IVD clinical diagnostic methods: enzyme-linked immunosorbent assay and chemiluminescence assay

Release time:

2025-05-23


In the field of in vitro diagnostics (IVD) clinical diagnosis, enzyme-linked immunosorbent assay and chemiluminescence assay each provide support for the diagnosis and monitoring of diseases based on their technological advantages. These two methods have both similarities and significant differences in their principles, characteristics, and applications. Let's take a look together below.

 

(Glucose dehydrogenase)

 

Enzyme linked immunosorbent assay: a detection technique that combines specificity and catalysis

 

1. Principle

 

Enzyme linked immunosorbent assay cleverly combines the specificity of enzyme catalyzed reactions with the specificity of antigen antibody reactions. Its core lies in binding enzymes with antibodies or antigens to form enzyme labeled complexes, which retain both the immunological activity of the antigen or antibody and the catalytic activity of the enzyme towards the substrate. In practical testing, after the enzyme labeled antibody completes a specific reaction with the antigen, the corresponding substrate for enzyme action is added, and the enzyme catalyzes the substrate to undergo a colorimetric reaction, thereby achieving localization, qualitative, and quantitative determination of the antigen or antibody.

 

2. Technical features

 

Enzyme linked immunosorbent assay has the advantage of relatively low cost, and its reagents and equipment are relatively affordable, making it suitable for widespread development in grassroots institutions. This method is relatively easy to operate and can be proficiently mastered by technicians who have received simple training. But its sensitivity is relatively limited, and there may be a risk of missed detection for low concentration antigen or antibody detection. The detection time is relatively long, usually taking several hours to obtain results, which limits its application in emergency and other time sensitive scenarios.

 

3. Application Fields

 

Enzyme linked immunosorbent assay (ELISA) is widely used in the detection of infectious diseases, including the detection of antibodies against hepatitis B and hepatitis C. In clinical screening, it is possible to quickly conduct preliminary testing on a large number of samples, providing a basis for further diagnosis. In terms of cancer biomarker detection, enzyme-linked immunosorbent assay (ELISA) is often used to detect carcinoembryonic antigen (CEA), alpha fetoprotein (AFP), etc., to help doctors monitor changes in patients' condition.

 

Chemiluminescence method: combination of high sensitivity and high specificity

 

1. Principle

 

Chemiluminescence immunoassay technology combines highly sensitive chemiluminescence assay with highly specific immune responses. It consists of two parts: the immune response system and the chemiluminescence analysis system. In the immune response system, antigens and antibodies undergo specific binding; In a chemiluminescence analysis system, the free energy released through a chemical reaction excites the intermediate, causing it to return from the excited state to the ground state. When the intermediate returns from the excited state to the ground state, photons of equal energy levels are released, and quantitative analysis of the target substance is achieved by measuring the photons. In thyroid function testing, taking thyroid stimulating hormone (TSH) testing as an example, TSH antibodies are combined with chemiluminescent substances (such as acridine esters). When TSH in the sample binds to the antibody, a reagent that triggers a chemiluminescent reaction is added to generate a photon signal. The concentration of TSH is determined by detecting the intensity of the photon.

 

2. Characteristics

 

The chemiluminescence method has high sensitivity and can detect extremely low concentrations of target substances. In early screening of biomarkers, changes in low biomarker concentrations can be detected, greatly improving the accuracy of early diagnosis. It has strong specificity and antigen antibody specific binding, reducing the interference of non-specific reactions. The detection has a wide linear range and can adapt to the detection needs of samples with different concentrations. This method has a fast detection speed and can generally obtain results within half an hour, making it suitable for emergency and other time sensitive scenarios. However, the equipment and reagent costs of chemiluminescence method are relatively high, and the requirements for laboratory environment and technical personnel are also high.

 

3. Application scenarios

 

In clinical endocrine testing, chemiluminescence is widely used in thyroid and other tests to provide data for the diagnosis of endocrine disorders. In the diagnosis and monitoring of cancer, chemiluminescence method for highly sensitive detection of multiple biomarkers is helpful for early detection, disease assessment, and prognosis judgment.

 

(Isoluminol powder)

 

Hubei Xindesheng Materials Technology Co., Ltd. plays an important role in the development process of IVD clinical diagnostic methods. Xindesheng focuses on the research and production of in vitro diagnostic reagent raw materials, providing reliable raw material support for enzyme-linked immunosorbent assay and chemiluminescence assay. In terms of raw materials for enzyme-linked immunosorbent assay reagents, the enzymes produced by Xindesheng have the characteristics of high activity and good stability, which can ensure the rapid and stable development of enzyme catalyzed color reactions. In the field of chemiluminescence reagent raw materials, Xin Desheng's acridine ester and other chemiluminescence substances have advantages such as high purity, high luminescence efficiency, and strong stability. They can generate strong and stable photon signals, improve the sensitivity and accuracy of chemiluminescence immunoassay, and become a trusted partner in the industry. If you have any purchasing needs, please feel free to contact us at any time!