Access hsTnI (High Sensitivity Troponin I) Assay
Confidently report accurate results with the first true high-sensitivity troponin I assay cleared by the FDA
Access hsTnI is a true high-sensitivity troponin assay that demonstrates <10% CV at the upper reference limits (URL) for men and women and detects troponin in >50% of the healthy population. In an independent study, the assay detected troponin in >99% of healthy men and women.1 Access hsTnI provides reliable test results that your physicians can count on to make faster and more confident decisions about patient management.
This product may not be available in your country or region at this time. Please contact your Beckman Coulter sales representative or distributor for more information.
Benefits of the Access hsTnI High-sensitivity Troponin I Assay
- 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
- 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
- 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
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. The Access hsTnI assay demonstrated a URL of 17.5 pg/mL (ng/L) with a 95% confidence interval (CI) of 12.6–20.7 pg/mL (ng/L) (see Table 1).6
Table 1. 99th Percentile URL of a Healthy Population
| Population |
N |
99th percentile pg/mL (ng/L) (95% CI) |
| 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) |
Access hsTnI provides sex-specific cutoff values.
Assay details
|
|
Serum, plasma‡ 55 µL delivery |
|
|
5.6 pg/mL (ng/L) |
|
|
2.3 pg/mL (ng/L) |
|
|
2.3 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.
Available on These Immunoassay Analyzers
1Pretorius, 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.
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