61Overview of the system
Roche Diagnostics
cobas
®
pulse · Software version 01.03 · User Assistance · Publication version 1.0
The term “linearity” describes the ability of the system to
maintain a constant accuracy over the full range of
specified values.
If test results were plotted against expected values as a
curve over the full range of these values, the ideal (high
linearity) would be a straight line. Linearity is the range
of values from the lowest to the highest for which the
instrument is proven capable of giving accurate results.
i
The instrument does not perform a linear
regression.
Linearity testing intervals
The linearity of the system should be checked before it is
used the first time for patient testing.
Linearity testing can also be run when you want to check
the overall performance of the system.
The intervals for subsequent linearity tests are
determined by the healthcare facility that operates the
system.
The instrument passes a linearity test when all 12 results
(each level is measured twice) were within the specified
target range of each level.
Information stored during linearity testing
The following information is recorded for a linearity test:
• Test result
• Lot number of the linearity material
• Linearity level (level 1 to level 6)
• User ID (if configured)
• Lot number of the test strips
• Time and date of test
• Comments (if applicable)
Linearity kit
The linearity kit contains glucose solutions in 6 levels (6
bottles, 2.5 mL each). For additional information about
the contents and handling of the kit, refer to the package
insert.
2 Overview of the system
To Next Page
Loading...
Need help?
General
