cell image analysis apparatus <NUM> does not satisfy the precision requirement is output.

Herein, determining whether the ratio of deviation between the first test result and the second test result of the quality control sample is outside a preset range may include: comparing result values of a plurality of preset parameters. The result values of the preset parameters may be test values of various types of cells such as neutrophilic segmented granulocytes, lymphocytes, and eosinophils. If a deviation between the result values of any type of cells in the first test result and in the second test result is outside a range, it is indicated that the ratio of deviation between the first test result and the second test result of the quality control sample is outside the preset range. If deviations of the result values of all preset parameters in the first test result and in the second test result are not outside the preset range, it is indicated that the ratio of deviation between the first test result and the second test result of the quality control sample is not outside the preset range.

Certainly, in an optional embodiment, if a deviation between corresponding results in the first test result and in the second test result of the quality control sample is outside a preset range, the controller controls the dispatching apparatus to transfer the sample to be analyzed (the quality control sample) to another hematology analyzer for retesting, to obtain a first retest result using said hematology analyzer; the controller compares the first retest result with the second test result, to determine whether a deviation between the first retest result value and the second test result value is outside a preset range, whether a ration of deviation between the first retest result and the second test result is outside a preset range, and so on. A specific process is the same as the foregoing comparison process of the first test result and the second test result, and details are not described herein again. Retesting by another hematology analyzer instead of the hematology analyzer can eliminate interference caused by the hematology analyzer itself to quality control for the cell image analysis apparatus <NUM>.

In an optional embodiment, if a deviation between corresponding results in the first test result and in the second test result of the quality control sample is outside a preset range, the controller may alternatively control the dispatching apparatus to transfer the sample to be analyzed (quality control sample) to another cell image analysis apparatus for retesting, to obtain a second retest result using said cell image analysis apparatus; and then compare the second retest result with the first test result, to determine whether a deviation between the first test result value and the second retest result value is outside a preset range, whether a ratio of deviation between the first test result and the second retest result is outside a preset range, and so on. A specific process is the same as the foregoing comparison process of the first test result and the second test result, and details are not described herein again. Retesting by another cell image analysis apparatus instead of the cell image analysis apparatus <NUM> can eliminate interference caused by the cell image analysis apparatus <NUM> itself to quality control for the cell analyzer.

In an optional embodiment, if a deviation between corresponding results in the first test result and in the second test result of the quality control sample is outside a preset range, the controller may alternatively control the dispatching apparatus to transfer the sample to be analyzed (quality control sample) to the original hematology analyzer and the original cell image analysis apparatus for retesting, to obtain a first retest result using the original hematology analyzer and a second retest result using the original cell image analysis apparatus; and further compare the first retest result with the second retest result. A specific comparison process thereof is the same as the foregoing comparison process of the first test result and the second test result, and details are not described herein again.

As mentioned above, retesting of the quality control sample includes retesting by a new hematology analyzer, retesting by a new cell image analysis apparatus, or retesting by the original hematology analyzer or cell image analysis apparatus. Retesting of the quality control sample is performed again upon failure of initial quality control, and quality control determination may be performed again to obtain a more accurate quality control result.

In an optional embodiment, if a deviation between a corresponding result in the first test result of the quality control sample and that in the second test result of the quality control sample is outside a preset range, the controller may reselect a quality control sample from the samples to be analyzed that have been tested to conduct retesting, and perform quality control determination again to improve accuracy.

It can be seen that automated quality control for the cell image analysis apparatus <NUM> is achieved through the foregoing process, facilitating user to control the precision of the cell image analysis apparatus <NUM>. The accuracy of test results of the cell image analysis apparatus can only be guaranteed after the cell image analysis apparatus <NUM> passes quality control.

The cell image analysis apparatus <NUM> and the hematology analyzer <NUM> have their respective advantages in sample testing. The cell image analysis apparatus <NUM> is more accurate than the hematology analyzer <NUM> in terms of morphology testing of cells. Therefore, test results obtained by the cell image analysis apparatus <NUM> may be used for quality control determination for the hematology analyzer <NUM>. Specifically, the first test result of the quality control sample includes abnormality information that satisfies the preset condition for triggering quality control. For example, in step <NUM>, a sample with abnormality information is selected as a quality control sample, and the quality control sample is further used for quality control on the hematology analyzer <NUM>. The controller determines, through comparison, whether abnormality information in the first test result of the quality control sample is consistent with abnormality information in the second test result of the quality control sample; and if the abnormality information in the first test result of the quality control sample is inconsistent with the abnormality information in the second test result of the quality control sample, outputting corresponding prompt information via the display apparatus, for example, outputting prompt information indicating that testing performed by the hematology analyzer <NUM> for abnormality information is unsatisfactory. Certainly, if the two test results have consistent abnormality information, prompt information indicating that testing performed by the hematology analyzer <NUM> for abnormality information is satisfactory is outputted via the display apparatus. For example, the cell image analysis apparatus <NUM> can generally obtain more accurate corresponding test results for abnormality information such as malaria parasites, PLT aggregation, red blood cell aggregation, and abnormal cell warning. In this case, precision management may be performed on the hematology analyzer <NUM> based on the test results obtained by the cell image analyzer <NUM>. In embodiments of the disclosure, automated quality control is implemented for both the cell image analysis apparatus <NUM> and the hematology analyzer <NUM>.

Further, in an embodiment of the disclosure, quality of smearing and staining of the quality control blood smear may be further determined based on the second test result obtained by the cell image analysis apparatus <NUM>, that is, quality control may also be determined for the smearing machine and the staining machine. The second test result includes test information based on cell imaging and analysis, and test information related to quality of smearing and staining of the cell image analysis apparatus. When imaging the quality control blood smear in the quality control mode, the cell image analysis apparatus <NUM> may capture images of the quality control blood smear, and may identify blood film shape, blood film color, and the like based on an image identification algorithm; or the cell image analysis apparatus <NUM> may scan the blood smear by using its objective lens to identify information such as cell distribution, blood film boundary, blood film shape, and blood film color of the quality control blood smear. After the information related to smearing and staining is obtained, whether the quality of smearing and staining meets expectation may be determined. Because the quality control blood smear is prepared based on the preset smearing parameter and the preset staining parameter or the preset staining mode, blood film size and shape, cell distribution, color, and the like of the quality control blood smear are supposed to match the preset smearing parameter and the preset staining parameter or the preset staining mode. If it is found through the cell image analysis apparatus <NUM> that the blood film size and shape, cell distribution, color, or the like of the quality control blood smear does not match the preset smearing parameter and the preset staining parameter or the preset staining mode, it may be determined that the smear preparation apparatus fails to pass quality control.

Specifically, the controller may identify at least one of blood film morphology and cell distribution of the quality control blood smear based on the test information related to smearing in the second test result; and determine smearing quality of the smearing machine based on at least one of the blood film morphology and cell distribution of the quality control blood smear. The test information related to smearing in the second test result includes at least one of blood film morphology and cell distribution of the quality control blood smear that are obtained by the cell image analysis apparatus <NUM>, for example, a blood film morphology image and a cell distribution image of the quality control blood smear that may be obtained by the image analysis apparatus <NUM>. The controller may identify the blood film morphology in the image based on the blood film morphology image of the quality control blood smear. The controller identifies the cell distribution based on the cell distribution image of the quality control blood smear, for example, to determine whether positional distribution of specified cells in the blood film is satisfactory, if not, it indicates that the smearing is unqualified.

Similarly, the controller may further identify at least one of blood film color and color shade of the quality control blood smear based on the test information related to staining in the second test result; and determine staining quality of the smear preparation apparatus based on at least one of the blood film color and the color shade of the quality control blood smear. Herein, the test information related to staining in the second test result includes at least one of blood film color and color shade of the quality control blood smear that are obtained by the cell image analysis apparatus <NUM>. For example, the controller identifies the blood film color (such as chromatic value) and the color shade (such as gray-scale value) based on the blood film image in the second test result, or certainly, may obtain the blood film color and the color shade of the quality control blood smear directly by using the cell image analysis apparatus <NUM>; determines whether the blood film color is a preset color, and if the blood film color is not the preset color, it indicates that the staining performed by the staining machine is unqualified; and determines whether the color shade of the blood film is consistent with a preset depth, and if the color shade of the blood film is not consistent with the preset depth, it indicates that the staining is unqualified.

Therefore, automated quality control for the sample analysis system may be implemented through the foregoing process, thereby realizing high automation.

In the process shown in <FIG>, in step <NUM>, after the second test result is obtained, the controller determines the smearing quality and the staining quality, and step <NUM> is performed after it is determined that the smearing quality and the staining quality is qualified. In other words, quality control is performed on the cell image analysis apparatus <NUM> after it is determined that the smearing machine and staining machine are functioning properly in performing smearing and staining. In this way, interference caused by the smearing quality and the staining quality to the quality control for the cell image analysis apparatus <NUM> is avoided, thereby obtaining high quality control accuracy.

In conclusion, in the disclosure, quality control is implemented for the smearing machine, the staining machine, and the slide scanner based on the entire blood analysis pipeline system. Not only the entire blood analysis pipeline system performs processing automatically with little or no manual participation, and the test results may also reflect consistency and correlation of the entire pipeline system, thereby facilitating comprehensive determination on the pipeline system. Because a regular sample is tested only based on test items to obtain a result, a test process is simple, and the result can reflect only some functions and features of the system. In the disclosure, however, processes such as sample selection, smearing, staining, and slide scanning are all performed in accordance with quality control needs, with functions and features of the system all covered, and quality control determination is thus comprehensive with high accuracy.

As shown in <FIG>, in an embodiment, an automated precision management method for a sample analysis system is provided and applied to a blood analysis pipeline system including a hematology analyzer, a smear preparation apparatus and a cell image analysis apparatus. The method includes the following steps:
Step S1: After the pipeline system is ready, a user places samples to be analyzed. The pipeline system being ready means that software and hardware of the pipeline system are ready in a state capable of testing samples after the pipeline system is turned on or quits hibernation. After the samples to be analyzed are placed, the system may start a process of automated sample transfer and testing.

Batch sample testing is started. Samples in a batch are samples placed into one or more sample racks by the user, and the hematology analyzer may test these samples in sequence. The sample rack is configured to hold at least one sample, and usually is capable of holding a plurality of samples.

Step S2: The hematology analyzer tests a current sample at its test position to obtain a first test result of the sample, which is a blood routine examination result in this embodiment.

Step S3: A controller automatically selects a sample for preparing a quality control blood smear based on the blood routine examination result. The sample needs to satisfy a specific parameter requirement, for example, the sample has a WBC count between <NUM> × <NUM><NUM>/L and <NUM> × <NUM><NUM>/L, an RBC count between <NUM> × <NUM><NUM>/L and <NUM> × <NUM><NUM>/L, an MCV value between <NUM> fL and <NUM> fL, and so on. If a blood routine examination result of a specific sample satisfies this requirement, the sample may be automatically selected as a quality control sample. There may be one quality control sample. Alternatively, there may be a plurality of quality control samples. For example, some quality control samples are samples with all test items falling within a normal range, or some quality control samples are samples with some parameters being outside a limit, for example, samples whose blood routine examination results include high HCT, uneven size of RBCs, abnormal white blood cells, and the like.

Steps S4: The controller controls the dispatching apparatus to automatically transfer the quality control sample to the smearing machine.

Step S5: The controller controls the smear preparation apparatus to prepare a quality control blood smear, namely to collect a blood sample, drop the blood sample onto a slide, and spread the blood sample into a blood film. As shown in <FIG>, a method for preparing the quality control blood smear includes the following steps:.

The controller determines whether the smearing machine and the staining machine works properly based on imaging and analysis of the blood smear performed by the cell image analysis apparatus.

Step S9: The controller compares a morphology analysis result obtained by the cell image analysis apparatus with a test result obtained by one or more earlier used hematology analyzers, to determine whether the cell image analysis apparatus passes quality control. A specific process in which the controller compares the morphology analysis result obtained by the cell image analysis apparatus with the test result obtained by the earlier used hematology analyzer is described in the foregoing embodiments. Certainly, a plurality of hematology analyzers may alternatively be used to test the quality control sample in advance, and then the controller compares the morphology analysis result obtained by the cell image analysis apparatus with test results obtained by the plurality of hematology analyzers, so as to further ensure accuracy of the first test result, facilitating quality control determination for the cell image analysis apparatus. The specific quality control for the cell image analysis apparatus has been described in the foregoing embodiments, and details are not described herein again.

The controller also determines whether some test results obtained by the hematology analyzer satisfy expectation based on the morphology analysis result obtained by the cell image analysis apparatus (an instrument classification result obtained by the cell image analysis apparatus or an accurate result obtained through manual adjustment). For example, for some items that cannot be tested through regular quality control for the hematology analyzer, for example, accuracy of malaria parasites, PLT aggregation, red blood cell aggregation, abnormal cell warning, and the like, regular quality control for the hematology analyzer generally cannot lead to an accurate quality control result. The cell image analysis apparatus, however, can more intuitively and accurately test the items such as malaria parasites, PLT aggregation, red blood cell aggregation, and abnormal cell warning. In this case, test results obtained by the cell image analysis apparatus may be used for quality control on test results of these items obtained by the hematology analyzer.

Therefore, a method for automated precision management on various instruments in a pipeline system by using a quality control blood smear may be derived. As shown in <FIG>, the method specifically includes the following steps:.

If the two results are consistent or the deviation therebetween is within the acceptable range, it indicates that accuracy of the classification result of the cell image analysis apparatus is satisfactory. If the five-classification result of white blood cells obtained by the hematology analyzer and the pre-classification result of the cell image analysis apparatus are consistent or the deviation is within the acceptable range, it indicates that accuracy of the classification result of the cell image analysis apparatus is satisfactory.

Referring to <FIG>, in another embodiment, an automated precision management method applied to a sample analysis system is proposed. The sample analysis system may be a blood analysis pipeline system including a hematology analyzer, a smear preparation apparatus and a cell image analysis apparatus. The method includes the following steps:.

The specific processes of the steps in the embodiment illustrated in <FIG> have been described in the foregoing embodiments, and details are not described herein again. Certainly, the foregoing embodiments may alternatively be combined with each other. Particularly, quality control for the hematology analyzer, quality control for the smear preparation apparatus, quality control for the cell image analysis apparatus, and the like may be combined with each other. For example, based on the foregoing sample analysis system, quality control is performed on the smear preparation apparatus separately, that is, quality of smearing and staining is determined. A specific process is shown in <FIG>, and includes steps S1 and S2, steps S4 to S8, and step S9', wherein steps S1 and S2, and steps S4 to S8 may be the same as those in the embodiment illustrated in <FIG>, and details are not described herein again.

Claim 1:
An automated precision management method for a sample analysis system, characterized in that the method comprises the following steps:
testing samples to be analyzed by a hematology analyzer (<NUM>), to obtain first test results of the samples to be analyzed, wherein the samples to be analyzed are fresh blood samples of patients;
when a preset condition for triggering quality control is satisfied, selecting, by a controller (<NUM>), a quality control sample from the samples that have been tested, based on the first test results obtained by the hematology analyzer (<NUM>);
controlling, by the controller (<NUM>), a dispatching apparatus (<NUM>, <NUM>) to transfer the quality control sample to a smearing machine;
preparing a quality control blood smear from the quality control sample by the smearing machine;
staining the quality control blood smear by a staining machine;
controlling, by the controller (<NUM>), the dispatching apparatus (<NUM>, <NUM>) to transfer the quality control blood smear to a cell image analysis apparatus (<NUM>);
imaging and analyzing the quality control blood smear by the cell image analysis apparatus (<NUM>), to obtain a second test result;
comparing the first test result with the second test result of the quality control sample;
outputting a result of the comparison; and
automatically performing, by the controller (<NUM>), quality control on the hematology analyzer (<NUM>) or the cell image analysis apparatus (<NUM>)
wherein, if the first test result is used as a baseline, then it can be determined through the comparison whether the second test result is accurate, so as to perform quality control on the cell image analysis apparatus (<NUM>); and if the second test result is used as a baseline, it can be determined through the comparison whether the first test result is accurate, so as to perform quality control on the hematology analyzer (<NUM>).