Next Gen CBC and Sepsis Diagnostic System Targets Faster, Earlier, Easier Results

Every hour is critical in protecting patients from infections, yet there are currently limited tools to assist in early diagnosis before patients reach a hospital. The complete blood count (CBC) is a common blood test that screens for various conditions, including anemia, infection, leukemia, and bleeding. It measures the levels of red and white blood cells as well as platelets. Now, an enhanced diagnostic system aims to provide lab-quality results at lab-grade costs at the patient’s side for this frequently ordered test, which serves as the first line of triage. This system intends to be the most comprehensive patient-side CBC and the first to report immature granulocytes and the neutrophil-to-lymphocyte ratio in community settings, such as physician offices, cancer centers, and ambulances, facilitating earlier identification and triage of severe infections.

Ad Astra Diagnostics (AAD, Morrisville, NC, USA) is developing the user-friendly QScout CBC to deliver quicker CBC test results and enable the earlier detection of severe infections, including sepsis. The QScout CBC measures immature granulocytes, which are early markers of sepsis. AAD's QScout CBC system is being created as the next generation of the company’s QScout RLD, which received 510(k) clearance from the U.S. Food and Drug Administration (FDA) following successful field trials that compared it to central lab tests.

Image: QScout CBC will give a complete blood count in 2 minutes from fingerstick or venous blood (Photo courtesy of Ad Astra Diagnostics)

The QScout CBC system will incorporate various enhancements, such as a smaller physical footprint and broader diagnostic capabilities, including faster and more straightforward CBC testing. This innovative system is essentially a "lab in a box," as it contains a computer, microscope, camera, and robotics. To conduct a test, the user simply places a blood sample obtained from a finger stick or venous draw onto a low-cost test cartridge and inserts it into the QScout Lab. There is no need for sample preparation. The system then utilizes artificial intelligence-trained algorithms to identify cells and cellular parameters, providing a test result in approximately two minutes.

"Coupling a full CBC with a sepsis risk score on a small, simple and rugged platform expands the market and increases access to on-site critical testing and early identification of severe illness and sepsis to help prevent unnecessary deaths from infection," said Joy Parr Drach, CEO of AAD.

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