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Abbott Diagnostics, CELL-DYN Emerald 22

Abbott Diagnostics, CELL-DYN Emerald 22

Hematology analyzers, November 2017

Contact Information

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

Name of instrument CELL-DYN Emerald 22*
First year installed in U.S./Outside U.S./No. of units sold in 2016 2016/2016/—
No. units installed in U.S./Outside U.S./List price —/—/$64,000
Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, neut %&#, mono, lymph, eos, baso) standard menu (left) plus: RDW, MPV
• Laboratory
• Flags dispersional data alerts, suspect parameter flags, and count invalidation 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 UNI-FLOW Optical Technology
Analytical measurement range:
• WBC count/RBC count 0.4–90 K/µL/1.2–8.3 M/µL
• Hemoglobin/Platelet 5.5–22 g/dL/11–1,485 K/µL
• MCV (fL) or Hct (%) 53.2–118.4 (MCV), 12.1–66.1 fL (Hct)
• WBC count/RBC count 0.8–2.3% CV/0.7–1.4% CV
• Hemoglobin/Platelet 0.2–0.9% CV/2.2–5.2% CV
• MCV or Hct 0.3–0.6% CV (MCV), 0.8–1.5% CV (Hct)
Accuracy of automated differential compared with manual differential (per CLSI H20-A2)
Interfering substances:
• WBC cryoglobulin, cryofibrinogen, heparin, monoclonal proteins, nucleated red cells, platelet clumping, unlysed red cells, clotting, smudge cells, uremia plus immunosuppressants
• RBC cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/μL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells
• MCV or Hct cryoglobulin, cryofibrinogen, giant platelets, high white cell count (>50,000 K/μL), hyperglycemia (>600 mg/dL), autoagglutination, clotting, in vitro hemolysis, microcytic red cells, reduced red cell deformability, swollen red cells
• Platelet cryoglobulin, cryofibrinogen, in vivo and in vitro hemolysis, microcytic red cells, red cell inclusions, white cell fragments, clotting, giant platelets, heparin, platelet clumping, platelet satellitosis
• Hemoglobin carboxyhemoglobin (>10%), cryoglobulin, cryofibrinogen, in vivo hemolysis, heparin, high white cell count (>50,000 K/μL), hyperbilirubinemia, lipemia, monoclonal proteins
Interfering substances: differential platelet aggregates, NRBCs, giant platelets, cryoglobulins, incomplete lysis of RBCs, small lymphocytes, fibrin clots, shift in WBC cell distrib. due to EDTA anticoagulant equilibration
Maximum CBCs per hour/Maximum CBCs and differentials per hour 45/45
Minimum specimen volume open/Closed/Sample dead volume closed 17 µL/—/—
Microsample capability no
Prepares microscope slides automatically or flags problems for slide prep yes
Number of automatic slidemakers available/List price
Archives patient data/Previous patient results incl. with recent results yes/no
Maximum archived data accessible when system online 300,000 on USB and 1,000 records with histograms on internal memory
No. specimens for which numeric results saved in memory at once 300,000 on USB and 1,000 records with histograms on internal memory
No. specimens for which histo/cytogram results saved in memory at once 300,000 on USB and 1,000 records with histograms on internal memory
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 yes
Histogram display: color with thresholds yes
User interface can display choice of specimen or result information yes
LIS interface formats supported proprietary (instrument or vendor specific)
Information transferred on LIS interface numeric and flag results, instrument to LIS
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, Chinese post, code 39 full ASCII, code 93, EAN8, EAN13, EAN128, IATA, Industrial 2 of 5, Italian pharmaceutical, Matrix 2 of 5, MSI/Plessey, UK/Plessey, Telepen, TriOptic, S-Code, UPC A, UPC E
Accommodates barcode placement per CLSI standard AUTO02-A2 yes
No. of cleaning or maintenance reagents/No. of routine liquid reagents 1/2
Time required for daily, weekly, monthly maintenance weekly: 5 minutes; quarterly: 2 minutes
Onboard diagnostics for troubleshooting/Limited to software problems no/no
Manufacturer can perform diagnostics via modem no
Distinguishing features (supplied by company) compact design: small physical footprint, only 3 reagents used (2 of 3 reagents stored onboard), built-in monitor minimizes footprint; ease of use: simple to use and maintain, automated start-up, shut-down, and cleaning; 5-part differential using UNI-FLOW optical flow cytometry technology with a patented lyse allowing for clear separation of the 5 WBC cell populations
Note: a dash in lieu of an answer means company did not answer question or question is not applicable *refer to CELL-DYN Emerald 22 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.