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基于悬浮阵列和逻辑计算器的高通量、超高灵敏非法药品杂质识别方法。

A high-throughput and ultrasensitive identification methodology for unauthorized GMP component based on suspension array and logical calculator.

机构信息

Chinese Academy of Inspection and Quarantine, Beijing, 100029, China.

Guangdong Entry-Exit Inspection and Quarantine Bureau, Guangdong, 510000, China.

出版信息

Sci Rep. 2019 May 13;9(1):7311. doi: 10.1038/s41598-019-43863-7.

DOI:10.1038/s41598-019-43863-7
PMID:31086245
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6513989/
Abstract

To solve the problem of the unauthorized GMP components within import and export goods, the LI-US (Logic Identification of unauthorized GMP content by Universal-primer Suspension-array) system, which takes advantage of suspension array and logic calculator, was developed in the present study. Seventeen signal input channels have been optimized and validated in our research to ensure the multiplex practicality of the LI-US system. Three LI-US logic gates, including a YES gate, an OR gate and an AND gate, were designed as different detection strategies for GMP identification. The feasibility and specificity of the LI-US system were validated in the present study. Combining the optimization and evaluation of the signal input procedure, the sensitivity of this LI-US system reached 0.05% of the GMP mass concentration. The practicability evaluation of LI-US demonstrated its application within different substrates and varieties. In conclusion, the LI-US system was developed with extremely high specificity, sensitivity and practicability among different substrates and varieties, which could meet the demands of unauthorized GMP contents for both import and export goods.

摘要

为了解决进出口货物中未经授权的 GMP 成分问题,本研究利用悬浮阵列和逻辑计算器开发了 LI-US(通过通用引物悬浮阵列进行非法 GMP 内容的逻辑识别)系统。在本研究中,已经对 17 个信号输入通道进行了优化和验证,以确保 LI-US 系统的多路复用实用性。设计了三个 LI-US 逻辑门,包括 YES 门、OR 门和 AND 门,作为 GMP 识别的不同检测策略。本研究验证了 LI-US 系统的可行性和特异性。通过对信号输入过程的优化和评估,该 LI-US 系统的灵敏度达到了 GMP 质量浓度的 0.05%。LI-US 的实用性评估表明,它可以在不同的基质和品种中得到应用。总之,LI-US 系统在不同的基质和品种中具有极高的特异性、灵敏度和实用性,可以满足进出口货物中对未经授权的 GMP 内容的需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/f378252724f4/41598_2019_43863_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/d2e2ec641126/41598_2019_43863_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/9c71717b128c/41598_2019_43863_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/dcb9200ceae5/41598_2019_43863_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/f378252724f4/41598_2019_43863_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/d2e2ec641126/41598_2019_43863_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/9c71717b128c/41598_2019_43863_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/dcb9200ceae5/41598_2019_43863_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2f41/6513989/f378252724f4/41598_2019_43863_Fig4_HTML.jpg

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