Clin Chem Lab Med 2019; aop
Jooyoung Cho, Kyeong Jin Oh, Beom Chan Jeon, Sang-Guk Lee* and Jeong-Ho Kim
Comparison of five automated urine sediment
analyzers with manual microscopy for accurate
identification of urine sediment
https://doi.org/10.1515/cclm-2019-0211
Received February 22, 2019; accepted June 1, 2019
Abstract
Background: While the introduction of automated urine
analyzers is expected to reduce the labor involved, turn-
around time and potential assay variations, microscopic
examination remains the “gold standard” for the analysis
of urine sediments. In this study, we evaluated the analyti-
cal and diagnostic performance of five recently introduced
automated urine sediment analyzers.
Methods: A total of 1016 samples were examined using
five automated urine sediment analyzers and manual
microscopy. Concordance of results from each automated
analyzer and manual microscopy were evaluated. In addi-
tion, image and microscopic review rates of each system
were investigated.
Results: The proportional bias for red blood cells (RBCs),
white blood cells (WBCs) and squamous epithelial cells in
the automated urine sediment analyzers were within ±20%
of values obtained using the manual microscope, except
in the cases of RBCs and WBCs analyzed using URiSCAN
PlusScope and Iris iQ200SPRINT, respectively. The sen-
sitivities of Roche Cobas® u 701 and Siemens UAS800 for
pathologic casts (73.6% and 81.1%, respectively) and crys-
tals (62.2% and 49.5%, respectively) were high, along with
high image review rates (24.6% and 25.2%, respectively).
The detection rates for crystals, casts and review rates can
be changed for the Sysmex UF-5000 platform according to
cut-off thresholds.
*Corresponding author: Sang-Guk Lee, MD, PhD, Department
of Laboratory Medicine, Yonsei University College of Medicine,
Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722,
Korea, Phone: +82-2228-2455, Fax: +82-2-364-1583,
E-mail: comforter6@yuhs.ac
Jooyoung Cho: Department of Laboratory Medicine, Yonsei
University College of Medicine, Seoul, Korea; and Department of
Laboratory Medicine, Yonsei University Wonju College of Medicine,
Wonju, Korea. https://orcid.org/0000-0002-9628-2334
Kyeong Jin Oh, Beom Chan Jeon and Jeong-Ho Kim: Department
of Laboratory Medicine, Yonsei University College of Medicine,
Seoul, Korea
Conclusions: Each automated urine sediment analyzer
has certain distinct features, in addition to the common
advantages of reducing the burden of manual process-
ing. Therefore, laboratory physicians are encouraged to
understand these features, and to utilize each system in
appropriate ways, considering clinical algorithms and
laboratory workflow.
Keywords: automated urine sediment analyzer; Cobas®
u 701; Iris iQ200SPRINT; UAS800; UF-5000; URiSCAN
PlusScope.
Introduction
Urinalysis is one of the most commonly performed diag-
nostic tests in clinical laboratories, after serum chemistry
and complete blood count [1]. Urinalysis is relatively easy
and enables overall investigation of both physiologic and
anatomic properties in a wide range of disorders, includ-
ing urinary tract infection, kidney disease, and metabolic
and systemic diseases [2].
Urinalysis is composed of two main components –
physicochemical testing using reagent strips and urine
sediment analysis [2–4]. Urine reagent strip testing is
easy to perform at low cost, but the interpretation of the
reagent strip is affected by factors, such as discoloration
by moisture or heat, interference, and inter-individual
variability with regard to visual reading [2–6]. Urine sedi-
ment analysis can provide information regarding spe-
cific particles, which is helpful in interpreting urinalysis
results [2]. However, microscopic examination is time-
consuming, labor intensive and has a large inter-observer
variation [7–12].
The introduction of automation in urinalysis has
improved the accuracy and reliability of test results,
with high throughput and reduced labor, time and
potential variations [6–9, 12–15]. However, automated
urine ­ sediment analyzers have certain limitations,
such as lack of precision and standardization, and
deficits in ­ sensitivity and specificity [8, 16–18]. For
these reasons, manual microscopy remains the “gold
­standard” [11, 18, 19].
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2 Cho et al.: Comparison of five automated urine analyzers
Urine sediment analyzers can be divided into two dif-
ferent systems based on their principle of function; one
is a digital image-based system, and the other is flow
cytometry-based system [2, 5, 9]. Digital image-based
systems analyze urine sediments based on several images
taken by a built-in digital camera, followed by automatic
particle recognition and sorting [7, 8, 11, 12, 15, 20]. Flow
cytometry-based systems analyze electrical impedance,
forward-scattered light (FSC), side-scattered light (SSC),
and side fluorescence light (SFL) of urine sediments in
order to distinguish between the particles [6, 9, 10, 14, 17,
19]. With generational increments in platform instrumen-
tation, both of these systems have improved in analytical
performance, and exhibit better concordance rates with
manual microscopy than they did previously [3, 15, 17, 20,
21]. Hence, full automation of urinalysis in the near future
is promising, and is expected to replace more traditional
or manual methods in routine laboratory use.
Recently, next-generation automated urine sediment
analyzers have been introduced in clinical practice. Some
of these include the UF-5000 systems from Sysmex Cor-
poration (Kobe, Japan), Cobas® u 701 from Roche Diag-
nostics (Rotkreuz, Switzerland), UAS800 from Siemens
Healthineers (Erlangen, Germany), Iris iQ®200SPRINT
from Beckman Coulter (Brea, CA, USA), and URiSCAN®
PlusScope from YD diagnostics (Yongin, Korea). With the
development of these next-generation automated systems,
urine analyzers are expected to yield more precise and
clinically valid results, thus eliminating the need for
manual microscopy in most cases. In the present study,
we evaluated the analytical and diagnostic performance
of five recently introduced automated urine sediment
analyzers and compared their performance with manual
microscopy.
Materials and methods
Specimens and study design
From September to November 2017, a total of 1016 urine specimens
were selected randomly from in-patient samples submitted to the
clinical laboratory for routine urinalysis at a tertiary-level, univer-
sity-affiliated Severance Hospital (Seoul, Korea). Fresh urine samples
were collected from in-patients in 50 mL sterile culture cups, using
the clean catch mid-stream technique. Just after the routine urinaly-
sis was completed, each sample was aliquoted into two conical tubes
– 12 mL for manual microscopy, and 15 mL for the five urine sediment
analyzers. In order to prevent order bias, the measurement sequence
was changed for each run, based on our prepared order scheme
(e.g. ABCDE, BCDEA, CDEAB, DEABC and EABCD). The samples
were measured in series by five analyzers without any time interval
between the measurements. In accordance with the CLSI guideline
GP16-A3, all samples were analyzed within 2 h of their receipt in our
laboratory [22]. There was no significant contamination (less than
1%) from previous samples in carry-over study that used high- and
low-level pooled samples of red blood cells (RBCs) and white blood
cells (WBCs) (data not shown).
Parameters that were common for all five urine analyzer plat-
forms were tested: RBCs, WBCs, squamous epithelial cells (SQEPs),
non-squamous epithelial cells (NECs), crystals, hyaline casts, patho-
logic casts, yeast, sperm and mucous threads. Bacteria were not eval-
uated in this study because urine culture is a reference method and
not a manual microscopy technique.
This study was performed with authorization from the Insti-
tutional Review Board (IRB) of Severance Hospital (IRB no. 1-2017-
0038).
Automated urine sediment analyzers
Sysmex UF-5000 is a third-generation urine sediment analyzer
developed by the Sysmex Corporation [21]. The UF-5000 uses a flow
cytometry-based system, with FSC, SSC and SFL. In addition to these
components, the UF-5000 uses depolarized side scattered light (DSS)
to differentiate between RBCs and crystals. This analyzer is a fully
automated urinalysis system with a modular concept for urinalysis
workflow, and can be used with UD-10, a newly developed urine
image viewer.
Roche Cobas® u 701 is a urine sediment analyzer that uses the
digital image-based system. The modular Cobas® 6500 urinalysis
platform is composed of Roche Cobas® u 701 and Roche Cobas® u
601 instruments. Urine specimens are pipetted into a cuvette, and
then centrifuged at 260 g for 10 s to create a monolayer of particles
at the bottom. A built-in digital camera takes 15 microscopic images,
which they are analyzed by an Automated Image Evaluation Module
(AIEM).
Siemens UAS800 is a brand-new urine sediment analyzer from
Siemens Healthineers. The UAS800 uses a digital image-based
system, which provides complete fields of view, similar to manual
microscopy. With the integration of CLINITEK Novus, Siemens
Healthineers has launched the Atellica 1500 for urinalysis. The basic
principles of UAS800 are similar to those of the Roche Cobas® u 701
platform.
Beckman Coulter Iris iQ®200SPRINT functions on a digital
image-based system. However, its main principle differs from that of
Siemens UAS800 and Roche Cobas® u 701. Urine samples are stained
and passed through a lamina flow cell chamber, similar to flow
cytometry. A digital camera captures 500 pictures, and an Auto Par-
ticle Recognition (APR™) system sorts and classifies each of the pic-
tures taken [5, 7, 20]. On the result screen, images of each parameter
can be viewed, and the operator can verify each particle, or identify
novel parameters.
YD URiSCAN® PlusScope is based on a digital image-based sys-
tem. The URiSCAN® PlusScope uses a multi-counting chamber, and
the built-in automated microcopy captures real microscopic images.
A Coordinate Positioning Tracking Recognition (CPTR™) system
uses one of two tracking modes depending on sample type. A low-
power field (LPF, ×100 magnification) lens is used to take 10 images,
and then a high-power field (HPF, ×400 magnification) lens tracks
particles and takes 10 images upon consideration of each of the
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parameters detected by the LPF lens. Finally, the images are analyzed
by a built-in automated analyzer. In this study, we used a prototype
of a YD URiSCAN® PlusScope, as it was not yet officially launched.
Manual microscopic examination
Sediment examination using manual microscopy was performed
according to CLSI guideline GP16-A3 [22]. It has been established that
the gold standard chamber for the microscopic examination is the
Fuchs-Rosenthal chamber. However, we used the standardized KOVA
cell chamber system [KOVA® Systemic Super Pac 1000 w Counting
Grids (KOVA International Inc., Garden Grove, CA, USA)] for micro-
scopic counting because it provides a standardized quantitation [23].
Each 12 mL urine sample was centrifuged at 400 g for 5 min, and
then approximately 11 mL of supernatant was removed. The mean
final volume of precipitate that remained after centrifugation was
1.10 ± 0.05 mL (mean ± standard deviation, n = 50). The concentra-
tion fold for sediment from total urinary volume used was 10.91. Each
chamber consisted of 9 × 9 small grids. The total area under the grids
(Agrids) was 9 mm2 (3 × 3 mm) and total volume of these grids (Vgrids)
was 0.9 μL (chamber depth: 0.1 mm). Thus, the volume of one small
grid was 0.0111 μL (≈0.9 μL/81) (Supplementary Table 1). Therefore,
when converting particles/grid to particles/μL, the value was multi-
plied by 90 (1 μL = 90 grids). According to the instructions posted on
the website of KOVA International Inc. [24], we estimated the con-
version factor from particles/grid to particles/μL using the following
formula:
particles/µL
= (particles/grid) × 90 grid/µL/fold concentration (= 10.91)
= (particles/grid) × 8.25 grid/µL
Two well-trained laboratory technicians counted each type of cells
in the sediments in ten small grids at HPF, and the average number
of particles/grid was converted to particles/μL, using the formula
above. This value was then used as reference for each sample. Inter-
observer coefficient of variation (CV) between the two technologists
was 3.70% for RBCs and 3.56% for WBCs.
Comparative study of urine sediment analyzers and
manual microscopy
For RBCs, WBCs and SQEPs, the mean number of cells counted by
two technologists were compared with numbers obtained from
each automated urine sediment analyzers using the Passing-Bablok
regression analysis. For other parameters (crystal, hyaline cast,
pathologic cast, NEC, yeast, sperm and mucous thread), the result
was expressed as either “positive” or “negative”. The cut-off values
for bacteria and each of the qualitative parameters were determined
using values suggested by the platform manufacturers (Supplemen-
tary Table 2).
Image and microscopic review rate
Image review rate was determined using the percentage of the follow-
ing cases: cases reported as “invalid” (cannot be analyzed) and cases
Cho et al.: Comparison of five automated urine analyzers 3
reported as “positive” for the presence of either crystal, pathologic
cast, yeast or sperm. If a case met the criteria of image review, a flag
was displayed. Because the UF-5000 is a flow cytometry-based sys-
tem and cannot provide digital camera images, the UD-10 was used
in the image review process. For other devices, we could review their
own camera screen. The microscopic review rate is the percentage of
uninterpretable cases (as determined by image review) due to being
out of focus, low image quality or involving crowded particles. There-
fore, such cases were confirmed by manual microscopy.
Interference study
We evaluated the effect of interference on RBC, WBC and bacterial
counts by crystals, pathologic casts (non-hyaline casts) and yeast.
The differences between semi-quantitative grades of RBC, WBC and
bacteria in total and specific samples (“positive” for each interfer-
ent, as determined by manual microscopy) were analyzed [25]. The
results for RBC and WBC counts were categorized into six ranges as
follows: 0–2/HPF, 3–5/HPF, 6–10/HPF, 11–20/HPF, 21–50/HPF and
>50/HPF. These categories were then converted to the corresponding
numbers (from 0 to 5). For bacteria, the result was expressed as ‘neg-
ative’, ‘1 + ’, ‘2 + ’, and ‘3 + ’, and these semi-quantitative grades were
converted to the corresponding numbers (from 0 to 3). Median grades
of RBC, WBC and bacteria in the total samples and each selected
group were calculated. The differences between these median grades
were compared using the Mann-Whitney test, and the difference was
considered significant if p-value < 0.05.
Statistical analysis
Passing-Bablok regression was used for comparison of quantitative
parameters (RBC, WBC and SQEP). For qualitative parameters (crys-
tal, hyaline cast, pathologic cast, NEC, yeast, sperm and mucous
thread), we evaluated clinical performance using agreement rate,
sensitivity, specificity, positive predictive value (PPV), negative pre-
dictive value (NPV) and Cohen’s kappa value. Statistical analysis was
performed using SPSS version 20.0 (IBM Corp., Armonk, NY, USA)
and Microsoft Excel 2010 (Microsoft Corp, Redmond, WA, USA) with
Analyse-it version 3.90.7 (Analyse-it Software, Ltd., Leeds, UK).
Results
Comparison of quantitative parameters
of urine sediment analyzers with manual
microscopy
Numeric data for RBC, WBC and SQEP were analyzed using
Passing-Bablok regression. Manual microscopic counts
using KOVA chamber were used as reference (X axis) and
counts from each of automated urine sediment analyzers
were used for comparison (Y axis). The Passing-Bablok
equations for the five urine sediment analyzers are pre-
sented in Table 1. The proportional biases between RBCs
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 4 Cho et al.: Comparison of five automated urine analyzers

–
0.64

0.74
0.61
0.76
measured using the UF-5000, Cobas® u 701, and UAS800

RBC, red blood cell; WBC, white blood cell; SQEP, squamous epithelial cell; p/μL, particles per microliter; CI, confidence interval. aThe Cobas® u 701 reports the SQEP as semi-quantitative value
instead of quantitative value. Manual microscopic counts using the standard KOVA chamber were used as reference (X axis) and counts from each of automated urine sediment analyzers were
compared with values measured using the manual micro-
scope were within ±20% of each other. The slopes for RBC

−5.56 (−8.28 to −2.93)

−2.38 (−3.10 to −1.94)
determined using the UF-5000, Cobas® u 701, UAS800, and
Intercept (95% CI)

1.78 (0.86–3.07)

0.00 (0.00–0.00)
Iris iQ®200SPRINT were 0.99, 0.87, 0.88, and 0.84, respec-
Not availablea tively. For WBC, the UF-5000, Cobas® u 701, UAS800, and
SQEP, p/μL

URiSCAN® PlusScope showed bias within ±20% and had

slopes of 1.14, 1.14, 0.91 and 0.80, respectively. The slopes
for SQEP were 1.12, 1.16, 0.96 and 0.96 using the UF-5000,
UAS800, Iris iQ®200SPRINT, and URiSCAN® PlusScope,
1.12 (0.93–1.39)

1.16 (1.07–1.31)
0.96 (0.71–1.25)
0.96 (0.78–1.24)
Slope (95% CI)

respectively. The Cobas® u 701 reported the SQEP as semi-

Not availablea

quantitative value instead of quantitative value, so we could

not calculate the slopes using the Passing-Bablok analysis.
r

0.92
0.71
0.76
0.91
0.77

Diagnostic accuracy of qualitative

parameters of urine sediment analyzers
−9.27 (−12.94 to −6.44)
−1.89 (−2.14 to 1.57)

−0.79 (−1.11 to 0.00)

Table 2 summarizes the analytical performance of quali-

0.06 (−0.20 to 0.20)
Intercept (95% CI)

0.00 (0.00–0.00)

tative parameters: Crystal, hyaline casts, pathologic

casts, NECs, yeast, sperm and mucous threads. For crys-
WBC, p/μL

tals, the sensitivity using the Cobas® u 701, UAS800, Iris

iQ®200SPRINT, and URiSCAN® PlusScope were 62.2%,
49.5%, 68.5% and 18.0%, respectively. The UF-5000 dis-
solves amorphous crystals using a special reagent, so
Slope (95% CI)

1.14 (1.04–1.24)
1.14 (1.02–1.25)
0.91 (0.85–1.00)
1.28 (1.12–1.35)
0.80 (0.63–1.05)

amorphous urate and amorphous phosphate could not be

detected: Overall sensitivity for crystals, including amor-
phous crystals of the UF-5000, was 29.7%, but after exclud-
ing amorphous crystals, the sensitivity for crystals rose to
46.8%. For hyaline casts, the UAS800 showed high sensi-
r

0.74
0.63
0.50
0.68
0.73

tivity (65.4%). For pathologic casts, both Cobas® u 701 and

UAS800 showed high sensitivity (73.6% and 81.1%, respec-
Table 1: Results of the Passing-Bablok regression for RBC, WBC and SQEP.

tively). For NECs, the UF-5000 and Cobas® u 701 showed

−6.76 (−12.00 to −3.10)
−5.48 (−10.00 to −3.64)

−8.65 (−14.74 to −5.96)

−5.06 (−9.72 to −3.66)

relatively high sensitivity. For yeast, the UF-5000, Cobas®

Intercept (95% CI)

u 701 and UAS800 showed relatively high sensitivity. For

0.00 (0.00–0.00)

sperm, the Cobas® u 701 showed 100% sensitivity. For

RBC, p/μL

mucous threads, four of the five urine sediment analyzers

(except for the UF-5000) showed 70% ~ 90% sensitivity.
In addition, detailed information about the analy-
sis of specific crystals and pathologic casts is shown
Slope (95% CI)

0.99 (0.74–1.32)
0.87 (0.63–1.37)
0.88 (0.64–1.39)
0.84 (0.72–0.96)
0.73 (0.52–1.01)

in Table 3 (crystals) and Table 4 (pathologic casts). For

specific crystals, the Iris iQ®200SPRINT showed higher
detection rates than other analyzers. The Cobas® u 701
and UAS800 yielded similar, but lower, detection rates
used for comparison (Y axis).

compared with those obtained by Iris iQ®200SPRINT.

The UF-5000 showed comparable sensitivity for calcium
URiSCAN® PlusScope
Iris iQ®200SPRINT

oxalate crystals and uric acid crystals with other image-

based analyzers, while it had lower sensitivity for triple
Cobas® u 701

phosphate crystals. For pathologic casts, the Cobas® u 701

UF-5000

UAS800

and UAS800 showed significantly high detection rates,

both in cellular and granular casts.

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 Cho et al.: Comparison of five automated urine analyzers 5

Table 2: Diagnostic accuracy of qualitative parameters of the five urine sediment analyzers compared with manual microscopy.

Parameter Agreement Sensitivity Specificity PPV NPV Kappa (95% CI)

Crystal (n = 111)
UF-5000a
Overall 91.7% 29.7% 99.8% 94.4% 91.6% 0.42 (0.37–0.47)
With the exception of amorphous crystal 96.0% 46.8% 99.8% 93.8% 96.0% 0.59 (0.53–0.65)
Cobas® u 701 91.2% 62.2% 95.1% 61.7% 95.0% 0.57 (0.52–0.61)
UAS800 92.3% 49.5% 97.9% 75.0% 93.7% 0.55 (0.51–0.60)
Iris iQ®200SPRINT 87.9% 68.5% 90.4% 47.9% 95.7% 0.49 (0.46–0.53)
URiSCAN® PlusScope 87.7% 18.0% 96.7% 41.2% 90.2% 0.20 (0.15–0.24)
Hyaline cast (n = 26)
UF-5000b 95.3% 23.1% 97.2% 17.6% 98.0% 0.18 (0.11–0.25)
Cobas® u 701 92.3% 19.2% 94.2% 8.1% 97.8% 0.08 (0.03–0.13)
UAS800 86.0% 65.4% 86.6% 11.3% 99.0% 0.16 (0.12–0.19)
Iris iQ®200SPRINT 96.4% 3.8% 98.8% 7.7% 97.5% 0.04 (−0.02 to 0.09)
URiSCAN® PlusScope 96.4% 3.8% 98.8% 7.7% 97.5% 0.04 (−0.02 to 0.09)
Pathologic cast (n = 53)
UF-5000 92.0% 23.6% 95.9% 25.0% 95.6% 0.20 (0.14–0.26)
Cobas® u 701 89.4% 73.6% 90.2% 30.4% 98.4% 0.38 (0.34–0.43)
UAS800 84.6% 81.1% 84.8% 23.6% 98.8% 0.31 (0.27–0.35)
Iris iQ®200SPRINT 94.1% 0.0% 99.5% 0.0% 94.6% –
URiSCAN® PlusScope 94.6% 0.0% – 0.0% – –
Non-squamous epithelial cell (n = 211)
UF-5000 86.6% 44.4% 88.2% 12.1% 97.7% 0.14 (0.10–0.18)
Cobas® u 701 80.1% 44.4% 81.4% 8.1% 97.6% 0.08 (0.05–0.11)
UAS800 94.1% 19.4% 96.8% 18.4% 97.0% 0.16 (0.10–0.22)
Iris iQ®200SPRINT 96.0% 8.3% 99.2% 27.3% 96.7% 0.11 (0.05–0.18)
URiSCAN® PlusScopec – – – – – –
Yeast (n = 36)
UF-5000 95.3% 44.4% 97.1% 36.4% 97.9% 0.38 (0.31–0.45)
Cobas® u 701 94.4% 58.3% 95.7% 33.3% 98.4% 0.39 (0.33–0.46)
UAS800 94.9% 50.0% 96.5% 34.6% 98.1% 0.38 (0.32–0.45)
Iris iQ®200SPRINT 91.8% 33.3% 94.0% 16.9% 97.5% 0.19 (0.13–0.24)
URiSCAN® PlusScope 96.7% 25.0% 99.3% 56.3% 97.3% 0.33 (0.25–0.42)
Sperm (n = 5)
UF-5000 99.6% 20.0% 100.0% 100.0% 99.6% 0.33 (0.09–0.58)
Cobas® u 701 96.3% 100.0% 96.2% 11.6% 100.0% –
UAS800 97.9% 0.0% 98.4% 0.0% 99.5% –
Iris iQ®200SPRINT 99.5% 0.0% – 0.0% – –
URiSCAN® PlusScope 99.5% 0.0% – 0.0% – –
Mucous thread (n = 145)
UF-5000 88.8% 39.3% 97.0% 68.7% 90.6% 0.44 (0.40–0.49)
Cobas® u 701 89.6% 89.7% 89.6% 58.8% 98.1% 0.65 (0.62–0.68)
UAS800 91.7% 81.4% 93.5% 67.4% 96.8% 0.69 (0.66–0.72)
Iris iQ®200SPRINT 88.3% 75.2% 90.5% 56.8% 95.6% 0.58 (0.54–0.61)
URiSCAN® PlusScope 92.5% 70.3% 96.2% 75.6% 95.1% 0.69 (0.65–0.72)

PPV, positive predictive value; NPV, negative predictive value; CI, confidence interval. aThe UF-5000 dissolves amorphous crystals using a
special reagent, so amorphous urate and amorphous phosphate could not be detected. bThe UF-5000 reports total casts instead of hyaline
casts. cThe URiSCAN® PlusScope has no parameters for non-squamous epithelial cells.

Image and microscopic review rate
Image review rates and microscopic review rates are
shown in Table 5. We obtained relatively high flagging
rates for crystals using the Cobas® u 701 (11.3%) and Iris
iQ®200SPRINT (16.2%). Flagging rates for pathologic casts
were relatively high in the Cobas® u 701 (13.3%) and UAS800
(18.8%). The rates of “invalid” calls were relatively higher
in the Cobas® u 701 (3.2%) and UAS800 (4.2%). Consider-
ing these factors together, the overall image review rates
for the UF-5000, Cobas® u 701, UAS800, Iris iQ®200SPRINT
and URiSCAN® PlusScope were 9.0%, 24.6%, 25.2%, 17.7%

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6 Cho et al.: Comparison of five automated urine analyzers

Table 3: Detection rates (sensitivity) of specific crystals of the five urine sediment analyzers.

Crystal

Amorphous Amorphous Calcium Leucine Triple Uric acid Total

phosphate urate oxalate (n = 1) phosphate (n = 16) (n = 111)
(n = 41) (n = 8) (n = 32) (n = 13)

UF-5000
Overall 4.9% 25.0% 71.9% 0.0% 7.7% 31.3% 29.7%
With the exception of amorphous crystal – – 71.9% 0.0% 7.7% 31.3% 46.8%
Cobas® u 701 65.9% 75.0% 71.9% 0.0% 46.2% 43.8% 62.2%
UAS800 58.5% 62.5% 50.0% 0.0% 38.5% 31.3% 49.5%
Iris iQ®200SPRINT 78.0% 75.0% 75.0% 0.0% 53.8% 43.8% 68.5%
URiSCAN® PlusScope 0.0% 12.5% 50.0% 100.0% 0.0% 12.5% 18.0%

Table 4: Detection rate (sensitivity) of specific pathologic casts of in the Iris iQ®200SPRINT, and by yeast in the UAS800.
the five urine sediment analyzers. The median level of bacteria was significantly influenced
by crystals and pathologic casts in the UAS800 and Iris
Pathologic cast
iQ®200SPRINT (Table 6).
Cellular Granular Total
(n = 8) (n = 45) (n = 53)

UF-5000
Cobas® u 701
12.5%
50.0%
26.7%
77.8%
24.5%
73.6%
Discussion
UAS800 87.5% 80.0% 81.1%
Iris iQ®200SPRINT 0.0% 0.0% 0.0% In this study, we evaluated the diagnostic performance of
URiSCAN® PlusScope 0.0% 0.0% 0.0% five recently introduced automated urine sediment ana-
lyzers. For quantitative comparisons of RBC, WBC and
SQEP, urine sediment analyzers showed that the propor-
and 6.5%, respectively. Microscopic review rates were tional bias was ±20% of values obtained using the manual
similar among the five systems (2.3%–4.5%). microscopic with the standard KOVA chamber. However,
the Iris iQ®200SPRINT for WBC and URiSCAN® PlusScope
for RBC showed proportional bias greater than 20%. The
Interference study reasons for these biases are unclear, but there are several
possible disadvantages of the manual methods such as
The median of RBC count is significantly influenced the inaccuracies associated with manual counting, the
by crystals in the Iris iQ®200SPRINT and URiSCAN® problems in sample processing and storage, and cell loss
PlusScope. In addition, the RBC count was also influenced during centrifugation. Furthermore, correct identification
by yeast in the UF-5000, Iris iQ®200SPRINT and URiSCAN® of RBC is difficult because of the presence of dysmorphic
PlusScope. However, the RBC count was not significantly RBCs, ghost RBCs, or misclassification with yeasts or other
influenced by pathologic casts. The median of WBC possible interferents [21]. In addition, other possible error
count was influenced by crystals and pathologic casts sources including focused field variation, recognition of

Table 5: Image review rates and microscopic review rates of the five automated urine sediment analyzers.

Image review rate Microscopic

review rate
Crystal positive Pathologic cast positive Yeast positive Sperm positive Invalid Total

UF-5000 3.5% 5.1% 4.3% 0.1% 0.1% 9.0% 2.6%

Cobas® u 701 11.3% 13.3% 6.2% 4.2% 3.2% 24.6% 3.1%
UAS800 7.5% 18.8% 5.1% 1.6% 4.2% 25.2% 2.3%
Iris iQ®200SPRINT 16.2% 0.5% 7.0% 0.0% 0.0% 17.7% 4.5%
URiSCAN® PlusScope 5.0% 0.0% 1.6% 0.0% 0.0% 6.5% 2.3%

RBC, red blood cell; WBC, white blood cell.

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 Table 6: The effects of interference on RBC, WBC, and bacterial counts by specific crystals, pathologic casts, or yeast.

All samples Crystal positive samples Pathologic cast positive samples Yeast positive
samples
Amorphous Amorphous Calcium oxalate Triple Uric acid (+) Total Cellular Granular Total
phosphate (+) urate (+) (+) phosphate (+) cast (+) cast (+)

Median Median p-Value Median p-Value Median p-Value Median p-Value Median p-Value Median p-Value Median p-Value Median p-Value Median p-Value Median p-Value

RBC (gradinga)
UF-5000 0.255 – – – – 0.625 0.006 0.538 0.138 0.188 0.344 0.382 0.089 0.375 0.701 0.378 0.050 0.264 0.099 0.639 0.002
Cobas® u 701 0.231 0.951 0.159 1.250 0.333 0.125 0.749 0.154 0.318 0.491 0.085 0.491 0.975 0.125 0.872 0.444 0.277 0.396 0.348 0.250 0.065
UAS800 0.254 0.561 0.876 1.250 0.341 0.438 0.513 0.308 0.690 0.509 0.991 0.509 0.723 0.000 0.358 0.356 0.134 0.302 0.301 0.444 0.115
Iris iQ®200SPRINT 0.114 0.024 0.885 1.000 0.039 1.031 0.000 0.385 0.018 0.455 0.655 0.455 0.000 0.250 0.045 0.267 0.138 0.189 0.547 0.417 0.015
URiSCAN® PlusScope 0.167 0.171 0.306 0.500 0.829 1.031 0.000 0.154 0.469 0.473 0.204 0.473 0.002 0.000 0.484 0.200 0.873 0.170 0.906 0.667 0.000
WBC (gradinga)
UF-5000 0.216 – – – – 0.313 0.729 0.308 0.868 0.375 0.329 0.355 0.115 −0.250 0.020 0.200 0.653 0.132 0.645 0.333 0.246
Cobas® u 701 0.253 0.512 0.581 0.000 0.253 0.438 0.816 0.154 0.305 0.063 0.120 0.327 0.158 0.375 0.890 0.244 0.611 0.264 0.604 0.500 0.083
UAS800 0.216 0.537 0.970 0.000 0.315 0.344 0.484 0.385 0.774 0.063 0.359 0.355 0.727 0.000 0.052 0.200 0.271 0.170 0.081 0.583 0.007
Iris iQ®200SPRINT 0.230 0.902 0.000 1.125 0.020 0.719 0.000 0.385 0.380 0.625 0.266 0.764 0.000 0.500 0.466 0.511 0.006 0.509 0.005 0.333 0.222
URiSCAN® PlusScope 0.088 0.341 0.054 0.375 0.536 0.281 0.526 0.154 0.790 0.188 0.069 0.227 0.295 0.125 0.037 0.267 0.130 0.208 0.551 0.444 0.094
Bacteria (gradingb)
UF-5000 0.037 – – – – 0.063 0.668 0.077 0.288 0.000 0.668 0.018 0.453 0.000 0.762 0.022 0.276 0.019 0.263 0.083 0.397
Cobas® u 701 0.404 1.780 0.000 1.125 0.027 0.625 0.098 1.154 0.005 0.438 0.934 1.127 0.000 0.875 0.018 1.044 0.000 1.019 0.000 0.361 0.931
UAS800 0.548 1.780 0.000 1.125 0.198 0.844 0.061 1.231 0.013 0.688 0.524 1.236 0.000 1.250 0.008 1.156 0.000 1.170 0.000 0.722 0.136
Iris iQ®200SPRINT 0.045 0.585 0.000 0.125 0.929 0.156 0.259 0.462 0.037 −0.063 0.393 0.318 0.001 0.000 0.878 0.333 0.080 0.283 0.120 0.333 0.113
URiSCAN® PlusScope 0.048 0.122 0.111 0.125 0.459 0.000 0.264 0.000 0.715 0.125 0.297 0.073 0.416 0.250 0.016 0.111 0.148 0.057 0.681 0.028 0.851

RBC, red blood cell; WBC, white blood cell; p/HPF, particles per high-power field. Bold font indicates statistical significance (p-value < 0.05). aThe results for RBC and WBC counts were
categorized into 6 ranges as follows: 0–2/HPF, 3–5/HPF, 6–10/HPF, 11–20/HPF, 21–50/HPF and >50/HPF. These categories were then converted to the corresponding numbers (from 0 to 5).
b
For bacteria, the results were expressed as ‘Negative’, ‘1 + ’, ‘2 + ’, and ‘3 + ’, and these semi-quantitative grades were converted to the corresponding numbers (from 0 to 3). A Mann-Whitney
test was performed to compare the median grading values between total samples and specific samples with possible interferents.
Cho et al.: Comparison of five automated urine analyzers

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8 Cho et al.: Comparison of five automated urine analyzers
clumped cells or misidentification of particles could the
cause of bias [3, 12, 21, 26]. There were several limitations
in the microscopic quantitative results of RBC, WBC and
SQEP in our study. First, we did not consider the differ-
ences of fields between a digital camera and manual
microscopy [4]. Second, we counted the cells in ten small
grids of KOVA chamber according to instructions from
KOVA International Inc. However, counting the entire
chamber would have been better for quantitation accu-
racy. Additionally, we did not verify the conversion factors
(from particles/HPF to particles/μL), but rather used the
values provided by each manufacturers. So, further study
may be needed in order to verify the conversion factors.
We evaluated the concordance of qualitative results
from five urine sediment analyzers with results from
manual microscopy for crystals, hyaline casts, pathologic
casts, yeast, sperm and mucous threads. Although the
clinical importance of these sediments is negligible when
present in small amounts, this study focused on analyti-
cal performance according to their individual cut-offs. For
crystals, the Cobas® u 701 and Iris iQ®200SPRINT showed
high sensitivity (over 60%) but with relatively low speci-
ficity. It has been reported that some of the false-positive
results for crystals found in image based analyzers may be
due to their misclassification as other types of particles,
such as dysmorphic erythrocytes and yeast, and some
of the false-negative results may be due to specific crys-
tals such as calcium oxalate monohydrate being similar
to erythrocytes [7, 21, 27]. Sysmex UF-5000 showed rela-
tively low detection rates for crystals because UF-5000
uses a special reagent to intentionally dissolve amor-
phous crystals. Therefore, when we analyzed diagnostic
performance (excluding amorphous urate and amorphous
phosphate), we found that sensitivity for crystals was
increased, which was comparable with other image-based
analyzers. However, sensitivity for triple phosphate crys-
tals was lower in UF-5000 than image-based analyzers,
while detection of calcium oxalate and uric acid crystals
showed similar sensitivity between UF5000 and image-
based analyzers. Our study is the first to evaluate detec-
tion rates of each specific kind of crystal. We found that
there were some differences in the sensitivity for each
crystal among the five sediment analyzers. Sensitivity
ranged from 50.0% to 75.0% for calcium oxalate, from
0.0% to 53.8% for triple phosphates, and from 12.5% to
43.8% for uric acid crystals.
It is difficult to accurately distinguish casts from
other sediments. Aggregation of other sediments might
make them look like casts, or existing casts may be lysed
or dissolved so as to be below the detectable range in
sample processing process [3]. The UAS800 and Cobas® u
701 showed relatively higher sensitivity for casts than the
other three analyzers. However, these analyzers showed
low positive predictive values (PPVs) and kappa values
due to high false-positive rates [3, 9, 27]. In contrast, the
UF-5000 showed relatively lower sensitivity, although the
sensitivity for casts can be altered depending on cut-off
values. The universal cut-off for casts has not yet been
established for the UF-5000. For UF-1000i, a previous
model from Sysmex Corp., many laboratories use 1.0/μL
or 1.5/μL as cut-off values. We used 1.5/μL for hyaline
casts and 1.0/μL for pathologic casts as cut-off values for
UF-5000 in this study. Additionally, upon applying the
cut-off of 0.53/μL for hyaline casts and 0.23/μL for patho-
logic casts as suggested by a recent study [21], the sensitiv-
ity increased from 23.1% to 57.7% for hyaline casts (data
not shown), and from 23.6% to 56.4% for pathologic casts
(Supplementary Table 3). However, increased sensitiv-
ity was accompanied with a rise image review rates and
false-positive rates. For NECs, the UF-5000 and Cobas®
u 701 showed relatively high sensitivity, but their PPV
and kappa values were low. A previous study reported
that renal tubular epithelial cells look like WBCs, which
may have caused confusion [11]. For yeast, the UF-5000,
UAS800 and Cobas® u 701 identified the hyphae well. For
sperm, the Cobas® u 701 showed the highest sensitivity.
The UF-5000 and UAS800 also showed numeric results
over 0, but still below the cut-off value, while sperms were
observed using manual microscopy. Therefore, adjust-
ment of cut-offs for sperm is recommended. For mucous
threads, four out of the urine sediment analyzers (except
for the UF-5000), showed 70% ~ 90% sensitivity. This may
be due to the difference in principle between flow cytom-
etry-based methods and digital image-based approaches.
The performance of the Cobas® u 701 and
UAS800 showed high sensitivity for crystals and casts
and was usually also accompanied with high-false posi-
tive rates. Previous studies have also reported that digital
image-based systems show higher false-positive rates than
flow cytometry-based systems [3, 5, 27]. Contrary to flow
cytometry-based systems, digital image-based systems
have shown a greater tendency to make false positive calls
in the presence of mucus, fibers or other contaminants
[3, 21]. In general laboratory practice for reporting urine
sediment results, laboratory technicians confirm results
by additional image review, or by microscopic review,
when urine sediment analyzers identify the existence of
crystals and casts. Therefore, false positive identifications
can be filtered and/or confirmed with time and effort, by
either medical technologists, or by clinical pathologists,
and reliable results can eventually be reported. From this
point of view, methods with high sensitivity for crystals
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and casts might be preferred. However, the preference
can vary, depending on perspectives on the efficiency and
clinical importance of urinary crystals and casts.
Among the parameters measured using urine sedi-
ment analyzer, bacteria were excluded in the diagnostic
performance analysis such as sensitivity and specific-
ity. As urine culture is the reference method rather than
manual microscopy, additional study comparing bacteria
result from urine sediment analyzers with conventional
urine culture is needed. In our following study, we are
planning to compare diagnostic performance for bacteria
in these five automated urine sediment analyzers using
urine bacterial culture as a reference method.
In addition, we evaluated image review and micro-
scopic review rates. The Cobas® u 701 and UAS800 showed
higher review rates than other instruments, which
resulted mostly from flagging frequencies for crystals
and casts. The UF-5000 showed relatively lower review
rates when higher cut-off values were applied for casts.
However, after applying a cut-off of 0.23/μL, the flagging
rate for the pathologic casts increased from 5.1% to 17.9%,
and total image review rates rose from 8.6% to 23.0% (data
not shown), similar to those of the UAS800 and Cobas®
u 701. The Iris iQ®200SPRINT, the APR™ system auto-
matically sorts and classifies each of the images taken.
However, in some cases, sediments identifiable by image
review were classified as “UNCC” or “UNCX”. If the opera-
tor reviews the results screen and marks each particle to
be verified or moved to other parameter category, sensitiv-
ity for crystals and casts can be significantly enhanced.
However, the Iris iQ®200SPRINT had higher microscopic
review rates because the operator occasionally could not
identify the particle on the screen from the image review.
Likewise, the accuracy for the Cobas® u 701 and UAS 800
can be increased by modifying (correcting) images of
the recognized particles, but we evaluated only unmodi-
fied results which were automatically reported by the
manufacturer’s image processing software. And, because
we evaluated a prototype of the URiSCAN® PlusScope,
the automatic image processing software was not the
final version. Therefore, the performance of URiSCAN®
PlusScope should be confirmed in future studies using the
final released product.
In interference studies, the levels of RBC counts were
influenced by crystals, especially by calcium oxalate
monohydrate crystals, and by yeast with single or small
hyphae. The level of bacteria detected is also influenced
by the presence of crystals, especially by amorphous phos-
phates and urates, and by casts. As mentioned already,
digital imaged-based systems confuse small particles
with bacteria. Therefore, further technical advances for
Cho et al.: Comparison of five automated urine analyzers 9
the accurate identification of small particles are needed,
which would facilitate the achievement of high sensitivity
and specificity for each sediment.
In conclusion, for RBCs and WBCs, all five analyzers
showed excellent performance, and use of automated
urine chemistry and sediment analyzers can replace tra-
ditional manual microscopy. However, the Cobas® u 701
and UAS800, which are based on digital image-based
systems, showed high false positive rates in detecting bac-
teria, while the UF-5000, based on flow cytometry, showed
better performance than any of the other platforms for
bacteria. In contrast, the sensitivity of the Cobas® u 701
and UAS800 for pathologic casts and crystals was high,
although image review rates were also high. The detection
rate for crystals and casts, and review rates can be changed
reciprocally according to cut-offs for the UF-5000. Auto-
mated urine analyzers are expected to reduce the burden
of manual processing, with reliable results. However, each
automated urine sediment analyzer has certain distinct
features. Therefore, laboratory directors are encouraged
to understand these features, and use each system in an
appropriate way, considering clinical algorithms and lab-
oratory workflows.
Author contributions: All authors have accepted respon-
sibility for the entire content of this manuscript and have
approved its submission.
Research funding: This work was supported by five com-
panies – Sysmex Corporation (Kobe, Japan), Roche Diag-
nostics International (Rotkreuz, Switzerland), Siemens
Healthineers (Erlangen, Germany), Beckman Coulter
(Brea, CA, USA), and YD diagnostics (Yongin, Korea).
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organizations played
no role in designing the study, collection, analysis and
interpretation of data, writing of the report, or in the deci-
sion to submit the findings for publication.
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Supplementary Material: The online version of this article offers
supplementary material (https://doi.org/10.1515/cclm-2019-0211).
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