CardioChek® Plus Analyzer Lipid + eGLU TM Test Strips Smart Bundle TM Pack CardioChek Plus Analyzer...

CardioChek® Plus AnalyzerLipid + eGLUTM Test Strips Smart BundleTM Pack

CardioChek Plus AnalyzerAccuracy and PrecisionLipid and Glucose Testing

• Portable – use in multiple exam rooms• Battery operated• Results in as little as 90 seconds• Only requires a small drop and 40 μL

of blood from finger stick• Easy to use – minimal training required• Reimbursable• Low maintenance

PTS Diagnostics’ CardioChek Plus® Lipid + eGLU Test Strips Smart BundleTM Pack

Analyzer here

PTS Diagnostics’ CardioChek Plus® Analyzer andLipid + eGLU Test Strips Smart BundleTM Pack

Recognizing the linkage between heart attack, stroke, and diabetes, the CardioChek Plus analyzer provides rapid on-site lipid panel plus glucose results to help identify at-risk individuals. Handheld and battery-powered, the CardioChek Plus analyzer requires a small blood sample from a simple fingerstick. The capability to deliver both results in as little as 90 seconds enables healthcare professionals to improve their throughput, which is particularly important in today’s health promotion environment. The CardioChek family includes products for both professional and home use and is available in many global markets.

Principles of the Lipid Test (Reflectance)

• Test results are based on readings of light reflected off a test strip that has changed color after blood is applied.

• The intensity of the color is proportional to the concentrations of cholesterol, HDL cholesterol, and triglycerides in the sample.

• The analyzer converts these reflectance photometry readings into cholesterol, HDL cholesterol, and triglycerides results and displays them.

• The enzymatic reactions that occur are listed below.

CholesterolCholesterol ester + H2O cholesterol esterase Cholesterol + fatty acidCholesterol + H2O + O2

cholesterol oxidase Cholesterol-4-en-one + H2O2

2H2O2 + 4-AAP + disubstituted aniline peroxidase quinoneimine dye + 4H2O

HDL CholesterolVLDL, LDL, HDL plasma VLDL, LDL, depleted

plasmaCholesterol ester + H2O cholesterol esterase Cholesterol + fatty acidCholesterol + H2O + O2

cholesterol oxidase Cholesterol-4-en-one + H2O2

2H2O2 + 4-AAP + disubstituted aniline peroxidase quinoneimine dye + 4H2O

TriglyceridesTriglycerides + 3H2O lipoprotein lipase glycerol + 3 fatty acidGlycerol + ATP glycerol kinase Glycerol-3-

PO4 + ADPGlycerol-3-PO4 + O2

glycerophosphate oxidase Dihydroxyacetone-PO4 + H2O2

2H2O2 + 4-AAP + N,N-disubstituted aniline peroxidase quinoneimine dye + 4H2O

Principles of the eGLU Test (Electrochemical)

• The eGLU test strips use electrochemical (amperometric) technology to produce a glucose result.

• When blood is applied to the test strip, the blood starts a chemical reaction that produces an electrical current.

• The current is converted into a glucose result and is displayed on the analyzer screen.

• The enzymatic reaction that occurs is listed below.

Glucosea) Glucose + GOx-FAD (ox) → Gluconolactone + GOx-FADH2 (red) [above electrode] b) Kferri(ox) + GOx-FADH2 → GOx-FAD + Kferri(red) [above electrode] c) Kferro(red) → Kferri(ox) [at electrode] 2Fe(CN)6

4- (ferro) → 2Fe(CN)63- (ferri) + 2e- (detection of ferro at carbon electrode

+400mV)

Measuring Range

Measuring Range: PTS Panels® lipid panel test strips will provide numeric results in the following ranges:

Cholesterol: 100-400 mg/dL (2.59-10.36 mmol/L, 1-4 g/L)HDL Cholesterol: 15-100 mg/dL (0.39-2.59 mmol/L, 0.15-1 g/L)Triglycerides: 50-500 mg/dL (0.57-5.65 mmol/L, 0.50-5 g/L)

Results below the test ranges will read “<___” (less than measuring range). Results above these ranges will read “>___” (greater than measuring range).

Measuring Range

Measuring Range: The electrochemical glucose test system will detect glucose levels from 40-600 mg/dL (2.22-33.3 mmol/L, 0.40-6 g/L) and will display a number value for results in this range.

If the display reads “<___” (less than measuring range), the glucose level is below 40 mg/dL (2.22 mmol/L, 0.40 g/L). Results above 600 mg/dL (33.3 mmol/L, 6 g/L) will read “>___” (greater than measuring range).

The linear regression data shows a strong correlation between the CardioChek Plus analyzer and the reference laboratory.

y = 1.12x – 27.5R- = 0.95 n = 26

y = 0.93x + 13.5R = 0.91 n = 478

0 50 100 150 200 2500

50

100

150

200

250

300

350Cholesterol

Roche Cobas® Integra

Ca

rdio

Ch

ek

Plu

s V

en

ipu

nc

ture

0 50 100 150 200 250 300 350 4000

50

100

150

200

250

300

350

400Cholesterol

Roche Cobas® IntegraC

ard

ioC

he

k P

lus

Fin

ge

rsti

ck

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack (cholesterol) Relative to the Cobas® Integra 400 Plus Reference Method

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack (HDL cholesterol) Relative to the Cobas® Integra 400 Plus Reference Method


y = 1.21x -6.8R = 0.92 n = 23

y = 1.10x -2.1R = 0.94n = 455

0 10 20 30 40 50 60 70 800

10

20

30

40

50

60

70

80

90

100HDL Cholesterol


CC

Plu

s V

en

ipu

nc

ture

0 10 20 30 40 50 60 70 80 901000

20

40

60

80

100

120HDL Cholesterol


CC

Plu

s F

ing

ers

tic

k

Card

ioCh

ek P

lus

Veni

punc

ture

Card

ioCh

ek P

lus

Fing

ersti

ck


y = 0.95x -8.8R = 0.99 n = 22

y = 1.08x -7.1R = 0.98n = 422

0 50 100 150 200 250 3000

50

100

150

200

250

300Triglycerides


Ca

rdio

Ch

ek

Plu

s V

en

ipu

nc

ture

0 50 100 150 200 250 300 350 4000

50

100

150

200

250

300

350

400

450Triglycerides


Ca

rdio

Ch

ek

Plu

s F

ing

ers

tic

k

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack (triglycerides) Relative to the Cobas® Integra 400 Plus Reference Method

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack (eGLU) Relative to the Cobas® Integra 400 Plus Reference Method


y = 0.873x + 8.668R = 0.95 n = 431

0 50 100 150 200 250 300 350 4000

50

100

150

200

250

300

350

400 Electrochemical Glucose


Ca

rdio

Ch

ek

Plu

s F

ing

ers

tic

k

Correlation of PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLUTM Test Strips Smart BundleTM Pack Relative to the Cobas® Integra 400 Plus Reference Method


0 100 200 300 400 500 6000

100

200

300

400

500

600

f(x) = 1.00683663503494 x − 4.48122615253834R² = 0.993117637536542

eGLU

Roche Cobas® Integra(mg/dL)

Card

ioCh

ek P

lus A

naly

zer (

mg/

dL)

0 50 1001502002503003504000

50

100

150

200

250

300

350

400

450

f(x) = 1.13029834143885 x − 11.5062959665109R² = 0.989403373236203

f(x) = 0.92962322846856 x + 5.40175401502177R² = 0.961644989170016

f(x) = 0.993534827681352 x + 3.19206341024034R² = 0.960892425210919

Lipid Panel

Total Cholesterol on CC Plus

Linear (Total Cholesterol on CC Plus)

HDL on CC Plus

Linear (HDL on CC Plus)

Trigs on CC Plus

Linear (Trigs on CC Plus)

Roche Cobas® Integra(mg/dL)

Card

ioCh

ek P

lus A

naly

zer (

mg/

dL) Total Cholesterol on

CardioChek Plus

HDL on CardioChek Plus

Trigs on CardioChek Plus

PTS Diagnostics’ CardioChek® Plus Analyzer and Lipid + eGLU Test Strips Smart BundleTM Pack Precision

Excellent precision at the low, mid and high range of the assay.

MeanSD

%CVMean

SD%CV

MeanSD

%CV7.6 9.5

Cholesterol

HDL

Trig

4.4 5.5

5.25.24.6

128.5

39.1

261.6181.4

79.1

47.9

204.2

Level 1 Level 2 Level 3

3.8

4.5 3.7 3.2

77.5

296.7

4.9 8.0 14.4

1.8 2.5 4.0

3.6

Level 1

Reference Value (mg/dL) 61

Average (mg/dL) 60.5

SD 3.5

CV 5.8

Level 2


Average(mg/dL) 105.2

SD 9.9

CV 9.4

Level 3


Average(mg/dL) 265.6

SD 6.1

CV 2.3

eGlu Test

CardioChek Plus analyzerN=50 for all levels

PTS Diagnostics’ CardioChek Plus® Analyzer and Lipid + eGLU Test Strips Smart BundleTM Pack Linearity

All chemistries are linear throughout the dynamic range of each assay. LIT0

0171

6 Re

v. 0

3/1

5

0.000 0.200 0.400 0.600 0.800 1.000 1.2000

2

4

6

8

10

12

f(x) = NaN x + NaNR² = 0

f(x) = 0R² = 0

eGlucose Linearity

Dilution Factor

Card

ioCh

ek P

lus (

mg/

dL)

0.000 0.200 0.400 0.600 0.800 1.000 1.2000

50

100

150

200

250

300

350

400

450

f(x) = 408.073987117798 x + 20.9981048166135R² = 0.983312852765222f(x) = − 198.503920627445 x² + 634.746176643996 x − 28.8241700104022

R² = 0.996849775849743

Total Cholesterol Linearity

Dilution Factor

Card

ioCh

ek P

lus (

mg/

dL)

0.000 0.200 0.400 0.600 0.800 1.000 1.2000

100

200

300

400

500

600

f(x) = 512.406071223973 x + 25.9565242331181R² = 0.989551183809651f(x) = − 107.308023351633 x² + 619.714094575606 x + 9.86032073037312

R² = 0.992936262134223

Triglycerides Linearity

Dilution Factor

Card

ioCh

ek P

lus (

mg/

dL)

0.000 0.200 0.400 0.600 0.800 1.000 1.2000

20

40

60

80

100

120

140

f(x) = 123.456006856465 x + 0.807734818022425R² = 0.998374918494589

f(x) = 13.2233483321936 x² + 109.018514722861 x + 3.63766250175645R² = 0.999121354617553

HDL Cholesterol Linearity

Dilution Factor

Card

ioCh

ek P

lus (

mg/

dL)

CardioChek® Plus Analyzer Lipid + eGLU TM Test Strips Smart Bundle TM Pack CardioChek Plus Analyzer...

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