ms_05092744190V6.

Troponin T hs
Troponin T hs (high sensitive)

Elecsys 2010
MODULAR ANALYTICS E170
05092744 190 200 cobas e 411
cobas e 601
cobas e 602

English The Troponin T hs calibrators (Troponin T hs CalSet) contain recombinant

human cardiac troponin T (rec. hcTnT). The rec. hcTnT is isolated from cell
Intended use culture of E. coli BL21 containing a pET vector with human cardiac
Immunoassay for the in vitro quantitative determination of cardiac troponin T isoform 3 gene. After fermentation, the cells are disrupted by
troponin T in human serum and plasma. This assay can be used as an aid sonication and rec. hcTnT is purified by ion exchange chromatography.
in the differential diagnosis of acute coronary syndrome to identify necrosis, Purified rec. hcTnT is further characterized by SDS PAGE, Western
e.g. acute myocardial infarction. The test is further indicated for the risk blotting, immunological activity, and protein content.42
stratification of patients presenting with acute coronary syndrome and for
cardiac risk in patients with chronic renal failure. The test may also be Test principle
useful for the selection of more intensive therapy and intervention in Sandwich principle. Total duration of assay: 18 minutes.
patients with elevated levels of cardiac troponin T.
▪ 1st incubation: 50 µL of sample, a biotinylated monoclonal cardiac
The electrochemiluminescence immunoassay “ECLIA” is intended for use troponin T‑specific antibody, and a monoclonal cardiac
on Elecsys and cobas e immunoassay analyzers. troponin T‑specific antibody labeled with a ruthenium complexa) react to
Summary form a sandwich complex.
Troponin T (TnT) is a component of the contractile apparatus of the striated ▪ 2nd incubation: After addition of streptavidin-coated microparticles, the
musculature. Although the function of TnT is the same in all striated complex becomes bound to the solid phase via interaction of biotin and
muscles, TnT originating exclusively from the myocardium (cardiac TnT, streptavidin.
molecular weight 39.7 kD) clearly differs from skeletal muscle TnT. As a ▪ The reaction mixture is aspirated into the measuring cell where the
result of its high tissue‑specificity, cardiac troponin T (cTnT) is a microparticles are magnetically captured onto the surface of the
cardio‑specific, highly sensitive marker for myocardial damage.1 Cardiac electrode. Unbound substances are then removed with
troponin T increases approximately 3‑4 hours after myocardial infarction ProCell/ProCell M. Application of a voltage to the electrode then induces
(AMI) and may persist up to 2 weeks thereafter.2,3 In contrast to chemiluminescent emission which is measured by a photomultiplier.
ST‑elevation myocardial infarction (STEMI), the diagnosis of non‑ST
elevation myocardial infarction (NSTEMI) heavily relies on cardiac troponin ▪ Results are determined via a calibration curve which is instrument-
result. According to the new universal definition of myocardial infarction, MI specifically generated by 2‑point calibration and a master curve provided
is diagnosed when blood levels of cardiac troponin are above the 99th via the reagent barcode.
percentile of the reference limit (of a healthy population) together with a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
evidence of myocardial ischemia (symptoms, ECG changes or imaging Reagents - working solutions
results). The definition requires a troponin assay with an imprecision
(coefficient of variation) at the 99th percentile less than or equal to 10 %.4 The reagent rackpack is labeled as TNT‑HS.
Cardiac troponin T (cTnT) is an independent prognostic marker which can M Streptavidin-coated microparticles (transparent cap), 1 bottle, 12 mL:
predict the near-, mid- and even long‑term outcome of patients with acute
coronary syndrome (ACS).5,6,7,8,9 Streptavidin-coated microparticles 0.72 mg/mL; preservative.
In addition, 4 multicenter trials involving more than 7000 patients have R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 14 mL:
shown that cardiac troponin T is also useful to identify patients that benefit
from anti‑thrombotic therapy (GPIIb/IIIa inhibitors, low molecular weight Biotinylated monoclonal anti-cardiac troponin T-antibody (mouse)
heparin).10,11,12,13,14 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0; preservative;
Cardiac troponin is also the preferred marker of myocardial injury in the new inhibitors.
guidelines for the diagnosis and treatment of non‑ST‑segment elevation R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 14 mL:
acute coronary syndromes.15,16
Low concentrations of troponin T can be detected in clinically stable Monoclonal anti-cardiac troponin T-antibody (mouse) labeled with
patients such as patients with ischemic or non‑ischemic heart failure,17,18,19, ruthenium complex 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0;
20 patients with different forms of cardiomyopathy,21 renal failure,22,23,24,25,26,
preservative.
27,28 sepsis29 and diabetes.30

Elevated levels of troponin T correlate with the severity of coronary artery Precautions and warnings
disease and to poor outcome independent of natriuretic peptide (BNP or For in vitro diagnostic use.
NT‑proBNP) levels.17,18,31,32 Exercise the normal precautions required for handling all laboratory
Low concentrations of troponin T are an independent predictor of reagents.
cardiovascular events including occurrence and recurrence of atrial Disposal of all waste material should be in accordance with local guidelines.
fibrillation.33 Safety data sheet available for professional user on request.
Myocardial cell injury leading to elevated cTnT concentrations in the blood Avoid foam formation in all reagents and sample types (specimens,
can also occur in other clinical conditions such as myocarditis,34 heart calibrators and controls).
contusion,35 pulmonary embolism36 and drug‑induced cardiotoxicity.37 Reagent handling
Other diagnostic tests such as myoglobin, CK‑MB, NT‑proBNP, PlGF and The reagents in the kit have been assembled into a ready‑for‑use unit that
CRP can complement the diagnostic and prognostic information of cannot be separated.
troponin T in different indications.31,38,39 All information required for correct operation is read in from the respective
The Elecsys Troponin T hs assay employs two monoclonal antibodies reagent barcodes.
specifically directed against human cardiac troponin T.40,41 The antibodies
recognize two epitopes (amino acid position 125‑131 and 136‑147) located Storage and stability
in the central part of the cardiac troponin T protein, which consists of Store at 2‑8 °C.
288 amino acids. Do not freeze.

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Troponin T hs
Troponin T hs (high sensitive)

Store the Elecsys reagent kit upright in order to ensure complete Accessories for all analyzers:
availability of the microparticles during automatic mixing prior to use.
▪  11298500316, Elecsys SysClean, 5 x 100 mL system cleaning
Stability: solution
unopened at 2‑8 °C up to the stated expiration date Assay
For optimum performance of the assay follow the directions given in this
after opening at 2‑8 °C 12 weeks document for the analyzer concerned. Refer to the appropriate operator’s
on the analyzers 4 weeks manual for analyzer‑specific assay instructions.
Resuspension of the microparticles takes place automatically prior to use.
Specimen collection and preparation Read in the test‑specific parameters via the reagent barcode. If in
Only the specimens listed below were tested and found acceptable. exceptional cases the barcode cannot be read, enter the 15‑digit sequence
Serum collected using standard sampling tubes or tubes containing of numbers.
separating gel. MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers:
K2‑EDTA, K3‑EDTA, Li‑heparin and Na‑heparin plasma. PreClean M solution is necessary.
Plasma (EDTA, heparin) and serum samples should not be used Bring the cooled reagents to approx. 20 °C and place on the reagent disk
interchangeably. (20 °C) of the analyzer. Avoid foam formation. The system automatically
regulates the temperature of the reagents and the opening/closing of the
Criterion: Slope 0.8‑1.2 + coefficient of correlation ≥ 0.95. bottles.
Stable for 24 hours at 2‑8 °C, 12 months at ‑20 °C. Freeze only once. Calibration
The sample types listed were tested with a selection of sample collection Traceability: The Troponin T hs assay (  05092744) has been
tubes that were commercially available at the time of testing, i.e. not all standardized against the Troponin T hs STAT assay (  05092728). This
available tubes of all manufacturers were tested. Sample collection systems in turn was originally standardized against the Enzymun‑Test Troponin T
from various manufacturers may contain differing materials which could (CARDIAC T) method.
affect the test results in some cases. When processing samples in primary
tubes (sample collection systems), follow the instructions of the tube Every Elecsys reagent set has a barcoded label containing specific
manufacturer. information for calibration of the particular reagent lot. The predefined
master curve is adapted to the analyzer using the relevant CalSet.
Centrifuge samples containing precipitates before performing the assay.
Calibration frequency: Calibration must be performed once per reagent lot
Do not use samples and controls stabilized with azide. using fresh reagent (i.e. not more than 24 hours since the reagent kit was
Ensure the samples, calibrators and controls are at 20‑25 °C prior to registered on the analyzer). Renewed calibration is recommended as
measurement. follows:
Due to possible evaporation effects, samples, calibrators and controls on ▪ after 1 month (28 days) when using the same reagent lot
the analyzers should be analyzed/measured within 2 hours.
▪ after 7 days (when using the same reagent kit on the analyzer)
Materials provided
▪ as required: e.g. quality control findings outside the defined limits
See “Reagents – working solutions” section for reagents.
Quality control
Materials required (but not provided) For quality control, use PreciControl Troponin.
▪  05092752190, Troponin T hs CalSet, for 4 x 1 mL In addition, other suitable control material can be used.
▪  05095107190, PreciControl Troponin, for 2 x 2 mL each of Controls for the various concentration ranges should be run individually at
PreciControl Troponin 1 and 2 least once every 24 hours when the test is in use, once per reagent kit, and
▪  03609987190, Diluent MultiAssay, 2 x 16 mL sample diluent following each calibration.
▪ General laboratory equipment The control intervals and limits should be adapted to each laboratory’s
individual requirements. Values obtained should fall within the defined
▪ Elecsys 2010, MODULAR ANALYTICS E170 or cobas e analyzer limits. Each laboratory should establish corrective measures to be taken if
Accessories for Elecsys 2010 and cobas e 411 analyzers: values fall outside the defined limits.
▪  11662988122, ProCell, 6 x 380 mL system buffer Follow the applicable government regulations and local guidelines for
quality control.
▪  11662970122, CleanCell, 6 x 380 mL measuring cell cleaning
solution Calculation
▪  11930346122, Elecsys SysWash, 1 x 500 mL washwater additive The analyzer automatically calculates the analyte concentration of each
sample either in pg/mL, ng/L, ng/mL, μg/L (MODULAR ANALYTICS E170,
▪  11933159001, Adapter for SysClean cobas e 601 and cobas e 602 analyzers) or in pg/mL, ng/mL, μg/L
▪  11706802001, Elecsys 2010 AssayCup, 60 x 60 reaction vessels (Elecsys 2010 and cobas e 411 analyzers).
▪  11706799001, Elecsys 2010 AssayTip, 30 x 120 pipette tips Limitations - interference
Accessories for MODULAR ANALYTICS E170, cobas e 601 and The assay is unaffected by icterus (bilirubin < 428 µmol/L or < 25 mg/dL),
cobas e 602 analyzers: hemolysis (Hb < 0.062 mmol/L or < 0.1 g/dL; samples showing visible signs
of hemolysis may cause interference), lipemia (Intralipid < 1500 mg/dL) and
▪  04880340190, ProCell M, 2 x 2 L system buffer biotin (< 82 nmol/L or < 20 ng/mL).
▪  04880293190, CleanCell M, 2 x 2 L measuring cell cleaning Falsely depressed results are obtained when using samples with
solution hemoglobin concentrations > 0.1 g/dL.
▪  03023141001, PC/CC‑Cups, 12 cups to prewarm ProCell M and Criterion: Recovery within ± 20 % of initial value at troponin T
CleanCell M before use concentrations < 100 ng/L or pg/mL (± 10 % at troponin T concentrations
▪  03005712190, ProbeWash M, 12 x 70 mL cleaning solution for run ≥ 100 ng/L or pg/mL).
finalization and rinsing during reagent change Samples should not be taken from patients receiving therapy with high
▪  03004899190, PreClean M, 5 x 600 mL detection cleaning solution biotin doses (i.e. > 5 mg/day) until at least 8 hours following the last biotin
administration.
▪  12102137001, AssayTip/AssayCup Combimagazine M, No interference was observed from rheumatoid factors up to a
48 magazines x 84 reaction vessels or pipette tips, waste bags concentration of 1500 IU/mL.
▪  03023150001, WasteLiner, waste bags There is no high-dose hook effect at troponin T concentrations up to
▪  03027651001, SysClean Adapter M 100000 ng/L (pg/mL).

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In vitro tests were performed on 52 commonly used pharmaceuticals. No It is important to obtain a careful history and a precise description of the
interference with the assay was found. symptoms. A physical examination with particular attention to the possible
In rare cases, interference due to extremely high titers of antibodies to presence of cardiac contusion, acute and chronic heart failure, aortic
analyte‑specific antibodies, streptavidin or ruthenium can occur. These dissection, aortic valve disease, hypertrophic cardiomyopathy, tachy- or
effects are minimized by suitable test design. bradyarrhythmias, apical ballooning syndrome, rhabdomyolysis with cardiac
injury, pulmonary embolism, severe pulmonary hypertension, acute
For diagnostic purposes, the results should always be assessed in neurological disease, infiltrative diseases, drug toxicity, respiratory failure,
conjunction with the patient’s medical history, clinical examination and other sepsis, burns is required.16
findings.
An electrocardiogram is recorded for allowing differentiation of patients with
Limits and ranges suspicion of ACS (ST‑segment elevation or ST‑segment changes but
Measuring range without persistent ST‑segment elevation or normal ECG).
3-10000 ng/L or pg/mL (defined by the Limit of Blank and the maximum of Laboratory assessment should include markers of myocardial damage,
the master curve). Values below the Limit of Blank are reported as < 3 ng/L preferably cardiac troponin. If concentrations of troponin or cardiac
or pg/mL. Values above the measuring range are reported as > 10000 ng/L enzymes rise, irreversible cell damage will have occurred and these
or pg/mL (or up to 100000 ng/L or pg/mL for 10‑fold diluted samples). patients must be regarded as having had myocardial infarction as defined
Lower limits of measurement by the consensus conference. Finally a second cardiac troponin
measurement should be obtained after 6 to 12 hours.16,47
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation
(LoQ) Factors associated with elevated values48,49,50,51,52,53,54
Limit of Blank = 3 ng/L (pg/mL) Published clinical studies have shown elevations of cardiac troponin T in
patients with myocardial injury, as seen in unstable angina pectoris, cardiac
Limit of Detection = 5 ng/L (pg/mL) contusions, and heart transplants. Elevations have also been seen in
Limit of Quantitation = 13 ng/L (pg/mL) patients with rhabdomyolysis and polymyositis.
The Limit of Blank and Limit of Detection were determined in accordance Each laboratory should investigate the transferability of the expected values
with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A to its own patient population and if necessary determine its own reference
requirements. ranges.
The Limit of Quantitation was determined using the result of functional Specific performance data
sensitivity testing. Representative performance data on the analyzers are given below.
The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of Results obtained in individual laboratories may differ.
analyte‑free samples over several independent series. The Limit of Blank
corresponds to the concentration below which analyte‑free samples are Precision
found with a probability of 95 %. Precision was determined using Elecsys reagents, samples and controls in
a protocol (EP5‑A2) of the CLSI (Clinical and Laboratory Standards
The Limit of Detection is determined based on the Limit of Blank and the Institute): 2 runs per day in duplication each for 21 days (n = 84). The
standard deviation of low concentration samples. The Limit of Detection following results were obtained:
corresponds to the lowest analyte concentration which can be detected
(value above the Limit of Blank with a probability of 95 %). Elecsys 2010 and cobas e 411 analyzers
The Limit of Quantitation (functional sensitivity) is the lowest analyte
concentration that can be reproducibly measured with an intermediate Repeatability Intermediate
precision CV of ≤ 10 % (10 independent runs; 1 run per day). It has been precision
determined using low concentration troponin T samples. Sample Mean SD CV SD CV
Dilution ng/L ng/L % ng/L %
Samples with cardiac troponin T concentrations above the measuring range (pg/mL) (pg/mL) (pg/mL)
can be diluted with Diluent MultiAssay. The recommended dilution is 1:10 Human serum 1 7.5 0.4 5.6 1.1 15.0
(either automatically by the MODULAR ANALYTICS E170, Elecsys 2010 or
cobas e analyzers or manually). The concentration of the diluted sample Human serum 2 13.5 0.4 3.0 0.7 5.2
must be > 1000 ng/L (pg/mL).
Human serum 3 24.0 0.6 2.4 0.8 3.1
After manual dilution, multiply the result by the dilution factor.
Human serum 4 300 2.7 0.9 3.8 1.3
After dilution by the analyzers, the MODULAR ANALYTICS E170,
Elecsys 2010 and cobas e software automatically takes the dilution into Human serum 5 894 7.4 0.8 13.5 1.5
account when calculating the sample concentration.
Human serum 6 2665 24.1 0.9 37.5 1.4
Expected values
Human serum 7 9044 63.5 0.7 115 1.3
In studies performed with the Elecsys Troponin T hs assay involving 533
healthy volunteers, the upper reference limit (99th percentile) for troponin T PreciControl TN1 27.9 0.7 2.6 1.0 3.4
was 14 ng/L (pg/mL), 95 % confidence interval 12.7‑24.9 ng/L (pg/mL). PreciControl TN2 2049 33.9 1.7 40.7 2.0
The lowest concentration with a CV less than or equal to 10 % (LoQ) with
the Elecsys Troponin T hs assay was 13 ng/L (pg/mL). MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers
Based on the WHO criteria for the definition of AMI43 from the 1970's, the
cutoff (clinical discriminator) value for troponin T is 0.1 µg/L (ng/mL) or Repeatability Intermediate
100 ng/L (pg/mL) as determined from ROC analysis in results with an precision
earlier test generation of the Elecsys Troponin T assay.44,45 Sample Mean SD CV SD CV
The WHO definition of AMI has been recently updated and takes into
consideration the ESC/ACCF/AHA/WHF definition recommending the ng/L ng/L % ng/L %
detection of a rise and/or fall of cardiac troponin in the clinical setting of (pg/mL) (pg/mL) (pg/mL)
myocardial ischemia using the 99th percentile troponin cutoff value.46 Human serum 1 6.5 0.5 7.8 0.6 8.6
Due to the release kinetics of cardiac troponin T, an initially test result < 99th Human serum 2 11.0 0.5 4.8 0.6 5.2
percentile within the first hours of the onset of symptoms does not rule out
myocardial infarction with certainty. If myocardial infarction is still Human serum 3 23.4 0.3 1.4 0.5 2.2
suspected, repeat the test at appropriate intervals (6‑12 hours after initial
assessment).16,47 Human serum 4 293 2.3 0.8 4.5 1.5
Human serum 5 886 6.5 0.7 14.5 1.6

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MODULAR ANALYTICS E170, cobas e 601 and cobas e 602 analyzers Time from admission Sensitivity N 95 % confid­ Specificity N 95 % confid­
(hours) % ence interval % ence interval
Repeatability Intermediate
(%) (%)
precision
3-6 90 37/41 77-97 99 320/324 97-100
Sample Mean SD CV SD CV
6-9 97 32/33 84-100 100 218/219 98-100
ng/L ng/L % ng/L %
(pg/mL) (pg/mL) (pg/mL) 9-12 100 11/11 72-100 100 50/50 93-100

Human serum 6 2647 19.8 0.7 41.9 1.6 > 12 100 21/21 84-100 100 66/66 95-100

Human serum 7 8723 80.8 0.9 117 1.3 Sensitivity and specificity calculated with AMI defined according to
PreciControl TN1 29.0 0.4 1.3 0.5 1.9 the ESC/ACCF/AHA/WHF guidelines
Patients with AMI were defined by routine cardiac troponin values above
PreciControl TN2 2106 18.8 0.9 33.9 1.6 the 99th percentile/10 % CV criteria, and presence of chest pain or ECG
changes. Sensitivity and specificity at peak troponin T, high sensitive values
Method comparison were calculated at the 99th percentile of 14 ng/L (pg/mL).
A comparison of the Elecsys Troponin T hs assay
(MODULAR ANALYTICS E170 analyzer; y) with the Elecsys Sensitivity N 95 % Specificity N 95 %
Troponin T hs STAT assay (Elecsys 2010 analyzer; x) using clinical % confidence % confidence
samples gave the following correlations (ng/L or pg/mL): interval (%) interval (%)
Number of samples measured: 142
100 112/112 97-100 75 297/395 71-79
Passing/Bablok55 Linear regression Sensitivity and specificity of the Elecsys Troponin T hs assay was
y = 0.99x + 0.47 y = 1.02x - 14 calculated at different troponin T levels.
τ = 0.951 r = 0.999 Troponin Sensitivity LCIb) UCIc) Specificity LCI UCI
The sample concentrations were between approximately 3 and 8100 ng/L T hs % % % % % %
(pg/mL). pg/mL
Analytical specificity 30 98 93.7 99.5 93 90.0 95.1
The Elecsys Troponin T hs assay does not show any significant 50 95 88.8 97.5 98 96.1 99.0
cross‑reaction with the following substances (tested with TnT
concentrations of approximately 18 ng/L (pg/mL) and 38 ng/L (pg/mL); 70 84 76.0 89.6 99 98.2 99.9
concentration of cross‑reacting substances 500 ng/mL): 100 75 66.2 82.1 99 98.2 99.9
h‑skeletal muscle troponin T 0.003 %, h‑cardiac troponin I 0.2 %, h‑skeletal
muscle troponin I 0.003 %, human troponin C < 0.001 %. b) LCI = lower confidence interval
c) UCI = upper confidence interval
Diagnostic sensitivity and specificity
The sensitivity and specificity at the 99th percentile (Elecsys Troponin T hs
One clinical center in Germany, one center in India, one center in assay)/10 % CV (Elecsys Troponin T assay, 4th gen.; 0.03 ng/mL) criteria
Switzerland, and two centers in the US participated in prospective studies in were in addition calculated for different time intervals from admission to the
patients presenting with chest pain in the emergency department. hospital:
507 patients were ruled in for calculation of sensitivity and specificity as
selected by the following criteria: Chest pain for > 20 minutes, assessment Time from Test genera­ Sensitivity N 95 % con­ Specificity N 95 % con­
by 12‑lead ECG, age > 20 years, no pregnancy, no previous MI within admission tion Troponin T % fidence % fidence
3 weeks before admission and a minimum of two blood draws. The patients (hours) interval (%) interval (%)
were diagnosed for acute MI by application of:
1. WHO criteria43 including ECG changes, symptoms characteristic for ACS 0 4th gen. 71 40/56 58-83 99 142/143 96-100
and elevation of cardiac troponin, and Troponin T hs 93 52/56 83-98 76 109/143 68-83
2. Criteria defined by the Joint ESC/ACCF/AHA/WHF task force.15
0-3 4th gen. 81 75/93 71-88 99 356/359 98-100
Sensitivity and specificity calculated with AMI defined according to
WHO criteria Troponin T hs 98 91/93 93-100 79 282/359 74-83
The optimal cutoff for the assessment of acute myocardial infarction by 3-6 4th gen. 83 53/64 71-91 100 300/301 98-100
troponin T was previously calculated by ROC analysis at 0.1 μg/L (ng/mL)
or 100 ng/L (pg/mL) in a study with an earlier test generation of the Elecsys Troponin T hs 100 64/64 94-100 77 232/301 72-82
Troponin T assay.45,47 Sensitivity and specificity in peak troponin T values 6-9 4th gen. 86 42/49 73-94 99 201/203 97-100
with the Elecsys Troponin T hs assay were calculated at this ROC
Troponin T hs 98 48/49 89-100 76 155/203 70-82
optimized AMI cut‑off at 0.1 μg/L (ng/mL) or 100 ng/L (pg/mL).
9-12 4th gen. 83 15/18 59-96 100 43/43 92-100
Sensitivity N 95 % Specificity N 95 %
Troponin T hs 94 17/18 73-100 72 31/43 56-85
% confidence % confidence
interval (%) interval (%) > 12 4th gen. 83 25/30 65-94 98 56/57 91-100

99 78/79 93-100 98 420/428 96-99 Troponin T hs 100 30/30 88-100 60 34/57 46-72

The sensitivity and specificity at 0.1 ng/mL (100 pg/mL) were in addition References

calculated for the Elecsys Troponin T hs assay at different time intervals 1 European patent 394816 and US patent 6376206 by Roche
from admission to the hospital: Diagnostics GmbH. Specific antibodies to Troponin T, their production
Time from admission Sensitivity N 95 % confid­ Specificity N 95 % confid­ and use in a reagent for the determination of myocardial necrosis.
(hours) % ence interval % ence interval 2 Katus HA, Remppis A, Looser S, et al. Enzyme linked immunoassay of
(%) (%) cardiac troponin T for the detection of acute myocardial infarction in
patients. Mol Cell Cardiol 1989;21(7):1349-1353.
0 64 23/36 46-79 98 160/163 95-100
3 Katus HA, Scheffold T, Remppis A, et al. Proteins of the troponin
0-3 83 54/65 72-91 100 385/387 98-100 complex. Laboratory Medicine 1992;23(5):311-317.

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Troponin T hs (high sensitive)

4 Alpert JS, Thygesen K, Jaffe A, et al. The universal definition of 23 Ooi DS, Zimmerman D, Graham J, et al. Cardiac troponin T predicts
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5 Hamm CW, Ravkilde J, Gerhardt W, et al. The prognostic value of 24 Apple FS, Wu AHB. Myocardial infarction redefined: Role of cardiac
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1992;327(3):146-150. 25 deFilippi C, Wasserman S, Rosanio S, et al. Cardiac Troponin T and C-
6 Ohmann EM, Armstrong PW, Christenson RH, et al. Cardiac troponin T reactive protein for predicting prognosis, coronary atherosclerosis, and
levels for risk stratification with admission cardiac troponin T levels in cardiomyopathy in patients undergoing long term hemodialysis. JAMA
acute myocardial ischemia. GUSTO IIA Investigators. N Engl J Med 2003;290:353-359.
1996;335:1333-1334. 26 Iliou MC, Fumeron C, Benoit MO, et al. Prognostic value of cardiac
7 Christenson RH, Duh SH, Newby LK, et al. Cardiac troponin T and Markers in ESRD: Chronic Hemodialysis and New Cardiac markers
cardiac troponin I: relative values in short-term risk stratification of Evaluation (CHANCE) study. Am J Kidney Dis 2003;42:513-523.
patients with acute coronary syndromes. Clin Chem 27 Scott B, Deman A, Peeters P, et al. Cardiac troponin T and
1998;44(3):494-501. malondialdehyde modified plasma lipids in haemodialysis patients.
8 Lindahl B, Diderholm E, Lagerqvist B, et al. Mechanisms behind the Neprhol Dial Transplant 2003;18:737-742.
prognostic value of Troponin T in unstable coronary artery disease: a 28 Madsen LH, Ladefoged S, Hildebrandt P, et al. Comparison of four
FRISC II substudy. J Am Coll Card 2001;38:979-986. different cardiac troponin assays in patients with end-stage renal
9 Aviles RJ, Askari AT, Lindahl B, et al. Troponin T levels in patients with disease on chronic haemodialysis. Acute Card Care
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Troponin T hs
Troponin T hs (high sensitive)

© 2013, Roche Diagnostics

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For further information, please refer to the appropriate operator’s manual for
the analyzer concerned, the respective application sheets, the product
information and the Method Sheets of all necessary components (if
available in your country).
A point (period/stop) is always used in this Method Sheet as the decimal
separator to mark the border between the integral and the fractional parts of
a decimal numeral. Separators for thousands are not used.
Symbols
Roche Diagnostics uses the following symbols and signs in addition to
those listed in the ISO 15223‑1 standard.
Contents of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume after reconstitution or mixing

COBAS, COBAS E, ELECSYS, MODULAR and PRECICONTROL are trademarks of Roche. INTRALIPID is a
trademark of Fresenius Kabi AB. Patent No. US 6376206 and US 6333397.
All other product names and trademarks are the property of their respective owners.
Significant additions or changes are indicated by a change bar in the margin.

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