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First Rapid-Result Hematology Analyzer Reports Measures of Infection and Severity at POC

By LabMedica International staff writers
Posted on 23 Nov 2023
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Image: The QScout hematology analyzer has received US FDA 510(k) clearance (Photo courtesy of Ad Astra Diagnostics)
Image: The QScout hematology analyzer has received US FDA 510(k) clearance (Photo courtesy of Ad Astra Diagnostics)

Sepsis, a critical medical condition that arises as an extreme response to infection, poses a significant health threat. It occurs when an infection triggers a widespread inflammatory response in the body. Identifying sepsis early is crucial, and one key indicator is the elevated presence of immature granulocytes (IGs), which have been shown to signal sepsis earlier than other common measures such as lactate and procalcitonin levels. Additionally, the neutrophil-to-lymphocyte ratio (NLR) has emerged as a vital predictor of adverse health outcomes, especially noted during the recent pandemic. Now, a rapid-result hematology system capable of delivering these vital diagnostic measures almost instantaneously has the potential to revolutionize patient care.

Ad Astra Diagnostics (Morrisville, NC, USA) has introduced the QScout rapid-result hematology system, a groundbreaking platform that provides quick, point-of-care white blood cell counts (WBCs), NLR, and accurately differentiates between five types of mature WBCs and IGs. QScout stands out as the first hematology platform designed for easy, rapid use at the point of care. It delivers lab-quality results right beside the patient, aiding in screening for various health conditions including infections, leukemia, other blood cancers, allergies, and more.

The QScout RLD test is notably the first to provide point-of-care reporting of infection-fighting IGs and NLR. To administer the test, whole blood is applied to the QScout RLD test, which contains a specialized dried reagent for staining cells. When placed into the QScout Lab analyzer, an advanced optical system captures images, and a sophisticated algorithm identifies cells in real-time. The process delivers results within approximately two minutes. Remarkably, QScout requires no extensive startup time or sample preparation, no liquid reagents for change or disposal, and no pumps. The system can be activated and ready to deliver initial results in around three minutes and is designed for simple operation with minimal training. Ad Astra has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its innovative QScout rapid-result hematology system.

"QScout uses a cutting-edge 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," said Jasper Pollard, Chief Technology Officer, Ad Astra Diagnostics. "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."

"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," said Joy Parr Drach, AAD's President & CEO. "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."

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