First-Ever Rapid-Result Hematology Analyzer Measures Disease and Infection at POC

Sepsis is a severe medical emergency that occurs when the body reacts strongly to an infection. This life-threatening condition is triggered by a chain reaction throughout the body, often starting from infections in the lung, urinary tract, skin, or gastrointestinal tract. Nearly any infection can lead to sepsis, which occurs when a localized infection progresses to severe infection throughout the body. According to a 2020 study, sepsis caused almost 11 million deaths worldwide in 2017, accounting for nearly 20% of all deaths in that year. Now, a new rapid-result hematology system comes with the capability to count immature infection-fighting granulocytes, one of the earliest markers for sepsis.

The QScout RLD rapid-result hematology system from Ad Astra Diagnostics, Inc. (AAD, Morrisville, NC, USA) is designed to measure white blood cell count, neutrophil-to-lymphocyte ratio, and counts of six white blood cell types in fingerstick or venous blood. QScout is the first hematology platform designed to quickly and accurately measure disease and infection, including a ratio of two white blood cell types (neutrophil-to-lymphocyte ratio) and count of immature granulocytes, at the point of care.

The QScout system uses a Rapid Leukocyte Differential (RLD) test that contains a dried reagent to stain cells. Whole blood is added to the test and inserted into the QScout Lab analyzer. The analyzer's optical system captures images of the cells, while an algorithm quickly identifies them, and results are displayed within two minutes. Ad Astra has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the QScout RLD. The company aims to expedite the regulatory review process to obtain clearance for the system's use at the point of care, where faster results can improve health outcomes, and in the lab, where it can enhance efficiency.

“QScout RLD was designed as a quick, quantitative 'scout' for infection that is simple enough to operate yet robust enough to deliver reliable data patient-side,” said AAD's chief scientific officer and co-founder, Rudy Rodriguez. “In doing so, QScout RLD offers the potential to democratize access to quality diagnostics, while providing healthcare professionals with a potentially life-saving tool.”

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