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Homogeneous immunoassay reagent kit for detecting beta human chorionic gonadotropin and preparation method and application thereof

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, affecting the precision of the analysis method, and increasing the difference between the detection intervals, etc., and achieves a wide range of signal values, High sensitivity and high precision effect

Active Publication Date: 2018-08-24
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 reagent kit for detecting beta human chorionic gonadotropin and preparation method and application thereof
  • Homogeneous immunoassay reagent kit for detecting beta human chorionic gonadotropin and preparation method and application thereof
  • Homogeneous immunoassay reagent kit for detecting beta human chorionic gonadotropin and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

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

[0079] The acceptor used in this example is a microparticle (luminescent microsphere) containing an aldehyde group (-CHO) coated on latex particles to form a chelate filled with a derivative of dimethylthiophene and a lanthanide Eu. The receptor is linked 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 pH 9.6 carbonate buffer (CB); 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 pH 9.6 CB buffer, rotate at room temperature for 2h; fully wash the microspheres, and finally use pH 8.0 0.1M Tris-HCl Solution Dil...

Embodiment 2

[0094] Example 2: The reagent set prepared by the method of the present invention is used to detect β-human chorionic gonadotropin in a sample.

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

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

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

[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) Laser irradiates the microwells and calculates the signal value of each well; draws a standard curve according to the signal value of the calibrator, and calculates the concentration of β-human chorionic gonadotropin in the sampl...

Embodiment 3

[0110] Embodiment 3: the detection precision of the reagent set prepared by the method of the present invention

[0111] Precision is an important index to measure intra-assay and inter-assay variation 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-batch precision evaluation method: with low (L), medium (M), high (H) value samples, the product of 3 batches is analyzed independently, and each batch is repeatedly measured 10 times (using embodiment 2) Determination by the method described), calculate the average value of 10 measurement results and standard deviation (SD), according to the formula Calculate the coefficient of variation (CV), and the results are shown in Table 4.

[0113] Inter-batch precision evaluation method: with low (L), middle (M), high (H) value sample, the product of 3 batches is analyzed independent...

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Abstract

The invention relates to a homogeneous immunoassay reagent kit for detecting beta human chorionic gonadotropin and a preparation method and application thereof. The homogeneous immunoassay reagent kitof the beta human chorionic gonadotropin obtained by the method provided by the invention has a wide range of signal values and reaches a quantitative test standard when used for analyzing in a photoexcited chemiluminescence immunoassay platform; the homogeneous immunoassay reagent kit is high in sensitivity and can be used for accurate in-vitro diagnosis of beta-hCG levels in serum or urine; thehomogeneous immunoassay reagent kit has good stability and high precision; and by analysis system optimizing (antibody dosage and buffer and the like), the analytical performance meets industry standards, and a reference is provided for clinical pregnancy diagnosis and dynamic monitoring of hydatidiform moles and therapeutic effect of chorio-epithelioma.

Description

technical field [0001] The invention belongs to the technical field of immune analysis, and in particular relates to a homogeneous immunoassay reagent set for detecting beta human chorionic gonadotropin and its preparation method and application. Background technique [0002] Human β-human chorionic gonadotropin (β-hCG) is the most important hormone in the placenta, which is mainly synthesized by placental syncytiotrophoblast cells. β-hCG is a glycoprotein with a heterodimer structure, which is composed of α and β subunits non-covalently combined, and the end of its sugar chain is sialic acid. The main role of β-hCG is to maintain the secretory function of the corpus luteum of the ovary in the first few weeks of pregnancy to support the needs of early embryonic development. The most important marker to determine pregnancy is the quantification of serum or urine β-hCG. Pregnancy can be diagnosed when the urinary β-hCG level exceeds the level in the first week after menopaus...

Claims

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Application Information

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IPC IPC(8): G01N33/76
CPCG01N33/76
Inventor 徐静心强中华李会强刘宇卉李临
Owner CHEMCLIN DIAGNOSTICS CO LTD
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