CN111398608A - In-vitro diagnosis analyzer and quality control processing method thereof - Google Patents
In-vitro diagnosis analyzer and quality control processing method thereof Download PDFInfo
- Publication number
- CN111398608A CN111398608A CN201910001832.8A CN201910001832A CN111398608A CN 111398608 A CN111398608 A CN 111398608A CN 201910001832 A CN201910001832 A CN 201910001832A CN 111398608 A CN111398608 A CN 111398608A
- Authority
- CN
- China
- Prior art keywords
- quality control
- sample
- user
- control product
- prompt
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
- G01N35/1009—Characterised by arrangements for controlling the aspiration or dispense of liquids
- G01N35/1016—Control of the volume dispensed or introduced
Landscapes
- Engineering & Computer Science (AREA)
- Quality & Reliability (AREA)
- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Automatic Analysis And Handling Materials Therefor (AREA)
Abstract
The invention provides an in vitro diagnosis analyzer and a quality control processing method thereof, which perform quality control test by sucking a quality control sample on a sample sucking position; transferring the quality control product to a temporary storage area for temporary storage; acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition; and processing the quality control product according to a preset processing mode when the preset triggering condition is met. Therefore, the automatic operation of the quality control test is realized, and the efficiency is improved.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to an in-vitro diagnosis analyzer and a quality control processing method thereof.
Background
A biochemical immunoassay analyzer is generally composed of an analysis module, a sample processing system, operating software and the like. The analysis module is used for analyzing the analytes in serum, plasma and other human body fluids. The sample processing system mainly has the functions of inputting, dispatching, transmitting, positioning and recovering the sample rack and the automatic identification function of the bar code information of the sample rack and the sample tube. The operation software automatically completes the data input and output of the analyzer, the result evaluation, the quality control and the like.
Generally, before a user starts a daily test, the user needs to perform a quality control test on the analyzer, and the result of the quality control test is used to evaluate whether the performance of the analyzer meets the use requirement and the management standard of a department. If the quality control is out of control (the result does not reach the standard), only the identification of the out-of-control result is given, the user needs to automatically judge how to process the out-of-control result, if the user experience is less than a moment, the user may not have to take the next step, if the user needs to retest, the user needs to manually operate again, and the process is complicated and low in efficiency.
Disclosure of Invention
The invention mainly provides an in-vitro diagnosis analyzer and a quality control processing method thereof, aiming at improving the automation degree of quality control test and improving the efficiency.
An embodiment provides a quality control processing method of an in vitro diagnostic analyzer, comprising the following steps:
sucking a sample of a quality control product on the sample sucking position and carrying out quality control test;
transferring the quality control product to a temporary storage area for temporary storage;
acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition;
and if so, processing the quality control product according to a preset processing mode.
In an embodiment, the processing the quality control product according to a preset processing manner includes:
and transferring the quality control product in the temporary storage area to a sample sucking position for sucking the sample and carrying out quality control test again.
In one embodiment, the transferring the quality control product in the temporary storage area to the sample sucking position for sucking the sample and performing the quality control test again comprises:
and sending out sound, light or electric signals to prompt a user to process the in-vitro diagnosis analyzer, transferring the quality control product in the temporary storage area to a sample sucking position to suck samples after the processing is finished, and carrying out quality control test again.
In one embodiment, after transferring the quality control product in the temporary storage area to the sample sucking position for sample sucking and quality control testing again, the method further includes: and transferring the quality control product to a recovery area for recovery.
In one embodiment, after transferring the quality control product in the temporary storage area to the sample sucking position for sample sucking and quality control testing again, the method further includes:
acquiring a quality control result of the re-performed quality control test, and judging whether the quality control result meets a preset trigger condition;
if yes, sound, light or electric signals are sent out to give an alarm.
In one embodiment, the method further comprises the steps of: and respectively marking the quality control results obtained by the two quality control tests to show the distinction.
In an embodiment, the processing the quality control product according to a preset processing manner includes:
transferring the quality control product in the temporary storage area to a recovery area for recovery.
In an embodiment, the processing the quality control product according to a preset processing manner further includes:
sending out sound, light or electric signals to prompt a user to replace the quality control product for retesting;
alternatively, the first and second electrodes may be,
sending out sound, light or electric signals to prompt a user to calibrate the in-vitro diagnostic analyzer and then replace the quality control material for retesting;
alternatively, the first and second electrodes may be,
and sending out sound, light or electric signals to prompt the user to replace the in-vitro diagnostic analyzer for retesting so as to determine whether the quality control product is available.
An embodiment provides a quality control processing method of an in vitro diagnostic analyzer, comprising the following steps:
sucking a sample of a quality control product on the sample sucking position and carrying out quality control test;
transferring the quality control product to a recovery area for recovery;
acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition;
if yes, sending out a prompt according to a preset processing mode.
In an embodiment, the sending the prompt according to the preset processing mode includes:
sending out sound, light or electric signals to prompt a user to replace the quality control product for retesting;
alternatively, the first and second electrodes may be,
sending out sound, light or electric signals to prompt a user to calibrate the in-vitro diagnostic analyzer and then replace the quality control material for retesting;
alternatively, the first and second electrodes may be,
and sending out sound, light or electric signals to prompt the user to replace the in-vitro diagnostic analyzer for retesting so as to determine whether the quality control product is available.
In one embodiment, before the step of sampling and testing the quality control material at the sampling position, the method further includes:
the trigger condition is determined based on user input.
In one embodiment, the step of determining the trigger condition according to the input of the user includes:
displaying a trigger condition option on a display interface, and determining a trigger condition selected by a user according to a selection signal for selecting the trigger condition;
alternatively, the first and second electrodes may be,
and displaying a trigger condition input box on the display interface, and determining a trigger condition according to the input of a user.
In one embodiment, the triggering condition includes a deviation range consisting of a mathematical expectation and a standard deviation of the quality control result.
An embodiment provides an in vitro diagnostic analyzer provided with a buffer and a recovery zone, comprising:
the transfer device is used for transferring the quality control product among the temporary storage area, the sample sucking position and the recovery area;
the testing device is used for sucking the sample of the quality control product on the sample sucking position and carrying out quality control testing;
the processor is used for sucking the quality control sample on the sample sucking position through the testing device and carrying out quality control testing; transferring the quality control product to a temporary storage area for temporary storage through a transfer device; acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition; and if so, processing the quality control product according to a preset processing mode.
In one embodiment, the processing the quality control product by the processor according to a preset processing mode includes:
and transferring the quality control product of the temporary storage area to a sample sucking position through a transfer device, sucking the sample through a testing device and carrying out quality control testing again.
In one embodiment, the system further comprises a human-computer interaction device; the treater passes through transfer device and transports the quality control article of buffers to inhaling on the appearance position, inhales the appearance through testing arrangement and carries out the quality control test again and include:
sending out sound, light or electric signals by a man-machine interaction device to prompt a user to process the in-vitro diagnosis analyzer; and transferring the quality control product of the temporary storage area to a sample sucking position through a transfer device after the treatment is finished, sucking the sample through a testing device and carrying out quality control testing again.
In one embodiment, the processor is further configured to transfer the quality control product to the recovery area for recovery by the transfer device after the sample is aspirated by the testing device and the quality control test is performed again.
In one embodiment, the processor is further configured to:
after the sample is sucked by the testing device and the quality control test is carried out again, obtaining the quality control result of the quality control test carried out again, and judging whether the quality control result meets the preset triggering condition or not;
if yes, sound, light or electric signals are sent out to give an alarm.
In an embodiment, the processor is further configured to mark the quality control results obtained by the two quality control tests respectively to indicate the difference.
In one embodiment, the processing the quality control product by the processor according to a preset processing mode includes:
and transferring the quality control product of the temporary storage area to a recovery area through a transfer device for recovery.
In one embodiment, the processing the quality control product by the processor according to a preset processing mode further includes:
sending out sound, light or electric signals through the human-computer interaction device to prompt a user to replace the quality control product for retesting;
alternatively, the first and second electrodes may be,
sending out sound, light or electric signals by the man-machine interaction device to prompt a user to calibrate the in-vitro diagnostic analyzer and then replace the quality control material for retesting;
alternatively, the first and second electrodes may be,
and sending out sound, light or electric signals through the man-machine interaction device to prompt a user to replace the in-vitro diagnostic analyzer for retesting so as to determine whether the quality control product is available.
An embodiment provides an in vitro diagnostic analyzer provided with a buffer and a recovery zone, comprising:
the transfer device is used for transferring the quality control product among the temporary storage area, the sample sucking position and the recovery area;
the testing device is used for sucking the sample of the quality control product on the sample sucking position and carrying out quality control testing;
the processor is used for sucking the quality control sample on the sample sucking position through the testing device and carrying out quality control testing; transferring the quality control product to a recovery area through a transfer device for recovery; acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition; if yes, sending out a prompt according to a preset processing mode.
In one embodiment, the sending out the prompt by the processor according to the preset processing mode includes:
sending out sound, light or electric signals through the human-computer interaction device to prompt a user to replace the quality control product for retesting;
alternatively, the first and second electrodes may be,
sending out sound, light or electric signals by the man-machine interaction device to prompt a user to calibrate the in-vitro diagnostic analyzer and then replace the quality control material for retesting;
alternatively, the first and second electrodes may be,
and sending out sound, light or electric signals through the man-machine interaction device to prompt a user to replace the in-vitro diagnostic analyzer for retesting so as to determine whether the quality control product is available.
In one embodiment, the processor is further configured to:
and receiving input of a user through the man-machine interaction device so as to determine the trigger condition.
In one embodiment, the processor receives an input from a user through the human-computer interaction device, and the determining the trigger condition includes:
displaying trigger condition options on a display interface of a human-computer interaction device, and receiving a selection signal for selecting the trigger conditions through the human-computer interaction device so as to determine the trigger conditions selected by a user;
alternatively, the first and second electrodes may be,
and displaying a trigger condition input frame on a display interface of the man-machine interaction device, and receiving the input of a user through the man-machine interaction device so as to determine the trigger condition.
In one embodiment, the triggering condition includes a deviation range consisting of a mathematical expectation and a standard deviation of the quality control result.
An embodiment provides a computer readable storage medium comprising a program executable by a processor to implement a method as described above.
According to the in vitro diagnostic analyzer and the quality control processing method thereof of the embodiment, the quality control sample on the sample sucking position is sucked and subjected to quality control test; transferring the quality control product to a temporary storage area for temporary storage; acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition; and processing the quality control product according to a preset processing mode when the preset triggering condition is met. Therefore, the automatic operation of the quality control test is realized, and the efficiency is improved.
Drawings
FIG. 1 is a block diagram of an in vitro diagnostic analyzer according to an embodiment;
FIG. 2 is a block diagram of an in vitro diagnostic analyzer according to an embodiment;
fig. 3 is a flowchart illustrating acquiring a trigger condition and a processing manner in the quality control processing method according to an embodiment;
FIG. 4 is a flowchart of a quality control processing method according to an embodiment;
fig. 5 is a flowchart of a quality control processing method according to an embodiment.
Detailed Description
The present invention will be described in further detail with reference to the following detailed description and accompanying drawings. Wherein like elements in different embodiments are numbered with like associated elements. In the following description, numerous details are set forth in order to provide a better understanding of the present application. However, those skilled in the art will readily recognize that some of the features may be omitted or replaced with other elements, materials, methods in different instances. In some instances, certain operations related to the present application have not been shown or described in detail in order to avoid obscuring the core of the present application from excessive description, and it is not necessary for those skilled in the art to describe these operations in detail, so that they may be fully understood from the description in the specification and the general knowledge in the art.
Furthermore, the features, operations, or characteristics described in the specification may be combined in any suitable manner to form various embodiments. Also, the various steps or actions in the method descriptions may be transposed or transposed in order, as will be apparent to one of ordinary skill in the art. Thus, the various sequences in the specification and drawings are for the purpose of describing certain embodiments only and are not intended to imply a required sequence unless otherwise indicated where such sequence must be followed.
The numbering of the components as such, e.g., "first", "second", etc., is used herein only to distinguish the objects as described, and does not have any sequential or technical meaning. The term "connected" and "coupled" when used in this application, unless otherwise indicated, includes both direct and indirect connections (couplings).
As shown in fig. 1, the in vitro diagnostic analyzer provided by the present invention is used for analyzing a collected sample to be tested, and includes: the system comprises a placing area, a temporary storage area, a recovery area, a scanning device 10, a human-computer interaction device 20, a processor 30, a transfer device 40, a testing device 50 and a memory 60.
The human-computer interaction device 20 serves as an interaction interface between the analyzer and a user, and is used for receiving information input by the user and outputting the information in an acoustic, optical or electrical mode. For example, a touch screen can be used, which can receive an instruction input by a user and display visual information; a mouse, a keyboard, a trackball, a joystick, etc. may also be used as an input device of the human-computer interaction device 20 to receive instructions input by a user, and a display may be used as a display device of the human-computer interaction device 20 to display visual information. The display displays the analysis result and/or prompt information obtained by the processor 30, or information such as the detection progress, to the user in a visual mode.
The transfer device 40 is used for transferring the quality control product among the placing area, the temporary storage area, the sample sucking position and the recovery area. The placing area is used for placing a sample to be tested, such as a quality control product; the temporary storage area is used for temporarily storing the quality control product, and the recovery area is used for recovering the sample, such as the quality control product; the sample aspirating position is the specific position where the test device 50 aspirates the sample.
The testing device 50 is used for sucking a sample of the quality control product on the sample sucking position and performing a quality control test, and of course, the testing device 50 can also suck a sample of a conventional sample on the sample sucking position and perform a conventional test, suck a sample of the calibration product on the sample sucking position and perform a calibration test, and the like.
The memory 60 is used to store various test data, analysis results, and/or programs.
When the quality control test is performed, the processor 30 is configured to transfer the quality control material placed in the placement area to the sample suction position through the transfer device 40, and perform the quality control test on the quality control material on the sample suction position through the test device 50. The testing of the quality control takes a certain time to obtain the result, so the present invention provides two ways to move and process the quality control product after the sample is sucked, as shown in fig. 4 and 5, which are described in detail in the first embodiment and the second embodiment, respectively. One way is to transfer the quality control product to a temporary storage area for temporary storage through a transfer device 40 after sample suction; acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition; if so, processing the quality control product of the temporary storage area according to a preset processing mode, otherwise, transferring the quality control product of the temporary storage area to a recovery area through a transfer device 40 for recovery. The other way is that after the sample is sucked, the quality control product is transported to a recovery area by a transporting device 40 for recovery; acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition; if yes, sending out a prompt according to a preset processing mode. Therefore, after the quality control result is obtained, the automatic processing can be carried out through the preset triggering condition, so that the automatic operation of the quality control test is realized, and the efficiency is improved.
Taking the use environment of a hospital as an example, the quality control test is generally carried out every day by a clinical laboratory and is used for monitoring whether the detection quality of an analyzer is out of control. The quality control product is a liquid which can be analyzed on the analyzer, and whether the quality of the analyzer is out of control is monitored from the quality control result.
The scanning device 10 is used for scanning the sample rack entering the in-vitro diagnostic analyzer and the test tubes carried by the sample rack to obtain a scanning result. Each sample rack has an identification. The scan results include an identification of the sample rack, such as the sample rack number. Usually, the sample rack can carry a plurality of samples (e.g. quality control articles), i.e. the sample rack has a plurality of sample sites. The scan results may also include various sample positions on the sample rack. The sample rack is provided with two-dimensional codes, bar codes or radio frequency tags and the like, and scanning results are obtained by scanning the sample rack, so that the sample rack and sample positions thereof can be identified.
Fig. 2 is a block diagram of an in vitro diagnostic analyzer according to an embodiment, wherein 710 and 720 are a recovery area and an insertion area, respectively, and the insertion area 720 is close to a user for the user to place a sample rack. The buffer is not shown and may be located below the recycling area 710, or below the input area 720, or below both the recycling area 710 and the input area 720, but may be located elsewhere within the analyzer. Of course, in other embodiments, the positions of the put-in area and the recycle area may be exchanged, that is, 710 and 720 are the put-in area and the recycle area, respectively, and are not described in detail.
The testing device 50 is used for testing the samples in the sample rack a and outputting the testing results, for example, outputting the testing results to the processor 30 or storing the testing results in the memory 60. In the embodiment of the present invention, the testing device 50 may be used for performing immunoassay to detect antigen and antibody in a sample, and the corresponding in vitro diagnostic analyzer is an immunoassay analyzer; or biochemical analysis can be carried out to detect various substance components in the sample, and the corresponding in-vitro diagnosis analyzer is a biochemical analyzer. The components of the test apparatus 50 and the detection process vary depending on the purpose of analysis, and in the case of a biochemical analyzer, the test apparatus 50 generally includes a sampling mechanism (or referred to as a sample dispensing mechanism) 520, a reagent disk 530, a reaction disk 540, a measurement device 510, and a reagent collecting mechanism (or referred to as a reagent dispensing mechanism) 560. A test track 550 is generally disposed at the front end (i.e., the side close to the operator) or the rear end (i.e., the back of the apparatus) of the test device 50, a sample sucking site 551 is configured on the test track 550, and the sampling mechanism 520 is configured to suck a sample to be tested, such as a quality control material, from a sample rack a located at the sample sucking site 551 and add the sucked sample to a reaction vessel 541 placed in the reaction tray 540. The reagent collecting mechanism 560 serves to suck the reagent from the reagent tray 530 and add the reagent to the corresponding reaction container 541, so that the sample and the reagent react in the reaction container 541. The sampling mechanism 520 and the reagent collection mechanism 560 may be different mechanisms or may be the same mechanism. The measurement device 510 measures the reacted sample to obtain a detection result. In other embodiments, test apparatus 50 includes an analysis system that cascades at least two analyzers, such as two biochemical analyzers, two immunoassay analyzers, or a biochemical analyzer and an immunoassay analyzer.
In the embodiment of the present invention, the processor 30 may further implement the quality control processing method provided in the embodiment of the present invention, and the following description is given in detail by way of example with reference to the accompanying drawings.
Referring to fig. 3, a flow of the processor 30 acquiring the trigger condition and the corresponding processing manner is shown, which includes the following steps:
After the trigger condition and the corresponding processing mode are set, as shown in the first embodiment shown in fig. 4, the step of implementing, by the processor 30, the quality control processing method provided by the embodiment of the present invention includes:
and 73, transferring the quality control product in the placing area to a sample sucking position by the processor 30 through the transfer device 40.
And step 74, the processor 30 sucks the quality control sample on the sample sucking position through the testing device 50 and performs a quality control test.
And 75, transferring the quality control product to a temporary storage area for temporary storage by the processor 30 through the transfer device 40.
And step 77, the processor 30 judges whether the quality control result meets a preset trigger condition. If yes, go to step 79, otherwise go to step 78.
And step 78, if the quality control result does not meet the preset triggering condition, the quality control test is normal, so that the processor 30 transfers the quality control product in the temporary storage area to the recovery area for recovery through the transfer device 40.
In step 79, the quality control result satisfies the preset triggering condition, which indicates that the quality control test is abnormal, so the processor 30 processes the quality control product in the temporary storage area according to the preset processing mode. The specific implementation of this step varies depending on the processing method. For example, the processor 30 sends out an acoustic, optical or electrical signal to prompt the user to change the quality control quality (change the quality control quality) and measure again through the human-computer interaction device 20. For example, the processor 30 sends out an acoustic, optical or electrical signal through the human-computer interaction device 20 to prompt the user to perform a calibrated replacement quality re-measurement on the in-vitro diagnostic analyzer (calibrated replacement quality re-measurement). For example, the processor 30 may issue an audible, optical, or electrical signal via the human-computer interaction device 20 to prompt the user to replace the in vitro diagnostic analyzer to re-test the quality control to determine whether the quality control is available. For example, the quality control material in the buffer is directly transferred to the sample sucking position by the transfer device 40, and the sample is sucked by the testing device 50 and the quality control test is performed again (original quality control material retest). Therefore, when the quality control is out of control, the automatic retest can be carried out, the sample sucking position can be directly moved into the temporary storage area, the operation is very quick, the user does not need to carry out manual processing, and the automation degree and the efficiency of the quality control test are improved. The quality control material retest may be a direct retest, or a retest after processing the in vitro diagnostic analyzer, for example, the processor 30 sends out a sound, light or electric signal through the human-computer interaction device 20 to prompt the user to process the in vitro diagnostic analyzer, the quality control material in the temporary storage area is transferred to the sample sucking position through the transfer device 40 after the processing, and the test device 50 sucks the sample and performs the quality control test again. The user is prompted to process, and the intelligent processing system is very convenient and intelligent. The prompting of the user to process the in-vitro diagnostic analyzer specifically can be prompting of the user to calibrate the in-vitro diagnostic analyzer (retest of the original quality control product after calibration), prompting of the user to replace a reagent, prompting of the user to disable the reagent, and processing of the reagent also belongs to processing of the in-vitro diagnostic analyzer, so that the problem of whether the reagent is used or not is conveniently cleared. The processor 30, after aspirating the sample and re-performing the quality control test by the testing device 50, also transfers the quality control product to the recovery area for recovery by the transfer device 40. The processor 30, after sucking the sample through the testing device 50 and performing the quality control test again, also obtains the quality control result of the re-performed quality control test, and judges whether the quality control result meets the preset trigger condition; if yes, the human-computer interaction device 20 sends out sound, light or electric signals to give an alarm prompt, and the condition indicates that the two quality control tests reach the triggering condition, and the two quality control tests do not belong to accidental factors, so that the quality control is out of control. The processor 30 is further configured to mark the quality control results obtained from the two quality control tests, so as to distinguish the quality control results, and facilitate subsequent further analysis of the reason for the failure of the quality control. Of course, in some embodiments, according to different triggering conditions, the processor 30 may process the quality control product according to a preset processing manner, that is: the quality control products in the temporary storage area are transferred to a recovery area by a transfer device 40 for recovery.
For the trigger condition and the processing manner, the present embodiment also provides several specific manners, as follows:
the standard deviation of the trigger conditions is 2SD and 3SD, namely, the quality control result is within the deviation range of 2SD, the quality control is not out of control, and the retest is not needed. The corresponding processing mode is as follows: and transferring the quality control product in the temporary storage area to a recovery area.
Trigger condition 1: the quality control result is between 2SD and 3SD, and the quality control result does not appear in the previous day. And the condition that the quality control result is between 2SD and 3SD does not occur in the previous day, so that the quality control is not out of control. The corresponding processing mode is as follows: and transferring the quality control product in the temporary storage area to a recovery area without retesting.
Trigger condition 2: the quality control result is between 2SD and 3SD, and the quality control result of the previous day is between 2SD and 3 SD. Under the condition, the conclusion of quality control runaway can be obtained, the reason needs to be checked, and the corresponding processing mode is as follows: and transferring the quality control product in the temporary storage area to a sample sucking position for sucking the sample and carrying out quality control test again.
Trigger condition 3: the quality control result exceeds 3SD deviation (for example, high-value quality control materials and low-value quality control materials are put back). Under the condition, the conclusion that the quality control is out of control can be obtained, the problem is possibly serious, the reason needs to be checked, and the corresponding processing mode is as follows: and transferring the quality control product of the temporary storage area to a recovery area, and prompting and alarming.
In the second embodiment shown in fig. 5, the steps of implementing the quality control processing method provided by the embodiment of the present invention by the processor 30 include:
step 73', the processor 30 transfers the quality control material of the input area to the sample aspirating position by the transfer device 40.
Step 74', the processor 30 samples the quality control material at the sample suction position by the testing device 50 and performs a quality control test.
Step 75', the processor 30 transfers the quality control product to the recycling area for recycling via the transfer device 40.
Step 76', the processor 30 obtains the quality control result of the quality control test.
In step 77', the processor 30 determines whether the quality control result satisfies a predetermined trigger condition. If yes, go to step 79; if the quality control is not normal, the user can be prompted to be normal through the human-computer interaction device 20.
Step 79', the quality control result meeting the preset triggering condition indicates that the quality control test is abnormal, so the processor 30 sends out a prompt according to the preset processing mode. The specific implementation of this step varies depending on the processing method. For example, the processor 30 sends out an acoustic, optical or electrical signal to prompt the user to change the quality control quality (change the quality control quality) and measure again through the human-computer interaction device 20. For another example, the processor 30 sends out an acoustic, optical or electrical signal through the human-computer interaction device 20 to prompt the user to perform a calibration and then replace the quality control re-measurement on the in-vitro diagnostic analyzer (i.e., replace the quality control re-measurement after calibration). Also for example, the processor 30 may prompt the user to replace the in-vitro diagnostic analyzer to re-measure the quality control (replace the in-vitro diagnostic analyzer to re-measure) via the human-computer interaction device 20 to determine whether the quality control is available.
For the trigger condition and the processing manner, the present embodiment also provides several specific manners, as follows:
the triggering condition comprises a normal result range corresponding to the quality control product. For example, trigger condition 1: the quality control result of the low-value quality control product is in the normal result range corresponding to the high-value quality control product. The corresponding processing mode is as follows: the human-computer interaction device 20 sends out sound, light or electric signals to prompt the user to put the quality control product reversely, and can further prompt the user to replace the high-value quality control product which is put by mistake at present with the low-value quality control product for retesting. Likewise, trigger condition 2: the quality control result of the high-value quality control product is in the normal result range corresponding to the low-value quality control product. The corresponding processing mode is as follows: the human-computer interaction device 20 sends out sound, light or electric signals to prompt the user to put the quality control product reversely, and can further prompt the user to replace the current misplaced low-value quality control product with a high-value quality control product for retesting. Because the quality control of a project needs to simultaneously carry out high-value quality control test and low-value quality control test, a user easily puts the high-value quality control product and the low-value quality control product in a reverse mode, and the abnormal condition caused by putting the quality control product in a reverse mode by the user can be automatically solved by the set of triggering conditions and the corresponding processing mode.
As another example, trigger condition 3: the quality control result is close to 0. The corresponding processing mode is as follows: the human-computer interaction device 20 sends out sound, light or electric signals to prompt the user to put the quality control product in error, and can further prompt the user to replace the quality control product for retesting. The quality control result of the quality control product theoretically has the lowest value, which is not usually close to 0. The result of quality control close to 0 indicates that the analyzer cannot detect the detected object (such as specific antigen and antibody) of the current quality control product, and the quality control result is not the quality control result of the current quality control product, namely the quality control product is misplaced.
Also for example, trigger condition 4: the quality control result exceeds the normal result range, but does not meet other triggering conditions. The corresponding processing mode is as follows: the processor 30 sends out sound, light or electric signals through the man-machine interaction device 20 to prompt the user to replace the in-vitro diagnostic analyzer to re-measure the quality control product so as to determine whether the quality control product is available.
In the first embodiment, after the quality control material absorbs the sample, the quality control material directly enters the temporary storage area to wait for processing, and in the second embodiment, after the quality control material absorbs the sample, the quality control material directly enters the recovery area to be recovered; in the third embodiment, the method may further include the steps of: the processor 30 transfers the quality control product to the temporary storage area or the recovery area through the transfer device 40 according to a preset processing mode after the quality control product absorbs the sample. For example, the processing method is as follows: the quality control product is re-tested or re-tested after calibration, and then the quality control product is transferred to a temporary storage area through a transfer device 40 after the quality control product sucks a sample; the processing method comprises the following steps: and (3) replacing the quality control product for retesting, replacing the quality control product for retesting after calibration or replacing the in-vitro diagnostic analyzer for retesting to determine whether the quality control product is available, and transferring the quality control product to a recovery area through a transfer device 40 after the quality control product absorbs a sample. Other steps are the same as those in the first and second embodiments, and therefore are not described in detail.
Reference is made herein to various exemplary embodiments. However, those skilled in the art will recognize that changes and modifications may be made to the exemplary embodiments without departing from the scope hereof. For example, the various operational steps, as well as the components used to perform the operational steps, may be implemented in differing ways depending upon the particular application or consideration of any number of cost functions associated with operation of the system (e.g., one or more steps may be deleted, modified or incorporated into other steps).
Additionally, as will be appreciated by one skilled in the art, the principles herein may be reflected in a computer program product on a computer readable storage medium, which is pre-loaded with computer readable program code. Any tangible, non-transitory computer-readable storage medium may be used, including magnetic storage devices (hard disks, floppy disks, etc.), optical storage devices (CD-ROMs, DVDs, Blu Ray disks, etc.), flash memory, and/or the like. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified. These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including means for implementing the function specified. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified.
While the principles herein have been illustrated in various embodiments, many modifications of structure, arrangement, proportions, elements, materials, and components particularly adapted to specific environments and operative requirements may be employed without departing from the principles and scope of the present disclosure. The above modifications and other changes or modifications are intended to be included within the scope of this document.
The foregoing detailed description has been described with reference to various embodiments. However, one skilled in the art will recognize that various modifications and changes may be made without departing from the scope of the present disclosure. Accordingly, the disclosure is to be considered in an illustrative and not a restrictive sense, and all such modifications are intended to be included within the scope thereof. Also, advantages, other advantages, and solutions to problems have been described above with regard to various embodiments. However, the benefits, advantages, solutions to problems, and any element(s) that may cause any element(s) to occur or become more pronounced are not to be construed as a critical, required, or essential feature or element of any or all the claims. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, system, article, or apparatus. Furthermore, the term "coupled," and any other variation thereof, as used herein, refers to a physical connection, an electrical connection, a magnetic connection, an optical connection, a communicative connection, a functional connection, and/or any other connection.
Those skilled in the art will recognize that many changes may be made to the details of the above-described embodiments without departing from the underlying principles of the invention. Accordingly, the scope of the invention should be determined from the following claims.
Claims (27)
1. A quality control processing method of an in-vitro diagnosis analyzer is characterized by comprising the following steps:
sucking a sample of a quality control product on the sample sucking position and carrying out quality control test;
transferring the quality control product to a temporary storage area for temporary storage;
acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition;
and if so, processing the quality control product according to a preset processing mode.
2. The method of claim 1, wherein the processing the quality control material according to a predetermined processing mode comprises:
and transferring the quality control product in the temporary storage area to a sample sucking position for sucking the sample and carrying out quality control test again.
3. The method of claim 2, wherein transferring the control material from the buffer to the blotting station and performing a new quality control test comprises:
and sending out sound, light or electric signals to prompt a user to process the in-vitro diagnosis analyzer, transferring the quality control product in the temporary storage area to a sample sucking position to suck samples after the processing is finished, and carrying out quality control test again.
4. The method of claim 2 or 3, wherein after transferring the control material from the buffer zone to the blotting station for blotting and resuming the quality control testing, the method further comprises: and transferring the quality control product to a recovery area for recovery.
5. The method of claim 2 or 3, wherein after transferring the control material from the buffer zone to the blotting station for blotting and resuming the quality control testing, the method further comprises:
acquiring a quality control result of the re-performed quality control test, and judging whether the quality control result meets a preset trigger condition;
if yes, sound, light or electric signals are sent out to give an alarm.
6. A method according to claim 2 or 3, further comprising the step of: and respectively marking the quality control results obtained by the two quality control tests to show the distinction.
7. The method of claim 1, wherein the processing the quality control material according to a predetermined processing mode comprises:
transferring the quality control product in the temporary storage area to a recovery area for recovery.
8. The method of claim 7, wherein the processing the quality control material according to a predetermined processing mode further comprises:
sending out sound, light or electric signals to prompt a user to replace the quality control product for retesting;
alternatively, the first and second electrodes may be,
sending out sound, light or electric signals to prompt a user to calibrate the in-vitro diagnostic analyzer and then replace the quality control material for retesting;
alternatively, the first and second electrodes may be,
and sending out sound, light or electric signals to prompt the user to replace the in-vitro diagnostic analyzer for retesting so as to determine whether the quality control product is available.
9. A quality control processing method of an in-vitro diagnosis analyzer is characterized by comprising the following steps:
sucking a sample of a quality control product on the sample sucking position and carrying out quality control test;
transferring the quality control product to a recovery area for recovery;
acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition;
if yes, sending out a prompt according to a preset processing mode.
10. The method of claim 9, wherein said issuing a prompt according to a predetermined processing manner comprises:
sending out sound, light or electric signals to prompt a user to replace the quality control product for retesting;
alternatively, the first and second electrodes may be,
sending out sound, light or electric signals to prompt a user to calibrate the in-vitro diagnostic analyzer and then replace the quality control material for retesting;
alternatively, the first and second electrodes may be,
and sending out sound, light or electric signals to prompt the user to replace the in-vitro diagnostic analyzer for retesting so as to determine whether the quality control product is available.
11. The method of claim 1 or 9, wherein prior to the step of pipetting and testing the quality control at the pipetting station, further comprising:
the trigger condition is determined based on user input.
12. The method of claim 11, wherein the step of determining a trigger condition based on user input comprises:
displaying a trigger condition option on a display interface, and determining a trigger condition selected by a user according to a selection signal for selecting the trigger condition;
alternatively, the first and second electrodes may be,
and displaying a trigger condition input box on the display interface, and determining a trigger condition according to the input of a user.
13. The method of claim 12, wherein the triggering condition comprises a deviation range consisting of a mathematical expectation and a standard deviation of the quality control result.
14. An in vitro diagnostic analyzer, characterized in that it is provided with a buffer and a recovery zone, comprising:
the transfer device is used for transferring the quality control product among the temporary storage area, the sample sucking position and the recovery area;
the testing device is used for sucking the sample of the quality control product on the sample sucking position and carrying out quality control testing;
the processor is used for sucking the quality control sample on the sample sucking position through the testing device and carrying out quality control testing; transferring the quality control product to a temporary storage area for temporary storage through a transfer device; acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition; and if so, processing the quality control product according to a preset processing mode.
15. The in vitro diagnostic analyzer of claim 14, wherein the processor processing the quality control according to a predetermined processing profile comprises:
and transferring the quality control product of the temporary storage area to a sample sucking position through a transfer device, sucking the sample through a testing device and carrying out quality control testing again.
16. The in vitro diagnostic analyzer of claim 15, further comprising a human-computer interaction device; the treater passes through transfer device and transports the quality control article of buffers to inhaling on the appearance position, inhales the appearance through testing arrangement and carries out the quality control test again and include:
sending out sound, light or electric signals by a man-machine interaction device to prompt a user to process the in-vitro diagnosis analyzer; and transferring the quality control product of the temporary storage area to a sample sucking position through a transfer device after the treatment is finished, sucking the sample through a testing device and carrying out quality control testing again.
17. The in vitro diagnostic analyzer of claim 15 or 16, wherein the processor is further configured to transfer the quality control product to the recovery area for recovery via the transfer device after aspiration and resumption of the quality control test via the testing device.
18. The in vitro diagnostic analyzer of claim 15 or 16, wherein the processor is further configured to:
after the sample is sucked by the testing device and the quality control test is carried out again, obtaining the quality control result of the quality control test carried out again, and judging whether the quality control result meets the preset triggering condition or not;
if yes, sound, light or electric signals are sent out to give an alarm.
19. The in vitro diagnostic analyzer of claim 15 or 16, wherein the processor is further configured to mark the quality control results of the two quality control tests for differentiation.
20. The in vitro diagnostic analyzer of claim 14, wherein the processor processing the quality control according to a predetermined processing profile comprises:
and transferring the quality control product of the temporary storage area to a recovery area through a transfer device for recovery.
21. The in vitro diagnostic analyzer of claim 20, wherein the processor processing the quality control according to a predetermined processing regime further comprises:
sending out sound, light or electric signals through the human-computer interaction device to prompt a user to replace the quality control product for retesting;
alternatively, the first and second electrodes may be,
sending out sound, light or electric signals by the man-machine interaction device to prompt a user to calibrate the in-vitro diagnostic analyzer and then replace the quality control material for retesting;
alternatively, the first and second electrodes may be,
and sending out sound, light or electric signals through the man-machine interaction device to prompt a user to replace the in-vitro diagnostic analyzer for retesting so as to determine whether the quality control product is available.
22. An in vitro diagnostic analyzer, characterized in that it is provided with a buffer and a recovery zone, comprising:
the transfer device is used for transferring the quality control product among the temporary storage area, the sample sucking position and the recovery area;
the testing device is used for sucking the sample of the quality control product on the sample sucking position and carrying out quality control testing;
the processor is used for sucking the quality control sample on the sample sucking position through the testing device and carrying out quality control testing; transferring the quality control product to a recovery area through a transfer device for recovery; acquiring a quality control result of a quality control test, and judging whether the quality control result meets a preset trigger condition; if yes, sending out a prompt according to a preset processing mode.
23. The in vitro diagnostic analyzer of claim 22, wherein the processor issuing prompts according to predetermined processing regimes comprises:
sending out sound, light or electric signals through the human-computer interaction device to prompt a user to replace the quality control product for retesting;
alternatively, the first and second electrodes may be,
sending out sound, light or electric signals by the man-machine interaction device to prompt a user to calibrate the in-vitro diagnostic analyzer and then replace the quality control material for retesting;
alternatively, the first and second electrodes may be,
and sending out sound, light or electric signals through the man-machine interaction device to prompt a user to replace the in-vitro diagnostic analyzer for retesting so as to determine whether the quality control product is available.
24. The in vitro diagnostic analyzer of claim 14 or 22, wherein the processor is further configured to:
and receiving input of a user through the man-machine interaction device so as to determine the trigger condition.
25. The in vitro diagnostic analyzer of claim 24, wherein the processor receives user input via the human-computer interface device, whereby determining the trigger condition comprises:
displaying trigger condition options on a display interface of a human-computer interaction device, and receiving a selection signal for selecting the trigger conditions through the human-computer interaction device so as to determine the trigger conditions selected by a user;
alternatively, the first and second electrodes may be,
and displaying a trigger condition input frame on a display interface of the man-machine interaction device, and receiving the input of a user through the man-machine interaction device so as to determine the trigger condition.
26. The in vitro diagnostic analyzer of claim 25, wherein the triggering condition comprises a deviation range consisting of a mathematical expectation and a standard deviation of the quality control result.
27. A computer-readable storage medium, comprising a program executable by a processor to implement the method of any one of claims 1-13.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910001832.8A CN111398608A (en) | 2019-01-02 | 2019-01-02 | In-vitro diagnosis analyzer and quality control processing method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910001832.8A CN111398608A (en) | 2019-01-02 | 2019-01-02 | In-vitro diagnosis analyzer and quality control processing method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111398608A true CN111398608A (en) | 2020-07-10 |
Family
ID=71433892
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910001832.8A Pending CN111398608A (en) | 2019-01-02 | 2019-01-02 | In-vitro diagnosis analyzer and quality control processing method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN111398608A (en) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH04130271A (en) * | 1990-09-21 | 1992-05-01 | Hitachi Ltd | Chromatograph apparatus |
| JP2002196005A (en) * | 2000-12-25 | 2002-07-10 | Hitachi Ltd | Automatic chemical analyzer having recalculating function |
| US20130316461A1 (en) * | 2012-03-30 | 2013-11-28 | Sysmex Corporation | Sample analyzer, sample container for quality control, quality control method |
| CN104020270A (en) * | 2014-06-23 | 2014-09-03 | 耿炜 | Multifunctional remote quality control device for water quality |
| CN106203786A (en) * | 2016-06-27 | 2016-12-07 | 温冬梅 | Medical laboratory's automatic assembly line indoor method of quality control and control system thereof |
| WO2017012168A1 (en) * | 2015-07-22 | 2017-01-26 | 江苏英诺华医疗技术有限公司 | Optimized biochemical detection method suitable for medical examination |
| CN107340399A (en) * | 2017-05-25 | 2017-11-10 | 长沙金域医学检验所有限公司 | A kind of biochemical luminous quality control method |
| US20180209999A1 (en) * | 2015-07-31 | 2018-07-26 | The Catholic University Of Korea Industry-Academic Cooperation Foundation | Automatic quality control device of blood cell analyzer |
| CN109030803A (en) * | 2018-06-15 | 2018-12-18 | 浙江省人民医院 | Biochemistry detection quality control method |
-
2019
- 2019-01-02 CN CN201910001832.8A patent/CN111398608A/en active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH04130271A (en) * | 1990-09-21 | 1992-05-01 | Hitachi Ltd | Chromatograph apparatus |
| JP2002196005A (en) * | 2000-12-25 | 2002-07-10 | Hitachi Ltd | Automatic chemical analyzer having recalculating function |
| US20130316461A1 (en) * | 2012-03-30 | 2013-11-28 | Sysmex Corporation | Sample analyzer, sample container for quality control, quality control method |
| CN104020270A (en) * | 2014-06-23 | 2014-09-03 | 耿炜 | Multifunctional remote quality control device for water quality |
| WO2017012168A1 (en) * | 2015-07-22 | 2017-01-26 | 江苏英诺华医疗技术有限公司 | Optimized biochemical detection method suitable for medical examination |
| US20180209999A1 (en) * | 2015-07-31 | 2018-07-26 | The Catholic University Of Korea Industry-Academic Cooperation Foundation | Automatic quality control device of blood cell analyzer |
| CN106203786A (en) * | 2016-06-27 | 2016-12-07 | 温冬梅 | Medical laboratory's automatic assembly line indoor method of quality control and control system thereof |
| CN107340399A (en) * | 2017-05-25 | 2017-11-10 | 长沙金域医学检验所有限公司 | A kind of biochemical luminous quality control method |
| CN109030803A (en) * | 2018-06-15 | 2018-12-18 | 浙江省人民医院 | Biochemistry detection quality control method |
Non-Patent Citations (1)
| Title |
|---|
| 韩利蓉;: "采用新鲜血比对进行血液分析仪室内质控", 中外健康文摘(新医学学刊), no. 09 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US7707010B2 (en) | Sample analyzer and error information displaying method | |
| JP5924950B2 (en) | Sample analyzer | |
| CN108700603B (en) | Automatic analyzer | |
| JP5993865B2 (en) | Automatic analysis system | |
| US9244086B2 (en) | Sample analyzing system, sample analyzer, and management method of sample analyzing system | |
| CN111381065B (en) | In-vitro diagnosis analyzer and sample frame processing method thereof | |
| US20130244274A1 (en) | Sample processing apparatus and reagent information informing method | |
| US9213037B2 (en) | Sample analyzer and sample analyzing method | |
| JP5961424B2 (en) | Sample analyzer, sample analysis method, and sample analysis system | |
| JP6400312B2 (en) | Clinical laboratory equipment | |
| CN111351948A (en) | Sample detection method, sample detection device and storage medium | |
| CN111856045A (en) | Sample reinspection method and sample analyzer | |
| CN111624356A (en) | Sample analysis system, sample scheduling method and storage medium | |
| JP6954949B2 (en) | Automatic analyzer | |
| WO2016017291A1 (en) | Automatic analysis device | |
| JP5174629B2 (en) | Automatic analyzer | |
| JP2009244177A (en) | Analyzer, analysis method, and computer program | |
| EP3971579A1 (en) | Automatic analyser | |
| CN111381064B (en) | In-vitro diagnosis analyzer and method for improving use efficiency of sample rack | |
| CN111398608A (en) | In-vitro diagnosis analyzer and quality control processing method thereof | |
| CN112782413A (en) | In-vitro diagnosis analyzer and quality control processing method thereof | |
| CN111381063B (en) | In-vitro diagnosis analyzer and multiplexing method of sample rack thereof | |
| CN117795345A (en) | Automatic analysis device and automatic analysis system | |
| CN113196065B (en) | Automatic analysis device and analysis method | |
| US20200400699A1 (en) | Automatic analyzer |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |