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Abstract：
BACKGROUND: Accurate, high-confidence data is critical for assessing potential biothreat incidents. In a biothreat event, false-negative and -positive results have serious consequences. Worst case scenarios can result in unnecessary shutdowns or fatalities at an exorbitant monetary and psychological cost, respectively. Quantitative PCR assays for agents of interest have been successfully used for routine biosurveillance. Recently, there has been increased impetus for adoption of amplicon sequencing (AS) for biosurveillance because it enables discrimination of true positives from near-neighbor false positives, as well as broad, simultaneous detection of many targets in many pathogens in a high-throughput scheme. However, the high sensitivity of AS can lead to false positives. Appropriate controls and workflow reporting can help address these challenges.
OBJECTIVE: Data reporting standards are critical to data trustworthiness. The standards presented herein aim to provide a framework for method quality assessment in biodetection.
METHODS: We present a set of standards, Amplicon Sequencing Minimal Information (ASqMI), developed under the auspices of the AOAC INTERNATIONAL Stakeholder Program on Agent Detection Assays for making actionable calls in biosurveillance applications. In addition to the first minimum information guidelines for AS, we provide a controls checklist and scoring scheme to assure AS run quality and assess potential sample contamination.
RESULTS: Adoption of the ASqMI guidelines will improve data quality, help track workflow performance, and ultimately provide decision makers confidence to trust the results of this new and powerful technology.
CONCLUSIONS: AS workflows can provide robust, confident calls for biodetection; however, due diligence in reporting and controls are needed. The ASqMI guideline is the first AS minimum reporting guidance document that also provides the means for end users to evaluate their workflows to improve confidence.
CONCLUSIONS: Standardized reporting guidance for actionable calls is critical to ensuring trustworthy data.
OBJECTIVE: Data reporting standards are critical to data trustworthiness. The standards presented herein aim to provide a framework for method quality assessment in biodetection.
METHODS: We present a set of standards, Amplicon Sequencing Minimal Information (ASqMI), developed under the auspices of the AOAC INTERNATIONAL Stakeholder Program on Agent Detection Assays for making actionable calls in biosurveillance applications. In addition to the first minimum information guidelines for AS, we provide a controls checklist and scoring scheme to assure AS run quality and assess potential sample contamination.
RESULTS: Adoption of the ASqMI guidelines will improve data quality, help track workflow performance, and ultimately provide decision makers confidence to trust the results of this new and powerful technology.
CONCLUSIONS: AS workflows can provide robust, confident calls for biodetection; however, due diligence in reporting and controls are needed. The ASqMI guideline is the first AS minimum reporting guidance document that also provides the means for end users to evaluate their workflows to improve confidence.
CONCLUSIONS: Standardized reporting guidance for actionable calls is critical to ensuring trustworthy data.
摘要：
背景：准确，高置信度数据对于评估潜在的生物威胁事件至关重要.在生物威胁事件中，假阴性和假阳性结果有严重后果。最坏的情况可能导致不必要的停工或死亡，代价是高昂的金钱和心理成本，分别。目的试剂的定量聚合酶链反应测定已成功用于常规生物监测。最近,采用扩增子测序（AS）进行生物监测的动力增加，因为它能够区分真阳性和近邻假阳性，以及广泛的，在高通量方案中同时检测许多病原体中的许多靶标。然而,AS的高灵敏度可导致假阳性。适当的控制和工作流报告可以帮助解决这些挑战。
目标：数据报告标准对于数据可信度至关重要。本文提出的标准旨在为生物检测中的方法质量评估提供框架。
方法：我们提出了一套标准，扩增子测序最小信息(AsqMI)，在AOAC国际利益相关者代理检测分析计划的主持下开发，用于在生物监督应用中进行可操作的调用。除了AS的第一个最低信息指南之外，我们提供对照检查表和评分方案,以确保AS运行质量并评估潜在的样品污染.
结果：采用AsqMI指南将提高数据质量，帮助跟踪工作流性能，并最终为决策者提供信心，让他们相信这项新的强大技术的结果。
结论：AS工作流程可以提供稳健的，自信地呼吁生物检测；然而，在报告和控制方面需要尽职调查。AsqMI指南是第一个AS最低报告指导文件，它还为最终用户提供了评估其工作流程以提高信心的方法。
结论：可操作呼叫的标准化报告指南对于确保可信数据至关重要。
目标：数据报告标准对于数据可信度至关重要。本文提出的标准旨在为生物检测中的方法质量评估提供框架。
方法：我们提出了一套标准，扩增子测序最小信息(AsqMI)，在AOAC国际利益相关者代理检测分析计划的主持下开发，用于在生物监督应用中进行可操作的调用。除了AS的第一个最低信息指南之外，我们提供对照检查表和评分方案,以确保AS运行质量并评估潜在的样品污染.
结果：采用AsqMI指南将提高数据质量，帮助跟踪工作流性能，并最终为决策者提供信心，让他们相信这项新的强大技术的结果。
结论：AS工作流程可以提供稳健的，自信地呼吁生物检测；然而，在报告和控制方面需要尽职调查。AsqMI指南是第一个AS最低报告指导文件，它还为最终用户提供了评估其工作流程以提高信心的方法。
结论：可操作呼叫的标准化报告指南对于确保可信数据至关重要。
