Performance Characteristics - Abbott Afinion HbA1c Mode D'emploi

Verifying the control results
The measured value should be within the acceptable limits stated
for the control material. Consult the Afinion HbA1c Control
Package Insert.
If the result obtained for the Afinion HbA1c Control is outside the
acceptable limits, make sure that:
• patient samples are not analysed until control results are within
acceptable limits.
• the control vial has not passed its expiry date.
• the control vial has not been used for more than 60 days.
• the control vial and Afinion HbA1c Test Cartridge have been stored
according to recommendations.
• there is no evidence of bacterial or fungal contamination of the control
vial.
Correct any procedural error and retest the control material.
If no procedural errors are detected:
• examine the laboratory's quality control record to investigate the
frequency of control failures.
• ensure that there is no trend in out-of-range quality control results.
• retest the control material using a new control vial.
• Patient results must be declared invalid when controls do not perform
as expected. Contact your local supplier for advice before analysing
patient samples.
TROUBLESHOOTING
To ensure that correct HbA1c results are reported, the Afinion Analyzer
performs optical, electronic and mechanical controls of the capillary, the
test cartridge and all individual processing steps during the course of each
analysis. When problems are detected by the built-in failsafe mechanisms,
the Analyzer terminates the test and displays an information code.
The table below contains Afinion HbA1c specific information codes.
Consult the Afinion Analyzer User Manual for information codes not
listed in this table.
Code #
103
104
105
106

PERFORMANCE CHARACTERISTICS

The performance data presented in this section are representative
data from internal and external studies. Results obtained in individual
laboratories may vary.
Method comparison
Fingerstick and venous whole blood samples from 120 patients (4.6-11.4
% HbA1c), 38-42 at each of three sites, were analysed with the Alere
Afinion AS100 Analyzer using three different Afinion HbA1c lots. The
venous samples were sent to a laboratory for duplicate analysis with an
HPLC method. The results are shown in Table 1 and Table 2.
EN
12 Afinion HbA1c
Cause
The hemoglobin concentration is below 6,0 g/dL
The hemoglobin concentration is above 20,0 g/dL
The HbA1c value is below measuring range
The HbA1c value is above measuring range