Klinisk Biokemi i Norden · 1 2020
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both under optimal conditions (Figure 2) and in the
PHCCs (Figure 3). At the medical decision point of
40 mg/L there was a small but statistically significant
bias between
cobas b
101 CRP and the comparison
method of approximately –3 %. The user-friendliness
was rated as satisfactory.
Conclusion
The quality goals set for the evaluation of
cobas b
101 CRP were fulfilled for both repeatability and
accuracy under optimal conditions as well as by
intended users. The quality goal for user-friendliness
was also fulfilled.
The complete evaluation report is available at
.
Figure 2.
Accuracy of CRP results on
c
obas b
101 CRP achieved under optimal conditions.
The x-axis represents the mean CRP result of
the comparison method. The y-axis represents
the deviation in % of the first capillary whole
blood sample measurement on
cobas b
101
CRP from the mean result of the correspon-
ding sample of the comparison method. The
different lots of test discs are illustrated with
the symbols ● (lot 822152-01), ♦ (lot 823151-
01) and * (lot 913151-01). Stippled lines repre-
sent the allowable deviation limits of ≤±2,0
mg/L for CRP concentrations <10 mg/L and
≤±20,0 % for CRP concentrations ≥10 mg/L.
Number of results (n) = 93. Results reported
from
cobas b
101 as <3,0 mg/L are not inclu-
ded in the plot.
Figure 3.
Accuracy of CRP results on
cobas
b
101 CRP achieved by intended users. The
x-axis represents the mean CRP result of the
comparison method. The y-axis represents
the deviation in % of the first capillary whole
blood sample measurement on
cobas b
101
CRP from the mean result of the correspon-
ding sample of the comparison method. The
different PHCCs are illustrated with the
symbols ▲ (PHCC1) and ■ (PHCC2). Stippled
lines represent the allowable deviation limits
of ≤±2,0 mg/L for CRP concentrations <10
mg/L and ≤±20,0 % for CRP concentrations
≥10 mg/L. Number of results (n) = 76. Results
reported from
cobas b
101 as <3,0 mg/L are
not included in the plot.
