A multi-link quality control product for novel coronavirus nucleic acid detection laboratory quality control and a preparation method thereof

CN120555374A8Pending Publication Date: 2025-11-04JINHUA KANGCHUANG WUJIANG BIOTECHNOLOGY CO LTD +1
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Patent Information

Application Number
CN202510701152.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-05-28
Publication Date
2025-11-04

AI Technical Summary

Technical Problem

Existing quality control products cannot achieve comprehensive quality control of the entire process of nucleic acid testing for the new coronavirus, especially the synchronous monitoring of nucleic acid extraction, reverse transcription and amplification. In addition, DNA residues in the fake virus result in false positive results during the preparation process, affecting the accuracy of detection.

Method used

A complex quality control product consisting of three substances: pseudovirus, RNA and DNA is used to prepare fake virus particles through gene recombination technology, simulate the real virus particles to monitor the nucleic acid extraction process, naked RNA molecules monitor the reverse transcription process, and plasmid DNA monitor the amplification process to form multi-component collaborative design to achieve synchronous monitoring of the entire process.

Benefits of technology

It realizes accurate stratified monitoring of the entire process of nucleic acid extraction, reverse transcription and amplification, avoids DNA residual interference, improves detection accuracy and efficiency, and is suitable for large-scale quality control needs.

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Abstract

The present application relates to the technical field of genetic engineering, and specifically provides a multi-link quality control product for novel coronavirus nucleic acid detection laboratory quality control and a preparation method thereof. The multi-link quality control product is a multi-component composite system, which is formed by mixing three substances of a pseudo virus, a target gene RNA molecule and an internal standard plasmid DNA. The pseudo virus is a pseudo virus particle of a vesicular stomatitis virus vector wrapping a novel coronavirus ORF1ab gene RNA, which is used for monitoring virus nucleic acid extraction; the target gene RNA molecule is a novel coronavirus N gene RNA molecule, which can monitor reverse transcriptase activity; and the internal standard plasmid is a plasmid DNA of a human source housekeeping gene RPP30, which monitors whether there is inhibition or failure in the amplification link. The present application realizes synchronous layered monitoring of the whole process of nucleic acid extraction, reverse transcription and amplification, solves the monitoring blind area of traditional single-component quality control products, and significantly improves the accuracy and efficiency of laboratory detection quality control.
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