(People's Daily health client reporter Hou Jiaxin Tan Qixin) "Please Zhang Fu to the No. 3 station to collect blood!" With the completion of specimen collection, the automated inspection line also began to operate. The test tubes of different colors are numbered and scanned for registration, and after the classification and sorting is completed, they are put into the biochemical analyzer, chemiluminescence immunoassay analyzer and other equipment for testing, and finally the test results are generated on the information management platform, and the whole testing process does not take more than 10 minutes.
This is a daily test carried out by thousands of hospitals across the country, but 30 years ago, such a test required multiple processes such as blood collection, plate coating, and machine loading, which could be completed in as little as half a day and as long as a day.
"In the past 30 years, the number of inspection items has grown from less than 100 to more than 600 today, and the speed, accuracy and quality of the inspection have improved by leaps and bounds. On December 21, 2023, Cui Wei, chairman-designate of the Laboratory Branch of the Chinese Medical Association and director of the Laboratory Department of the Cancer Hospital of the Chinese Academy of Medical Sciences, lamented to the reporter of the People's Daily health client that from the most inconspicuous "laboratory" in the hospital to the "laboratory medicine department" of today's fully automated inspection, laboratory medicine in mainland China has entered the era of informatization and intelligence.
At the beginning of the establishment of the laboratory department of Peking Union Medical College Hospital, the blood routine testing technology was greatly trained. Wang Huizhen, Department of Clinical Laboratory, Peking Union Medical College Hospital
The number of inspection items has increased from less than 100 30 years ago to more than 600 today
This year is the 34th year that Zhang Yi, director of the Laboratory Medicine Center and discipline leader of Qilu Hospital of Shandong University, has been engaged in laboratory medicine, and since graduating in 1989, he has witnessed the "golden age" of China's laboratory medicine discipline from a slow start to rapid development.
Looking back on the past 34 years, what makes Zhang Yi feel the most is the "hard days" when he first entered the industry. In the 90s of the last century, the development of laboratory medicine in mainland China was in the ascendant, and the laboratory departments in most hospitals were still only "laboratories".
"Dozens of square meters of huts, a few pieces of equipment is the whole picture of the original hospital laboratory, and there are more than 100 inspection items that can be carried out, but because it is almost entirely manual operation, the team of 30 or 40 people has been busy. Zhang Yi recalls that at that time, even the most routine tests were time-consuming and laborious.
Taking blood glucose testing as an example, unlike today's fully automatic analyzers, blood glucose testing at that time mainly relied on "boiling". After the patient draws the blood sample, the inspector must manually add the sample, put the sample and the reagent together in the water bath to heat to a specific temperature, and then judge the result by visual observation or color comparison, "The test results also need to be manually recorded by the inspector, and then feedback to the clinician, under the conditions at that time, it is more qualitative analysis or semi-quantitative testing, accurate quantification is still more difficult, and there is a lack of standardized quality control measures." Zhang Yi told reporters.
Hu Min, chairman of the Laboratory Professional Committee of Hunan Medical Association and director of the Laboratory Medicine Department of the Second Xiangya Hospital of Central South University, also had deep feelings. When she first joined the laboratory department in 1991, there were less than 100 tests that could be done in the hospital, and most of them had to be completed by hand.
"At that time, it took a whole day to wait for basic tests such as blood glucose, biochemistry, liver function, kidney function, and blood lipids that can get results in a few minutes, and patients basically had to wait until the next day to get the test report. Hu Min explained that manual blood sugar testing requires four or five processes, such as sampling, color development, color comparison, recording, calculation, etc., the process is cumbersome and complex, and each step takes a lot of time.
However, for critically ill patients such as myocardial infarction, timely diagnosis is very important, and doctors have to race against time. In Hu Min's memory, because the clinical tests were basically manual operations, in addition to the long time of experiments, there was no enough specific and sensitive protein marker detection method, "In those days, the role of the laboratory department in the medical process of rescuing critically ill patients was very weak. ”
From a "handicraft workshop" to an automation and information laboratory
In addition to the experimental methods and operations, the reagents and equipment required for the experiment need to be prepared and made by hand.
Hu Min remembers that in the past, many experimental materials in the laboratory were "homemade", such as rabbit brain powder was needed for blood coagulation experiments, and the predecessors of the test were all raising rabbits by themselves, killing rabbits, taking out the brain marrow, roasting and pounding into powder, and then preparing reagents to do experiments. In addition, in order to prepare petri dishes for bacterial culture, the teachers in the laboratory have to take turns to go to the farm for a few days a month to draw sheep blood for the preparation of culture media.
It wasn't until 1995 that that changed. Hu Min recalled that that year, the state equipped a number of tertiary hospitals across the country with fully automatic biochemical instruments, "Our hospital also allocated two." Since then, the laboratory department has ushered in a big development opportunity. By 1998, the laboratory departments of many hospitals began to have automated assembly lines, and the inspection efficiency has been qualitatively improved. ”
As one of the first batch of inspectors in China to contact flow cytometry, when Cui Wei first came to work at the Xi of Laboratory Science in 1995, the first large-scale testing instrument he came into contact with was the flow cytometer, "At that time, the flow cytometer was a behemoth, covering an area of 8 square meters The size of a room. ”
Staff from the Institute of Pediatrics of Xi'an Children's Hospital conducted blood and urine tests in the liquid chromatography mass spectrometry room. Xinhua News Agency
It was not easy to operate this massive instrument. Cui Wei remembers that at that time, he had to go to the dimming path when he turned on the machine every day, and he had to manually replace the filter after each test, and he had to take off the flow chamber regularly for cleaning and disinfection. Each test result needs to be manually copied into the test sheet, and then entered into the computer word by word to form a report.
Later, the instrument changed from manual to semi-automated, Cui Wei no longer had to adjust the optical path and replace the filter by himself, he only needed to put the specimen on the machine after processing, and the instrument could automatically complete the detection. In the past decade, the "behemoth" has become smaller and smaller, and now a flow cytometer is only the size of an office printer, and at the same time, the instrument can "tune" more and more colors.
"Originally, only 3 colors could be displayed, and then gradually to 8 colors, and now 12 colors can be achieved, the richer the colors, the more immune indicators we detect, and the more clinicians can further achieve accurate diagnosis, with accurate diagnosis, precision treatment is possible." Cui Wei said.
With the rapid development of laboratory medicine and the cross-integration of multiple disciplines, new technologies such as gene sequencing, mass spectrometry, and microfluidics are emerging. In the eyes of Professor Wang Chuanxin, chairman of the Laboratory Medicine Branch of the Chinese Medical Association and dean of the Institute of Laboratory Medicine Innovation Technology of Shandong University, from the workshop-style inspection of simple indicators obtained by manual operation to the automation and information laboratory, now, the mainland laboratory medicine is striding towards a new era of digitalization and intelligence.
"In every test-tube specimen is a living patient"
After 30 years in the industry, Cui Wei still remembers the "magical" moment when he first came into contact with testing in the classroom.
"At that time, the first practical lesson of the test course offered by the school was to look at the cells, through the microscope, push a drop of the patient's blood into a piece, and the red blood cells and white blood cells appeared one by one, and we counted the cells one by one to determine which cells the patient had more or less cells, whether there was anemia, and whether it was healthy. The first laboratory class at the university made Cui Wei realize that every specimen in the test tube was a living patient.
"The test is not just a clinical test report. In Cui Wei's view, the laboratory department is responsible for the important task of providing high-quality test reports for the clinic, and excellent laboratory physicians are the bridge between the laboratory and the clinic, and the diagnostic information provided by the clinical laboratory accounts for more than 70% of the total auxiliary diagnostic information.
Wang Chuanxin said that laboratory medicine is an important support platform for disease diagnosis and treatment, that is, it is patient-centered, closely connecting medical staff, medical institutions, medical equipment and patients, and participating in the screening, prevention, diagnosis, treatment and prognosis of diseases in an all-round way. Laboratory data is not only a true reflection of human health status and disease development, but also a scientific basis for guiding clinical decision-making, which makes clinicians increasingly inseparable from laboratory medicine in disease diagnosis and treatment.
"Through pathogen genetic testing, we can detect tens of thousands of pathogen species that cannot be detected with traditional testing techniques. "From a certain point of view, the development of detection medicine has expanded the boundaries of disease diagnosis and treatment, allowing clinicians to explore disease areas outside of textbooks, thus providing clues for the diagnosis and treatment of rare and rare intractable diseases in clinical practice." ”
With the rapid development of laboratory medicine in mainland China, the relevant quality control system is also constantly updated and upgraded.
Cong Yulong, chairman of the fifth and sixth chairman of the Laboratory Medicine Branch of the Chinese Medical Association and professor of the All-Army Medical Laboratory Quality Control Center, introduced, "In 2005, the mainland began to recognize ISO 15189, which is a quality management system standard for medical laboratories, also known as the requirements and evaluation guidelines for medical laboratory quality management systems. At that time, I set up the first testing laboratory that met the standard, and today there are more than 800 laboratories that meet this standard. ”
In Cong Yulong's view, only by applying the results of laboratory medicine to clinical patients can laboratory medicine exert its true value. Adhering to this concept, in the future, laboratory medicine will sink advanced laboratories and testing technologies to lower-level medical alliances, which will play an important role in the future health cause of the mainland.
Accelerate the construction of the National Laboratory Medicine Center, so that patients can be tested at home
"At present, the development of laboratory medicine in China is still facing the problems of prominent level differences between regions and obvious gaps in the level of hospitals at different levels. Zhang Yi said frankly that to solve this problem, promoting the construction of regional medical testing centers is the best starting point.
On February 9, the National Health Commission and other six ministries and commissions decided to carry out the pilot construction of compact urban medical groups across the country, and issued the "Pilot Work Plan for the Construction of Compact Urban Medical Groups", requiring the overall construction of medical testing and other resource sharing centers, and upgrading the construction of regional medical testing centers to the national level.
On July 17, 2017, staff from the Henan Institute of Medical Genetics tested the extracted genes. Photo by Xinhua News Agency reporter Li An
Zhang Yi introduced that the regional laboratory medicine center is established or independently established by relying on the laboratory department of the core hospital in the region, and uniting with other medical institutions in the region to optimize, integrate and share the testing resources in the region, and build a central laboratory covering the entire region.
"After the establishment of the regional inspection center, the inspection items with complex technical equipment conditions and high personnel requirements can be tested in the inspection center, and the laboratory department of the primary hospital retains the requirements of routine inspection and emergency items, which can reduce the repeated investment in the inspection of the whole region and save medical insurance expenses. It can also realize the reintegration of medical resources in the region, reduce the investment in the inspection of primary medical units, and use limited resources to strengthen the cultivation of other capabilities. Zhang Yi said.
At the same time, Zhang Yi mentioned that the samples of primary medical units are uniformly tested and sent by the regional testing center, which in fact achieves the effect of mutual recognition of test results and avoids repeated inspections. This method of "primary sampling and central inspection" can also use the more professional technical platform and business capabilities of the regional laboratory center to quickly improve the medical service level of grassroots units and ensure the quality of patients' treatment, which is also one of the means to solve the problem of "difficult and expensive medical treatment".
Promoting the construction of laboratory medicine centers is inseparable from discipline construction and talent training. In Wang Chuanxin's view, as a secondary discipline of clinical medicine, laboratory medicine still has limitations such as lack of distinctive discipline characteristics and relatively weak scientific research strength. "In the future, the laboratory discipline should seek a breakthrough in the education system, and cultivate more innovative and compound talents from the university period, such as understanding both clinical and scientific research, or understanding both medical laboratory technology and department management, both technical craftsmen and leading talents. ”
Cui Wei believes that how to establish an integrated innovation ecosystem of "discipline-talent-scientific research" is the key to the current development of testing disciplines. On the one hand, refinement and specialization are the only way for the development of disciplines. Laboratory medicine should strengthen the construction of subspecialties, and gradually create a discipline development direction with distinctive specialty characteristics with the help of multidisciplinary integration. On the other hand, we should give full play to the role of scientific research and innovation engine, aim at the key scientific and technological problems of the industry, promote the development model of scientific research and education with scientific research projects, and finally form a long-term development mechanism of "clinical-teaching-scientific research".
"Inspection has been my life's work. When I entered the Department of Laboratory Science by mistake, I didn't expect to work for a lifetime. Now Zhang Yi, whose temples have turned a little white, still talks about his favorite laboratory medicine. In his eyes, laboratory medicine still has an infinitely broad future, and there are still many unknowns waiting for him to explore.