Infopia CLOVER A1c Self, Instructions For Use Manual

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CLOVER A1c Self • 25 •
11. TESTING HbA1c
HbA1c standard test results
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.
4
5
6
7
8
9
10
11
12
65
100
135
170
205
240
275
310
345
3.5
5.5
7.5
9.5
11.5
13.5
15.5
17.5
19.5
Approximate Mean
Plasma Glucose*
mg/dL
GHB(%)
mmol/L Interpretation
Non-Diabetic
Range
ADA Target
Action
Suggested
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]
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
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.
CAUTION :
Discard cartridge in proper container, according to your standard
laboratory procedures.
Expected values
11. TESTING HbA1c
CLOVER A1c Self • 24 •
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
check cartridge. Take out the cartridge, and use the
to match the type of cartridge, and press to
confirm.
2. After selecting the type of cartridge, use the to
match the code number of the cartridge, then press
to confirm, and the test result is displayed.
08/03/30
HbA1c
AM10:08
Glucose
CODE
OK?
3961
08/03/30
HbA1c
AM10:08
Glucose
Test
OK?
Cartridge