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

Calibration Verification is a procedure performed to confirm that the calibration 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 Calibration Verification and i‑STAT TriControls Calibration Verification
solutions can be used with a non-customized instrument. See the AlinIQ CWi section of
this manual for instruction on creating and assigning customization profiles to
instruments.
The following four items are reasons to perform calibration verification:
1. Validate the reportable range of a test before the test system is put into use.
The accuracy of results over the entire reportable range could be assessed by testing the same
patient samples on the new system and on a system with known accuracy and comparing results
using an acceptable difference criteria.
The target values have been determined over many lots of cartridges and results on these solutions
when compared to the target values indicate the performance of a particular lot of cartridges.
2. Verify that a change in reagent lot numbers does not affect either the reportable range or control
values.
Lot-to-lot variation over the entire reportable range for any reagent system could be assessed by
testing calibration verification solutions on old and new lots in parallel. Quality controls samples with
concentrations at decision points should always be used to assess new lots of reagent before results
are reported.
3. Verify that results have not been affected by maintenance or repair procedures.
The user cannot perform any maintenance procedures on the i‑STAT Alinity System. The software in
the instrument is updated periodically. Calibration verification solutions could be tested to verify that
the system performs as before the upgrade.
Repaired and newly purchased instruments are received with factory calibration. Testing calibration
verification samples or comparing patient sample results on a new or repaired instrument with an
older instrument will assess cartridge performance. The Electronic Simulator, rather than calibration
verification or control solutions, provides better assurance that the instrument is functioning
correctly. Any variations in instrument performance will not be statistically discernable above the
performance of the cartridges. When multiple instruments are to be used at a facility, Abbott Point of
Care Inc. recommends including at least two instruments in any performance verification studies so
that statistics reflect 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 calibration
verification samples with very low or very high concentrations could be helpful in characterizing a
reagent problem. The characteristics of the sensors and results of control solutions are sufficient for
Technical Support specialists to help users resolve out-of-range control problems.
i-STAT Alinity — System Operations Manual

1.11 - Calibration Verification (Cal Ver)

Art: 745537-01 Rev. F
79
Rev. Date: 02-Nov-2022