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Abbott Diagnostics, CELL-DYN Ruby

Abbott Diagnostics, CELL-DYN Ruby

Hematology analyzers, November 2017

Contact Information

Abbott Diagnostics
Christy Thiessen
christy.thiessen@abbott.com
100 Abbott Park Rd.
Abbott Park, IL 60064
800-323-9100


Name of instrument CELL-DYN Ruby*
First year installed in U.S./Outside U.S./No. of units sold in 2016 2006/2006/ —
No. units installed in U.S./Outside U.S./List price >550/>2,700/$185,000
Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) standard menu (left) plus: MPV, RDW, retic %&#
• Laboratory
• Flags NRBC, FWBC, NWBC, RRBC, band, IG, blast, variant lymph, RBC morph., DFLT, MCHC, LRI, URI, LURI, ATYPDEP, high-low interp. message, WBC
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 atypical depolarization flag
Differential method(s) used MAPSS (multi-angle polarized scatter separation)
Analytical measurement range:
• WBC count/RBC count 0.02–246 × 10^3/µL/0.00–7.50 × 10^6/µL
• Hemoglobin/Platelet 0.00–25.0 g/dL/0.00–3,000 × 10^3/µL
• MCV (fL) or Hct (%) 58–139 (MCV), 8.3–79.8% (Hct)
•Reticulocytes
Precision:
• WBC count/RBC count 2.4%/1.8%
• Hemoglobin/Platelet 1.4%/3.8%
• MCV or Hct 0.8% (MCV)
Accuracy of automated differential compared with manual differential (per CLSI H20-A2) neut% r=0.983, slope=0.97, y=-1.98; lymph% r=0.921, slope=0.95, y=0.94; mono% r=0.711, slope=1.10, y=1.93; eos% r=0.952, slope=1.04, y=0.01; baso% r=0.146, slope=0.18, y=1.22
Interfering substances:
• WBC fragile WBC, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulins
• RBC elevated WBC, increased numbers of giant PLTs, autoagglutination, in vitro hemolysis
• MCV or Hct MCV: elevated WBC, hyperglycemia, in vitro hemolysis, increased number of giant PLTs
• Platelet WBC fragments, in vitro hemolysis, microcytic RBCs, cryofibrinogen, cryoglobulins, PLT clumping, increased number of giant PLTs
• Hemoglobin elevated WBC, increased plasma substances (triglycerides, bilirubin, in vivo hemolysis), lytic-resistant RBCs
Interfering substances: differential fragile WBC, neutrophil aggregates, lytic-resistant RBCs, NRBCs, PLT clumps, cryofibrinogen, cryoglobulins, paraproteins
Maximum CBCs per hour/Maximum CBCs and differentials per hour 84/84
Minimum specimen volume open/Closed/Sample dead volume closed 150 µL/230 µL/1.2 mL
Microsample capability no
Prepares microscope slides automatically or flags problems for slide prep yes
Number of automatic slidemakers available/List price —/$125,000
Archives patient data/Previous patient results incl. with recent results yes/yes
Maximum archived data accessible when system online 10,000 results
No. specimens for which numeric results saved in memory at once 10,000 results
No. specimens for which histo/cytogram results saved in memory at once 10,000 results
Performs delta checks no
Tags and holds results for follow-up, confirmatory testing, or rerun yes
Parameters for flags for holding samples defined by user or vendor user or vendor
Scattergram display: cell-specific color yes
Histogram display: color with thresholds yes
User interface can display choice of specimen or result information yes
LIS interface formats supported LIS1/LIS2 CLSI
Information transferred on LIS interface numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast; host query for patient demographics and orders
LOINC codes transmitted with all results no
Sent in message to LIS no
Listing of machine codes and corresponding LOINC for each test no
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, ISBT
Accommodates barcode placement per CLSI standard AUTO02-A2 yes
No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/3
Time required for daily, weekly, monthly maintenance daily: 30 seconds; weekly: 5 minutes; monthly: 10 minutes (times are estimated)
Onboard diagnostics for troubleshooting/Limited to software problems yes/no
Manufacturer can perform diagnostics via modem yes
Distinguishing features (supplied by company) touch-sensitive screen, all optical technology; onboard maintenance videos; lyse-resistant RBC mode; rules-based result annotations
Note: a dash in lieu of an answer means company did not answer question or question is not applicable *refer to CELL-DYN Ruby operator’s manual for warnings, limitations, and precautions
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.