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7.4.1 Precision (continued)
In a separate precision study, intra- and inter-run
precision were assessed using a dual level QBC
Control (#424304). The controls were assayed on
multiple days at three sites using QBC AccuTubes
and the QBC Autoread Plus System. The results of
this study are presented in Table 7-2.
7-3
Table 7-2
.
AccuTube Precision Using QBC Control
Normal Level Abnormal Level
Parameter Site Mean Value
Intra-run Inter-run
Mean Value
Intra-run Inter-run
% CV. df % CV. df % CV. df % CV. df
HCT(%)
#1 33.67 1.28 28 0 14 28.47 0.94 26 0.66 14
#2 33.87 0.92 22 0 11 28.49 1.10 22 0 11
#3 34.75 0.51 24 0 12 29.34 0.82 24 0 12
HGB (g/dL)
#1 11.85 0.47 28 0.32 14 10.09 0.68 28 0 14
#2 11.96 0.56 22 0 11 10.24 0.43 22 0.21 11
#3 12.15 0.58 24 0 12 10.35 0.61 24 0 12
PLT (× 10
9
/L)
#1 386.89 5.15 28 5.09 14 141.05 6.03 28 4.14 14
#2 387.91 6.69 22 8.88 11 128.50 5.38 22 2.96 11
#3 330.37 4.50 24 1.09 12 129.38 4.74 24 2.70 12
WBC
(× 10
9
/L)
#1 9.55 9.07 28 6.70 14 19.06 9.05 28 0 14
#2 7.36 7.24 22 4.31 11 16.09 4.75 22 6.15 11
#3 7.69 8.11 24 2.78 12 15.51 5.47 24 3.83 12
GRAN (× 10
9
/L)
#1 6.15 9.30 28 5.76 14 10.29 8.28 28 0 14
#2 4.67 8.58 22 7.33 11 8.01 3.66 22 4.08 11
#3 4.94 8.39 24 3.61 12 8.27 4.73 24 3.18 12
LYMPH/MONO
(× 10
9
/L)
#1 3.40 12.05 28 8.95 14 8.77 11.32 28 0 14
#2 2.68 7.60 22 8.21 11 8.07 6.53 22 8.71 11
#3 2.74 11.86 24 4.13 12 7.24 9.09 24 5.49 12
Key to QBC Control Precision Table:
Intra-run precision = variability between duplicate tubes during the same run.
Inter-run precision = variability between two runs per day over multiple days.
df = degrees of freedom
0 = negative estimate (variance was negative)
Site #1 & Site #2 = POLs
Site #3 = BDPCD