EKF Diagnostics DiaSpect Tm, Руководство пользователя

Страница: 19 / 28

19
DiaSpect Tm User Manual
DiaSpect Tm has not been evaluated for capillary samples with hemoglobin values
below 8.5 g/dL as such samples are very rarely seen in the primary care setting.
It is recommended that patients showing a capillary hemoglobin of less than 8.5
g/dL are referred to a confirmatory laboratory test.
c) Accuracy, Blood Donation Centers
A method comparison of 150 capillary and 147 venous samples was conducted at
two blood bank settings, giving the following results:
Sample
Type
N
DiaSpect Tm
Minimum
DiaSpect Tm
Maximum
Hb301
Minimum
Hb301
Maximum
K2-EDTA 147 10.4 g/dL 22.0 g/dL 11.1 g/dL 20.7 g/dL
Capillary 150 10.5 g/dL 20.6 g/dL 10.7 g/dL 20.7 g/dL
DiaSpect Tm vs HemoCue Hb 301 (linear regression)
Matrix N Slope (95% CI) Intercept (95% CI) r
Capillary 150 0.9541 (0.9134~0.9948) 0.2619 (-0.3496~0.8733 ) 0.967
Venous 147 1.1465 (1.1068~1.1863) -2.5299 (-3.4183~-2.1122) 0.978
DiaSpect Tm vs HemoCue Hb 301 (Passing-Bablok regression)
Matrix N Slope (95% CI) Intercept (95% CI) r
Capillary 150 1.000 (0.9512~1.032) -0.45 (-1.011~0.2805) 0.967
Venous 147 1.140 (1.100~1.179) -2.477 (-3.067~-1.895 0.978
The bias of the DiaSpect Tm at the hemoglobin deferral levels for male and female
donors was calculated from the regression curves using the Hb 301 as the
reference method.
Donor Cutoff, Hb 301
DiaSpect Tm Capillary DiaSpect Tm Venous
Hb Level % Bias Hb Level % Bias
Adult Female, 12.5 g/dL 12.2 g/dL -2.4% 11.8 -5.6%
Adult Male, 13 g/dL 12.7 g/dL -2.3% 12.4 -4.8%
Using the HemoCue Hb301 as the reference method, the agreements for blood
donor eligibility are as follows: