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Performance Evaluation of Abbott CELL-DYN Ruby For Routine Use
Performance Evaluation of Abbott CELL-DYN Ruby For Routine Use
The reagents, calibrators, and quality controls rec- dilution of fresh patient samples (from 100% to
ommended by the manufacturer were used in the 10%). The analyzer’s primary dilution fluid was used
study. Three levels of quality control material were as diluent.
used with Abbott CELL-DYN Ruby for between-day
precision studies. For the reticulocyte between-day
Interinstrument agreement
precision study, two quality controls with different
concentrations were used. The interinstrument comparability studies were car-
ried out by analyzing in singlicate 100 randomly
selected blood samples for CBC analysis and 50 sam-
Imprecision
ples for RETC from the daily workload on the labora-
Within-run precision was evaluated by performing 10 tory’s Abbott CELL-DYN Sapphire.
consecutive measurements on three fresh blood sam-
ples. Between-day open-mode precision was evaluated
RESULTS
by running commercial controls twice a day over a
period of 10 days (replicative runs; total n = 20), after
Imprecision
which the coefficient of variation (CV%) for each
parameter was calculated. The total variation (paired The results of the within-run and between-day preci-
precision) was evaluated by analyzing 30 patient sam- sion analyses are shown in the Tables 1–3. Precision
ples without analyzer flags in duplicate. They were was good at all levels for the CBC parameters, CV%
analyzed randomly among other samples using both being 2.3, except for very low WBC with CV% of
open and closed modes. In open mode specimen is ana- 2.6 and for low-level PLT with CV% of 6.9. CV%
lyzed manually using open mode probe and in closed for reticulocyte percentage was highest at the low
mode specimen is analyzed automatically using sample level (10.4). In the WBC differentials, the between-
loader rack. Total variation was calculated by a two- days precision was good for all parameters (CV%:
tailed paired t-test using Microsoft Excel. A P-value of 8.0), except basophil percentage (B%) and absolute
<0.05 was considered statistically significant. Paired basophil count (CV%: 31.8 and 31.3, respectively).
precision was determined by linear regression analysis Additionally, in the commercial control level I with
and by the CV%s of the combined results. the low WBC count (2.5 · 109/l), the precisions in
the WBC differentials were 16.9%. The cell types
that occur in low numbers showed higher CVs, as
Carryover
expected.
Carryover was assessed by analyzing three pairs of The open and closed mode paired precision of
samples. A high-concentration sample was first ana- CELL-DYN Ruby (Table 4) was determined during a
lyzed consecutively in triplicate (H1, H2, and H3), fol- 2-week evaluation period. Open mode precision was
lowed immediately by a low-concentration sample excellent (R2 0.99) for WBC, RBC, HGB, and mean
consecutively in triplicate (L1, L2, and L3). The mean corpuscular volume (MCV). For mean corpuscular
percentage of carryover for each parameter was calcu- hemoglobin (MCH), PLT, and mean platelet volume
lated using the following formula: carryover (MPV), the correlation coefficients were 0.94, 0.97,
% = (L1 ) L3)/(H3 ) L3) · 100. Carryover was calcu- and 0.77, respectively. The correlation coefficients of
lated for WBC count, PLT, RBC count, HGB, and the closed mode were almost similar to those of the
RETC. open mode (R2 0.99) for WBC, RBC, HGB, and
MCV, with the exception of the correlation coefficients
for MCH and MPV being 0.97 and 0.90, respectively.
Linearity
The comparative performance characteristics for
The linearity ranges for the basic blood cell count open and closed mode routine CBC measurements
parameters are specified by the manufacturer. We were also evaluated by comparing the mean values of
verified the linearities for HGB, WBC, RBC, PLT, and each pair. Correlations were excellent for WBC, RBC,
RETC. Linearity studies were performed by serial HGB, MCV, and PLT (R2 0.99), and the correlation
2007 The Authors
Journal compilation 2007 Blackwell Publishing Ltd, Int. Jnl. Lab. Hem. 2008, 30, 400–407
T. LEHTO AND P. HEDBERG EVALUATION OF RUBY HEMATOLOGY ANALYZER 403
Table 1. Within-run precision using three patient samples with different concentrations
White blood cells (·109/l) 1.53 0.04 2.6 7.78 0.10 1.3 19.9 0.29 1.5
Red blood cells (·1012/l) 2.26 0.04 1.8 3.31 0.03 0.8 4.44 0.07 1.7
Hemoglobin (g/l) 81.2 0.03 0.0 121 0.03 0.3 159 0.07 0.4
Hematocrit (l/l) 0.23 0.31 1.3 0.43 0.52 1.2 0.41 0.58 1.4
MCV (fl) 75.1 0.45 0.6 88.2 0.47 0.5 107 0.85 0.8
Platelets (·109/l) 57 2.39 4.2 202 3.00 1.5 486 6.44 1.3
Reticulocytes (%) 1.10 0.07 5.9 4.15 0.18 4.4 6.97 0.23 3.3
Neutrophils (%) 36.8 1.73 4.7 61.4 0.67 1.1 72.0 0.62 0.9
Lymphocytes (%) 52.2 3.32 6.4 24.9 0.71 2.9 15.1 0.55 3.7
Monocytes (%) 5.45 3.08 56.4 8.10 0.69 8.5 9.93 0.52 5.3
Eosinophils (%) 4.7 1.07 22.7 4.67 0.19 4.0 0.67 0.28 42
Basophils (%) 0.9 0.22 25.2 0.9 0.22 24.6 2.39 0.22 9.1
Neutrophils (·109/l) 0.56 0.03 4.7 4.78 0.09 1.9 14.4 0.28 2.0
Lymphocytes (·109/l) 0.80 0.06 7.0 1.93 0.05 2.7 3.00 0.11 3.6
Monocytes (·109/l) 0.08 0.05 58.5 0.63 0.05 8.7 1.98 0.09 4.4
Eosinophils (·109/l) 0.07 0.02 21.8 0.36 0.02 4.9 0.13 0.06 42.9
Basophils (·109/l) 0.01 0.00 26.7 0.07 0.02 24.1 0.48 0.05 9.9
Table 2. Between-days precision using three different commercial controls (CELL-DYN 22 Controls, Abbott
Laboratories) with different concentrations
coefficients for MCH and MPV were 0.97 and 0.87, counts, the R2 values varied within 0.96–0.98 in both
respectively. modes. Only the correlation coefficients for basophil
The correlation coefficients for neutrophil and lym- absolute counts were poorer in the open and closed
phocyte absolute counts in the open and closed modes modes (R2 0.62 and 0.76, respectively). In the com-
were 0.99. For monocyte and eosinophil absolute parative performance study between open and closed
2007 The Authors
Journal compilation 2007 Blackwell Publishing Ltd, Int. Jnl. Lab. Hem. 2008, 30, 400–407
404 T. LEHTO AND P. HEDBERG EVALUATION OF RUBY HEMATOLOGY ANALYZER
Coefficient of variation, CV %
12 5.08 5.08
(±4.66)
40 (±15.38)
(±4.66)
2.91 30
8 (±3.31) 7.44
(±10.39)
20 3.89 4.64
4 0.78 0.85 1.01 (±4.93) (±3.25)
0.65
(±0.82) (±1.04) 10 (±0.75)
(±0.54) 0.16
(±0.20)
0 0
WBC RBC HGB MCV MCH P LT MPV N# L# M# E# B#
Coefficient of variation, CV %
10
Coefficient of variation, CV %
40 15.90
8 3.15 (±13.17)
(±2.68) 30
6 2.14 7.06
(1.98) 20 7.00 (±5.59)
3.70
4 1.19 (±4.64)
(±3.54)
(±0.92) 0.61 0.63 0.63 10 0.98
2 (±0.64) (±0.62) 0.19 (±0.67) (±0.76)
(±0.16)
0
0
WBC RBC HG B M CV M CH PLT M PV N# L# M# E# B#
Figure 1. CELL-DYN Ruby’s open and closed mode paired precision determined as the CVs of the combined results
for the cell blood count and the white blood cell differential. The columns represent the mean values of CV% of
each replicate run. Error bars represent the +/)SD of these CVs.
CELL-DYN Sapphire
CELL-DYN Sapphire
4
12
3
8
2
4 1
0
0 0 1 2 3 4 5 6
0 4 8 12 16 20
CELL-DYN Ruby
CELL-DYN Ruby
CELL-DYN Sapphire
140 0.4
120 0.3
100 0.2
80 0.1
60 0
60 80 100 120 140 160 180 0 0.1 0.2 0.3 0.4 0.5 0.6
CELL-DYN Ruby CELL-DYN Ruby
CELL-DYN Sapphire
600
100
90 400
80
200
70
60 0
60 70 80 90 100 110 120 0 100 200 300 400 500 600 700 800
CELL-DYN Ruby CELL-DYN Ruby
RETC x 10e9/L
(g) 250
y = 0.9468x + 5.2907
R 2 = 0.8155
200
CELL-DYN Sapphire
150
100
50
0
0 50 100 150 200
CELL-DYN Ruby
Figure 2a–g. Correlation between CELL-DYN Ruby and CELL-DYN Sapphire cell blood count and reticulocyte abso-
lute count parameters evaluated by Deming regression analysis.
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national Committee for Standardization multi-center evaluation of the Abbott
Buttarello M. (2004) Quality specification in Haematology (1984) Protocol for Cell-Dyn Sapphire hematology analyzer.
in haematology: the automated blood evaluation of automated blood cell Laboratory Hematology 12, 15–31.
cell count. Clinica Chimica Acta 346, counters. Clinical and Laboratory Hae- Rajamäki A. & Laitinen M. (1990)
45–54. matology 6, 69–84. Automaattisen verisoluanalysaattorin
England J.M., Rowan R.M., van Assend- Müller R., Mellors I., Johannessen B., koestusohjelma. Moodi 4, 202–209.
elft O.W., Coulter W.H., Groner W., Aarsand A.K., Kiefer P., Hardy J., Ken-
Jones A.R., Koepke J.A., Lewis S.M.,