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Abbott Diagnostics, CELL-DYN Sapphire

Abbott Diagnostics, CELL-DYN Sapphire

Hematology analyzers, November 2017

Contact Information

Abbott Diagnostics
Christy Thiessen
100 Abbott Park Rd.
Abbott Park, IL 60064

Name of instrument CELL-DYN Sapphire*
First year installed in U.S./Outside U.S./No. of units sold in 2016 2005/2005/—
No. units installed in U.S./Outside U.S./List price >165/>750/$250,000
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 %&#, IRF, NRBC %&#, CD61, CD3T %&#, CD4T %&#, CD8T %&#, 4/8
• Laboratory
• Flags band, IG, blast, variant lymph, nvWBC, rstRBC, IR, PLT clump, ASYM, FP, CD61 agglutination, clot detected aspiration, short sample
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 CD61 for PLTs, CD3/4, CD3/8 (immuno T-cell)
Differential method(s) used MAPSS (multi-angle polarized scatter separation) and three-color fluorescence
Analytical measurement range:
• WBC count/RBC count 0.0–250.0 × 10^3/µL/0.0–7.50 × 10^6/µL
• Hemoglobin/Platelet 1.0–25.0 g/dL/0.0–2,000 × 10^3/µL
• MCV (fL) or Hct (%) 37.0–179.0 fL (MCV)
•Reticulocytes 0.0–1,500 × 10^3/µL
• WBC count/RBC count <2.7%/≤1.5%
• Hemoglobin/Platelet ≤1.0%/≤4.0%
• MCV or Hct ≤1.0% (MCV)
Accuracy of automated differential compared with manual differential (per CLSI H20-A2) neut% r=0.942, slope=0.947, y=0.446; lymph% r=0.936, slope=0.943, y=2.811; mono% r=0.623, slope=1.057, y=0.851; eos% r=0.446, slope=1.024, y=0.288; baso% r=0.232, slope=0.257, y=0.350
Interfering substances:
• WBC PLT clumps, neutrophil aggregates, HbC crystals, lyse-resistant RBCs, cryoglobulin, cryofibrinogen, fragile WBC, NRBCs
• RBC autoagglutination, cold agglutinins, elevated WBC, giant PLTs, hemolysis, sm WBC
• MCV or Hct autoagglutination, cold agglutinins, elevated WBC, giant PLTs, hemolysis, hyperglycemia
• Platelet auto and cold agglutinins, cryoglobulins, cryofibrinogen, giant PLT, micro RBCs, PLT clumps, RBC fragments, WBC fragments, PLT satellitism
• Hemoglobin lipids>700 mg/dL, WBCs>250 × 10^9/L, bilirubin>33 mg/dL, HbC crystals
Interfering substances: differential see WBC
Maximum CBCs per hour/Maximum CBCs and differentials per hour 105/105
Minimum specimen volume open/Closed/Sample dead volume closed 120 µL/120 µL/0.5 mL, 0.3 mL for 10.25 × 64 mm tubes
Microsample capability yes
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 yes
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 ASTM 1394
Information transferred on LIS interface numeric and flag results, 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
Accommodates barcode placement per CLSI standard AUTO02-A2 yes
No. of cleaning or maintenance reagents/No. of routine liquid reagents 0/4
Time required for daily, weekly, monthly maintenance daily: 30 seconds; weekly: 10 minutes; monthly: 5 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) four optical and three fluorescent detectors provide multiple scatterplot analysis; 2-D optical platelets prevent interferences; fluorescent analysis of reticulocytes, NRBCs, and three-color monoclonal analysis on routine hematology analyzer; OpenFlow MAb test selections; touch-sensitive screen, interfaces to Accelerator a3600 track system
Note: a dash in lieu of an answer means company did not answer question or question is not applicable *refer to CELL-DYN Sapphire 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.