Access hsTnI (High Sensitivity Troponin I Assay)
The first true high-sensitivity troponin I assay cleared by the FDA
Confidently report accurate test results with Access hsTnI – quality results, optimal precision, easy interpretation. Plus, it provides sex-specific upper reference limits to enable more accurate identification of women with AMI.
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High-sensitivity Troponin Tests
High-sensitivity troponin tests support accelerated decision making and improved care for patients with suspected acute coronary syndrome. Find out how.
Demonstrates <10% CV at the upper
reference limits (URL) for men and women
Detects troponin in >50% of the healthy
population
Detected troponin in >99% of healthy men
and women in an independent studyi
High-quality
- Delivers quality results with a new robust design to minimize the effects of pre-analytical variability and known interferences
- Demonstrates optimal precision at concentrations ~10x lower than previous generations of assays
Accurate
- Accurately identifies ≥94% of true acute myocardial infarction (AMI) patients in as little as one hour after presentation
- Enables more accurate identification of women with AMI by providing separate sex-specific upper reference limits
- Provides >99% confidence in ruling out AMI when a patient’s troponin result is below the URL
Timely
- Enables easier interpretation of test results by using whole-number reporting
- Increases testing flexibility as the only high-sensitivity assay to use either plasma or serum samples
Access hsTnI delivers tangible advances in patient care
A multicenter prospective study to establish the 99th percentile URL in a population of healthy adults was conducted. Study participants had no known cardiovascular diseases, other acute or chronic diseases, or infections. (See Tables 1 and 2.)
Table 1. 99th Percentile URL of a Healthy Population: UniCel DxI
Sample Type |
Population |
N |
99th percentile pg/mL (ng/L) |
95% CI pg/mL (ng/L) |
Lithium heparin plasma |
Females |
593 |
14.9 |
10.1–27.1 |
Males |
495 |
19.8 |
15.9–38.4 |
Overall |
1,088 |
17.9 |
14.7–27.1 |
Serum |
Females |
592 |
13.6 |
10.0–25.6 |
Males |
493 |
19.8
|
15.4–44.8 |
Overall |
1,085 |
18.1 |
14.3–25.6 |
Table 2. 99th Percentile URL of a Healthy Population: Access 2
Sample Type |
Population |
N |
99th percentile pg/mL (ng/L) |
95% CI pg/mL (ng/L) |
Lithium heparin plasma |
Females |
595 |
11.6 |
8.4–18.3 |
Males |
494 |
19.8 |
14.0–42.9 |
Overall |
1,089 |
17.5 |
12.6–20.7 |
Serum |
Females |
595 |
11.8 |
8.7–18.7 |
Males |
493 |
19.7
|
14.3–44.3 |
Overall |
1,088 |
18.2 |
13.1–23.1
|
Access hsTnI provides sex-specific cutoff values.
Assay details
|
Lithium heparin plasma, serum/55μL
|
|
5.6 pg/mL (ng/L) |
|
2.3 pg/mL (ng/L) |
|
2.3 pg/mL (ng/L) |
|
Lithium heparin plasma, serum/55μL
|
|
4.1 pg/mL (ng/L) |
|
2.0 pg/mL (ng/L) |
|
2.0 pg/mL (ng/L) |
hsTnI Toolbox
Adoption of high-sensitivity troponin assays that meet International Federation of Clinical Chemistry and Laboratory Medicine guidelines is recommended by the recently released Fourth Universal Definition of Myocardial Infarction. These assays have higher analytical precision at lower concentrations, yielding greater clinical sensitivity for myocardial injury, including new insights into troponin levels in women thanks to sex-specific reference ranges. The assays also support shorter interval serial measurement strategies for managing patients with possible acute myocardial infarction in the emergency department.
Many stakeholders in the healthcare system are impacted by these insights, including laboratorians, nurses, cardiologists and emergency medicine physicians. Understanding and addressing the unique concerns of all stakeholder groups is key to the implementation of these new assays. The hsTnI Toolbox is a curated set of customer self-service tools to aid in the implementation of the Access hsTnI assay.
Acute MI Detection with a High-sensitivity Cardiac Troponin Assay
Overburdened EDs must triage patients quickly. See how next-generation troponin assays streamline care for a vast number of patients presenting with chest pain.
Access hsTnI Scientific Literature
Review the latest peer-reviewed analytical and clinical evaluations highlighting the value Access hsTnI can bring to your patients.
High-sensitivity Troponin I: Opportunities in Emergency Care
Learn how high-sensitivity troponin I delivers fast and accurate results. When used in conjunction with TIMI risk scores, troponin assays may enable early definitive care and disposition of most ED patients with possible ACS.
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References:
iPretorius, C.J., et. al. “A critical evaluation of the Beckman Coulter Access hsTnI: Analytical performance, reference interval and concordance.” Clinical Biochemistry, vol. 55, 2018 May, pp. 49–55. https://doi.org/10.1016/j.clinbiochem.2018.03.003. Accessed 22 June 2018.