GloCyte is currently FDA cleared for CSF only. 

GloCyte provides a red blood cell (RBC) count and a total nucleated cell (TNC) count. It does not perform a differential cell count.

GloCyte received FDA clearance in 2016.

Yes, GloCyte is CE marked.

According to CLIA guidelines, GloCyte is classified as moderately complex.

Yes, GloCyte is part of the Automated Body Fluid Survey (ABF-1).

No, the system comes with a computer with display specification specific to the GloCyte software.

GloCyte has unlimited result storage. Each database holds ~1500 records. When a database is full, a new database can be created.

GloCyte results can be viewed and shared in multiple ways. After testing GloCyte, results are displayed on the screen and stored in the GloCyte software database. GloCyte offers printable reports and results can be exported in .csv format for viewing in Excel. GloCyte can also be connected to the LIS (a driver is needed).

Yes, currently an interface is available through Data Innovations (D.I.), Epic (via D.I.), McKesson (via D.I.), Vista (via D.I.), and Sunquest. The GloCyte LIS Interface Specification is available upon request.

Yes, you can print results by connecting to a local or network printer. To minimize the system’s footprint, GloCyte does not come with a printer.

GloCyte requires minimal maintenance. We recommend replacing the vacuum station O-ring every 6 months to ensure the integrity of the vacuum seal. In addition, we recommend calibrating the 30 and 10 µL pipettes at least once per year. For cleaning, as necessary wipe up any spills on the instrument sample drawer, the vacuum station, or the sample preparation tray with a soft, damp cloth and isopropyl alcohol or 1% bleach solution. For more information, please reference the GloCyte user guide.

No, GloCyte pipettes can be calibrated by any service that meets your laboratories ISO or regulatory requirements.

Yes, the 30 µL and 10 µL pipettes included with GloCyte contain custom stainless-steel insert designed for accurate and precise delivery of small sample volumes. Laboratories may use their own pipettes for dilutions as needed.

Yes, we cannot guarantee the stated performance specifications of the GloCyte with alternate tips.

Unopened, GloCyte reagents and controls must be stored at 2 to 8°C. GloCyte reagents are stable for 2 weeks once opened and can be stored at 2 to 25°C. GloCyte controls are stable for 30 days once opened and must be stored at 2 to 8°C when not in use. For more information, please reference the GloCyte reagent and control product inserts.

Yes, GloCyte is linear down to 0 cells/µL for both TNC and RBC. It is able to detect down to 1 cell/µL for both TNC and RBC.

Yes, GloCyte can report up to 615,644 red blood cells (RBC) per µL and 6,500 total nucleated cells (TNC) per µL. GloCyte provides dilution guidance for colored specimens.

GloCyte uses two separate reagents to stain red blood cells and nucleated cells respectively. The TNC Reagent is a nucleic stain that stains any cell with a nucleus. The RBC Reagent is an antibody stain that tags antigens on the surface of the red blood cell. Therefore, nucleated red blood cells (nRBCs) will be included in both the RBC and TNC count.

Interference studies were performed to assess the effect of potentially interfering substances that might be present in CSF. Pathological “worst case scenario levels”, where available, were used to determine the highest concentration of each potential interferent tested. For a full list of potential interferents evaluated, refer to the GloCyte user guide.