Click here for a schedule of hs Trop MD Education as of 11.9 (003)

Effective December 7, 2021, Laboratory Alliance will be offering a new 5th Generation High
Sensitivity Troponin I (HsCTNI) assay. The test will be available 24/7 and will be performed on
the new Siemens Atellica platform. It will replace the Troponin I assay (CTNI) currently being
performed on the Siemens Vista platform. This new assay is defined as high sensitivity based on
the criteria set forth by the International Federation of Clinical Chemistry (IFCC) Task Force on
Clinical Applications of Cardiac Bio-Markers:

  • Total imprecision (CV) at the 99th percentile value should be at or below 10%.
  • Measurable concentrations should be attainable at concentrations above the limit of
    detection (LoD) in at least 50% of healthy individuals.

The increased analytical sensitivity of HsCTNI facilitates expedited evaluation and triage of
patients with possible acute coronary syndromes. It allows for the use of accelerated serial
collection times, for example, 0 and 1 hour. A single HsCTNI value of >115 ng/L is highly
suggestive of myocardial ischemia. HsCTNI will have distinct male and female reference ranges,
the results will be in whole numbers and the units will be ng/L instead of the current ng/mL. The
results may not be directly comparable to results from the previous assay.

As with other cardiac biomarkers, HsCTNI values must be evaluated in the context of the
patient’s clinical presentation, risk factors, and EKG. Serial testing is recommended to detect the
temporal rise and or fall of troponin levels characteristic of acute myocardial infarction (AMI). The
demonstration of a rise and or fall in troponin is needed to distinguish AMI from sustained
troponin elevations associated with non-AMI conditions, such as renal failure, arrhythmias,
pulmonary embolism, chronic renal disease, myocarditis, and cardiotoxicity.

The patient report will include the following interpretive comment to help providers assess the
significance of any change (delta) in repeat Troponin results:

When assessing risk for Acute Coronary Syndrome, an initial HsCTNI below the 99th percentile
reference value (females < 34 ng/L and males < 53 ng/L) and a 1-hour delta less than 15 ng/L
should be considered low risk for myocardial injury when evaluated in the context of patient
history, age, risk factors and EKG. A single HsCTNI value of >115 ng/L is highly suggestive of
myocardial ischemia.