Sales Presentation Launch, Rev 10 31 02

ADVIA 120 CSF Assay

ADVIA 120 CSF Assay ADVIA 120... gets it right the 1st time,now 1st to market with an FDA cleared

automated CSF assay

Making a positive difference to human health

….daily.

ADVIA® 120 CSF Assay

ADVIA 120... gets it right the 1st

time!

Now,

ADVIA 120... 1st

to market with

an FDA cleared

automated CSF

assay

Now,

ADVIA 120... 1st

to market with

an FDA cleared

automated CSF

assay

ParameterParameter AdultsAdults NeonatesNeonates

RBC (cells/µL)RBC (cells/µL) 00 00

WBC (cells/µL)WBC (cells/µL) 0 - 5 0 - 5 0 - 300 - 30

Lymphocytes (%)Lymphocytes (%) 60 60 20%20% 20 20 20%20%

Monocytes (%)Monocytes (%) 30 30 15%15% 70 70 20%20%

Neutrophils (%)Neutrophils (%) 2 2 4%4% 4 4 4%4%

CSF Reference Values - Cell Counts

• Normal CSF:~ if cells present would be 100% mononuclear cells

• Abnormal samples: Neuts (PMN’s)

Untreated acute bacterial infections, meningitis Lymphs/Monos (MN’s)

Viral infections, multiple sclerosis, fungal infections, CNS* syphilis, tuberculosis

Eos Parasitic CNS* infestations

All cell populationsMixed infections

* Central Nervous System

Cell Distributions in CSF samples

CSF SampleCSF SampleCurrent PracticeCurrent Practice

WBC and RBCWBC and RBCCell CountsCell Counts

WBCWBCDifferentialDifferential

Chamber CountChamber Count2-10 min2-10 min

Cytospin Sample10-15 min

Prepare Sample Dilution Prepare Slide & Stain

Repeat Chamber CountRepeat Chamber Count Slide Review 5-15 minSlide Review 5-15 min

High Cell Count?

Total Labor : 30 min - 45 min

CombineEqual VolumeCSF + Reagent

Patient CSF Result:RBCWBC

WBC Diff

ADVIA 120 CSF Assay Flow Chart

Patient CSF Sample

CSF Reagent

Prepared Sample

ChamberCounts

CytospinSlide

StainSlide

ReviewSlide

RBCWBCDiff

30 - 45min

InspectSample

RBCWBCDiff

5 - 10 min

InspectSample

ADVIA120

ManualManual

ADVIA 120ADVIA 120

ChamberCounts

DiluteSample

Prepare Sample

HighWBC?

CSF CSF SampleSample

WBC and RBCWBC and RBCCell CountsCell Counts

WBCDifferential

Chamber CountChamber Count2-10 min2-10 min

Cytospin Sample10-15 min

Dilute Sample Prepare Slide & Stain

Repeat Chamber Repeat Chamber CountCount

Review Slide 5-15 min

High Cell Count

Current Practice



CSF Assay Kit Components

• Start up installation kit contains:– hardware key

• installs on the parallel port of the ADVIA 120 computer• accesses the proprietary CSF software

• Reagent kit contains:– CSF reagent - 8 ml bottle

• sufficient for 25 tests/vial

• Control kit:– 1 vial each of 2 levels

• sufficient for 10 tests/vial

Software Installation kit contains:– Access key

Reagent kit contains:– CSF reagent

• 25 30 day open stability Tests

Control kit:– 2 Levels Low & High

• 1 vial each • 10 tests/vial• 10 day open stability

CSF Assay Kit Components

HL

Kit Components

Running a Sample: Routine Operations, Manual ID Screen

Running a Sample

On Board Advertisement in V3 Software

CSF Screen

CSF Sample Run Screen

lymphs

noise

RBC’s

monos

neuts

noise

eosResearch Use Only

Neut

RBC

Mono

Lymph Eos

ADVIA 120 Manual

# WBC 2 3

# RBC 1 2

# Neuts 0 0

# Lymphs 2 3

# Monos 0 0

# PMN 0 0

# MN 2 3

ADVIA 120 CSF AssayNormal Sample

Eos

Reportable Results are...• Displayed on the Run Screen, printed & transmitted to

the LIS.• Automated WBC on all samples• Automated RBC on samples < 1500 RBC’s cells/L • PMN, MN, and Differential on samples with >20 / L

(absolute and %)• WBC Differential includes:

– Neutrophils– Lymphocytes– Monocytes– Eosinophils (currently for research use only, not reportable)

Reportable Results

• Automated WBC on all samples

• Automated RBC on samples < 1500 RBC’s cells/L

• Differential, PMN and MN (absolute and %) on samples with >20/L WBC

• WBC Differential includes:– Neutrophils– Lymphocytes– Monocytes– Eosinophils (currently for research use)

MonoNeut

Lymph

RBC

Eos

ADVIA 120 Manual

# WBC 94 95

# RBC 298 325

% Neuts 47 52

%Lymphs 34 44

%Monos 20 4

%PMN 47 48

% MN 53 52

ADVIA 120 CSF Assay: Abnormal

ADVIA 120 Manual

# WBC 6 4

# RBC 284 248

# Neuts 1 1

# Lymphs 5 3

# Monos 0 0

# PMN 1 1

# MN 5 3

ADVIA 120 CSF Assay Sample with High RBC

Neut

RBC

Mono

Lymph Eos

ADVIA 120 Manual

# WBC 124 135

# RBC 4 3

# Neuts 31 29

# Lymphs 38 45

# Monos 47 52

# Eos 7 9

# PMN 32 38

# MN 85 97

ADVIA 120 CSF Assay Sample with High WBC

Neut

RBC

Mono

Lymph Eos

ADVIA 120 Manual

# WBC 94 95

# RBC 298 325

% Neuts 47 52

%Lymphs 34 44

%Monos 20 4

%PMN 47 48

% MN 53 52

ADVIA 120 CSF Assay Abnormal Sample

MonoNeut

Lymph

RBC

Eos

Results• WBC Linearity

Range Max. Deviation

0-50 / L 5 cells

50 - 5,000 / L 10%

• RBC Linearity


0-50 / L 5 cells

50 - 1,500 / L 10%

• Within Run Precision and Accuracy (Nominal 100 cells / L; 150 samples, at least 50% abnormal)

Parameter Stan. Dev. / Bias %CV / %Bias

WBC 15 15%

RBC 15 15%

# PMN 20 20%

#MN 20 20%

Summary of features• Reduces:

– labor intensive manual testing– turn around time– workstations– need for specialist to perform the test

• Standardizes CSF analysis– Provides Quality control for method previously uncontrolled

• Extends the useful life of the prepared sample for up to 4 hours • Provides a platform for future developments

– investigate feasibility of adapting method to other body fluid assays (I.e. - synovial, pleural, amniotic)

Summary of Features

• Reduces:– Labor intensive manual testing– Turn around time

• Standardizes CSF analysis– Provides Quality Control for method previously

uncontrolled – No specialist needed to perform the test

• Provides a platform for future developments – Investigating feasibility of other fluid assays

• Synovial• Pleural• Amniotic

CSF Assay Performance Characteristics

Performance Characteristics• WBC Linearity


0 - 50 / L 5 cells

50 - 5,000 / L 10%

• RBC LinearityRange Max. Deviation

0 - 50 / L 5 cells

50 - 1,500 / L 10%

• Within Run Precision and Accuracy (Nominal 100 cells / L; 150 samples, at least 50% abnormal)Parameter Stan. Dev. / Bias %CV / %Bias

WBC 15 15%

RBC 15 15%

# PMN 20 20%

#MN 20 20%

ADVIA 120 CSF Assay RBC Count

r = 0.988y = 0.93x + 5Syx = 62Manual Mean = 139ADVIA 120 Mean = 135Bias = -4

0

500

1000

1500

2000

2500

3000

0 500 1000 1500 2000 2500 3000

Manual RBC

AD

VIA

120

RB

C

ADVIA 120 CSF AssayWBC Count

r = 0.988y = 0.87x + 8Syx = 29Manual Mean = 55ADVIA 120 Mean = 56Bias = 1

0

500

1000

1500

2000

2500

3000

0 500 1000 1500 2000 2500 3000

Manual WBC

AD

VIA

12

0 W

BC

ADVIA 120 CSF AssayMononuclear and Polymorphonuclear Cells

r = 0.981y = 0.81x + 2Syx = 14Manual Mean = 18ADVIA 120 Mean = 17Bias = -1

0

100

200

300

400

500

600

700

800

0 200 400 600 800

Manual # PMNA

DV

IA 1

20 #

PM

N


0

50

100

150

200

250

300

350

400

450

500

0 100 200 300 400 500

Manual # MN

AD

VIA

120

# M

N

Comparison of manual mononucelar (MN) and polymorphonuclear (PMN) cell counts to ADVIA 120

ADVIA 120 CSF AssayWBC Differential


0

50

100

150

200

250

300

0 100 200 300

Manual # Neut

AD

VIA

120

# N

eut


0

50

100

150

200

250

300

350

400

0 100 200 300 400

Manual # Lymph

AD

VIA

120

# L

ymph


0

20

40

60

80

100

120

140

160

180

200

0 50 100 150 200

Manual # Mono

AD

VIA

120

# M

ono

Comparison of Manual Neuts, Lymph and Mono counts to ADVIA 120

ADVIA 120 CSF AssayRBC and WBC Linearity

0

500

1000

1500

2000

2500

3000

0 500 1000 1500 2000 2500 3000

Expected RBCO

bse

rve

d R

BC

0

1000

2000

3000

4000

5000

6000

0 1000 2000 3000 4000 5000 6000

Expected WBC

Obs

erve

d W

BC

CSF Analysis Artifacts


Signature of Oil or Fatty SubstanceSignature of Oil or Fatty Substance

ManualManual: : RBC= 28 Cells/RBC= 28 Cells/L L WBC= 1 WBC= 1 Cells/Cells/L L ADVIA120ADVIA120:: RBC= 46 Cells/RBC= 46 Cells/L L WBC= 3 WBC= 3 Cells/Cells/L L

RBC Coincidence in samples with RBC counts > 1500 cells/L


WBC/L RBC/LManual Result 25 64300Incorrect ADVIA 120 Result 1772 38313


High RBC Cell Count sample - diluted with PBSComplete Sphering after 4 minutes incubation

Undiluted Sample Diluted Sample with PBS


High RBC Cell Count sample - diluted with SalineIncomplete sphering > 4 minutes requires longer incubation

4 minute incubationincomplete sphering

10 minute incubationsphering complete

Sample with RBC populations that fail to sphere Sample with RBC populations that fail to sphere completelycompletely

RBCs in Lymph Region


WBC/L RBC/L %Lymphs

Manual Result 17 1060 25

ADVIA 120 Result 61 650 86


RBCs in Noise Region

WBC/L RBC/L

Manual Result 75 1807

ADVIA 120 Result 81 1277

Sample containing Microcytic and/or Hypochromic RBC’s

CSF Analysis ArtifactsSample with Budding Yeast Forms (Circled)

WBC/L RBC/L %Lymphs

Manual Result 2 16 100

ADVIA 120 Result 40 38 93

Back up slides

Cerebrospinal Fluid (CSF)

Normal SampleNormal Sample

100 % mononuclear100 % mononuclear

Multiple Sclerosis Multiple Sclerosis

Lymphs/Monos/PMN’sLymphs/Monos/PMN’s

CSF microscope slides

CSF CytogramsCell Analysis Regions

Noise

NoiseRBC

Lymphs

Monos

NeutsEos

Research Use Only

Sales Presentation Launch, Rev 10 31 02

Documents

Transcript of Sales Presentation Launch, Rev 10 31 02