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In-vitro diagnostic reagent preservative and application thereof

An in vitro diagnosis and preservative technology, which is applied in the field of medical testing and determination, can solve the problems such as the decrease in the measurement precision of diagnostic reagents, the decrease in the activity of tool enzymes and antibodies, and the toxicity of preservatives. The effect of stability

Pending Publication Date: 2022-01-07
DAAN GENE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved in the embodiments of the present application is that the preservatives in the related art are toxic and inhibit the tool enzymes in the diagnostic reagents, resulting in a decrease in the activity of the tool enzymes and antibodies, which in turn leads to a decrease in the measurement precision of the diagnostic reagents

Method used

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  • In-vitro diagnostic reagent preservative and application thereof
  • In-vitro diagnostic reagent preservative and application thereof
  • In-vitro diagnostic reagent preservative and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Prepare aspartate aminotransferase (AST) assay reagents according to the components and concentrations in Table 1 below.

[0038] Table 1

[0039]

[0040] In this embodiment, the in vitro diagnostic reagent is an aspartate aminotransferase (AST) assay reagent, and the AST assay reagent is a dual reagent, the dual reagents are the first type reagent R1 and the second type reagent R2, and the dual reagents are stored separately. When in use, the AST assay reagent is prepared by mixing the first type reagent R1 and the second type reagent R2.

[0041] The components of AST assay reagents include trishydroxymethylaminomethane (Tris), L-alanine, lactate dehydrogenase (LDH), bovine serum albumin, α-ketoglutarate and NADH (Nicotinamide adenine dinucleotide, also Prototype coenzyme I), the above-mentioned components were added to purified water according to the concentration in Table 1, mixed and evenly mixed, and the pH value was adjusted.

[0042] Here, the preservative...

Embodiment 2

[0050] Prepare triglyceride (TG) assay reagents according to the components and concentrations in Table 3 below.

[0051] table 3

[0052]

[0053] In this embodiment, the in vitro diagnostic reagent is a triglyceride (TG) assay reagent, and the TG assay reagent is a single reagent. The components of TG assay reagents include piperazine-1,4-diethanesulfonic acid (PIPES), magnesium chloride hexahydrate, adenosine triphosphate, p-chlorophenol, ethylenediaminetetraacetic acid, Triton TX-100, lipoprotein lipase, Glycerol phosphate oxidase, glycerol kinase and peroxidase, the above-mentioned components were added to purified water according to the concentration in Table 3, mixed and evenly mixed, and the pH value was adjusted.

[0054] Here, the preservative is added to the TG measurement reagent using the above-mentioned sulfadoxine solution and trimethoprim solution. Two groups of TG assay reagents are set as a control group, the first group of TG reagents add the compositio...

Embodiment 3

[0061] Prepare reagents according to the components and concentrations in Table 5 below, as shown in Table 5:

[0062] table 5

[0063]

[0064] In this embodiment, the reagents are set into 3 groups, and the components of each group of reagents include disodium hydrogen phosphate, potassium chloride, sodium chloride and bovine serum albumin, and the above components are respectively added to the concentration in Table 5 and mixed with purified water. Mix well and adjust the pH. Three groups of reagents were added with different preservatives, group A was without addition, group B was added with 0.5g / L sodium azide as a preservative, and group C was added with preservatives containing sulfadoxine 6 μM and ditrimethoprim 360 μM.

[0065] The 3 groups of test reagents were stored in an incubator at 37°C for 4 weeks, and finally the bacterial confirmation test was carried out on each test material after storage.

[0066] Bacteria confirmation test: Smear and scrape small sam...

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Abstract

The embodiment of the invention belongs to the technical field of medical examination and determination, and relates to an in-vitro diagnostic reagent preservative. The in-vitro diagnostic reagent preservative comprises a composition of a sulfadoxine solution and a diaveridine solution, and the molar ratio of sulfadoxine in the sulfadoxine solution to diaveridine in the diaveridine solution is 0.002 to 1. The invention further relates to application of the in-vitro diagnostic reagent preservative. According to the technical scheme, the stability of the reagent can be improved, reagent reaction is not affected, and the reagent can be widely used.

Description

technical field [0001] The present application relates to the technical field of medical testing and determination, more specifically, to an in vitro diagnostic reagent preservative and its application. Background technique [0002] In vitro diagnostic reagents generally use water as a carrier and contain enzymes, antibodies, protein stabilizers, nucleic acids or polysaccharides, etc. These contents are prone to breed microorganisms in an environment containing more water. Microorganisms can come from planktonic bacteria in the air or bacteria brought by the raw materials themselves. When microorganisms enter the reagent, due to the influence of temperature and humidity, they may grow exponentially in the reagent. A large number of microbial production will reduce the activity of the above-mentioned enzymes, antibodies and other components, and the performance of the reagents such as measurement precision will tend to deteriorate. [0003] The preservatives currently used i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/52C12Q1/32C12Q1/61C12Q1/44C12Q1/26C12Q1/48C12Q1/28
CPCC12Q1/52C12Q1/32C12Q1/61C12Q1/44C12Q1/26C12Q1/485C12Q1/28G01N2333/904G01N2333/92G01N2333/91215
Inventor 蒋析文齐文闯吴润锋段少卿简俊兴刁雪
Owner DAAN GENE CO LTD
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