Clin. Lab.

2016;62:49-56
©Copyright
ORIGINAL ARTICLE

Urinalysis: The Automated Versus Manual Techniques;

Is It Time To Change?
Asmaa Ismail Ahmed, Heba Baz, Sarah Lotfy
Clinical and Chemical Pathology Department, Faculty of Medicine, Cairo University, Kasr Al Aini Street, Cairo, Egypt

SUMMARY

Background: Urinalysis is the third major test in clinical laboratory. Manual technique imprecision urges the need
for a rapid reliable automated test. We evaluated the H800-FUS100 automatic urine sediment analyzer and com-
pared it to the manual urinalysis technique to determine if it may be a competitive substitute in laboratories of
central hospitals.
Methods: 1000 urine samples were examined by the two methods in parallel. Agreement, precision, carry-over,
drift, sensitivity, specificity, and practicability criteria were tested.
Results: Agreement ranged from excellent to good for all urine semi-quantitative components (K > 0.4, p = 0.000),
except for granular casts (K = 0.317, p = 0.000). Specific gravity results correlated well between the two methods
(r = 0.884, p = 0.000). RBCS and WBCs showed moderate correlation (r = 0.42, p = 0.000) and (r = 0.44,
p = 0.000), respectively. The auto-analyzer's within-run precision was ≥ 75% for all semi-quantitative components
except for proteins (50% precision). This finding in addition to the granular casts poor agreement indicate the
necessity of operator interference at the critical cutoff values. As regards quantitative contents, RBCs showed a
mean of 69.8 ± 3.95, C.V. = 5.7, WBCs showed a mean of 38.9 ± 1.9, C.V. = 4.9). Specific gravity, pH, mi-
croalbumin, and creatinine also showed good precision results with C.Vs of 0.000, 2.6, 9.1, and 0.00 respectively.
In the between run precision, positive control showed good precision (C.V. = 2.9), while negative control's C.V.
was strikingly high (C.V. = 127). Carryover and drift studies were satisfactory. Manual examination of inter-
observer results showed major discrepancies (< 60% similar readings), while intra-observer's results correlated
well with each other (r = 0.99, p = 0.000).
Conclusions: Automation of urinalysis decreases observer-associated variation and offers prompt competitive re-
sults when standardized for screening away from the borderline cutoffs.
(Clin. Lab. 2016;62:49-56. DOI: 10.7754/Clin.Lab.2015.150520)

Correspondence: KEY WORDS

Asmaa Ismail Ahmed
Clinical and Chemical Pathology Department urine, automation, H800-FUS100, evaluation
Faculty of Medicine
Cairo University
Kasr Al Aini Street
Cairo, Egypt INTRODUCTION
Phone: +20 1093115275
Email: asmaa.foraida@yahoo.com Manual urine testing remains the most widely used
method for assessment of urine sediment. However,
urine testing protocols are not in consensus [1]. In the
manual urinalysis technique, microscopic examination
is used to check for the presence of formed elements.
Although the centrifugation step to concentrate the sam-
_____________________________________________ ple is necessary, it remains a major source of errors, as
Manuscript accepted June 16, 2015 it leads to a variable loss of erythrocytes and leukocytes.

Clin. Lab. 1+2/2016 49

 Asmaa Ismail Ahmed et al.
Routine sediment analysis can have intra-assay coeffi-
cient of variation as high as 100% when centrifugation
and residual sediment volume are taken into consider-
ation. On the other hand, neglecting centrifugation low-
ers the analytical sensitivity of the test. Strict standardi-
zation of all procedures for collection, transport, sample
preparation, and analysis are mandatory as the basis of
an effective diagnostic strategy for urine analysis [2].
Different automated analyzers are currently used to per-
form the task of automated urine analysis [3]. These an-
alyzers adopt two methodologies for urine sediment
analysis, one based on electrical impedance, and the
other depends on image-based analysis systems that sort
particles according to predetermined particle dimen-
sions [3,4].
The automated urine analyzer H800-Fus100 comprises
two subunits. The H800 unit represents the automated
strip analyzer which aspirates and drops urine onto each
reaction. The second unit is the microscopic examina-
tion unit FUS-100. It is based on the automatic particle
recognition system, which utilizes un-centrifuged urine
to capture and analyze 820 photos from each sample
(digital imaging). Artificial intelligence identification
technology is then used in order to auto-classify the
isolated images of the urine sediment constituents [5].
The aim of this study was to perform a comparison of
methods between the automatic urine sediment analyzer
-FUS-100/H-800 and the manual technique for the ex-
amination of urinary formed elements and to judge its
eligibility to widely replace the manual standard meth-
od.
MATERIALS AND METHODS
Subjects
A cohort of 1000 urine samples from patients attending
Kasr Al Aini hospitals during the period from July 2013
to March 2014 were enrolled in the study. A volume of
at least 15 mL urine in a clean cup, reaching the lab
within two hours of voiding was considered acceptable.
Urine samples which failed to fulfill the above criteria
were excluded from the study
The study was approved by the ethical committee of the
faculty of medicine, Cairo University and in accordance
with the code of ethics of the world medical association
(Declaration of Helsinki).
Methods
All collected samples were examined within one hour of
arrival, mixed properly and divided into two aliquots.
Manual method
Chemical analysis was done using Combur 10 Test UX
urine strips (Roche Diagnostics, United Kingdom) for
the assessment of the following: pH, specific gravity
(SG), albumin, bilirubin, urobilinogen, glucose, and ac-
etone. Manufacturer’s protocol was rigorously follow-
ed.
50
Microscopic examination
12 mL of the sample were centrifuged at 2000 rpm for
15 minutes. The supernatant was discarded, and the sed-
iment was re-suspended in 1 mL of residual urine vol-
ume. The sediment was examined microscopically at
10X and 40X magnification power for the presence of
cells, crystals, casts, and others. Overall, the quantita-
tive variables like RBCs, WBCs, and specific gravity
(SG) were expressed numerically. Semi-quantitative
values like pH, glucose, albumin, ketones, bilirubin,
urobilinogen, epithelial cells, crystals, casts, sperm, and
bacteria were expressed in pluses.
Furthermore, inter-observer precision (20 different ex-
aminers examined the same sample microscopically at
the same time) and intra-observer precision (a single ex-
aminer examined 12 samples microscopically before
and after rearrangement) were conducted for the manual
technique.
Automated urine analysis
Analysis was performed on the second aliquot using the
FUS-100/H-800.
Chemical examination
A DIRUI H14-Ca (H-800) (Dirui Industrial Co. Ltd.,
China) recorded chemical results for the same parame-
ters of the manual method.
Microscopic examination relied on the automated plat-
form and its integrated software as well as the examin-
er's editing upon identification of unclassified and im-
properly classified particles as recommended by the
manufacturer.
Also between-run precision (positive and negative con-
trols), within run precision (pooled urine divided into 20
aliquots), carry over (three normal samples assayed be-
fore and after 3 high samples), and drift (difference be-
tween results of the same sample when introduced at
early, middle, and end of the run) were performed for
the automated technique.
Other points of judgment were practicability criteria
such as economic considerations (cost per test, running
cost, and overhead cost) and operational considerations
(turnaround time, friendliness of the software, degree of
training required to operate the procedure).
Statistical methods
Data were statistically described in terms of mean
 standard deviation ( SD), CV, and range, or frequen-
cies and percentages when appropriate. Comparison of
numerical variables between manual and automated
techniques was done using paired t-test for matched
samples. For comparing categorical data, the McNemar
test was performed. Agreement was tested using kappa
statistics, and values were interpreted as follows:
< 0.4 = poor agreement, 0.4 - 0.7 = good agreement,
and > 0.7 = excellent agreement. P-values less than 0.05
were considered statistically significant. Statistical cal-
culations were done using the computer program SPSS
(Statistical Package for the Social Science; SPSS Inc.,
Clin. Lab. 1+2/2016
 Urinalysis, Automation Versus Manual

Table 1. Showing results of the manual and automated techniques for the tested parameters, with the corresponding method of
comparison results.

Manual Automated r, K *, †
Specific gravity 1019.8 (± 5.7) 1019 (± 7.2) r: 0.884,
[mean (± SD)] C.V. = 0.6 C.V. = 0.7 p = 0.00
pH Acidic Neutral Alkaline Acidic Neutral Alkaline
K: 0.914
(%) 89.9 2.0 8.1 89.9 3.6 6.5
Albumin Nil + ++ +++ ++++ Nil + ++ +++ ++++
K: 0.695
(%) 62.8 7.2 11.1 9.9 9.0 62.8 7.6 9.7 8.9 11.0
Glucose Nil + ++ +++ ++++ Nil + ++ +++ ++++
K: 0.78
(%) 88.0 3.5 4.1 4.2 0.2 87.8 3.2 2.4 6.2 0.4
Ketone Negative Positive Negative Positive
K:1
(%) 98.6 1.4 98.6 1.4
Nitrite Negative Positive Negative Positive
K:1
(%) 98.2 1.8 98.2 1.8
RBCs [median r: 0.417
1.5 (0.5 - 5) 4 (1.75 - 16)
(25th - 75th percentiles)] p = 0.00
WBCs [median r: 0.442,
1.5 (0.5 - 9) 2 (0.75 - 12)
(25th - 75th percentiles)] p = 0.00
Epithelial cells Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
K: 0.765
(%) 59.0 12.0 17.4 7.9 2.2 1.5 58.0 15.3 14.8 7.6 2.8 1.5
Calcium Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
K: 0.728
Oxalate 90.1 2.2 3.7 0.9 1.3 1.8 90.3 2.7 3.4 0.8 1.1 1.7
Crystals Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
Uric acid K: 0.65
(%) 93.5 1.6 2.2 1.2 0.8 0.7 94.4 1.9 1.7 0.8 0.5 0.7
Triple Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
K **
phosphate 99.6 0.2 0.0 0.1 0.0 0.1 99.7 0.1 0.1 0.0 0.0 0.1
Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
Urate K: 0.71
Amorphous 97.8 0.1 1.0 0.5 0.2 0.4 98.0 0.2 0.6 0.4 0.1 0.7
(%) Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
Phosphate K **
99.4 0.0 0.0 0.2 0.3 0.1 99.3 0.1 0.0 0.2 0.2 0.2
Nil Few + ++ Nil Few + ++
Hyaline K **
97.9 0.9 1.2 0.0 97.2 2.3 0.1 0.0
Casts Nil Few + Nil Few +
Granular K: 0.317
(%) 97.4 1.7 0.9 99.2 1.7 0.1
Nil Few Nil Few
Waxy K **
99.9 0.1 100.0 0.0
Bacteria Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
K: 0.74
(%) 72.9 4.9 7.3 4.1 3.2 7.6 72.1 7.6 5.9 3.9 3.3 7.2
Fungi Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
K: 0.57
(%) 92.1 2.6 2.4 0.9 1.0 1.0 88.2 6.5 2.4 0.9 1.3 0.7
Mucous Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
K: 0.559
(%) 83.5 0.4 8.4 4.6 2.2 0.9 76.1 7.7 9.9 3.4 2.1 0.8
Sperm Nil Few + ++ +++ ++++ Nil Few + ++ +++ ++++
K **
(%) 99.3 0.4 0.2 0.0 0.0 0.1 99.1 0.5 0.1 0.2 0.0 0.1

* Agreement was calculated for qualitative variables expressed in K, correlation was calculated for quantitative variables expressed in r.
** Kappa statistics could not be performed as it requires a symmetric 2-way table in which values of the first valuable must match the values
of the second variable. † The p-value of the kappa test was < 0.05 for all shown parameters denoting sound statistical calculations.

Clin. Lab. 1+2/2016 51

 Asmaa Ismail Ahmed et al.

Table 2. Performance characteristics of the H-800 versus the manual technique in diagnosis of hematuraia and pyuria.

Performance characteristics Hematuria: cutoff ≤ 5/HPF Pyuria: cutoff ≥ 10/HPF

Sensitivity% (95th CI) 98.8 (96.5 - 99.7) 98.7 (96.3 - 99.7)
Specificity% (95th CI) 76.7 (73.5 - 79.7) 94.7 (92.8 - 96.1)
PPV% (95th CI) 58.5 (53.6 - 63.2) 84.9 (80.1 - 88.9
NPV% (95th CI) 99.48 (98.5 - 99.89). 99.6 (98.8 - 99.9)
DOR (95th CI) 1.7 (1.5 - 1.78) 1.2 (1.12 - 1.25)

Table 3. Results of the within-run precision of the automated method.

Variable (n = 20) Mean (± SD) CV%

Erythrocytes 69.80 (± 3.955) 5.7
Leucocytes 38.90 (± 1.889) 4.9
Specific gravity 1,021.30 (± 0.470) 0.0
pH 5.95 (± 0.154) 2.6
Microalbumin 147.00 (± 13.416) 9.1
Creatinine 17.700 (± 0.00) 0.0

Table 4. Showing the descriptive statistics of the semiquantitative variables of the inter-observer study.

Number of observers (%)

(n = 20)
+ ++ +++ Few
Epithelial cells
9 (45) 7 (35) 1 (5.0) 3 (15)
Granular Hyaline
Nil
Casts Few + Few +
2 (10) 4 (20) 1 (5) 1 (5) 12 (60)
Calcium oxalate Uric acid
Nil
Crystals Few + ++ Few +
5 (25) 2 (10) 1 (5) 1 (5) 4 (20) 7 (35)
Nil Few +
Amorphous
12 (60) 4 (20) 4 (20)
Nil Few + ++
Bacteria
12 (60) 1 (5) 6 (30) 1 (5)
Nil
Fungi
20 (100)
Nil +
Mucus
19 (95) 1 (5)

Chicago, IL, USA) release 15 for Microsoft Windows RESULTS

(2006). Diagnostic test performance was performed us-
ing the following online calculator: All hospital departments were effectively represented as
http://araw.mede.uic.edu/cgi-bin/testcalc.pl. follows: outpatient clinic represented 22.5%, uro-sur-
gery 11.9%, rheumatology 10%, tropical medicine

52 Clin. Lab. 1+2/2016

 Urinalysis, Automation Versus Manual

Table 5. The descriptive statistics of the quantitative variables of the inter-observer study.

Variable N Mean Std. Deviation CV%

Erythrocytes 20 5.60 4.584 81.9
Leucocytes 20 4.43 1.794 40.5

Table 6. Practicability criteria of the manual technique versus the H800-FUS100.

Criterion Manual method H800-FUS100

User friendly and need for personal
skills
Required sample type
Required sample size
Throughput time
Need for reagents and its stability
Calibration and QC frequency
Results storage
Possibility of mixing patients' results
Cost/test
It is user friendly and requires a well-
A skilled examiner is needed trained operator (not totally dedicated)
especially for the editing process
Centrifuged urine sample Uncentrifuged urine sample
A minimum of 3 mL. (Aspiration volume of
5 - 12 mL
each of H800 and FUS100 is 1 mL)
30 samples/hour because of the
60 samples/hour (not including time needed
need for:
for the editing process) if analysis is applied
-manual use of test strips
using the 2 partitions (H800 chemistry and
-centrifugation
FUS100 microscopic)
-manual recording of results
Reagents including: QC, focus, sheath,
No need for reagents detergent, and diluent are needed and
generally they are stable until expiry date
No need for calibration, external
According to manufacturer's instructions
QC programs are inapplicable.
monthly calibration and daily running of
Internal QC is possible through
FUSs focus, positive and negative controls
repeating random samples by a
are recommended
different observer
Depends on the applied system in Results storage is available where enough
each laboratory: either daily memory is available:
results are not stored or stored; -10,000 routine results
in lab log-books or on the Lab -5000 emergency results
information system -1000 QC results
On application of bar coding, should not
Can happen.
happen
Cost depends on the price of materials used:
special tube, specific strips, focus, sheath,
Cost depends on the price of used
detergent, diluent. The overall running cost
test strips
is overall comparable between the two
methods

9.8%, general medicine 8.4%, dermatology 7.2%, neu-
rology 5.9%, ICUs collectively 6.6%, cardiology 3.7%.
The remaining 15% were patients of general and special
surgeries, psychiatry, and occupational health. Males
represented 48% of the cohort, while 52% were fe-
males.
Agreement and correlation studies’ results are shown in
Table 1. Figures 1 and 2 show how H800-FUS100 strat-
ified the studied patients as regards the diagnosis of he-
maturia and pyuria in comparison to the manual meth-
od. The derived performance characteristics of the
H800-FUS100 are shown in Table 2. Cutoff points were
considered > 5 cells/HPF for the diagnosis of hematuria
[5] and ≥ 10 for leukocytes as it is more relevant to the
reflex culture cutoff [6].
A second cutoff for hematuria was searched. It was des-
ignated by the researchers to be ≥ 10/HPF for the cases
tested by automation, and the specificity was recalculat-
ed. Specificity improved to 88.9%, sensitivity remained
acceptable at 98.8%, with DOR at 1.3 (CI; 1.22 - 1.36).
Within-run precision testing for the semi-quantitative
variables by FUS-100/H-800 showed exactly the same

Clin. Lab. 1+2/2016 53

 Asmaa Ismail Ahmed et al.

Figure 1. How the FUS100H800 stratified hematuria patients at cutoff more than 5HPF.

Figure 2. How the FUS100H800 stratified pyuria patients at cutoff equal or more than 10HPF.

results for 20 successive times for casts, bacteria, fungi,
urobilinogen, bilirubin, ketone, occult blood, glucose,
WBCs, and nitrite. Results of crystals, mucus, and epi-
thelial cells showed 95%, 80%, and 75% concordance
respectively. Protein content precision was the least
(50% ++, 45% +, and 5% nil). Quantitative variables of
within run precision are shown in Table 3.
In the between-run precision study, the positive control
showed a mean ± SD of 1050 ± 29.5, C.V. = 2.9%.
Negative control repeats had a mean ± SD of 1.04 ± 1.3
with a C.V. = 127%. Median negative control was 0.75
with (25th - 75th% = 0 - 2).
No carryover contaminated the three negative samples
run after three positive samples. No drift was observed.
For the manual technique, Tables 4 and 5 show the de-
scriptive statistics of the semi-quantitative and quantita-
tive variables of the inter-observer assay. In the intra-
observer study, a strong positive correlation was found
between the two runs of samples read by the same ob-
server with r = 0.999 for both erythrocytes and leuco-

54 Clin. Lab. 1+2/2016

 Urinalysis, Automation Versus Manual
cytes and a p = 0.000. Practicability criteria of both
methods are shown (Table 6).
DISCUSSION
Urine analysis is the third major diagnostic screening
test in the clinical laboratory, only preceded by serum/
plasma chemistry profiles and complete blood count
analysis [2]. A correct urine analysis result offers a di-
rect indication of the state of the patient's renal and gen-
itourinary system and a monitoring of other body sys-
tems [5].
In this study, the H800-FUS100 was assessed as an al-
ternative to the manual urine analysis testing procedure.
In contrast to other published studies; this study includ-
ed a large sample size, with a single observer perform-
ing both the manual microscopic examination and auto-
mated visual classification of unclassified particles. The
effectiveness of the manual technique as a standard
method was also explored.
The H800-FUS100 agreed well with the manual method
in ketone (K = 1), nitrite (K = 1), pH (k = 0.914), glu-
cose (k = 0.78), epithelial cells (k = 0.765), calcium ox-
alate crystals (k = 0.728), bacteria (k = 0.74), amor-
phous urates (k = 0.71), albumin (k = 0.695), uric acid
crystals (k = 0.65), mucous (k = 0.559), and fungi
(k = 0.57) with a p-value of (0.000) for all. Granular
cast was the only item that showed poor agreement be-
tween the two methods (k = 0.317) (p = 0.0000).
A good correlation was found between the two methods
as regards the specific gravity (r = 0.884, p = 0.000).
Also a moderate correlation was found for RBCs
(r = 0.42, p = 0.000) and WBCs (r = 0.44, p = 0.000).
Yuksel et al. [5] did a study on the same apparatus and
found that the strip tests for SG and pH and the micro-
scopic tests for leukocyte and epithelial cell counts
showed good correlations, while protein, glucose, ke-
tones, and erythrocytes showed moderate correlations.
Due to the small number of positive specimens for uro-
bilinogen and bilirubin, it was difficult to find concor-
dance either in our study or in theirs. However, nitrite
positive cases were prevalent enough in the current
study and thus agreement could be established.
The H800-FUS100 showed acceptable performance
characteristics; however, there was a high false positive
rate noted especially in erythrocytes, which means that
the H800-FUS100 diagnoses 41.2% more cases of he-
maturia than the manual method does. Another cutoff
was set for hematuria for the H800-FUS100 at ≥ 10HPF
and as expected the specificity (88.9%) was increased
with no major effect on the sensitivity (98.8%). This
means that the H800-FUS100 has more tendency to
classify results in the range of (> 5 - ≥ 10HPF) as a
round figure, a range at which manual microscopic ob-
servers may designate the sample as normal. It is not
certain whether this is due to automation overestimation
or to manual technique underestimation (cellular loss
during centrifugation or a manual counting error). A
Clin. Lab. 1+2/2016
further study relating the lab diagnosis to the clinical
outcome is mandatory to resolve this debate, and per-
haps new cutoffs for hematuria and pyuria will be des-
ignated for the automated count. Furthermore, regarding
the manual method, at the high level counts, erythro-
cytes and leucocytes are expressed as > 100/HPF. Auto-
mated methods, on the other hand, can read figures up
to orders of thousands. This means that automated
methods in general will yield higher readings when
compared to manual results especially at higher levels
of RBCs or WBCs, which is not necessarily clinically
significant. This is comparable to previously shown re-
sults [4] on a different instrument (IQ200 analyzer) in
which more RBCs and WBCs were obtained with the
automated than with the manual microscopy.
The fully automated urine devices classify some cells as
“unclassified” and allow the trained operator to correct
the designations of the cells. The device accuracy in-
creases when the operator examines these cells and
makes the correct designations [5].
Other performance criteria for the H800-FUS100
showed a good within-run precision for either semi-
quantitative or quantitative parameters except for the
protein content of the sample. Casts, bacteria, fungi,
urobilinogen, bilirubin, ketone, occult blood, glucose,
and nitrite showed exactly the same results for 20 re-
peated times. Calcium oxalate crystals, epithelial cells,
and mucus showed > 75% precision. Only the protein
content of the sample failed to show a good precision
with 50% of the times (10 times ) showing two pluses
(++), 45% showing one plus (+), and one time showing
a negative result.
Red blood cells content showed a mean of 69.8 ± 3.95
with a C.V. of 5.7. WBCs showed a mean of 38.9 ± 1.9,
C.V. = 4.9. Specific gravity, pH, microalbumin, and
creatinine also showed good precision results with C.Vs
of 0.000, 2.6, 9.1, and 0.00 respectively.
In the between-run precision, good results were found
for level II (positive) control, with a mean of 1050
+ 29.5, C.V. = 2.9. For level I (negative) control the
C.V. was strikingly high (C.V. = 127). However, this
can be explained by the very low values of the negative
control (0 - 4), which are below the critical medical de-
cision level of “5 particles/HPF”.
In Yuksel et al. [5] study, the between- and within-pre-
cision were lower for the specimens with fewer cells,
while for the specimens containing a large number of
cells, the reproducibility was much better, which is sim-
ilar to our study and to the previous studies [7].
Also, Mayo et al. [3] stated that precision studies pro-
vided adequate variation coefficient values except for
the samples with poor cellularity.
Lamchiagdhase et al. [8] also reported that between-run
CVs of RBC for negative and positive control were
61.6% and 6.4%, respectively.
The results of the carryover study were consistent with
all urine contents of the three negative samples remain-
ing the same, even when run after three positive sam-
ples. This ensures the efficiency of the apparatus in ana-
55
 Asmaa Ismail Ahmed et al.

lyzing each sample separately and eliminates the fear of Support:

positive contamination of negative samples from pro-
ceeding positive samples.
Carryover studies on other devices (UF-100, iQ200, and
sediMAX) showed no significant increase in the mean
values of the negative pool samples following the path-
ological urine samples (p > 0.05), except for WBC mea-
sured by the iQ200 analyzer [3,9].
To study the stability of the apparatus, drift was tested
and showed acceptable stability in spite of the diversity
of the samples which arrived from all departments of
the hospital. This can be considered an additional point
of strength to the excellent carry over results. This was
a weak point in Yuksel et al. [5] study because the ma-
jority of their specimens were from women and chil-
dren, and they were outpatients, so their pathological
specimens were few.
When comparing the inter-observer results of the manu-
al examination method, major discrepancies were
found, with only mucus and fungal contents reaching
95% and 100% agreement between observers, which is
probably because they were absent in all samples. For
all other contents, only ≤ 60% of observers had similar
readings. For example, only 60% of observers reported
casts as (Nil) and less percentages of observers reported
other options (few, +, ++). Only 35% of observers re-
ported crystals as (Nil) with less percentages reporting
the presence of Ca oxalate or uric acid crystals at differ-
ent quantities.
This huge unacceptable variability in inter-observer
findings is one of the most important causes for devia-
tion towards automation of urine analysis so as to mini-
mize the subjective effect of the lab technologist on pa-
tient results. This effect was proposed to be because
manual microscopic examination of centrifuged urine
has several variables associated with sample prepara-
tion, centrifugation, and counting variations [8].
In the intra-observer study of the manual technique, a
strong positive correlation was found between the two
runs of samples read by the same observer with r equal
to 0.999 for both RBCs and WBCs and a p = 0.000.
CONCLUSION
This work was supported by a fund from the Faculty of
Medicine, Cairo University.
Declaration of Interest:
The authors do not have any conflict of interest.
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The automation of urine examination may decrease ob-

server-associated variation and offer results comparable
to those of manual microscopy in a rapid, reproducible,
and accurate way. This is provided the reliability of the
analyzer is periodically reviewed and the apparatus is
used for screening away from the borderline cutoffs.
Revision either by the manual microscopic examination
or through visual revision of the apparatus images may
be needed to confirm positive readings, and revision of
the cutoffs themselves might be explored to enhance
performance characteristics of the H800-FUS100. It is
also recommended to standardize all pre-analytical pro-
cedures to reduce the huge percentage of fallacies in re-
sults.

56 Clin. Lab. 1+2/2016