Precision on controls – Bayer HealthCare Rapidlab 800 User Manual
Page 559
Performance Characteristics
EĆ33
Refer to Sample Collection Devices and Anticoagulants in Section 1 for the specific
requirements on sample handling and anticoagulants.
Table EĆ28.āăSubstances Interfering with the Lactate Measurement
Substance
Concentration Tested
Level of Interference
Sodium Fluoride
1000 mg/dL
1 mmol/L (9 mg/dL)
Sodium Fluoride/
Potassium Oxalate
1000 mg/dL
1 mmol/L (9 mg/dL)
Acetominophen
2 mg/dL
0.35 mmol/L (3.2 mg/dL)
Precision on Controls
Quality control materials and calibration verification materials were analyzed on
the 860 systems. The results are presented here.
Precision on aqueous quality control materials was estimated using fifteen 860
systems. Seventeen runs per instrument were made over a twenty-two day period.
Two replicates of each control level were analyzed in each run.
For glucose, precision on aqueous calibration verification materials was estimated
using fifteen 860 systems. Data from seven to sixteen runs per instrument were
available. The data were collected over a two-month period. Two replicates of each
control level were analyzed in each run.
For lactate, precision on aqueous calibration verification materials was estimated
using fifteen 860 systems. Six runs per instrument were made over an eight day
period. Two replicates of each control level were analyzed in each run.
Table E-29 summarizes the results of the 860 system precision on QC materials.
Table EĆ29.āă860 QC Precision Results
Parameter
Level
n
Mean
WRSD
*
TotSD
[
pH6.5
1
387
7.157
0.002
0.004
2
316
7.423
0.001
0.004
3
235
7.617
0.003
0.006
pCO
2
1
293
72.5
1.12
1.87
(Continued)