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Neuroimmune diseases include multiple sclerosis, neuromyelitis optica spectrum diseases, myelin oligodendrocyte glycoprotein (MOG) antibody-related diseases, autoimmune encephalitis, myasthenia gravis, and Guillambali syndrome.
The first disease in the prime of life is disability
.
The diagnosis, progress, and therapeutic effect of this group of diseases depend to a large extent on the laboratory tracking the immune response in the peripheral or central nervous system, that is, detecting the content of autoantibodies or antigens
.
The diagnostic reagents for neuroimmune diseases in China have been monopolized by European and American companies headed by Oumeng for a long time, and there are disadvantages such as unstable supply of reagents and high prices
.
At the same time, when the laboratory results are inconsistent with the clinical results, these European and American companies cannot provide communication with the sending doctor, and cannot solve the confusion of diagnosis and treatment in time
.
A more serious problem is that the industry lacks industry standards such as the content and interpretation of immune response required for the treatment of neuroimmune diseases
.
In response to the above problems, the third working and academic meeting of the Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association was held in Beijing on December 4, 2021.
39 academic group members and more than 10 academic group consultants participated in the meeting.
Live
.
Professor Hongjun Hao from Peking University First Hospital (Figure 1A) first introduced the characteristics, new understanding and clinical significance of the immune response of the central nervous system
.
Next, Professor Fudong Shi, the head of the neuroimmunology group (Figure 1B), conveyed that the Sixth Plenary Session of the 19th Central Committee of the Communist Party of China "based on a new stage of development, implements new development concepts, builds a new development pattern, promotes high-quality development, and promotes scientific and technological self-reliance" Strategy, then review and propose breakthroughs in the key technologies of independent research and development of reagents, and realize the standardization and process of immune disease antibody detection is imminent
.
Professor Shi introduced the plans of the Tianhai New Domain-Golden Domain Joint Laboratory based on the Beijing-Tianjin Neuroimmune Center to address the above key issues, including the optimization of the central four items (MBP, MOG, AQP4 and GFAP antibodies), autoimmune encephalitis and severe illness gravis diagnostic test methods
.
Professor Shi pointed out that the CBA (Cell based assay) method based on cell transfection is currently the internationally recommended method for autoantibody detection
.
However, there are also endogenous technical problems in the CBA testing system.
Dr.
Zhiguo Li will further elaborate on the relevant measures to upgrade the technology of the CBA testing method of the Beijing-Tianjin Shenmao Center and the Tianhai Xinyu Company, which is carried by the scientific research transformation
.
For the detection of myasthenia gravis autoantibodies, Professor Gao Feng of Henan Academy of Pharmaceutical Sciences (Figure 1C) first introduced the current status of myasthenia gravis antibody detection, and further proposed: 1) Autoantibody detection methodology is relevant to the detection results of myasthenia gravis Important impact, the consistency evaluation of different laboratories should be carried out as soon as possible (inter-laboratory evaluation), it is necessary to form the "Expert Consensus on the Clinical Application of Diagnostic Autoantibody Detection for Myasthenia Gravis" on the basis of full discussion; 2) CBA method detection The sensitivity and specificity of MG autoantibodies are higher than those of ELISA and radioimmunoassay (RIPA).
This method is recommended to improve the detection rate of antibodies within the allowable range of conditions
.
Dr.
Zhiguo Li from the Beijing-Tianjin Neuroimmune Center (Figure 1D) took myasthenia gravis as an example to describe the progress of autoantibody experimental diagnosis technology and the technical difficulties of AChR antibody detection, and summarized the improvement of the CBA detection method by the Beijing-Tianjin Neuroimmunity Center-Tianhai New Area Measures and technical advantages
.
The current problems faced by the CBA detection method include reagent storage, cell status and transfection efficiency are difficult to unify, single fluorescence is difficult to determine and low abundance signals are not sensitive
.
In response to these problems, the Beijing-Tianjin Shenmong Center has made technical improvements to the CBA method, including the use of a dual-color fluorescence interpretation system (increase internal reference control), the application of a 96-well plate detection system, improvement of reagent storage conditions, and enhancement of antigen signal stability.
A set of production + transportation + storage standardized quality control system
.
Especially for nearly 15% of the ambiguous samples that appear in the interpretation of the results of the conventional CBA method, the tyramide signal amplification system is used to specifically amplify the detection signal, which further improves the accuracy of conventional CBA detection, and also forms laboratory tests and clinical services.
integration system and so on
.
At the same time, it is introduced that domestic and foreign researches generally believe that the sensitivity (79.
5-91.
5%) and specificity (96%) of the ELISA method for detecting AChR antibodies are low, while the radioimmunoassay (RIPA) method has the advantage of specificity (99%) but cannot detect it.
Clustered AChR antibody and the inability to promote it due to radiological risks; domestic and foreign reports have reported that the specificity and sensitivity of the CBA method for detection of small samples of AChR antibody (less than 200 cases) is better than that of radioimmunoassay, but the detection methodologies of large samples need to be compared and verified
.
In order to improve the laboratory diagnosis technology of myasthenia gravis, the Beijing-Tianjin Center enrolled 1252 myasthenia gravis serum samples and conducted parallel comparison studies of CBA-TSA, RIPA and ELISA methodologies, confirming the accuracy and accuracy of the CBA-TSA method in detecting AChR antibodies.
Timeliness is better than RIPA method and ELISA method
.
At present, preparations are underway for a national multi-center methodological comparison study of myasthenia gravis autoantibody detection to provide core evidence for further optimization of myasthenia gravis antibody detection and lay the foundation for the establishment of new international recommendations
.
Figure 1 The main speakers of the third work and academic conference of the Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association in 2021 (Professor A Hao Hongjun, Professor B Shi Fudong, Professor C Gaofeng (online participation), D Li Zhiguo) The laboratory diagnosis guidelines for neuroimmune diseases, as well as the confusion of antibody test items on the market and large packages, the conference team conducted a national expert questionnaire survey (Figure 2-5)
.
Regarding autoimmune encephalitis, the survey results showed that the opinions of all members were basically the same, and all expressed their opposition to the autoimmune brain antibody detection package (Figure 2-4 Expert consensus questionnaire on issues related to laboratory diagnosis of autoimmune encephalitis )
.
On the contrary, the experts at the meeting had a highly consistent consensus on the content of autoantibody detection for myasthenia gravis disease and the selection of detection methodologies.
They believed that: 1) Myasthenia gravis specific autoantibody detection should be the first choice for auxiliary detection; 2) anti-AChR Or MuSK antibody as a specific laboratory diagnostic index for myasthenia gravis disease; 3) For the detection of anti-AChR or MuSK antibody, it is recommended to use the highly specific and sensitive CBA method for diagnostic qualitative and antibody semi-quantitative analysis, etc.
(Figure 5 Myasthenia gravis Expert consensus questionnaire on issues related to laboratory diagnosis)
.
The third working meeting of the Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association discussed the first draft of the laboratory diagnosis guidelines for central demyelination, autoimmune encephalitis and myasthenia gravis
.
Finally, Professor Guan Yangtai and Professor Feng Huiyu made a summary of the meeting, pointing out that this meeting is of great significance to the development of laboratory diagnostics for neuroimmune diseases in China, and affirmed the continued efforts to carry out a national multi-center methodological comparison of autoantibody detection for neuroimmune diseases.
It is necessary for the neuroimmunology team to promote the formation of international guidelines for diagnosis based on Chinese data; at the same time, it is believed that China’s accumulation of myasthenia gravis autoantibody CBA method detection technology is very likely to be the first to break through the bottleneck of foreign card neck technology and establish China International leading advantage in antibody detection for myasthenia gravis disease
.
Figure 2 Expert consensus questionnaire on laboratory diagnosis of autoimmune encephalitis Figure 3 Expert consensus questionnaire on laboratory diagnosis of autoimmune encephalitis (continued) Figure 4 Expert consensus survey on laboratory diagnosis of autoimmune encephalitis Questionnaire (continued) Figure 5 Expert consensus questionnaire on laboratory diagnosis of myasthenia gravis
The first disease in the prime of life is disability
.
The diagnosis, progress, and therapeutic effect of this group of diseases depend to a large extent on the laboratory tracking the immune response in the peripheral or central nervous system, that is, detecting the content of autoantibodies or antigens
.
The diagnostic reagents for neuroimmune diseases in China have been monopolized by European and American companies headed by Oumeng for a long time, and there are disadvantages such as unstable supply of reagents and high prices
.
At the same time, when the laboratory results are inconsistent with the clinical results, these European and American companies cannot provide communication with the sending doctor, and cannot solve the confusion of diagnosis and treatment in time
.
A more serious problem is that the industry lacks industry standards such as the content and interpretation of immune response required for the treatment of neuroimmune diseases
.
In response to the above problems, the third working and academic meeting of the Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association was held in Beijing on December 4, 2021.
39 academic group members and more than 10 academic group consultants participated in the meeting.
Live
.
Professor Hongjun Hao from Peking University First Hospital (Figure 1A) first introduced the characteristics, new understanding and clinical significance of the immune response of the central nervous system
.
Next, Professor Fudong Shi, the head of the neuroimmunology group (Figure 1B), conveyed that the Sixth Plenary Session of the 19th Central Committee of the Communist Party of China "based on a new stage of development, implements new development concepts, builds a new development pattern, promotes high-quality development, and promotes scientific and technological self-reliance" Strategy, then review and propose breakthroughs in the key technologies of independent research and development of reagents, and realize the standardization and process of immune disease antibody detection is imminent
.
Professor Shi introduced the plans of the Tianhai New Domain-Golden Domain Joint Laboratory based on the Beijing-Tianjin Neuroimmune Center to address the above key issues, including the optimization of the central four items (MBP, MOG, AQP4 and GFAP antibodies), autoimmune encephalitis and severe illness gravis diagnostic test methods
.
Professor Shi pointed out that the CBA (Cell based assay) method based on cell transfection is currently the internationally recommended method for autoantibody detection
.
However, there are also endogenous technical problems in the CBA testing system.
Dr.
Zhiguo Li will further elaborate on the relevant measures to upgrade the technology of the CBA testing method of the Beijing-Tianjin Shenmao Center and the Tianhai Xinyu Company, which is carried by the scientific research transformation
.
For the detection of myasthenia gravis autoantibodies, Professor Gao Feng of Henan Academy of Pharmaceutical Sciences (Figure 1C) first introduced the current status of myasthenia gravis antibody detection, and further proposed: 1) Autoantibody detection methodology is relevant to the detection results of myasthenia gravis Important impact, the consistency evaluation of different laboratories should be carried out as soon as possible (inter-laboratory evaluation), it is necessary to form the "Expert Consensus on the Clinical Application of Diagnostic Autoantibody Detection for Myasthenia Gravis" on the basis of full discussion; 2) CBA method detection The sensitivity and specificity of MG autoantibodies are higher than those of ELISA and radioimmunoassay (RIPA).
This method is recommended to improve the detection rate of antibodies within the allowable range of conditions
.
Dr.
Zhiguo Li from the Beijing-Tianjin Neuroimmune Center (Figure 1D) took myasthenia gravis as an example to describe the progress of autoantibody experimental diagnosis technology and the technical difficulties of AChR antibody detection, and summarized the improvement of the CBA detection method by the Beijing-Tianjin Neuroimmunity Center-Tianhai New Area Measures and technical advantages
.
The current problems faced by the CBA detection method include reagent storage, cell status and transfection efficiency are difficult to unify, single fluorescence is difficult to determine and low abundance signals are not sensitive
.
In response to these problems, the Beijing-Tianjin Shenmong Center has made technical improvements to the CBA method, including the use of a dual-color fluorescence interpretation system (increase internal reference control), the application of a 96-well plate detection system, improvement of reagent storage conditions, and enhancement of antigen signal stability.
A set of production + transportation + storage standardized quality control system
.
Especially for nearly 15% of the ambiguous samples that appear in the interpretation of the results of the conventional CBA method, the tyramide signal amplification system is used to specifically amplify the detection signal, which further improves the accuracy of conventional CBA detection, and also forms laboratory tests and clinical services.
integration system and so on
.
At the same time, it is introduced that domestic and foreign researches generally believe that the sensitivity (79.
5-91.
5%) and specificity (96%) of the ELISA method for detecting AChR antibodies are low, while the radioimmunoassay (RIPA) method has the advantage of specificity (99%) but cannot detect it.
Clustered AChR antibody and the inability to promote it due to radiological risks; domestic and foreign reports have reported that the specificity and sensitivity of the CBA method for detection of small samples of AChR antibody (less than 200 cases) is better than that of radioimmunoassay, but the detection methodologies of large samples need to be compared and verified
.
In order to improve the laboratory diagnosis technology of myasthenia gravis, the Beijing-Tianjin Center enrolled 1252 myasthenia gravis serum samples and conducted parallel comparison studies of CBA-TSA, RIPA and ELISA methodologies, confirming the accuracy and accuracy of the CBA-TSA method in detecting AChR antibodies.
Timeliness is better than RIPA method and ELISA method
.
At present, preparations are underway for a national multi-center methodological comparison study of myasthenia gravis autoantibody detection to provide core evidence for further optimization of myasthenia gravis antibody detection and lay the foundation for the establishment of new international recommendations
.
Figure 1 The main speakers of the third work and academic conference of the Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association in 2021 (Professor A Hao Hongjun, Professor B Shi Fudong, Professor C Gaofeng (online participation), D Li Zhiguo) The laboratory diagnosis guidelines for neuroimmune diseases, as well as the confusion of antibody test items on the market and large packages, the conference team conducted a national expert questionnaire survey (Figure 2-5)
.
Regarding autoimmune encephalitis, the survey results showed that the opinions of all members were basically the same, and all expressed their opposition to the autoimmune brain antibody detection package (Figure 2-4 Expert consensus questionnaire on issues related to laboratory diagnosis of autoimmune encephalitis )
.
On the contrary, the experts at the meeting had a highly consistent consensus on the content of autoantibody detection for myasthenia gravis disease and the selection of detection methodologies.
They believed that: 1) Myasthenia gravis specific autoantibody detection should be the first choice for auxiliary detection; 2) anti-AChR Or MuSK antibody as a specific laboratory diagnostic index for myasthenia gravis disease; 3) For the detection of anti-AChR or MuSK antibody, it is recommended to use the highly specific and sensitive CBA method for diagnostic qualitative and antibody semi-quantitative analysis, etc.
(Figure 5 Myasthenia gravis Expert consensus questionnaire on issues related to laboratory diagnosis)
.
The third working meeting of the Neuroimmunology Group of the Neurology Branch of the Chinese Medical Association discussed the first draft of the laboratory diagnosis guidelines for central demyelination, autoimmune encephalitis and myasthenia gravis
.
Finally, Professor Guan Yangtai and Professor Feng Huiyu made a summary of the meeting, pointing out that this meeting is of great significance to the development of laboratory diagnostics for neuroimmune diseases in China, and affirmed the continued efforts to carry out a national multi-center methodological comparison of autoantibody detection for neuroimmune diseases.
It is necessary for the neuroimmunology team to promote the formation of international guidelines for diagnosis based on Chinese data; at the same time, it is believed that China’s accumulation of myasthenia gravis autoantibody CBA method detection technology is very likely to be the first to break through the bottleneck of foreign card neck technology and establish China International leading advantage in antibody detection for myasthenia gravis disease
.
Figure 2 Expert consensus questionnaire on laboratory diagnosis of autoimmune encephalitis Figure 3 Expert consensus questionnaire on laboratory diagnosis of autoimmune encephalitis (continued) Figure 4 Expert consensus survey on laboratory diagnosis of autoimmune encephalitis Questionnaire (continued) Figure 5 Expert consensus questionnaire on laboratory diagnosis of myasthenia gravis
