said they wanted to avoid travel to more
The Sysmex XW-100 Analyzer
than one location, and eliminate follow-
up visits to discuss test results.
The XW-100 Automated Hematology
Analyzer is intended for use in patients 2
years of age and older who require a
whole blood cell count and white blood
cell differential. Test results can be used
with other clinical and laboratory
findings to provide early alerts of patients
with serious conditions such as severe
anemia and agranulocytosis, who require
additional testing. However, it is not
intended to diagnose or monitor patients
with primary and/or secondary
hematologic diseases, including oncology
and critically ill patients. The analyzer
provides a complete blood count and a 3-
part differential; a 12 parameter blood
component profile as part of an overall
• Mean Corpuscular Volume (MCV)
patient health assessment.
• Platelet Count (PLT)
Some in the clinical laboratory
• Neutrophil Count (NEUT#)
profession have expressed concern that a
• Lymphocyte Count (LYM#)
waived CBC test now has received FDA
• Other White Blood Cell Count
clearance. In part, that’s because there
(Other WBC#)
are examples of waived tests where
• Neutrophil Percentage (NEUT%)
untrained operators performed tests that
• Lymphocyte Percentage (LYM%)
produced inaccurate results for reasons
• Other White Blood Cell Percentage
ranging from an analyzer out of control
(Other WBC%)
and use of outdated reagents, to failure
• MCH (calculateda0
to properly perform quality control.
• MCHC(calculated)
These experiences are why it is important
• RDW-SD (calculated)
for Sysmex to tell the story behind the
• RDW-CV (calculated)
FDA’s clearance of a waived CBC. “Test
• MPV (calculated)
processes were stripped to the essentials
during the design process to meet
Key Differences in the New
requirements for ease-of-use, and to
reduce risk, user error, and erroneous test Sysmex Compared to Moderately
Complex Analyzers
results” said Ralph Taylor, CEO of
• Missing are comprehensive
Sysmex America, Inc.
reporting, and integration with the
LIS and/or EHR. “This was by
The CBC and Three-Part Differential:
design,” noted Taylor. The FDA
uses a 15 µL sample of venous blood to
clearance as a waived test allows
provide clinically useful results.
operators in CLIA-waived facilities
to operate the system.
Analyses include:
• The Sysmex XW-100 has several
• White Blood Cell Count (WBC)
innovative features. “This benchtop
• Red Blood Cell Count (RBC)
analyzer requires no additional
• Hemoglobin (HGB)
training to set up upon arrival,”
• Hematocrit (HCT)
“ Our goal with this
analyzer is to deliver
information within
the POL environment
that allows clinicians
to respond quickly
and rapidly to begin
treatment.”
Ralph Taylor, CEO, Sysmex America, Inc.
explained Taylor. “Operator
training consists of a brief video
outlining basic features. Everything
el se is handled through onscreen
prompts that walk operators step-
by-step through the initial data-
entry processes and starting the
CBC test. “When started, the
analyzer connects to Sysmex to
verify reagent authenticity and
expiration dates, and check control
values,” he continued. “The
instrument also stays connected to
Sysmex and rechecks these after
every eight hours of laboratory use,
and when reagents are changed”
• Unlike more complex hematology
analyzers, this system does not
report to Sysmex outside of
routine data checks. It also does
not transmit data locally within
the healthcare setting. Instead, it
produces paper printouts of CBC
and three-part differential results,
which the physician uses to
support diagnosis and treatment
decisions. In addition to the
print-out, the XW-100 stores the
results of the last 100 tests on a
first-in/first-out basis.
5