User's Manual

i15 Blood Gas and Chemistry Analysis System User Manual Parameters
- 134 -
If test results are inconsistent with the clinical assessment, the sample should be analyzed again
with a new test cartridge.
12.5.1 Intended Use
The Potassium test is intended for the quantification of potassium in arterial, venous, or capillary
whole blood samples.
Potassium is the most abundant cation in the intracellular fluid, and plays an important role in
nerve conduction and muscle function. It also helps maintain acid-base balance and osmotic
pressure.
Potassium value is important for patients who are undergoing infusion therapies, who are
experiencing heart insufficiency, and so on.
12.5.2 Traceability
Potassium ion concentration values assigned to calibrant and controls are traceable to NIST
standards.
12.5.3 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
1.92 0.014
Level 2
4.51 0.041
Level 3
6.70 0.047
Precision and recovery on whole blood samples was estimated using multiple whole blood