EKF Diagnostics DiaSpect Tm, User Manual

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DiaSpect Tm User Manual
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10. Expected Values
3 - 8
The unit of measure for the hemoglobin value is g/dL. The following hemoglobin
values are considered normal:
Population Age Range Cited Reference Range*
Adult Male ≥ 22 years 13.0 – 17.0 g/dL
Adult Female ≥ 22 years 12.0 – 15.0 g/dL
Child/Adolescent > 2 years to 21 years 11.0 – 15.5 g/dL
Infant 1 month to 2 years 9.4 – 16.5 g/dL
* Reference ranges are based on medically accepted published reference ranges
(Dacie and Lewis, Practical Haematology, Twelfth Edition, Elsevier Limited 2017).
These ranges are for general guidance only. Each laboratory should establish its
own normal range.
11. Performance Characteristics
a) Within Run and Total Precision
Repeatability and overall reproducibility of three samples was tested over 20
days.
b) Accuracy, Point-of-Care
The results of the comparison studies between the DiaSpect Tm and the predicate
device performed at the point-of-care are summarized in the following table. The
study was performed across four external sites.
Sample
Type
N Min Max Slope Correlation
Coefficient (r)
EDTA 344 4.1 g/dL 24.5 g/dL 0.9858 0.986
Li-heparin 120 10.4 g/dL 20.0 g/dL 0.9834 0.987
Capillary 363 8.5 g/dL 20.1 g/dL 0.9903 0.963
Sample Concentration Within-Run (SD, %CV) Total (SD, %CV)
Low 7.99 g/dL (0.085, 1.06%) (0.11, 1.38%)
Medium 12.58 g/dL (0.11, 0.88%) (0.14, 1.09%)
High 15.82 g/dL (0.15, 0.92%) (0.22, 1.41%)