Novel immunochromatography detection device

An immunochromatographic detection and detection device technology, applied in the field of biological detection, can solve the problems of not the most simplified operation steps, operation errors, increased virus transmission, etc., and achieve the effect of reducing utilization, convenient use, and reducing the risk of transmission

Pending Publication Date: 2022-04-29
VIVACHEK BIOTECH HANGZHOU
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

In samples without virus, no increase in fluorescent signal could be detected due to no amplification of the target gene
The detection of new coronavirus by nucleic acid has high specificity and sensitivity, but the detection method has high technical requirements, the specimen needs special treatment, and requires professional equipment such as PCR amplifier and gel electrophoresis. The test takes a long time, requires professional technicians to operate and judge the test results, and cannot be applied to the early preliminary screening of community hospitals, customs, CDC and other grassroots
[0004] At present, Chinese patent application 202010184358.X has disclosed a fluorescent immunochromatographic device for detecting COVID-19 and its use method for the above problems, and Chinese patent application 202010184382 has disclosed a colloidal gold immunochromatographic device for detecting COVID-19. The method of use, the corresponding product can be applied to the early primary screening at the grassroots level, but it still has certain operational defects, especially the method of detecting virus antigens needs to be diluted or lysed for the first time to further detect the collected samples, that is, using Two-step detection method, collect samples from the patient's oropharynx or nasopharynx, after sampling, process the collected samples in other auxiliary devices other than the detection device, and then add the processed samples to the detection device for result detection
This kind of sampling may increase the risk of virus transmission to medical staff and health care workers who lack adequate personal protective equipment. The operation steps are not the most simplified, which is easy to cause operational errors, which will have a certain impact on the test results.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Example 1 The novel immunochromatographic detection device provided by the present invention

[0064] The novel immunochromatographic detection device provided in this embodiment is as Figure 1-3 shown, where figure 1 It is a schematic diagram of the structure of the new immunochromatographic detection device, figure 2 It is a split diagram of each layer structure of the new immunochromatography detection device, image 3 It is a structural disassembly diagram of the sample collection part of the new immunochromatography detection device.

[0065] Such as figure 1 , the present invention provides a novel immunochromatographic detection device, the detection device includes a sample collection site 1 and a test strip 2, the test strip 2 includes a sample pretreatment pad 3, and the sample collection site 1 collects The sample can be transferred to the sample pretreatment pad 3, and the sample pretreatment pad 3 has a dry and fixed sample pretreatment liquid on it. ...

Embodiment 2

[0076] Example 2 Preparation of an immunochromatographic detection device (colloidal gold method) for detecting novel coronavirus

[0077] The preparation steps of the immunochromatographic detection test device (colloidal gold method) for detecting novel coronavirus SARS-CoV-2 provided by this embodiment include:

[0078] Step 1: Prepare the sample pretreatment pad

[0079] 1) Prepare phosphate buffer and adjust the pH to 7.5.

[0080] 2) Take a certain mass fraction of the above phosphate buffer: 0.01mol / L, a certain mass fraction of casein: 3%, a certain mass fraction of Triton X-100: 1%, a certain mass fraction of proclin 300: 0.01% configuration into a pretreatment solution.

[0081] 3) Evenly disperse the pretreatment solution on the glass fiber, dry overnight in a 37°C drying oven, take it out and seal it in an aluminum foil bag for later use.

[0082] Step 2: Sample Pad Processing

[0083] 1) Configure boric acid buffer and adjust the pH to 7.5.

[0084] 2) Take a...

Embodiment 3

[0103] Example 3: Preparation of another immunochromatographic detection device (colloidal gold method) for detecting novel coronavirus

[0104] Same as Example 2, the difference is to use stearic acid monoethanolamide instead of TritonX-100 in the preparation of the pretreatment pad, and all the other ingredients are the same as other contents in Example 2, and according to the mass fraction of stearic acid monoethanolamide Different, divided into three recipes for the preparation of pre-treatment pads.

[0105] Formula 1: 0.01 mol / L phosphate buffer, 3% casein, 0.5% stearic acid monoethanolamide, and 0.01% proclin 300.

[0106] Formula 2: 0.01 mol / L phosphate buffer, 3% casein by mass fraction, 1% stearic acid monoethanolamide, 0.01% proclin 300 by mass fraction.

[0107] Formula 3: 0.01 mol / L phosphate buffer, 3% casein by mass fraction, 1.5% stearic acid monoethanolamide, 0.01% proclin 300 by mass fraction.

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Abstract

The invention provides a novel immunochromatography detection device which comprises a sample pretreatment part, and when the device is used, a sample does not need to be subjected to pretreatment such as dilution or splitting decomposition, and one-step detection can be realized. The immunochromatography detection device provided by the invention is particularly suitable for rapid detection of the novel coronavirus SARS-CoV-2, sample collection can be carried out by adopting a mode of directly sampling a saliva sample in an oral cavity, self-sampling and self-detection of a patient are facilitated, positive and negative properties of the novel coronavirus can be diagnosed by a one-step method, and the immunochromatography detection device is convenient to use, simple, efficient and low in cost. The risk that viruses are spread to medical staff and health care workers is reduced, utilization of personal protection equipment is reduced, and the method is suitable for early-stage rapid diagnosis of infection conditions of the novel coronavirus by various medical institutions or individuals.

Description

[0001] This application is a divisional application with the application number 2020112540542, the application date is November 11, 2020, and the invention title is "A Novel Immunochromatographic Detection Device". technical field [0002] The invention belongs to the technical field of biological detection, and relates to a novel immunochromatographic detection device, in particular to a one-step immunochromatographic detection device including pretreatment for detecting novel coronaviruses. Background technique [0003] At present, the detection of new coronaviruses is mainly based on PCR-based viral nucleic acid detection. The detection principle is to use the unique gene sequence of the virus as the detection target, and through PCR amplification, the target DNA sequence we selected will increase exponentially. The more the target gene is amplified, the stronger the fluorescent signal will be accumulated. In samples without viruses, no increase in fluorescent signal coul...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/569G01N33/558G01N33/577
CPCG01N33/56983G01N33/558G01N33/577G01N2333/165G01N2469/10
Inventor 张敏杨蓉
Owner VIVACHEK BIOTECH HANGZHOU
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