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CN-122017270-A - System and method for detecting glycosylated hemoglobin with built-in hemolysis test

CN122017270ACN 122017270 ACN122017270 ACN 122017270ACN-122017270-A

Abstract

The invention relates to the technical field of medical detection, in particular to a glycosylated hemoglobin detection system and method with an in-machine hemolysis test, wherein the system comprises a biochemical analyzer main body, a sample adding needle cleaning mechanism and a hemolysis agent storage unit, and specifically adopts a discrete biochemical analyzer architecture, combines software design and control of a detection mechanism, simultaneously utilizes the descending depth of a Z axis of the sample adding needle to carry out classified detection on glycosylated hemoglobin items, conventional items and hemolysis reaction items, and further extends the cleaning depth from about 1cm to about 4cm by improving the sample adding needle cleaning mechanism so as to ensure that the cleanliness of the sample adding needle meets the detection requirement of a subsequent sample. According to the density layering characteristic of the hemolyzed sample, the invention realizes the selective absorption of the hemoglobin layer and the serum layer, is compatible with conventional project detection, can automatically trigger the in-machine hemolysis process through project name and sample type identification, does not need manual intervention, and further improves the detection work efficiency.

Inventors

  • ZHOU ZUZHEN
  • MA LI
  • WU BIN

Assignees

  • 桂林优利特医疗电子有限公司

Dates

Publication Date
20260512
Application Date
20260129

Claims (5)

  1. 1. A glycosylated hemoglobin detection system with an in-machine hemolysis test is characterized in that, The biochemical analyzer comprises a biochemical analyzer main body, a sample adding needle cleaning mechanism and a hemolytic agent storage unit, wherein the sample adding needle cleaning mechanism is an improved sample adding needle cleaning mechanism, and the cleaning depth can be expanded from about 1cm to about 4cm; the hemolytic agent storage unit stores the hemolytic agent by using a conventional reagent position of the biochemical analyzer; The biochemical analyzer main body adopts a discrete biochemical analyzer framework and comprises a sample processing unit, a sample adding unit, a reagent management unit, a reaction unit, a detection unit, a cleaning unit and a control unit, wherein the sample processing unit comprises a sample rotary table and a sample cup bracket, the sample rotary table can accommodate a plurality of sample positions, and a sample cup or a common blood sampling test tube can be placed in the sample cup bracket; the sample adding unit comprises a sample adding needle, a sample adding plunger pump and a sample adding needle driving mechanism; the reagent management unit comprises a reagent rotary table and a reagent bottle bracket, wherein the reagent rotary table can accommodate at least 60 reagent positions and can be used for accommodating reagent bottles with two specifications; The reaction unit comprises a reaction rotary table, a reaction cup bracket, a constant temperature control system and a stirring mechanism, wherein the constant temperature control system maintains the reaction temperature at 37+/-0.2 ℃; the detection unit is responsible for detecting absorbance or scattered light of the reaction liquid in the reaction cup; the cleaning unit comprises a reaction cup cleaning device and a waste liquid collecting system; The control unit comprises a software control system and is responsible for coordinating the work and the interactive operation of each hardware unit.
  2. 2. The system for detecting glycated hemoglobin as recited in claim 1, wherein, The software control system comprises an item identification module, an auxiliary item distribution module, a time sequence control module and a sample filling control module, wherein the item identification module is used for identifying that the item name is glycosylated hemoglobin and the sample type is whole blood, an in-machine hemolysis detection flow is triggered, the auxiliary item distribution module is used for automatically distributing 1 main reaction cup and 3 auxiliary reaction cups, the time sequence control module is used for controlling the hemolysis reaction time to be not less than 300 seconds, the sample filling control module is used for controlling a sample filling needle to descend to 80% of the depth of the reaction cup when the whole blood sample and the post-hemolysis sample are sucked, and the sample filling control module is used for adjusting the glycosylated hemoglobin item, the conventional item and the hemolysis reaction item by setting the sample filling depth.
  3. 3. A method for detecting glycosylated hemoglobin by using an internal hemolysis test according to claim 1, comprising the steps of: step 1, identifying that a detection item is glycosylated hemoglobin and a sample type is whole blood; Step2, distributing 1 main reaction cup and 3 auxiliary reaction cups; Step 3, adding a hemolytic agent and a whole blood sample into the auxiliary reaction cup 1, stirring and mixing, and carrying out hemolysis reaction for at least 300 seconds; Step 4, adding the glycosylated hemoglobin reagent 1 into the main reaction cup; Step 5, sucking the hemolyzed sample from the bottom of the auxiliary reaction cup 1, and filling the sample into the main reaction cup; Step 6, performing deep cleaning of the sample adding needle, wherein the cleaning depth is about 4cm; step 7, adding glycosylated hemoglobin reagent 2 into the main reaction cup to perform detection reaction; and 8, detecting and outputting a result.
  4. 4. The method for detecting glycosylated hemoglobin according to claim 3, wherein, The absorption depth of the hemolysis sample in the detection process is 70-90% of the depth of the reaction cup.
  5. 5. The method for detecting glycosylated hemoglobin according to claim 4, wherein, The main reaction cup used in the step 2 is used for glycosylated hemoglobin detection reaction and has the functions of adding a reagent 1, adding a hemolyzed sample, stirring, adding a test agent 2 and detecting; the auxiliary reaction cup 1 is used for hemolysis reaction and is used as a container/carrier for participating in the reaction; the auxiliary reaction cup 2 is used for cleaning the occupation period of the sample adding needle for the first time; The auxiliary reaction cup 3 is used for cleaning the occupation period of the sample adding needle for the second time; The auxiliary reaction cup 2 and the auxiliary reaction cup 3 do not actually participate in the reaction, and are not used as containers/carriers for participating in the reaction, and are used only for occupying time.

Description

System and method for detecting glycosylated hemoglobin with built-in hemolysis test Technical Field The invention relates to the technical field of medical detection, in particular to a glycosylated hemoglobin detection system and method with an in-machine hemolysis test. Background Glycosylated hemoglobin (Glycated Hemoglobin A c, hbA1c for short) is a stable product formed by a non-enzymatic saccharification reaction of glucose and hemoglobin in blood. As the average life of red blood cells is about 120 days, the HbA1c content can reflect the average blood glucose level of a patient for about 2-3 months and is not affected by short-term blood glucose fluctuations, eating states or drugs, and therefore becomes a "gold standard" indicator for diabetes screening, diagnosis, treatment monitoring and prognosis evaluation. At present, the following two technical schemes are mainly adopted for the detection of glycosylated hemoglobin in a clinical laboratory, namely, the detection of a special glycosylated hemoglobin analyzer is carried out, and the detection of an external hemolysis and a conventional biochemical analyzer is carried out, but the problems of obvious technical limitations and practicality exist, further, the clinical detection requirements of low cost, high efficiency, high accuracy and low manual intervention cannot be considered in the prior art, and the following common technical bottlenecks exist: (1) The equipment investment and the operation cost are high, and the special instrument scheme needs to be added with tens of thousands of equipment cost, so that the method is not suitable for basic medical institutions and small and medium-sized laboratories. (2) The manual operation has strong dependence, the manual hemolysis scheme is seriously dependent on the technical level and responsibility of operators, the standardization degree is low, and the quality control is difficult. (3) The detection efficiency and the flux are low, and the sample detection turnaround time is obviously prolonged no matter the detection is artificial hemolysis or special mode detection, so that the requirement of rapid detection of a large number of samples cannot be met. (4) The sample management is complex, and the links of sample split charging, transferring, marking and the like are added in the multi-instrument detection scheme, so that the error risk and the workload are increased. (5) The reliability of the detection result is unstable, the standardization of the artificial hemolysis is difficult to ensure, the batch-to-batch repeatability of the detection result is poor, and the accuracy of clinical diagnosis is affected. Disclosure of Invention The invention aims to provide a system and a method for detecting glycosylated hemoglobin by using an in-machine hemolysis test, which realize the integrated flow of automatic hemolysis and glycosylated hemoglobin detection of a whole blood sample in a conventional biochemical analyzer, keep compatibility with a conventional biochemical project, realize synchronous detection of the glycosylated hemoglobin project and the conventional project in the same sample and the same batch, and simultaneously consider the detection efficiency and the economy. In order to achieve the above object, the present invention provides a glycosylated hemoglobin detection system for an in-machine hemolysis test, comprising a biochemical analyzer main body, a sample needle cleaning mechanism and a hemolysis agent storage unit, wherein the sample needle cleaning mechanism is an improved sample needle cleaning mechanism, and the cleaning depth is extended from about 1cm to about 4cm; The biochemical analyzer main body adopts a discrete biochemical analyzer framework and comprises a sample processing unit, a sample adding unit, a reagent management unit, a reaction unit, a detection unit, a cleaning unit and a control unit, wherein the sample processing unit comprises a sample rotary table and a sample cup bracket, the sample rotary table can accommodate a plurality of sample positions, and a sample cup or a common blood sampling test tube can be placed in the sample cup bracket; the sample adding unit comprises a sample adding needle, a sample adding plunger pump and a sample adding needle driving mechanism; the reagent management unit comprises a reagent rotary table and a reagent bottle bracket, wherein the reagent rotary table can accommodate at least 60 reagent positions and can be used for accommodating reagent bottles with two specifications; The reaction unit comprises a reaction rotary table, a reaction cup bracket, a constant temperature control system and a stirring mechanism, wherein the constant temperature control system maintains the reaction temperature at 37+/-0.2 ℃; the detection unit is responsible for detecting absorbance or scattered light of the reaction liquid in the reaction cup; the cleaning unit comprises a reaction cup cleaning device and a waste liquid collecti