KUALA LUMPUR, Dec 5 -- Nanomix has received CE Mark for its S1 Assay for the rapid, simultaneous detection and quantification of lactate (LAC), procalcitonin (PCT) and C-reactive protein (CRP) from human plasma specimens.
LAC is commonly used in the initial evaluation of sepsis, but its results are neither specific nor sensitive enough to be used alone. The S1 Assay adds PCT and CRP, tests that indicate a patient’s inflammation and bacterial infection.
Nanomix, a leader in the development of mobile, affordable, point-of-care diagnostics for use in settings where time to diagnosis is critical, developed the S1 Assay to aid in the rapid detection of serious infections including sepsis and bacteremia.
The Nanomix S1 Assay is intended to provide critical diagnostic information rapidly to physicians, allowing them to accelerate and improve the clinical decision-making process, according to a statement.
Simple, accurate and cost-effective, the S1 Assay combines three tests in a unique point-of-care format that delivers results in the initial patient evaluation. It is designed for use with the Nanomix eLab analyser.
The Nanomix eLab analyser is an easy-to-use, mobile test system that provides laboratory-quality diagnostic results in minutes. It utilises a touchscreen graphical interface, includes a built-in barcode scanner, features both Bluetooth and USB connectivity.
Nanomix anticipates that the S1 Assay panel and eLab instrument will be available in CE-regulated markets next year through distribution. The company also plans to submit the product to the US Food and Drug Administration in 2020.
-- BERNAMA
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