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Advanced Instruments, GloCyte Automated Cell Counter for CSF

Advanced Instruments, GloCyte Automated Cell Counter for CSF

Hematology analyzers, November 2017

Contact Information

Advanced Instruments
Reem Kassab
reemk@aicompanies.com
2 Technology Way
Norwood, MA 02062
781-320-9000


Name of instrument GloCyte Automated Cell Counter for CSF
First year installed in U.S./Outside U.S./No. of units sold in 2016 2016/—/26
No. units installed in U.S./Outside U.S./List price 24/—/$17,500
Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) RBC, TNC
• Laboratory
• Flags
FDA-cleared tests not clinically released
Tests not available but submitted for 510(k) clearance
Tests in development
Tests for research use only
Tests unique to analyzer
Differential method(s) used
Analytical measurement range:
• WBC count/RBC count TNC: 3–123 cells/µL reportable range 3–6,500 cells/µL/ 2–123 cells/µL reportable range 2–615,644 cells/µL
• Hemoglobin/Platelet
• MCV (fL) or Hct (%)
•Reticulocytes
Precision:
• WBC count/RBC count TNC: 2.5–18.0% repeatability CV/2.7–16.3% repeatability CV
• Hemoglobin/Platelet
• MCV or Hct
Accuracy of automated differential compared with manual differential (per CLSI H20-A2)
Interfering substances:
• WBC TNC: nucleated RBCs
• RBC
• MCV or Hct
• Platelet
• Hemoglobin
Interfering substances: differential
Maximum CBCs per hour/Maximum CBCs and differentials per hour CSFs: ~12/—
Minimum specimen volume open/Closed/Sample dead volume closed 60 µL/—/—
Microsample capability no
Prepares microscope slides automatically or flags problems for slide prep no
Number of automatic slidemakers available/List price
Archives patient data/Previous patient results incl. with recent results no/no
Maximum archived data accessible when system online
No. specimens for which numeric results saved in memory at once 1,600 per database
No. specimens for which histo/cytogram results saved in memory at once
Performs delta checks no
Tags and holds results for follow-up, confirmatory testing, or rerun no
Parameters for flags for holding samples defined by user or vendor no
Scattergram display: cell-specific color no
Histogram display: color with thresholds no
User interface can display choice of specimen or result information yes
LIS interface formats supported RS232, bidirectional
Information transferred on LIS interface numeric and flag results, instrument to LIS; patient, orders, LIS to instrument—broadcast
LOINC codes transmitted with all results yes
Sent in message to LIS
Listing of machine codes and corresponding LOINC for each test
Interface available or planned to automated specimen-handling system none
Barcode symbologies read on specimen tube Codabar, codes 39 and 128, Interleaved 2 of 5, Data Matrix
Accommodates barcode placement per CLSI standard AUTO02-A2 yes
No. of cleaning or maintenance reagents/No. of routine liquid reagents 0/2 (RBC and TNC reagents)
Time required for daily, weekly, monthly maintenance change O-ring on vacuum every six months
Onboard diagnostics for troubleshooting/Limited to software problems yes/yes
Manufacturer can perform diagnostics via modem no
Distinguishing features (supplied by company) 1 cell/µL limit of detection for both RBC and TNC; consistent turnaround time for standarization and for lean practices; disposable test cartridges eliminate carryover for infectious samples
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.