NOVA BIOMEDICAL Stat Profile PRIME Instructions For Use Manual page 66

Prime CCS Instructions for Use Manual
additional whole blood specimens from consenting donors
were tonometered, spiked, or diluted with saline to cover the
analytical measurement range for all analytes. The number
of data points (N) varies for each parameter due to error,
instrument calibration status, or insufficient sample volume
to complete analysis.
A minimum of 150 whole blood specimens were analyzed
for each parameter in syringe collection devices. The
samples were analyzed on each of the Stat Profile Prime
CCS analyzers and on each of the pHOx Ultra analyzers.
The Stat Profile Prime CCS results for each analyzer were
compared to the average of the 2 results from the pHOx
Ultra comparative method.
A minimum of 100 whole blood specimens were analyzed for
each parameter in capillary collection tubes. Each specimen
was analyzed one time from a capillary container on each
Stat Profile Prime CCS analyzer and then immediately run
as a syringe specimen on the same Stat Profile Prime CCS
analyzer. The capillary test result was compared to the
syringe test result from each test system.
Bias Chart Results
The method comparison bias estimate was analyzed
using CLSI Standard EP09-A2 as a reference document.
The bias plots for each parameter are summarized and
include boundary lines that represent the 95% confidence
interval across the measurement range based upon
each parameter's between analyzer day-to-day (+/-2SD)
performance specification or CV% (whichever is greater).
Each bias plot represents 3 Stat Profile Prime CCS analyzers
compared to the average result from 2 Stat Profile pHOx Ultra
analyzers. Medically relevant low and high concentrations
are annotated.
A-6