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Beckman Coulter, Coulter LH 750 (Hematology 2012)

Beckman Coulter, Coulter LH 750 (Hematology 2012)

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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 Coulter LH 750
First year installed in U.S./Outside U.S./No. of units sold in 2011 2001/2001/261
No. units installed in U.S./Outside U.S./List price >2,300/>1,900/$195,000
Test menu: • Chartable (standard menu: WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, %&# neut, mono, lymph, eos, baso): standard menu (left) plus: RDW, MPV, retic #&%, IRF, MRV, graded RBC morph., NRBC %&#, TNC & RBC on CSF, synovial, and serous fluids
• Laboratory
• Flags user-definable age-, gender-, or location-based reference intervals; action and critical limits; user-definable RBC morphology; gradient messages (=+, ++, +++); user-selectable sensitivity for differential abnormal population suspect messages
FDA-cleared tests not clinically released
Tests not available but submitted for 510(k) clearance
Tests in development
Tests for research use only MSCV, HLR %&#, PDW, PCT, WBC research population data (RPD)
Tests unique to analyzer IVD: NRBC, body fluids; RUO: MSCV, WBC RPD
Differential method(s) used Coulter’s 3-D VCS biophysical flow cytometry with IntelliKinetics, AccuGate, and AccuFlex technologies
Linearity:
• WBC count/RBC count 0–400/0–8.0
• Hemoglobin/platelet 0–25/0–3,000
• MCV (fL) or Hct (%)
Precision:
• WBC count/RBC count ≤1.7 percent/≤0.8 percent
• Hemoglobin/platelet ≤0.8 percent/≤3.3 percent
• MCV or Hct ≤0.8 percent (MCV)
Accuracy of automated differential compared with manual differential (per CLSI H-20A2) lymph% = ±3.0%, neut% = ±2.0%, mono% = ±3.0%, eos% = ±1.0%, baso% = ±1.0%
Interfering substances:
• WBC unusual RBC abnormalities that resist lysing, NRBC, fragmented WBC, unlysed particle >35 fL, giant PLT, PLT clumps
• RBC very high WBC, high concentration large PLT, autoagglutinins
• MCV or Hct MCV and Hct: very high WBC, high concentration large PLT, autoagglutinins
• Platelet very small RBCs and WBC fragments may interfere
• Hemoglobin very high WBC, severe lipemia, heparin, rare lyse-resistant RBCs
Interfering substances: Differential high triglycerides may affect lysing
Maximum CBCs per hour/Maximum CBCs and differentials per hour 110/110
Minimum specimen volume open/Closed/Sample dead volume closed 200 µL/300 µL, 550 µL with slidemaker/1.0 mL
Microsample capability yes
Prepares microscope slides automatically or flags problems for slide prep yes, both
Number of automatic slidemakers available/List price >1,000 (U.S.)/$110,000
Archives patient data/Previous patient results included with recent results yes/yes
Maximum archived data accessible when system online 20,000 samples
No. specimens for which numeric results saved in memory at once 20,000 samples
No. specimens for which histo/cytogram results saved in memory at once 20,000 samples
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 user or vendor
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 RS-232, proprietary
Information transferred on LIS interface numeric and flag results, histograms and scatterplots, instrument to LIS; patient demographics, orders, LIS to instrument—broadcast
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; only as needed
Onboard diagnostics for troubleshooting/Limited to software problems yes/no
Manufacturer can perform diagnostics via modem yes
Distinguishing features (supplied by company) extensive decision support; enumeration of NRBCs with every differential; random access; automation ready; extended linearity for WBC and PLTs; RUO: WBC RPD
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.