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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 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. (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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