Advanced Instruments has received clearance from the US Food and Drug Administration (FDA) to market its GloCyte Automated Cell Counter System and GloCyte Low and High Level Controls. The GloCyte is now available for the UK market from Vitech Scientific.
The patented GloCyte system is intended to provide a quantitative determination of red blood cells (RBCs) and total nucleated cells (TNCs) in cerebrospinal fluid (CSF) collected from adult and paediatric patients. Currently, low cell counts often present a challenge to standard methods. The system provides superior accuracy of low cell counts in CSF samples.
“To date, there has not been a way to provide dependable, low cell counts,” said John Coughlin (president and CEO, Advanced Instruments). “We use a novel combination of fluorescence, microscopy with digital image analysis principles, highly specific reagents, and an intelligent counting algorithm to provide accurate and precise cell counts. We are very excited as this marks a major achievement in giving laboratories a new way to obtain reliable and timely CSF results.”
Additional benefits of the GloCyte system are that the test requires only 30 µL of sample per test, it uses disposable test cartridges ensuring no sample carryover and easy disposal, and it includes inbuilt quality control of Levey-Jennings charts and an audit table.
