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at the lowest quinidine concentration. The
12-week onboard stability of the cobas c
pack, along with calibration stability, allows
for a convenient and economical method
for TDM of quinidine in serum, K2 or K3
EDTA, or sodium or lithium-heparin plasma
on the Roche cobas c 501 analyzers.
Roche Diagnostics
Circle No. 375 in the Reader Service Card
Sample Validity Testing
The new Roche Diagnostics Sample Validity
Tests for use on the Roche Hitachi MODU-
LAR ANALYTICS systems include the test
reagents, assay-specific calibrators, and
multi-constituent controls for: pH, specific
gravity, nitrites, chromates, oxidants, and
creatinine. These assays fulfill SAMSHAmandated
requirements to test for sample
adulteration in certified labs and provide
convenient system packaging and enhanced
performance for high-throughput labs.
Roche Diagnostics
Circle No. 376 in the Reader Service Card
Elecsys Anti-TSHR Assay*
Introducing the fully automated Elecsys
Anti-TSHR assay for detection of autoanti-
bodies to the TSH receptor. This highthroughput
immunoassay will add to Roche’s
broad thyroid menu. The Anti-TSHR assay
is intended to be used as an aid in the assessment
of patients with suspected Graves’
disease, the leading cause of hyperthyroidism.
Graves’ disease affects approximately
750,000 people in the U.S. and nearly 32 million
people worldwide. Early and accurate diagnosis
supports Roche’s Passion to Improve
Lives. *Pending FDA Clearance.
Roche Diagnostics
Circle No. 377 in the Reader Service Card
Elecsys PTH STAT Assay
Parathyroid hormone plays an adjunct
role as a functional measure of parathyroid
surgery, confirming the adequacy of parathyroid
gland resection. Using the 9-minute
Parathyroid Hormone (PTH) test during
parathyroid surgery provides faster results for
surgeons, which may result in shorter surgeries
for patients. Used on Roche’s Elecsys 1010
and 2010 systems and cobas e 411 analyzer,
the test was FDA cleared in late 2007 for use
during surgery. A 9-minute STAT PTH
30 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
application is also in development for the
Roche Diagnostics cobas® 6000 analyzer
series.
Roche Diagnostics
Circle No. 378 in the Reader Service Card
ONLINE TDM Lidocaine Test
The ONLINE TDM Lidocaine assay is a
homogenous immunoassay based on kinetic
interaction of microparticles in solution
(KIMS). Microparticles coated with lidocaine
rapidly aggregate in the presence of a lidocaine
antibody. The presence of lidocaine in
the sample inhibits particle lattice formation,
generating a classic inhibition curve with
the maximum rate of aggregation at the
lowest lidocaine concentration. The 12-week
onboard stability of the 75 test cobas c pack,
along with calibration stability, allow for
a convenient and economical method for
TDM of lidocaine in serum, K2 or K3 EDTA,
or sodium or lithium-heparin plasma on the
Roche Diagnostics cobas c 501 analyzers.
Roche Diagnostics
Circle No. 379 in the Reader Service Card
ONLINE TDM Amikacin Assay
The ONLINE TDM Amikacin assay is a
homogenous immunoassay based on kinetic
interaction of microparticles in solution
(KIMS). Microparticles coated with amikacin
rapidly aggregate in the presence of an
amikacin antibody. The presence of amikacin
in the sample inhibits particle lattice formation,
generating a classic inhibition curve
with the maximum rate of aggregation at
the lowest amikacin concentration. The
12-week onboard stability of the cobas c
pack, along with calibration stability, allow
for a convenient and economical method for
TDM of amikacin in serum, K2 or K3 EDTA,
or sodium or lithium heparin plasma on the
Roche Diagnostics cobas c 501 analyzers.
Roche Diagnostics
Circle No. 380 in the Reader Service Card
Lithium Colorimetric Assay
Introducing the Lithium colorimetric assay
(Li) for the Roche Diagnostics cobas c 501
analyzer. Lithium present in the sample reacts
with a substituted porphyrin compound
at an alkaline pH, resulting in a change in
absorbance that is directly proportional to
the concentration of lithium in the sample.
The assay uses a liquid, ready-to-use reagent
packaged in a cobas c pack and the C.f.a.s.
calibrator, the calibrator common to most
general chemistry assays. Acceptable samples
include serum and K2-EDTA and Naheparin
plasma. The 100-test Lithium cobas
c pack is stable for 4 weeks onboard the
cobas c 501 analyzer, providing a convenient
method for lithium analysis.
Roche Diagnostics
Circle No. 381 in the Reader Service Card
CoaguChek® XS System
The CoaguChek XS System uses exclusive
smart technology to help ensure accurate
PT/INR results at the POC and offers the
flexibility and control healthcare professionals
need to confidently manage a wide range
of anticoagulation patients. The system
includes extended data management and QC
capabilities to help clinics and other facilities
that manage high volumes of patients. Using
the CoaguChek XS system at the POC may
help hospital-based labs realize the benefits
of systematic anticoagulation management,
such as immediate therapy adjustments and
lower indirect costs of patient management
(Wurster, M., Doran, T. Anticoagulation
management: A new approach. Disease
Management, 2006; 4:201-209.)
Roche Diagnostics/Point-of-Care
Circle No. 382 in the Reader Service Card
ACCU-CHEk® Inform II System*
The next generation in POC blood glucose
monitoring systems from Roche Diagnostics,
the ACCU-CHEK Inform II System is
designed to help healthcare professionals
ensure patient safety and enhance patient
care. Ideally suited for the ICU, the system
is designed to use ACCU-CHEK Performa
test strips that use the proven ACCU-CHEK
Aviva consumer strip technology. Design
goals include a 0.6-μL sample size, underdose
detection, optional wireless technology,
enhanced patient identification (EPID) features,
other test entry, observed test sequence,
and patient history query capabilities. *Pending
FDA clearance.
Roche Diagnostics/Point-of-Care
Circle No. 383 in the Reader Service Card
Jaguar Nucleic Acid System
Sample in, result out! HandyLab offers
the first rapid, cost-effective, easy-to-use
integrated molecular diagnostic platform
for infectious disease testing. The Jaguar is a
third-generation nucleic acid system that
provides labs with full molecular diagnostic
automation, including processing raw patient
samples into a real-time PCR and results in as
little as 45 minutes with minimal hands-on
time. This innovative system enables automation
of manual lab-developed tests and analyte
specific reagents. HandyLab is dedicated
to the development, manufacture, and sales
of novel diagnostic products based on its patented
and proprietary microfluidic real-time
PCR and nucleic acid extraction technologies.
HandyLab—Ahead of the Curve!
HandyLab, Inc.
Circle No. 384 in the Reader Service Card
StaRRsed Inversa 24M ESR Analyzer
The newly developed ESR analyzer performs
blood sedimentation in accordance with
the globally accepted Westergren method.
A built-in barcode reader, printer, credit
card charging system, QC program, and LIS
connectivity make the StaRRsed Inversa 24M
analyzer the ideal instrument for labs doing
up to 150 ESR’s a day. It works with standard
EDTA blood using an automated accurate
dilution with citrate solution, so no special
ESR tubes are needed. No disposables are
required either because the StaRRsed Inversa
24M automatically cleans pipettes for reuse.
The system performs 24 ESRs in 30 minutes,
unattended, saving time and money.
Mechatronics Instruments USA
Circle No. 385 in the Reader Service Card
Liquichek Diabetes Control
The Liquichek Diabetes Control is a liquid,
human, whole blood-based, third-party contol
for monitoring the precision of hemoglobin
A1c tests on commonly used methods
and instruments. This control provides an
unbiased assessment of the assay performance
helping to improve the quality of test
results. It is available in three levels and has
a 3-year (-10ºC to -70ºC) frozen shelf life.