BACKGROUND We undertook a prospective clinical study to evaluate PCR.Ai's (www.pcr.ai) accuracy and impact when automating the manual data-analysis and quality control steps associated with routine clinical pathogen testing using real-time PCR (qPCR). OBJECTIVES We evaluated the impact of PCR.Ai when used as the final interpretation/verification step for routine in-house qPCR tests for respiratory pathogens and for norovirus for a total of 22,200 interpretations. STUDY DESIGN We compared PCR.Ai to our existing manual interpretation, to determine accuracy and hands-on time savings. PCR.Ai was accurate. RESULTS AND CONCLUSIONS There was 100% concurrence between validated respiratory virus and norovirus detection by our manual routine analysis method and PCR.Ai. Furthermore, there were significant routine savings with PCR.Ai of 45 min/respiratory run and 32 min/norovirus run. Our conclusion is that PCR.Ai is a highly accurate time-saving tool that reduces complexity of qPCR analysis and hence the need for specialists and hands-on time. It demonstrated capabilities to enable us to get results out more quickly with lower costs and less risk of errors.

中文翻译：

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使用PCR.Ai进行临床分子检测的自动化和标准化-一项比较性能研究。

背景技术我们进行了一项前瞻性临床研究，以评估PCR.Ai（www.pcr.ai）的准确性和影响，该自动化和与使用实时PCR（qPCR）进行常规临床病原体检测相关的手动数据分析和质量控制步骤是自动化的。目的我们评估了PCR.Ai作为呼吸道病原体和诺如病毒的常规内部qPCR测试的最终解释/验证步骤的最终解释/验证步骤，总共进行了22,200次解释。研究设计我们将PCR.Ai与我们现有的人工解释进行了比较，以确定准确性和节省的动手时间。PCR.Ai是准确的。结果与结论通过我们的常规手动分析方法和PCR.Ai，经过验证的呼吸道病毒与诺如病毒检测之间有100％的一致性。此外，PCR可以节省大量常规费用。Ai为45分钟/呼吸运行和32分钟/诺如病毒运行。我们的结论是，PCR.Ai是一种高度精确的省时工具，可降低qPCR分析的复杂性，从而减少对专家和动手时间的需求。它展示了使我们能够以更低的成本和更少的错误风险更快地得出结果的功能。