Ad Astra Diagnostics (AAD) U.S. Food and Drug Administration (FDA) 510(k) clearance for its QScout rapid-result hematology system, a product that provides fast, point-of-care white blood cell counts (WBCs), neutrophil-to-lymphocyte ratio, and differentiates the number/percentage of five types of mature WBCs and immature granulocytes.

Ad Astra Diagnostics（AAD）美国食品和药物管理局（FDA）510（k）批准其QScout快速结果血液学系统，该产品可提供快速的即时白细胞计数（WBC），中性粒细胞与淋巴细胞比率，并区分五种成熟白细胞和未成熟粒细胞的数量/百分比。

QScout is touted as the first hematology platform designed for simple, fast operation at the point-of-care. It provides lab-grade, patient-side results that caregivers use to screen for various health conditions including infection, leukemia, and other blood-related cancers, allergies, and sepsis (the latter is a life-threatening medical emergency triggered by an infection).

QScout被誉为第一个血液学平台，旨在在护理点进行简单，快速的操作。它提供了实验室级的患者侧结果，护理人员可用于筛查各种健康状况，包括感染，白血病和其他与血液有关的癌症，过敏和败血症（后者是由感染引发的危及生命的医疗紧急情况）。

Elevated levels of IGs have been shown to differentiate sepsis earlier than commonly used measures like lactate and procalcitonin.1 Additionally, NLR is an increasingly important predictor of poor health outcomes that gained greater use during the pandemic. Development of the patent-protected QScout technology platform began in the livestock care setting.

与乳酸和降钙素原等常用指标相比，IGs水平升高可以更早地区分败血症。此外，NLR是在大流行期间获得更多使用的不良健康结果的越来越重要的预测指标。受专利保护的QScout技术平台的开发始于牲畜护理环境。

“By quickly providing vital metrics such as a WBC count with differential, IGs, and NLR, QScout has the potential to deliver life-saving information to millions of people working in even the most urgent emergency and intensive care settings where every minute matters,” said Ted Glynn, M.D., vice president, Medical Education and Research, at Sparrow Health System.

Sparrow Health System医学博士、医学教育与研究副总裁特德·格林恩（TedGlynn）说：“通过快速提供白细胞计数、差异、IGs和NLR等重要指标，QScout有可能为数百万在最紧急的紧急情况和重症监护环境中工作的人提供挽救生命的信息，即使这些环境每分钟都很重要。”

“Sepsis is the leading global killer, which is why I am excited to see this important regulatory achievement from our partners and colleagues at AAD. Delivering these critically informative diagnostic measures in close to real-time offers the potential to transform patient care.”

“脓毒症是全球头号杀手，因此我很高兴看到我们在AAD的合作伙伴和同事取得了这一重要的监管成就。以接近实时的方式提供这些批判性的信息诊断措施，有可能改变患者护理。”

“Achieving 510(k) clearance for the QScout platform is a momentous step for our AAD team, and we believe it will be the first of many positive interactions with the FDA,” Ad Astra President/CEO Joy Parr Drach said. “In developing QScout, we aim to enable and democratize rapid, point-of-care decision-making, and we are confident that its simple, easy-to-use, rugged, no maintenance design has the potential to be an invaluable tool in a variety of healthcare settings.”

Ad Astra总裁/首席执行官Joy Parr Drach说：“QScout平台获得510（k）许可对于我们的AAD团队来说是一个重要的步骤，我们相信这将是与FDA进行许多积极互动的第一步。”。“在开发QScout时，我们的目标是实现快速、即时的决策并使其民主化，我们相信其简单、易于使用、坚固耐用、无需维护的设计有可能成为各种医疗保健环境中的宝贵工具。”

To run the test, whole blood is added to a QScout RLD test, which contains a dried reagent that stains cells. When the test is inserted in the QScout Lab analyzer, an optical system takes images, and an algorithm identifies the cells in real time. Results are displayed in about two minutes.

为了进行测试，将全血添加到QScout RLD测试中，该测试包含染色细胞的干燥试剂。当测试插入QScout实验室分析仪时，光学系统会拍摄图像，并通过算法实时识别细胞。结果将在大约两分钟内显示。

“QScout uses an imaging-based system not prone to the challenges of flow cytometry, which means that cells are examined directly by an AI-trained system instead of indirect measures like light scatter or electrical resistance,” Ad Astra Chief Technology Officer Jasper Pollard stated. “With this 510(k) clearance, we move closer to bringing our innovative diagnostic platform to various point-of-care settings, where faster results can improve health outcomes, and to labs, where it can improve efficiency and operations.”

Ad Astra首席技术官贾斯珀·波拉德（JasperPollard）表示：“QScout使用基于成像的系统，不容易受到流式细胞仪的挑战，这意味着细胞直接由人工智能训练的系统进行检查，而不是像光散射或电阻这样的间接测量。”。“有了510（k）的许可，我们更接近于将我们的创新诊断平台带到各种护理点环境中，在那里更快的结果可以改善健康结果，并带到实验室，在那里它可以提高效率和操作。”

Testing to demonstrate equivalence of QScout RLD to a central lab hematology analyzer was performed at a central lab and at multiple point-of-care locations, which included a cancer treatment center, community health center, emergency department, bedside with in-patients in the ICU, hematology-oncology wards, and a phlebotomy draw center.

在中心实验室和多个护理点地点进行了测试，以证明QScout RLD与中心实验室血液分析仪的等效性，这些地点包括癌症治疗中心，社区卫生中心，急诊室，ICU住院患者的床边，血液肿瘤病房和静脉切开抽液中心。

This project has been funded in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, as part of BARDA’s Host Based Diagnostics Program.

该项目的部分资金来自美国卫生与公众服务部的联邦资金；战略准备和应对管理局；生物医学高级研究与发展局，作为BARDA基于主机的诊断计划的一部分。

Morrisville, N.C.-based Ad Astra Diagnostics Inc. provides rapid point-of-care diagnostics to enable fast health decisions. The company’s QScout system was designed to improve health, well-being and lab efficiency.

位于北卡罗来纳州莫里斯维尔的Ad Astra Diagnostics Inc.提供快速即时诊断，以实现快速的健康决策。该公司的QScout系统旨在改善健康、福祉和实验室效率。