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 hp
Sign In
Advertise with Us

Download Mobile App




Analytical Performance Evaluated for Troponin T Gen 5 Assay

By LabMedica International staff writers
Posted on 05 Sep 2019
Increased blood concentrations of cardiac troponin (cTn) I and T are indicative of myocardial injury and are the preferred biomarkers for diagnosing acute myocardial infarction (AMI). More...
The diagnosis of AMI requires a rise and/or fall in serial cTn measurements, in addition to other clinical features.

The introduction of high-sensitivity assays has enabled the rapid detection of subtle changes in cTn and facilitated earlier decision-making in the management of patients with suspected AMI, compared with less sensitive contemporary assays. These newer assays which can measure cTn concentrations 5 to 10 times lower than current assays and do so with improved analytical imprecision.

A team of Medical Scientists collaborating with the University of California San Diego Health (San Diego, CA, USA) analyzed the performance of the Elecsys Troponin T Gen 5 STAT assay. This assay is an electrochemiluminescence sandwich immunoassay, which uses two antibodies to form a sandwich complex with cTnT. A biotinylated monoclonal anti-cTnT-specific antibody and a monoclonal anti-cTnT-specific antibody labeled with ruthenium react to form a sandwich complex. Precision was evaluated per Clinical and Laboratory Standards Institute (CLSI) EP05-A2 using lithium-heparin plasma/quality control samples on Roche cobas e 411/cobas e 601 analyzers.

The scientists reported that the coefficients of variation (CV) for repeatability/intermediate precision were 0.7–5.6%/1.4–10.3% (cobas e 411; mean cardiac troponin T [cTnT]: 7.3–9,341 ng/L) and 0.7–3.0%/1.5–6.4% (cobas e 601; mean cTnT: 7.4–9,455 ng/L). There was no cross-reactivity with skeletal muscle troponin T (≤ 10,000 ng/L), skeletal muscle troponin I (≤ 100,000 ng/L), cardiac troponin I (≤ 10,000 ng/L), or human troponin C (≤ 80,000 ng/L). No interference was observed with biotin (≤ 20 ng/mL) or 34 drugs. The specified limit of blank and limit of detection were 3 ng/L and 5 ng/L, respectively, on the cobas e 411 analyzer, and 2.5 ng/L and 3 ng/L, respectively, on the cobas e 601 analyzer.

The authors concluded that the Elecsys TnT Gen 5 STAT assay demonstrated good analytical performance on cobas e 411 and cobas e 601 analyzers, with a CV of ≤ 10% at the 99th percentile URL. These findings support the routine use of the assay in clinical laboratories in the USA. The study was published in the August 2019 issue of the journal Clinica Chimica Acta.

Related Links:
University of California San Diego Health


New
Gold Member
Cardiovascular Risk Test
Metabolic Syndrome Array I & II
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Clinical Chemistry System
P780
New
ESR Analyzer
TEST1 2.0
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Molecular Diagnostics

view channel
Image: The ONC IN-CYT platform leverages cross indication biomarker cyto-signatures (Photo courtesy of OraLiva)

AI-Powered Cytology Tool Detects Early Signs of Oral Cancer

Each year, 54,000 Americans are diagnosed with oral cancer, yet only 28% of cases are identified at an early stage, when the five-year survival rate exceeds 85%. Most diagnoses occur in later stages, when... Read more

Hematology

view channel
Image: The microfluidic device for passive separation of platelet-rich plasma from whole blood (Photo courtesy of University of the Basque Country)

Portable and Disposable Device Obtains Platelet-Rich Plasma Without Complex Equipment

Platelet-rich plasma (PRP) plays a crucial role in regenerative medicine due to its ability to accelerate healing and repair tissue. However, obtaining PRP traditionally requires expensive centrifugation... Read more

Immunology

view channel
Image: PD-1 protein blockade is the standard treatment for advanced melanoma among the different types of immunotherapy (Photo courtesy of 123RF)

Precision Tool Predicts Immunotherapy Treatment Failure in Melanoma Patients

Melanoma, though accounting for only about 4% of skin tumors, is the deadliest form of skin cancer due to its high potential to metastasize. While immunotherapy, especially PD-1 protein blockade, has revolutionized... Read more

Pathology

view channel
Image: Researchers have developed a novel method to analyze tumor growth rates (Photo courtesy of Adobe Stock)

Novel Method To Analyze Tumor Growth Rates Helps Tracks Progression Between Diagnosis and Surgery

Patients diagnosed with breast cancer often worry about how quickly their tumors grow while they wait for surgery, and whether delays in treatment might allow the disease to spread beyond the point of cure.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.