The sample is manually dispensed by the User in the device.
The
sampling probes have capacitive level sensors to check that the reagents
be ransferred and dispensed in the reaction wells.
All the other operations (dilutions, dispensations, incubations, washings
and redings) are performed by the instrument itself.
The development of colour is read with a kinetic method in three reading
stations. The value of the first reading is subtracted from the value
of the third reading, as a blank, and the delta of absorbance is used
to calculate the final result.
The instrument has on board 1 tank for the washing buffer (used to wash
the reaction wells) and 1 tank for the cleaning solution (used to wash
internally and externally the sampling probes).
The 10 L waste tank is outside the instrument.
Devices
are single use and contain all the reagents needed to perform the tests.
The sample diluent contains a sample addition monitor that turns blue
when the sample is added. This colour change is recorded by the instrument,
allowing a control on the actual ispensing fo the sample.
The
volume of serum use are:
EIA: minimum 60 – maximum 150 L
CFT: minimum 120 – maximum 150 L
The
isntrument is programmed reading the bar-code on the devices. The bar-codes
contain all the information about the test, included the expiration
date.
The
kit format is 36 or 12 tests, and has been chosen on the basis of both
the frequency of the specific test and on its shelf-life. CFT kits have
a 12 devices format as the shelf-life is 6 months from the moment of
production. ELISA kits have a 36 devices format and the shelf-life is
12 months. The ELISA kits for the determination of the avidity of IgGs
have a 12devices format. Each ELISA kit contains 1 vial of freeze-dried
calibrator and 1 vial of freeze-dried positive control.