adam rwbc introduction - montreal biotech rwbc...adam-20 0 20 40 60 80 100 120 140 160 180 adam 150...

Quantitative id l WBCresidual WBC

counter

ADAMADAM WBCWBCADAMADAM--rWBCrWBC

Copyright @ NanoEnTek, All right Reserved 1

Product SummaryProduct Overview Specifications

Product name : ADAM-rWBC

Description : Residual Leukocyte Counter

Features :▪ Attractive alternatives to either Nageotte or

flow cytometry▪ Portable image cytometry with disposable

slide▪ Accurate and reliable results

( Scans sample for 203 images / Optimized image analysis)▪ Auto-stage control and auto-focusing / High g g g

speed measurements▪ Real-time live image viewing▪ User-friend interface


How to useHow to use

1P tiPreparation

Barcode Reading

2lSample

LoadingSample

PreparationSample

Loading in r Slide

3

r-Slide

3ADAM

OperationADAM

OperationResult


Operation

Comparison with existing residual Comparison with existing residual counting technologiescounting technologiescounting technologiescounting technologies

AdvantagesAdvantages DisadvantagesDisadvantages

N ttN tt Simple & inexpensive technologySimple & inexpensive technology Very labor intensiveVery labor intensiveNageotteNageotte Simple & inexpensive technologySimple & inexpensive technology Very labor intensiveVery labor intensiveVariable results depending upon staff Variable results depending upon staff

skillskillHigh coefficient of variation at low High coefficient of variation at low

WBC iWBC iWBC concentrationWBC concentration

Flow Flow CytometryCytometry Rapid, once set up, allows higher Rapid, once set up, allows higher throughput of specimensthroughput of specimens

Very expensiveVery expensiveHighly trained staff requiredHighly trained staff requiredg p pg p p Highly trained staff requiredHighly trained staff required

ADAM, rWBC RapidConsistent between usersConsistent between users High degree of correlation

with reference methods


Current LR StandardsCurrent LR Standards

Must be prepared by a method known to Must be prepared by a method known to d th l k t b t <5 10d th l k t b t <5 1066reduce the leukocyte number to <5 x 10reduce the leukocyte number to <5 x 1066

Validation and quality control shall Validation and quality control shall yydemonstrate that at least 95% of units demonstrate that at least 95% of units sampled meet this criterionsampled meet this criterionpp

Source: AABB standard 5.7.4.1 and FDA memorandum May 29,1996; Source: AABB standard 5.7.4.1 and FDA memorandum May 29,1996; R d ti d Li i i t f l k tR d ti d Li i i t f l k t d d bl dd d bl dRecommendations and Licensing requirements for leukocyteRecommendations and Licensing requirements for leukocyte--reduced blood reduced blood productsproducts


QuantitatingQuantitating residual WBC in residual WBC in leukoleuko reduced productsreduced productsleukoleuko--reduced productsreduced products

Validating a new device that uses fluorescence of proValidating a new device that uses fluorescence of pro pidiumpidiumValidating a new device that uses fluorescence of proValidating a new device that uses fluorescence of pro--pidiumpidiumiodide to identify nucleated cellsiodide to identify nucleated cells

GorlinGorlin, Jed B., Jed B.11; Janzen, Mark; Janzen, Mark11; ; AverbeckAverbeck, Deborah, Deborah11; Reynolds, Kendra; Reynolds, Kendra11; ; DoedenDoeden, Kim, Kim11; ; Gastineau, DennisGastineau, Dennis22; Jun, ; Jun, SeungSeung HwaHwa33; ; HurHur, Daesung3; Chung, Chanill, Daesung3; Chung, Chanill33

11Memorial Blood Centers St Paul MN United StatesMemorial Blood Centers St Paul MN United States11Memorial Blood Centers, St. Paul, MN, United States Memorial Blood Centers, St. Paul, MN, United States 22Mayo, Rochester, MN, United States Mayo, Rochester, MN, United States 33NanoEn NanoEn TekTek, Inc., Seoul, Korea, Republic of, Inc., Seoul, Korea, Republic of


Validation studyValidation study

Performed at Memorial Blood Centers and Performed at Memorial Blood Centers and Mayo Transfusion ServiceMayo Transfusion ServiceMayo Transfusion Service Mayo Transfusion Service Compared to Nageotte and BD LeucoCountCompared to Nageotte and BD LeucoCountTesting included:Testing included:

Reproducibility/PrecisionReproducibility/Precisionp yp yLinearity testingLinearity testingStabilityStabilityStabilityStabilityIRBIRB--Approved Clinical StudyApproved Clinical Study


Reproducibility/Precision

Sample Type WBC range/μl Mean SD % CV

~0-1 0.12 0.09 69.33

RBC 1~5 3.48 0.49 14.19

5~10 6.28 0.50 7.99

10 15 13 37 0 74 5 53n=20 at each dilution 10~15 13.37 0.74 5.53

15~20 15.66 0.84 5.39

20~300 168.20 3.93 2.34

Platelet

~0-1 0.16 0.10 62.70

1~5 3.51 0.41 11.64

5~10 7 41 0 55 7 47Platelet

n=20 at each dilution

5~10 7.41 0.55 7.47

10~15 11.30 0.71 6.24

15~20 17.75 0.84 4.76


20~300 104.10 2.22 2.13

Linearity

200

Equation y = a + b*x

Weight No WeightiResidual Sum of Squares

578.43938

0 9921

200Equation y = a + b*x

Weight No WeightiResidual Sum of Squares

51.25345

Adj. R-Squa 0.99927e

100

Man

ual

SquaresAdj. R-Squa 0.9921Value Standard Er

Manual Intercept -0.9301 1.64275Manual Slope 1.0913 0.02362

100

150

FAC

S

jValue Standard Er

FACSIntercept -0.059 0.48899Slope 1.0749 0.00703

RB

C

sam

ple

0

M

0

50

s

0 50 100 150 200

ADAM

-20 0 20 40 60 80 100 120 140 160 180

ADAM

150

Equation y = a + b*x

Weight No WeightiResidual 40.9047le

200Equation y = a + b*x

Weight No WeightiResidual 272.99566

100

CS

Sum of SquaresAdj. R-Squar 0.9992

Value Standard Er

FACSIntercept 0.6203 0.43729Slope 0.9890 0.00678

sam

p

100

150

ual

Sum of SquaresAdj. R-Squa 0.99546

Value Standard Er

ManualIntercept -0.710 1.12969Slope 1.0701 0.01752

0

50

FAC

late

let

50

Man

u


0 50 100 150

0

ADAM

Pl

0 50 100 150

0

ADAM

StabilityStability

RBC samples (n=20) and platelet samplesRBC samples (n=20) and platelet samplesRBC samples (n=20) and platelet samples RBC samples (n=20) and platelet samples (n=20) were tested within 1 minute of (n=20) were tested within 1 minute of leukoreductionleukoreductionleukoreductionleukoreductionRetested (10 times each) after a one hour Retested (10 times each) after a one hour holdholdNo statistically significant differences foundNo statistically significant differences foundNo statistically significant differences foundNo statistically significant differences found


Clinical StudyClinical Study

PrestoragePrestorage leukoreducedleukoreduced red cells (n=64) andred cells (n=64) andPrestoragePrestorage leukoreducedleukoreduced red cells (n=64) and red cells (n=64) and apheresisapheresis platelets (n=86) were measured on all platelets (n=86) were measured on all three platformsthree platformsthree platformsthree platformsRBC Samples: Both the ADAM and FACS were RBC Samples: Both the ADAM and FACS were significantly different (p=0 00 for both) whensignificantly different (p=0 00 for both) whensignificantly different (p 0.00 for both) when significantly different (p 0.00 for both) when compared to the manual procedure.compared to the manual procedure.Platelet Samples: No statistical differences betweenPlatelet Samples: No statistical differences betweenPlatelet Samples: No statistical differences between Platelet Samples: No statistical differences between the ADAM, Manual or FACS (removing outlier) the ADAM, Manual or FACS (removing outlier)


SummarySummary

Adam is an attractive alternative to eitherAdam is an attractive alternative to eitherAdam is an attractive alternative to either Adam is an attractive alternative to either NageotteNageotte or Flow or Flow CytometryCytometryApproved by the Korea Food & DrugApproved by the Korea Food & DrugApproved by the Korea Food & Drug Approved by the Korea Food & Drug Administration on December 2, 2009 Administration on December 2, 2009 D t h b b itt d t FDA f d iD t h b b itt d t FDA f d iData have been submitted to FDA for device Data have been submitted to FDA for device approval and are currently in evaluationapproval and are currently in evaluation


adam rwbc introduction - montreal biotech rwbc...adam-20 0 20 40 60 80 100 120 140 160 180 adam 150...

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