Contributed by: College of In Vitro Diagnostics Source: IVD Sales Practical Classroom
We will primarily introduce common devices in clinical testing, including: blood cell analyzers, flow cytometers, coagulation analyzers, urine dry chemical analyzers, urine formed component analyzers, fecal analyzers, biochemical analyzers, chemiluminescence immunoassay analyzers, enzyme immunoassay analyzers, fluorescence immunoassay analyzers, nucleic acid extraction instruments, real-time fluorescence PCR instruments, gene sequencers, microbial identification and drug sensitivity analyzers, fully automated blood culture instruments, mass spectrometers, blood type identification instruments, and assembly line systems.
01 Blood Cell Analyzer
Blood cell analyzers can be classified based on their ability to categorize white blood cells into those without white blood cell grouping functions, two-part grouping blood cell analyzers, three-part grouping blood cell analyzers, and five-part blood cell analyzers.
Currently, the majority of medical institutions use three-part and five-part blood cell analyzers.
The early blood cell detection devices can be traced back to 1590, when the Dutchmen Middelburg and Jansen designed and manufactured the most primitive microscope. Later, this microscope underwent development and improvement, and in 1658, the Italian Malpighi first observed red blood cells under a microscope, leading to the gradual realization that the number of cells in the blood is related to the occurrence and development of diseases, prompting scientists to begin researching methods for cell counting.
After more than 100 years of application, evolution, and development, by 1953, Wallace H. Coulter and his brother Joseph R. Coulter from Beckman Coulter Company proposed the famous Coulter principle, which is the principle of electrical impedance, and obtained a US patent that year, launching the first blood cell counter the following year. Thus, the Coulter principle has become the most classic principle in blood cell counting and analysis.
Here we discuss the origin of Beckman Coulter: In 1997, Beckman Company acquired Coulter Company and was renamed Beckman Coulter Company. Later, the Danaher Group also acquired Beckman Coulter, which is now known as Danaher Beckman.
In 1974, the first leukocyte analyzer with preliminary white blood cell classification function, Hema log D, was launched. This product could initially classify white blood cells into five categories: lymphocytes, monocytes, eosinophils, basophils, and neutrophils.
In 1980, this technology matured further, leading to the launch of the H6000 blood cell analyzer, which could accurately achieve five-part classification of blood cells. Since then, various companies have continuously innovated in five-part white blood cell classification technology, with representative products including Sysmex’s multi-channel impedance, radio frequency, and cytochemical combined detection technology, Abbott’s multi-angle polarized light (MAP) technology, and ABX’s cytochemical lipid staining technology combined with dual sheath flow (DHSS) technology.
In 2006, Shenzhen Mindray launched the first domestic five-part blood cell analyzer, BC-5500. Subsequently, domestic five-part blood cell analyzers were successively launched, including the URIT-5500 fully automated five-part blood cell analyzer developed by Guilin Yulite in 2009, the BF-5180 five-part blood cell analyzer launched by Changchun Dirui in 2010, the TEK8500 five-part blood cell analyzer from Jiangxi Tekang in 2011, and products from companies such as Shenzhen Lanyun, Shenzhen Leidu, and Dimai Biological have also been successively launched.
Currently, blood cell analysis technology has matured, forming a competitive landscape dominated by Mindray and Sysmex in the blood analysis field in both domestic and international markets. Of course, there are also manufacturers like Beckman, Abbott, and ABX that perform well in the blood field.
02 Flow Cytometer
Here we need to tell a little story, Mack Fulwyler is considered a pioneer of flow cytometry today, especially for cell sorting instruments. In 1965, Fulwyler published the first article on cell sorting in Science, and he is thus regarded as the “father of droplet sorting.” Fulwyler’s sorting is a combination of the Coulter principle and inkjet printer technology. This is early research on flow cytometers.
Flow cytometry (FCM) is a cell parameter analysis technology that uses flow cytometers to count and quantitatively analyze various biological and physical, biochemical properties of single-cell suspensions from blood, various body fluids, bone marrow, biopsies, and plant and animal tissues, including cells, platelets, organelles, sperm, microorganisms, and artificially synthesized microspheres, and can sort specific cell populations.
In simple terms, flow cytometry is a powerful tool for cell analysis and sorting, allowing for rapid quantitative analysis and sorting of individual cells or other microbial particles. It can measure cell size, the shape of internal particles, and detect cell surface and plasma cell antigens, as well as intracellular DNA and RNA content, etc. It can also detect and analyze a large number of cells in a short time and can classify, collect, or sort a specific subpopulation of cells with a sorting purity of over 95%.
We have a general understanding of these principles, and next, we will discuss which companies have related flow cytometer products.
Flow cytometers can be classified into analytical flow cytometers and sorting flow cytometers based on functional structure.
Currently, the flow cytometers used in China are mainly imported:
One is the American BD Company, whose flow products occupy over 40% of the global market share, offering a complete range of products including analytical flow, sorting flow, and flow liquid phase chips.
The other is Beckman Company, which produces a series of research and clinical flow cytometers and develops various monoclonal antibodies and fluorescent reagents used in FCM (flow cytometry). There are also foreign giants like Thermo Fisher and Agilent with flow cytometer products.
The first domestic flow cytometers were developed in the early 1980s, and domestic companies such as Mindray, Aisen, Weigong Technology, Zhongsheng Beikong subsidiary (Zhongsheng Suzhou), Boao Biological, Saijing Biological, and Xatai Biological are considered emerging players in the flow cytometer manufacturing industry.
03 Coagulation Analyzer
Coagulation analyzers are mainly used for laboratory tests of thrombosis and hemostasis, providing valuable indicators for the diagnosis and differential diagnosis of hemorrhagic and thrombotic diseases, thrombolysis, and anticoagulation treatment monitoring and efficacy observation.
So far, the development of coagulation analyzers has mainly gone through five stages: initial manual methods, electrical current methods, dual magnetic circuit bead methods, optical turbidity methods, and photoelectric magnetic bead methods.
Currently, different types of coagulation analyzers on the market use different principles, and the main detection methods currently used include: coagulation method, substrate colorimetric method, immunoassay, and latex agglutination method.
The coagulation instruments used in the domestic tertiary market are mainly imported instruments, with most concentrated in Japan’s Sysmex, France’s Stago, and the United States’ National Instruments Laboratory (IL, Werfen Group). In addition, there are also Japan’s Sekisui, Germany’s BE, etc.
The secondary and lower markets mainly include Shenzhen Mindray, Beijing Jiuqiang, Sichuan Mike, Shanghai Taiyang, Shenzhen Leidu, Zhongshan Biao Jia, Beijing Zhongchi Weiye, Beijing Beiken, Shandong Aikeda, Jiangsu Hong’en, Shaoxing Pushi Kang, etc. However, secondary hospitals still tend to use more imported products from the three giants.
Overall, domestic coagulation products have a long way to go in terms of replacing imports. Additionally, foreign imported coagulation platforms are generally open to each other; for example, Sysmex’s coagulation analyzer can use Sekisui’s coagulation reagents. However, generally, original equipment is still more commonly used. At that time, domestic reagents could not be used on imported platforms.
04 Urine Dry Chemical Analyzer and Urine Formed Component Analyzer
Urine analyzers are automated instruments used to determine certain chemical components in urine, with the main functions as follows:
① Mainly used for initial diagnosis of patients and health checks with 8-11 item screening combination urine test strips.
The 8 detection items include protein, glucose, pH, ketone bodies, bilirubin, urobilinogen, occult blood, and nitrite;
The 9 detection items add urine leukocyte testing to the above 8 items. The 10 item urine analyzer adds urine specific gravity testing to the 9 basic items. The 11 item detection adds vitamin C testing.
② Mainly used for efficacy observation of diagnosed diseases, such as renal diseases can use pH, protein, and occult blood (red blood cell) combination test strips; diabetes can use pH, sugar, and ketone body combination test strips; liver diseases can use bilirubin and urobilinogen combination test strips.
The urine formed component analyzer, also known as the urine sediment analyzer, is an indispensable part of routine urine analysis and an important project in clinical testing. Due to the wide variety of formed components in urine, their diverse shapes, and their susceptibility to damage or morphological changes, a large amount of experience accumulation is required, so it has always been primarily based on classic microscopic examination, with automation processes starting relatively late. In recent years, the continuous development of computer technology, digital imaging technology, and neural network technology has driven the progress and rapid development of this testing technology.
Regarding the manufacturers and market conditions of urine dry chemical analyzers and urine sediment analyzers, we will introduce:
High-end market: Mainly dominated by Dirui, Sysmex, and Beckman Coulter, with Sysmex being the first to enter the Chinese market, having no competition and the largest market share. However, as end users’ recognition of formed component analysis decreases, the market share of Sysmex has been shrinking year by year. Dirui Medical’s urine series products have been gradually increasing their market share in the high-end market, compressing Sysmex’s market share, while other brand products occasionally appear in the high-end market.
Mid-range market: Mainly consists of products from Dirui, Sysmex, Awei, and Kebo, with Sysmex’s market share in this market declining.
Low-end market: Mainly consists of products from Awei, Longxin, Tianhai, Huisheng, and Mindray, characterized by single technology and low prices, suitable for use with fewer sample volumes.
05 Fecal Analyzer
Fecal testing studies the changes in the appearance, morphology, and biochemical properties of feces under pathological conditions in the human body, as well as the pathogenic microorganisms in feces to identify sources of infection. The fecal analyzer is an automated device developed based on the experience and foundation of manual testing, aimed at automating fecal testing, improving efficiency, standardizing management, and improving the environment.
Related manufacturers include: Xindao Biological, Wovent Biological, Awei Technology, Lanjie Biological, Xieda Biological, Zhuhai Key Domain, Hailu Biological, Tekang Technology, Korye Medical, Chongqing Tianhai, Litou Biological, and Jinhun Medical. Among them, Wovent Biological has developed well in recent years, and manufacturers like Litou Biological, Zhuhai Key Domain, and Awei Technology also have a considerable market installation volume.
That concludes our introduction to the equipment in the clinical testing group, and next, we will share related learning on biochemical immunoassay equipment.
06 Biochemical Analyzer
Regarding biochemical analysis equipment, we mainly need to understand fully automated biochemical analyzers and dry biochemical analyzers, which are the most commonly used biochemical testing devices in secondary and tertiary hospitals. This classification is based on the reaction methods of biochemical analyzers; generally, fully automated biochemical analyzers are liquid reaction types, while dry biochemical analyzers are dry plate reaction types.
The development of biochemical analyzers has gone through three stages, from the initial spectrophotometer to semi-automated biochemical analyzers, and now to the widely used fully automated biochemical analyzers. Currently, both open and closed types coexist, but many large manufacturers are leaning towards closed types.
Currently, private hospitals mostly use biochemical analyzers with speeds ranging from 400 to 1200 tests per hour, as private hospitals are relatively smaller than public hospitals.
Currently, fully automated biochemical analyzers are mostly used in township hospitals with speeds of 400 tests per hour, while larger ones use 600 to 800 tests per hour. The speed refers to how many test items can be detected in one hour.
Secondary hospitals mostly use analyzers with speeds above 800 tests per hour, with the highest using single-module devices with speeds of 2000 tests per hour.
Tertiary hospitals often use modular assembly lines, with single modules generally being 2000 tests per hour, although smaller ones may also be below 2000 tests per hour.
Additionally, dry biochemical analyzers are mainly used in emergency departments, although some testing departments may also use them, but most are still placed in emergency departments. Generally, dry biochemical analyzers are mainly used in grade II and III hospitals, where there is a high volume of specimens at night, and a separate emergency department is set up to handle specimens. Smaller hospitals do not require this, as they have on-duty personnel who directly handle specimens in the testing department.
Next, let’s discuss the leading manufacturers in the biochemical analysis equipment field.
Imported manufacturers include:
Roche: Biochemical analyzers are mainly closed types, with some open channels reserved.
Abbott: Mainly promotes biochemical immunoassay cascades, assembly lines, and relatively few standalone machines, with some tertiary and secondary hospitals having installations.
Beckman: Originally integrated with Olympus, in 2009, Beckman Coulter acquired Olympus’s diagnostic business for $792 million, fully taking over Olympus’s clinical biochemical diagnostic business, merging the chemical product lines of both companies into a complete chemical supply system.
Siemens: Originally integrated with Bayer’s biochemical product line, Siemens mainly focuses on assembly lines in the biochemical field.
Canon: Originally Toshiba Biochemical, later acquired by Canon.
Hitachi: Hitachi has previously focused on open models in China, currently promoting the 008 series, while the previous 7600 series is still classic, with many tertiary hospitals still using it.
Ortho Clinical Diagnostics (formerly Johnson & Johnson’s dry biochemical), holds a high market share in the dry biochemical field, with most tertiary hospitals using Ortho’s dry biochemical analyzers.
We will not list specific models here.
Next, we will discuss domestic biochemical analyzers, mainly from Shenzhen Mindray, Changchun Dirui, Shanghai Kehua, Shenzhen Leidu, Guilin Yulite, Shenzhen Kubeier, Nanjing Yingnuohua, Shenzhen Nanyun, and Beijing Songshang.
In the in vitro diagnostic market, the clinical biochemical field has gradually entered a relatively mature and stable growth period. However, in terms of technology, continuous progress is still needed. Currently, in tertiary and secondary hospitals, most testing departments still prefer to use imported biochemical analyzers.
07 Chemiluminescence Analyzer
Chemiluminescence immunoassay technology (CLIA) began in the early 1980s and rapidly developed in the 1990s, becoming a new measurement technology following fluorescence immunoassay, radioimmunoassay, and enzyme-linked immunoassay.
It has advantages such as high sensitivity, strong specificity, stable and long-lasting reagents, stable and rapid methods, wide detection linearity, and simple operation. Its rapid innovation has made this technology the mainstream automated detection technology in immunoassay, widely applied in various fields of clinical testing.
Electrochemiluminescence immunoassay technology (ECLIA) emerged in the 1990s, with Roche as the owner of the electrochemical patent technology and a promoter of technological development.
In 2016, the patent for electrochemiluminescence expired, and in 2017, Shenzhen Pumen registered and launched the first domestic electrochemiluminescence analyzer.
Chemiluminescence immunoassay technology entered the Chinese market between 2003 and 2006. In 2008, the technology penetrated the domestic market, and New Industry launched the first domestic fully automated direct chemiluminescence immunoassay analyzer. Between 2011 and 2013, manufacturers such as Mike, Antu, and Mindray successively launched fully automated chemiluminescence analyzers. In addition to large chemiluminescence analyzers, some domestic manufacturers have also launched small, instant detection POCT chemiluminescence analyzers, such as Guosai’s enzyme-promoted chemiluminescence analyzer and Norman’s direct chemiluminescence, mainly used for rapid diagnosis of cardiac markers, procalcitonin (PCT), and other emergency projects. Chemiluminescence has now become the most widely used and advanced technology in immunoassay applications, and is a hot field in immunodiagnostics in recent years.
For mainstream manufacturers of chemiluminescence analyzers, the main imported brands currently on the market include Roche, Abbott, Beckman, Siemens, Sysmex, and Solvay.
Domestic leading manufacturers include: Mindray, Antu, New Industry, Mike, Boao Sais, Komei, Yahui Long, Toukang, Pumen, Changguang Huayi, and Haooubo.
Currently, there are hundreds of manufacturers in the entire chemiluminescence market in China. Specific information can be found through various industry media platforms, which have relevant reference materials.
08 Enzyme Immunoassay Analyzer
Enzyme-linked immunosorbent assay (ELISA) is the third major labeled immunoassay technology following fluorescence immunoassay and radioimmunoassay. Due to the advantages of enzyme immunoassay technology (EIA), such as high sensitivity, simple operation, long reagent shelf life, and low environmental pollution, it has gradually replaced radioimmunoassay technology.
In recent years, enzyme immunoassay technology has developed rapidly, and enzyme immunoassay analyzers are specialized instruments for ELISA determination. In the early 1980s, ordinary enzyme immunoassay analyzers, or enzyme markers, were commercially available. China produced its first enzyme marker (510 type enzyme colorimeter) in 1981.
In the 1990s, enzyme markers gradually became widely used in clinical laboratories of hospitals and blood stations. With the application and development of ELISA technology, various new types of enzyme immunoassay analyzers with various functions have been developed abroad, transforming enzyme immunoassay analyzers from single colorimetric reading functions to fully automated enzyme immunoassay analyzers that integrate multiple functions, allowing a single machine to automatically perform all steps of the ELISA experiment from sample addition, incubation, washing, oscillation, colorimetric analysis to qualitative or quantitative analysis, and finally complete report storage and printing according to user-designed programs.
Based on the development process of fully automated enzyme immunoassay analyzers, they can be divided into three generations of products.
The first generation of fully automated enzyme immunoassay analyzers achieved integration of single-needle and multi-needle sample addition systems with enzyme marker plate processing systems, but most microplate incubation positions require at least 4 plates.
The second generation of fully automated enzyme immunoassay analyzers is single-task and single-track, but because it cannot process two processes simultaneously (e.g., washing plates while adding reagents), the time to complete the experiment is extended.
The third generation of fully automated enzyme immunoassay systems is characterized by multi-tasking and multi-channel processing, fully achieving parallel process handling.
Currently, the manufacturers of enzyme immunoassay analyzers on the market are as follows:
Domestic brands include: Aikang Biological, Aidekang, Mindray, Antu, Leidu, Kehua, and Kereidi.
Imported brands are mainly fully automated enzyme immunoassay analyzers produced by Hamilton in Switzerland, which have a high market share. In China, Yantai Ausbon is responsible for promotion and sales, such as the Fermi fully automated enzyme marker. Additionally, there are other imported brands such as Italy’s DAS based on pneumatic displacement principles for enzyme immunoassay sample addition systems.
09 Immunofluorescence Analyzer
Immunofluorescence analysis technology combines the high sensitivity of fluorescence technology with the high specificity of immunological techniques, providing a unique detection technology for immunology, clinical histochemistry, and laboratory diagnostics that cannot be replaced by other methods.
Currently, immunofluorescence analyzers are used not only for the identification of bacteria, viruses, protozoa, worms, and fungi, but also widely used for the detection of serum antibodies (including autoantibodies), diagnosis and research of autoimmune diseases, identification and localization of pathological antigens, antibodies, and complement, pathological research of immune complexes, antigen relationships between bacteria, viruses, and hosts, receptor and ligand studies, and tumor immunology diagnosis and research, as well as studies of cell membrane surface antigens and their receptors.
Immunofluorescence analyzers mainly consist of a sample addition center and a testing center. The sample addition center includes three concentric disks, namely the test tube disk, reagent kit disk, and sample disk.
Domestic representative manufacturers include: Guangzhou Wanfu, Shenzhen Yahui Long, Jidan Biological, Jiangsu Liangdian, Suzhou Dingshi, Nanjing Nuowei, Hunan Litou Biological, and Ali Biological.
That concludes our explanation of common laboratory equipment related to biochemical immunoassay in the clinical testing department. Next, we will introduce common equipment in the molecular laboratory of the clinical testing department.
10 Nucleic Acid Extraction Instrument
We know that most nucleic acid testing products adopt the “real-time fluorescence RT-PCR detection” method, which involves sample collection, transportation, inactivation, and other processing in the early stage, nucleic acid testing products are mainly divided into two steps during the detection process: nucleic acid extraction and amplification detection. The amplification detection part mainly depends on the purity of the nucleic acid extracted in the previous step and the performance of the amplification instrument. Therefore, the differences in nucleic acid testing products are primarily determined by the “nucleic acid extraction” step.
In recent years, the in vitro diagnostic industry has made rapid technological advancements, progressing from
Regardless of whether nucleic acid extraction is a “one-step” or “two-step” process, the goal is to extract nucleic acids of considerable purity. This is an unavoidable step in the entire nucleic acid testing industry, as the purity of nucleic acid extraction from a clinical sample often directly determines the validity of the test results.
From the perspective of market technology platforms, there are manual extraction platforms, which are manual extraction methods; and there are instrument extraction platforms, which are nucleic acid extraction instruments. Currently, the mainstream automated nucleic acid extraction platforms are still based on magnetic bead nucleic acid extraction technology platforms.
There are many brands of nucleic acid extraction instruments, with major imported brands including Roche Diagnostics, Germany’s Qiagen, Germany’s Jenoptik, Abbott, Thermo Fisher, and Beckman.
Domestic nucleic acid extraction instrument manufacturers include: Da’an Gene, Shengxiang Biological, Xi’an Tianlong, Zhijiang Biological, Jiangsu Shuoshi, Hangzhou Borui, Bojie Medical, Zhizhan Biological, Beijing Baiketai, Aikang Biological, Shanghai Kehua, and Shanghai Jienuo.
11 Real-time Fluorescence PCR Instrument
PCR, translated as polymerase chain reaction. Since the invention of PCR technology in 1985, the technology has matured significantly, and PCR instruments can be divided into three categories, namely: conventional PCR instruments, real-time fluorescence quantitative PCR instruments, and digital PCR instruments.
Today, we will mainly discuss real-time fluorescence PCR instruments.
The most notable advancement in PCR technology over the past 30 years is the development of real-time quantitative PCR technology (real-time quantitative PCR, or qPCR).
Quantitative PCR technology has truly achieved a leap from qualitative to quantitative PCR, allowing for real-time monitoring of the PCR process, enabling specific, sensitive, rapid, and repeatable precise quantification of the initial template concentration, and has been increasingly widely applied in both research and clinical diagnostic fields.
The working principle of PCR involves three steps: denaturation, annealing, and extension.
For the working principle of real-time fluorescence PCR instruments, it involves mixing Taqman probes labeled with fluorophores with template DNA, completing high-temperature denaturation, low-temperature annealing, and temperature-appropriate extension thermal cycling, and following the rules of polymerase chain reaction. The Taqman probes that complementarily pair with the template DNA are cleaved, releasing the fluorophores into the reaction system, which emit fluorescence under specific light excitation; as the number of cycles increases, the amplified target gene fragments grow exponentially, and the corresponding fluorescence signal intensity changes with the amplification is detected in real-time to obtain the Ct value (cycle threshold, i.e., the number of cycles experienced when the fluorescence signal in each reaction tube reaches the set threshold), and by using several known template concentrations as controls, the copy number of the target gene in the sample can be determined.
It may be difficult to fully understand this explanation, but you can think of it this way: a real-time fluorescence quantitative PCR instrument has two key systems, an optical system and a temperature control system. The optical system is used for collecting and converting optical signals, while the temperature control system maintains the temperature conditions required for nucleic acid amplification. Finally, the computer’s built-in software system will calculate the clinical quantitative results based on the relevant relationship equations.
The main manufacturers of real-time fluorescence PCR instruments are as follows:
Imported manufacturers include Roche Diagnostics, Bio-Rad from the USA, and ABI (ABI has been acquired by Thermo Fisher).
Domestic established manufacturers include: Shanghai Hongshi, Hangzhou Borui, and Xi’an Tianlong.
12 Gene Sequencer
To date, the development of gene sequencing technology has seen the emergence of four generations of sequencing technologies. Currently, second-generation sequencing technology is the market mainstream, with typical representatives including Illumina’s Solexa (SBS, sequencing by synthesis) technology, Roche’s 454 technology, and Life Tech’s SOLID technology. In recent years, third-generation technologies represented by single-molecule sequencing technology and fourth-generation nanopore sequencing technology have emerged, marking the future development direction of sequencing technology.
Currently, the global gene sequencer market is highly monopolized, with Illumina occupying 62% of the global gene sequencer installation volume, and Thermo Fisher occupying 31%, with the two giants accounting for 93% of the total installed gene sequencers worldwide. Due to extremely high technical barriers, the gene sequencer market exhibits high concentration characteristics, with Illumina and Thermo Fisher’s market share (sales ratio) reaching 90%.
From the perspective of the domestic market, over 70% of sequencers still come from imports, and most domestic second-generation sequencers are produced using foreign technology for OEM production, such as Berry Genomics collaborating with Illumina to produce the NextSeq CN500, and Da’an Gene collaborating with LifeTech to produce the DA8600.
That concludes our explanation of the main equipment in the molecular laboratory of the clinical testing department, and next, we will explain common equipment in the microbiology laboratory of the clinical testing department: Microbial identification and drug sensitivity analyzers, fully automated blood culture instruments, mass spectrometers.
13 Microbial Identification and Drug Sensitivity Analyzer
A key role of the microbiology laboratory is to isolate, identify, and analyze pathogenic microorganisms that cause infectious diseases in humans. Its importance is reflected in three aspects:
① Cultivating suspected pathogenic microorganisms from patient specimens;
② Isolating microorganisms and classifying and confirming their identification;
③ Predicting and interpreting the sensitivity of related pathogenic microorganisms to antimicrobial drugs.
The cultivation method remains the gold standard of classical microbiology, and for decades, microbiological testing has undergone a development process from manual, semi-automated to fully automated identification systems.
Based on the degree of automation, identification and drug sensitivity analysis systems are divided into semi-automated analysis systems and fully automated analysis systems.
Semi-automated analysis systems only have result interpretation devices, using endpoint methods to interpret and explain results.
Fully automated analysis systems integrate sample addition, incubation, and result interpretation, using rate methods or endpoint methods to interpret and explain results. Imported products include both semi-automated and fully automated identification and drug sensitivity analyzers, while domestic products currently only include semi-automated identification and drug sensitivity analyzers.
Major imported brands include Beckman from the USA, bioMérieux from France, BD from the USA, Siemens, Thermo Fisher from the USA, and France’s 12a.
Domestic brand manufacturers include: Zhuhai Deer Biological, Shandong Xinke Biological, and Zhuhai Meihua Medical.
14 Fully Automated Blood Culture Instrument
Blood culture testing is the gold standard for detecting bloodstream infections, through in vitro culture to detect microorganisms in human blood or other sterile body fluids under normal conditions. Relevant manufacturers can refer to the aforementioned manufacturers of microbial identification and drug sensitivity analyzers.
15 Mass Spectrometer
Developed countries in Europe and America were the first to introduce mass spectrometry technology into medical testing departments, and it has developed relatively maturely. Currently, there are over 400 clinical diagnostic projects served by mass spectrometry, mainly involving clinical chemistry, clinical immunology, and clinical microbial identification, and it is also used to establish reference measurement procedures for clinical chemistry testing projects and develop reference materials. With the increasing demand for personalized and precise medical care, research results in genomics, proteomics, and metabolomics based on mass spectrometry technology are continuously being translated into clinical practice.
Currently, the domestic mass spectrometer market is basically monopolized by SCIEX, Agilent, Thermo Fisher, and Bruker, with the four traditional analytical instrument manufacturing giants occupying over 70% of the mass spectrometer market.
From the perspective of mass spectrometer manufacturers, major imported brands include SCIEX, Agilent, Thermo Fisher, Bruker, Shimadzu, Waters, and BD.
Domestic brands include Antu Biological, Bohui Innovation, Tianrui Instruments, Dongxi Analysis, Hexin Instruments, Yingsheng Biological, BGI, and Zhuhai Deer.
That concludes our introduction to common equipment in the microbiology laboratory.
16 Blood Type Identification Instrument
Since the discovery of blood types in 1900, blood type identification has undergone two stages internationally: manual and automated.
In the first stage, the manual method was commonly used, where samples and reagents were manually dropped onto paper or glass plates, mixed with cotton swabs, and results were judged visually. This method is simple and easy to operate, but it is inefficient, has a high error rate, and does not preserve original results or qualitative data, making traceability impossible.
In the second stage, starting in the 1970s, automation technology was applied to blood type testing, gradually achieving fully automated blood type analysis. Depending on the experimental carrier, it is generally divided into card-type and plate-type analysis instruments.
In 1982, the world’s first fully automated blood type identification instrument, PK7000, was born at Olympus, which is now Danaher Beckman.
Currently, the best brands for fully automated blood type identification and cross-matching analysis systems on the market are Diana and Johnson & Johnson. Other manufacturers include Beckman, Bio-Rad, and the American Medisense Scientific Technology Company.
In China, manufacturers include Aikang Biological, Shenzhen Aijie, and others.
17 Laboratory Assembly Line Systems and Information Systems
Laboratory automation assembly line systems connect and integrate different analytical instruments through hardware and information network-related devices, achieving automation of the entire testing process from specimen loading, centrifugation, classification, lid removal, detection, to rechecking through specimen barcoding, modular testing analysis, and networked data management.
Internationally, the academic full name of the assembly line is LAS, which can be divided into two categories: TLA, which is a total laboratory automation system, and a separate pre-processing system called TTA. Any system with two or more of the four main pre-processing functions of “centrifugation, lid removal, classification, and cup separation” can be referred to as TTA.
Currently, laboratory assembly line systems in China are mainly controlled by Roche, Abbott, Beckman, and Siemens, which dominate the secondary and tertiary markets. Ortho Clinical Diagnostics mainly focuses on emergency assembly lines.
Domestic companies like Mindray, Antu, and Toukang are also actively promoting assembly lines. For example, Antu has a good installation volume, but in the domestic assembly line sector, most are developed in collaboration with foreign brands, such as Antu collaborating with Toshiba, Toukang with Hitachi, New Industry with Thermo Fisher, and Mindray claiming to have developed independently, while Yahui Long is working on open assembly lines, etc.
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