IVD is ‘in vitro diagnostic’, IVD refers to medical devices, in vitro diagnostik reagents and drugs, IVD as a branch of medical devices, has a unique definition and regulatory supervision by FDA
, The Council of the European Union
Compared with in vivo experiments, test in vitro use the entire organism to conduct experiments, which can achieve species specificity, which is simpler, more convenient, and more detailed analysis.
In-vitro diagnostic medical device refers to any medical device that the manufacturer intends to use for in-vitro examination of samples obtained from the human body, including blood and tissue donors, whether used alone or in combination, including reagents, reagent products, calibration materials, control materials, Kits, instruments, devices, equipment or systems.
, as an independent branch of medical devices, has its own unique definition and regulatory system, especially the US Food and Drug Administration (FDA
) and European Union (EC
). IVD mainly includes instruments, reagents or systems for in vitro diagnostics. However, the situation in China is different. IVD is not independently distinguished and defined, that is, there is no concept of IVD. The products included in the international IVD concept are broken down and belong to medical devices (MD), in vitro diagnostic reagents (IVD Reagents) and medicines.
In China, except for in vitro diagnostic reagents for blood source screening and the use of radionuclide-labeled in-vitro diagnostic reagents that are defined as drug management, all other IVD products are under medical device (MD)
In vitro diagnostic reagents (IVD) can be divided into in vitro biodiagnosis and medical device management according to management classification.
In vitro biodiagnosis
In vitro biological diagnostic reagents managed by drugs include:
1. Blood type and tissue matching reagents;
2. Microbiological antigen, antibody and nucleic acid detection reagents;
3. Tumor marker reagents;
4. Immunohistochemistry and human tissue cell reagents;
5. Human genetic testing reagents;
7. Allergy diagnostic reagents.
Medical device management
1. Clinical basic test reagents;
2. Clinical chemistry reagents;
3. Reagents for blood gas and electrolyte determination;
4. Vitamin determination reagents;
5. Cell histochemical stains;
6. Autoimmune diagnostic reagents;
7. Microbiological testing reagents.
There are some types of IVD diagnostics: Biochemical diagnostic reagents, immunodiagnostic reagents, molecular diagnostic reagents, microbiological diagnostic reagents, urine diagnostic reagents, coagulation diagnostic reagents, hematology, flow cytometric diagnostic reagents and Lateral Flow Immunodiagnostic, etc.
There are lots of Lateral Flow IVD test kit widely used in our daily life. Easy to buy amazon, ebay, drug store, supper market, etc. For example:
Test kit for detecting drug residues in egg, meat, milk, fish, rice, etc.
Test kit for detecting diseases in cattle, dog, cat, goat, sheep, etc.
Beckman Coulter / Danaher
Cepheid / Danaher
Danaher Corp. (including Radiometer A/S)
Instrumentation Laboratory / Werfen
LabCorp, Laboratory Corporation of America
Ortho Clinical Diagnostics
Roche Diagnostics (including Ventana Medical Systems)
Sysmex CorporationThermo Fisher Scientific
In vitro technologies
6 technologies in the IVD industry
1. Microfluidic chip technology
Microfluidic chip, also known as Lab on a Chip, refers to a miniaturized, integrated, and automated chemistry and biology experiment platform diagram built on a chip of a few square centimeters or less.
Through the microfluidic chip, the experimenter can complete the functions of sampling, pretreatment, reaction, separation and detection in the chemical laboratory on a micrometer-scale chip, and automatically complete the analysis.
Biological macromolecules exist at the nanometer scale, and single molecule detection is inseparable from nanoscience. Nanomedicine is an important emerging field of nanoscience research. It is a frontier field of interdisciplinary research closely related to human health that is prioritized by all countries in the world. It is full of opportunities and challenges for scientific innovation.
3. Third-generation single molecule sequencing technology
The third-generation single-molecule direct sequencing technology does not require PCR amplification, and can directly detect a single DNA molecule, avoiding the errors and preference problems introduced by PCR amplification, while also greatly simplifying sample processing and sequencing steps and shortening the sequencing cycle.
4. Big data and artificial intelligence
5. Single molecule immune array technology
(SiMoA) Multiple detection technology
SiMoA is currently the most sensitive immunoassay method, similar to the traditional enzyme-linked immunosorbent assay (ELISA), but the sensitivity is increased by 1,000 times compared to ELISA.
Because in the ELISA detection method, the fluorescence produced by the labeling enzyme will be dispersed in a large range, and it is impossible to detect low concentrations of trace substances; while SiMoA cleverly uses a femtomole level reaction chamber array to capture and detect single molecules and control the fluorescence divergence, so that the detection accuracy is greatly improved.
6. Liquid biopsy CTC detection sample processing
Current liquid biopsies mainly use ctDNA / RNA, CTC (circulating tumor cells) and Exosomes (exosomes) in the blood as biomarkers for tumor diagnosis. Comprehensive liquid biopsies should also include body fluids other than blood, such as urine and saliva, Tumor-derived information in pleural effusion and cerebrospinal fluid. The clinical value of liquid biopsy is based on the clinical relevance of indicators and the sensitivity and specificity of detection and analysis techniques.
In vitro diagnostic equipment
1. Divided by diagnostic methods: clinical chemistry analysis instruments, immunochemical analysis instruments, blood analysis
instruments, microbiological analysis instruments.
2. According to the matching reagents: open system and closed system.
In vitro diagnostic reagents
According to the test principle: biochemical diagnostic reagents, immunodiagnostic reagents, molecular diagnostic reagents, microbiological diagnostic reagents, urine diagnostic reagents, coagulation diagnostic reagents, hematology and flow cytometric diagnostic reagents.
The world's top IVD companies
As of 2017, Swiss-based pharmaceutical company Roche has become the global leader in the in vitro diagnostic (IVD) market, with revenues in this area exceeding US $ 10 billion. It is predicted that Roche will maintain its leading position and will exceed US $ 14 billion by 2024.
Roche diagnosis includes five parts: diabetes care, molecular diagnosis, centralized diagnosis, proximal patient testing and applied science. Diabetes care and the central diagnostic department both account for 70% of the department's revenue, and both account for 35%.
Founded in 1888 and headquartered in Illinois, USA; Abbott Laboratories is involved in the discovery, development, manufacture and sale of healthcare products. The company operates through four business units, namely mature medicines, diagnostic products, nutritional products and cardiovascular and neuromodulation products. The company provides IVD products under the Diagnostic Products Business Unit, which includes core laboratory diagnostics, molecular diagnostics, point-of-care, rapid diagnostics, and ibis diagnostics. In October 2017, the company acquired Alere Inc. to strengthen its point-of-care (part of IVD diagnosis) diagnostic product portfolio.
3. Danaher Corporation
Founded in 1969 and headquartered in Washington, USA; Danaher Corporation designs, manufactures and sells professional, ivd medical, industrial, and commercial products and services. Danaher's business consists of four parts: life sciences; diagnostics; dental and environmental and application solutions. The company provides IVD-related analytical instruments, reagents, consumables, software and services in the diagnostic business area. These products are distributed under multiple brands of APERIO, BECKMAN COULTER, CEPHEID, HEMOCUE, IRIS, LEICA BIOSYSTEMS, MAMMATOME, RADIOMETER and SURGIPATH. The company provides these products to hospitals, physicians' offices, reference laboratories, and intensive care units.
4. Thermo Fisher Scientific Inc.
Founded in 2006 and headquartered in Waltham, USA; Thermo Fisher Scientific Inc. is committed to providing analysis for research, manufacturing, analysis, discovery, and diagnosis under the brands of Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, and Unity Lab Services Instruments, equipment, reagents and consumables, software and services. The company provides IVD products for hospitals, clinical diagnostic laboratories, universities and research institutions. The company operates four business units, namely analytical instruments, life science solutions, laboratory products and services, and special services. The company provides IVD products under the professional diagnostic business unit.
5. Bio-Rad Laboratories，Inc.
Founded in 1952 and headquartered in California, USA; Bole Lab Co., Ltd. is engaged in providing instruments, consumables and software for protein quantification, cell biology, food safety, protein purification, gene expression, drug discovery and manufacturing, and science education. The company's products and solutions are based on the technology of separation, purification, identification, analysis and amplification of biological materials (such as cells, bacteria, antibodies, proteins and nucleic acids). The company operates through three business units, namely life sciences, clinical diagnosis and other operations. The company provides IVD products under its clinical diagnostics business unit.
6. Ortho Clinical Diagnostics
Founded in 1994 and headquartered in New Jersey, USA; Ortho Clinical Diagnostics is committed to manufacturing and providing IVD products for clinical laboratories and immunohematology. The company provides its products through the chemical and immunodiagnostic and transfusion medicine departments. The company provides IVD products such as integrated chemical systems, immunodiagnostic systems, laboratory automation and middleware solutions.
7. Sysmex Corporation
Founded in 1968 and headquartered in Kobe, Japan; Sysmex Corporation was formerly known as TOA Medical Electronics Co., Ltd. and was renamed Sysmex Corporation in October 1998. The company is engaged in the development, manufacturing, sales and import and export of diagnostic instruments, reagents and related software. The company serves national and other public hospitals, private hospitals, universities, research institutions and other medical institutions.
8. Becton, Dickinson and Company
Founded in 1897 and headquartered in New Jersey, USA; Becton, Dickinson and Company is engaged in the development, manufacture and sale of ivd medical supplies, equipment, laboratory equipment and diagnostic products for medical institutions, life science researchers, clinical laboratories, pharmaceuticals Industry and public use. The company's business includes two business units, namely BD Medical and BD Life Sciences. BD Life Sciences provides products for the safe collection and transportation of diagnostic specimens, as well as instruments and reagent systems for detecting various infectious diseases, healthcare-related infections (HAI), and cancer.
9. bioMérieux S.A.
Founded in 1963 and headquartered in Marcy l'Etoile, France; bioMérieuxSA is engaged in the development and production of IVD solutions (systems, reagents and software) and hospital laboratories, mainly for the diagnosis of infectious diseases, but also for the detection of agricultural food and medicine and microbial products in cosmetics.
10. DiaSorin S.p.A.
Founded in 1968 and headquartered in Saluggia, Italy; DiaSorin SpA is committed to developing, manufacturing, and commercializing diagnostic tests for a wide range of clinical fields. The company provides highly routine and professional examinations for a wide range of clinical fields, such as infectious diseases, gastrointestinal infections, bones and minerals, endocrinology, hypertension, oncology, tumor hematology, and autoimmunity.
Major Chinese IVD manufacturer
1. DAAN Gene Co., Ltd.
Daan Gene is a biomedicine high-tech enterprise integrating molecular diagnostic technology as the leading factor, integrating the research and development, production and sales of clinical testing reagents and instruments, as well as clinical testing services of independent national chain medical laboratories.
2. Shanghai Keue Bio-Engineering Co., Ltd.
Keue Bio-Engineering main business covers in vitro diagnostic reagents and medical testing instruments. Its reagent products cover the three major areas of immunodiagnosis, biochemical diagnosis and molecular diagnosis in IVD. Its instrument products also have biochemical analyzer series, immunological series and chemiluminescence The instrument series has more complete IVD products. Its traditional advantage is in the field of immunodiagnosis.
3. Beijing Leadman Biochemistry Co., Ltd.
Leadman is a diversified enterprise that has competitiveness in the fields of biochemistry, in vitro assay reagents and medical devices. Its main products of diagnostic reagents are biochemical reagents, and it is currently developing in the field of immunoluminescence chemiluminescence.
4. Beijing Strong Biotechnologies, Inc.
Strong Biotechnologies is a company with a full line of biochemical diagnostic reagents and world-class automatic biochemical analyzer equipment. The company has established biochemical strategic cooperative relations with many well-known foreign in vitro diagnostic companies.
5. Guangzhou Wondfo Biotech Co., Ltd.
Wondfo Biotech is a company dedicated to rapid testing products (including reagents and instruments) in the biomedical in vitro diagnostic industry, including research and development, production and sales. Its main products are various POCT quantitative testing platforms, various logo products and various tests Products
6. Changchun Dirui IVD Products Co., Ltd.
Dirui Medical is a company mainly engaged in urinalysis, urine component analysis, biochemical analysis, blood cell analysis and other products and related test paper reagents.
7. Medicalsystem Biotechnology Co., Ltd.
Meikang Bio is a company whose main industry is in vitro biochemical diagnostic reagents, instruments and independent third-party medical diagnostic services.
8. Sinocare Inc.
Sinocare Bio is a company dedicated to the development, production and sale of products for rapid detection of chronic diseases using biosensing technology.
9. Maccura Biotechnology Co., Ltd.
Maccura Bio is a research and production enterprise that integrates in vitro diagnostic products. Its main products are biochemical products, chemiluminescent products, rapid detection products and blood diagnostic products.
10. Chaozhou Hybribio Biochemistry Ltd.
Hybribio Bio is a company focusing on independent research and development of molecular diagnostic technology and actively expanding the application field of nucleic acid molecular diagnostic technology.
work in Lateral Flow Immunodiagnostic research & development more than 12 years. Especially in Colloidal gold & Fluorescence platform, we had launched 8 types test kit
basic on both platform. We focus on food safety test kit, but also pay more attention and research in IVD medical devices for human beings.