Bayer HealthCare Ascensia Elite XL - Manual (Page 31)

SECTION
Limitations of the Procedure
13
27
1. PRESERVATIVES:
• Fluoride – Do not use fluoride as a preservative for blood specimens.
• Iodoacetic acid – Do not use iodoacetic acid as a preservative for
blood specimens.
2. ARTERIAL SPECIMEN: Arterial specimens with pO
2
of >200 mmHg had
a small bias (average of –6%) on the Ascensia E LITE in comparison to the
laboratory method glucose results. The reference range for arterial pO
2
is
80 to 110 mmHg (11.04 to 14.36 kPa).
3. NEONATAL USE: The Ascensia E LITE ™ XL System is the only
Ascensia E LITE System qualified for neonatal use. It is intended for
monitoring treatment of hypoglycemia in neonates. The Ascensia
E LITE XL System is not intended for diagnosis of neonates for
hypoglycemia. Do not use any other Ascensia E LITE ™ Blood Glucose
Meter for neonatal testing.
4. METABOLITES: Reducing substances such as ascorbic acid and uric
acid at normal blood concentrations do not significantly affect Ascensia
ELITE XL blood glucose test results.
5. HEMATOCRIT: At normal glucose levels, Ascensia E LITE Test Strip results
are not significantly affected by hematocrits in the range of 20% to 60%.
At glucose levels above 300 mg/dL (16.7 mmol/L), hematocrit levels
above 55% will cause lowered results. For Neonatal Use: At glucose
levels between 20 mg/dL (1.1 mmol/L) and 120 mg/dL (6.7 mmol/L),
Ascensia
E LITE XL results are not significantly affected by hematocrit
levels in the range of 20% to 70%.
6. LIPEMIC SPECIMEN: Cholesterol up to 500 mg/dL (13.0 mmol/L) or
triglycerides up to 3000 mg/dL (33.9 mmol/L) do not significantly affect
the results. Glucose values, however, in specimens beyond these levels
should be interpreted with caution.
CONTRAINDICATION (Bayer advises against): Capillary blood glucose
testing may not be clinically appropriate when peripheral blood flow is
decreased. Shock, severe hypotension, hyperosmolar hyperglycemia and
occurrence of severe dehydration are examples of clinical conditions which
may adversely affect the measurement of glucose in peripheral blood.
1
1 Atkin S, Jaker MA, Chorost MI, Reddy S, Fingerstick Glucose Determination in Shock.
Annals of Internal Medicine 1991, 114: 1020–24