User's Manual

i15 Blood Gas and Chemistry Analysis System User Manual Parameters
- 125 -
12.1.4 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 control 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
7.161 0.0061
Level 2
7.401 0.0104
Level 3
7.565 0.0074
Precision and recovery on whole blood samples was estimated using multiple whole blood
samples with pH values spanning the measurement range.
Parameter N Expected Observed Swr bias %Recovery
pH
9 7.085 7.110 0.021 0.025 100.4%
9 7.325 7.357 0.020 0.032 100.4%
9 7.581 7.559 0.011 -0.022 99.7%
9 7.656 7.673 0.010 0.017 100.2%
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.