Hematopathology / EVALUATION OF THE ABBOTT CELL-DYN 4000 HEMATOLOGY ANALYZER

Evaluation of the Abbott CELL-DYN 4000 Hematology

Analyzer
Ernesto Grimaldi, MD, and Francesco Scopacasa, PhD
Key Words: Abbott CD 4000; Blood cell counter; Automated hematology analyzer; Accuracy; Precision; Interference

Abstract
A new generation hematology analyzer, Abbott
CELL-DYN 4000 (CD 4000), capable of providing 26
parameters, including fully automated reticulocyte,
nucleated RBC, blast, band, and immature granulocyte,
and variant lymphocyte counts, was evaluated by using
the National Committee for Clinical Laboratory
Standards H20-A protocol and compared with the
Bayer-Technicon H-2 analyzer, which is used routinely
in our laboratory. A lipid interference experiment and a
sample aging study also were performed. Linearity,
carryover, and precision were within the limits
established by the manufacturer, and satisfactory
agreement was found with the H-2 analyzer. The
evaluation of leukocyte differential counts indicated an
excellent correlation with the manual reference method
for neutrophils and lymphocytes, a good correlation for
monocytes and eosinophils, and a poor correlation for
basophils in samples with low counts; for basophil
counts of 2% or higher, we found an improvement of the
correlation coefficient. In the lipid interference
experiment, only hemoglobin determination was
influenced significantly on the CD 4000, but by using a
new Abbott hemoglobin reagent, the interference was
eliminated. The CBC and differential counts were stable
and reportable up to at least 24 hours. Intrasample
viability information on leukocytes provided a quality
check on each individual specimen.

American Society of Clinical Pathologists

The Abbott CELL-DYN 4000 (CD 4000) (Abbott Diagnostics, Abbott Park, IL) is a new generation fully automated
hematology analyzer that uses 4-angle argon laser light scatter
and 2-color fluorescence flow cytometry.1 The analyzer provides
the laboratory with up to 26 blood count parameters, including
reticulocytes, immature reticulocyte fraction, nucleated RBCs,
blasts, bands, immature granulocytes, and variant lymphocytes;
in addition, fluorescence technology2 also provides a new
intrasample quality control feature, the WBC viable fraction.3 A
confidence fraction for blasts, bands, immature granulocytes,
and variant lymphocytes also was provided.1
During a 3-month period, we evaluated, on the basis of the
H20-A protocol of the National Committee for Clinical Laboratory Standards,4 the CBC and differential WBC count performance of the CD 4000 in comparison with a reference fully
automated hematology analyzer in use in our laboratory, the
Bayer-Technicon H-2 (Bayer-Technicon, Tarrytown, NY) and
with the reference manual method (differential WBC count
only). We also evaluated the lipid interference on both instruments and the sample aging effects on CD 4000 measurements.

Materials and Methods

System Description
All analyses were performed on the Abbott CELL-DYN
4000 using software version R4-12F without individualized
laboratory settings for the laser scatter channels (Abbott setup).
The system incorporates 4 different measurement
technologies,1 including fluorescence flow cytometry, and uses
an argon laser to undertake analyses of reticulocytes and
nucleated RBCs in particular. The analyzer fluorometer section
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has 2 fluorescence emission laser optics (4 angles of light

scatter). Blasts, immature granulocytes, bands, and variant
lymphocytes are detected by a multiparameter, multiweighted,
discriminant function; this function generates a flag and
reports a confidence fraction from 0.50 to 0.99 (ie, the probability that these cells were classified correctly). After detection
by the discriminant function, cell counts are estimated by
using light scatter. Determination of the hemoglobin concentration is based on spectrophotometry. The default system
measurements of the RBC and platelet counts are by impedance and optical methods, respectively; in addition, a simultaneous determination of optical RBC and impedance platelet
counts are performed. Discrepancies between the 2 measurements provide an alert suggesting the presence of sample
interferences.
Fluorescence technology also provides a new intrasample
quality control feature, the WBC viable fraction, determined
from the ratio of unstained to total WBCs. By combining the
WBC viable fraction results with the fluorescence information, the CD 4000 can flag specimens (nonviable WBCs) for
potential sample deterioration.3
The CD 4000 and H-2 analyzers were calibrated
following the manufacturers guidelines and using their own
calibration samples; the instruments were controlled by
routine quality control methods. The low, normal, and high
control samples were supplied by the manufacturers.
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. In particular, for differential WBC count abnormalities, 10% of these samples had
blasts, 20% immature granulocytes, 10% variant lymphocytes,
5% nucleated RBCs, and 5% progranulocytes; 50% had no
abnormalities; bands ranged from 0% to 20%. All samples
were collected in evacuated 3.5-mL 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.
Carryover Assessment
Carryover assessment was performed according to
method of Broughton5: a sample in the high range was tested 3
consecutive times (H1, H2, H3), and a sample in the low range
was tested 3 consecutive times (L1, L2, L3). The percentage
of carryover for each parameter was calculated as follows:
[(L1 L3)/(H3 L3)] 100.
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Linearity
Linearity was evaluated by analyzing serial dilutions of 5
specimens in platelet-free autologous plasma.6 The results
were evaluated in accordance with the International Council
for Standardization in Haematology recommendation.5
Imprecision
For the between- and within-batch imprecision study, 20
samples in triplicate and in 2 batches on the same day were
analyzed. The instrument was switched off and recalibrated
between the 2 batches.
The results were expressed as mean, SD, and coefficient
of variation percentage.
Comparability
We selected 120 blood samples on the basis of the recommended International Council for Standardization in Haematology range of values7 and analyzed them side-by-side with
the CD 4000 and H-2 instruments. Calibration was done
following the manufacturers guidelines. Measured WBC,
RBC, hemoglobin, mean corpuscular volume, platelet, and
differential WBC count parameters were compared by linear
regression analysis, and correlation coefficients (r) were calculated. Since bands and immature granulocytes are counted
together with neutrophils by the H-2 analyzer, these cells, well
defined by the CD 4000, were added to neutrophil counts in
the statistical evaluation.
We also compared 112 normal blood samples with the
manual differential WBC count; all films were examined independently by 4 experienced technologists4; results were
compared by linear regression, and correlation coefficients
were calculated.
Interference Study
Lipid interference was evaluated in 10 blood samples
added with increasing amounts of Intralipid (soya lipids)
(Pharmacia AB, Uppsala, Sweden); they were analyzed sideby-side by using the 2 instruments, and each test was
performed in triplicate. The results were expressed as the
mean value of 3 determinations. The lipid concentration was
measured as triglycerides.
At the end of the evaluation period, Abbott supplied a
new hemoglobin reagent, Tri-Methyl-Tetra-Decyl-ammonium
chloride free (TTAB free), and a new software version (R8-1)
that are able to eliminate any interference on CD 4000 hemoglobin determination. The lipid interference experiment also
was performed with these new components.
Time (Aging) Study
We analyzed 25 normal samples in duplicate within 2,
24, 48, and 72 hours after venipuncture and storage at room
temperature (25 C) or under refrigeration (4 C).
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Hematopathology / ORIGINAL ARTICLE

binomial confidence limits for a 400-cell differential WBC

count. In Figure 1, several outliers were identified by 95%
confidence limits; no outliers were identified in Figure 2.

Results
Carryover
Carryover data for the WBC, RBC, hemoglobin, and
platelet values are given in Table 1. The results for high to
low carryover testing were less than 0.5%.
Linearity
Linearity data are given in Table 2. Excellent correlation was found between expected and obtained values for
all parameters sensitive to dilution, also in a very low
range. Statistical analysis revealed a correlation coefficient
higher than 0.997 for WBC, RBC, hemoglobin, and hematocrit values and a lower correlation for platelet values
(0.992). We also found that the unflagged percentage for
the WBC differential count results were reproducible and
linear down to a level of 0.20 109/L (data not shown).
Imprecision
As shown in Table 3 , there is good within- and
between-batch reproducibility for all parameters, including
the CBC and WBC differential counts. Only for basophils
was the coefficient of variation higher than 20%.
Comparability
As shown in Table 4, the CD 4000 gave CBC and
differential WBC count results that compared very well
with data obtained by the H-2. The results for basophils
showed poor agreement (r = 0.297) between the 2 instruments in the low range of counts and good agreement (r =
0.920) for high basophils counts.
The results of correlation and linear regression
between the CD 4000 and manual differential are given in
Table 5. Correlation was excellent for neutrophils and
lymphocytes, and monocytes and eosinophils showed a
good correlation, while basophils results yielded a lower
correlation in the low range of values (<2%). The correlation for basophils became excellent when only samples
with basophil values of 2% or higher (n = 25) were
considered.
The comparability data plot for the CD 4000 vs the
manual differential count for the basophil counts, low and
high ranges, are given in Figure 1 and Figure 2, respectively. The identity line is displayed together with the 95%

Interference Study
As shown in Figure 3, a significant (P < .001) inaccuracy of the hemoglobin determinations was observed on
both instruments starting from a lipid value of 450 mg/dL,
resulting a hemoglobin overestimation of 1 g/dL or more.
Conversely, no interference was found with either instrument in the WBC and differential WBC counts (data not
shown). The RBC and platelet counts in hyperlipidemic
samples Figure 4 and Figure 5 were overestimated on
the H-2 system, but only for high lipid concentrations,
while no interference was found on the CD 4000. No more
interference in the hemoglobin determination was observed
using the new Abbott hemoglobin reagent (TTAB free) and
the new software version Figure 6.
Time (Aging) Study
In stored samples, no significant changes were
observed in WBC, platelet, RBC and hemoglobin determinations by the CD 4000 (data not shown).
In the WBC count, the WBC viable fraction decreased
significantly (P < .001) between 24 and 48 hours, particularly in samples stored at room temperature Figure 7. At
48 hours, a significant (P < .001) increase of samples
showing the nonviable WBC flag was observed Figure 8.
No significant changes were observed in the differential WBC count in stored samples; only a minor reduction
in the proportion of eosinophils was noted in samples
stored for 48 hours at room temperature Figure 9 .
Conversely, a significant (P < .001) change was observed in
the segmented neutrophil and band subpopulations Figure
10. The time course shows a progressive decrease in the
number of mature neutrophils (segmented) and a side-byside, progressive increase in the number of bands; this
feature is more evident in samples stored at 4 C Figure
11. No significant changes were observed in immature
granulocytes (Figure 10). In stored samples, the confidence
fraction for neutrophil subpopulations was always less than
0.76, whereas the fraction was always 0.76 or more in fresh
blood samples Figure 12.

Discussion
Table 1
Percentage of Carryover in the CELL-DYN 4000 Analyzer*
WBC

RBC

0.05

0.38

Hemoglobin
0.32

Platelets
0.50

In our study, the CELL-DYN 4000 reproducibility

(between-batch and within-batch imprecision) results were
satisfactory with the exception of the basophil count.
Furthermore, the CELL-DYN 4000 demonstrated minimal
carryover and a good linearity.

* Abbott Diagnostics, Abbott Park, IL.

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Table 2
Linearity of the CELL-DYN 4000 Analyzer*
Range
WBC (109/L)
RBC (1012/L)
Hemoglobin (g/dL)
Hematocrit (%)
Platelets (109/L)

0.15-100
0.17-7.0
0.50-20.0
1.5-60.0
6.20-1,000

Intercept

Slope

0.998
0.997
0.999
0.999
0.992

0.030
0.091
0.125
0.452
3.460

0.998
1.035
1.012
1.000
0.955

* Abbott Diagnostics, Abbott Park, IL.

Table 3
Within- and Between-Batch Precision Observed With the Abbott CELL-DYN 4000* in 20 Samples
Within Batch
Mean
WBC (109/L)
RBC (1012/L)
Hemoglobin (g/dL)
Hematocrit (%)
Mean corpuscular volume (fL)
Platelets (109/L)
Neutrophils (%)
Lymphocytes (%)
Monocytes (%)
Eosinophils (%)
Basophils (%)
*

SD

8.02
4.10
14.70
45.20
90.50
269.10
49.35
40.79
6.57
3.00
0.27

0.19
0.10
0.08
0.82
0.28
6.40
0.65
0.63
0.25
0.10
0.07

Between Batch
CV (%)
2.44
1.98
0.54
1.82
0.31
2.38
1.32
1.55
3.80
3.32
24.80

Mean

SD

CV (%)

8.10
5.00
14.70
45.20
90.30
270.00
50.10
41.00
6.60
3.06
0.30

0.20
0.10
0.81
0.85
0.27
5.95
0.67
0.63
0.26
0.15
0.06

2.47
2.02
0.55
1.88
0.30
2.20
1.34
1.53
3.93
4.90
21.33

Abbott Diagnostics, Abbott Park, IL.

Table 4
Comparability Test Between Abbott CELL-DYN 4000* and Bayer-Technicon H-2* for 120 Samples

WBC (109/L)
RBC (1012/L)
Hemoglobin (g/dL)
Mean corpuscular volume (fL)
Platelets (109/L)
Neutrophils (%)
Lymphocytes (%)
Monocytes (%)
Eosinophils (%)
Basophils (%)
Range of values, 0% to <2%
Range of values, 2% to 10%
*

Intercept

Slope

0.053
0.073
0.035
6.606
2.147
0.061
0.042
0.028
0.285

0.971
1.034
1.018
1.019
0.911
0.970
1.031
1.206
1.053

0.998
0.997
0.998
0.990
0.986
0.981
0.976
0.996
0.975

0.151
0.940

0.227
0.290

0.297
0.920

Abbott Diagnostics, Abbott Park, IL, and Bayer-Technicon, Tarrytown, NY.

Segmented neutrophils, bands, and immature granulocytes.
Normal and variant lymphocytes.

Table 5
Results of Inaccuracy Assessment: Comparison Between CELL-DYN 4000* and Manual Differential Leukocyte Count

Neutrophils (%)
Lymphocytes (%)
Monocytes
Eosinophils
Basophils (%)
Range of values, 0% to <2%
Range of values, 2% to 10%
*

Intercept

Slope

0.890
1.045
0.630
0.400

0.995
0.985
0.888
0.925

0.992
0.971
0.830
0.888

0.360
1.786

0.009
0.820

0.020
0.940

Abbott Diagnostics, Abbott Park, IL.

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CD 4000

10

CD 4000

2.5

1.5

0.5

0
0

0.5

1.5

2.5

10

12

400-Cell Manual Differential Count

400-Cell Manual Differential Count

Figure 1 Percentage of basophils with the CELL-DYN 4000

(Abbott Diagnostics, Abbott Park, IL) compared with 400cell manual differential count for basophil counts in the low
range. The identity line is displayed with the 95% binomial
confidence limits. Few outliers are identified.

Figure 2 Percentage of basophils with the CELL-DYN 4000

(Abbott Diagnostics, Abbott Park, IL) compared with 400cell differential count for the basophil counts in the high
range. The identity line is displayed with the 95% binomial
confidence limits. No outliers are identified.

24

20
12

RBCs (10 /L)

Hemoglobin (g/dL)

22

18

16

14

12

10
100

1,100

2,100

3,100

4,100

Triglycerides (mg/dL)

2
100

1,100

2,100

3,100

4,100

Triglycerides (mg/dL)

Figure 3 Interference of hyperlipidemic samples on the

hemoglobin determination. Both the Abbott CELL-DYN 4000
(Abbott Diagnostics, Abbott Park, IL) (squares) and BayerTechnicon H-2 (Bayer-Technicon, Tarrytown, NY) (diamonds)
show significant overestimation (1 g/dL or more) starting
from a triglyceride value of 450 mg/dL or more.

Figure 4 Interference of hyperlipidemic samples on the

RBC count. The RBC count is stable on both instruments
(Abbott CELL-DYN 4000, Abbott Diagnostics, Abbott Park, IL
[squares]; and Bayer-Technicon H-2 Bayer-Technicon, Tarrytown, NY [diamonds]) up to a triglyceride value of 200
mg/dL. With higher lipid concentrations, only the H-2
analyzer shows an RBC count overestimation.

For the CBC and differential WBC counts, we found a

good correlation with H-2 analyzer. Blasts and variant
lymphocytes were both counted as large unstained cells by
the H-2, while they were well defined by the CD 4000;

therefore only neutrophil, lymphocyte, monocyte,

eosinophil, and basophil data were comparable.
High nucleated RBCs would give invalid WBC comparison data (interference with the WBC count on the H-2

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300

25

20

Hemoglobin (g/dL)

Platelets (10 /L)

250

200

150

15

10

100
100

1,100

2,100

3,100

0
100

4,100

1,100

2,100

3,100

4,100

Triglycerides (mg/dL)

Triglycerides (mg/dL)

Figure 5 Interference of hyperlipidemic samples on the

platelet count. The platelet count performed by the Abbott
CELL-DYN 4000 (Abbott Diagnostics, Abbott Park, IL)
(squares) is stable up to a triglyceride value of 4,500 mg/dL.
The platelet count by the Bayer-Technicon H-2 (Bayer-Technicon, Tarrytown, NY) (diamonds) shows significant overestimation starting from a triglyceride value of 1,200 mg/dL.

Figure 6 Interference of hyperlipidemic samples on the

hemoglobin determination performed by CELL-DYN 4000
(Abbott Diagnostics, Abbott Park, IL) using the new Abbott
hemoglobin reagent (TriMethyl-Tetra-Decyl-Ammonium chloride free) (squares) compared with the Bayer-Technicon H-2
(Bayer-Technicon, Tarrytown, NY) (diamonds). No more
interference on the hemoglobin determination was
observed when using the new free hemoglobin reagent.

Nonviable WBCs (% of Samples)

100

WBC Viable Fraction (%)

95
90
85
80
75
70
65
60
55
50
0

24

48

72

96

Time (h)

100

80

60

40

20

2
2

48

24

72

Time (h)

Figure 7 Time course of the WBC viable fraction in stored

samples. In the WBC count, the viable fraction decreased
significantly (P < .001) within 48 hours, particularly in
samples stored at room temperature. Diamonds, samples
stored at 4 C; squares, samples stored at room temperature.

Figure 8 Nonviable WBC flag in stored samples. A significant

increase (P < .001) of samples showing the nonviable flag was
observed only in samples stored more than 24 hours, especially at room temperature. Gray bars, samples stored at room
temperature; black bars, samples stored at 4 C.

analyzer). Because only a few samples with nucleated RBCs

passed through the laboratory during this evaluation, a statistically insignificant number of these samples was included in our
study (5%), and no interference with comparison was observed.

We also found a good correlation with the reference

manual differential for all WBC subpopulations except for
basophils in the low range (0% to <2%). Probably, the high
coefficients of variation for basophils and the poor correlation

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60

60

50

2 hours

2 hours

Percentage

Percentage

50

24 hours

40

48 hours
72 hours

30
20

24 hours

40

48 hours
72 hours

30
20
10

10

0
Ne

Ly

Mo

Eo

Ne

Ba

Ly

Mo

Eo

Ba

Differential

Differential

Figure 9 Differential WBC count in stored samples. A, Only minor reduction in the proportion of eosinophils was observed
in samples stored at room temperature. B, No significant changes were observed in samples stored at 4 C. Ne, neutrophils;
Ly, lymphocytes; Mo, monocytes; Eo, eosinophils; Ba, basophils.

60

Percentage

Percentage

60

40

20

40

20

0
0

12

24

36

48

60

72

Time (h)

0
0

12

24

36

48

60

72

Time (h)

Figure 10 Time course of neutrophil subpopulations in

samples stored at room temperature. Significant changes
(P < .001) were observed in the segmented neutrophil and
band fractions: the time course shows a progressive reduction in the proportion of segmented neutrophils and a sideby-side, progressive increase in the proportion of bands. No
change in the immature granulocyte fraction was observed.
Diamonds, segmented neutrophils; squares, band
neutrophils; triangles, immature granulocytes.

Figure 11 Time course of neutrophil subpopulations in

samples stored at 4 C. In samples stored at 4 C, the time
course shows a greater reduction in the fraction of
segmented neutrophils and a greater progressive increase
in the band fraction than in samples stored at room temperature. No change in the immature granulocyte fraction was
observed. Diamonds, segmented neutrophils; squares,
band neutrophils; triangles, immature granulocytes.

between the 2 instruments are not related primarily to poor

performance of the analyzers for the WBC differential
count but to the low number of basophils counted. The low
correlation with the reference method could be due to the
low number and irregular distribution of the cells in the

peripheral blood films or, more probably, to the interference of nonviable WBCs, which were present in all the
identified outliers. Finally, when analyzing samples with
high basophil counts, a dramatic increase of the correlation
coefficient was found.

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1.0

0.8

Value

0.6

0.4

0.2

0.0
2

24

48

72

Time (h)

Figure 12 Time course of the confidence fraction in stored

samples. In samples stored at room temperature and
samples stored at 4 C, the confidence fraction (ie, the probability that the cells were classified correctly) for segmented neutrophils, bands, and immature granulocytes was
always less than 0.76, whereas the fraction was always
0.76 or more in samples that were not stored.

An excellent correlation for monocytes was found with

the H-2 analyzer (r = 0.990) and a moderate correlation with
the reference method (r = 0.830). This finding is in agreement with those of other reports8,9 and seems to be due to
artifact distribution for these cells during preparation of the
blood films and to difficulties in differentiating small monocytes from large lymphocytes.
In the lipid interference study, we observed, as expected,
a significant (P < .001) inaccuracy of hemoglobin determination on both instruments starting from a lipid value of 450
mg/dL, while very high lipid amounts (4,800 mg/dL)
showed no interference with the WBC, RBC, and platelet
counts performed by the CD 4000. These data suggest the
adequacy of the Abbott CELL-DYN 4000 algorithm for
discriminating high amounts of hyperlipidemic particles and
excluding them from counts as well. Finally, the Abbott
TTAB free hemoglobin reagent improves the accuracy of the
hemoglobin determination by the CD 4000 analyzer,
including in samples with very high lipid amounts.
In stored samples, the increase in the percentage of
nonviable cells was much slower in refrigerated samples
(4 C), while storage at higher temperatures induced an acceleration of the process.
The apparent change in the relationship of segmented
neutrophils to bands (Figures 10 and 11) with storage time is
opposite what might be expected with the passage of time.
This apparent change should be due to the changes in
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neutrophil nuclear morphologic features (loss of lobularity)

in aged samples, as evident when examining the blood films.
Finally the WBC viable fraction, the nonviable WBC
flag, and the confidence fraction are sensitive intrasample
quality checks, and they could contribute to increased accuracy of the counts, particularly when the discrimination
between mature granulocytes and bands is of clinical
interest. In particular, the confidence fraction, which indicates the probability that a cell population was classified
correctly, in our study was always 0.76 or more in samples
that were not stored, whereas the confidence fraction was
always less than 0.76 in stored samples for all WBC subsets.
In fact, in the presence of high band counts, a WBC viable
fraction of 95% or less and/or a nonviable WBC flag and/or
a confidence fraction less than 0.76 could indicate sample
deterioration and, therefore, the need for a fresh sample.

Conclusions
Our evaluation data show that the Abbott CELL-DYN
4000 is a precise device, and it is at least as accurate as the
Bayer-Technicon H-2. The results are linear to extreme
counts, and no significant carryover was observed.
Derived from a DNA fluorescence analysis,2 the availability of quantitative and qualitative viability information
for WBCs is a new feature on a hematology analyzer and is a
very useful tool for analyzing aged blood specimens. In addition, we found that ease of use contributes to the CELLDYN 4000 performance, which may prove very useful in the
clinical laboratory. The Abbott CD 4000 analyzer represents
a substantial advance in hematology instrumentation and has
considerable potential for extending the clinical role of
hematologic studies.
From the Department of Laboratory Medicine, Universit
Federico II, Naples, Italy.
The CELL-DYN 4000 analyzer, reagents, and calibration and
control samples were provided free of charge for this evaluation
by Abbott Diagnostics, Abbott Park, IL.
Address reprint requests to Dr Grimaldi: Dipartimento
Assistenziale di Medicina di Laboratorio, Policlinico
Universitario Federico II, Via S Pansini 5, 80131 Napoli, Italy.

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