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Method for improving stability of latex suspension liquid

A technology of suspension and stability, applied in the application field of in vitro diagnostic kits, can solve problems such as long-term stability

Active Publication Date: 2010-11-24
AILEX TECH GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Latex-enhanced method is a new clinical diagnostic method. By covalently cross-linking antigens or antibodies with latex particles and then reacting with the corresponding antibodies or antigens, the sensitivity of ordinary immunization methods is greatly enhanced. The turbidity is improved by at least one order of magnitude, which can reach the level of radioimmunoassay (RIA), but there is no radioactive contamination, the operation is simple, and it can be measured by ordinary biochemical analyzers, which meets the requirements of current clinical testing and realizes the quantification of some low-level substances. It was determined that due to the use of latex particles and the binding of proteins on the particles, the volume of the formed latex reinforced particles is usually 0.05-0.5um. However, they exist in a suspended state in the solution and cannot be stable in the solution for a long time, so Stability of latex-bound antigen or antibody particles must be addressed

Method used

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  • Method for improving stability of latex suspension liquid
  • Method for improving stability of latex suspension liquid
  • Method for improving stability of latex suspension liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Prepare latex-enhanced C-reactive protein reagent (CRP) reagent according to Table 1

[0017] Table 1

[0018] substance

concentration

MES solution

25mmol / L

Emulsion of latex particles cross-linked with CRP antibody

2.5g / L

EDTA.Na2

5mmol / L

BSA

10g / L

sucrose

5g / L

PBS buffer pH=8.0

100mmol / L

[0019] Each component is mixed to obtain latex-enhanced C-reactive protein reagent (CRP) reagent solution;

[0020] Then add some non-ionic surfactants, such as Tween20, to the C-reactive protein reagent (CRP) reagent prepared above according to Table 2.

[0021] Table 2

[0022] Solution number

Protective agent

[0023] 1

no added

2

0.05% Tween 20

3

0.10% Tween 20

4

0.15% Tween 20

5

0.20% Tween 20

[0024] In Table 2, 0.05% Tween 20 means that the added weight of Tween 20 is 0.05% of the C-reactive prote...

Embodiment 2

[0031] Prepare rheumatoid factor reagent (RF) reagent solution as follows.

[0032] Table 4

[0033] substance

concentration

MES solution

25mmol / L

Emulsion of latex particles of cross-linked human IgG

2.5g / L

EDTA.Na2

5mmol / L

BSA

10g / L

sucrose

5g / L

PBS buffer pH=8.0

100mmol / L

[0034] The components are mixed to obtain a rheumatoid factor reagent (RF) reagent solution.

[0035] Then add some sodium salicylate, a substance that can improve the charging state of the particle surface, to the above prepared rheumatoid factor (RF) reagent according to the following table.

[0036] table 5

[0037] serial number

Protective agent

1

no added

2

5mmol / L sodium salicylate

3

10mmol / L sodium salicylate

4

100mmol / L sodium salicylate

5

200mmol / L sodium salicylate

[0038] Store the rheumatoid factor reagent (RF) solutions numb...

Embodiment 3

[0044] Utilize the latex reagent preserved under the common solution condition prepared by the present invention to carry out the comparative study of pH, what use here is the CRP common latex reagent and the RF common latex reagent prepared in example 1 and example 2.

[0045] Table 7

[0046] C-reactive protein reagent (CRP) reagent

[0047] substance

concentration

MES solution

25mmol / L

Emulsion of latex particles cross-linked with CRP antibody

2.5g / L

EDTA.Na2

5mmol / L

BSA

10g / L

sucrose

5g / L

PBS buffer pH=8.0

100mmol / L

[0048] Rheumatoid reagent (RF) reagent

[0049] substance

concentration

MES solution

25mmol / L

Emulsion of latex particles of cross-linked human IgG

2.5g / L

EDTA.Na2

5mmol / L

BSA

10g / L

sucrose

5g / L

PBS buffer pH=8.0

100mmol / L

[0050] The above solution obtained according to Table 7 was divi...

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Abstract

The invention provides a method for improving the stability of latex suspension liquid, comprising the following steps of adding nonionic surfactant and substances which can enhance the condition of surface charging of particles in reagent solution or regulating pH of the reagent solution. The invention can make a biological fluid sample in a stable state when quantitatively determining the biological fluid sample and analyzing the concentration of an analyte in the sample and can achieve better repeatability of a measurement result of a clinical diagnosis reagent without various problems of precipitate at the bottom of the reagent, gap elevating, sensitivity lowering and the like after being stored for a certain period.

Description

technical field [0001] The present invention relates to a method for improving the stability of latex-bound antigen or antibody particles, suitable for use in in vitro diagnostic kits. Background technique [0002] In 1956, Singer and Plotz began to use micron-sized particles to detect some trace substances present in body fluids through the qualitative slide agglutination method of antigens or antibodies attached to latex particles and antibodies or antigens in serum. Mainly include rheumatoid, prealbumin, progesterone and so on. With the development of particle synthesis technology, the diameter of particles is increased from micron to nano, and the surface of particles can be treated according to the needs to generate active groups. Nano particles are used in immunoturbidimetric assays. A series of diagnostic reagents for quantitative determination, including rheumatoid, anti-O, Lp(a), urinary microglobulin, prealbumin, C-reactive protein, progesterone, B2 microglobulin,...

Claims

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Application Information

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IPC IPC(8): G01N33/531
Inventor 李子樵练子富崔鹏飞
Owner AILEX TECH GRP CO LTD
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