DaVita Study Demonstrates Clinical Application of Sysmex Reticulocyte Hemoglobin...

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Wed Jun 10, 2009 10:48am EDT

DaVita Study Demonstrates Clinical Application of Sysmex Reticulocyte
Hemoglobin Equivalent (RET-He) Parameter

RET-He Parameter Demonstrates Potential Value as an Indicator of Anemia
Treatment Decisions for Physicians in ESRD patients on hemodialysis.

MUNDELEIN, Ill., June 10 /PRNewswire/ -- Sysmex America, Inc. today announced
that a study titled "Day-to-Day, Week-to-Week, and Day-of-the-Week Variations
in Tests of Anemia and Iron Status in Hemodialysis Patients" has identified
Sysmex's Reticulocyte Hemoglobin Equivalent (RET-He) parameter result as key
input used by physicians to assist in Anemia treatment decisions in ESRD
patients on hemodialysis. David Van Wyck, M.D., Vice President of Clinical
Affairs at DaVita Inc., and Emeritus Professor of Medicine and Surgery at the
University of Arizona College of Medicine, in Tucson et. al followed five
hematologic parameters in 30 patients undergoing hemodialysis three times a
week. The patients were followed for 12 consecutive treatment days. The
parameters studied were Hb, Hct, reticulocyte Hb (RET He or CHr), TSAT and
ferritin levels.

The purpose of the DaVita(R) study was to evaluate the clinical value of these
five parameters for supporting the physician's ability to make informed dosing
decisions for ESA and IV iron therapy.

According to Dr. Van Wyck, "It has been difficult to know if the observed
variability is within the 'expected ranges' for these patients or if changes
in these markers signify a trend. Prior to this study, little information was
available on expected day-to-day, within-patient variability among patients
undergoing dialysis."

Over the course of the study, ESA doses were held constant and IV iron therapy
was withheld. Same-sample analytic variability was measured, as was
within-patient "biologic" variability. The number of sampling days needed to
determine the true average value for each analyte was calculated with a 5%
significance level and an 80% level of accuracy.

For all five parameters, "biologic" variation exceeded analytic variation,
particularly for TSAT and ferritin. Hb and Hct were affected by the day of the
week blood was drawn, with Hb levels averaging 0.06g/dL higher midweek versus
those obtained the first dialysis day of the week. Hb, Hct and Ret-He/CHr
values were measured using a Sysmex XE-2100 instrument.

The authors concluded that because of the high "biologic" variation observed,
multiple test days are needed to achieve clinically meaningful accuracy and
that HB, Hct and reticulocyte Hb (Ret-He or CHr) were useful analytes to guide
ESA and IV iron therapy, whereas ferritin and TSAT were not reliable guides
for month to month dose adjustments for ESA or IV iron. They may, however, be
useful for assessing iron status or setting broad therapeutic targets in large
patient populations. Day of the week effects are minimal for HB and Hct, and
undetectable for other analytes.

"The advantages inherent in directly assessing immature cells are potentially
under-recognized. The publication of this study supports our belief that the
advantages of direct cellular analysis versus indirect assumptions on iron
status [storage or transport protein measurement, serum iron, or algorithms]
may well be a means of refining complex anemia treatment decisions," said Ian
Giles, M.D., Director of Scientific Affairs, Sysmex America, Inc.

The study poster was presented at the recent 2009 National Kidney Foundation
Spring Clinical Meeting held in Nashville, TN and attended by nearly 2,500
attendees including physicians, fellows and residents, physician assistants,
nurse practitioners, nurses and technicians, renal and clinical dietitians,
and social workers.

DaVita is a registered trademark of DaVita Inc. All other trademarks are the
property of their respective owners.

About RET-He
RET-He is an established parameter in the National Kidney Foundation's KDOQI
(Kidney Disease Outcomes Quality Initiative) guidelines for assessing the
initial iron status of patients with chronic kidney disease on hemodialysis as
well as IV iron replacement in these patients. The Sysmex XE-5000, XE-2100 and
the XT-2000i Automated Hematology Analyzers provide the RET-He parameter,
which quantifies the hemoglobin content of reticulocytes. Sysmex technology
uses proprietary polymethine dyes that have an affinity to, and fluorescently
label, nucleic acids. Detection and characterization of immature cells may
well be a more valuable approach than measuring storage or transport proteins,
serum iron, or algorithms which incorporate indirect assumptions.

About Sysmex America, Inc.
Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe,
Japan), is a world leader in clinical laboratory systemization and solutions,
including clinical diagnostics, automation and information systems. Serving
customers for over 40 years, Sysmex focuses on extending the boundaries of
diagnostic science while providing the management information tools that make
a real difference in clinical and operational results for people worldwide.
For more information about Sysmex, please visit www.sysmex.com/usa.

About DaVita Inc.
DaVita Inc., a FORTUNE 500(R) company, is a leading provider of kidney care in
the United States, providing dialysis services and education for patients with
chronic kidney failure and end stage renal disease. Recognized as the only
FORTUNE 500(R) company on WorldBlu's annual List of Most Democratic Work
Places(TM), DaVita manages more than 1,475 outpatient facilities and acute
units in more than 700 hospitals located in 43 states and the District of
Columbia, serving approximately 114,000 patients - nearly one-in-three of all
dialysis patients in the United States. As part of DaVita's commitment to
building a healthy, caring community, DaVita develops, participates in and
donates to numerous programs dedicated to transforming communities and
creating positive, sustainable change for children, families and our
environment. For more information about DaVita, its kidney education materials
and its community programs, please visit www.davita.com.



SOURCE  Sysmex America

Tammy Kutz, Manager, Media & Events of Sysmex America, Inc., +1-847-996-4531,
kutzt@sysmex.com
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