Infopia CLOVER A1c Self Instructions For Use Manual page 13

11. TESTING HbA1c
Code confirmation display after the test
In the event of an error in the process of recongnizing the cartridge code, the
analyzer asks for the type and code of the cartridge.
1. It asks to confirm if the cartridge is a test cartridge or a
08/03/30 AM10:08
check cartridge. Take out the cartridge, and use the
HbA1c Glucose
to match the type of cartridge, and press
Test
Cartridge
confirm.
OK?
2. After selecting the type of cartridge, use the
08/03/30 AM10:08
HbA1c Glucose
match the code number of the cartridge, then press
CODE
to confirm, and the test result is displayed.
3961
OK?
CLOVER A1c Self • 24 •
11. TESTING HbA1c
Expected values
Mean blood glucose results are 10.0-15.0%
lower.
Non-Diabetic Range is 4.0~6.0% and the ADA
most recent Clinical Practice Recommenda-
tion for diabetes specifies a treatment goal of
less than 7%.
[Reference]
to
The Diabetes Control and Complications Trial
(DCCT) :
a five-year progress report. Clin Chem 47
:1985–1992, 2001.
Defining the relationship between plasma
glucose and HbA1c: analysis of glucose
to
profiles and HbA1c in the Diabetes Control
and Complications Trial. Diabetes Carel 25:
275-278, 2002
*Perform the A1C test at least two times a year in patients who are meeting treatment
goals (and who have stable glycemic control).
*Perform the A1C test quarterly in patients whose therapy has changed or who are not
meting glycemic goals.
Limitation of Procedure
The CLOVER A1c™ Self assay gives accurate and precise results over a range of total
Hemoglobin of 7 to 20 g/dL. Most patients will have hemoglobin concentrations within
those values. However, patients with severe anemias may have Hemoglobin concentra-
tions ower than 7 g/dL, and patients with polycythemia may have Hemoglobin concentra-
tions above 24 g/dL. Patients known to have these condition should be assayed by a test
employing a different assay principle if their Hemoglobin concentrations are outside of
the acceptable range.
CAUTION :
HbA1c standard test results
GHB(%)
4
5
6
7
8
9
10
11
12
Discard cartridge in proper container, according to your standard
laboratory procedures.
CLOVER A1c Self • 25 •
Approximate Mean
Plasma Glucose*
mg/dL
mmol/L Interpretation
65
3.5
100 Non-Diabetic
5.5
Range
135
7.5
ADA Target
170
9.5
205
11.5
240
13.5
Action
Suggested
275
15.5
310
17.5
345
19.5