Limitations Of The Procedure - Bayer HealthCare Ascensia Elite XL User Manual

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
a small bias (average of –6%) on the Ascensia E
laboratory method glucose results. The reference range for arterial pO
80 to 110 mmHg (11.04 to 14.36 kPa).
3. NEONATAL USE: The Ascensia E
Ascensia E
LITE
monitoring treatment of hypoglycemia in neonates. The Ascensia
E XL System is not intended for diagnosis of neonates for
LITE
hypoglycemia. Do not use any other Ascensia E
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
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
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
Atkin S, Jaker MA, Chorost MI, Reddy S, Fingerstick Glucose Determination in Shock.
Annals of Internal Medicine 1991, 114: 1020–24
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Limitations of the Procedure

System qualified for neonatal use. It is intended for
XL results are not significantly affected by hematocrit
LITE
™ XL System is the only
LITE
™ Blood Glucose
LITE
13
SECTION
of >200 mmHg had
2
in comparison to the
Test Strip results
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1
is
2