Analytical characteristics of the Roche highly sensitive troponin T assay and its application to a cardio-healthy
G Koerbin1, J R Tate, P E Hickman
1ACT Pathology, The Canberra Hospital, Woden, ACT 2605, Australia. gus.koerbin@act.gov.au
Insights
The new highly sensitive troponin T (hs-TnT) assay accurately measures cardiac troponin levels, even in healthy individuals. This advancement improves precision for diagnosing myocardial infarction and assessing patient risk.
Area of Science:
- Clinical Chemistry
- Cardiology
- Biomarker Analysis
Background:
- Current cardiac troponin (cTn) assays aim to meet diagnostic criteria for myocardial infarction, requiring a rise and fall above the 99th percentile.
- Evaluating new assays is crucial for accurate diagnosis and risk assessment in patients with suspected heart attack.
Purpose of the Study:
- To assess the analytical performance of a new highly sensitive troponin T (hs-TnT) assay.
- To determine if the hs-TnT assay meets diagnostic specifications using a healthy Australian reference population.
Main Methods:
- Determined the imprecision profile of the Roche hs-TnT assay across multiple analyses.
- Analyzed troponin T distribution in 104 samples from a cardio-healthy Australian population.
Main Results:
- The hs-TnT assay demonstrated a coefficient of variation below 10% at the 99th percentile in the reference population.
- 42% of healthy individuals had detectable troponin T concentrations above the limit of detection.
- Observed variations in troponin T levels based on age and gender.
Conclusions:
- The new hs-TnT assay offers enhanced precision and sensitivity for detecting low troponin concentrations.
- Detectable troponin levels are common in apparently healthy individuals, underscoring the need for clinical judgment.
- The assay supports improved diagnosis and risk stratification for myocardial infarction.
Background:
It is desirable that current assays for cardiac troponin (cTn) are able to meet the recommended criterion that the diagnosis and risk assessment of patients present with symptoms of myocardial infarction requires a rise and fall in cTn with at least one point above the 99th percentile of a reference population. We have evaluated the analytical characteristics of the new highly sensitive troponin T (hs-TnT) assay to see if it meets this criterion and applied it to a carefully defined, cardio-healthy Australian reference population.
Methods:
An imprecision profile was determined for the Roche hs-TnT assay (Roche Diagnostics, Sydney, Australia) using multiple samples analysed on nine separate occasions. The distribution of troponin T was determined using 104 samples from a cardio-healthy population.
Results:
The new hs-TnT assay meets the specifications of a coefficient of variation of 10% at the 99th percentile of our cardio-healthy reference population. Of the 104 samples analysed 44 showed troponin T concentrations above the manufacturer's quoted limit of detection. Age and gender differences in the median and 99th percentile troponin T concentration were observed.
Conclusions:
The new hs-TnT assay shows improved precision and sensitivity at very low troponin concentration. We have shown that a significant number of individuals in this cardio-healthy population had detectable circulating troponin concentration. With many apparently healthy people having detectable troponin, clinical judgement will become more important in interpreting troponin results.
More Related Videos
Related Concept Videos
Blood Studies for Cardiovascular System I: Cardiac Biomarkers
The essential diagnostic tools for detecting myocardial necrosis and monitoring individuals suspected of having acute coronary syndrome (ACS) include:
Troponins
Troponins, particularly cardiac troponins I and T, are the most precise and sensitive markers of myocardial injury. They are detectable within 4-6 hours of myocardial injury and remain...
Acute Coronary Syndrome III: Diagnostic Studies
Blood Studies for Cardiovascular System II: CRP, Hcy, and Cardiac Natriuretic Peptide Markers
These markers indicate stress or strain on the heart muscle:
Natriuretic Peptides (BNP)
Cardiac myocytes produce these hormones in response to ventricular stretching...
Acute Coronary Syndrome I: Introduction
Electrocardiogram
Three major waveforms are present in a typical ECG recording: the P wave, the QRS complex, and the T...


