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用于基因组分析的口腔和鼻腔微针拭子的安全性测试及临床研究。

Safety tests and clinical research on buccal and nasal microneedle swabs for genomic analysis.

作者信息

Kim JeongHyeon, Moon Jae-Woo, Kim Gyeong Ryeong, Kim Wonsub, Hu Hae-Jin, Jo Won-Jun, Baek Seung-Ki, Sung Gil-Hwan, Park Jung Ho, Park Jung-Hwan

机构信息

Department of Bionano Technology and Gachon BioNano Research Institute, Gachon University, Seongnam, Republic of Korea.

Endomics Inc, Seongnam, Republic of Korea.

出版信息

Front Bioeng Biotechnol. 2023 Dec 5;11:1296832. doi: 10.3389/fbioe.2023.1296832. eCollection 2023.

DOI:10.3389/fbioe.2023.1296832
PMID:38116201
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10729317/
Abstract

Conventional swabs have been used as a non-invasive method to obtain samples for DNA analysis from the buccal and the nasal mucosa. However, swabs may not always collect pure enough genetic material. In this study, buccal and nasal microneedle swab is developed to improve the accuracy and reliability of genomic analysis. A cytotoxicity test, a skin sensitivity test, and a skin irritation test are conducted with microneedle swabs. Polymer microneedle swabs meet the safety requirements for clinical research and commercial use. When buccal and nasal microneedle swabs are used, the amount of genetic material obtained is greater than that from commercially available swabs, and DNA purity is also high. The comparatively short microneedle swab (250 μm long) cause almost no pain to all 25 participants. All participants also report that the microneedle swabs are very easy to use. When genotypes are compared at five SNP loci from blood of a participant and from that person's buccal or nasal microneedle swab, the buccal and nasal microneedle swabs show 100% concordance for all five SNP genotypes. Microneedle swabs can be effectively used for genomic analysis and prevention through genomic analysis, so the utilization of microneedle swabs is expected to be high.

摘要

传统拭子已被用作一种非侵入性方法，用于从口腔和鼻腔黏膜获取样本以进行DNA分析。然而，拭子可能并不总能收集到足够纯净的遗传物质。在本研究中，开发了口腔和鼻腔微针拭子以提高基因组分析的准确性和可靠性。对微针拭子进行了细胞毒性试验、皮肤敏感性试验和皮肤刺激性试验。聚合物微针拭子符合临床研究和商业用途的安全要求。使用口腔和鼻腔微针拭子时，获得的遗传物质数量比市售拭子更多，且DNA纯度也很高。相对较短的微针拭子（长250μm）对所有25名参与者几乎没有造成疼痛。所有参与者还报告说微针拭子非常易于使用。当在一名参与者的血液以及该人的口腔或鼻腔微针拭子的五个单核苷酸多态性（SNP）位点比较基因型时，口腔和鼻腔微针拭子在所有五个SNP基因型上的一致性均为100%。微针拭子可有效地用于基因组分析以及通过基因组分析进行预防，因此微针拭子的利用率有望很高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/f89e2d2c39cf/fbioe-11-1296832-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/09991625b9ca/fbioe-11-1296832-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/905978a44369/fbioe-11-1296832-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/93e221f0ba44/fbioe-11-1296832-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/70fd921b5c0c/fbioe-11-1296832-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/f89e2d2c39cf/fbioe-11-1296832-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/09991625b9ca/fbioe-11-1296832-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/905978a44369/fbioe-11-1296832-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/93e221f0ba44/fbioe-11-1296832-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/70fd921b5c0c/fbioe-11-1296832-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/50fc/10729317/f89e2d2c39cf/fbioe-11-1296832-g005.jpg

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