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.



A Highly-sensitive Assay

10 %
Demonstrates <10% CV at the upper reference limits (URL) for men and women
50 %
Detects troponin in >50% of the healthy
population
99 %
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
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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

DxI Sample Type/Size

Lithium heparin plasma, serum/55μL

10% CV LoQ

5.6 pg/mL (ng/L)

20% CV LoQ

2.3 pg/mL (ng/L)

LoD

2.3 pg/mL (ng/L)

 

Access 2 Sample Type/Size

Lithium heparin plasma, serum/55μL

10% CV LoQ

4.1 pg/mL (ng/L)

20% CV LoQ

2.0 pg/mL (ng/L)

LoD

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.

hsTnI

Webinar Access hsTnI Presentation for Laboratorians

Provide reliable results that physicians can use with confidence to make decisions about patient management. This webinar provides an overview of the clinical guidelines supporting high sensitivity troponin, clinical benefits and key considerations when transitioning to a high sensitivity troponin assay.

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Medical laboratorian pointing at a tactical diagram for an Access hsTnI implementation guide

Guide Access hsTnI Implementation Guide

Transitioning from contemporary Troponin to High Sensitivity Troponin is a journey. It is important to assess where you are starting as well as your desired destination. Careful planning can help you navigate around potential obstacles, ensuring a successful implementation. This guide has been assembled to serve as a compass, outlining key considerations and insightful guidance from experts in this field.

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Laboratorians interpreting elevated cardiac troponin values on a computer monitor

Webinar Access hsTnI Presentation for Clinicians

A successful implementation of high sensitivity troponin includes collaboration with clinicians. This presentation will share fundamental concepts surrounding high sensitivity troponin and how this new test can accelerate a clinician's ability to rule in or rule out myocardial infarction and provide efficiency improvements in cardiac patient management.

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We offer product training courses and guides to give you the skills and knowledge you need to operate your clinical laboratory instruments.

See all product training courses and guides ›

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.

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Access hsTnI Scientific Literature

Review the latest peer-reviewed analytical and clinical evaluations highlighting the value Access hsTnI can bring to your patients.

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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.