Quality Control - Abbott Afinion HbA1c Mode D'emploi

Limitations of the test
• Any cause of shortened erythrocyte life span will reduce exposure
of erythrocytes to glucose, resulting in a decrease in HbA1c values,
regardless of the method used. Caution should be used when
interpreting the HbA1c results from patients with conditions such as
hemolytic anemia or other hemolytic diseases, homozygous sickle cell
trait, pregnancy, blood loss, polycythemia, iron deficiency etc.
• This test should not be used to diagnose:
- diabetes during pregnancy
- patients with an elevated fetal hemoglobin (HbF >10 %) such as
hereditary persistence of fetal hemoglobin (HPFH)
- patients with a hemoglobinopathy but normal red cell turnover (e.g.
sickle cell trait)
- patients that have received a blood transfusion within the past 3
weeks
- patients that have received cancer chemotherapy within the past 3
weeks
• In cases of rapidly evolving type 1 diabetes the increase of HbA1c
values might be delayed compared to the acute increase in glucose
concentrations. In these conditions diabetes mellitus must be diagnosed
based on plasma glucose concentration and/or the typical clinical
symptoms.
• Diluted samples cannot be used with Afinion HbA1c.
• Coagulated or hemolysed samples cannot be used with Afinion HbA1c.
• If the sample has a hemoglobin value below 6,0 g/dL or above
20,0 g/dL, no test result will be reported and an information code will
be displayed.

QUALITY CONTROL

Quality control testing should be done to confirm that your Afinion
System is working properly and providing reliable results. Only when
controls are used routinely and the values are within acceptable ranges can
accurate results be assured for patient samples.
It is recommended to keep a permanent record of all quality
control results. The Afinion Analyzer automatically stores the
control results in a separate log. Consult the Afinion Analyzer User
Manual.
Choosing control material
Afinion HbA1c Control from Abbott is recommended for routine
quality control testing. Consult the Afinion HbA1c Control
Package Insert.
If controls from another supplier are used, the precision must be
determined and acceptable ranges for the Afinion System must be
established. Lyophilised cell free lysate or hemolysed whole blood control
materials cannot be used with Afinion HbA1c.
Frequency of control testing
Controls should be analysed:
• anytime an unexpected test result is obtained.
• with each shipment of Afinion HbA1c Test Kits.
• with each new lot of Afinion HbA1c Test Kits.
• when training new operators in correct use of the Afinion HbA1c and
the Afinion Analyzer.
• in compliance with national or local regulations.
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