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验证 Applied Biosystems RapidHIT ID 仪器和 ACE GlobalFiler Express 样品盒。

Validation of the Applied Biosystems RapidHIT ID instrument and ACE GlobalFiler Express sample cartridge.

机构信息

Center for Human Identification, University of North Texas Health Science Center, Fort Worth, TX, USA.

Department of Microbiology, Immunology, and Genetics, University of North Texas Health Science Center, Fort Worth, TX, USA.

出版信息

Int J Legal Med. 2022 Jan;136(1):13-41. doi: 10.1007/s00414-021-02722-9. Epub 2021 Oct 13.

Abstract

Rapid DNA platforms are fully automated systems capable of processing DNA from biological samples and interpreting the results in approximately 90 minutes with minimal human intervention. With a greater reliance on the system than on the analyst, validation data are especially needed to define the performance and limitations of commercially available Rapid DNA systems. Thus, validation studies of a Rapid DNA workflow consisting of the Applied Biosystems RapidHIT ID Instrument and RapidLINK software with a focus on the ACE GlobalFiler Express Sample Cartridge and reference buccal swabs were performed in accordance with Scientific Working Group on DNA Analysis Methods Validation Guidelines. These validation studies included assessments of sensitivity, contamination, concordance, reproducibility and repeatability, stability, inhibition, mixtures, sample reprocessing, precision, and first-pass success rate. Overall, the current Applied Biosystems RapidHIT ID Instrument with the ACE GlobalFiler Express sample cartridge was found to be a reliable tool for generation of STR profiles from reference-type buccal swabs.

摘要

快速 DNA 平台是一种全自动系统,能够处理生物样本中的 DNA,并在大约 90 分钟内完成分析,几乎无需人工干预。由于对系统的依赖程度大于对分析人员的依赖程度,因此特别需要验证数据来定义市售快速 DNA 系统的性能和局限性。因此,按照 DNA 分析方法验证准则科学工作组的要求,对包含 Applied Biosystems RapidHIT ID 仪器和 RapidLINK 软件的 Rapid DNA 工作流程进行了验证研究,重点是 ACE GlobalFiler Express 样品试剂盒和参考口腔拭子。这些验证研究包括灵敏度、污染、一致性、重现性和可重复性、稳定性、抑制、混合物、样品重新处理、精密度和首次通过率的评估。总的来说,当前的 Applied Biosystems RapidHIT ID 仪器与 ACE GlobalFiler Express 样品试剂盒结合使用,是一种从参考型口腔拭子生成 STR 图谱的可靠工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3337/8511620/bb984d91d1a8/414_2021_2722_Fig1_HTML.jpg

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