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MAS to Integrate
ITC’s
AVOXimeter 4000 and AVOXimeter 1000E to RALS®-Plus
Click here
Quest Diagnostics HemoCue Subsidiary to Add U.S.
Hospital Laboratory Connectivity to Its HemoCue 201
DM Point-of-Care
Click here
Radiometer Announces Limited Launch of ABL®
Series Blood Gas Analyzer Module to RALS®-Plus
Click here
Blood Glucose Benchmarking
Results in U.S. Hospitals for 2008 Announced
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Wireless Monitoring of Blood
Glucose
Adoption of tight
glycemic control (TGC) is increasing across the United
States due to the reduction it offers in hyperglycemia,
a common and serious condition in hospitalized patients
associated with increased morbidity, mortality, length
of stay and healthcare costs. TGC requires frequent
testing of blood glucose and making any necessary
insulin adjustments after each reading. It has been
shown that intensive insulin therapy significantly
decreases mortality and morbidity in hospitalized
patients.1
But simply
performing the tests at the point of care (POC) isn't
enough. Wireless blood glucose monitors that transmit
results in real time are helping hospitals most
effectively realize the benefits that TGC has to offer.
Implications Because hyperglycemia is found commonly in
ICU patients, TGC should regularly be utilized for all
critically ill patients—not only for those already
diagnosed with diabetes.
More >
Published Studies
Validating Improved StatStrip® Glucose Strip Performance Now Available
From Nova Biomedical
Waltham, MA, August 21, 2008 – The first
published studies providing strong, independent validation of the
laboratory quality performance of Nova Biomedical’s StatStrip® Glucose
Test Strip for bedside glucose testing are now available. These studies
were performed by leading hospitals in various parts of the world,
including the Mayo Clinic (Rochester, MN), Washington University School
of Medicine & St. Louis Children’s Hospital (St. Louis, MO), and Rama
Hospital (Bangkok, Thailand).
The studies
compared StatStrip for precision, accuracy, and
interferences versus current technology analyzers as
well as reference chemistry analyzers used in the
central laboratory. The results demonstrate that
StatStrip consistently outperforms the conventional
analyzers in terms of eliminating interferences and
correlates closely to the laboratory reference methods.
Nova
StatStrip™ Glucose And StatSensor™ Creatinine Meters Now
Allow Off-Line Entry Of POC Test Results
Waltham, MA, August
6, 2008 – A new software enhancement for Nova StatStrip™
Glucose and StatSensor™ Creatinine point-of-care
monitoring systems allows off-line entry of POC test
results for immediate data capture. With the enhanced
NovaNet™ instrument manager software, operators can use
StatStrip touchscreen to manually enter virtually any
off-line POC test result, such as pregnancy or
urinalysis, and use the meter as a POC communication
device to transmit the information to the hospital’s
electronic database. The off-line entry capability saves
time and labor compared to manually charting the result
and then having to enter it later into the database. The unique NovaNet
open system architecture allows results and reporting to
be entirely user configurable. StatStrip and StatSensor
meters can be pre-configured so that test results can be
entered numerically, via multiple choice, or text.
Results are displayed along with normal and abnormal
ranges. QC results can be entered as well. Because the
meters can be configured by location, the hospital can
control which areas or departments can utilize this
feature and which tests can be entered. All ADT and
positive patient ID features are available for offline
entry. A security feature requires operator
certification to restrict data entry to authorized
users. The enhanced
NovaNet software also provides StatStrip and StatSensor
Meters with the capability to scan both 1D and 2D
barcodes. The codes supported are pdf417, Data Matrix,
and Maxicode. Nova StatStrip
Glucose and StatSensor Creatinine are handheld, whole
blood meters for point-of-care testing. StatStrip
Glucose test strips feature new Multi-Well™ measuring
technology that creates a new class of analytical
performance comparable to central laboratory testing.
StatStrip Glucose measures and eliminates interferences
from hematocrit, maltose, oxygen, acetaminophen,
ascorbic acid, and uric acid. StatSensor Creatinine
measures creatinine on whole blood in just 30 seconds,
and calculates estimated glomerular filtration rate (eGFR)
by the MDRD or Cockcroft-Gault equations. StatSensor
Creatinine’s small 1.2 microliter sample volume allows
easy and virtually painless sample acquisition from a
finger prick.
The FDA has granted 510(k)
clearance to Radiometer for its
ABL80 Flex CO-OX, a portable
blood gas analyzer.
The device measures pH, blood
gases, electrolytes, glucose and
vital CO-oximetry parameters.
The company’s CO-oximetry
technology uses multiwavelength
technology combined with an
ultrasonic hemolyzation process.
It provides clinicians with
information needed to assess an
acutely ill patient's oxygen
status, including oxygen uptake,
transport and release,
Radiometer said.
FDA approves Response
Biomedical's point-of-care NT-proBNP
test
The Food and Drug Administration
granted regulatory clearance for
Response Biomedical Corp. to
market its RAMP NT-proBNP
(N-terminal prohormone brain
natriuretic peptide) test as an
aid in the diagnosis of heart
failure.
Results from the point-of-care
test are clinically concordant
with those of Roche's Elecsys
proBNP test, allowing hospitals
to have standardized clinical
decision points for NT-proBNP in
both their emergency rooms and
central laboratories, according
to Response Biomedical.
"As the first full-range
point-of-care assay for NT-proBNP,
the RAMP test will present a
major step forward for rapid and
confident diagnosis of HF using
this important blood test," said
Dr. James Januzzi, director of
the coronary care unit at
Massachusetts General Hospital.
Response Biomedical also
recently entered into a
partnership granting rights to
Roche Diagnostics to market
Response Biomedical's line of
cardiovascular point-of-care
tests.
Point of Care Diagnostics to
Chip in 34% in Global IVD Market
The Point of Care
Diagnostics market is expected
to account for around 34% share
in the global IVD market on the
back of multiple benefits it
offers, says new research by
RNCOS.
The leading market research firm
RNCOS has launched its new
report, “Global In Vitro
Diagnostic Market Analysis”,
that anticipates the worldwide
In Vitro Diagnostic (IVD) market
to hit the total revenues of
about US$ 53 Billion by 2012.
Out of this, Point of Care
Diagnostics (POCT) currently
makes up for the largest share
in the global IVD market and is
projected to maintain its share
during the forecasted period.
POCT is real-time diagnostic
testing which is performed near
to or at the patient’s site with
the result may leading to a
change in the patient’s
treatment.According to the RNCOS research,
POCT is one of the fastest
growing and biggest segments of
the IVD market. The segment
accounted for around 33.4% of
the total market in 2007. The
POCT segment is forecasted to
gain more popularity in future
due to the multitude of benefits
its offers, including faster
results, availability of new
computer systems and biosensor
technologies, rising adoption of
self-testing products, and
improving demand for more
efficient testing methods by
physicians.
As a result, revenues from the
POCT market are forecasted to
register CAGR growth of nearly
6.9%, higher than the overall
market’s growth (in CAGR terms)
of around 6.7%. Blood glucose
testing, which contributed 70%
share in the POCT market, is
likely to remain the largest
segment in future, while cardiac
markers with 3% share are
expected to emerge as the
fastest growing one.“Global In Vitro Diagnostic
Market Analysis” provides
comprehensive and detailed
overview on the global IVD
market with thorough analysis on
traditional IVD market, new
emerging technologies, market
size, growth, share,
geographical distribution,
segmentation, growth factors,
trends and challenges for the
development of the market. The
report also gives forecast on
regional IVD market,
segment-wise (clinical segment)
IVD market, like molecular
diagnostics, immune chemistry,
clinical chemistry, microbiology
and blood screen immunoassays.
HemoCue granted FDA waiver for
point-of-care testHemoCue, a wholly owned subsidiary of
Quest Diagnostics,
has announced that its HemoCue Albumin 201 System is the
first quantitative point-of-care test for screening,
diagnosing and monitoring microalbuminuria to be granted
a CLIA waiver by the FDA.
With the FDA CLIA waiver, non-laboratory
trained physicians and other
health care
professionals in any health care facility with a
Clinical Laboratory Improvement Amendments (CLIA)
certificate of waiver in the US will be able to use the
HemoCue Albumin 201 System to screen patients for
microalbuminuria and begin treatment based on the test's
results during a single office visit.
The HemoCue Albumin 201 System, which produces results
within 90 seconds, enables physicians to identify and
quantify low levels of albumin at the point of care for
the purpose of screening, diagnosing, monitoring and to
supplement clinical evidence in the treatment of
microalbuminuria.
Stephen Suffin, interim chief laboratory officer of
Quest Diagnostics, said: "The availability of a fast,
reliable point-of-care test that physicians can perform
in their own offices to quantitatively assess
microalbumin may help patients at risk for chronic
kidney disease to begin receiving the care they need at
the time of their appointment with their physician."
For
glucoses, tight theory a tough practice
What’s the difference
between a protocol on paper and a protocol in practice?
The cardiothoracic intensive care unit at Maine Medical
Center, Portland, knows the answer from firsthand
experience with implementing a program of tight glycemic
control. “We’ve probably been
hammering away on tight glycemic control for about three
years, but a couple of years ago we really started to
take a closer look at compliance by the nursing staff to
see whether they were actually following the protocol we
thought was so wonderful,” says Cheryll St. Onge, RN,
BSN, MS, the unit’s nursing director. “The bottom line was,
they weren’t.” More and more hospitals are adopting TGC—the
active use of insulin to keep patients’ blood glucose at
or near normal levels—as an effective strategy for
improving patient outcomes. As they do, the data from
the field are confirming what the literature has
concluded: Tight glycemic control works. But it’s no
cakewalk to implement it in a hospital.
At Maine Medical
Center, in fact, the paper was the problem. After
looking into the matter, St. Onge found that the
original protocol, about five pages long and written in
narrative form, was bogging down the process. “People
just didn’t have or take the time to go through the fine
details of what they should be doing,” she says.
More > |