Fecal occult blood detection kit

A detection kit and fecal occult blood technology, applied in the field of medical detection, can solve problems such as high detection cost, poor detection repeatability, and reduced sensitivity, and achieve the effect of simple and easy-to-obtain raw materials, reduce detection cost, and ensure stability

Active Publication Date: 2019-11-12
BYRON DIAGNOSTICS SHANGHAI
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

During latex immunoturbidimetric detection, the sample will be mixed with reagent 1 and reagent 2 and reacted at 37°C for 3-10 minutes. If reagent 1 and 2 cannot maintain the stability of HB, HB will continue to degrade during the detection process, which will cause sensitivity Reduced, poor detection repeatability, serious lead to missed detection
In addition, because HB is extremely unstable, it is difficult to obtain stable calibrators and quality controls; without stable calibrators and quality controls, the detection accuracy cannot be guaranteed
[0005] The latex immunoturbidimetric detection reagent developed by Japan's Eiken can well solve the problem of HB instability, and HB14d still has good stability when stored in sample diluent at 4°C, calibrator and quality control product Stored at 4°C for 6 months, the stability is good 7 days after reconstitution; however, the detection cost is high, and only super-large tertiary hospitals in China such as Peking Union Medical College Hospital can conduct it, and it cannot be widely used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Verifying the influence of reagent 1 and reagent 2 on the stability of fecal occult blood detection

[0040] Reagent 1 and reagent 2 were respectively prepared using the formulas of experimental groups 1-3 and the control group, and the solvent was water, and the antibodies of each group were labeled on the latex microspheres according to the conventional chemical coupling method.

[0041] Experimental group 1

[0042] Reagent 1: 4-hydroxyethylpiperazineethanesulfonic acid 23.8g / L, sodium chloride 70.1g / L, tris(2-carboxyethyl)phosphine (TCEP) 1g / L, glutathione 1g / L, Glutamic acid 1g / L, arginine 0.1g / L, cysteine ​​0.1g / L, disodium edetate 1g / L, bovine serum albumin (IgG free grade) 1g / L, polyethylene Diol 6000 10g / L, Tween-20 2ml / L, blocking agent HBR-X (Scantibody Company) 2ml / L, sodium hydroxide to adjust PH6.90, preservative ProClin300 0.6ml / L.

[0043]Reagent 2: 12.2 g / L of trismethylaminopropanesulfonic acid, 45 g / L of trehalose, 1.8 g / L of 300 nm latex ...

Embodiment 2

[0061] Embodiment 2 verifies the impact of sample diluent on sample storage stability

[0062] Experimental group 4 sample diluent: 4-hydroxyethylpiperazineethanesulfonic acid 11.9 / L, sodium chloride 46.8g / L, trehalose 30g / L, sucrose 60g / L, sodium lauryl polyoxyethylene ether sulfate 10g / L L, tris(2-carboxyethyl)phosphine (TCEP) 1g / L, glutathione 1g / L, glutamic acid 1g / L, arginine 0.1g / L, cysteine ​​0.1g / L, Disodium edetate 1g / L, bovine serum albumin (IgGfree grade) 1g / L, sodium hydroxide to adjust PH6.90, preservative ProClin300 0.6ml / L; solvent is water.

[0063] Experimental group 5 sample diluent: 4-hydroxyethylpiperazineethanesulfonic acid 23.8g / L, sodium chloride 58.4g / L, trehalose 30g / L, sucrose 80g / L, sodium lauryl polyoxyethylene ether sulfate 10g / L, tris(2-carboxyethyl)phosphine (TCEP) 1g / L, glutathione 2g / L, glutamic acid 2g / L, arginine 0.2g / L, cysteine ​​0.2g / L , disodium edetate 2g / L, bovine serum albumin (IgG free grade) 2g / L, sodium hydroxide adjusted to 7.20...

Embodiment 3

[0073] The impact of embodiment 3 calibrator / quality control product background buffer solution on storage stability

[0074] Experimental group 7 calibrator / quality control background buffer: 4-hydroxyethylpiperazineethanesulfonic acid 5.96g / L, sodium chloride 2.9g / L, trehalose 45g / L, maltose 10g / L, three (2 -Carboxyethyl)phosphine (TCEP) 1g / L, glutathione 1g / L, glutamic acid 1g / L, arginine 0.1g / L, cysteine ​​0.1g / L, ethylenediaminetetraacetic acid Disodium 1g / L, mannitol 2g / L, fetal bovine serum (mycoplasma-free Chlamydia grade) 50ml / L, sodium hydroxide to adjust PH6.90, preservative ProClin300 0.6ml / L, solvent is water.

[0075] Experimental group 8 calibrator / quality control background buffer: 4-hydroxyethylpiperazineethanesulfonic acid 11.9g / L, sodium chloride 5.8g / L, trehalose 45g / L, maltose 20g / L, three (2 -Carboxyethyl)phosphine (TCEP) 1g / L, glutathione 2g / L, glutamic acid 2g / L, arginine 0.2g / L, cysteine ​​0.2g / L, ethylenediaminetetraacetic acid Disodium 2g / L, mannit...

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Abstract

The invention discloses a fecal occult blood detection kit. The fecal occult blood detection kit comprises a sample diluent, a calibrator, a quality control material, a reagent 1 and a reagent 2; thereagent 1 is a reaction buffer solution; the reagent 2 is a hemoglobin antibody sensitized latex solution; and 1 g/L tris(2-carboxyethyl)phosphine, 1 to 2 g/L glutathione, 1 to 2 g/L glutamic acid, 0.1 to 0.2 g/L arginine, 0.1 to 0.2 g/L cysteine and 1 to 2 g/L ethylene diamine tetraacetic acid are added into the sample diluent, a background buffer solution of the calibrator, a background buffer solution of the quality control material, the reagent 1 and the reagent 2. According to the fecal occult blood detection kit, the stability in the storage and detection reaction process of HB can be improved; various reagent and raw materials are simple and easily obtained; and the fecal occult blood detection kit is convenient to prepare and wide in application range.

Description

technical field [0001] The invention relates to the field of medical detection, in particular to a detection kit for fecal occult blood. Background technique [0002] Fecal occult blood (fecal occult blood referred to as FOB): also known as fecal occult blood, refers to a small amount of bleeding in the digestive tract, red blood cells are digested and destroyed, and the stool contains a small amount of destroyed red blood cells; there is no abnormal change in the appearance of the stool, which cannot be confirmed by naked eyes and microscopes bleeding. Fecal occult blood is important information for gastrointestinal diseases and an important screening indicator for early diagnosis of gastrointestinal malignancies. Fecal occult blood detection and screening by detecting hemoglobin (HB) in stool can detect gastrointestinal lesions early. [0003] Conventional fecal occult blood detection methods include colloidal gold method and latex immunoturbidimetric method. At present,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/543G01N33/545G01N33/72
CPCG01N33/54393G01N33/54313G01N33/545G01N33/721
Inventor 王钊唐向珍
Owner BYRON DIAGNOSTICS SHANGHAI
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