What are the quality inspection methods for in vitro diagnostic reagent raw materials?

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In vitro diagnostic (IVD) reagents are important tools for clinical diagnosis, and their quality is directly related to the accuracy of diagnostic results and the possibility of misjudgment of patient conditions. Therefore, quality inspection of IVD reagent raw materials is crucial. Although quality is not determined by inspection, inspection methods are a way and means of quality management that can prevent non-conforming products from entering the market or the next stage. Below, we will discuss in detail the main quality inspection methods for in vitro diagnostic reagent raw materials.


In vitro diagnostic (IVD) reagents


Physical inspection of IVD reagent raw materials


Physical inspection mainly involves examining the physical properties of raw materials, such as appearance, color, and solubility. These properties are fundamental characteristics of the raw material and can be obtained through simple observation and measurement.


1. Appearance and color: Observe with the naked eye or microscope whether the appearance and color of the raw materials meet the specification requirements. For example, Tris buffer powder reagents need to present specific colors and particle sizes, and any abnormal color or clumping phenomenon may indicate quality issues.


2. Solubility: Solubility testing refers to the solubility of raw materials in solvents. By adding a specific amount of raw materials to the solvent and observing their dissolution, it is determined whether they meet the requirements. Poor solubility may affect the uniformity and effectiveness of the reagent.


Chemical analysis of IVD reagent raw materials


Chemical analysis is the process of detecting specific component contents and impurities in raw materials through chemical reactions or instrumental analysis. The commonly used chemical analysis methods include titration, spectroscopic analysis, chromatographic analysis, etc.


1. Titration method: Titration method is a method of determining the content of reagents through chemical reactions. Common titration methods include acid-base titration, oxidation-reduction titration, complexometric titration, etc. For example, when measuring the metal ion content in certain reagents, EDTA complexometric titration is commonly used.


2. Spectral analysis method: Spectral analysis method is a method of analyzing components and structures by utilizing the absorption, emission, or scattering characteristics of substances towards light. Common spectral analysis methods include ultraviolet visible spectroscopy (UV Vis), infrared spectroscopy (IR), atomic absorption spectroscopy (AAS), etc. For example, UV Vis spectroscopy can be used to determine the purity and concentration of certain organic reagents.


3. Chromatographic analysis: Chromatographic analysis is a method of separation and analysis that utilizes the different distribution coefficients of substances in stationary and mobile phases. Common chromatographic methods include gas chromatography (GC), liquid chromatography (HPLC), etc., such as HPLC, which is commonly used to detect trace impurities in complex reagents.


Purity determination of IVD reagent raw materials


Purity is an important indicator for measuring the quality of reagents, and high-purity reagents can provide more accurate results in experiments. Purity determination is usually carried out through methods such as chromatography and electrophoresis.


1. Chromatographic purity analysis: The purity percentage is obtained by analyzing the main components and impurities in the reagent through liquid chromatography (HPLC) or gas chromatography (GC). Chromatography has high sensitivity and resolution, making it suitable for detecting trace impurities in complex reagents.


2. Electrophoretic purity analysis: Electrophoresis is a method of separating charged molecules by using an electric field to induce different migration rates. Common electrophoresis methods include polyacrylamide gel electrophoresis (PAGE), agarose gel electrophoresis, etc. For example, PAGE is commonly used to detect the purity of protein reagents.


Biological testing of IVD reagent raw materials


Biological testing mainly tests the function and activity of bioactive reagents. The commonly used methods include enzyme activity measurement, antigen antibody reaction detection, etc.


1. Enzyme activity measurement: Enzyme activity is an important indicator of enzyme reagents, and by measuring the rate at which an enzyme catalyzes a specific reaction, the activity of the enzyme can be evaluated. For example, detecting the activity of DNA polymerase can be indirectly measured by PCR amplification efficiency.


2. Antigen antibody reaction detection: For antibody reagents, ELISA, Western blot and other methods are used to test the antibody's ability to react to specific antigens, evaluate its specificity and sensitivity. For example, ELISA can be used to detect the titer and specificity of antibodies.


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Stability testing of IVD reagent raw materials


Stability testing is the evaluation of a reagent's ability to maintain its quality and function during storage and use. The commonly used methods include accelerated aging test, long-term stability test, etc.


1. Accelerated aging test: By placing the reagent under unfavorable conditions such as high temperature and humidity, observe the changes in its properties and functions, and evaluate its stability under conventional storage conditions. For example, storing the reagent at 40 ℃ for one month, measuring its activity and purity changes, and predicting its long-term stability at room temperature.


2. Long term stability test: Store the reagent under specified storage conditions for a long time, take regular samples to test its properties and functions, and evaluate its stability under actual storage conditions. For example, storing the reagent at room temperature for one year and testing its activity and purity every three months to evaluate its shelf life.


The quality inspection of in vitro diagnostic reagent raw materials involves multiple aspects, from physical inspection, chemical analysis, purity determination to biological testing and stability testing, each step is crucial. The quality of IVD reagents can be ensured through systematic quality inspection methods. As a professional IVD reagent supplier, Desheng strictly adheres to quality inspection standards and provides customers with high-quality products. If you are interested, please click on the website to inquire about details and purchase!