pts Diagnostics CardioChek Plus User Manual page 11

II. INTRODUCTION TO THE CARDIOCHEK PLUS
PROFESSIONAL TEST SYSTEM, continued
4. NEONATAL USE and ARTERIAL BLOOD: This product has not been tested using
neonatal or arterial blood. This test system should not be used with these blood
samples. This test system is specific for glucose. Other sugars or reducing substances
such as ascorbic acid at normal blood concentrations have no significant effect on test
results. Acetaminophen (Tylenol) and dopamine may interfere causing the test result to
be higher than the actual glucose. Not every drug was tested.
5. METABOLITES: This test system is specific for glucose. Other sugars and other
reducing substances such as Vitamin C at normal blood concentrations have no
significant effect on test results.
6. HEMATOCRIT: Hematocrit values above 55% or lower than 30% may incorrectly lower
the glucose result.
7. ALTITUDE: Testing at altitudes up to 5280 feet has no effect on results.
8. DEHYDRATION: Severe dehydration and excessive water loss may produce falsely low
results.
PTS Panels Lipid Panel Test Strips
LIMITATIONS OF THE PROCEDURE
Studies were performed to test for substances that may interfere with these tests. The
results are below.
1. PRESERVATIVES: EDTA and heparin in venous blood collection tubes had no effect on
the results of the test strip.
2. DRUGS: Dopamine and methyldopa decreased the results of all the lipids.
3. METABOLITES: Extremely high doses of ascorbic acid (Vitamin C) decreased the
results of all the lipids.
4. HEMATOCRIT: No hematocrit effect was observed for samples between 30 and 45%
HCT.
5. NEONATAL USE: This product has not been tested using neonatal blood. This test
system should not be used with these samples.
6. Cosmetics such as hand creams or lotions often contain glycerol. Use of these products
may cause inaccurate results.
7. Displayed results are rounded.
Each test strip is for a single test only. Do not reuse the strips. Use a new test strip each
time you test. Use only fresh capillary whole blood from the finger or venous whole blood
(EDTA or heparin). Performance testing was done using EDTA preserved whole blood. Do
not use serum or plasma unless specified in the package insert. Each test strip has a
package insert which contains instructions for use specific to that test strip.
Only auto-disabling, single use lancing devices should be used with this device.
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