Cardiac Troponinfor Earlier Diagnosis of Myocardial Infarctions

Time is Muscle – Earlier MI Diagnosis with High-sensitivity Troponin Assays
The detection of a rise and/or fall of cardiac troponin (cTn) plays a key role in the earlier diagnosis of myocardial infarction (MI). Cardiac troponins are markers of myocardial necrosis, and, because of their high cardiac-specificity, are the preferred biomarker for the diagnosis of MI.

Reliable Answers for Critical Needs
As a recognized worldwide leader in CVD testing, Siemens Healthineers High-Sensitivity Troponin I assays provide the clinical sensitivity and precision needed for earlier detection of necrosis and MI versus less-precise assays.

Troponin

Preferred Biomarker of Cardiac Injury

Cardiac troponins are released into circulation in response to myocardial necrosis. As such, cardiac troponins are the preferred biomarkers for the detection of cardiac injury, and have long assisted physicians in improving diagnostic strategies for the effective management of patients with chest pain.

High-Sensitivity Troponin I

High-Sensitivity Troponin I is the latest addition to Siemens Healthineers’ comprehensive cardiac menu to assist clinicians with the diagnosis and treatment of chest pain patients. Designed to aid in diagnosing acute myocardial infarctions (AMI) through the quantitative measurement of cardiac troponin I in serum or plasma, high-sensitivity troponin plays a critical role in the timely diagnosis of AMI, or heart attacks.

High-sensitivity Troponin I is now available on the Atellica® IM Analyzer, ADVIA Centaur® Immunoassay Systems, Dimension® EXL™ and Dimension Vista® Integrated Systems.

Siemens Healthineers offers proven, true high-sensitivity cardiac troponin I assays with fast, accurate, and actionable test results:

Demonstrates clinical proof that the Siemens Healthineers' are true high-sensitivity troponin I assays according to the IFCC guidelines.¹
Offers fast, accurate, and actionable results to leverage faster protocols
Provides confidence in results due to minimal assay interferences

Compared to traditional troponin assays, the Siemens Healthineers Atellica IM, ADVIA Centaur, Dimension EXL and Dimension Vista high-sensitivity troponin I assays are able to detect lower levels of troponin and smaller changes to a patient’s troponin levels, which may be an early indication of AMI. This design affords clinicians greater confidence in patient results below the 99th percentile by delivering precision that provides the ability to measure slight, yet critical, changes between serial troponin I values.

Precision between the limit of quantification and the 99th percentile is important to minimize analytic variation that could confuse a clinician’s assessment of a clinically significant change. With this data in hand, clinicians have the ability to more quickly diagnose and treat patients with suspected AMI, in some cases in as little as one to three hours.

Assay Specifications

Atellica IM High-Sensitivity Troponin I Assay

Sample Type	Serum, lithium heparin plasma
Sample Volume	100 µL
Assay Range	2.50 - 25,000.00 pg/mL (ng/L)
Time to First Result	10 minutes
On-board Stability	28 days
Calibration Interval	47 days
LoB	0.50 pg/mL (ng/L)
LoD	1.60 pg/mL (ng/L)
LoQ	2.50 pg/mL (ng/L)

Download white paper showing performance data of the Atellica IM High-Sensitivity Troponin I Assay (pdf) 0.17 MB

ADVIA Centaur High-Sensitivity Troponin I Assay

Sample Type	Plasma (lithium heparin)
Sample Volume	100 µL
Assay Range	2.50 – 25,000.00 pg/mL (ng/L)
Time to First Result	XP/XPT: 18 minutes
Throughput	Up to 240 tests/hour
On-board Stability	28 days
Calibration Interval	28 days
LoB	0.50 pg/mL (ng/L)
LoD	1.60 pg/mL (ng/L)
LoQ (20% CV)	2.50 pg/mL (ng/L)
LoQ (10% CV)	4.50 pg/mL (ng/L)
99th Percentile	47.34 ng/L (pg/mL)

Download white paper showing performance data of the ADVIA Centaur High-Sensitivity Troponin I Assay. (pdf) 0.29 MB

Dimension EXL High-Sensitivity Troponin I Assay

Sample Type	Plasma (lithium heparin)
Sample Volume	10 µL
Assay Range	4.0 - 25,000.00 pg/mL (ng/L)
Time to First Result	10 minutes
Throughput	Up to 200 tests/hour
On-board Stability	7 days open well 30 days onboard unpunctured
LoB	1.1 pg/mL (ng/L)
LoD	2.7 pg/mL (ng/L)
LoQ (20% CV)	4.0 pg/mL (ng/L)
LoQ (10% CV)	12.0 pg/mL (ng/L)
99th percentile (n = 2010)	Combined: 60.4 pg/mL (ng/L)^† Male: 76.2 pg/mL (ng/L) Female: 51.4 pg/mL (ng/L)

†99th percentile value determined using combined gender data and lithium heparin sample type.

Dimension Vista High-Sensitivity Troponin I Assay

Sample Type	Plasma (lithium heparin)
Sample Volume	10 µL
Assay Range	3.0 - 25,000.00 pg/mL (ng/L)
Time to First Result	10 minutes
Throughput	Up to 200 tests/hour
On-board Stability	7 days open well 30 days onboard unpunctured
LoB	1.0 pg/mL (ng/L)
LoD	2.0 pg/mL (ng/L)
LoQ (20% CV)	3.0 pg/mL (ng/L)
LoQ (10% CV)	10.0 pg/mL (ng/L)
99th percentile (n = 2010)	Combined: 58.9 pg/mL (ng/L)^† Male: 78.5 pg/mL (ng/L) Female: 53.7 pg/mL (ng/L)

†99th percentile value determined using combined gender data and lithium heparin sample type.

Cardiac Menu

	Atellica® Solution	ADVIA Centaur® Systems	Dimension® EXL™ Systems	Dimension Vista® Systems	IMMULITE® Systems	Stratus® CS Systems
BNP	√	√		√
CKMB Mass	√	√	√	√	√	√
CKMB Isoenzyme			√	√
D-Dimer					√	√
High-Sensitivity CRP			√	√	√	√
High-Sensitivity Troponin I	√	√¹	√	√
Myoglobin	√	√	√	√	√	√
NT-proBNP	√*	√*	√	√		√
Troponin I			√^ǂ	√^ǂ	√	√^ǂ

* Not available for sale in the U.S.
ǂ Contemporary sensitive assay.
Available on the ADVIA Centaur XP and XPT Systems only

The products featured here may not be commercially available in all countries. Due to regulatory restrictions, their future availability cannot be guaranteed. Please contact your local Siemens Healthineers representative for further details.

Clinical Guidelines

4th Universal Definition of Myocardial Infarction

The 2018 Fourth Universal Definition of MI (ESC/ACC/AHA/WHF Expert Consensus Document) elaborates on the use of hs-cTn assays for differentiating myocardial injury due to ischemic MI and myocardial injury due to nonischemic conditions, both of which can cause elevated cTn concentrations.¹

Fourth Universal Definition of Myocardial Infarction Guidelines

AHA/ACC Guidelines - Cardiac Troponin Highlights

99th percentile for cardiac troponin is appropriate cutoff for considering myocardial necrosis
For contemporary assays, serial cardiac troponin levels should be measured at presentation and 3 to 6 hours after symptom onset in all patients who present with chest pain symptoms. This identifies a rising and/or falling pattern
In evaluating serial changes, absolute changes appear to have a significantly higher diagnostic accuracy for AMI than relative changes

http://circ.ahajournals.org/content/130/25/e344

ESC Guidelines for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-segment Elevation

The 99th percentile for cTn is the single decision limit for both AMI and risk in patients presenting with symptoms of cardiac ischemia (either cTnI or cTnT can be used)
Labs may establish a decision limit for each biomarker based on a normal, healthy population with no evidence of heart disease or use the manufacturer’s established value.
Imprecision (CV) at the 99th percentile decision point should be ≤ 10%
Small myocardial injury can be detected using high-sensitivity assay or imaging
Rising or falling kinetics helps discriminate acute from chronic illness

European Heart Journal (2016) 37, 267-315

https://academic.oup.com/eurheartj/article/37/3/267/2466099

IFCC Task Force Recommendations

Supports 99th Percentile

99th percentile cut-off universally endorsed
Determined in a healthy population
Derived from peer-reviewed literature, or manufacturer
Analytical precision should be ≤ 10% CV

Defines High-Sensitivity Troponin

High-sensitivity refers to the assay's performance characteristics, not a difference in the form of cardiac troponin being measured

%CV at the 99th percentile should be ≤10%¹
Measureable concentrations below the 99th percentile should be attainable with a concentration above the assay's LoD for at least 50% of healthy individuals¹
The guidelines have been extended on this second point by requiring both men and women individually attain measurable concentrations, with at least 50% measurable concentrations above the assay's LoD.²

_{1) Apple F., Sandoval Y., Jaffe A., and Ordonez-Llanos J. Cardiac Troponin Assays: Guide to Understanding Analytical Characteristics and Their Impact on Clinical Care. Report of the IFCC Task Force on Clinical Applications of Cardiac Biomarkers. Clinical Chemistry 63:01 (2016) ; Not available for sale in the U.S. Product availability varies by country}

_{2) Alan H.B. Wu, Clinical Chemistry 64:4 645 -655 (2018)}

IFCC Task Force on Clinical Applications of Cardiac Biomarkers

Download White Paper

Services & Support

Education & Training

Did this information help you?

* Not available for sale in the U.S.

§ Defined by the ESC/ACC committee as an imprecision level of ≤10% at the 99th percentile of normal.

1. Thygesen K, Alpert JS, Jaffe AS, et al. Fourth universal definition of myocardial infarction (2018). J Am Coll Cardiol. 2018.

Additional sources:

Boeddinghaus J, et al. Clin Chem. 2018;64:1347-1360. (APACE)

Chapman AR, et al. Heart 2018;0:1 -7. doi:10.1136/heartjnl-2018-314093. (High STEACS)

Nowak R, et al.: Results From the HIGH-US Study, https://doi.org/10.1016/j.annemergmed.2019.12.008. (HIGH US)