Fluorescent standard card and test method for calibration and quality control of fluorescent immunoassay analyzer

Abstract

The invention discloses a fluorescent standard card for calibration and quality control of a fluorescent immunoassay analyzer. The fluorescent standard card comprises a fluorescent standard card bodyand a fluorescent detecting unit. The fluorescent detecting unit is made of a fluorescent solution, a photocurable fluorescent material, fluorescent printing ink or fluorescent ink. Compared with theuse of a quality control product, reference product or standard product, the fluorescent standard card has the characteristics of stable luminescent properties, being not easy to decay with time, highline width precision, uniform spatial distribution of fluorescent substances, linearity of fluorescent substance amount and fluorescent intensity and great preparation consistency. The invention further discloses a test method. The method and parameters of a fluorescent standard card evaluation device are established. The method has the advantages of complete evaluation content and easy operation, is a systematic measurement and evaluation scheme, is beneficial for calibration and quality control of the fluorescent immunoassay analyzer, and improves the detection accuracy of the fluorescent immunoassay analyzer. The traceability scheme of each method can reliably ensure that the properties of the fluorescent standard card are strictly controlled during production and use.

Description

technical field [0001] The invention belongs to the technical field of fluorescence immunoassay, and in particular relates to a fluorescence standard card and a test method for calibration and quality control of a fluorescence analyzer. Background technique [0002] Fluorescence immunoassay technology is one of the earliest developments in labeling immunology technology, and it is a method that combines the specificity of antigen-antibody reaction with the sensitivity and intuitiveness of fluorescent substance detection. The principle is: label the antibody (or antigen) with a fluorochrome that does not affect the activity of the antigen or antibody, and after combining with the corresponding antigen (or antibody), a specific fluorescent reaction will be presented under a fluorescent microscope. Fluorescence immunoassay technology has the advantages of strong specificity, high sensitivity, and good practicability, and can be used to detect low-level biologically active compo...

AI Technical Summary

Problems solved by technology

[0004] The above method has the following technical problems: (1) When the nanocrystalline material solution is poorly prepared, it tends to attenuate significantly over time, causing the signal of the standard card to change, and it cannot be used as a stable standard to reliably evaluate the equipment. , when the solution is used for fine-line printing, the line width accuracy is difficult to guarantee. If the solution is chromatographic or diffused on the substrate, the consistency of the standard card is even more difficult to ensure, and solidification by the gel method often fails to achieve good dispersion. The individual differences of the standard cards produced are large, so they cannot be used as standard judgment objects

(2) The LED light itself has differences in luminous intensity and color, and the standard card made of LED lights or light bars has poor consistency. In addition, the LED lights or light bars themselves are light sources rather than stimulated light, so it is difficult to adjust Optical modules for evaluating laser light source performance

Existing schemes generally design a single T line, and perform linear fitting through the relationship between the fluorescence signal intensity of the T line and the solution concentration, but for the design principle of the fluorescence analyzer, since the final output signal is generally amplified Signal, and the multiple of signal amplification is often dynamic. If you want to perform linear fitting, you need to normalize the multiple, which is inconvenient to operate. At the same time, for a single T line, in the production process, low concentration and high concentration The T-line produced by the solution often has inconsistent attenuation over time, and it is difficult to ensure a stable linear relationship after long-term use

Moreover, the current existing methods only explain the production method and structure of the fluorescent standard card, and do not combine the fluorescent standard card with the characteristics of the equipment to form a reasonable and systematic measurement and evaluation plan and traceability plan

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