PENGENDALIAN

KUALITAS
HEMATOLOGI
Verification And Quality Control Of
Routine Hematology Analyzers
Albert Huisman, Department of Clinical Chemistry and
Hematology, University Medical Center Utrecht, G.03.550,
Heidelberglaan 100, 3584 CX Utrecht, The Netherlands.

accepted for publication 23 February 2016

Validation, for example, according to CLSI
guidelines, should in principle be performed by
the manufacturer for the intended scope, and
verification by the clinical laboratory of the
manufacturers claim is sufficient. Caution with
different body fluids (e.g., synovial, peritoneal,
pleural, pericardial, cerebrospinal fluid (CSF), or
wound drainages) and different tubes (plain,
heparin, or citrate vs. EDTA) is warranted, as not
all HA have yet been validated for these
purposes. A full validation may also be required
for adjusted methods and measurements
outside of the analytical measurement range.
The underlying algorithms that generate these flags
may be totally different, making a comparison
between two types of HA challenging. Usually
manufacturers try to make sure that all pathological
samples are recognized, for example, the samples
with malignant WBCs (blasts). To avoid missing these
pathological samples, the flagging algorithm
generates flags with a low positive predictive value
(PPV) [and usually a high negative predictive value
(NPV)], that is, a lot of normal samples get a
suspicious flagging and need (microscopic) review,
thereby unnecessary increasing the workload of the
laboratory. Lastly, establishing reference intervals by
manufacturers can be arduously, especially in the
pediatric population. Obtaining samples from healthy
children and neonates, has shown to be difficult.
Reference intervals in the pediatric
population are often based on publications
from decades ago, using technology that is
no longer widely available, making it
questionable whether these reference
ranges can be applied in the present time;
or there are new parameters or parameters
using a new analytical technique for which
there are no published reference ranges
available. Therefore, manufacturers should
make considerable efforts to generate
reference intervals in these groups for their
new HA.
Lastly, establishing reference intervals by
manufacturers can be arduously, especially in
the pediatric population. Obtaining samples
from healthy children and neonates, has shown
to be difficult. Reference intervals in the
pediatric population are often based on
publications from decades ago, using techno-
logy that is no longer widely available, making
it questionable whether these reference ranges
can be applied in the present time; or there are
new parameters or parameters using a new
analytical technique for which there are no
published reference ranges available