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Mona D. Jensen, PhD R&D Manager IDEXX Laboratories, Inc. July 2009 PERFORMANCE OF IDEXX Catalyst Dx ® Chemistry Analyzer IDEXX Technical Support U.S./Canada/Latin America 1-800-248-2483 Europe 00800 1234 3399 Australia 1800 655 978 New Zealand 0800 102 084

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Page 1: perFOrmance OF IDEXX Catalyst Dx Chemistry Analyzercms2.netnews.cz/files/attachments/67030/20594-09-68136-00-CTDx... · perFOrmance OF IDEXX Catalyst Dx ... VITROS 250 Concentration

Mona D. Jensen, PhD

R&D Manager

IDEXX Laboratories, Inc.

July 2009

perFOrmance OF IDEXX Catalyst Dx® Chemistry Analyzer

iDexx technical supportU.S./Canada/Latin America 1-800-248-2483

Europe 00800 1234 3399Australia 1800 655 978

New Zealand 0800 102 084

Page 2: perFOrmance OF IDEXX Catalyst Dx Chemistry Analyzercms2.netnews.cz/files/attachments/67030/20594-09-68136-00-CTDx... · perFOrmance OF IDEXX Catalyst Dx ... VITROS 250 Concentration

Spreading layerFilters sample to minimize interference from lipemic, icteric and hemolyzed samples.

reagent/regiStration layer(S)Chemical reaction takes place here

Support layer

Objective: to correlate accuracy and precision of the ideXX Catalyst dx® Chemistry analyzer with a nationally recognized reference standard, the VitroS® 250 Chemistry System from ortho-Clinical diagnostics, a Johnson & Johnson company.

summary:Canine, feline and equine serum, plasma and whole blood samples were tested, as well as urine samples for uCre and upro. Samples were chosen to cover the entire dynamic range of individual chemistry tests.

patient samples were analyzed on three Catalyst dx Chemistry analyzers and in duplicate on one VitroS 250 Chemistry System for 24 different chemistries.

a high degree of correlation was observed for all chemistries between the VitroS 250 Chemistry System and the Catalyst dx Chemistry analyzer. Correlation coefficients ranged from 0.959 to 0.998

clinical implicatiOns: the Catalyst dx Chemistry analyzer is used to perform clinical chemistry analyses in a timely manner. it is important that such technologies meet reference methodology standards. By comparing the Catalyst dx Chemistry analyzer results to those of the VitroS 250 Chemistry System, which is referenced against the international Federation of Clinical Chemistry (iFCC), the Clinical and laboratory Standards institute (ClSi) and the Center for disease Control (CdC) recommended and/or approved methods, Catalyst dx Chemistry analyzer accuracy has been established.

Dry-sliDe technOlOgy:Both the VitroS 250 Chemistry System and the Catalyst dx Chemistry analyzer utilize dry-slide technology, which offers many advantages. the dry slide is made of several layers that help minimize interferences from lipemic, icteric and hemolyzed samples. dry slides are easier to use, have less user variability, provide flexible testing options and are more economical than liquid reagent analyzers. Chemical reactions that take place on dry slides are read optically and processed by either endpoint or rate protocols.

insiDe the catalyst Dx® chemistry analyzer sliDe:

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

R2 = 0.97Slope = 1.03

Intercept = -0.08n = 2736

7

6

5

4

3

2

1

00 1 2 3 4 5 6 7

albbun

Cat

alys

t Dx

Con

cent

ratio

n (U

/L)

VITROS 250 Concentration (U/L)

2000

1500

1000

500

00 500 1000 1500 2000

R2 = 0.98Slope = 1.01

Intercept = -3.37n = 2741

alKp

Cat

alys

t Dx

Con

cent

ratio

n (U

/L)

VITROS 250 Concentration (U/L)

1000

900800700

600500400

300200

1000

0 100 200 300 400 500 600 700 800 900

R2 = 0.99Slope = 0.93

Intercept = 9.31n = 2436

alt

Cat

alys

t Dx

Con

cent

ratio

n (U

/L)

VITROS 250 Concentration (U/L)

2400

2000

1600

1200

800

400

00 200 600 1000 1400 1800 2200

R2 = 0.97Slope = 1.02

Intercept = 1.14n = 1349

amyl

Cat

alys

t Dx

Con

cent

ratio

n (U

/L)

VITROS 250 Concentration (U/L)

1000

800

600

400

200

00 200 400 600 800 1000

R2 = 0.99Slope = 0.94

Intercept = 1.99n = 699

ast

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

140

120

100

80

60

40

20

00 10 20 30 40 50 60 70 80 90 110 130

R2 = 0.99Slope = 0.99

Intercept = 0.84n = 2610

bun

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

16

14

12

10

8

6

4

2

0

R2 = 0.98Slope = 0.95

Intercept = 0.15n = 2352

0 2 4 6 8 10 12 14 16

ca

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

500450400350300250200150100

500

0 50 100 150 200 250 300 350 400 450 500

R2 = 0.99Slope = 0.99

Intercept = 3.50n = 1737

chOl

Cat

alys

t Dx

Con

cent

ratio

n (U

/L)

VITROS 250 Concentration (U/L)

200018001600140012001000

800600400200

00 200 400 600 800 1200 1600 2000

R2 = 0.99Slope = 1.02

Intercept = -7.85n = 591

cK

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

14

12

10

8

6

4

2

00 1 2 3 4 5 6 7 8 9 10 11 12 13 14

R2 = 0.99Slope = 0.99

Intercept = 0.03n = 2687

crea

Cat

alys

t Dx

Con

cent

ratio

n (U

/L)

VITROS 250 Concentration (U/L)

1000

900

800700

600500400300

200

1000

0 100 200 300 400 500 600 700 800 900

R2 = 0.99Slope = 0.93

Intercept = 2.04n = 1862

ggt

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

700

600

500

400

300

200

100

00 100 200 300 400 500 600 700

R2 = 0.99Slope = 1.01

Intercept = -1.01n = 2500

glu

materials and methods: Canine, feline and equine serum, plasma and whole blood samples were evaluated on both the VitroS® 250 Chemistry System and the Catalyst dx® Chemistry analyzer according to the applicable users’ guides. urine samples were similarly assayed for upro and uCre. Samples were run on three or four Catalyst dx Chemistry analyzers. reference concentration is the mean of two runs on the VitroS 250 Chemistry System. data was collected and plotted on graphs to determine regression statistics.

results: the Catalyst dx Chemistry analyzer has a high degree of correlation for each of the 24 chemistries with the VitroS 250 Chemistry System. Below are correlation graphs for individual chemistries showing correlation coefficient (r2), slope, intercept, and number of samples (n).

legend: Canine + Equine x Feline

the cOmparisOnthe evaluatiOn

Page 3: perFOrmance OF IDEXX Catalyst Dx Chemistry Analyzercms2.netnews.cz/files/attachments/67030/20594-09-68136-00-CTDx... · perFOrmance OF IDEXX Catalyst Dx ... VITROS 250 Concentration

Cat

alys

t Dx

Con

cent

ratio

n (m

mol

/L)

VITROS 250 Concentration (mmol/L)

11

9

7

5

32

00 1 2 3 4 5 6 7 8 9 10 11 12

R2 = 0.99Slope = 0.99

Intercept = 0.01n = 137

lac

Cat

alys

t Dx

Con

cent

ratio

n (U

/L)

VITROS 250 Concentration (U/L)

2800

2400

2000

1600

1200

800

400

00 200 600 1000 1400 1800 2200 2600

R2 = 0.99Slope = 0.97

Intercept = 9.29n = 594

lDh

Cat

alys

t Dx

Con

cent

ratio

n (U

/L)

VITROS 250 Concentration (U/L)

6000

5000

4000

3000

2000

1000

00 1000 2000 3000 4000 5000 6000

R2 = 0.96Slope = 1.05

Intercept = 81.62n = 1316

lipa

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

5

4

3

2

1

00 1 2 3 4 5

R2 = 0.99Slope = 0.95

Intercept = 0.10n = 223

mgC

atal

yst D

x C

once

ntra

tion

(µm

ol/L

)

VITROS 250 Concentration (µmol/L)

1000

900

800700

600500

400

300200

1000

0 100 200 300 400 500 600 700 800 900

R2 = 0.96Slope = 1.12

Intercept = 7.97n = 590

nh3

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

16

14

12

10

8

6

4

2

00 2 4 6 8 10 12 14 16

R2 = 0.99Slope = 1.03

Intercept = -0.20n = 1908

phOs

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

28

24

20

16

12

8

4

00 2 4 6 8 10 12 14 16 18 20 22 24 26 28

R2 = 0.99Slope = 1.02

Intercept = -0.01n = 1848

tbil

Cat

alys

t Dx

Con

cent

ratio

n (g

/dL)

VITROS 250 Concentration (g/dL)

12

10

8

6

4

2

00 2 4 6 8 10 12

R2 = 0.97Slope = 0.99

Intercept = 0.18n = 2424

tp

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

350

300

250

200

150

100

50

00 50 100 150 200 250 300 350

R2 = 0.99Slope = 0.98

Intercept = 0.93n = 92

trig

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

350

300

250

200

150

100

50

00 50 100 150 200 250 300 350

R2 = 0.99Slope = 0.96

Intercept = 2.28n = 188

ucre

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

400

350

300

250

200

150

100

50

00 50 100 150 200 250 300 350 400

R2 = 0.98Slope = 1.06

Intercept = -10.00n = 365

uprO

Cat

alys

t Dx

Con

cent

ratio

n (m

g/dL

)

VITROS 250 Concentration (mg/dL)

20

15

10

5

00 5 10 15 20

R2 = 0.99Slope = 1.01

Intercept = -0.52n = 21

uric

cOmparisOn cont.

the ideXX Catalyst dx® Chemistry analyzer provides accurate and consistent analysis of blood and urine components as compared to nationally recognized standards, the international Federation of Clinical Chemistry (iFCC), the Clinical and laboratory Standards institute (ClSi) and the Center for disease Control (CdC). the ideXX Catalyst dx Chemistry analyzer provides unmatched diagnostic decision support for in-house analysis.

© 2009 IDEXX Laboratories, Inc. All rights reserved. • 09-68136-00VitroS is a registered trademark of ortho-Clinical diagnostics. all other ®/tM marks are owned by ideXX laboratories, inc. or its affiliates in the united States and/or other countries.

cOnclusiOn