Routine Utilization And Measurement; Instrument Operation And Sample Preparation; Specimen; Procedure - Human HumaFIA User Manual

3 ROUTINE UTILIZATION AND MEASUREMENT

3 ROUTINE UTILIZATION AND MEASUREMENT

3.1 Instrument operation and sample preparation

The HumaFIA analyser is a semi-automated instrument. The user must prepare the sample, incubate the
cartridge (automatically inside the analyser or manually outside), insert a sample cartridge in the analyser at
the Cassette input slot of the analyser, and start the reading of the results. See below for more details.
For sample preparation, incubation and cartridge handling, follow the instruction for use of each HumaFIA
parameter, since sample types, anticoagulants, sample volumes and use of buffer are also parameter
dependent.

3.1.1 Specimen

1. Typically, whole blood, serum and plasma can be used.
2. The serum or plasma should be separated by centrifugation within 2 hours from the time of blood
collection.
3. Test the sample immediately or within 2 hours of sample collection. If testing cannot be completed
within 2 hours, store the serum or plasma at +2 - +8 °C for 8 hours; if longer storage is required, store
the serum or plasma below -20 °C for up to 3 months. Do not heat inactivated samples. Discard
haemolysis samples.

3.1.2 Procedure

Follow the procedures exactly as described:
1. Before sample testing, read the instructions and applicable Instrument User Manual carefully. Before
using a refrigerated test cartridge, allow it to reach the operating temperature (18-28 °C). Place the
test cartridge on a level, horizontal surface.
2. Check that the LOT number of the test cartridge matches that of the calibration card.
3. Insert the calibration card into the calibration card port of the instrument for tests.
4. Refrigerated serum or plasma specimens must reach room temperature before testing. Frozen
plasma or serum samples should be vortexed and centrifuged after thawing. The supernatant liquid
should be obtained and reach room temperature before testing.
5. If required, pipette serum/plasma/whole blood into the vial of diluent (see parameter IFU). Reclose
the cap of the vial and mix the sample mixture by inverting the vial 10 times.
6. Pipette exactly 80 µl of the (diluted) sample into the sample port of the test cartridge. Start the timer,
a few minutes (according to IFU) are needed for the reaction.
7. Insert the test cartridge into the analyser after reaction time has elapsed, select the accurate sample
type as described below for one of the three modes to run a sample. The test cartridge type is
detected and checked automatically by the analyser. Once the test is read by the analyser, the result
will be displayed on the screen and can be printed when the analysis is complete.
8. After the assay is completed, remove the cartridge from the analyser.
9. Dispose of the used cartridge and pipette tips in accordance with any applicable regulations.
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