Abbott NycoCard HbA1c Manual Del Usuario página 6

Reference range
For methods reporting DCCT traceable values,
the upper limit of non-diabetic reference range
is 6.4% HbA1c .
11,12
Measuring range
Hemoglobin measuring range: 7-18 g/dL.
The NycoCard Reader II displays the HbA1c
concentration in mmol/mol, percentage (%) or
in combination, depending on the serial number
of the instrument.
SN ≥ 78450: Consult the NycoCard Reader II
User Manual for instructions on how to change
the HbA1c measuring unit.
NycoCard READER II
™
SN < 59681
SN 59681-78449
SN ≥ 78450
Precision
In professional use, a coefficient of variation
(CV) < 5% is usually obtained.
STORAGE
Unopened kits
The expiry date of the kit applies to storage at
2-8°C in the original container. Avoid direct
sunlight or exposure to temperatures above
25°C. Do not freeze.
Opened kits
R1/Reagent must be stored dark at 2-8°C.
Equilibrate the R1/reagent to room temperature
(20-25°C) before use. Equilibration to room
temperature can be achieved by holding the tube
in a closed hand for 30 seconds. The reagent
tube can be stored for maximum 6 hours at room
temperature before use. Avoid direct sunlight.
6
HbA1c (%)
Measuring range
3-18
4-15
4-15
HbA1c measuring units
Two different measuring units are in use for
reporting HbA1c test results
• mmol/mol – the HbA1c values are aligned to the
IFCC Reference Method for Measurements of
HbA1c.
• percentage (%) – the HbA1c values are aligned
to the assay used in the DCCT study, also
known as NGSP-HbA1c.
A linear relationship has been established
between the two units
DCCT-HbA1c (%) = 0.092 x IFCC-HbA1c
(mmol/mol) + 2.15
HbA1c (mmol/mol)
Unit Measuring range
0.1 ---
0.1 ---
0.1 20-140
Limitations of the test
• Elevated amounts of glucose, bilirubin, lipids
and fructosamine were added to blood samples
with normal and elevated HbA1c values. No
interference was obtained.
• Hemolysed samples
Hb >3 g/100 mL will interfere with the test
system.
TD/Test device can be stored at room
temperature (15-25°C). Store the test devices
in the original bag and avoid humidity below 20%
and above 70%. The TD/test device should have
room temperature when used.
R2/Washing solution can be stored at room
temperature (15-25°C). The R2/washing
solution should have room temperature when
used.
Sample material
Blood samples with anticoagulant (EDTA,
heparin and NaF) can be stored up to 10 days at
2-8°C before analysis. Do not freeze.
:
7-10
:
9
Unit
---
---
1.0
with plasma