¾ Introducing Hemolysis Detection in
Point-of-Care
Blood Gas Testing for the First Time Ever ¾
BEDFORD,
Mass., July 30, 2024 /PRNewswire/ -- Werfen today
announced the introduction of the GEM Premier 7000 with Intelligent
Quality Management 3 (iQM3) at the Association for Laboratory
Medicine (ADLM) Annual Meeting (formerly the American Association
for Clinical Chemistry), which has received 510(k) clearance by the
US Food and Drug Administration. The GEM Premier 7000 with iQM3
represents a breakthrough in blood gas testing, offering hemolysis
detection for the first time at the point-of-care (POC).
As the number one source of preanalytical error, hemolysis
accounts for up to 70% of all such errors.1 Despite its
prevalence throughout different areas of the hospital, hemolysis is
not visible in whole blood, and can go unrecognized. Hemolysis
occurs when red blood cell membranes rupture, causing cellular
contents to leak into the surrounding fluid, which can elevate
potassium results up to 152%.2 In samples impacted by
hemolysis, low potassium levels can appear normal and normal levels
can appear high. Consequences of in vitro hemolysis can include
inappropriate patient management, increased length of stay, and
increased costs, among others.3-7
"While hemolysis in point-of-care testing has been widely
recognized as a significant problem, and the potential value of its
detection tremendous, most have viewed this as an unsolvable
challenge—until now. We are exceptionally proud to have solved this
challenge with the patented technology in our new GEM Premier 7000
with iQM3 system," said Remo Tazzi,
Vice President Worldwide Marketing and Service at Werfen. "Feedback
from our initial customers has been very positive, and we look
forward to expanding placements of these new systems throughout the
US, and ultimately, the world, to enhance both patient care and
efficiency."
"Every day our clinicians make critical decisions, based on
potassium measurements. Knowing whether a blood sample is hemolyzed
is crucial for interpretation of potassium results," said
Heather Stieglitz, PhD, D(ABCC),
Co-Director of Clinical Chemistry and Point-of-Care Testing, The
Ohio State University Wexner Medical
Center, Columbus, Ohio. "While we
have had the capability to detect hemolysis in a central
laboratory, it was missing at the point of care. The GEM Premier
7000 closes this gap, and we are confident that our potassium
results will allow clinicians to make safe and rapid decisions for
the care of our patients."
In vitro hemolysis is prevalent throughout the hospital. In
neonatal intensive care units, up to half of whole blood samples
have been shown to be hemolyzed, while in emergency departments,
approximately 20% can be hemolyzed.1,8–10 Undetected
hemolysis can lead to inappropriate or delayed treatment,
unnecessary redraws, increased staff time, and higher
costs.3-7
The system's hemolysis detection is based upon patented
acoustofluidic technology for plasma separation, combined with
photometric determination. In just 45 seconds, the GEM Premier 7000
detects hemolysis, while delivering a complete menu of results (pH,
pO2, pO2, sodium, potassium,
ionized calcium, chloride, glucose, lactate, hematocrit, total
hemoglobin, total bilirubin and CO-Oximetry (tHb, O2Hb,
COHb, MetHb, HHb, sO2).
iQM3, a real-time, automated, quality management system,
continuously ensures sample quality across the most common
preanalytical errors, including hemolysis, micro-clots, bubbles and
lipemia. It automatically checks sample integrity before, during,
and after every analysis, and corrects and documents errors. This
helps assure quality results and compliance, 24/7, and informs and
expedites critical decision-making.
The all-in-one GEM PAK cartridge automates labor- and
skill-intensive processes and offers a variety of menu and
test-volume configurations, tailored to the clinical setting.
GEMweb Plus 500 Custom Connectivity simplifies control and
compliance, enabling comprehensive management of all systems,
operators, and data oversight. Its sample handling reports help
identify operator competency gaps and training needs, for
continuous quality improvement.
The GEM Premier 7000 with iQM3 system is the latest innovation
in Werfen's long line of GEM Premier blood gas testing systems. The
most recent, previously introduced model is the GEM Premier 5000
with iQM2, which introduced IntraSpect™, performing continuous
quality checks during sampling, in addition to before and after
every sample.
The GEM Premier 7000 with iQM3 system is not Health
Canada-licensed. It is not available in all countries.
About Werfen's Acute Care Diagnostics Portfolio
The
GEM Premier 7000 with iQM3 system is part of Werfen's integrated
and comprehensive ACD product portfolio—helping clinicians and
laboratorians achieve better patient outcomes, lower total cost of
care, assure accreditation compliance and improve operational
efficiency in hospital acute care settings. For Whole Blood
Hemostasis testing, ROTEM viscoelastic testing systems, the
GEM Hemochron™ 100 system, and the VerifyNow™ platelet-reactivity
testing system inform key clinical decisions regarding transfusion,
bleeding risk and heparin dose adjustment during surgical and
interventional procedures along with a clinical assessment of the
patient's condition and other laboratory tests. For Blood Gas
testing, the GEM Premier systems, including GEM Premier 7000, 5000
and 3500 systems, and the Avoximeter™ 1000 portable CO-Oximeter,
simplify POC operations by automating key labor- and
skill-intensive tasks, including quality management and system
maintenance. From Cardiovascular Operating Rooms and
Catheterization Labs, to Intensive Care Units and Emergency
Departments, whole-blood, cartridge-based systems with Werfen's
integrated data management solutions, help hospitals improve
efficiency and enhance patient care.
References
- Lippi G, Salvagno GL, Favaloro EJ, Guidi GC. Survey on the
prevalence of hemolytic specimens in an academic hospital according
to collection facility: opportunities for quality improvement.
Clin Chem Lab Med. 2009;47(5):616–618.
doi:10.1515/CCLM.2009.132.
- Lippi G, Plebani M, Di Somma S, Cervellin G. Hemolyzed
specimens: a major challenge for emergency departments and clinical
laboratories. Crit Rev Clin Lab
Sci. 2011;48(3):143–153.
doi:10.3109/10408363.2011.600228.
- O'Hara M, Wheatley EG, Kazmierczak SC. The impact of
undetected in vitro hemolysis or sample contamination on patient
care and outcomes in point-of-care testing: a retrospective study.
J Appl Lab Med. 2020;5(2):332-341.
doi:10.1093/jalm/jfz020.
- Phelan MP, Ramos C, Walker LE, et al. The hidden cost of
hemolyzed blood samples in the emergency department. J Appl Lab
Med. 2021;6(6):1607–1610. doi:10.1093/jalm/jfab035.
- Phelan MP, Hustey FM, Good DM, Reineks EZ. Seeing red: blood
sample hemolysis is associated with prolonged emergency department
throughput. J Appl Lab Med. 2020;5(4):732–737.
doi:10.1093/jalm/jfaa073.
- Wilson M, Adelman S, Maitre JB, et al. Accuracy of
hemolyzed potassium levels in the emergency department. West J
Emerg Med. 2020;21(6):272–275.
doi:10.5811/westjem.2020.8.46812.
- Milutinović D, Andrijević I, Ličina M, Andrijević L. Confidence
level in venipuncture and knowledge on causes of in vitro hemolysis
among healthcare professionals. Biochem Med.
2015;25(3):401–409. doi:10.11613/BM.2015.040.
- Nichols JH, Apple FS. Prevalence of hemolyzed results in
acute care settings. J Appl Lab Med. 2023;8:431-434.
doi:10.1093/jalm/jfac141
- Tóth J, Oláh AV, Petercsák T, et al. Detection of haemolysis, a
frequent preanalytical problem in the serum of newborns and adults.
EJIFCC. 2020;31(1):6
- Khedr S, Blake V, Erdogan E. Neonatal unit hemolysis rates from
an academic medical center: A quality improvement project. Arch
Path Lab. 2016;140(6):502-503.
doi:10.5858/arpa.2015-0252-le
Werfen (www.werfen.com), founded in 1966, is a worldwide
developer, manufacturer and distributor of specialized diagnostic
instruments, related reagents, automation workcells, and data
management solutions for use primarily in hospitals and independent
clinical laboratories. The Company's clinical areas of focus
include Hemostasis, Acute Care, Transfusion, Autoimmunity, and
Transplant. Werfen's Acute Care portfolio includes the new GEM
Premier 7000 with iQM3, the GEM® Premier™ 5000 with
iQM®2, GEM Premier 3500 system with iQM, GEM Premier
ChemSTAT™ system, ROTEM® viscoelastic testing
systems, Hemochron™ systems, VerifyNow™ platelet function testing
system, and Avoximeter™1000 CO-Oximeter, GEMweb® Plus
500 Custom Connectivity and GEMweb Live. The Hemostasis
portfolio includes ACL TOP® Family 50 Series and ACL TOP
Family Hemostasis Testing Systems, ACL AcuStar® system,
ACL Elite® systems, HemoCell™ Specialized Lab
Automation, HemoHub™ Intelligent Data Manager, along with the
comprehensive line of HemosIL® assays.
The Werfen logo is a trademark of Werfen. GEM, Premier, GEM
Premier ChemSTAT, GEMweb, iQM, ChemSTAT, HemosIL, ACL, ACL TOP, ACL
Elite, ACL AcuStar, ReadiPlasTin, RecombiPlasTin, SynthASil,
SynthAFax, ROTEM, Hemochron, VerifyNow and Avoximeter are
trademarks of Instrumentation Laboratory Company, d.b.a Werfen,
and/or one of its subsidiaries or parent companies and may be
registered in the United States
Patent and Trademark Office and in other jurisdictions. All other
product names, company names, marks, logos, and symbols are
trademarks of their respective owners.
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