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management solution that automatically
recommends and implements optimum QC
rules. By setting up proper QC design, the
module decreases false rejections and helps
attain designated quality goals with the highest
error detection and lowest false rejection
rate possible. This reduces false error flags
and saves labs time and money associated
with the reduction of unnecessary troubleshooting
and repeats. The Westgard Advisor
online module is very easy to use with a
four-step wizard that guides users through
the rule selection process.
Bio-Rad Laboratories, Inc.
Circle No. 391 in the Reader Service Card
UnityWeb 2.0 QC Data Management System
UnityWeb 2.0 is an entry-level, Web-based
QC data management solution that facilitates
regulatory compliance under CLIA and ISO
15189. The UnityWeb 2.0 system reduces IT
dependence because no software installation
is required. The program provides statistical
process control with audit trails, charts
and reports for data analysis, and enables
participation in the Unity Interlaboratory
Program for peer comparisons. The Unity-
Web 2.0 system can also be used with the
optional Westgard Advisor online module
to automatically recommend and implement
optimum QC rules. With the WebConnect
program, QC data can be uploaded directly
into the UnityWeb 2.0 system, eliminating
manual entry of QC data.
Bio-Rad Laboratories, Inc.
Circle No. 392 in the Reader Service Card
Liquichek Tumor Marker Control
The Liquichek Tumor Marker Control is
a liquid, human serum-based, third-party
control used for monitoring the precision of
tumor marker testing. This trilevel, multi-analyte
control features 17 tumor markers: CA
15-3, CA 19-9, CA 27.29, CA 72-4*, CA 125,
AFP, β-2-microglobulin, CEA, cyfra 21-1*,
ferritin, hCG/β-hCG, IGF-1, PAP, prolactin,
total PSA, free PSA, and thyroglobulin.
The control has a 2-year shelf life when
stored frozen, and 30-day, open-vial stability
at 2–8ºC for most analytes. Assayed values
are provided for manual and automated test
methods, and participation in the Unity
32 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
Interlaboratory Program is available.
*International use only.
Bio-Rad Laboratories, Inc.
Circle No. 393 in the Reader Service Card
Alfred 60 Urine Culture System
The Alfred 60 is a fully automated system
for urine culture that offers rapid results and
reliability in sample identification and standardized
working protocols. The patented
technology allows detection of intense bacteria
replication activity and plotting of the
specific growth curves in real time, indicating
the quantitative value expressed in CFU/
mL. Strongly positive samples are flagged
after only 45 minutes from the start of the
analysis, and the positivity threshold can be
customized according to the lab’s needs. A
user can simultaneously perform the residual
antimicrobial activity test and the culture
test to avoid false-negative results caused by
substances with antibacterial properties.
ALIFAX S.p.A.
Circle No. 394 in the Reader Service Card
POC Controls: Urine, Hb, and Occult Blood
Thermo Scientific’s Point-of-Care Controls
for near-patient testing in hospitals and physician
offices focus on urinalysis, hemoglobin,
and occult blood testing. The urinalysis
control is a ready-to-use, liquid control that
can be stored at room temperature for 6
months and works with most major brands.
The hemoglobin control is a liquid, wholeblood
control with 2-year, closed-vial dating;
60-day, open-vial stability; and 30-day,
room-temperature storage. The occult blood
control is the only commercial external
control available on the market featuring a
12-month room-temperature storage and a
2-year shelf life.
Thermo Fisher Scientific
Circle No. 395 in the Reader Service Card
OneTouch® TGC® Advisor Program
Tight glycemic control creates extra work for
hospital staff; therefore, products that facilitate
its management are needed. That’s why
LifeScan, Inc., is proud to present this new
software program that measures and manages
the information necessary for tight
glycemic control programs. The OneTouch
TGC Advisor, an upgrade for the OneTouch®
DataLink® Data Management System, is
configurable by location and reportable by
patient. It generates real-time patient graphs
and trend reports that can be distributed
via e-mail. It also helps users assess protocol
compliance and patient outcomes. The
OneTouch TGC Advisor is a key component
of LifeScan, Inc.’s Integrated IntelligenceSM
solutions for improved clinical decision
making.
LifeScan, Inc.,
a Johnson & Johnson Company
Circle No. 396 in the Reader Service Card
OneTouch® DataLink® Wireless V2 System
With this product, LifeScan, Inc., brings
a new level of efficiency to the POC envi-
ronment. Now, healthcare providers can
enjoy flexible, secure wireless connectivity
between OneTouch® Flexx Meters and the
OneTouch® DataLink® Data Management
System. The OneTouch DataLink Wireless
V2 improves workflow and the data transfer
process, with meter data reportable in near
real time for enhanced clinical decisions. The
OneTouch DataLink Wireless V2 is a key
product component of LifeScan, Inc.’s Integrated
IntelligenceSM solutions, providing
healthcare institutions with the products and
technology they need to advance care across
the continuum.
LifeScan, Inc.,
a Johnson & Johnson Company
Circle No. 397 in the Reader Service Card
StatusFirst® Drugs of Abuse 10 Panel
LifeSign introduces the StatusFirst Drugs of
Abuse 10 panel test, a rapid, POC assay that
is instrument read. A qualitative immunoassay
for the detection of drugs-of-abuse in
urine, the StatusFirst DOA 10 panel features
a simple procedure: dispense two drops of
urine into a StatusFirst DOA 10 device and
then read the results in the DXpress® Reader
in 5 minutes. The DXpress Reader eliminates
operator subjectivity and provides a hard
copy printout while delivering accurate results.
The StatusFirst DOA 10 Panel features
the following drug combination: MET/OPI/
COC/THC/PCP/BZO/BAR/MTD/TCA/
AMP. A five-panel test is also available.
LifeSign, LLC
Circle No. 398 in the Reader Service Card
STATUS-COLON ASSURE Test
LifeSign introduces the CLIA-waived
STATUS-COLON ASSURE test, a rapid
POC assay. The STATUS-COLON ASSURE
is a two-tier collection and testing system
combining the traditional fecal occult blood
detection (guaiac) method with immunochemical
testing for the detection and
confirmation of human hemoglobin on one
test card. The iFOBT portion of the test has
a sensitivity of 50 μg Hgb/g feces for a higher
detection rate of colon disease. The combo
test card can be stored up to 30 days at room
temperature without affecting the results.
LifeSign, LLC
Circle No. 399 in the Reader Service Card
EliA Autoimmune Assays
For more than 30 years, Phadia has revolutionized
immunoassay technology and advanced
the science of allergy and immunology
as the worldwide leader in specific IgE
blood testing. From this platform of proven
performance, Phadia is proud to introduce
EliA Autoimmune assays. EliA Autoimmune
assays are fully automated, moderately
complex, and run on the proven Immuno-
CAP instrument systems (100ε/250). EliA
Autoimmune assays include: CCP antibodies
(cyclic citrullinated peptide); Celikey® tTG
antibodies (tissue transglutaminase); gliadin
antibodies; and Symphony ANA and dsDNA
antibodies. Visit Phadia booth #1331 or
contact Customer Service at 800.346.4364
to learn how EliA Autoimmune assays can
enhance your lab’s performance and bottom
line.
Phadia U.S., Inc.
Circle No. 400 in the Reader Service Card
SpinGard Large Capacity Tabletop Centrifuges
NuAire’s SpinGard Large Capacity Tabletop
Centrifuges offer faster speeds for optimum
separation. The SpinGard allows instant
rotor exchange in just a matter of seconds.
The SpinGard centrifuges have automatic
recognition of all the rotors and calculate
the rotational speed. A duel-door lock and
imbalance detector enhances the safety on
each unit. All SpinGard units have a large
LCD display for all the information, from
diagnostic messages to the rotor library and
running conditions.
NuAire, Inc.
Circle No. 401 in the Reader Service Card
ELISA 5-in-1 Workstation
The walk-away solution for immunoassays in
microplate format, the ELISA 5-in-1 Workstation
combines the five basic functions to
process ELISA assays in 96-well microplate