We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
LGC Clinical Diagnostics

Download Mobile App




New Troponin Assays Receive US Marketing Clearance

By LabMedica International staff writers
Posted on 08 Aug 2018
Print article
Image: The High-Sensitivity Troponin I assay (TnIH) (Photo courtesy of Siemens Healthineers).
Image: The High-Sensitivity Troponin I assay (TnIH) (Photo courtesy of Siemens Healthineers).
Two high precision assays for the measurement of the cardiac marker troponin I (TnIH) have been certified for marketing in the United States.

The detection of a rise and/or fall of cardiac troponin (cTn) plays a key role in the early diagnosis of myocardial infarction (MI). Cardiac troponins are markers of myocardial necrosis, and, because of their high cardiac-specificity, are the preferred biomarker for the diagnosis of MI.

Troponin is a complex of three contractile regulatory proteins, troponin C, T, and I that control the calcium mediated interactions between actin and myosin in cardiac and skeletal muscles. Troponin I and T are specific to cardiac muscles, unlike troponin C which is associated with both cardiac and skeletal muscles. Both troponin I and troponin T are released into circulation at the time of injury following the same release pattern in the system. However, cardiac troponin I is slightly more differentiated from skeletal troponin I than cardiac troponin T is from skeletal troponin T.

Siemens Healthineers (Erlangen, Germany) has announced that two of its high precision troponin assays have been cleared by the [U.S.] Food and Drug Administration. The High-Sensitivity Troponin I assays (TnIH) for Siemens' Atellica (immunoassay and clinical chemistry analyzer) and ADVIA Centaur XP/XPT (immunoassay system) instruments are now available in the United States.

The high-sensitivity performance of the two new TnIH assays enables detection of lower levels of troponin at significantly improved precision at the 99th percentile, and detects smaller changes in a patient’s troponin level during repeated testing.

The High-Sensitivity Troponin I assays from Siemens Healthineers will be highlighted during the 70th AACC Annual Scientific Meeting & Clinical Lab Expo taking place from July 31 to August 2, 2018, in Chicago, IL, USA.

“Our emergency department is overcrowded with patients. If we can do a more efficient job at triaging patients to receive the proper level of care and to discharge the patients who do not need to stay in the emergency department, this will have a tremendous economic advantage for our healthcare system,” said Dr. Alan Wu, chief of clinical chemistry and toxicology at Zuckerberg San Francisco General Hospital and Trauma Center.

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
Complement 3 (C3) Test
GPP-100 C3 Kit
New
Gold Member
Fully Automated Cell Density/Viability Analyzer
BioProfile FAST CDV

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The study showed the blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% (Photo courtesy of Guardant Health)

Blood Test Shows 83% Accuracy for Detecting Colorectal Cancer

Colorectal cancer is the second biggest cause of cancer deaths among adults in the U.S., with forecasts suggesting 53,010 people might die from it in 2024. While fewer older adults are dying from this... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test (Photo courtesy of Hemex Health)

First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy

Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read more

Microbiology

view channel
Image: The new platform is designed to perform blood-based diagnoses of nontuberculosis mycobacteria (Photo courtesy of 123RF)

New Blood Test Cuts Diagnosis Time for Nontuberculous Mycobacteria Infections from Months to Hours

Breathing in nontuberculous mycobacteria (NTM) is a common experience for many people. These bacteria are present in water systems, soil, and dust all over the world and usually don't cause any problems.... Read more

Industry

view channel
Image: These new assays are being developed for use on the recently introduced DxI 9000 Immunoassay Analyzer (Photo courtesy of Beckman Coulter)

Beckman Coulter and Fujirebio Expand Partnership on Neurodegenerative Disease Diagnostics

Beckman Coulter Diagnostics (Brea, CA, USA) and Fujirebio Diagnostics (Tokyo, Japan) have expanded their partnership focused on the development, manufacturing and clinical adoption of neurodegenerative... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.