Chemiluminescence IVD Industry Technical Responsibility (Part 1)

In the past two years, the global epidemic has brought leap-forward development to China's in vitro diagnostic (IVD) industry
.

In order to meet the needs of clinical screening, the IVD industry has continued to invest in the research and development and production of various types of virus detection products, which has played an important role in the response and prevention of epidemics at home and abroad in different periods
.

 Now, let's briefly introduce the IVD industry
.

In vitro diagnosis (IVD) is simply to take blood, body fluids, tissues and other samples from the human body, and use in vitro detection reagents, kits, calibrators, quality control materials, etc.
to test and verify the samples, so as to obtain clinical diagnostic information , and then determine the product of disease or body function
.

 Needless to say, everyone should know that IVD products are very common but very important.
Pregnancy test sticks are a typical IVD product
.

In addition, the tests performed by the hospital laboratory belong to the category of IVD
.

 IVD products are mainly composed of diagnostic instruments and diagnostic reagents
.

 The diagnostic reagents can be divided into five categories: immunodiagnosis; biochemical diagnosis; molecular diagnosis; POCT diagnosis; blood diagnosis; others
.

 As shown in the figure below, the largest share is immunodiagnosis
.

 Immunodiagnosis Most of the disease markers in the human body are proteins, and the human body will produce corresponding antibodies under specific disease states.
Immunodiagnosis is based on the specific immune response between antigens and antibodies to detect various diseases or physiological states.
method
.

 Immunodiagnosis usually needs to label antibodies or antigens, and then determine the concentration of disease markers in the body through specific physical or chemical reactions, so as to achieve the purpose of assisting the diagnosis of corresponding diseases
.

 Various immunodiagnostic methods have been derived according to the different labeling signals
.

 From the perspective of its development history, it has gone through the stages of radioimmunoassay technology, immunocolloidal gold technology, enzyme-linked immunoassay technology, time-resolved fluorescence immunoassay technology and chemiluminescence immunoassay technology.
Luminescence immunoassay technology has become the mainstream of immunodiagnostic technology
.

  I'm the most powerful.
It's too late ♫.
♪~♬.
.
♩Chemiluminescence about it Let me introduce from a technical point of view, what indicators are you looking for in IVD testing? It is nothing more than fast, accurate, stable, high sensitivity, etc.
Just think about our commonly used contraceptive test strips.
Do you all want to buy fast and accurate tests? If it is slow and inaccurate, won’t it mislead many women? In a small case, if it involves clinically major diseases, such as cardiovascular diseases, if the detection is not accurate, it will really reach the level of making money and killing people
.

 Then our chemiluminescent brother has successfully defeated other immunodiagnostic reagents clinically because of the help of acridine esters or other chemiluminescent substances, and is widely used in infectious diseases, heart diseases, tumors, thyroid function testing, pregnancy testing etc.
test items
.

 Compared with other types of immunodiagnosis, what are the advantages of chemiluminescence little brother: 1.
Fast, easy to operate, just put on the instrument; 2.
Sensitive, no matter how low the amount can be detected; 3.
Detection range Width and height can also be detected; 4 is stable, the same result is obtained every day
.

Then we will introduce the principle and development process of chemiluminescence in detail
.

Chemiluminescence immunoassay is to use chemiluminescent substances and enzymes to label antigens or antibodies.
After the antigen-antibody reaction is added, a luminescent initiator or a luminescent substrate of an enzymatic reaction is added.
After oxidation by an oxidant, an intermediate in an excited state is formed, which will Emit photons to release energy to return to a stable ground state, and use a chemiluminescence photomultiplier to analyze the yield of received light quantum, and to display the effect of antigen-antibody reaction by light signal intensity
.

 There are currently two types of chemiluminescence devices in the domestic market: the microplate type and the magnetic particle type.
Among them, the magnetic particle chemiluminescence has great advantages in terms of sensitivity, single-sample detection time, detection range and instrument automation.
Secondary hospitals with high traffic volume
.

 Tubular chemiluminescence is the mainstream technology of immunodiagnosis.
According to the different markers, it can be divided into three categories, namely direct chemiluminescence immunoassay, chemiluminescence enzyme immunoassay and electrochemiluminescence immunoassay
.

 01 Background of chemiluminescence immunoassay technology The principle of chemiluminescence immunoassay (take one-step indirect luminescence as an example), and finally calculate the antigen concentration in the sample through the pre-established luminescence intensity-concentration standard curve
.

Figure | Classification and advantages and disadvantages of chemiluminescence immunoassays Whether it is chemiluminescence or other immunodiagnostic reagents, the most important raw materials are antibodies and antigens.
The Medix Biochemcia brand represented by our company is one of the famous raw material brands in immunodiagnosis.
Biomarkers containing various indicators are produced in an optimized, serum-free, protein-free, industrial-grade in vitro culture
.

 The Medix Biochemcia product line includes sub-brands such as medixMab Antibodies, Medix Antigens, Lee biosolutions, Eastcoast Bio and more
.

 Among them, medix antibodies and medix antigens detection reagents supporting antigen antibodies cover inflammatory markers, tumor markers, cardiovascular markers, hormone markers, metabolic markers, bone metabolism markers, thyroid markers, kidney markers, infectious disease markers thing
.

For example, FSH antibodies for hormones and TSH antibodies for thyroid function are used by almost all chemiluminescence manufacturers
.

 Lee Biosolutions specializes in developing high-purity biomarkers for the immunodiagnostic and pharmaceutical fields
.

Provide natural proteins/antigens, which can be used as calibrators and quality control products, including cardiovascular markers, tumor markers, inflammatory markers, thyroid markers, hormone markers, metabolic markers, kidney markers, infectious disease markers Biochemicals, serology, autoimmune antigens, clinical biochemical enzymes/lipoproteins, clinical biological samples (such as interfering serum, etc.
)
.

 Eastcoast bio's main products include infectious diseases/animal diagnosis/drug abuse/cardiomyoid/tumor/hormone antigen antibodies, SeaBlock sealants, plasma proteins,
etc.