UPDATE IN URINALYSIS

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UPDATE IN URINALYSIS Diane Gaspari, SH(ASCP) Division Manager, Core Lab York Hospital, York, PA [email protected]

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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. - PowerPoint PPT Presentation

Transcript of UPDATE IN URINALYSIS

Page 1: UPDATE IN URINALYSIS

UPDATE IN URINALYSIS

Diane Gaspari, SH(ASCP)

Division Manager, Core Lab

York Hospital, York, PA

[email protected]

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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.

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Did You Know . . .“Urinalysis is the most valuable single test of the anatomic integrity of the kidneys that is readily available to the clinician”

SchreinerFrom J. Szwed, The Importance of Microscopic Examination of the Urinary Sediment, American Journal of Medical Technology, 48:2, Feb. 1982

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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

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National Kidney Foundation

• http://www.kidney.org/kls/index/cfm

• http://www.kidney.org/professionals/kdoqi/guidelines

• New Guidelines February 2002

• Addition to Guidelines in 2003, 2005, 2006, 2007, 2008, and 2012.

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Incidence and Prevalence of End-Stage Renal Disease in the

U.S.

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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.

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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

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CHRONIC KIDNEY DISEASE

• Symptoms– fatigue– difficulty concentrating– poor appetite– sleeplessness– muscle cramping at night– swollen feet and ankles

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CHRONIC KIDNEY DISEASE

• Symptoms (cont.)– Puffiness around the eyes, especially in the

morning– Dry, itchy skin– Frequent urination, especially at night

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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

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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

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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

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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

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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.

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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.

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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.

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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

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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

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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.

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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

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NKF Guidelines (cont.)

• Patients with a positive dipstick (1+ or greater): confirm proteinuria by a quantitative measurement (protein-to-creatinine ratio >200 mg/g or albumin-to-creatinine 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

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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.

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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.

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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.

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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.

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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 side-effects of treatment

– More research is needed to better manage CVD in dialysis patients

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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

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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)

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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

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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.

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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

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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

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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).

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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.

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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.

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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.

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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.

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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

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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

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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)

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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

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Urinalysis Testing

• Pre-analytic variables– Specimen collection: need written or clear-

cut oral instructions on specimen collection– Type of specimen collection (random, clean

catch, cath)– Delay in specimen delivery– Specimen storage conditions

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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

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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

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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

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Manual Urine Sediment Microscopy

• Subjective element identification

• Poor reproducibility

• Lack of standardization

• Time consuming/labor intensive

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Sysmex UF-1000i

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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

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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

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UF-1000i Tube Rotator

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UF-1000i Reagents

UFII SEARCH™-SED

UFII PACK™-SEDUFII SHEATH™

UFII SEARCH™ -BAC

UFII PACK™-BAC

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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

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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

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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

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UF-1000iManual Sample Page

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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

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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

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Flow cell

Laser light

Laminar Flow

particlesSheath reagent

Sheath nozzle

Scattered light

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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)

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UF-1000i Detection Parameters

MucusBacteria

Sperm

YeastHyaline Casts

Small Round CellsEpithelial Cells

CrystalsWBC

Pathological CastsRBC

Flagged ParametersEnumerated Parameters

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RBC

Small - medium size

Low fluorescenceFl

Fsc

Fl

FscMedium - large size

Medium - high fluorescence

Fl

FscVery small size

Siz

e (s

ecti

on

al a

rea)

Large

Small

Fluorescence HighLow

Bacteria

WBC

Low fluorescence

S_FLH

S_FscS1: FLH / Fsc - Scattergram

YLC

X’TAL

Sperm

Low to medium fluorescenceFl

FscSmall size

Medium fluorescenceFl

Fsc

Small size

Fl

FscSmall - large size

no fluorescence

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YLC

RBC

Small - medium size

Low fluorescenceFl

Fsc

Fl

Fsc

Fl

Fsc

Siz

e (s

ecti

on

al a

rea)

Large

Small

Fluorescence HighLow

Bacteria

WBC

Low fluorescence

S_FLL

S_Fsc

S2: FLL / Fsc - Scattergram

Low to medium fluorescenceFl

Fsc Small size

Medium fluorescenceFl

FscSmall size

Fl

FscMedium – very large size

Medium - high fluorescence EC

SpermVery small size

Medium - high fluorescence

Medium - large size

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S3: FLLW2 / FLLW - Scattergram

FLLW2

S_FLLW2

Large

Small

Length of stained particleShort S_FLLW

FLLW

FLLW2

Little to more stainable inclusions

FLLW

FLLW

Long

Length of stained inclusions

Casts (no inclusions)Len

gth

of

s ta i

ne d

in

clu

s io

ns

Short – medium lengthof inclusions No to little inclusions

More stainable inclusions

Path. casts

Epithelia

l cells

Mucus

FLLW2

FLLW

No inclusions

SRC

WBC

FLLW2

Long

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B1: Fsc / FLH - ScattergramB_FSC

Large

Small

Stainability of particlesLow B_FLH

Siz

e o

f p

arti

c le s

BACTDebris

Weak fluorescenceFlH

FscSmall size

FSC

FLH

Small to big size

No fluorescence

High

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UF-1000i Sediment

1

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UF-1000iSediment 2

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UF-1000iSediment

3

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UF-1000iSediment

4

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UF-1000iSediment

5

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UF-1000iBacteria 1

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UF-1000iBacteria

2

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UF-1000iBacteria

3

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UF-1000i Technology

BacteriaSediments

BacteriaSediments Stain

IncubationIncubation

DetectionDetection unitunit

Sediments BacteriaDiluents

Two chambers for stain and dilution

Improved determination of bacteria

Red semiconductor laser•Down sizing•Long life•Reduced power consumption

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UF-1000i Technology

Fluorescence

  Stain DNA/RNA

Non-specific staining with debris

Forw

ard

Sca

tter

Specific stain for Nucleic Acid Specific stain for Nucleic Acid

DyeDye

Dye

Dye

DyeDye

Dye

DyeDyeDyeDye

Dye

Dye

Dye

DyeDye

Dye

Dye

Dye

DyeDyeDye

DyeDye

DyeDyeDyeDye

1) Enhanced detection of bacteria

2) Staining bacteria nuclei

Polymethine dye

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UF-1000i Technology Method ComparisonUF-1000i Parameters

0.0 – 9383.4y = 0.1465 x – 51.8650.23340.4831BACTERIA

0.00 – 28.04y = 0.6125 x + 0.06290.91360.9558CAST

0.0 – 176.5y = 0.864 x – 0.11340.95580.9777EC

0.0 – 2557.5y = 0.8622 x – 1.68180.93480.9669WBC

0.0 – 4628.1y = 0.9544 x – 3.00090.98420.9921RBC

RangeRegression EquationRegression

r2

Correlation

r

Parameter

The sediment parameters, RBC, WBC, EC and CAST, demonstrate excellent correlation with the UF-100 system.

Source: Clinical Data for FDA submission

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UF-1000i Technology Method Comparison

The bacteria reference intervals for the UF-1000i were significantly lower than the UF-100.

UF-100 vs UF-1000iBACT (Range 1-10,000/μL)

r = 0.4831

y = 0.1465x - 51.865

R2 = 0.2334

0

1000

2000

3000

4000

5000

6000

7000

8000

9000

10000

0 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000

UF-100

UF-1

000I

84.30%Negative Predictive Value

91.66%Positive Predictive Value

83.22%Percent Agreement

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.

UF-1000: ~1200/µL

UF-100: ~ 2800/µL

Source: Clinical Data for FDA submission

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UF-1000i Technology

0.0%0CARRYOVER

0.9%1Conductivity error

0.0%0

RBC/YLC discrimination error

1.7%2

RBC/BACT 、 DEBRIS discrimination error

0.0%0

RBC/X’TAL discrimination error

REVIEW rate :2.6%

UF-1000iN=120

0.9%1P.CAST*

4.3%5SRC*

0.9%1Conductivity error

0.0%0Discrimination error

1.7%2Total count error

* Review setting is default

REVIEW rate : 6.0%UF-100

Source:SCJ R&D Study

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UF-1000i Technology

UF-100 :RBC 119.8/µLX’TAL 0.0 /µL

UF-1000i: RBC   3.3/µL   X’TAL 102.7/µL

Microscopy :RBC 5.6/µLX’TAL (2+)

false-positive by X’TAL interference

Reduction of false-positive by X’TAL interference to RBCScattergram

UF-100UF-1000i

The more complex the surface or inner construction, the more intensive SSC signal is.

S-FSC

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UF-1000i Technology

UF-100 :EC 83.4/µL

  UF-1000i:       EC       18.2/µL

Microscopy:EC 24.5/µL

WBC cluster can be detected as EC. It is false positive of EC.

Reduced false positive EC with high positive WBC

Scattergram

UF-100UF-1000i

SSC parameters can help UF to distinguish WBC and EC.

WBC is accurately classified by SSC signals.

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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

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UF-1000i Sample with No Flagging

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UF-1000i Sample with Flagging

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UF-1000i “Cumulative” screen

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UF-1000i “Service 1” screen

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UF-1000i “Service 2” screen

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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.

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UF-1000i Anti-Carryover

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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

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UF-1000i 24 Control Files

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UF-1000i QC Charts

L-J Charts

Radar Charts

300 data points

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UF-1000i Flagging (Review Settings)

• X’TAL: 25.0/uL

• YLC: 25.0/uL

• SRC: 10.0/uL

• Path.CAST: 1.5/uL

• MUCUS: 10.0/uL

• SPERM: 10.0/uL

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UF-1000i Q-Flags

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UF-1000i Factory Defined Review Flags

• RBC/X’TAL Abn. Cls.: RBC*

• RBC/BACT Abn. Cls.: RBC*, BACT*

• RBC/YLC Abn. Cls.: RBC*

• Debris High?: BACT*

• Abn. DC Sensitivity: ≤3.0 or ≥39.0 mS/cm

• Carryover?: BACT*

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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

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UF-1000i Reference Intervals

• RBC: ≤23.0/uL

• WBC: ≤28.0/uL

• EC: ≤31.0/uL

• Casts: ≤1.00/uL

• Bacteria: ≤358.0/uL

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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

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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

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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

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YH Urinalysis AutomationObjectives

• 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.

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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

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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

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Thank You!

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Questions?