User's Manual

i15 Blood Gas and Chemistry Analysis System User Manual Parameters
- 139 -
12.7.3 Performance Characteristics
Experiments are designed according to the following CLSI guidelines: CLSI EP6-A for linearity
studies, CLSI EP9-A2 for method comparison studies, and CLSI EP7-A2 for interference studies.
Typical performance data presented below were obtained by technologists, nurses, physicians and
therapists trained in the use of the system and the comparative method.
Repeatability on RNA Medical
®
QC823 Blood Gas●Electrolyte●Metabolite●BUN controls was
estimated using one lot of test cartridges, and 20 replicates of each level were successively analyzed
on one i15 Blood Gas and Chemistry Analysis System. RNA Medical
®
QC823 Blood
Gas●Electrolyte●Metabolite●BUN controls are traceable to NIST standards.
In the following repeatability data table below, SD refers to the standard deviation.
Controls Mean
SD
Level 1
78.8 0.62
Level 2
96.7 0.84
Level 3
127.1 0.76
Precision and recovery on whole blood samples was estimated using multiple whole blood
samples with Cl
-
values spanning the measurement range.
Parameter N Expected Observed Swr bias %Recovery
Cl
-
9 80.0 80.0 0.3 0.0 100.0%
9 106.5 106.6 1.3 0.1 100.1%
9 133.0 133.0 1.8 0.0 100.0%
Linearity was estimated using reference materials and reference methods. Three replicates of
each level of materials were analyzed in parallel on the i15 Blood Gas and Chemistry Analysis
System and the Rapidpoint 400 system. Reference materials used were RNA Medical
®
CVC123
Calibration Verification Controls, and they were traceable to NIST standards. In the table below, Sy.x
refers to the standard error of estimate.
Parameter N Slope Intercept
Correlation
Coefficient
Sy.x Range
Cl
-
15 0.98 0.37 0.99998 0.2404 72 - 146