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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