Clinical Diagnostic Products and Solutions / Immunoassay / Access hsTnI
hsTnI Assay

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.

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Benefits of Access hsTnI

  • Provide results with the highest diagnostic accuracy of any hsTnI assay currently commercially available*,1–5
    • Trust that myocardial damage will not be missed with the best sensitivity profile available: 97% at 1–3 hours after patient presentation
    • Triage patients faster than with traditional troponin assays. This may offer significant benefits to emergency departments in terms of efficiency and patient outcomes6
  • Experience high-sensitivity performance for the advanced management of AMI
    • Deliver results with confidence with an assay that meets the most current international guidelines for high sensitivity6
      • Ensure optimal precision with <10% CV at the 99th-percentile upper reference limit (URL)
      • Gain reliability of low-end results with the ability to measure cardiac troponin values above the LoD in >50% of a healthy population
    • Detect circulating troponin earlier in the progression of acute myocardial injury with an improved low-end measuring range, with an observed LoD at 2.3 pg/mL (ng/L)
  • Minimize the effect of pre-analytical sample variability and known interferences and reduce false positives
  • Implement the latest guideline recommendations with delta values (which may aid in establishing early rule-in/rule-out protocols)† and sex-specific 99th-percentile URL values

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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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.

Read more

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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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