Troponin

troponin green image
troponin green image
troponin green image

Value of high-sensitivity troponin assays1,2

Clinical

  • Can enable faster decisions on discharge and admission
  • May improve diagnosis of MI in women
  • Aids in faster, more accurate diagnosis of MI

Analytical

  • Improved precision
  • Improved sensitivity

Financial

  • Can minimize unnecessary procedures and tests
  • May reduce costs, length of stay, admissions rates and overnight stays
Challenge

The burden of heart disease and mi

 

6 - 8m

6-8 million people present to US Emergency Departments every year with suspected Myocardial Infarction (MI).3

 

 

 

8-15%

Only 8-15% are having an MI so, in theory, the majority could be discharged.4

Rapidly diagnosing and triaging chest pain patients

Emergency departments continually face the challenge of rapidly diagnosing and triaging patients with chest pain.5

Biomarkers can help clarify the clinical picture. Timely action on cardiac laboratory results is critical and may improve patient outcomes.6

 

 

Abbott’s high-sensitivity troponin I meets ifcc criteria

Ifcc definition of hs-ctn assay7

For an assay to be considered a high-sensitivity troponin assay, the following criteria should be met:

  1. Total imprecision at the 99th percentile value should be <10% CV.
  2. Measurable concentrations below the 99th percentile should be attainable with an assay at a concentration value above the assay’s limit of detection (LoD) for at least 50% of healthy men and women.

 

 Alinity i hstni_STAT8ARCHITECT hsTnI_STAT9  
 99th percentile CV at medical decision points% of peope detected at ≥LoD10  99th percentile CV at medical decision points% of peope detected at ≥LoD10 
 Female14 ng/L 2.7% at 13.9 ng/L 63.4%17 ng/L  5.0%  54.12%
 Male35 ng/L 2.0% at 36.9 ng/L 87.3%35ng/L  4.1%  77.42%
 Overall27 ng/L 3.3% at 20.3 ng/L 75.3%28 ng/L  4.3%  65.77%

 

 

Percent healthy individuals detected by troponin assays

>50% OF HEALTHY MALES AND FEMALES HAVE DETECTABLE VALUES (ABOVE THE LoD)

% measurable values > lod

Adapted from Apple FS, et al. Clin Chem 58(11):1574-1581

For In Vitro Diagnostic Use

Intended use

The Alinity i and ARCHITECT STAT High-Sensitivity Troponin-I assays are chemiluminescent microparticle immunoassays (CMIA) used for the quantitative determination of cardiac troponin I (cTnI) in human plasma (lithium heparin on Alinity i or dipotassium {K2} edta on ARCHITECT) on the Alinity i and ARCHITECT systems.

The Alinity i and ARCHITECT STAT High Sensitivity Troponin-I assays are to be used as an aid in the diagnosis of myocardial infarction (MI).


Aha/acc clinical guidelines11

“high-sensitivity cTn is preferred because it allows rapid detection of myocardial injury and has increased diagnostic accuracy”

 

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References
  1. Jülicher, P., Greenslade, J.H., Parsonage, W.A., et al. The organisational value of diagnostic strategies using high-sensitivity troponin for patients with possible acute coronary syndromes: a trial-based cost-effectiveness analysis. BMJ Open 2017;7:e013653. doi:10.1136/ bmjopen-2016-013653.
  2. Shah, A., et. al. High sensitivity cardiac troponin and the under-diagnosis of myocardial infarction in women: prospective cohort study. BMJ 2015;350:g7873 doi: 10.1136/bmj.g7873.
  3. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Benjamin EJ, et al. Circulation. 2019 Mar 5;139(10):e56-e528.  Sandoval et al, AJC 2017.
  4. Sandoval, Y., et. al. Rapid rule-out of acute myocardial injury using a single high-sensitivity cardiac troponin I measurement. Clinical Chemistry 2017;63:1:369-376
  5. The utility of troponin measurement to detect myocardial infarction: review of the current findings; Vascular Health and Risk Management 2010:6 691–699.
  6. The Challenge of Triaging Chest Pain Patients: The Bernese University Hospital Experience; Emergency Medicine International Volume 2012, Article ID 975614, 7 pages doi:10.1155/2012/975614.
  7. 2018 IFCC AACC HsTn Recommendations Wu Clin Chem.
  8. Alinity i High-Sensitivity Troponin-I Package Insert: H14937R01.
  9. ARCHITECT STAT High-Sensitivity Troponin-I H03755/R01.
  10. Data on file at Abbott.
  11. 2021 AHA ACC Clinical Practice Guidelines.

 

 
Important safety information
 

Instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions.

For laboratory professional use only.

•  For In Vitro Diagnostic Use

•  Rx Only (For use by or on the order of a physician only)

This product contains human-sourced and/or potentially infectious components. It is recommended that these reagents and human specimens be handled in accordance with the OSHA Standard on Bloodborne Pathogens.