Calibration; Calculation Of Results; Quality Control; Reference Value - Human HumaFIA User Manual

3 ROUTINE UTILIZATION AND MEASUREMENT

3.1.3 Calibration

Master curve calibration: Every HumaFIA SR reagent kit has a calibration card [CAL] that contains LOT-
specific information for the calibration. After upload of the calibration curve from the card, the calibration for
this LOT is stored on the instrument. All subsequent samples may be tested without further upload. Content
of calibration cards can be uploaded any

3.1.4 Calculation of results

The HumaFIA system automatically calculates the analyte concentration of each sample. See upload of
calibration curve, chapter 3.3.5 Calibration cards overview in the QC module.

3.1.5 Quality control

For quality control, use the corresponding quality control products provided by HUMAN:
•
Once every day, before testing.
•
If there are any unexpected test results.
•
After each upload of a calibration curve.
Quality control results that do not fall within reference ranges may indicate invalid test results.

3.1.6 Reference value

Reference values are provided in the IFU and can be stored at the analyser as reference value/range for each
parameter.
It is recommended that each laboratory establish its own expected values for the population it serves.

3.1.7 Interpretation of results

If the concentration in the sample exceeds the linear range, dilute the sample with 5 % BSA normal saline
solution before testing. HumaFIA offers a software option to calculate values for prediluted samples
automatically. Each sample can be diluted up to 3 times.
The test results should not be used as the sole basis for diagnosis and should be combined with other clinical
and laboratory data for clinical diagnosis. If the test results do not match the clinical assessment, further tests
should be performed.

3.1.8 Limitations

Certain samples containing antibodies directed against reagent components may cause interference. For this
reason, assay results should be interpreted taking into consideration the patient's clinical history, and the
results of any other tests performed.
If a sample contains a high concentration of triglyceride, cholesterol, bilirubin or haemolysis, the test result
will be affected.
As with any assay employing mouse antibodies, interference by human anti-mouse antibodies (HAMA) in the
sample is possible. The test has been formulated to minimise this interference; however, specimens from
patients who have been routinely exposed to animal products or to animal serum may contain heterophile
antibodies which may cause erroneous results. For further details see IFU.
Note: The inner packaging/pouch of each cartridge must be tightly sealed without leakage. The surface of
the test card should be smooth, without burrs, and uniform in colour.
Safety Notes: All patient specimens, calibrators and controls should be handled as potentially infectious. All
donor units of human origin have been tested for HBsAg, HIV and HCV-antibodies and found to be non-
reactive using approved methods. All materials of animal origin avoid many risks associated with the use of
human serum (e.g. Hepatitis B and C, HIV). Nevertheless, all materials of human or animal origin should still
be treated as potentially infectious material.
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