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Dilute of alkaline phosphatase maker and application thereof

A diluent, phosphatase technology, applied in instruments, measuring devices, scientific instruments, etc., can solve problems such as negative impact on patients' life or psychology, delay in treatment timing, false positives or false negatives, etc., to reduce the probability of false positive results, The effect of reducing false positive results and improving accuracy

Pending Publication Date: 2020-02-21
AILEX TECH GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Many infectious diseases such as hepatitis B can be screened by immunoassay, but the screening is often prone to false positive or false negative results, which will bring negative impact on the life or psychology of patients, or delay the timing of treatment, resulting in false negatives There are many reasons for false positives, mainly affected by the inspection method, reagent selection and operation method
[0004] However, reports on enzyme conjugate diluents in the prior art focus more on how to improve the stability effect of enzyme conjugates. For example, CN102115737A discloses a stabilizer of alkaline phosphatase or its marker and its preparation method, and adopts The stabilizer stabilizes the method for alkaline phosphatase or its marker

Method used

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  • Dilute of alkaline phosphatase maker and application thereof
  • Dilute of alkaline phosphatase maker and application thereof
  • Dilute of alkaline phosphatase maker and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] This embodiment provides a kind of dilution solution of alkaline phosphatase marker, and described dilution solution comprises following components:

[0060]

[0061] The preparation method is as follows: with a preparation volume of 50mL, calculate the dosage of various raw materials according to the formula; add 40mL of purified water into the container, then add the above-mentioned raw materials, stir and dissolve; adjust the pH value; add purified water to the preparation volume; use The dilution of the alkaline phosphatase marker was obtained by suction filtration with a 0.22 μm filter membrane.

[0062] The resulting dilution was used for HBeAg magnetic particle chemiluminescence immunoassay, specifically as follows:

[0063] Two strains of HBeAb monoclonal antibodies purchased from Fapon were coated and labeled respectively. The HBeAb-alkaline phosphatase marker was diluted to the working concentration (0.1 μg / mL) with this diluent, and detected in 500 normal ...

Embodiment 2

[0069] This embodiment provides a kind of dilution solution of alkaline phosphatase marker, and described dilution solution comprises following components:

[0070]

[0071]

[0072] Its preparation method refers to embodiment 1.

[0073] The resulting dilution was used for HBeAg magnetic particle chemiluminescence immunoassay, specifically as follows:

[0074] Two strains of HBeAb monoclonal antibodies purchased from Fapon were coated and labeled respectively. The HBeAb-alkaline phosphatase marker was diluted to the working concentration (0.1 μg / mL) with this diluent, and detected in 500 normal human serum Samples were measured and counted as negative or positive, and the coincidence rate of positive results was compared with other methodologies (method 1, method 2).

[0075] Use embodiment 2 dilution to detect 4 false positive samples in 500 normal human sera (false positive samples are all re-inspected 2 times, and the positive results greater than or equal to 2 time...

Embodiment 3

[0080] This embodiment provides a kind of dilution solution of alkaline phosphatase marker, and described dilution solution comprises following components:

[0081]

[0082]

[0083] Its preparation method refers to embodiment 1.

[0084] The resulting dilution was used for HBeAg magnetic particle chemiluminescence immunoassay, specifically as follows:

[0085] Two strains of HBeAb monoclonal antibodies purchased from Fapon were coated and labeled respectively. The HBeAb-alkaline phosphatase marker was diluted to the working concentration (0.1 μg / mL) with this diluent, and detected in 500 normal human serum Samples were measured and counted as negative or positive, and the coincidence rate of positive results was compared with other methodologies (method 1, method 2).

[0086] 11 false positive samples occurred in 500 normal human sera using the dilution of Example 3 (false positive samples were all re-inspected 2 times, and the positive results greater than or equal to...

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Abstract

The invention relates to a dilute of an alkaline phosphatase maker and application thereof. The diluent comprises a buffer, a protein, a surfactant, a zinc ion, a magnesium ion, a preservative and anadditive, wherein the additive comprises a blocking agent and / or alkaline phosphatase; and the alkaline phosphatase is a low-active alkaline phosphatase and / or inactive alkaline phosphatase. The invention creatively adds the blocking agent and / or alkaline phosphatase to the traditional diluent for diluting alkaline phosphatase markers, and can well reduce non-specific reactions and ultimately reduce the probability of false positive results in clinical samples to improve the accuracy of detection and analysis results.

Description

technical field [0001] The invention belongs to the technical field of medical reagents, and relates to a diluent of an enzyme marker and its application, in particular to a diluent of an alkaline phosphatase marker and its application, in particular to an alkaline phosphatase that can reduce non-specific reactions. Dilutions of phosphatase markers and their applications. Background technique [0002] In a suitable buffer system, alkaline phosphatase can catalyze chromogenic and chemiluminescent substrates containing phosphate groups. Therefore, alkaline phosphatase, as a labeling enzyme, is widely used in clinical immunoassays. The alkaline phosphatase marker solution is one of the components of the in vitro diagnostic kit. When the serum reaction is measured, the reaction microenvironment is almost entirely provided by the dilution of the enzyme marker, that is, the antigen-antibody reaction is obtained when the enzyme marker is diluted. performed in liquid. [0003] Man...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/535G01N33/576
CPCG01N33/535G01N33/5761
Inventor 李子樵张辰欢
Owner AILEX TECH GRP CO LTD
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