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Kit for quantificationally and qualitatively detecting smooth muscle antibodies

A qualitative detection and smooth muscle technology, applied in biological testing, measuring devices, material inspection products, etc., to achieve high sensitivity, strong specificity, and high use value

Inactive Publication Date: 2019-04-16
AUTOBIO DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Different from the diversity of other autoantibody detection methods, the detection of anti-smooth muscle antibodies is still mainly performed clinically by indirect immunofluorescence. The reagent for detecting anti-smooth muscle antibody by luminescence method is still blank

Method used

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  • Kit for quantificationally and qualitatively detecting smooth muscle antibodies
  • Kit for quantificationally and qualitatively detecting smooth muscle antibodies
  • Kit for quantificationally and qualitatively detecting smooth muscle antibodies

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1 Preparation of a kit for detecting anti-smooth muscle antibodies

[0050] 1. Preparation of magnetic particle reagents

[0051] 1. Prepare magnetic particle reagent storage buffer:

[0052] Add 1000ml of purified water, 6.05g of Tris and 9.0g of sodium chloride into the container and stir to dissolve; add 10g of bovine serum albumin, 1ml of Proclin300, 0.2g of Bro and 0.4g of MgCl·6H 2 Add O into the container and stir until completely dissolved; use 6M hydrochloric acid to adjust the pH to 7.4±0.1, prepare the storage buffer, and store it at 2-8°C for later use;

[0053] 2. Prepare magnetic particle reagent buffer 1:

[0054] Add 1000ml of purified water, 0.58g of sodium dihydrogen phosphate, 5.78g of disodium hydrogen phosphate, and 8.78g of sodium chloride into the container, stir and dissolve fully, measure the pH value between 7.0-7.5, and store at 2-8°C for later use;

[0055] 3. Prepare magnetic particle reagent buffer 2:

[0056] Add 1000ml of puri...

Embodiment 2

[0075] Embodiment 2 The detection method of kit of the present invention

[0076] 1. Sample requirements

[0077] 1. Use correct medical technology to collect serum or plasma samples: Serum samples can be collected using ordinary tubes or procoagulant tubes, and plasma samples can be collected using EDTA, heparin sodium, or sodium citrate anticoagulant tubes.

[0078] 2. The sediment and suspended matter in the sample may affect the test results, and should be removed by centrifugation, and the sample can only be used after confirming that it has not deteriorated.

[0079] 3. Samples with lipemia, hemolysis or turbidity cannot be used for the determination of this project.

[0080] 4. After the sample is collected, it should not be stored at room temperature for more than 8 hours; if it is not tested within 8 hours, the sample should be placed in a refrigerator at 2~8°C; if it needs to be stored or transported for more than 48 hours, it should be frozen at -20°C , avoid repe...

Embodiment 3

[0089] Embodiment 3 The performance test of the kit prepared by the present invention

[0090] 1. Blank limit,

[0091] Use the zero-concentration calibrator as the sample for detection, repeat the measurement 20 times, obtain the luminescence value (RLU) of the 20 measurement results, calculate the mean (M) and standard deviation (SD), and obtain the RLU corresponding to M+2SD. The concentration value and signal value of each point of the calibrator are fitted according to the four-parameter lin-log method, and the RLU corresponding to M+2SD is substituted into the fitting curve to obtain the corresponding concentration value, which is the blank limit. The blank limit of this method requires no more than 5AU / ml. See Table 1 for blank limit data:

[0092] Table 1 Blank limit evaluation

[0093]

[0094] It can be seen from the data in Table 1 that the obtained blank limit is smaller than the required blank limit, which meets the needs of clinical use.

[0095] 2. Linear...

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Abstract

The invention discloses a kit for quantificationally and qualitatively detecting smooth muscle antibodies. The kit comprises a magnetic microparticle reagent marked with streptavidin, a goat anti-human IgG storage buffer solution containing HRP marks, a biotin antigen reagent, a smooth muscle antibody calibration product, a smooth muscle antibody critical value quality control product and a smoothmuscle antibody negative quality control product, wherein the surfaces of the magnetic microparticles contain carboxyl groups; and biotin antigens in the biotin antigen reagent are marked with actin.The kit has the advantages that the detection is convenient and fast; the quantificational and qualitative detection on the smooth muscle antibodies can be realized in a short time, so that the typeand the serious degree of autoimmune liver diseases can be accurately diagnosed; and the clinic medication of a doctor is guided. The prepared kit has the advantages of high sensitivity, high specificity and high accuracy, and is applicable to a semi-automatic or fully-automatic detection system. The kit combines a chemiluminescence technology with a magnetic microparticle technology, has a high use value on clinics, and is suitable for being popularized and applied.

Description

technical field [0001] The present invention relates to magnetic particle chemiluminescence technology, in particular to a kit for quantitatively and qualitatively detecting anti-smooth muscle antibody prepared by using magnetic particle chemiluminescence technology. Background technique [0002] Autoimmune liver disease (autoimmune liver disease, ALD) is a special type of chronic liver disease. The gender and age distribution of the patients are similar to those of lupus erythematosus, and they are often accompanied by extrahepatic symptoms, and even the phenomenon of "lupus" can be seen. Therefore, it is speculated that Its pathogenesis is related to autoimmunity. [0003] In recent years, due to the accumulation of clinical experience and the advancement of laboratory diagnostic techniques, the number of patients with autoimmune liver disease in the Chinese population has gradually increased. Domestic articles on the pathogenesis of autoimmune liver disease, related auto...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N21/76
CPCG01N21/76G01N33/6893G01N2800/08
Inventor 何丽张慧萍乔晓芳李晓霞尚晓楠李忠信孙萌郑业焕渠海付光宇
Owner AUTOBIO DIAGNOSTICS CO LTD
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