EKF Diagnostics DiaSpect Tm User Manual

DiaSpect Tm User Manual
18
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%)

EKF Diagnostics DiaSpect Tm Specifications

General

Brand	EKF Diagnostics
Model	DiaSpect Tm
Category	Medical Equipment
Language	English