Cardiac Troponinfor Earlier Diagnosis of Myocardial Infarctions

Time is Muscle – Earlier MI Diagnosis with Sensitive 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
Troponin is a complex of three contractile regulatory proteins, troponin C, T and I, that control the calcium mediated interactions between actin and myosin in cardiac and skeletal muscles.

Troponin I and T are specific to cardiac muscles, unlike troponin C which is associated with both cardiac and skeletal muscles.
Troponin C is not used in the diagnosis of myocardial damage.
Both Troponin I and Troponin T are released into circulation at the time of injury following the same release pattern in the system. However, cardiac Troponin I is slightly more differentiated from skeletal Troponin I than cardiac Troponin T is from skeletal Troponin T.

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.

Relatively non-specific markers of myocardial damage, such as creatine kinase (CK), creatine kinase-MB (CK-MB), and myoglobin (MYO), were used in diagnostic laboratories prior to the commercial release of the troponin assays.
Numerous clinical studies on troponin have indicated its superior cardiac specificity in comparison to CK, CK-MB, or MYO.
Troponin levels remain elevated in the blood longer than CK-MB or MYO, providing an extended diagnostic window for MI.

Cardiac Assay Menu

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 System, Dimension® EXL™* and Dimension Vista® Integrated Systems.

Offers improved patient care with a high-sensitivity cardiac troponin assay that meets current guideline recommendations.
Allows you to measure slight, yet critical, changes between serial troponin I values, giving you confidence in patient results at the low end of the assay range.
Delivers reliable results from proven, trusted technology coupled with three new monoclonal antibodies.

Compared to traditional troponin assays, the Siemens Healthineers Atellica IM, ADVIA Centaur, Dimension EXL and Dimension Vista TNIH 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 at the low end of the assay range by delivering precision that provides the ability to measure slight, yet critical, changes between serial troponin I values.

Precision at the low end 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 Cardiac Troponin I Assay

Sample Type	Serum, lithium heparin plasma
Sample Volume	100 µL
Assay Range	2.51 - 25,000.00 pg/mL
Time to First Result	10 minutes
On-board Stability	31 days
Calibration Interval	47 days
LoB	0.58 pg/mL
LoD	1.27 pg/mL
LoQ	2.51 pg/mL

ADVIA Centaur High-Sensitivity Cardiac Troponin I Assay

Sample Type	Human serum, 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	14 days
LoB	0.90 pg/mL (ng/L)
LoD	2.21 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) 0.25 MB

Dimension EXL High-Sensitivity Cardiac Troponin I Assay*

Sample Type	Human serum, 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 Cardiac Troponin I Assay

Sample Type	Human serum, 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.

ǂGuideline-acceptable

1. 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

Download white paper:

High-Sensitivity Troponin Testing in Accordance with the 2018 Fourth Universal Definition of Myocardial Infarction

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 sensitive 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 assays (hs-assays) should measure cTn > limit of detection (LoD) in ≥ 50% of the healthy subjects used to determine the 99th percentile
Results reported in ng/L or pg/mL instead of µg/L (gives whole number values instead of decimals for easier interpretation)

IFCC Task Force on Clinical Applications of Cardiac Biomarkers

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