Automated Cerebrospinal Fluid Cell Counter Granted USA Diagnostics Marketing Approval

The [U.S.] Food and Drug Administration has granted diagnostic use marketing approval (510(k) clearance) for an automated cell counting system that accurately quantifies the low number of cells found in cerebrospinal fluid (CSF).

The Advanced Instruments, Inc., (Norwood, MA, USA) patented GloCyte Automated Cell Counter System delivers highly accurate and precise total nucleated cell (TNC) and red blood cell (RBC) results using a novel combination of fluorescence technology, highly specific reagents, and an intelligent counting algorithm. It provides accurate cell counts at clinically relevant low levels and reduces valuable time spent counting those more difficult specimens.

Analyses preformed with the GloCyteSystem require only 30 microliters of sample per test. The instrument uses disposable test cartridges ensuring no sample carryover and easy disposal, and it includes built-in quality control.

The GloCyte instrument, which should be available in the USA from September 2016, is complemented by the 510(k) approved GloCyte Low and High Level Controls.

“To date, there has not been a way to provide dependable low cell counts,” said John Coughlin, president and CEO of 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.”

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