Access hsTnI (High Sensitivity Troponin I) Assay

High sensitivity and optimal precision supporting early management of acute coronary syndrome

The Access hsTnI assay is a powerful tool for laboratories supporting emergency care, delivering advanced capabilities to aid in the diagnosis and management of acute myocardial infarction (AMI). For use on any of the Access family of immunoassay analyzers, the Access hsTnI assay offers true high-sensitivity performance, minimizes effects of pre-analytical variables and provides optimal precision.

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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

Sample Type/Size	Serum, plasma^‡ 55 µL delivery
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)

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.

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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Brochure 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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Article The Advantages of High-sensitivity Troponin Tests

High-sensitivity troponin assays detect circulating troponin at lower levels and provide improved diagnostic clarity. Find out how these tests support accelerated decision making and improved care for patients with suspected acute coronary syndrome.

*As of January 2018.
^†The use of delta values for rule-in/rule-out protocols has not been approved by the FDA for use in the U.S.
^‡Countries outside the U.S. only; please see IFU plasma specifications for your region.

¹Instructions for use: Beckman Coulter Access hsTnI.
²Instructions for use: Siemens High-Sensitivity Troponin I (TNIH). 11200076_EN Rev. A 2017-03.
³Instructions for use: Abbott STAT High Sensitive Troponin-I. G1-0139/R02, 2013.
⁴Instructions for use: Roche Elecsys Troponin T Gen 5 STAT. 2017-03 V 1.0 English.
⁵Instructions for use: Roche Elecsys Troponin T US.
⁶Clinical Applications of Cardiac Bio-markers. IFCC: International Federation of Clinical Chemistry and Laboratory Medicine, 26 July 2014. Web. 10 Oct 17.

Information addressed to health professionals. The products presented on this site are for professional use only, and, where applicable, comply with the requirements of the IVD Directive 98/79 / EC. Instructions for use must be consulted before using these products.

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Access hsTnI (High Sensitivity Troponin I) Assay

Benefits of the Access hsTnI High-sensitivity Troponin I Assay

Assay details

Sample Type/Size

10% CV LoQ

20% CV LoQ

LoD

hsTnI Toolbox

Guide Access hsTnI Implementation Guide

Webinar Access hsTnI Presentation for Clinicians

Brochure Access hsTnI Scientific Literature

Article The Advantages of High-sensitivity Troponin Tests

Available on These Immunoassay Analyzers

Access 2

DxI 600

DxI 800

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