McKesson Consult - Expected Hemoglobin Values; Performance Characteristics of the System

20
CONSULT
®
HEMOGLOBIN TESTING SYSTEM USER MANUAL
EXPECTED VALUES
3  8
The unit of measure for the hemoglobin value is g/dL. The following hemoglobin values are
considered normal:
* 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.
PERFORMANCE CHARACTERISTICS
a) Within Run and Total Precision
Repeatability and overall reproducibility of three samples was tested over 20 days.
b) Accuracy
The results of the comparison studies between the Consult
®
Hemoglobin and the predicate device are
summarized in the following table. The study was performed across four external sites.
Consult
®
Hemoglobin 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.
Population
Adult Male
Adult Female
Child/Adolescent
Infant
Age Range
> 22 years
>
22 years
> 2 years to 21 years
1 month to 2 years
Potential Interferent
13.0 – 17.0 g/dL
12.0 – 15.0 g/dL
11.0 – 15.5 g/dL
9.4 – 16.5 g/dL
Sample
Level 1
Level 2
Level 3
Mean Hb
Concentration
7.99 g/dL
12.58 g/dL
15.82 g/dL
Within-Run
(SD, %CV)
(0.085, 1.06%)
(0.11, 0.88%)
(0.15, 0.92%)
Total
(SD, %CV)
(0.11, 1.38%)
(0.14, 1.09%)
(0.22, 1.41%)
Sample Type
EDTA
Capillary
N
344
363
Min
4.1g/dL
8.5g/dL
Max
24.5g/dL
20.1g/dL
Slope
0.9858
0.9903
Correlation
Coefficient (r)
0.986
0.963