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Beckman Coulter, UniCel DxH 800 (Hematology 2013)

Beckman Coulter, UniCel DxH 800 (Hematology 2013)

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Contact Information


Beckman Coulter

Bill Bailey
bdbailey@beckman.com
250 South Kraemer Blvd.
Brea, CA 92821
714-961-4440


Name of instrument UniCel DxH 800
First year installed in U.S./Outside U.S./No. of units sold in 2011 2008/2008/—
No. units installed in U.S./Outside U.S./List price >1,600/>1,200/$229,000 (USD)
Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, %&# neut, mono, lymph, eos, baso): standard menu (left) plus: RDW-CV, RDW-SD, MPV, retic#, retic%, IRF, MRV, NRBC# and %, body fluids-total nucleated count, and RBC count for synovial, serous, and CSF fluids
• Laboratory
• Flags flags and codes for values requiring review: suspect, system and exception messages for samples requiring review
FDA-cleared tests not clinically released
Tests not available but submitted for 510(k) clearance
Tests in development
Tests for research use only body fluid mononuclear (BFM% and BFM#), body fluid polymorphonuclear (BFP% and BFP#), early granulated cells (EGC% and EGC#), high light scatter reticulocytes (HLR% and HLR#), low hemoglobin density (LHD), microcytic anemia factor (MAF), mean sphered cell volume (MSCV), plateletcrit (PCT), platelet distribution width (PDW), reticulocyte distribution width (RDWR and RDWR-SD), red cell size factor (RSF), unghosted red cells (UGC% and UGC%), leukocyte estimates (UWROP, WDOP, WNOP, WROP), cell population data research parameters
Tests unique to analyzer
Differential method(s) used flow cytometric digital analysis using volume, conductivity, and five angles of light scatter, digital signal processing, advanced algorithm applications, high-definition cellular resoluton, DataFusion
Linearity:
• WBC count/RBC count 0.050–400.000/0.005–8.500
• Hemoglobin/platelet 0.10–25.50/3.0–3000.0
• MCV (fL) or Hct (%) 0.005–8.500 (MCV)
Precision:
• WBC count/RBC count ≤3.0 percent/≤1.5 percent
• Hemoglobin/platelet ≤1.5 percent/ ≤3.5 percent
• MCV or Hct ≤1.0 percent
Accuracy of automated differential compared with manual differential (per CLSI H-20A2) NE = ±2.0; LY, MO = ±3.0; EO,BA = ±1.0 (or 10% percent, whichever is greater)
Interfering substances:
• WBC precipitated elevated proteins, cryoglobulin, fragmented white cells, agglutinated white cells, lyse-resistant red cells, giant platelets, platelet clumps, unlysed particles >35 fL in size
• RBC very high WBC count, high concentration of very large platelets, autoagglutinins
• MCV or Hct very high WBC count, high concentration of very large platelets, autoagglutinins
• Platelet platelet clumps, white cell fragments, very small red cells, red cell fragments, giant platelets, electric noise
• Hemoglobin severe lipemia, heparin, certain unusual RBC abnormalities that resist lysing
Interfering substances: Differential elevated triglycerides, precipitated elevated proteins
Maximum CBCs per hour/Maximum CBCs and differentials per hour >100/>100
Minimum specimen volume open/Closed/Sample dead volume closed 165 µL/165 µL/300–400 µL
Microsample capability yes
Prepares microscope slides automatically or flags problems for slide prep yes
Number of automatic slidemakers available/List price —/DxH SMS $165,000 (USD)
Archives patient data/Previous patient results included with recent results yes/no
Maximum archived data accessible when system online 40,000 standalone
No. specimens for which numeric results saved in memory at once 40,000 standalone
No. specimens for which histo/cytogram results saved in memory at once 40,000
Performs delta checks yes
Tags and holds results for followup, confirmatory testing, or rerun yes
Parameters for flags for holding samples defined by user or vendor yes
Scattergram display: cell-specific color yes
Histogram display: color with thresholds yes
User interface can display choice of specimen/result information yes
LIS interface formats supported CLSI LIS01-A2
Information transferred on LIS interface numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, patient orders, LIS to instrument—broadcast; host query for patient demographics and orders (available with release of workcell)
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 Beckman Coulter
Bar-code symbologies read on specimen tube Codabar, codes 39 and 128, interleaved 2 of 5, NW7
Accommodates bar-code placement per CLSI standard Auto2A yes
Time required for maintenance by lab personnel no routine maintenance; all maintenance procedures are on as-needed basis
Onboard diagnostics for troubleshooting/Limited to software problems yes/no
Manufacturer can perform diagnostics via modem yes
Distinguishing features (supplied by company) integrated automation with auto repeat-reflex testing based on extended onboard user-defined decision rules; single aspiration pathway negates mode-to-mode comparisons; flow cytometric digital morphology with five angles of light scatter; separate channel for WBC, NRBC, reticulocyte analysis; digital signal processing, DataFusion; future scalability
Note: a dash in lieu of an answer means company did not answer question or question is not applicable
Tabulation does not represent an endorsement by the College of American Pathologists.