Drucker Diagnostics Paralens Advance - Manual (Page 48)

7.2 TEST LIMITATIONS (continued)
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, verification 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 immuno deficiencies.
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.
7.3 EXPECTED VALUES
The following table provides normal ranges reported in
the literature.
1,12 Offices or laboratories may choose
to develop normal hematology ranges based on the
characteristics of their patient population.
Parameter Range
Hematocrit Males (%)
42-50
Hematocrit Females (%) 36-45
Hemoglobin Males (g/dL) 14-18
Hemoglobin Females (g/dL) 12-16
MCHC (g/dL) 31.7-36.0
Platelet Count (× 10 9 /L) 140-440
WBC (× 10 9 /L) 4.3-10.0
Granulocyte Count (× 10 9 /L) 1.8-7.2
Lymphocyte/Monocyte Count (× 10 9 /L) 1.7-4.9
7.4 SPECIFIC PERFORMANCE
CHARACTERISTICS
7.4.1 Precision
Data on typical within-run precision tests on
AccuTubes tested in the QBC Autoread Plus
analyzer are shown in Tables 7-1a and 7-1b. The
precision data represents the analysis of ten whole
blood specimens, each assayed in replicates of 10.
Table 7-1a.
Precision
Parameter Mean Value C.V.
HCT (%) 40.4 0.6 %
HB (g/dl) 13.3 0.6 %
PLT (× 10 9 /dl) 287 4.4 %
WBC (× 10 9 /dl) 8.1 6.3 %
Table 7-1b.
Precision
Parameter Range S.D.
GRAN (%) 40-80 < 3.3
LYMPH/MONO
(%)
20-55 < 3.3
7-2