In Vitro Diagnostic Industry in China

This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

• Language: English
• Publisher: Springer
• Release date: Jul 28, 2021
• ISBN: 9789811623165

Book preview

Part IOverview of In Vitro Diagnostics Industry in China

© Shanghai Scientific and Technical Publishers 2021

H. Song, J. Yao (eds.)In Vitro Diagnostic Industry in Chinahttps://doi.org/10.1007/978-981-16-2316-5_1

1. Interim Market Analysis

Haibo Song¹, ²  , Yaoyi Zhu³, Linda Zhang⁴  , Qi Chen⁴   and Wenting Xiao⁴  

(1)

China Association of In Vitro Diagnostics, Shanghai, China

(2)

Shanghai Academy of Experimental Medicine, Shanghai, China

(3)

IVD Branch of China Association of Medical Devices Industry, Beijing, China

(4)

Shanghai Fosun Long March Medical Science Co., Ltd., Shanghai, China

Haibo Song

Email: [e-mail]

Linda Zhang (Corresponding author)

Email: [e-mail]

Qi Chen

Email: [e-mail]

Wenting Xiao

Email: [e-mail]

New advances have taken place in the medical environment, medical device industry, and in vitro diagnostics field from 2019 to 2020. For the whole industry and all Chinese professionals, these changes are both difficulties and possibilities. This article performs an industry analysis and presents the situation analysis of in vitro diagnostics industry.

1.1 Market Analysis of IVD Industry

1.1.1 Market Overview of Domestic Enterprises and Market Summary of 77 Enterprises Listed on the NEEQ Market

According to the market summary, China’s in vitro diagnostics market’s total market value was at 100 billion RMB (equivalent to 14 billion US dollars) in 2019, with a year-on-year growth of 15%. The imported products account for 55% of the market.

In 2019, the total revenue of 77 listed companies was 73.49 billion RMB, showing a YOY growth of 19.9%. Furthermore, the total net profit is 7.95 billion RMB, which shows a YOY decrease of 3.04%. By the end of 2019, the total market value of 27 listed companies in the in vitro diagnosis industry of mainboard, small and medium-sized board, technology innovation board was 471 billion RMB, with an average static P/E ratio of 44.01.

1.1.2 Market Segments

1.1.2.1 Biochemistry

Biochemical testing accounts for 25% of the in vitro diagnostics market, and the growth rate is estimated to be 5%.China’s biochemical diagnosis market is capable of providing biochemical analyzers and biochemical reagents. However, most of them are clustered in the low-end market. Domestic products occupy more than 50% of the biochemical analyzer market. Moreover, the overall technology development level has reached the international level of the same period. Considering the biochemical analyzer with relatively high technical requirements, although domestic products have relative competitive advantages, there is still a big gap between domestic products and the imported products in terms of detection accuracy and performance stability. International communities recognize and use a closed system for a biochemical diagnosis. The Chinese market will follow that same direction of a closed system with instruments and reagents in the future. Domestic manufacturers should continuously improve the overall design, production process, and track function of biochemical diagnosis instruments and coordinate instrument and reagent development.

1.1.2.2 Immunology: The Largest and the Newest Market In Vitro

Immunodiagnosis is the largest and newest segment driven by the chemiluminescence market in recent years. At present, it accounts for about 35% of the in vitrodiagnostics market, and the growth rate is expected to reach more than 15%.

In 2019, the market share of domestic products in the immune market is 20%–30%.

The low-cost enzyme-linked immunosorbent assay (ELISA) is still the leading testing platform in primary hospitals and many basic projects. Domestic products account for 60%–70%. However, with the increased spending on research and development, chemiluminescence will replace ELISA with a more economic-friendly development. At present, chemiluminescence is mainly imported products, accounting for 70%–80%.

With the progressing development of medical policy on reimbursement control, China is establishing an incentive mechanism for the active use of domestic medical resources, focusing on promoting the implementation and distribution of domestic medical equipment in tertiary hospitals. And chemiluminescence will further expand import substitution. Enterprises with good compatibility, a large amount of detection, and rich detection projects have strong competitive advantages. In the future, chemiluminescence instruments will develop into high-throughput, modular, and assembly line.

1.1.2.3 Molecular Diagnostics: In Vitro

The molecular diagnostics market is still dominated by overseas brands, with domestic products taking only 20%–30% of the market majorly by PCR products. PCR instruments and gene chip instruments in the middle reaches of molecular diagnosis have been partially localized. Chemiluminescence quantitative PCR is the mainstream platform, and advanced PCR with ultra-high sensitivity is still under development in the early stage. The market scale of PCR diagnosis accounts for more than 30% of the molecular diagnosis market. PCR is estimated to be the mainstream technology in the next 3–5 years.

Looking forward, the biggest implementation of molecular diagnosis will be in the field of cancer, including tumor susceptibility gene screening, early diagnosis, concomitant diagnosis, medication guidance, and post-treatment monitoring. With the rise of specially targeted medicine and personalized treatment, the application of molecular diagnosis will be broader. At present, the domestic molecular diagnosis market is still in its early stage, but under the promotion of nationwide policies, the molecular diagnosis industry will have a robust development.

1.1.2.4 Blood and Body Fluid

The blood and body fluid testing market includes coagulation testing, blood cell analysis, urine analysis, and urine visible analysis. The overall market accounted for about 10% of the in vitro diagnostics market, with a growth rate of 10%.

At present, Western enterprises have an absolute advantage in China’s coagulation market, which is forecasted to occupy more than 80% of the market share. The market value of low-end and medium-end blood coagulation instruments will grow significantly under the development of grading diagnosis and treatment policy in recent 2 years; and the continuous promotion of community hospitals and other related concepts. On the other hand, with the introduction of the concept of automated blood coagulation, the high-end market will gradually integrate and upgrade to automation.

Hematology analyzer market is the most successful and a relatively mature market segment of the IVD industry in China, with domestic products accounting for more than 50% of the total market. The three-part differential instruments are mainly domestic, and the imported products are penta-differentiated.

As one of the routine medical detection means, urine analyzer plays an important role in medical devices. In the past, foreign brands have occupied a high proportion of the market share in this field, and they are in a leading position in research and development. With the maturedomestic brand technology and a large number of domestic suppliers, the market share of imported brands has declined, and domestic brands have gradually replaced imports, with a market share of more than 50%.

1.1.2.5 POCT

Presently, the overall market scale of POCT accounts for more than 10% of the total market value of in vitro diagnostics, with a growth rate of more than 15%. POCT is one of the fastest-growing areas in the in vitro diagnostics industry. With the development of precision medicine in recent years, there are higher requirements for IVD instruments’ accuracy. Biochip technology and microfluidic technology are scaling rapidly in the field of POCT. For medical enterprises, the sensitivity and repeatability of future products will be the crucial area of competition. But POCT on autoimmune items and molecular diagnostics will have a bright future, whereas domestic products account for about 50% of the Chinese POCT market now.

Due to the increasing implementation of hierarchical diagnosis and treatment and a chest pain center’s construction, POCT products will have more opportunities in primary hospitals, heart failure centers, and other departments. Besides, in the era of Internet plus, such as big data, cloud computing, and the Internet of things, the big POCT platform with smart POCT as the core will bring the gospel to most patients.

1.1.2.6 Microbiology

Microbiological diagnosis in China started relatively late, with a share of about 5% and an increase of about 10%. The microbiological diagnosis provides the basis for the prevention, diagnosis, treatment, and curative effect observation of clinical infectious diseases through etiological diagnosis and drug sensitivity analysis.

From 2019 to 2020, microbial detection is developing in two directions. On the one hand, microbial detection is advancing rapidly on the road of integration. And major manufacturers have launched a series of overall solutions for each project of microbial detection through process optimization and information integration; on the other hand, POCT diagnostic products have the advantages of fast and simple, high efficiency, low cost, short test cycle, and less sample consumption. It has attracted growing attention from the clinical industry. However, over 80% of the microbiology market is still dominated by imports.

1.1.2.7 Pathology

Pathology generally includes histopathology, cell pathology, and molecular pathology. In China, pathology takes less than 5% of the IVD market at a steady annual growing rate of 10%. As the most commonly used pathological diagnosis method, immunohistochemistry has an important and extensive clinical application value in tumor diagnosis, differentiation, and treatment. Domestic products account for 20%–30% of the pathological market in 2020.

In cytopathology, liquid-based cell technology puts exfoliated cells in the preservation solution that can better preserve DNA information and greatly improve the positive detection rate.

Nowadays, the commonly used molecular pathological detection techniques are chromosome karyotype analysis, chemiluminescence in situ hybridization, PCR, gene chip, and first-generation sequencing. In targeted medicine, molecular pathology has substantial applications in the detection of the tumor, infectious diseases, and genetic diseases. As a result, high throughput will become the main trend of molecular pathology technology.

1.2 Industry Distributions

1.2.1 Regional Distribution of Domestic IVD Enterprises (Fig. 1.1)

By the end of 2018, there are about 1450 IVD manufacturers in China and nearly 50,000 distributors and dealers (excluding pharmacies and business enterprises with class I certificates) [1].

../images/485288_1_En_1_Chapter/485288_1_En_1_Fig1_HTML.png

Fig. 1.1

Number of IVD Enterprises by Region in 2019

1.2.2 Distribution of Subdivided Fields [1] (Fig. 1.2)

../images/485288_1_En_1_Chapter/485288_1_En_1_Fig2_HTML.png

Fig. 1.2

Distribution of in vitro diagnostics industry segments

1.3 Listed Companies Overview (Fig. 1.3)

In 2019, there were 108 listed companies in the industry, including 8 on the mainboard, 3 on the small and medium-sized board, 15 on the growth enterprise board, 7 on the science and technology innovation board, 70 on the new third board, and 5 on the Hong Kong stock market [1].

../images/485288_1_En_1_Chapter/485288_1_En_1_Fig3_HTML.png

Fig. 1.3

Listed companies of IVD In 2019 (Fr: Making the correct judging of IVD situation and current situation by Haibo Song)

1.4 Organization Category (Table 1.1)

Table 1.1

In vitro diagnostic industry association

1.5 Product Registration

According to the Announcement on Approval and Registration of Medical Device Products launched by the National Medical Products Administration of China each month, the approval data is counted by the first registration. Statistics show that in 2019, the National Medical Products Administration approved 524 domestic (class III) and imported in vitro diagnostic products’ registration. There are 352 domestic in vitro diagnostic products (class III, 67% of the total. 172 imported ones, 33% of the total. There is no exact data for the approval and registration of domestic class II and class I products by provincial and municipal bureaus [2].

Compared with the past 4 years, see Table 1.2 for details.

Table 1.2

Aata analysis of registered medical device products (first registered medical device) released by NMPA

The noteworthy points are:

1.

The number of registered medical devices approved in 2019 is the highest in the recent 3 years.

2.

In 2019, the proportion of in vitro diagnostic products in the total approved registered medical device products increased by about 5% compared with that in 2018, which was 31%; in 2018, it was 26%.

3.

This data also shows that the number of in vitro diagnostic products of class III and imported diagnostic products made in China in 2019 is far higher than that in 2018, but still slightly lower than that in 2017.

4.

Compared with the number of approved registrations of imported diagnostic products, the increase in the number of annotated registrations of domestic diagnostic products (class III) in 2019 dramatically exceeds the imported diagnostic products.

References

1.

Haibo Song. A Correct Analysis of the Status and Situation of IVD Market. http://​www.​caivd-org.​cn/​ArticleDetail/​Index?​combId=​77c01bda-b765-4916-97a6-2a50147c7227,77c01bda-b765-4916-97a6-2a50147c7227&​articleId=​7cbfbad1-68d5-454f-a1d1-e5e1dbc3bfa5.

2.

National Medical Products Administration. Announcement on Approved Registration of Medical Device Products. https://​www.​nmpa.​gov.​cn/​ylqx/​ylqxjgdt/​2020031715270179​7.​html

© Shanghai Scientific and Technical Publishers 2021

H. Song, J. Yao (eds.)In Vitro Diagnostic Industry in Chinahttps://doi.org/10.1007/978-981-16-2316-5_2

2. Opportunities and Challenges

Yaoyi Zhu¹, Linda Zhang²  , Qi Chen²   and Wenting Xiao²  

(1)

IVD Branch of China Association of Medical Devices Industry, Beijing, China

(2)

Shanghai Fosun Long March Medical Science Co., Ltd., Shanghai, China

Linda Zhang (Corresponding author)

Email: [e-mail]

Qi Chen

Email: [e-mail]

Wenting Xiao

Email: [e-mail]

2.1 Opportunities

2.1.1 The Medical Industry Is on the Rise

According to China’s medical industry’s statistical bulletin in 2019 [1], the total national health expenditure in 2019 is expected to reach 6519.59 billion RMB, with 4656.7 RMB per capita, accounting for 6.6% of GDP. According to the outpatient and inpatient statistics, in 2019, the total number of services by medical and health institutions in China reached 8.72 billion, with the increase of 410 million (4.9%) over the previous year. In 2019, the average outpatient cost of the hospital was 290.8 RMB, which is 6.1% higher than that of the previous year and 3.1% higher than that of the comparable price; the average hospitalization cost is 9848.4 RMB, which is 6.0% higher than that of the previous year and 3.0% higher than that of the comparable price.

2.1.2 The Market Demand for Gene Sequencing Increases

The cancer rate is growing worldwide, and China ranks first in the world [2]. As the cancer rate is closely related to individual gene information, and each person’s gene information is different, individualized precision medicine is becoming the mainstream, and gene sequencing technology is an essential part of personalized cancer treatment. With the reform of the medical insurance payment structure and the increase of national investment in medical insurance, a variety of mainstream targeted drugs have been added to medical insurance since 2017, with the obvious price reduction. Because the medical insurance policy requires patients to go through target detection before using targeted drugs to avoid the waste of medical insurance funds, the expansion of the targeted drug market also means the corresponding increase of domestic market demand for molecular diagnosis of targeted drugs in tumor precision medicine.

2.1.3 Pathogen Screening Promotes Instant Diagnosis

In vitro diagnostics has obvious advantages in detecting and preventing infectious diseases and can play an important role in pathogen screening. There is a huge demand for diagnosing and treating seasonal diseases and detecting common respiratory and intestinal diseases. The rise of the incidence rate of infectious diseases has greatly promoted the in vitro diagnostic industry’s development. Meanwhile, with the increasing control of infectious diseases in the country, the in vitro diagnostic market’s development will be further promoted.

2.1.4 Aging Populations Push Chronic Disease Monitoring and Health Management Aging

According to the statistical bulletin of health development in 2019, residents’ average life expectancy increased from 77.0 years in 2018 to 77.3 years in 2019 [3]. With the aggravation of China’s aging society and the promotion of family doctor mode under the hierarchical diagnosis and treatment policy, the demand for family chronic disease management is also increasing, promoting the development of diabetes rapid detection, myocardial infarction rapid detection, and home coagulation market. Simultaneously, with the development of big data and Internet technology, in vitro diagnostic products and technologies will play an essential role in prevention, early screening, treatment, drug screening, and treatment prognosis monitoring in the research of elderly health and chronic disease management.

2.1.5 Possible Application of AI in IVD

According to the data of Tractica, a famous American market research institution, it is estimated that by 2025, medical institutions will pay more than 34 billion US dollars for artificial intelligence technology [4]. In 2019, the application of medical AI in diagnosis, imaging, disease prediction and analysis, and medical management will continue to grow. The demand of the medical and health industry for AI comes from the following aspects:

Irregular diagnosis and treatment behavior.

Demand for precision medicine for data analysis.

The increase of outpatient surgery in pursuit of timeliness.

Continuous development of telemedicine.

2.1.6 Promotion and Policy of Medical Insurance in IVD

The government policy on medical insurance makes the hospital constantly grapple between testing quality and cost control. Domestic high-quality IVD products gradually get the opportunity of import substitution, and the policy accelerates import substitution. In primary hospitals, the implementation of hierarchical diagnoses and treatments policy increases the number of diagnosis and treatment on the one hand and increases the demand for essential testing equipment on the other hand. The impact of the slight reduction of testing price on domestic IVD leading companies is far less than the market share increase brought by import substitution and hierarchical diagnosis and treatment.

2.1.7 Registration System

Under the medical device registrant system, innovators focus on product development that can be directly entrusted to qualified enterprises. This can restrain the low-level repetitive construction of the medical device industry, reduce the early investment, accelerate the pace of innovation and launching, and stimulate the vitality of industrial innovation and development to enhance the ability of innovation and R&D. OEM enterprises can give full play to their manufacturing advantages and provide sample production conditions for R&D personnel. After the product is approved, OEM enterprises can apply for a production license to maximize existing plants, equipment, and labor efficiency. The industrial layout and social division of labor will be further refined, R&D and production will perform their respective duties and hold their certificates, and the allocation of social resources will be significantly optimized.

2.1.8 Active M&A in IVD Industry

Compared with the global market, China’s IVD industry is still very scattered, including more than 1400 local manufacturers and more than 50,000 distributors. The distribution industry of IVD in China has been relatively scattered. In recent years, large companies have been acquiring small local distributors, and the distribution industry has been concentrated. Besides, if the new two invoices regulation is extended to the procurement of in vitro diagnostic products (which is still mainly limited to prescription drugs), the merger trend will accelerate.

2.1.9 Global Influences in China IVD Market

Unlike many import-dependent developing countries, domestic manufacturers in China are increasingly prominent in mature fields such as clinical chemistry, hematology, and urine analysis and in high growth fields such as immunoassay and molecular diagnosis. Domestic manufacturers have made progress in new technologies, including mass spectrometry, NGS, and liquid biopsy. Multinational companies are facing more and more confident domestic competitors who benefit from the improvement of R&D capability and are supported by government initiatives and policies, such as centralized procurement and laboratory fee reform. Although the performance of China’s high-end market has declined in recent years, compared with its population size and GDP, the proportion of China’s market income in the global market has been very small, which means that there will be sufficient growth opportunities in the next few years, especially in the global low-end market.

2.2 Challenges

2.2.1 Expenditure Control of Medical Insurance

In 2018, the national primary medical insurance fund’s total expenditure was 1782.2 billion RMB, an increase of 23.6% over the previous year. Medical expense’s rapid growth brought tremendous pressure on the medical insurance fund’s smooth operation [5]. In 2018, the total balance of the national primary medical insurance fund was 2344 billion RMB. From the perspective of expenditure, these balances can only maintain the total expenditure of the national basic medical insurance fund for 1 year, and the risk resistance is not high. To mitigate the perils of collapse of the medical insurance fund, it is imperative to control medical insurance expenditure.

With the deepening of the medical reform, the medical expenses will be controlled continuously, which will inevitably affect the testing fees, and the testing fees will continue to decline. It will inevitably affect the use of diagnostics products, especially new technology and new products.

2.2.2 DRG Payment System Application and Recommendations

Although DRG can help hospitals contain unreasonable expenses, it also has some limitations. Due to the price of current medical charges, it is roughly calculated according to the average value of medical expenses that the cost can vary. The same disease diagnosis may lead to prominent differences in medical expenses due to different manufacturers of the instruments. At the same time, the DRG cost control system will also affect the innovation of medical technology. To control costs, hospitals may be cautious in using new technologies and carrying out new projects. Besides, to control the cost, the hospital will guide the patients to bear at their own expense, which does not apply to the outpatients and special diseases, which is easy to lead to the increase of outpatient expenses.

2.2.3 Bidding Procurement

Under the pressure of medical reform in China, the in vitro diagnostics industry faces a lot of pressure, such as bidding price reduction, procurement policy, and two-bill system. Simultaneously, with the increasing pressure of domestic and global medical insurance payments, end customers will increase the weight of product cost-effectiveness when purchasing products. The market competition pattern is increasingly fierce, which puts forward new challenges for the company to improve its market competitiveness continuously. If the product price is greatly reduced, it may affect the company’s future profitability.

2.2.4 Tightening Industry Supervision

In the past 2 years, the admittance threshold of in vitro diagnostics industry has been relaxed. The policies such as license separation, pilot of the registrant system, and newly revised medical device catalog free of clinical trials have promoted the industry, including shortening the time to market of specific products, bringing products with core technology invention and significant clinical value into the priority examination channel, but regulating the product quality in the middle and back end. Especially after the vaccine incident, the frequency of flight inspection increased significantly.

2.2.5 New Uncertainties Brought by Sino-US Trade War

In November 2018, the US Department of Commerce issued an export control framework for the latest 14 categories of key technologies and related products, including genome and genetic engineering-related technologies [6]. On September 17, 2019, the US Treasury Department issued a proposed regulation to fully implement the Foreign Risk Review Modernization Act (FIRRMA), refining sensitive personal data. This proposal asked CFIUS to review all investments contributed to us genetic research projects; the scope includes cancer, personalised medicine, genomics, and regenerative medicine [7].

2.2.6 Market Competition

China’s in vitro diagnostics industry is in the stage of rapid development. At the same time, due to the large gap between the overall market size and per capita consumption and the mature market, the domestic in vitro diagnosis market has a broad market space. It will maintain a rapid growth rate in the future under the influence of economic development, medical system reform, aging population, and the increase of resident income. These factors will attract many in vitro diagnostic enterprises at home and abroad to join the competition. The level of market competition will also change from price and resource orientation to technology and application orientation, and the degree of market competition will become increasingly fierce.

References

1.

National Health Commission of the People’s Republic of China. China’s Statistical Bulletin on the Development of Health Services in 2019. http://​www.​nhc.​gov.​cn/​guihuaxxs/​s10748/​202006/​ebfe31f24cc145b1​98dd730603ec4442​.​shtml.

2.

World Health Organization (WHO). Global Cancer Report 2014. https://​www.​who.​int/​cancer/​publications/​WRC_​2014/​en.

3.

National Health Commission of the People’s Republic of China. China’s Statistical Bulletin on the Development of Health Services in 2019. http://​www.​nhc.​gov.​cn/​guihuaxxs/​s10748/​202006/​ebfe31f24cc145b1​98dd730603ec4442​.​shtml.

4.

Vcbeat. These Phenomena will Affect Breakthroughs in Medical AI in 2019. https://​med.​sina.​com/​article_​detail_​111_​2_​60914.​html.

5.

National Healthcare Security Administration. 2018 National Statistical Communique on the Development of Basic Medical Security. http://​www.​nhsa.​gov.​cn/​art/​2019/​6/​30/​art_​47_​1476.​html.

6.

US Department of Commerce, Bureau of Industry and Security (BIS). Advanced Notice of Proposed Rulemaking (ANPRM). https://​www.​commerce.​gov/​news/​press-releases/​2019/​05/​department-commerce-amends-countervailing-duty-process.

7.

US Department of the Treasury. Foreign Investment Risk Review Modernization Act (FIRRMA). https://​www.​treasury.​gov/​resource-center/​international/​Documents/​Summary-of-FIRRMA.​pdf.

Part IIImmunoassay

© Shanghai Scientific and Technical Publishers 2021

H. Song, J. Yao (eds.)In Vitro Diagnostic Industry in Chinahttps://doi.org/10.1007/978-981-16-2316-5_3

3. R&D, Manufacture, and Market

Zengli Yang¹, Xuedong Zhang¹  , Peng Li¹, Guangpu Sha¹ and Guangyu Fu¹

(1)

Autobio Diagnostics Co., Ltd., Zhengzhou, Henan, China

Xuedong Zhang

Email: [e-mail]

The rapid development of immunology has brought many new thoughts and ideas for clinical immunology assays. In the era of clinical pathway management, personalized medicine, and precision medicine, the clinical laboratory testing and management system consisting of immunoassay reagents, instruments, quality controls, and software need to offer better service to the clinical application.

Several key questions remained to all IVD companies such as how to catch up the trends and changes immune equipment and reagents accurately, to establish more sufficient pathway of clinical immunoassay, to integrate the concepts to the pathway management, to promote the application of personalized medicine and precision medicine, and to develop the proper technique and products required for clinical application.

This chapter combines the history of immunological detection technology, the development of major immunological instruments and reagents domestic and abroad, and the status and capacity analysis of manufacturers and elaborates on the current status and thinking in this subdivided field.

3.1 Development of Immunoassay Technology

Throughout the history of the entire immunoassay development, it could be roughly divided into the classical immunoassay period, the modern immunoassay period, and the automated immunoassay period; and it is currently entering the period of intelligent immunoassay.

3.1.1 The Period of Classical Immunoassay

Classical immunoassay techniques included immunological precipitation, immunological agglutination, and complement fixation. At present, immunological agglutination