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Development method of IVD streaming product

A product, streaming technology, applied in the field of IVD product development, can solve the problems of lack of identification process and insufficient product accuracy, and achieve the effect of improving accuracy and product quality

Pending Publication Date: 2022-01-07
杭州联科生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, the common development method lacks an identification process during operation, which makes the developed product less accurate.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] A development method of an IVD flow type product, the development method of the IVD flow type product comprises the following steps:

[0029] S1: After confirming the requirements of the test sample, first perform the coupling of APC-Cy7, PE-Cy7 and PerCP-Cy5.5; first balance the EDC to room temperature, add 2mg of APC-Cy7, 5mg of PE-Cy7H and 7mg of PerCP -Cy5.5 to 200ul coupling buffer, if the thermoelectric carrier protein is dissolved in sterile water; in step S1, the requirements for the test sample include the sample processing method and the type of anticoagulant, wherein the sample processing method includes sample hemolysis Conditions and methods of handling, storage, and transportation; anticoagulants include EDTA, heparin sodium, and sodium citrate;

[0030] S2: Dissolve 2mg of polypeptide or hapten into 500ul of coupling buffer and add 200ul of carrier protein; in step S2, combine APC-Cy7 or PE-Cy7, dissolve 10mg of EDC into 1ml of ultrapure water and immedia...

Embodiment 2

[0041] A development method of an IVD flow type product, the development method of the IVD flow type product comprises the following steps:

[0042]S1: After confirming the requirements of the test sample, first perform the coupling of APC-Cy7, PE-Cy7 and PerCP-Cy5.5; first balance the EDC to room temperature, add 2mg of APC-Cy7, 5mg of PE-Cy7H and 7mg of PerCP -Cy5.5 to 200ul coupling buffer, if the thermoelectric carrier protein is dissolved in sterile water; in step S1, the requirements for the test sample include the sample processing method and the type of anticoagulant, wherein the sample processing method includes sample hemolysis Conditions and methods of handling, storage, and transportation; anticoagulants include EDTA, heparin sodium, and sodium citrate;

[0043] S2: Dissolve 2mg of polypeptide or hapten into 500ul of coupling buffer and add 200ul of carrier protein; in step S2, combine APC-Cy7 or PE-Cy7, dissolve 10mg of EDC into 1ml of ultrapure water and immediat...

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PUM

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Abstract

The invention discloses a development method of an IVD streaming product. The requirements of a test sample comprise a sample treatment method and the type of an anticoagulant, and the sample treatment method comprises conditions and methods of sample hemolysis treatment, preservation and transfer; the anticoagulant comprises EDTA, heparin sodium and sodium citrate; if the carrier protein using the thermoelectricity is dissolved with sterile water, the stability before dyeing and after dyeing is tested, a flow cytometer with higher occupancy on the market is tested by linking a testing mechanism, an IVD streaming product can be developed after testing, a marker dialyzed overnight is taken, and free fluorescein is separated through a sephadexG-25 or G-50 column; then the collected and marked fluorescent antibody is identified; therefore, whether the antibody is marked or not can be identified, the accuracy of subsequent IVD streaming product development is improved, and the product quality is improved.

Description

technical field [0001] The invention belongs to the technical field of IVD product development, in particular to a development method of IVD flow type products. Background technique [0002] As an independent branch of medical devices, VD has its own unique definition and regulatory system, especially the US Food and Drug Administration FDA and the European Union EC. IVD mainly includes instruments, reagents or systems for in vitro diagnostics. But the situation in China is different. IVD has not been independently distinguished and defined, that is, there is no concept of IVD. However, the products included in the usual IVD concept in the world are broken up and belong to medical devices, in vitro diagnostic reagents and pharmaceuticals. [0003] However, the common development method lacks an identification process during operation, which makes the precision of the developed product not high enough. Contents of the invention [0004] The object of the present inventio...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/533
CPCG01N33/533
Inventor 宋路红
Owner 杭州联科生物技术股份有限公司