Limitations; Expected Values - QBC Diagnostics Star Operators & Service Manual

QBC STAR™ System User's Manual

Limitations

Quality medical care requires that laboratory values be correlated with each patient's symptoms and signs by a trained prac-
titioner.
Operating Ranges lists the validated upper and lower limits of the operating range. Values above and below these validated
ranges are not displayed and should be confi rmed by an alternate method.
The QBC STAR reagent tube has been formulated to provide optimum packing and layering of normal cells. In a small number
of patients, however, the system cannot read certain parameters and will not report a value. User errors in processing or use of
outdated or inappropriately stored tubes can also result in non-reported results. Practitioners must not assume that unreported
values are normal; further testing with an alternative method is essential.
Automated granulocyte and lymphocyte/monocyte differential counts cannot replace the conventional manual differential.
Due to the grouping by density of the cell populations by the QBC test method, the system cannot discriminate between
normal and abnormal cell types in disease states characterized by the presence of abnormal white cell types or nucleated red
blood cells. If abnormal cell populations are suspected, verifi cation of QBC test results or testing and diagnosis by alternative
methods is essential.
The combined lymphocyte/monocyte count should not be used to test for lymphocytopenia in evaluating patients with known
or possible immunodefi ciencies. Further evaluation of lymphocyte/monocyte counts in relevant situations must include a manual
differential and lymphocyte subset analysis.
The presence of abnormally sized platelets may lead to discrepancies between the QBC test method platelet count, which is based
on platelet mass, and results obtained with an impedance counter, which are based on measurement of particle number.

Expected Values

The following table provides normal ranges reported in the literature
hematology ranges based on the characteristics of their patient population.
Parameter
Hematocrit Males (%)
Hematocrit Females (%)
Hemoglobin Males (g/dL)
Hemoglobin Females (g/dL)
MCHC (g/dL)
Platelet Count (x10 9
WBC (x10 /L)
9
Granulocyte Count (x10
Lymphocyte/Monocyte Count (x10
5–4
Range
42.0 – 50.0
36.0 – 45.0
14.0 – 18.0
12.0 – 16.0
31.7–- 36.0
/L) 140 – 440
4.3 – 10.0
/L) 1.8 – 7.2
9
/L) 1.7 – 4.9
9
. Offi ces or laboratories may choose to develop normal
11, 13
L–000867(A)