1.11 - Calibraon Vericaon (Cal Ver)
Calibraon Vericaon is a procedure performed to conrm that the calibraon 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 Calibraon Vericaon and i‑STAT TriControls Calibraon Vericaon
soluons can be used with a non-customized instrument. See the AlinIQ CWi secon of
this manual for instrucon on creang and assigning customizaon proles to
instruments.
The following four items are reasons to perform calibraon vericaon:
1. Validate the reportable range of a test before the test system is put into use.
The accuracy of results over the enre reportable range could be assessed by tesng the same
paent samples on the new system and on a system with known accuracy and comparing results
using an acceptable dierence criteria.
The target values have been determined over many lots of cartridges and results on these soluons
when compared to the target values indicate the performance of a parcular lot of cartridges.
2. Verify that a change in reagent lot numbers does not aect either the reportable range or control
values.
Lot-to-lot variaon over the enre reportable range for any reagent system could be assessed by
tesng calibraon vericaon soluons on old and new lots in parallel. Quality controls samples with
concentraons at decision points should always be used to assess new lots of reagent before results
are reported.
3. Verify that results have not been aected by maintenance or repair procedures.
The user cannot perform any maintenance procedures on the i‑STAT Alinity System. The soware in
the instrument is updated periodically. Calibraon vericaon soluons could be tested to verify that
the system performs as before the upgrade.
Repaired and newly purchased instruments are received with factory calibraon. Tesng calibraon
vericaon samples or comparing paent sample results on a new or repaired instrument with an
older instrument will assess cartridge performance. The Electronic Simulator, rather than calibraon
vericaon or control soluons, provides beer assurance that the instrument is funconing
correctly. Any variaons in instrument performance will not be stascally discernable above the
performance of the cartridges. When mulple instruments are to be used at a facility, Abbo Point of
Care Inc. recommends including at least two instruments in any performance vericaon studies so
that stascs reect 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 calibraon
vericaon samples with very low or very high concentraons could be helpful in characterizing a
reagent problem. The characteriscs of the sensors and results of control soluons are sucient for
Technical Support specialists to help users resolve out-of-range control problems.
79
i-STAT Alinity — System Operaons Manual Art: 745537-01 Rev. F Rev. Date: 02-Nov-2022
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