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Homogeneous immunoassay kit for detecting β-human chorionic gonadotropin and its preparation method and application

A chorionic gonadotropin and immune detection technology, applied in the field of immune analysis, can solve the problems affecting the accuracy and sensitivity of the analysis method, the precision of the analysis method, and the washing error of the immune analysis, etc., and achieves a wide range of signal values ​​and sensitivity. High and satisfactory analytical performance

Active Publication Date: 2021-11-02
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the solid-phase adsorption separation method has many advantages such as simplicity and rapidity, multiple washings will inevitably bring washing "errors" to immunoassays, which will affect the precision of the analytical method, thereby affecting the accuracy and analytical sensitivity of the analytical method.
In addition, clinical requirements for β-hCG quantification have a wide detection interval, while the detection intervals of existing diagnostic reagents have increased differences, and specimens need to be diluted to obtain test results

Method used

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  • Homogeneous immunoassay kit for detecting β-human chorionic gonadotropin and its preparation method and application
  • Homogeneous immunoassay kit for detecting β-human chorionic gonadotropin and its preparation method and application
  • Homogeneous immunoassay kit for detecting β-human chorionic gonadotropin and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0077] Example 1: Preparation of a homogeneous immunoassay reagent kit for detecting β-human chorionic gonadotropin

[0078] (1) Preparation of receptors bound to antibodies:

[0079] The acceptor used in this example was microparticles (luminescent microspheres) containing aldehyde groups (-CHO) coated on latex particles to form chelates filled with derivatives of dimethylthiophene and lanthanide Eu. The receptor is attached to the antibody molecule through an aldehyde group.

[0080] Biological material: β-hCG monoclonal antibody

[0081] Preparation process: take 2 mg of luminescent microsphere solution and dilute it to 5 mg / ml with 0.05M carbonate buffer (CB) pH 9.6; transfer 0.02 mg of β-hCG monoclonal antibody to the diluted luminescent microsphere solution Mix well, overnight at 4°C; then add 20uL of BSA solution diluted to 10mg / ml with 0.05M CB buffer at pH 9.6, rotate at room temperature for 2h; wash the microspheres thoroughly, and finally use 0.1M Tris-HCl at pH 8...

Embodiment 2

[0094] Example 2: Detection of β-human chorionic gonadotropin in a sample using the reagent kit prepared by the method of the present invention.

[0095] The reagent set used is the homogeneous immunodetection reagent set for β-human chorionic gonadotropin prepared in Example 1. The detection process is automatically completed by the automatic photo-excited chemiluminescence analysis system and the detection results are output. The specific steps are as follows:

[0096] 1) Add 10 μl of the sample to be tested or calibrator and quality control product to the reaction wells;

[0097] 2) Add 25 μl R1 and 25 μl R1 to the reaction well in turn;

[0098] 3) Incubate at 37°C for 15 minutes;

[0099] 4) Add 175 μl R3;

[0100] 5) Incubate at 37°C for 15 minutes;

[0101] 6) Irradiate the microwell with laser and calculate the signal value of each well; draw a standard curve according to the signal value of the calibrator, and calculate the concentration of β-human chorionic gonad...

Embodiment 3

[0110] Example 3: Detection precision of the reagent kit prepared by the method of the present invention

[0111] Precision is an important indicator to measure the intra- and inter-assay variability of in vitro diagnostic reagents, and is an important basis for evaluating the effectiveness of products to be marketed, usually including intra-assay precision and inter-assay precision.

[0112] Intra-assay precision evaluation method: use samples with low (L), medium (M), and high (H) values ​​to independently analyze 3 batches of products, and repeat the determination 10 times for each batch (using the method in Example 2). method described), calculate the average of 10 measurements and standard deviation (SD), according to the formula The coefficient of variation (CV) was calculated and the results are shown in Table 4.

[0113] Inter-batch precision evaluation method: use samples with low (L), medium (M), and high (H) values ​​to independently analyze 3 batches of product...

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Abstract

The invention relates to a homogeneous immunoassay reagent kit for detecting beta human chorionic gonadotropin in the technical field of immunoassay, and a preparation method and application thereof. The homogeneous immunodetection reagent kit for β-human chorionic gonadotropin obtained by the method provided by the present invention has a wide range of signal values ​​when analyzed by the photo-excited chemiluminescence immunoassay platform, and reaches the quantitative test standard; the sensitivity is high, and can be accurately detected. The serum or urine β-hCG level is used for in vitro diagnosis; it has good stability and high precision; and by optimizing the analysis system (antibody dosage and buffer solution, etc.), the analysis performance meets the industry standard, which is used for clinical pregnancy diagnosis and dynamic monitoring of hydatidiform mole and hydatidiform mole. Provide reference for the therapeutic effect of choriocarcinoma.

Description

technical field [0001] The invention belongs to the technical field of immunoassay, and in particular relates to a homogeneous immunoassay reagent kit for detecting beta human chorionic gonadotropin and a preparation method and application thereof. Background technique [0002] Human beta human chorionic gonadotropin (beta-hCG) is the most important hormone in the placenta, which is mainly synthesized by placental syncytiotrophoblast cells. β-hCG is a heterodimeric glycoprotein composed of α and β subunits non-covalently bound, and its sugar chain ends are sialic acid. The main role of β-hCG is to maintain the secretory function of the ovarian corpus luteum during the first few weeks of pregnancy to support the needs of early embryonic development. The most important marker for determining pregnancy is serum or urine β-hCG quantification. Pregnancy can be diagnosed when urinary β-hCG levels exceed the levels in the first week after menopause, and serum quantification tests...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/76
CPCG01N33/76
Inventor 徐静心强中华刘宇卉李临
Owner CHEMCLIN DIAGNOSTICS CO LTD
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