TRUEresult
®
Quality Assurance / Quality Control Manual
7
• The most accurate results are obtained using fresh, capillary whole
blood from the fingertip. Venous whole blood drawn in EDTA
(purple top tube) or heparin (green top tube) may be used for testing.
Mix tube contents gently before using. Use venous blood within 30
minutes after drawing. Serum, clotted blood, or plasma cannot be
used with the TRUEresult System.
• Capillary blood from the forearm may be used. Check with the
Doctor or Healthcare Professional to see if forearm testing may be
used for glucose testing on the patient. Results from the forearm are
not always the same as results from the fingertip. Use fingertip
instead of forearm:
- Within 2 hours of eating, exercise, or taking insulin,
- If the patient’s blood glucose may be rising or falling rapidly or
their results often fluctuate,
- If the patient is ill or under stress,
- If the glucose result may be low or high,
- If symptoms of low or high glucose levels are not evident.
2
• For evaluation or Quality Control procedures where TRUEresult
blood glucose values are compared to blood glucose values given by
a laboratory, it is recommended that capillary or venous whole blood
obtained from the same site be used for both the laboratory
instrument as well as the TRUEresult System. Laboratory tests should
be performed within 30 minutes of a blood glucose meter test to
minimize the changes in glucose values due to glycolysis. Results
from the TRUEresult System are considered accurate if within +
20%
of laboratory results. If patient has recently eaten, finger results
from the TRUEresult System can be up to 70 mg/dL higher than
venous laboratory results.
3
• The TRUEresult System cannot be used in the diagnosis of diabetes
or to test blood glucose in neonates.
• Inaccurate results may occur in severely hypotensive patients or
patients in shock. Inaccurate results may occur for patients
experiencing a hyperglycemic-hyperosmolar state, with or without
ketosis. Critically ill patients should not be tested with a blood
glucose meter.
4
• Testing at altitudes up to and including 10,150 feet will not affect
accurate results.
5
• Hematocrit levels between 20% and 60% will not affect accurate
results.
5