Interpretation Of Results; Quality Control - Abbott NycoCard HbA1c Manual Del Usuario

INTERPRETATION OF RESULTS

Interpret the NycoCard 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

QUALITY CONTROL

A quality control material with NycoCard HbA1c
specific target values should be used to confirm
the efficacy of the reagents and the correct
performance of the test. The measured value
should be within the acceptance limits stated
for the control material. Do not analyse patient
samples when control values are outside range.
TROUBLE SHOOTING
Possible cause
1 – Unexpected low test results
R1/reagent was too cold when used.
R1 has been exposed to light or room temperature
> 8 hours.
A hemolysed sample material was used.
2 – Unexpected high test results
Too little R2 was added to the TD/test device.
There are white spots on the TD membrane.
3 – The R2/washing solution does not soak into the TD/test device membrane
A hemolysed sample material was used.
4 – The NycoCard
™
The Hb concentration of the sample is below the
measuring range.
5 – The NycoCard
™
The Hb concentration of the sample is above the
measuring range.
8
READER II displays "Hb conc. too low"
READER II displays "Reduce Hb conc."
appear inconsistent with the test result, retest
the sample or confirm the result using another
method. Analyse control materials frequently
to verify the performance of the NycoCard
Reader II Test System.
Do not use lyophilised control materials with the
NycoCard HbA1c Assay.
Keeping a permanent record of all quality control
results is recommended.
Corrective action
Equilibrate R1 to 20-25°C before use.
Discard the test kit. Retest the sample with a new kit.
Collect a new sample.
Make sure that 25 μL of R2 is applied to the test
device.
Apply the sample quickly, in the middle of the test well.
Avoid air bubbles.
Collect a new sample.
Retest the sample. Fill 2 capillaries with sample
(= 10 μL) and drop both capillaries into one tube of R1.
The NycoCard Reader II will display the correct test
result; no manual calculation is required.
Retest the sample. Mix R1 from two tubes
(= 400 μL) and apply 1 capillary (5 μL) with sample.
The NycoCard Reader II will display the correct test
result; no manual calculation is required.