IL-6 and IL-10 bigeminy colloidal gold immunochromatography kit for rapid diagnosis on sepsis

An immunochromatographic test strip and rapid diagnosis technology, which is applied in the field of medical testing to achieve the effects of reducing the economic burden, reducing the fatality rate, and promoting mass production.

CN107389925AActive Publication Date: 2017-11-24SHANGHAI CHILDRENS MEDICAL CENT AFFILIATED TO SHANGHAI JIAOTONG UNIV SCHOOL OF MEDICINE
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2017-11-24

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Abstract

The invention relates to an IL-6 and IL-10 bigeminy colloidal gold immunochromatography kit for rapid diagnosis on sepsis. The kit comprises immunochromatography test paper, a colloidal gold pad and a nitrocellulose membrane, wherein the colloidal gold pad and the nitrocellulose membrane are positioned on the test paper; gold-labeled antibodies on the colloidal gold pad include an IL-6 antibody and an IL-10 antibody; the nitrocellulose membrane comprises a detection line wrapping the IL-6 antibody, a detection line wrapping the IL-10 antibody, and a quality control line wrapping a goat anti mouse antibody from left to right sequentially. The invention further provides a standard colorimetric card for judging detection results, and the standard colorimetric card is used for comparing and distinguishing early-stage sepsis, serious sepsis, gram-negative bacterium infection and gram-positive bacterium infection. The kit provided by the invention has the advantages of stability, simplicity, rapidness, accuracy, no pollution, low expense and the like; on-scale production can be achieved, the early-stage rapid sepsis diagnosis efficiency is improved, the economic burden of patients is reduced, the case fatality rate of sepsis is reduced, and remarkable economic benefits can be made.
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Description

technical field

[0001] The invention relates to the technical field of medical detection, in particular to an IL-6 and IL-10 dual colloidal gold immunochromatography kit for rapid diagnosis of sepsis. Background technique

[0002] Sepsis is a common serious infectious disease in hospitals at all levels, and most of its infection sources are bacteria. The case fatality rate of severe sepsis is high, can be as high as 30-50%, and the number of people who die of sepsis in China is nearly 1 million every year. The key to successful sepsis treatment is early diagnosis and early intervention. Therefore, early and rapid diagnosis of sepsis is a key factor in determining the prognosis of sepsis. IL-6 is a pro-inflammatory factor secreted by Th-2 cells, which promotes the proliferation and differentiation of B cells and secretes antibodies, and promotes the differentiation of T cells into CTLs. phase protein (CRP). IL-10 is an anti-inflammatory factor secreted by Th-2 cells. It in...

Examples

Embodiment 1

[0021] Example 1 Preparation of IL-6 and IL-10 Colloidal Gold Immunochromatography Kit

[0022] 1.1 Determine the critical value of IL-6 and IL-10 for diagnosis of sepsis

[0023] (1) IL-6 greater than 40.6pg / mL and IL-10 greater than 20.0pg / mL were defined as sepsis.

[0024] (2) IL-6 greater than 227.7pg / mL, IL-10 greater than 42.0pg / mL was defined as severe sepsis.

[0025] (3) IL-6 greater than 227.7pg / mL and IL-10 greater than 96.0pg / mL were defined as Gram-negative bacterial infection.

[0026] (4) IL-6 greater than 227.7pg / mL and IL-10 less than 96.0pg / mL were defined as Gram-positive bacterial infection.

[0027] IL-6 set two concentration gradients of 227.7pg / mL and 40.6pg / mL; IL-10 set three concentration gradients of 96.0pg / mL, 42.0pg / mL and 20.0pg / mL.

[0028] 1.2 Preparation of colloidal gold by trisodium citrate reduction method

[0029] Take 100ml of 0.01% chloroauric acid aqueous solution and heat it to boiling. Accurately add 0.7ml of 1% trisodium citrate ...

Embodiment 2

[0067] Example 2 Detection and verification of clinical specimens of the kit

[0068] (1) For the diagnosis of sepsis, refer to the 2015 Chinese Expert Consensus on Septic Shock in Children: Diagnosis of sepsis: fever (rectal temperature > 38.5°C) or hypothermia (rectal temperature < 35°C), tachycardia (those with hypothermia can without tachycardia), accompanied by abnormal function of at least one of the following organs: altered consciousness, hypoxemia, increased serum lactic acid or flooded pulse.

[0069] (2) The whole blood of patients with sepsis is used for testing, the color of the test strip is compared with the standard color card, and the absolute value of cytokines detected by flow cytometry in clinical patients is compared with the absolute value of cytokines to further verify the immune colloidal gold The accuracy, reliability and speed of the kit.

[0070] (3) To further verify the accuracy of the present invention's rapid diagnosis of IL-6 and IL-10 colloida...