UPDATES IN URINALYSIS - American Medical Technologists

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Transcript UPDATES IN URINALYSIS - American Medical Technologists

UPDATE IN URINALYSIS
Diane Gaspari, SH(ASCP)
Division Manager, Core Lab
York Hospital, York, PA
[email protected]
Program Objectives
• Enhance knowledge of CKD and the NKF’s
guidelines for laboratory diagnosis &
monitoring of CKD.
• Identify pre-analytic variables of urinalysis
testing & analytic variables of manual urine
sediment testing.
• Understand the technology, software features,
and flagging parameters of the Sysmex
UF-1000i automated urine sediment analyzer.
• Identify the benefits of automated urine
sediment analysis.
Did You Know . . .
“Urinalysis is the most
valuable single test of the
anatomic integrity of the
kidneys that is readily
available to the clinician”
Schreiner
From J. Szwed, The Importance of Microscopic
Examination of the Urinary Sediment, American Journal of
Medical Technology, 48:2, Feb. 1982
Functions of Kidney
• Remove waste products & drugs from
body.
• Balance body’s fluid, release hormones to
regulate blood pressure, and produce
active vitamin D.
• Regulation of body’s salt, potassium, &
acid content
National Kidney Foundation
• http://www.kidney.org/kls/index/cfm
• http://www.kidney.org/professionals/kdo
qi/guidelines
• New Guidelines February 2002
• Addition to Guidelines in 2003, 2005,
2006, 2007, 2008, and 2012.
Incidence and Prevalence of
End-Stage Renal Disease in the
U.S.
CHRONIC KIDNEY
DISEASE
• CKD is a world-wide public health
problem that is under-diagnosed and
under-treated.
• Early diagnosis is critical as kidney
disease is often silent in the early stages.
• Most common causes of CKD in North
America is diabetes, hypertension, and
glomerular disease.
CHRONIC KIDNEY
DISEASE
• Presence of excessive amounts of urine
protein is most common clinical sign of
early kidney dysfunction.
• Other markers of kidney damage
– abnormal urine sediment
– abnormal findings on imaging studies
– abnormal blood & urine chemistry results
that identify renal tubular syndromes
CHRONIC KIDNEY
DISEASE
• Symptoms
–
–
–
–
–
–
fatigue
difficulty concentrating
poor appetite
sleeplessness
muscle cramping at night
swollen feet and ankles
CHRONIC KIDNEY
DISEASE
• Symptoms (cont.)
– Puffiness around the eyes, especially in the
morning
– Dry, itchy skin
– Frequent urination, especially at night
Complications of CKD
• Result of reduction of GFR, disorder of
tubular function, or reduction in
endocrine function of the kidney
–
–
–
–
Hypertension
Malnutrition
Anemia
Low serum albumin and serum calcium
Complications of CKD
– High serum phosphate concentration and
high serum parathyroid hormone
concentration
– Reduced activities of daily living
– Lower quality of life
– Increased risk of cardiovascular disease and
stroke
Laboratory Diagnosis and
Monitoring of CKD
• Definitive diagnosis of the type of kidney
disease is based on biopsy or imaging
studies
– Biopsy and invasive imaging procedures are
associated with a risk or serious
complications and are usually avoided unless
a definitive diagnosis would change
treatment or prognosis
Laboratory Diagnosis and
Monitoring of CKD
• GFR is the best overall index of kidney
function
– Decreased GFR precedes the onset of kidney
failure and persistently reduced GFR is a
specific indicator of CKD.
– Drug dosing in CKD is based on GFR levels
Laboratory Diagnosis and
Monitoring of CKD
• GFR cannot be measured directly
– Serum creatinine is used to measure GFR in
most cases
• Use of an international standard or traceable
standard for creatinine calibration is
recommended.
• Creatinine clearance is considered too inaccurate
due to difficulties in obtaining a correctly timed
specimen.
Laboratory Diagnosis and
Monitoring of CKD
• The NKF guidelines recommend that
clinical labs report an estimate of GFR
using the MDRD prediction equation in
addition to the serum creatinine.
• Variables that will affect the estimation
of GFR include: age, sex, race, diet, body
build, medication, and pregnancy.
• If the variables are significant, use the
creatinine clearance.
Laboratory Diagnosis and
Monitoring of CKD
• Serum creatinine is recommended at
least yearly in patients with CKD.
• The rate of decline in GFR can be used to
estimate the interval until onset of kidney
failure and facilitate planning for
therapy, diet, or kidney replacement.
• An acute decline in GFR may be
superimposed on CKD and result in
acute deterioration of kidney function.
Laboratory Diagnosis and
Monitoring of CKD
• Most common causes of deterioration of
kidney function are:
– Reduced blood flow to the kidney, usually
related to volume depletion.
– Toxic insult
– Obstruction from tumors, stones, or blood.
– Inflammation and infection
Cystatin C
• 13 kDa cysteine protease inhibitor constantly
produced by all nucleated cells
• Advantages over creatinine
– Constant rate of production, freely filtered by the
glomerulus
– Unaffected by muscle mass, diet or gender
– No renal tubular secretion
– Good assay precision (~3% CV throughout assay
range)
– Assay unaffected by spectral interferences
NKF Guidelines for Adults and
Children
• Under most circumstances, untimed
(“spot”) urine samples should be used to
detect and monitor proteinuria.
• First morning urines preferred but
random specimens are acceptable. Timed
urine collection (overnight or 24 hr) is
not necessary.
NKF Guidelines (cont.)
• In most cases, screening with urine
dipsticks is acceptable for detecting
proteinuria
– Standard urine dipsticks are acceptable for
detecting increased total urine protein.
– Albumin-specific dipsticks are acceptable for
detecting albuminuria
NKF Guidelines (cont.)
• Patients with a positive dipstick (1+ or
greater): confirm proteinuria by a
quantitative measurement (protein-tocreatinine ratio >200 mg/g or albumin-tocreatinine ratio >30 mg/g) within 3 mos.
• Patients with 2 or more positive
quantitative tests temporally spaced by
1-2 weeks: diagnosed as persistent
proteinuria; further evaluation needed
NKF Guidelines (cont.)
• Monitoring proteinuria in patients with
CKD should be performed using
quantitative measurements.
• Children Without Diabetes:
– orthostatic proteinuria must be excluded by
repeat measurement on a first morning
specimen if the initial proteinuria was
obtained on a random specimen.
NKF Guidelines (cont.)
• Children Without Diabetes:
– Screen spot urine sample for total urine
protein using either: standard urine dipstick
or total protein-to-creatinine ratio
– When monitoring proteinuria for CKD, total
protein-to-creatinine ratio should be
measured in spot urine specimens.
NKF Guidelines (cont.)
• Children With Diabetes:
– Screening and monitoring of post-pubertal
children with diabetes of 5+ years duration
should follow the adult guidelines.
– Screening and monitoring other children
with diabetes should follow the guidelines for
children without diabetes.
2005 Additions to NKF Guidelines
• Bone Metabolism & Disease in Children with
Chronic Kidney Disease: 10/05
– Warns that bone disease begins early in the
course of CKD in children & calcium
balance must be in order for growth &
cardiovascular development
– Physicians need to place greater emphasis on
vitamin D nutrition, levels of parathyroid
hormone, & excesses of calcium intake which
can lead to development of vascular
calcifications.
2005 Additions to NKF Guidelines
• Cardiovascular Disease in Dialysis
Patients: 4/05
– Warns that CVD is leading cause of death
among dialysis patients but treatment is not
as effective as in general population
– Dialysis patients are more prone to sideeffects of treatment
– More research is needed to better manage
CVD in dialysis patients
2006 Additions to NKF Guidelines
• Treatment of Anemia in Chronic Kidney
Disease: 5/06
– Patients with all stages of CKD should be
evaluated for anemia
– Definition of anemia is <13.5 g/dL for males
& <12.0 g/dL for females
– Treat patients with ESA(erythropoiesis
stimulating agent) &/or iron when Hgb is
<11g/dL
2007 Additions to NKF Guidelines
• Chronic Kidney Disease and Diabetes: 2/07
– Emphasizes diabetes prevention, screening &
management of kidney disease
– New term: diabetic kidney disease (DKD)
2012 Additions to NKF Guidelines
• Diabetes and Chronic Kidney Disease
– Target HbA1c of ~7.0% to prevent or delay
progression of microvascular complications
of diabetes, including DKD.
– Lipid-lowering treatment with statins
suggested for patients with diabetes and
CKD, including kidney transplant recipients
2012 Additions to NKF Guidelines
(cont.)
• Diabetes and Chronic Kidney Disease
– Withholding statin treatment initiation in
dialysis patients is suggested.
– Treatment of normotensive patients with
diabetes & elevated levels of albuminuria by
ACE inhibitors or angiotensin receptor
blockers (ARB).
– Statin combination therapy reduces risk of
CVD events.
International Classification of
Diseases, 9th Revision Clinical
Modification (ICD-9-CM)
• Diagnosis codes for CKD to be based on
NKF’s KDOQI Guidelines
– Codes allow medical professionals to clearly
note the stage of kidney disease
– Ability to identify CKD patients who are
kidney transplant recipients
– Ability to link specific treatments to
appropriate CKD stage
Legislative Mandate for Labs to
Report eGFR
• States with laws requiring reporting of eGFR
– New Jersey, Tennessee, Michigan, Louisiana,
Connecticut, and Pennsylvania
• PA General Assembly House Bill 2639
– Passed into PA state law in November, 2006
– eGFR must be calculated for serum
creatinine for patients > 18 years
– All labs had to comply within 2 years of
passage
Facts of Kidney Disease
• More than 26 million Americans have
CKD. More than 20 million more are at
increased risk for developing kidney
disease and most do not know it.
• At the end of 2010, there were 651,000
Americans receiving treatment for
kidney failure (end stage renal disease or
ESRD).
Facts of Kidney Disease
• Each year, more than 70,000 Americans
die from causes related to kidney failure.
• Every month, the number of Americans
waiting for kidney transplants increases.
Approximately 96,292 patients are
awaiting kidney transplants and >2,500
are waiting for kidney-pancreas
transplants.
Facts of Kidney Disease
• Shortage of organ donations is major
contributing factor to the growing
number of people on the waiting list. A
new name is added every 12 minutes and
eighteen people die daily while waiting.
• CKD has a disproportionate impact on
minority populations, especially African
Americans, Hispanics, Asians, and
American Indians.
Facts of Kidney Disease
• Diabetes is the leading cause of kidney
failure: 51% of new cases and 45% of all
cases of kidney failure in U.S.
• Uncontrolled or poorly controlled high
blood pressure is the second leading
cause of kidney failure in U.S: 28% of
new cases and 25% of kidney failure in
U.S.
Facts of Kidney Disease
• Third & fourth leading causes of kidney
failure in U.S. are glomerulonephritis
and polycystic kidney disease: 8.2% and
2.2% of new cases in U.S.
• Kidney and urologic diseases continue to
be major causes of work loss, physician
visits, and hospitalizations among men
and women.
Laboratory’s Involvement
With NKF Guidelines
• Good creatinine calibration
• Add GFR prediction equation to report
• Understand limits of urine test strip
protein
• Add urine test with good low end
sensitivity to urine albumin
(microalbumin)
• Improve urine sediment testing
Preventing Kidney Disease
•
•
•
•
Blood glucose & blood pressure checks
Regular physician check-ups
Taking medications as prescribed by physician
Regular exercise; lose weight if overweight;
low-fat diet
• Avoid tobacco use; moderate alcohol
consumption
• Cholesterol levels in target range
Siemens Clinitek
Microalbumin 2 Reagent Strips
• Provide albumin, creatinine, and albumin to
creatinine ratio results in 1 minute
• Can be used by POC or physicians’ offices
• Use with Clinitek 50 or Clinitek Status
analyzers
– Sensitivity as low as 2mg/dL for urine
protein
– More reliable; less affected by interferences
(e.g. specific gravity and pH)
Siemens Clinitek
Microalbumin 9 Reagent Strips
• Provide albumin, blood, creatinine, glucose,
ketone, leukocyte, nitrite, pH, & protein and
albumin to creatinine ratio & protein to
creatinine ratio
• Use with Clinitek Status or Advantis analyzers
– Random sample; no timed or 24 hr urine
sample required
– Accurate identification of microalbuminuria
Urinalysis Testing
• Pre-analytic variables
– Specimen collection: need written or clearcut oral instructions on specimen collection
– Type of specimen collection (random, clean
catch, cath)
– Delay in specimen delivery
– Specimen storage conditions
Manual Urine Sediment
Analysis
• Analytic variables
– Mixing of samples by inversion, not swirling
– Standardized volume for centrifugation;
note volume if less than 12mL
– Time and G force for centrifugation; do not
use brake
– Inconsistent decantation and re-suspension
steps after centrifugation
Manual Urine Sediment
Analysis
• Analytical variables (cont.)
– Reduced recovery rate of urine elements
after centrifugation
– Variability in concentration ratio
•
•
•
•
Supernatant removal
Mixing of suspension
Filling of chamber; technique-dependent
Distributional errors
Manual Urine Sediment Analysis
• Commercial slide systems
–
–
–
–
Provide some standardization
Technique-dependent
Vary in concentration ratios: 1:5 to 1:48
Addition of drop of stain also varies
concentration ratio
– Low & high power fields of view are
microscope dependent; reporting unit
inequity
Manual Urine Sediment
Microscopy
•
•
•
•
Subjective element identification
Poor reproducibility
Lack of standardization
Time consuming/labor intensive
Sysmex UF-1000i
Sysmex UF-1000i
• Laser-based flow cytometer utilizing 2 stains
with fluorescent dyes to stain cellular elements
• Separate bacteria channel for improved
discrimination
• Forward scatter, hydrodynamic focusing,
forward fluorescent light, conductivity
measurements, and adaptive cluster analysis
Sysmex UF-1000i System
Components
• Main unit with integrated pneumatic unit
• IPU (information processing unit)
Windows XP operating system
• Sampler unit with tube rotator unit
• Bar code reader
• Laser Jet graphic printer/line printer
(1 device, 2 settings)
• Handheld bar code reader
UF-1000i Tube Rotator
UF-1000i Reagents
UFII PACK™-BAC
UFII SHEATH™
UFII PACK™-SED
UFII SEARCH™ -BAC
UFII SEARCH™-SED
UF II PACK-SED / UF II
SEARCH-SED
• UF II PACK-SED
– Removal of amorphous salts together with heating (up to 35°C)
• UF II SEARCH-SED
– Polymethine dye
– Chromogen chain with electron donor and acceptor group
– Stains parts of nucleus, parts of cytoplasm and membranes
– Excitation wavelength is 635 nm
– Emission wavelength is over 660 nm
UF II PACK-BAC / UF II
SEARCH-BAC
• UF II PACK-BAC
– UF II PACK-BAC (e.g. its pH value) together with
heating to >40°C suppresses non-specific staining of
particles other than bacteria
• UF II SEARCH-BAC
– Polymethine dye
– Distinctively stains nucleic acid elements in bacteria
UF-1000i Sample Volumes
• Minimum sample volume:
– Manual mode: 1 mL
– Sampler mode: 4 mL
• Aspiration volume:
– Manual mode: 800 µL
– Sampler mode: 1,200 µL
• Processed sample volume (SRV) in sampler and manual
mode:
– 150 µL for the sediment analysis
– 62.5 µL for the bacteria analysis
UF-1000i
Manual Sample Page
Sample Volumes and Dilution
• Addition of reagent leads to a dilution of
the urine
– for the SED analysis exactly by the factor 4:
• 150 µL sample plus 435 µL diluent plus 15 µL
dye equals 600 µL
– for the BAC analysis exactly by the factor 8:
• 62.5 µL sample plus 425 µL diluent plus
12.5 µL stain equals 500 µL
Sample Incubation
• Incubation time at certain temperature
ranges needed for staining
– for the SED analysis:
• 10 seconds at 35°C
– for the BAC analysis:
• 20 seconds at 42°C
Laminar Flow
Laser light
Scattered
light
Flow cell
particles
Sheath
nozzle
Sheath
reagent
UF-1000i Scattergram
Information
•
•
•
•
•
•
•
Forward Scatter (FSC)
Fluorescence High (FLH)
Fluorescence Low (FLL)
Fluorescence Low Width 2 (FLLW2)
Fluorescence Low Width (FLLW)
Side Scatter (SSC)
Forward Scatter Width (FSCW)
UF-1000i Detection Parameters
Enumerated Parameters
Flagged Parameters
RBC
Pathological Casts
WBC
Crystals
Epithelial Cells
Small Round Cells
Hyaline Casts
Yeast
Bacteria
Mucus
Sperm
S1:
FLH
/
Fsc
Scattergram
S_Fsc
Fsc
Large
Small - large size
X’TAL
Fl
WBC
no fluorescence
Fsc
Small - medium size
Fsc
Medium - large size
Fl
Low fluorescence
Fsc
Fl
Medium - high
fluorescence
Small size
Low to medium fluorescence
Fl
RBC
Fsc
Small
Bacteria Fl
Low
Sperm Fsc
Small size
Very small size
Low fluorescence
Fl
Fluorescence
Medium fluorescence
High
S_FLH
S2: FLL / Fsc - Scattergram
S_Fsc
Fsc
Medium – very large size
Large
Medium - high fluorescence
Fsc
Small - medium size
Fl
Low fluorescence
Fsc
RBC
Fl
WBC
Fl
EC
Fsc
Medium - large size
Fl
Medium - high fluorescence
Small size
Low to medium fluorescence
Fsc
Fsc
Sperm
Small size
Very small size
Small
Bacteria
Low
Fl
Low fluorescence
Fl
Fluorescence
Medium fluorescence
High
S_FLL
S3: FLLW2 / FLLW Scattergram
S_FLLW2
Large
FLLW2
FLLW2
More stainable inclusions
FLLW
Little to more stainable
inclusions
FLLW
Length of stained inclusions
Short –
medium length
of inclusions
SRC
Small WBC
Short
FLLW2
Path.
casts
No to little inclusions
FLLW
Casts (no inclusions)
FLLW2
Mucus
Length of stained particle
No inclusions
Long
FLLW
Long
S_FLLW
B1: Fsc / FLH - Scattergram
B_FSC
Large
FSC
Small to big size
FLH
Debris
No fluorescence
BACT
Fsc
FlH
Small size
Weak fluorescence
Small
Low
Stainability of particles
High
B_FLH
UF-1000i
Sediment
1
UF-1000i
Sediment 2
UF-1000i
Sediment
3
UF-1000i
Sediment
4
UF-1000i
Sediment
5
UF-1000i
Bacteria 1
UF-1000i
Bacteria
2
UF-1000i
Bacteria
3
UF-1000i Technology
Improved
determination of
bacteria
Diluents
Sediments
Bacteria
Sediments
Bacteria
Incubation
Detection
unit
Red semiconductor
laser
•Down sizing
•Long life
•Reduced power
consumption
Sediments
Bacteria
Stain
Two chambers for stain and dilution
UF-1000i Technology
1) Enhanced
detection of
bacteria
Dye
Dye
Dye
Dye
Dye Dye
DyeDye
Dye
Dye
Dye
DyeDye
Forward Scatter
2) Staining
bacteria nuclei
Dye
DyeDye
Dye Dye
Dye
Dye
Dye
Dye
Dye
Dye Dye
Dye
DyeDye
Non-specific staining with debris
Specific stain for Nucleic Acid
Polymethine dye
Stain DNA/RNA
Fluorescence
UF-1000i Technology Method Comparison
UF-1000i Parameters
Parameter
Correlation
r
Regression
r2
Regression Equation
Range
RBC
0.9921
0.9842
y = 0.9544 x – 3.0009
0.0 – 4628.1
WBC
0.9669
0.9348
y = 0.8622 x – 1.6818
0.0 – 2557.5
EC
0.9777
0.9558
y = 0.864 x – 0.1134
0.0 – 176.5
CAST
0.9558
0.9136
y = 0.6125 x + 0.0629
0.00 – 28.04
BACTERIA
0.4831
0.2334
y = 0.1465 x – 51.865
0.0 – 9383.4
The sediment parameters, RBC, WBC, EC and CAST, demonstrate excellent
correlation with the UF-100 system.
Source:
Clinical Data for FDA submission
UF-1000i Technology Method Comparison
UF-100 vs UF-1000i
BACT (Range 1-10,000/μL)
r = 0.4831
y = 0.1465x - 51.865
2
R = 0.2334
10000
9000
8000
7000
UF-1000I
6000
Percent Agreement
83.22%
Positive Predictive Value
91.66%
Negative Predictive Value
84.30%
5000
4000
A comparison of the data was performed to
determine the percent agreement (bacteria
count) of the samples based upon the different
reference intervals listed below.
3000
2000
1000
UF-1000:
~1200/µL
0
0
1000
2000
3000
4000
5000
6000
7000
8000
9000
10000
UF-100
The bacteria reference intervals
for the UF-1000i were
significantly lower than the UF100.
UF-100: ~
2800/µL
Source:
Clinical Data for FDA submission
UF-1000i Technology
N=120
UF-1000i
REVIEW rate:2.6%
RBC/X’TAL
discrimination error
0
0.0%
RBC/BACT、DEBRIS
discrimination error
2
1.7%
RBC/YLC discrimination
error
0
0.0%
Conductivity error
1
0.9%
CARRYOVER
0
0.0%
Source: SCJ R&D Study
UF-100
REVIEW rate:6.0%
Total count error
2
1.7%
Discrimination error
0
0.0%
Conductivity error
1
0.9%
SRC*
5
4.3%
P.CAST*
1
0.9%
* Review setting is default
UF-1000i Technology
Scattergram
UF-1000i
UF-100
Reduction of false-positive by X’TAL interference to RBC
false-positive by X’TAL
interference
S-FSC
Microscopy :
RBC 5.6/µL
X’TAL (2+)
The more
complex the
surface or inner
construction,
the more
intensive SSC
signal is.
UF-1000i: RBC
3.3/µL
X’TAL 102.7/µL
UF-100 :
RBC 119.8/µL
X’TAL 0.0 /µL
UF-1000i Technology
UF-1000i
Scattergram
Microscopy:
EC
24.5/µL
UF-100
Reduced false positive EC
with high positive WBC
WBC is accurately
classified by SSC
signals.
SSC parameters can
help UF to distinguish
WBC and EC.
UF-1000i:
EC
18.2/µL
WBC cluster can be
detected as EC. It is
false positive of EC.
UF-100 :
EC
83.4/µL
UF-1000i Data Storage
• HDD with minimum 20 GB for data storage
including graphics
• Sample Explorer/Data Browser: 10,000
samples measurement data including
histograms & scattergrams
• Work List: 3,000 orders
• Patient information: 5,000 patients data
• 100 reagent logs & error logs
• Doctor & ward master
UF-1000i Sample with No Flagging
UF-1000i Sample with Flagging
UF-1000i “Cumulative” screen
UF-1000i “Service 1” screen
UF-1000i “Service 2” screen
UF-1000i Anti-Carryover Action
• Trigger: bacteria count only
• Sequential mode:
– If the bacteria count exceeds the cut-offs preset in the
anti-carry-over settings, additional autorinse cycles are
performed before the next sample is aspirated.
• Overlapping mode:
– If the bacteria count exceeds the cut-offs preset in the
anti-carry-over settings, additional autorinse cycles are
performed. The next sample will be aspirated twice.
UF-1000i Anti-Carryover
UF-1000i Quality Control
• UF II Control: two level commercial
controls containing particles representing
RBC, WBC, EC, casts, and bacteria
• Controls also monitor conductivity plus
the high level monitors sensitivity
parameters-FSC, FSCW, FLH, FLL,
FLLW, SSC.
• Levy Jennings & Radar Charts
UF-1000i 24 Control Files
UF-1000i QC Charts
L-J Charts
Radar Charts
300 data points
UF-1000i Flagging
(Review Settings)
•
•
•
•
•
•
X’TAL:
YLC:
SRC:
Path.CAST:
MUCUS:
SPERM:
25.0/uL
25.0/uL
10.0/uL
1.5/uL
10.0/uL
10.0/uL
UF-1000i Q-Flags
UF-1000i Factory Defined
Review Flags
•
•
•
•
•
RBC/X’TAL Abn. Cls.:
RBC/BACT Abn. Cls.:
RBC/YLC Abn. Cls.:
Debris High?:
Abn. DC Sensitivity:
• Carryover?:
RBC*
RBC*, BACT*
RBC*
BACT*
≤3.0 or ≥39.0
mS/cm
BACT*
UF-1000i Linearity
•
•
•
•
•
RBC: 1.0-5000.0/uL
WBC: 1.0-5000.0/uL
EC: 1.0-200.0/uL
Casts: 1.0-30.0/uL
Bacteria: -5.0-10,000.0/uL
UF-1000i Reference Intervals
•
•
•
•
•
RBC: ≤23.0/uL
WBC: ≤28.0/uL
EC: ≤31.0/uL
Casts: ≤1.00/uL
Bacteria: ≤358.0/uL
UF-1000i Maintenance
• Daily
– Perform shutdown
– Check for fluid in trap chamber of Pneumatic Unit & empty if
needed
• Monthly or every 9000 cycles
– Clean the sample rotor valve (SRV)
• As Needed
– Clean or replace sample filter if clogged or aspiration is
affected
– Empty waste container if not connected to floor drain
UF-1000i
•
•
•
•
Walk-away system
Uses uncentrifuged urine sample
No interference with amorphous urates
Results in 1 minute; cells reported/uL or
/HPF or /LPF
• Review only by exception; no image
review
Benefits of Automated Urine
Microscopy
• Objective, analytical measurements
• Reduction of subjective identification of
elements
• Reduction of tech to tech variability
• Improved accuracy and reproducibility
• Improved workflow, productivity,
efficiency, turnaround time
• Decreased labor expense
YH Urinalysis Automation
Objectives
• Annual UA volume: 58,000; 78%
microscopics
• Automated dipstick analysis with Clinitek
Atlas system (sample tray) in 8/95.
• Updated to Clinitek Atlas Rack system in
4/03.
• Decision to automate urine sediment
analysis with the Sysmex UF-100. “Live
date” June 4, 2001. UF-1000i installed
12/07.
YH Benefits Using Automated
Sediment Analysis
• Reduced manual microscopic review rate to ~11%
• Reduced turnaround time to <30 minutes from
>60 minutes
• Reduction of 1 FTE through attrition
• Improved workflow: can operate Urinalysis
Department with ~1.5 FTE instead of 3.0 FTE
• Reduction in number of urine cultures
• Culture criteria: WBC >28/uL, bacteria >358/uL,
& positive urine nitrite
YH Benefits Using Automated
Sediment Analysis
(cont.)
• ~15% volume increase since 2001 with no
additional staffing required; current fiscal
year-no volume increase
• Minimal maintenance
• >99% uptime
• Smooth transition; very few physician
concerns or questions
Thank You!
Questions?