Turk J Biochem 2023; aop

Research Article

Nilufer Bayraktar* and Deniz Ilhan Topcu

User verification of Abbott Alinity HQ

hematology analyzer
https://doi.org/10.1515/tjb-2023-0185 analytical performance of Alinity HQ was found to be satis-
Received August 20, 2023; accepted October 17, 2023; factory. Alinity HQ is an accurate, highly precise analyzer
published online December 11, 2023 with good analytical performance, suitable for high-volume
laboratories.
Abstract
Keywords: method verification; hematology analyzer; CLSI
Objectives: This study aims to evaluate the performance H26-A2; ICSH guideline; CLSI EP15-A3
characteristics of the Alinity HQ hematology analyzer in a
routine laboratory setting.
Methods: In the study, precision (short-term and long-term
precision), accuracy (method comparison with Abbott Cell
Introduction
Dyn Ruby and estimation of bias), confirmation of a back-
Hematology analyzers are becoming more technologically
ground (Limit of Blank, LoB), and carry-over were used to
advanced and are now available for complete blood counts
evaluate the performance of Alinity HQ as recommended by
(CBCs) with high sample throughput and reduced turn-
ICSH, CLSI guidelines EP15-A3, EP09, EP17A2, and H26-A2.
around time. They are based on different technologies, such
Acceptance criteria were based on manufacturer technical
as electrical particle counting (impedance), optical and
specifications and the EFLM Biological Variation Database.
fluorescence flow cytometry, and digital imaging‐based
Results: According to the short-term precision results, except
principles [1]. The recently introduced Abbott Alinity HQ
for mean corpuscular volume (MCV) and mean corpuscular
module, which uses optical and fluorescence flow cytometry
hemoglobin concentration (MCHC), all measurements
principles, is a new generation, multi-parameter, and high-
exhibited coefficient variations (CV) lower than their verifi-
throughput automated hematology analyzer for CBCs [2].
cation limits. Basophil, eosinophil, and monocyte counts, as
Manufacturers design devices that aim to minimize
well as mean corpuscular hemoglobin (MCH), MCHC, and red
interventions while maintaining precision and optimally
cell distribution width standard deviation (RDW-SD), did not
utilizing their potential. Considering the various technolo-
meet the allowable imprecision criteria for the long-term
gies different manufacturers use, each analyzer has certain
precision study. The estimated bias for all analytes was within
performance characteristics that can be highly sample-
verification limits. However, the method comparison study
dependent. Manufacturers validate their analyzers accord-
showed concentration-dependent variations for MCHC, MCH,
ing to global and regional requirement guidelines. The most
and mean platelet volume (MPV) parameters. Furthermore,
informative way is to select the optimum analyzer for lab-
the correlation of parameters between Alinity HQ and Cell
oratory verification studies with relevant samples before a
Dyn Ruby ranged from 0.46 to 1.00. The LoB and carry-over
new diagnostic analyzer is put into routine use [3]. Never-
studies demonstrated satisfactory performance for the Alinity
theless, it is a requirement to evaluate the performance of a
HQ analyzer.
particular analyzer under laboratory conditions where the
Conclusions: Although some parameters had higher CVs
device will be run using the samples of a specific targeted
than expected and concentration-dependent bias, the overall
population and operated by laboratory personnel.
International standards, such as the International
*Corresponding author: Nilufer Bayraktar, Department of Medical Council for Standardization in Hematology (ICSH) guidelines
Biochemistry, Başkent University Faculty of Medicine, Ankara, Türkiye, [4], the Clinical Laboratory Standards Institute (CLSI) guide-
Phone: +90 533 332 22 03, E-mail: [email protected]. https://orcid.
lines [5–8], and the ISO 15189 standards [9], state that every
org/0000-0002-7886-3688
Deniz Ilhan Topcu, Department of Medical Biochemistry, Başkent
laboratory should verify the performance of their hematology
University Faculty of Medicine, Ankara, Türkiye. https://orcid.org/0000- analyzers. The verification methods described by these guide-
0002-1219-6368 lines include precision, accuracy, comparability, carry-over,
Open Access. © 2023 the author(s), published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 International License.
2 Bayraktar and Topcu: User verification of Alinity HQ

background (limit of blank [LoB]), and linearity throughout the operation, patient samples are sequentially pipetted into these blocks
expected range of results [4–10]. However, the assessment of to enable high throughput. Here, for a more comprehensive assess-
ment, the precision of each block was evaluated separately. In addition
analytical performance on different levels is usually not
to calibration and quality control (QC), carry-over should also be
detailed, and interpretation is the responsibility of the labora- assessed on the two incubation blocks [12].
tory professionals. It is up to the laboratory specialist or labo- The CELL-DYN Ruby (Abbott Laboratories, Diagnostic Division,
ratory procedures to decide which standard to follow or which Abbott Park, IL, USA) provides 22 blood count parameters, including a
verification limit to use [10]. five-part WBC differential. The system utilizes the Multiangle Polarized
Scatter Separation technology and laser flow cytometry. The CELL-DYN
This study aimed to verify the performance characteris-
Ruby also provides an integral reticulocyte analysis and nuclear optical
tics of the Alinity HQ hematology analyzer compared with the
count [13].
previously used Abbott Cell Dyn Ruby in a routine laboratory
setting according to the CLSI H26-A2, CLSI EP15-A3, CLSI EP09,
CLSI EP17, and ICSH guidelines [4–8]. We analyzed precision Performance evaluation
(short-term and long-term), accuracy (method comparison
and estimation of bias as a measure of trueness), confirmation Precision studies: The precision study was performed in two stages:
of a LoB, and carry-over to offer guidance on the verification short-term precision and long-term precision, as recommended by the
ICSH and CLSI guidelines, EP15-A3 and H26-A2, respectively [4–6].
of the automated hematology analyzer.
Imprecision was reported in terms of CV%. All precision studies were
performed for both incubation blocks.

Materials and methods Short-term precision: Repeatability and within-laboratory imprecision

studies were performed as short-term precision evaluations. Repeat-
Study protocol ability was calculated by measuring (1) three different levels of patient
samples and (2) three-level internal quality control (IQC) materials (low,
medium, and high). Within-laboratory imprecision was calculated using
The Ethics Committee of Başkent University approved the study with the only IQC materials.
decision numbered KA21/333, dated October 14, 2022. Repeatability (CVr) and within-laboratory precision (CVwl) studies
for IQC materials were performed according to the CLSI EP15-A3 guideline
Specimen collection and preparation by measuring three IQC samples per day, five replicates on the left block
and five on the right for five days. As per the guidelines, the precision
calculation can be summarized as follows: outliers were removed from
The samples used in this evaluation were sourced from the outpatient and the dataset using Grubbs’ test, and one-way analysis of variance (ANOVA)
inpatient departments of Başkent University Hospital. For routine CBC was applied. The variance components obtained from ANOVA, VB and VW,
analyses, all samples were collected using K2‐ethylenediaminetetraacetic were utilized to calculate repeatability, between-run standard deviations,
acid Vacusera blood collection tubes (Disera, İzmir, Turkey). Samples with and CV% values. Subsequently, actual manufacturer claims were used to
visible hemolysis, coagulation, or blood clots were excluded, with the determine verification limits for the precision study. Ten different patient
samples selected according to normal and abnormal hematological samples were analyzed in 10 replicates according to the ICSH guidelines
profiles of the subjects. The whole‐blood samples were stored at room for patient sample repeatability, with mean, standard deviation (SD), and
temperature (18–26 °C) until analysis, as required by the CLSI H26A CV% values calculated for these samples.
guideline [5]. We also proposed a novel plot for evaluating the precision study
results in accordance with the EP15-A3 guideline. In this representation,
Complete blood count analysis CV% values are plotted on the x-axis, while repeatability and within-lab CVs
are illustrated on the y-axis. Different colors are used to differentiate the
various QC sample levels. Manufacturer claims are represented by solid-
Alinity HQ (Abbott Laboratories, Diagnostics Division, Hematology,
colored bars, and extended verification limits – sourced from the precision
Santa Clara, CA, USA) is a new high-sample throughput hematology
study results – are depicted in transparent colors. A black bar is used to
analyzer. The Alinity HQ uses optical principles for all measurements.
highlight the acquired CV% values. The code associated with this plot is
Hemoglobin levels are determined using spectrophotometry. Alinity
available on GitHub (https://github.com/ditopcu/EP15A3_Precision_Plot).
HQ utilizes advanced multi-angle polarized scatter separation
(MAPSS™) technology, using seven light detectors positioned at
different angles and a fluorescence detector. The analyzer employs a Long-term precision: A long-term QC precision study as a within-batch
combination of photometry, optical flow cytometry, fluorescence precision was carried out for 30 days in alignment with the ICHS
analysis, and advanced software algorithms to enumerate cells and guideline. During this period, a three-level QC study was conducted
report 29 different parameters. Nucleated cells are measured using a three times a day for both incubation blocks (90 runs per block) at 8-h
fluorescent nuclear dye reagent, staining the nuclei for MAPSS. intervals in accordance with the laboratory’s routine practice.
Nucleated cells are reported as six-part white blood cell (WBC) dif-
ferentials, including immature granulocytes and nucleated red blood Accuracy studies
cell (RBC) counts [11]. Each Alinity HQ module has two unique mea- Method comparison: Initially, patient samples of different levels were
surement units, the “left block” and the “right block.” In routine tested using the new Abbott Alinity HQ analyzer and the routinely used
 Bayraktar and Topcu: User verification of Alinity HQ 3

Abbott Cell Dyn Ruby analyzer. The results were then evaluated using Carry-over: Carry-over was assessed by analyzing three pairs of samples
Passing–Bablok regression analysis and Bland–Altman plots. To [4, 5]. The data yield from a high-concentration sample followed by a low
ensure a comprehensive comparison of various CBC parameters, we concentration could be evaluated by running sample A (high sample)
utilized a minimum of 120 patient samples. These samples were spe- three times (A1, A2, and A3), followed by sample B (low sample) three
cifically selected from diverse departments, including but not limited times (B1, B2, and B3). The percentage of carry-over for RBC, PLT, and
to normal, hematological, oncological, adult, and pediatric units. Due WBC parameters was calculated as follows:
to inherent workload and cost constraints, we maintained the sample
Carryover% = [(B1 − B3)/(A3 − B3)] × 100
size at around 120 for method comparison according to the CLSI EP09
guideline [7].
During the study, IQC materials from Abbott Diagnostics (IL, USA) Statistical evaluation: All statistical analyses were performed using R
were assessed every 8 h, and monthly proficiency testing (PT) was statistical software 4.3.1. In this study, we utilized up-to-date imprecision
conducted using RANDOX quality controls (County Antrim, United and bias targets sourced from the biological variation (BV) due to its
Kingdom) to ensure the analytical performance of the Abbott Cell Dyn more rigorous criteria instead of adhering to the clinical decision levels
Ruby analyzer. All necessary corrective actions were performed outlined in CLSI H26-A2. The precision study conducted with patient
according to the laboratory policy for IQC results, and all results were samples was evaluated according to BV imprecision limits sourced from
evaluated as acceptable for proficiency testing. the EFLM Biological Variation database [14]. Repeatability and within-
laboratory precision results for IQC materials were evaluated according
to the manufacturer’s claims. Finally, long-term precision results were
Estimation of the bias: The estimation of bias was performed using PT
assessed using the BV imprecision data. All limits related to precision
samples in bias studies, as they are prioritized over IQC samples
and accuracy studies are given in Supplementary Table 1. The method
according to the CLSI guideline. However, the study was designed to
comparison results were not normally distributed, and Spearman cor-
span three days due to constraints with the PT samples, allowing for
relation coefficients were thus calculated for method comparisons. A
only three replicates in the left incubation block. In accordance with
degree of agreement between the same parameters analyzed with the
CLSI EP15-A3 [6], four RANDOX quality control PT samples were used to
two hematology analyzers was evaluated using the non-parametric
evaluate whether the results obtained by the laboratory were within
Passing–Bablok regression method. The mean percentage differences
the verification limits. Grand means x were determined, and standard
were calculated from the Bland–Altman plots and were used to assess
error of means (sex) were calculated using the sr and swl values
the agreement between the methods. The minimum allowable bias from
obtained from the precision study. Peer results from the PT were used
the BV database was used as the limit of agreement [14].
as the target value (TV), and the standard error of the target value
(serm) was calculated using peer-group standard deviation and number
of peers. Using sex and serm combined, standard error (sec) of mean and
TV were calculated. The multiplier factor (m) was calculated for four Results
samples, and verification intervals (VI) were determined. The calcu-
lation steps are given in the following equations:where m is multipli-
cation factor; PT is proficiency testing; SD is standard deviation; sec is
Precision study results
combined standard error; serm is standard error of the target value; sex
is standard error of means; TV is target value, and VI is verification Short-term precision
interval.
Repeatability and within-laboratory imprecision
Based on the repeatability results (Table 1) regarding patient
samples, it was observed that for the RBC measurements, the
CV% values for all levels in both incubation blocks were
consistently lower than the optimal analytical allowable
imprecision (CVA) of 0.7 %, which was calculated in accor-
dance with BV data. For the PLT measurements, the CV% for
Evaluation of limit of blank: The LoB is determined by analyzing mul- the low level was less than the minimum CVA determined via
tiple sample replicates with no analyte present and then computing the BV data at 5.7 %. Moreover, the CV values were under the
average result and the standard deviation. The determination of the LoB
optimum CVA of 1.9 % for the medium and high levels in the
for WBCs, RBCs, and platelets (PLTs) was conducted in accordance with
the CLSI EP17 guideline, utilizing 60 blank samples and employing the two incubation blocks. Finally, the WBC measurements
following formula [8]: showed that the CV values for all levels in both incubation
LoB = M B + C p × SDb
blocks remained generally below the minimum CVA as
1.645 defined by BV data. An exception was seen in the left block
cp =
readings, where the low-level CV value slightly exceeded the
1 − (4(B−K)
1
)
minimum CVA threshold.
where LoB is limit of blank; MB is mean of blank samples; SDb is standard The results for the evaluation of repeatability CV (CVr)
deviation of blank samples; Cp is multiplier; B is total number of blank and within-laboratory CV (CVwl) values obtained according
results; and K is number of blank samples. to manufacturer claims are given in Table 2 and Figure 1. As
4 Bayraktar and Topcu: User verification of Alinity HQ

Table : Repeatability study results conducted with patient samples. Table 2 shows, for both blocks, the CVwl values in level 1
and level 2 MCV measurements are above the verification
Test Level Left block Right block limit calculated according to the CV values given by the
Mean CV, % Mean CV, % manufacturer. Moreover, CVwl values in level 1 and level 2

WBC, × /L Low . . . . MCHC QC measurements of the left block were above the
Normal . .  . compliance limit calculated according to the CV values
High . . . . given by the manufacturer. All other measurement results
RBC, ×/L Low . . . . were within calculated limits.
Normal . . . .
High . . . .
PLT, ×/L Low . . , . Long-term precision
Normal  .  .
High  .  .
When the long-term precision data were analyzed, the CV values
CV, coefficient of variation; WBC, white blood cell. obtained for the basophil count at all levels and for eosinophil

Table : Repeatability and within-laboratory study results conducted with internal quality control (IQC) materials provided by the manufacturer.

QC Manufac- Left block Right block

level turer claim

CVr, CVwl, Mean Actual Limit Actual Limit Mean Actual Limit Actual Limit
% % CVr, % CVr, % CVwl, % CVwl, % CVr, % CVr, % CVwl, % CVwl, %

WBC, ×/L Level  . . . . . . . . . . . .
Level  . . . . . . . . . . . .
Level  . .  . . . . . . . . .
Neutrophils, Level    . . . . . . . . . .
×/L Level    . . . . . . . . . .
Level    . . . . . . . . . .
Lymphocytes, Level  . . . . . . . . . . . .
×/L Level    . . . . . . . . . .
Level    . . . . . . . . . .
Monocytes, Level  . . . . . . . . . . . .
×/L Level    . . . . . . . . . .
Level     . . . . . . . . .
Basophils, ×/ Level    . .  . . . .  . .
L Level    .    . . .  . .
Level    . . . . . . . . . .
Eosinophils, Level    . .  . . . .  . .
×/L Level  . . . . . . . . . . . .
Level    . . . . . . . . . .
RBC, ×/L Level  . . . . . . . . . . . .
Level  . . . . . . . . . . . .
Level  . . . . . . . . . . . .
Hemoglobin, Level  . . . . . . . . . . . .
g/dL Level  . .  . . . .  . . . .
Level     . . . .  . . . .
Hematocrit, % Level  . . . .  . .  .  . .
Level  . . . . . . . . . . . .
Level  . . . . . . . . . . . .
MCV, fL Level    . . . . . . . . . .
Level    . . . . . .  . . .
Level    . . . . . . . . . .
MCH, pg Level  . . . . . . . . . . . .
Level  . . . . . . . . . . . .
Level  . .  . . . . . . . . .
MCHC, g/L Level  . .  . . . . . . . . .
Level  . . . . . . .  . . . .
Level  . . . . . . . . . . . .
 Bayraktar and Topcu: User verification of Alinity HQ 5

Table : (continued)

QC Manufac- Left block Right block

level turer claim

CVr, CVwl, Mean Actual Limit Actual Limit Mean Actual Limit Actual Limit
% % CVr, % CVr, % CVwl, % CVwl, % CVr, % CVr, % CVwl, % CVwl, %

RDW-SD, fL Level  . .  . . . .  . , . .
Level    . . . . . . . . . .
Level  . . . . . . . . . . . .
PLT, ×/L Level    . . . . . . . . . .
Level     . . . .  . . . .
Level     . , . .  . . . .
MPV, fL Level  . . . . . . . . . . . .
Level  . . . . . . . . . . . .
Level  . . . . . . . . . . . .

CV, coefficient of variation; CVr, repeatability CV; CVwl, with-in laboratory CV.

Figure 1: Internal quality control (IQC) precision study results. Black line represents actual coefficient of variation (CV) values. CV% values are plotted on
the x-axis, with repeatability and within-lab CVs depicted on the y-axis. Various colors distinguish different QC sample levels. Solid bars represent
manufacturer claims, while transparent bars indicate extended verification limits obtained from the precision study. A black bar highlights acquired CV%
values. Black line represents actual CV values. Green, pink and blue bars represent level 1, level 2 and level 3 QC materials respectively. Dark colors indicate
manufacturer claims and transparent colors indicate limits calculated according to the CLSI EP15A3. CV, coefficient of variation; CVr, repeatability CV;
CVwl, within-laboratory CV.

and monocyte counts at level 1 were above the minimum CVA Accuracy study results
value determined according to BV data. Similarly, the MCH,
MCHC, and RDW-SD parameters also exhibited values above Method comparison
the minimum permitted CVA for all levels and blocks. In
terms of MCV values, the level-1 CV for both blocks and level-2 In the patient result comparison, the correlation coefficients
CV for the right block were higher than CVA. In addition, varied from 0.46 to 1.00, as shown in Table 4. According to
level three CV values for RBC and hematocrit measurements the Passing–Bablok regression analysis results, the slope
were above the minimum permitted CVA (Table 3). All other confidence interval included 1, and the intercept confidence
measurement results were found to follow the BV claims. interval included 0 only for the eosinophil and monocyte
6 Bayraktar and Topcu: User verification of Alinity HQ

Table : Intermediate precision for  days using manufacturer internal quality control (IQC) materials.

Left block Right block

Low level Normal level High level Low level Normal level High level

Mean CV, % Mean CV, % Mean CV, % Mean CV, % Mean CV, % Mean CV, %

WBC, × /L . . . . . . . . . . . .
Neutrophils, ×/L . . . . . . . . . . . .
Monocytes, ×/L . . . . . . . . . . . .
Lymphocytes, ×/L . . . . . . . . . . . .
Basophils, ×/L . . . . . . . . . . . .
Eosinophils, ×/L . . . . . . . . . . . .
RBC, ×/L . . . . . . . . . . . .
Hemoglobin, g/dL . . . . . . . . . . . .
Hematocrit, % . . . . . . . . . . . .
MCV, fL . . . . . . . . . . . .
MCH, pg . . . . . . . . . . . .
MCHC, g/L . . . . . . . . . . . .
RDW-SD, fL . . . . . . . . . . . .
PLT, ×/L . . . . . . . . . . . .
MPV, fL . . . . . . . . . . . .

CV, coefficient of variation.

tests (Figure 2). The confidence intervals for the other tests were analyzed, a concentration-dependent pattern was
were extremely close to the desired intervals, except for the observed in the MCHC, MCH, and MPV parameters, including
MCHC and basophil tests. When the Bland–Altman plots the calculation shown in Figure 3.

Table : Method comparison results.

Test n Range Spearman Passing–Bablok regression analysis Bland–Altman Limit of agree-

correlation menta %
Abbott Abbott R Slope, CI Intercept, CI Mean % diff.
Rubby Alinity HQ (mean absolute
diff)

WBC, ×/L  .–. .–. . . (.–.) . (.–.) . (.) .
Neutrophils,  .–. .–. . . (.–.) . (.–.) . (.) .
×/L
Monocytes,  .–. .–. . . (.–.) −. (−. to .) −. (−.) .
×/L
Lymphocytes,  .–. .–. . . (.–.) . (−. to .) . (.) .
×/L
Basophils, ×/  .–. .–. . . (.–.) −. (−. to −.) . (.) .
L
Eosinophils,  .–. .–. . . (.–.) . (−. to .) . (.) .
×/L
Erythrocytes,  .–. .–. . . (.–.) . (.–.) . (.) .
×/L
Hemoglobin,  .–. .–. . . (.–.) . (.–.) . (.) .
g/dL
Hematocrit, %  .–. .–. . . (.–.) . (−. to .) . (.) .
MCV, fL  .– .– . . (.–.) −. (−. −. (−.) .
to −.)
MCH, pg  .–. .–. . . (.–.) . (.–.) −. (−.) .
MCHC, g/L  .–. .–. . . (.–.) . (.–.) −. (−.) .
RDW-SD, fL  .–. .–. . . (.–.) . (.–.) −. (−.) .
PLT, ×/L  .– .– . . (.–.) −. (−. to .) −. (−.) .
MPV, fL  .–. .–. . . (.–.) . (.–.) −. (−.) .

CI, confidence interval; Diff., difference. aThe minimum allowable bias from BV database.
 Bayraktar and Topcu: User verification of Alinity HQ 7

Figure 2: Passing–Bablok regression analysis. Identity lines (y=x) are dashed green, confidence intervals are claret and regression lines are blue.

Figure 3: Bland–Altman plots for method comparison study. y=0 lines are dashed green, mean differences (%) are blue, confidence intervals are solid
gray. Second y axis represents CIs. Green area indicates the limit of agreement (minimum allowable bias 24.17 %).
8 Bayraktar and Topcu: User verification of Alinity HQ

Evaluation of the estimation of bias Limit of blank

The results of all parameters were within the verification The LoB was calculated as 0.086 × 109/L for WBCs,
ranges, except for the low-level QC results of PLT, as shown 0.002 × 1012/L for RBCs, and 0.331 × 109/L for PLTs, below the
in Table 5. manufacturer’s claims, as shown in Supplementary Table 2.

Table : Estimation of bias according to the CLSI EP-A.

Test Grand mean (x)a sex Proficiency testing Verification interval

Sample serm m.sec Target value (peer mean)


WBC, × /L . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.
RBC, ×/L . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.
Hemoglobin, g/dL . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.
Hematocrit, % . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.
MCV, fL . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.
MCH, pg . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.
MCHC, g/L . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.
RDW-SD, fL . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.
PLT, ×/L . .  . . . .–.
. .  . . . .–.
. .  . .  –
. .  . .  –
MPV, fL . .  . . . .–.
. .  . . . .–.
. .  . . . .–.
. .  . . . .–.

m, multiplication factor; sec, combined standard error; serm, standard error of the target value; sex, standard error of means. aGrand mean must be between
verification interval.
 Bayraktar and Topcu: User verification of Alinity HQ 9

Carry-over and MCV measurements were above the minimum allow-

able CVA. The poor performance of the long-term precision
The carry-over results for all three parameters were results compared with the short-term precision results was
between 0 and 1 %, below the manufacturer’s claims, as thought to be due to the relatively low stability of the he-
shown in Supplementary Table 3. matology IQC materials and the use of a new IQC bottle,
albeit with the same lot, approximately every 7 days during
the one-month period.
In comparing the Alinity HQ analyzer with the Cell Dyn
Discussion Ruby, the correlation coefficients varied from 0.46 to 1.00. For
the eosinophil and monocyte tests, the Passing–Bablok results
In this study, we assessed the analytical performance char- indicated that the slope confidence interval included 1,
acteristics of the Abbott Alinity HQ automated hematology and the intercept confidence interval included 0. However,
system. We concurrently compared the Alinity HQ with the except for the MCHC and basophil tests, the confidence
Cell Dyn Ruby hematology analyzer, the latter of which is intervals were extremely close to the desired intervals.
routinely used in our hospital laboratory. Our short-term Another interesting finding from the Bland–Altman plots
precision results for IQC materials, patient samples, and bias was the concentration-dependent pattern observed in the
estimation were within an acceptable range. However, the MCHC and MCH parameters. It was thought that the differ-
long-term precision results did not meet the BV-based ences in the measurement methods of both devices may
acceptability criteria. have caused this pattern. The lower level of correlation
We conducted an extended repeatability study using among the various parameters, such as differential mono-
both patient samples and IQC material for short-term pre- cyte, eosinophil, basophil counts, and calculated parameters
cision. Based on the repeatability results with patient sam- (e.g., RBC indices and PLT counts) in the thrombocytopenic
ples, the CV values for RBC measurement in both incubation range, is documented in most analyzers [9–12]. Khodaiji et al.
blocks fell below the optimal CVA calculated according to BV [15] observed that the correlation of results between ELite
data. In addition, the CV for PLT measurement was below the 580 and LH 780 was r2≥0.92 except for MCHC (0.35), MPV
minimum CVA based on BV data. In terms of WBC mea- (0.88) and basophils (0.06). They also found satisfying esti-
surement, the CV values in both incubation blocks were mated bias results for all WBC differential counts except for
below the BV-calculated minimum CVA, with the left incu- basophils in the same study.
bation block slightly exceeding this value. These results According to the published studies, the variability is
suggest that the analyzer demonstrated high performance usually greater than intra-patient variation when
for repeatability. Determining the repeatability was impor- comparing two hematology devices because analyzers are
tant to determining the test quality of the analyzer and independent analytical systems [3, 4, 16]. The use of various
confirming the good repeatability of analyzing samples with methods of determination is one of the reasons for the
minimum differences. variability, as well as the use of calibrators and quality
In the short-term precision study conducted using IQC control materials from multiple manufacturers. Reflecting
materials, CVr and CVwl values were calculated for both on this, we believe that these factors may have come into
incubation blocks. The CV values obtained were below the play in our study. We surmise that the reason for the
limits claimed by the manufacturer for almost all tests. The incompatible results in the method comparison in this study
CVwl values in level-1 and level-2 MCV QC measurements for may be related to how the Alinity HQ employs a combination
both blocks and the MCHC at level-1 and level-2 QC mea- of photometry, optical flow cytometry, fluorescence anal-
surements of the left block were above the compliance limit ysis, and advanced software algorithms. In contrast, Cell Dyn
calculated according to the CV values given by the manu- Ruby’s limited technology uses a less sensitive optical
facturer. This was an interesting finding; both incubation method.
blocks had similarly higher CVs for the same tests. Due to the technological differences between the Alinity
When the long-term precision data were analyzed, the HQ and Cell Dyn Ruby analyzers, bias estimation was per-
CV values obtained for basophils at all levels and the formed to evaluate the accuracy, in addition to the method
eosinophil and monocyte counts at level-1 samples were comparison study. Our study included assessing results
above the minimum allowable CVA. Similarly, the MCH, obtained from the precision study for trueness estimation.
MCHC, and RDW-SD parameters also exhibited values above We evaluated the statistical significance of the actual bias as
the minimum permitted CVA for all levels and blocks. per EP15-A3 guidelines, for which we followed a step-wise
Furthermore, the CV values obtained in the RBC, hematocrit, approach toward finding the verification interval of the
10 Bayraktar and Topcu: User verification of Alinity HQ

target value, which had a 95 % probability of true difference. Acknowledgments: We would like to thank the staff mem-
For all parameters, the estimated bias in this study was bers of hematology.
within the Vis, except for the low-level QC results for PLT Research ethics: The study was approved by the Ethics
count. Committee of the Başkent University with the decision
According to the relevant guidelines and previous numbered KA21/333, and dated October 14, 2022.
studies, a LoB check of the hematology analyzer is impor- Informed consent: None declared.
tant. The manufacturer defines the limit of background Author contributions: The authors have has accepted
electronic noise; for optimal conditions, the background responsibility for the entire content of this manuscript and
counts should be zero. This is especially important in body approved its submission.
fluids with extremely low cell counts, such as cerebrospinal Competing interests: The authors state no conflict of
fluid [4, 5, 17]. Here, the LoB was calculated as 0.086 × 109/L interest.
for WBCs, 0.002 × 1012/L for RBCs, and 0.331 × 109/L for PLTs, Research funding: None declared.
with all below the manufacturer’s claims. Data availability: Not applicable.
The carry-over values in this analytical performance
study were better than those recommended by the Alinity
HQ manufacturer; the carry-over for WBC and PLT must be
1 % and for RBC≤0.5 %. These data showed that there was no References
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