High-sensitivity Troponin Assay Access hsTnI | Beckman Coulter

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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Overview
Specifications
Documents


A Highly-sensitive Assay

93.3 %
Concordance with PCR Minutes to first results Analyzers
 
25
Minutes to first results
2
Analyzers

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

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)
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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.