Automated cell counts on CSF samples: A multicenter performance evaluation of the GloCyte system

Area of Science:

• Clinical Chemistry
• Hematology
• Medical Diagnostics

Background:

• Manual cell counting in cerebrospinal fluid (CSF) is labor-intensive due to the unreliability of automated methods at low cell counts.
• Laboratories often maintain manual CSF counts despite automated methods for other body fluids.

Purpose of the Study:

• To evaluate the GloCyte System, an automated cell counter, for accuracy and precision in enumerating low cell counts in CSF.
• To determine if the GloCyte System can replace manual CSF cell counts.

Main Methods:

• A multicenter clinical trial using residual CSF samples from adult and pediatric patients.
• Comparison of cell counts obtained via the manual hemocytometer method and the GloCyte System.
• Determination of the GloCyte System's limits of detection, quantitation, precision, and accuracy.

Main Results:

• The GloCyte System detected as low as 1 cell/μL and reliably counted 3 total nucleated cells/μL and 2 red blood cells/μL.
• High correlation (>97%) was observed between GloCyte and hemocytometer counts, even at very low cell concentrations.
• The total coefficient of variation for the GloCyte System was under 20%.

Conclusions:

• The GloCyte instrument provides precise, accurate, and stable cell counts for CSF samples.
• Automated enumeration of very low cell numbers in CSF is feasible with the GloCyte System.
• The GloCyte System is a viable alternative to manual methods for all CSF cell counting needs.