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

A fluorescence immunoassay and standard card technology, applied in the fluorescence standard card and testing field of fluorescence analyzer calibration and quality control, can solve the problem that the consistency of the standard card is difficult to guarantee, the performance evaluation of the laser light source of the optical module is difficult, and the signal change of the standard card is difficult to solve. and other problems, to achieve the effect of not easily decaying with time, improving detection accuracy, and evaluating complete content.

Inactive Publication Date: 2019-04-16
SHENZHEN KINGFOCUS BIOMDICAL ENG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] This embodiment provides a fluorescent standard card for calibration and quality control of a fluorescent immunoassay analyzer, please refer to figure 1 , the fluorescent standard card 1 includes a fluorescent standard card body 11 and a fluorescent detection unit 12, and the fluorescent detection unit 12 is made of fluorescent solution, photocurable fluorescent material, fluorescent ink or fluorescent ink.

[0031] Specifically, the fluorescent standard card body 11 is a shell made of organic materials, metal materials, inorganic non-metallic materials or wood, and has an observation window 13, and a detection card is arranged in the observation window 13, and the detection card A groove for accommodating the fluorescent detection unit 12 is arranged on the top, the groove is in the shape of a strip, and a fluorescent solution is arranged in it, and the groove containing the fluorescent solution forms a detection line, and the fluorescent solution is made of a fluoresce...

Embodiment 2

[0038] This embodiment provides a fluorescent standard card for calibration and quality control of a fluorescent immunoassay analyzer, please refer to image 3 , which includes a fluorescent standard card body 1 and a fluorescent detection unit 12, the fluorescent detection unit 12 is made of fluorescent ink or fluorescent ink, fluorescent pigments, fluorescent inks, fluorescent inks contain anti-aging agents and stabilizers, wherein the fluorescent substance It has good dispersion and particle uniformity, and has higher stability than other conventional fluorescent materials. It is arranged in the fluorescent standard card body 1 . In this embodiment, the fluorescence detection unit 12 includes a slide 121, the surface of which is printed or printed with a fluorescence detection part, the fluorescence detection part is a printed or printed fluorescent ink layer or a fluorescent ink layer, and the fluorescence detection part Part can be observed from the observation window 13...

Embodiment 3

[0041] This embodiment also provides a test method for calibrating and quality-controlling a fluorescent immunoassay analyzer using the fluorescent standard card described in Examples 1 and 2, using the relationship between the fluorescence intensity and the concentration of the fluorescent substance, and the relationship between the fluorescence intensity and the luminescent area According to the principle, the performance of the equipment is evaluated by the concentration reference method and the area reference method respectively.

[0042] 1. Concentration reference method

[0043] Within a certain concentration range, the solution concentration of the fluorescent substance has a linear relationship with the light intensity (Lambert-Beer’s law). The degree of internal dispersion remains unchanged, that is, the concentration of the space remains unchanged. Since the light-curing adhesive is a transparent substance, it does not affect the transmission of light. Therefore, th...

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PUM

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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...

Claims

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Application Information

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IPC IPC(8): G01N35/00G01N21/64
CPCG01N21/64G01N35/00623G01N35/00693G01N2021/6497G01N2035/00702G01N2035/00633
Inventor 招睿雄蒋庭彦杜沛深王炯李浩勃张二盈章国建
Owner SHENZHEN KINGFOCUS BIOMDICAL ENG CO LTD
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