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Device description:

Cell-Dyn has five main modules:

The analyzer which aspirates dilutes and analyzes each whole blood specimen.
The autoloader which automatically identifies mixes and presents specimens for
processing.
The pneumatic unit which controls fluid movement in the analyzer and in the autoloader.
The data station which controls all system processing and provides the primary operator
interface with the system.
The color printer which generates reports automatically or on demand.

The Cell-Dyn 4000 system uses an Argon-ion laser as the optical light source. The optical
bench detects light in the form of scatter from blood cell surfaces and internal structures or
fluorescent light from specially stained blood cells.
Principles used in Cell-Dyn
The analyzer counts, sizes and classifies blood cells by the combination of flow cytometry
methods: Impedance, Laser light scatter and Fluorescence detection

Impedance: the impedance principle is also known as the coulter principle, of counting
and sizing cells is based on measurable changes in electrical resistance produced by
nonconductive blood cells suspended in an electrolyte solution such as saline are pulled
through an aperture (orifice) in a glass tube. In the counting chamber low-frequency
electrical current is applied between an external electrode and an internal electrode.
Electrical resistance between the two electrodes, or impedance in the current, occurs as
the cell pass through the sensing aperture, causing voltage pulses that are measurable.
Laser light scatter: Cell counting and fluorescence measurements are made when a
hydrodynamically focused stream containing the test cells is passed through a flow cell
that is also being intersected by a laser light. As each individual cell passes through the
flow cells sensing zone the laser light is simultaneously interrupted and scattered, then
excites any endogenous or reagent-dependent fluorescent molecules. The amount and
form of light scatter, which is dependent on refractive index, size, and shape of each cell
as it passes through the sensing zone, allows their differentiation into different cell types.
Fluorescence detection: When fluorescent dyes are added to the cells before their
introduction into the analyzer, they will stain certain cell membrane and intracellular
structures. As these cells are passed through the sensing zone they emit different
wavelengths of fluorescent light, which vary according to the properties of the
fluorochrome. Photo detectors collect and measure the light in different wavelength
ranges and scatter wavelengths by the use of specific optical filters. Cells are then
categorized according to their side-scattered light and fluorescence-intensity
characteristics by software analysis of the data file that contains all the measurement
made on a cell-by-cell basis.

For the WBC parameters and NRBCs, whole blood is diluted with a reagent containing a red
fluorescent dye. NRBCs, identified by fluorescence, are excluded automatically from the WBC
count. For RBC and platelet parameters, whole blood is diluted with a reagent that prepares the
cells for measurement. The dilution is split and measured by both laser optical scatter and
focused flow impedance with injection metering. For the hemoglobin parameters whole blood is
diluted with cyanide free reagent and measured optically by absorbance. For reticulocyte
parameters, an aliquot of RBC/PLT dilution is diluted with a reagent containing a green
fluorescence as each cell passes through the laser beam.
Parameters of Abbott CELL-DYN 4000
Methods for Hemogram and Reticulocyte Count Determination
WBC
Optical scatter (primary count), Impedance (secondary count)
RBC
Impedance
Hb
Modified cyanmethemoglobin (540nm)
Hct
(RBC X MCV) / 10
MCV
Mean of RBC volume distribution histogram
MCH
(Hb X RBC) X 10
MCHC
(Hb X Hct) X 100
Platelet count
Impedance (approximately 2-30 fL)
RDW
Relative value, equivalent to CV
Reticulocyte
Proprietary stain (CD4K530), multiangle scatter and fluorescence
count
detection
Hb, hemoglobin; Hct, hematocrit; MCH, mean cell hemoglobin; MCHC, mean cell hemoglobin
concentration; MCV, mean cell volume; WBC, white blood cell; RBC, red blood cell; RDW, RBC
distribution width
White Blood Cell Differential Determination
Neutrophils
Multiangle Polarized Scatter Separation (MAPPS)
Lymphocytes
Multiangle Polarized Scatter Separation (MAPSS)
Monocytes
Multiangle Polarized Scatter Separation (MAPSS)
Eosinophils
Multiangle Polarized Scatter Separation (MAPSS)
Basophils
Multiangle Polarized Scatter Separation (MAPSS)

Multiangle Polarized Scatter Separation technology (MAPSS)


Reference/ normal range:

Histogram:

PLT and RBC histograms

WBC Histograms

Scatter of all WBC population by MAPSS technology

Sample required: Blood samples


The evaluation of the instrument was performed by analyzing blood specimens from routine
samples after obtaining patients informed consent. Specimens were selected to span the full
range of concentrations expected in clinical practice, and at least half the samples were from
patients with blood disorders giving results in abnormal low and high ranges. All samples were
collected in evacuated 3.5mL tubes containing EDTA K3 and were analyzed within 2 hours after
obtaining the blood sample. For the aging study, the samples were stored at room temperature
or refrigerated (4 C) and analyzed within 24, 48, and 72 hours.

Limitation and Interferences:

References:
Laboratory Hematology Practice edited by Kandice Kottke-Marchant with Bruce H. Davis
Hematology Clinical Principles and Application fourth edition by Bernadette F. Rodak
Ernesto Grimaldi, MD: Evaluation of the Abbott Cell-Dyn 4000 Hematology Analyzer. Am J Clin
Pathol 2000;113:497-505
www.accessdata.fda.gov/cdrh_docs/pdf/K971152.pdf