Roche cobas b 123 - Comparison of Micro Samples to Normal Samples; Glu; Lac

Roche Diagnostics
78 Instructions for Use · Version 13.0
3 Specifications cobas b 123 POC system
Performance data
Glu
Unit: [mmol/L]
Material: whole blood
Lac
Unit: [mmol/L]
Material: whole blood
Comparison of micro samples to normal samples
The trueness of measurement values in micro sample mode, BG-only (40 L) and BG
with COOX (55 L), have been confirmed by comparing measurement values in
normal sample mode (150 L).
Number of instruments: 8 cobas b 123 POC systems
Material: whole blood
Comparison instrument No. of samples [n] Bias
(1)
Slope [b] Intercept [a] Pearson’s Corr. coeff. [r]
cobas® 6000 686 -2.4 0.98 -0.04 0.98
Table 3-110 Glu
(1) Median absolute bias
Comparison instrument No. of samples [n] Bias
(1)
Slope [b] Intercept [a] Pearson’s Corr. coeff. [r]
cobas® 6000 590 --- 1.00 0.06 0.99
Table 3-111 Lac
(1) Median absolute bias
Parameter Unit No. of samples [n] Bias
(1)
Slope [b] Intercept [a] Pearson’s Corr. coeff. [r]
pH [pH units] 149 0.00 0.9932 0.0506 0.9996
PO
2
[mmHg] 205 0.564 0.994 1.0251 0.9995
PCO
2
[mmHg] 133 0.09 0.9646 1.4684 0.9989
Hct [%] 370 -0.026 1.0034 -0.1195 0.9988
tHb [g/dL] 244 -0.044 1.033 -0.4168 0.9998
O
2
Hb
[%] 403 0.571 0.9806 2.1444 0.9993
HHb [%] 403 -0.558 0.9799 -0.2087 0.9993
MetHb [%] 176 -0.332 0.9948 -0.0827 0.9999
COHb [%] 278 -0.034 1.0001 -0.038 1.0000
SO
2
[%] 484 0.431 0.9861 1.572 0.9992
Bili [mg/dL] 232 -0.506 0.9975 -0.4805 0.9982
Table 3-112 Sample comparison data
(1) Median absolute bias