Abbott i-STAT Alinity - Calibration Verification (Cal Ver)

1.11 - Calibraon Vericaon (Cal Ver)
Calibraon Vericaon is a procedure performed to conrm that the calibraon of an instrument or test
system has remained stable throughout the reportable range. This procedure is also called a linearity
check.
Note: Only i‑STAT Calibraon Vericaon and i‑STAT TriControls Calibraon Vericaon
soluons can be used with a non-customized instrument. See the AlinIQ CWi secon of
this manual for instrucon on creang and assigning customizaon proles to
instruments.
The following four items are reasons to perform calibraon vericaon:
1. Validate the reportable range of a test before the test system is put into use.
The accuracy of results over the enre reportable range could be assessed by tesng the same
paent samples on the new system and on a system with known accuracy and comparing results
using an acceptable dierence criteria.
The target values have been determined over many lots of cartridges and results on these soluons
when compared to the target values indicate the performance of a parcular lot of cartridges.
2. Verify that a change in reagent lot numbers does not aect either the reportable range or control
values.
Lot-to-lot variaon over the enre reportable range for any reagent system could be assessed by
tesng calibraon vericaon soluons on old and new lots in parallel. Quality controls samples with
concentraons at decision points should always be used to assess new lots of reagent before results
are reported.
3. Verify that results have not been aected by maintenance or repair procedures.
The user cannot perform any maintenance procedures on the i‑STAT Alinity System. The soware in
the instrument is updated periodically. Calibraon vericaon soluons could be tested to verify that
the system performs as before the upgrade.
Repaired and newly purchased instruments are received with factory calibraon. Tesng calibraon
vericaon samples or comparing paent sample results on a new or repaired instrument with an
older instrument will assess cartridge performance. The Electronic Simulator, rather than calibraon
vericaon or control soluons, provides beer assurance that the instrument is funconing
correctly. Any variaons in instrument performance will not be stascally discernable above the
performance of the cartridges. When mulple instruments are to be used at a facility, Abbo Point of
Care Inc. recommends including at least two instruments in any performance vericaon studies so
that stascs reect the “system.”
4. Troubleshoot when control values are out-of-range.
Should quality control sample results fall outside of the acceptable ranges, the use of calibraon
vericaon samples with very low or very high concentraons could be helpful in characterizing a
reagent problem. The characteriscs of the sensors and results of control soluons are sucient for
Technical Support specialists to help users resolve out-of-range control problems.
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i-STAT Alinity — System Operaons Manual Art: 745537-01 Rev. F Rev. Date: 02-Nov-2022