Abbott Afinion HbA1c Mode D'emploi page 9

INTERPRETATION OF RESULTS
Interpret the Afinion HbA1c test results with careful consideration to the
patient's medical history, clinical examinations and other laboratory results.
If the test result is questionable or if clinical signs and symptoms appear
inconsistent with the test result, analyze the Afinion HbA1c Controls and
retest the sample using a new Afinion HbA1c Test Cartridge. If the result is
still questionable, confirm the result with another method. Analyse control
materials frequently to verify the performance of the Afinion System.
HbA1c measuring units
Three different measuring units are in use for reporting HbA1c test
results :
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• 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
• estimated average glucose (eAG) – the HbA1c value is converted to an
equivalent average glucose value
Linear relationships have been established between the three units
NGSP-HbA1c (%) = DCCT-HbA1c (%) = 0.092 x IFCC-HbA1c (mmol/mol) + 2.15
eAG (mmol/L) = 1.59 x DCCT-HbA1c (%) – 2.59
Measuring range
The Afinion Analyzer displays the HbA1c value/concentration in
mmol/mol, percentage (%), as the calculated estimated average glucose
(eAG) or in combinations of these:
Unit
Measuring range
Values outside the HbA1c measuring range
Valid for SW ≤ 7.03 (Afinion AS100) and SW ≤ 21.09 (Afinion 2):
If the patient's HbA1c value is outside the measuring range, no test
result will be reported and an information code will be displayed (see
"Troubleshooting").
Valid for SW ≥ 7.04 (Afinion AS100) and SW ≥ 21.10 (Afinion 2):
• Test result below the measuring range is displayed as less than (<) the
lower limit.
• Test result above the measuring range is displayed as greater than (>)
the upper limit.
Important! Patient's HbA1c values should be reported in units
consistent with the national recommendations. Please contact your
local supplier if the national recommendation is unknown . Consult the
Afinion Analyzer User Manual for instructions on how to change the
HbA1c measuring unit.
Standardisation
Afinion HbA1c is traceable to the IFCC Reference Method for
Measurement HbA1c
Expected values
Patients with HbA1c levels between 5.7 and 6.4 % (39 and 47 mmol/mol)
are identified as being at risk for developing diabetes. The diagnostic cut-
off is 6.5 % (48 mmol/mol)
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HbA1c
mmol/mol
20-140
.
6
.
2
6,7
3,8,9
HbA1c
%
4.0-15.0
:
9,10
eAG
mmol/L
3.8-21.3
EN
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