CardioChek® PA Analyzer and PTS Panels® Glucose Test Strips (Reflectance)

CardioChek PA AnalyzerAccuracy and Precision Glucose Testing

PTS Diagnostics’ CardioChek® PA Analyzer and PTS Panels® Glucose Test Strips (Reflectance)

Glucose is a sugar that is the major energy source in the body, and maintaining appropriate glucose levels is very important. This system may be used to monitor glucose.

CardioChek® test systems are simple and convenient to use. They are one of the fastest, most cost-efficient, and user-friendly methods to accurately determine glucose values. CardioChek test systems provide values and measurements using the same technology as clinical laboratories. Handheld and battery-powered, a CardioChek analyzer requires a small blood sample from a simple fingerstick. The CardioChek PA analyzer is FDA-cleared, CE-marked, internationally registered, and is CLIA-waived by the Centers for Medicare & Medicaid Services. The CardioChek family includes products for both professional and home use and is available in many global markets.

Contents

• Portable – use in multiple exam rooms• Battery operated• Only requires 15 μL of blood from finger stick• Easy to use – minimal training required• Reimbursable• Low maintenance

PTS Diagnostics’ CardioChek® PA Analyzer and PTS Panels® Glucose Test Strips (Reflectance)

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

• The intensity of the colors is proportional to the concentrations of glucose in the sample.

• The analyzer converts these reflectance photometry readings into glucose results and displays them.

• The enzymatic reaction that occurs is listed below.

Glucose

Beta-D-Glucose + O2 glucose oxidase D-Gluco-1,5-Lactone

2H2O2 + 4-AAP + Disubstituted Aniline peroxidase Quinoneimine dye + 4H2O

Principles of the Test

Measuring Range: PTS Panels glucose test strips (reflectance) will provide numeric results in the following range:

Glucose: 20-600 mg/dL (1.11-33.3 mmol/L, 0.20-6 g/L)

If the display reads “<___” (less than measuring range), the glucose level is below 20 mg/dL (1.11 mmol/L, 0.20 g/L). Results above 600 mg/dL (33.3 mmol/L, 6 g/L) will read “>___” (greater than measuring range).

Measuring Range

Correlation of PTS Diagnostics’ CardioChek PA Analyzer and PTS Panels® Glucose Test Strips (Reflectance) Relative to the Cobas® Integra 400 Plus Reference Method

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

y = 0.89x + 6.1R = 0.87 n = 192

0 20 40 60 80 100 120 140 160 180 2000

50

100

150

200

Glucose

Roche Cobas® Integra

Ca

rdio

Ch

ek

PA

Ve

nip

un

ctu

re

Correlation of PTS Diagnostics’ CardioChek PA Analyzer and PTS Panels® Glucose Test Strips (Reflectance) Relative to theCobas® Integra 400 Plus Reference Method

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

Card

ioCh

ek P

A R

esul

ts F

inge

rstic

k (m

g/dL

)

Roche Cobas® Integra (mg/dL)

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

PTS Diagnostics CardioChek PA Analyzer andPTS Panels Glucose (Reflectance) Precision

PTS Panels Glucose Test Strip

N=50 for all levels

Level 1

Average (mg/dL) 76.00

SD 2.82

CV 3.70

Level 2

Average(mg/dL) 130.96

SD 5.13

CV 3.92

Level 3

Average(mg/dL) 190.10

SD 8.88

CV 4.67

CardioChek PA Analyzer

Glucose is linear throughout the dynamic range of each assay.

PTS Diagnostics CardioChek PA Analyzer andPTS Panels Glucose (Reflectance) Linearity

Glu

cose

Con

cent

ratio

n (m

g/dL

) on

Card

ioCh

ek P

A an

alyz

er

CardioChek PA Linearity (full range)

• PTS Diagnostics’ CardioChek PA analyzer with PTS Panels Glucose Test Strips (Reflectance):• Is accurate relative to the Roche Cobas® Integra reference method.• Exhibits a linear dynamic range. • Demonstrates excellent precision at the low, mid and high

ranges of the spectrum.

Conclusions

LIT001717 Rev. 0 3/15