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


Gold Member
Antipsychotic TDM Assays
Saladax Antipsychotic Assays
POC Helicobacter Pylori Test Kit
Hepy Urease Test
New
ESR Analyzer
TEST1 2.0
New
Autoimmune Disease Diagnostic
Chorus ds-DNA-G
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

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Immunology

view channel
Image: The test could streamline clinical decision-making by identifying ideal candidates for immunotherapy upfront (Xiao, Y. et al. Cancer Biology & Medicine July 2025, 20250038)

Blood Test Predicts Immunotherapy Efficacy in Triple-Negative Breast Cancer

Triple-negative breast cancer (TNBC) is an aggressive subtype lacking targeted therapies, making immunotherapy a promising yet unpredictable option. Current biomarkers such as PD-L1 expression or tumor... Read more

Microbiology

view channel
Image: New diagnostics could predict a woman’s risk of a common sexually transmitted infection (Photo courtesy of 123RF)

New Markers Could Predict Risk of Severe Chlamydia Infection

Chlamydia trachomatis is a common sexually transmitted infection that can cause pelvic inflammatory disease, infertility, and other reproductive complications when it spreads to the upper genital tract.... Read more

Technology

view channel
Image: The sensor can help diagnose diabetes and prediabetes on-site in a few minutes using just a breath sample (Photo courtesy of Larry Cheng/Penn State)

Graphene-Based Sensor Uses Breath Sample to Identify Diabetes and Prediabetes in Minutes

About 37 million U.S. adults live with diabetes, and one in five is unaware of their condition. Diagnosing diabetes often requires blood draws or lab visits, which are costly and inconvenient.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.