Calibration Verification And The I-Stat System - Abbott i-STAT 1 System Manual

Calibration Verification and the i-STAT System

IntroductIon
Calibration Verification is a procedure performed to confirm that the calibration of an instrument or test
system has remained stable throughout the reportable range. In many countries, this procedure is called
a linearity check. Because of the inherent stability of the i-STAT System, Abbott Point of Care Inc. does
not make any specific recommendations for the calibration verification procedure. Therefore, it is the
responsibility of the laboratory to determine when and how this procedure should be performed. The
information presented below is intended to help the laboratory make this determination.
In the United States, laboratory regulations (CLIA) require that for tests categorized as Non-Waived, a
calibration verification procedure be performed and documented at least once every six months. The
information presented below supports Abbott Point of Care Inc's. position that it is the cartridges, or more
specifically, the sensors, rather than the analyzers that should be subject to the six-month check on the
accuracy of the reportable range, and supports Abbott Point of Care Inc's. claim that all analyzers that pass
the Electronic Simulator test are equivalent, which should preclude the testing of three levels, twice a year,
on each and every analyzer on site.
In addition to the six-month time frame for a calibration verification procedure for Non-Waived tests, CLIA
and laboratory accrediting bodies in the US list the following as possible reasons to perform calibration
verification:
• validate the reportable range of a test before the test system is put into use.
•
verify that a change in reagent lot numbers does not affect either the reportable range or control
values.
•
troubleshoot when control values are out-of-range.
• verify that results have not been affected by maintenance or repair procedures.
Abbott Point of Care Inc. • Abbott Park, IL 60064 • USA
i-STAT
Technical BulleTin
Art: 715209-00E
®
Rev. Date: 06/11/08