Caption: Figure 14: Bland-Altman plots of HRV indices calculated for ECG channel 2 and ECG channel 3 with limits of agreement (blue dashed lines), bias (black lines), and acceptance limits
(red dotted lines).
Long Term Stability: The difference between initial concentration and after 7, 14 and 21 days did not show any significant difference while slight difference in concentration after 28th day was observed which is within the acceptance limit
([greater than or equal to] 15%) of accuracy and precision (Table-8).
In the first case, the acceptance limits
are defined by the inherent analytical imprecisions, and in the latter case the acceptance limits
are defined by the analytical quality specifications.
The agreement was first determined graphically with a scatterplot produced with the reference method (Cobas) as the x-axis, the compared method (CardioChek) as the j-axis, cholesterol values, equality line, acceptance limits
around the equality line, clinical allowable error limits around the equality line, and Passing-Ba-block regression line (Fig 1).
With regard to acceptable performance on PT, the agency said it intended to update the existing acceptance limits
(ALs) to reflect advancements in technology and analytical accuracy since the PT regulations were implemented in 1992.
A common practice is for the laboratory to establish a protocol whereby it tests the RMs at planned intervals, establishes acceptance limits
, and produces charts to detect trends.
Other policies, standards and procedures that may require a review or update include cleaning and cleaning validation where setting acceptance limits
If acceptance limits
are numerical, then data should be numerical.