Purpose; Principle; The Cardiochek Plus Test System; Test Strips - CardioChek PLUS User Manual

I.

Purpose

PTS Panels® Lipid + eGLU Smart Bundle (Smart Bundle) test strips measure total cholesterol, HDL
cholesterol, triglycerides, and glucose in whole blood. Measurements from the PTS Panels Lipid
Panel test strips are used in the diagnosis and treatment of lipoprotein metabolism and lipid
disorders, atherosclerosis, and various renal and liver diseases. The PTS Panels eGLU test strips
quantitatively measure glucose in whole blood. Glucose measurements are used in the diagnosis
and treatment of carbohydrate metabolism disorders
The CardioChek® Plus analyzer is intended for in vitro diagnostic use using fingerstick whole
blood samples with the Lipid Panel + eGLU Smart Bundle test strips, or whole blood samples
(venous or fingerstick) with the other PTS Panels (reflectance) test strips.
II.

Principle

The CardioChek Plus test system consists of three main parts, including the analyzer, the PTS
Panels test strips, and the MEMo Chip®.
A. The CardioChek Plus Test System
The CardioChek Plus test system uses reflectance photometry and electrochemical
biosensor technology. Reflectance test strips utilize an enzymatic reaction to produce a
color change that is detected by the analyzer after whole blood is applied.
Electrochemical test strips measure an electrical current when whole blood is applied.
B. Test Strips
Test strips are designed for specific analytes. For a reflectance test, a reflectance test strip is
inserted into the analyzer and blood is then applied to the blood application window. The
ensuing chemical reaction produces a color change, which the analyzer measures and
compares to the calibration curve stored in the MEMo Chip. The analyzer converts this color
reading into a test result displayed on the screen.
For an electrochemical test, an electrochemical test strip is inserted into the electrochemical
port, and the blood is wicked into the electrochemical channel at the end of the test strip.
The blood starts a chemical reaction that produces an electrical current. The current is
converted to a result using the calibration curve stored in the MEMo Chip.
Each PTS Panels test strip box contains a package insert that provides instructions for use
and information specific for each test.
C. The MEMo Chip
Each package of PTS Panels test strips
MEMo Chip contains the settings for each test.
notch. The bottom has a label with the test name and lot number. Always make sure the
contains a color-coded MEMo Chip. The color-coded
The top of the MEMo Chip has a finger
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