User's Manual

i15 Blood Gas and Chemistry Analysis System User Manual Parameters
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12.8.1 Intended Use
The hematocrit test is intended for the quantification of hematocrit in arterial, venous, or capillary
whole blood samples.
Hematocrit is a useful indicator for assessing states of blood volume, such as anemia and
erythrocytosis.
12.8.2 Traceability
Hematocrit values assigned to calibrant and controls are traceable to NIST standards.
12.8.3 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
®
QC900 Hematocrit 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
®
QC900 Hematocrit controls are traceable to NIST
standards.
In the following repeatability data table below, SD refers to the standard deviation.
Controls Mean
SD
Low
20.3 0.93
High
49.7 0.47
Precision and recovery on whole blood samples was estimated using multiple whole blood
samples with Hct values spanning the measurement range.
Parameter N Expected Observed Swr bias %Recovery
Hct
9 25.5 26.2 0.5 0.7 102.7%
9 44.0 44.6 0.9 0.6 101.4%
9 64.0 62.5 1.5 -1.5 97.7%
Linearity was estimated using reference materials and reference methods. Three replicates of