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Universal quality control product preservation solution for in-vitro diagnostic kit

An in vitro diagnosis and kit technology, applied in the preservation of microorganisms and other directions, can solve the problems of complex preparation process and large limitations, and achieve the effect of simple preparation, taking into account safety and good compatibility.

Pending Publication Date: 2021-03-16
英科新创(苏州)生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, this technical solution is specially aimed at the preservation solution of nucleic acid of human respiratory pathogens, which has relatively large limitations.
CN107447007A discloses a DNA tissue sample preservation solution and its application. Its formula is ammonium oxalate saturated solution, disodium edetate 0.05-2mM, trihydroxyaminomethane 10-50mM, polyethylene glycol octyl phenyl ether 0.2-0.5% (v / v), sodium chloride 0.5-1.5% (w / w), pH 7.2-8.1, this technical solution protects tissue samples, and the preparation process is relatively complicated
This technical solution can only be used for buccal swab samples

Method used

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  • Universal quality control product preservation solution for in-vitro diagnostic kit
  • Universal quality control product preservation solution for in-vitro diagnostic kit
  • Universal quality control product preservation solution for in-vitro diagnostic kit

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] According to the formula in Table 1 below, use the conventional dissolution method to prepare the quality control product preservation solution:

[0024] Table 1

[0025]

[0026]

[0027] The quality control product that this embodiment is used for checking preservation effect is mycoplasma (MH) quality control product, escherichia coli (E.coli) quality control product, HBV pseudovirus quality control product (DNA class pseudovirus), COVID-19 pseudovirus Quality control (RNA-like pseudovirus). Among them, Mycoplasma hominis and Escherichia coli are natural inactivated bacteria, HBV pseudovirus and COVID-19 pseudovirus are artificially synthesized, and they all contain corresponding target gene fragments.

[0028] Preparation of MH quality control product: MH mycoplasma is purchased from outside, and diluted with the quality control product preservation solution to the corresponding concentration to obtain the MH quality control product.

[0029] Preparation of ...

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Abstract

The invention discloses a universal quality control product preservation solution for in vitro diagnostic kit, which has a pH value of 7-8 and is composed of PBS, BSA, trehalose and EDTA. The preservation solution provided by the invention is simple in preparation and low in cost, and the stability of quality control products of mycoplasma, bacteria, DNA pseudoviruses and RNA pseudoviruses can beeffectively maintained for a long time. The preservation solution provided by the invention is good in compatibility, does not need to be removed by centrifugation, can be directly used as a subsequent one-step nucleic acid release agent, can also be extracted through a paramagnetic particle method, and is a universal preservation solution.

Description

technical field [0001] The invention belongs to the technical field of in vitro diagnostic kit reagents, and in particular relates to a universal quality control product preservation solution for in vitro diagnostic kits. Background technique [0002] In in vitro diagnostic kits, quality control products (including calibrators and reference products) are essential components, and most of them are composed of corresponding inactivated cultures or pseudoviruses. The stability of quality control products affects the reliability of experimental data. crucial. [0003] Most of the existing preservation solutions are aimed at a specific type of samples, such as respiratory sample preservation solutions, feces preservation solutions, blood preservation solutions, tissue preservation solutions, etc. There is no preservation solution formula specifically for the quality control products in the kit. And most of them have complex formulas, and some components are even potentially carc...

Claims

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Application Information

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IPC IPC(8): C12N1/04
CPCC12N1/04
Inventor 梅亚军樊俊陈红干马娇龙李兴翠王志宇
Owner 英科新创(苏州)生物科技有限公司
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