Troponin T hs STAT

Troponin T hs (high sensitive) STAT (Short Turn Around Time)

05092728 119 100 tests Cardiac troponin is also the preferred marker of myocardial injury in
the new guidelines for the diagnosis and treatment of non-ST-
• Indicates analyzers on which the kit can be used segment elevation acute coronary syndromes.15,16
Low concentrations of troponin T can be detected in clinically stable
patients such as patients with ischemic or non-ischemic heart
Elecsys 2010 cobas e 411 failure,17,18,19,20 patients with different forms of cardiomyopathy,21
renal failure,22,23,24,25,26,27,28 sepsis29 and diabetes.30
• • Elevated levels of troponin T correlate with the severity of coronary
artery disease and to poor outcome independent of natriuretic
English peptide (BNP or NT-proBNP) levels.17,18,31,32
Low concentrations of troponin T are an independent predictor of
Intended use cardiovascular events including occurrence and recurrence of atrial
Immunoassay for the in vitro quantitative determination of cardiac fibrillation.33
troponin T in human serum and plasma. The Elecsys Troponin T hs Myocardial cell injury leading to elevated cTnT concentrations in the
STAT assay can be used as an aid in the differential diagnosis of blood can also occur in other clinical conditions such as
acute coronary syndrome to identify necrosis, e.g. acute myocardial myocarditis,34 heart contusion,35 pulmonary embolism36 and drug-
infarction. The test is further indicated for the risk stratification of induced cardiotoxicity.37
patients presenting with acute coronary syndrome and for cardiac Other diagnostic tests such as myoglobin, CK-MB, NT-proBNP,
risk in patients with chronic renal failure. The test may also be useful PlGF and CRP can complement the diagnostic and prognostic
for the selection of more intensive therapy and intervention in information of troponin T in different indications.31,38,39
patients with elevated levels of cardiac troponin T. The Elecsys Troponin T hs STAT assay employs two monoclonal
The electrochemiluminescence immunoassay “ECLIA” is intended antibodies specifically directed against human cardiac
for use on Elecsys and cobas e immunoassay analyzers. troponin T.40,41 The antibodies recognize two epitopes (amino acid
position 125-131 and 136-147) located in the central part of the
Note cardiac troponin T protein, which consists of 288 amino acids.
Please note that the catalogue number appearing on the package The Elecsys Troponin T hs STAT calibrators (Elecsys Troponin T hs
insert retains only the first 8 digits of the licensed 11-digit Catalogue STAT CalSet) contain recombinant human cardiac troponin T (rec.
Number: 05092728190 for the Elecsys Troponin T hs STAT. The last hcTnT). The rec. hcTnT is isolated from cell culture of E. coli BL21
3 digits -190 have been replaced by -119 for logistic purposes. containing a pET vector with human cardiac troponin T isoform 3
gene. After fermentation, the cells are disrupted by sonication and
Summary rec. hcTnT is purified by ion exchange chromatography. Purified rec.
Troponin T (TnT) is a component of the contractile apparatus of the hcTnT is further characterized by SDS PAGE, Western blotting,
striated musculature. Although the function of TnT is the same in all immunological activity, and protein content.42
striated muscles, TnT originating exclusively from the myocardium
(cardiac TnT, molecular weight 39.7 kD) clearly differs from skeletal Test principle
muscle TnT. As a result of its high tissue-specificity, cardiac Sandwich principle. Total duration of assay: 9 minutes.
troponin T (cTnT) is a cardio-specific, highly sensitive marker for
myocardial damage.1 Cardiac troponin T increases approx. 3- • 1st incubation: 50 µL of sample, a biotinylated monoclonal anti-
4 hours after myocardial infarction (AMI) and may persist up to 2 cardiac troponin T-specific antibody, and a monoclonal anti-cardiac
weeks thereafter.2,3 In contrast to ST-elevation myocardial infarction troponin T-specific antibody labeled with a ruthenium complexa react
(STEMI), the diagnosis of non-ST elevation myocardial infarction to form a sandwich complex.
(NSTEMI) heavily relies on cardiac troponin result. According to the • 2nd incubation: After addition of streptavidin-coated microparticles,
new universal definition of myocardial infarction, MI is diagnosed the complex becomes bound to the solid phase via interaction of
when blood levels of cardiac troponin are above the 99th percentile biotin and streptavidin.
of the reference limit (of a healthy population) together with evidence • The reaction mixture is aspirated into the measuring cell where the
of myocardial ischemia (symptoms, ECG changes or imaging microparticles are magnetically captured onto the surface of the
results). The definition requires a troponin assay with an imprecision electrode. Unbound substances are then removed with ProCell.
(coefficient of variation) at the 99th percentile less than or equal to Application of a voltage to the electrode then induces
10 %.4 chemiluminescent emission which is measured by a photomultiplier.
Cardiac troponin T (cTnT) is an independent prognostic marker • Results are determined via a calibration curve which is instrument-
which can predict the near-, mid- and even long-term outcome of specifically generated by 2-point calibration and a master curve (5-
patients with acute coronary syndrome (ACS).5,6,7,8,9 point calibration) provided via the reagent barcode.
In addition, 4 multicenter trials involving more than 7000 patients a) Tris(2,2-bipyridyl)ruthenium(II)-complex (Ru(bpy) )
have shown that cardiac troponin T is also useful to identify patients
that benefit from anti-thrombotic therapy (GPIIb/IIIa inhibitors, low
molecular weight heparin).10,11,12,13,14

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Troponin T hs STAT
Troponin T hs (high sensitive) STAT (Short Turn Around Time)

Reagents - working solutions When processing samples in primary tubes (sample collection
M Streptavidin-coated microparticles (transparent cap), systems), follow the instructions of the tube manufacturer.
1 bottle, 12 mL: Centrifuge samples containing precipitates before performing the
Streptavidin-coated microparticles 0.72 mg/mL; assay. Do not use samples and controls stabilized with azide.
preservative. Ensure the patients’ samples, calibrators, and controls are at
ambient temperature (20-25 °C) before measurement.
R1 Anti-troponin T-Ab~biotin (gray cap), 1 bottle, 14 mL:
Biotinylated monoclonal anti-cardiac troponin T-antibody
Materials provided
(mouse) 2.5 mg/L; phosphate buffer 100 mmol/L, pH 6.0;
See “Reagents - working solutions” section for reagents.
preservative; inhibitors.
R2 Anti-troponin T-Ab~Ru(bpy) (black cap), 1 bottle, 14 mL: Materials required (but not provided)
Monoclonal anti-cardiac troponin T-antibody (mouse) • Cat. No. 05092736190, Troponin T hs STAT CalSet, for 4 x 1 mL
labeled with ruthenium complex 2.5 mg/L; phosphate buffer • Cat. No. 05095107190, PreciControl Troponin, for 2 x 2 mL each of
100 mmol/L, pH 6.0; preservative. PreciControl Troponin 1 and 2
• Cat. No. 03609987190, Diluent MultiAssay, 2 x 16 mL sample
Precautions and warnings diluent
For in vitro diagnostic use. • General laboratory equipment
Exercise the normal precautions required for handling all laboratory • Elecsys 2010 or cobas e 411 analyzer
reagents. • Cat. No. 11662988122, ProCell, 6 x 380 mL system buffer
Disposal of all waste material should be in accordance with local • Cat. No. 11662970122, CleanCell, 6 x 380 mL measuring cell
guidelines. cleaning solution
Safety data sheet available for professional user on request. • Cat. No. 11930346122, Elecsys SysWash, 1 x 500 mL washwater
Avoid the formation of foam with all reagents and sample types additive
(specimens, calibrators, and controls). • Cat. No. 11933159001, Adapter for SysClean
• Cat. No. 11706802001, Elecsys 2010 AssayCup, 60 x 60 reaction
Reagent handling vessels
The reagents in the kit have been assembled into a ready-for-use • Cat. No. 11706799001, Elecsys 2010 AssayTip, 30 x 120 pipette
unit that cannot be separated. tips
All information required for correct operation is read in via the • Cat. No. 11298500316, Elecsys SysClean, 5 x 100 mL system
respective reagent barcodes. cleaning solution

Storage and stability Assay

Store at 2-8 °C. For optimum performance of the assay follow the directions given in
Store the Elecsys Troponin T hs STAT reagent kit upright in order this document for the analyzer concerned. Refer to the appropriate
to ensure complete availability of the microparticles during automatic operator’s manual for analyzer-specific assay instructions.
mixing prior to use. Resuspension of the microparticles takes place automatically before
Stability: use. Read in the test-specific parameters via the reagent barcode. If
up to the stated expiration in exceptional cases the barcode cannot be read, enter the 15-digit
unopened at 2-8 °C
date sequence of numbers.
after opening at 2-8 °C 12 weeks
on the analyzers 4 weeks Elecsys 2010 and cobas e 411 analyzers: Bring the cooled
reagents to approx. 20 °C and place on the reagent disk (20 °C) of
the analyzer. Avoid the formation of foam. The system
Specimen collection and preparation automatically regulates the temperature of the reagents and the
Only the specimens listed below were tested and found acceptable. opening/closing of the bottles.
Serum collected using standard sampling tubes or tubes containing
separating gel. Calibration
K2-EDTA, K3-EDTA, Li-heparin, and Na-heparin plasma. Traceability: The Elecsys Troponin T hs STAT assay (Cat. No.
Criterion: Slope 0.8-1.2 + coefficient of correlation ≥ 0.95. 05092728) has been standardized against the Elecsys Troponin T
Stable for 24 hours at 2-8 °C, 12 months at -20 °C. Freeze only STAT assay (Cat. No. 04660307, 4th gen.). This in turn was
once. originally standardized against the Enzymun-Test Troponin T
The sample types listed were tested with a selection of sample (CARDIAC T) method.
collection tubes that were commercially available at the time of Every Elecsys Troponin T hs STAT reagent set has a barcoded label
testing, i.e. not all available tubes of all manufacturers were tested. containing the specific information required for calibration of the
Sample collection systems from various manufacturers may contain particular reagent lot. The predefined master curve is adapted to the
differing materials which could affect the test results in some cases. analyzer by the use of Elecsys Troponin T hs STAT CalSet.

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Troponin T hs STAT
Troponin T hs (high sensitive) STAT (Short Turn Around Time)

Calibration frequency: Calibration must be performed once per are reported as > 10000 ng/L or pg/mL (or up to 100000 ng/L or
reagent lot using fresh reagent (i.e. not more than 24 hours since the pg/mL for 10-fold diluted samples).
reagent kit was registered on the analyzer). Renewed calibration is
recommended as follows: Dilution
Elecsys 2010 and cobas e 411 analyzers: Samples with cardiac troponin T concentrations above the
• after 1 month (28 days) when using the same reagent lot measuring range can be diluted with Elecsys Diluent MultiAssay.
• after 7 days (when using the same reagent kit on the analyzer) The recommended dilution is 1:10 (either automatically by the
• as required: e.g. quality control findings outside the specified limits Elecsys 2010 and cobas e 411 analyzers or manually). The
concentration of the diluted sample must be > 1000 ng/L (pg/mL).
Quality control After manual dilution, multiply the result by the dilution factor. After
For quality control, use Elecsys PreciControl Troponin 1 and 2. dilution by the analyzers, the Elecsys 2010 and cobas e 411
Other suitable control material can be used in addition. software automatically takes the dilution into account when
Controls for the various concentration ranges should be run as calculating the sample concentration.
single determinations at least once every 24 hours when the test is
in use, once per reagent kit, and after every calibration. The control Expected values
intervals and limits should be adapted to each laboratory’s individual In studies performed with the Elecsys Troponin T hs assay involving
requirements. Values obtained should fall within the defined limits. 546 healthy volunteers, the upper reference limit (99th percentile) for
Each laboratory should establish corrective measures to be taken if troponin T was 14 ng/L (pg/mL), 95 % confidence interval 12.4-
values fall outside the limits. 24.9 ng/L (pg/mL).
Follow the applicable government regulations and local guidelines
for quality control. The lowest concentration with a CV less than or equal to 10 % (LoQ)
with the Elecsys Troponin T hs STAT assay was 13 ng/L (pg/mL).
Calculation Based on the WHO criteria for the definition of AMI43 from the 1970’s,
The analyzer automatically calculates the analyte concentration of the cutoff (clinical discriminator) value for troponin T is
each sample (either in pg/mL, ng/mL or optional in µg/L). 0.1 µg/L (ng/mL)/100 ng/L (pg/mL) as determined from ROC
analysis in results with an earlier test generation of the Elecsys
Limitations - interference Troponin T assay.44,45 Due to the release kinetics of cardiac
The assay is unaffected by icterus (bilirubin < 428 µmol/L or troponin T, an initially test result < 99th percentile within the first
< 25 mg/dL), hemolysis (Hb < 0.016 mmol/L or < 0.1 g/dL; samples hours of the onset of symptoms does not rule out myocardial
showing visible signs of hemolysis may be interfered. Falsely low infarction with certainty. If myocardial infarction is still suspected,
results are obtained when using samples with hemoglobin repeat the test at appropriate intervals (6-12 hours after initial
concentrations > 0.1 g/dL.), lipemia (Intralipid < 1500 mg/dL), and assessment).16,46 It is important to obtain a careful history and a
biotin < 82 nmol/L or < 20 ng/mL. precise description of the symptoms. A physical examination with
Criterion: Recovery within ± 20 % of initial value at troponin T particular attention to the possible presence of cardiac contusion,
concentrations < 100 ng/L or pg/mL (± 10 % at troponin T acute and chronic heart failure, aortic dissection, aortic valve
concentrations ≥ 100 ng/L or pg/mL). disease, hypertrophic cardiomyopathy, tachy- or bradyarrhythmias,
In patients receiving therapy with high biotin doses (i.e. > 5 mg/day), apical ballooning syndrome, rhabdomyolysis with cardiac injury,
no sample should be taken until at least 8 hours after the last biotin pulmonary embolism, severe pulmonary hypertension, acute
administration. neurological disease, infiltrative diseases, drug toxicity, respiratory
No interference was observed from rheumatoid factors up to a failure, sepsis, burns is required.16 An electrocardiogram is recorded
concentration of 1500 IU/mL. for allowing differentiation of patients with suspicion of ACS (ST-
There is no high-dose hook effect at troponin T concentrations up to segment elevation or ST-segment changes but without persistent
100000 ng/L (pg/mL). ST-segment elevation or normal ECG). Laboratory assessment
In vitro tests were performed on 52 commonly used pharmaceuticals. should include markers of myocardial damage, preferably cardiac
No interference with the assay was found. troponin. If concentrations of troponin or cardiac enzymes rise,
In rare cases, interference due to extremely high titers of antibodies irreversible cell damage will have occurred and these patients must
to analyte-specific antibodies (such as HAMA), streptavidin or be regarded as having had myocardial infarction as defined by the
ruthenium can occur. These effects are minimized by suitable test consensus conference. Finally a second cardiac troponin
design. measurement should be obtained after 6 to 12 hours.16,46
For diagnostic purposes, the results should always be assessed in Factors associated with elevated values 47,48,49,50,51,52,53
conjunction with the patient’s medical history, clinical examination Published clinical studies have shown elevations of cardiac
and other findings. troponin T in patients with myocardial injury, as seen in unstable
angina pectoris, cardiac contusions, and heart transplants.
Measuring range Elevations have also been seen in patients with rhabdomyolysis and
3-10000 ng/L or pg/mL (defined by the limit of blank and the polymyositis. Each laboratory should investigate the transferability of
maximum of the master curve). Values below the limit of blank are the expected values to its own patient population and if necessary
reported as < 3 ng/L (pg/mL). Values above the measuring range

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Troponin T hs STAT
Troponin T hs (high sensitive) STAT (Short Turn Around Time)

determine its own reference ranges. ≤ 10 % (10 independent runs; 1 run per day). It has been
determined using low concentration troponin T samples.
Specific performance data
Representative performance data on the analyzers are given below. Method comparison
Results obtained in individual laboratories may differ. A comparison of the Elecsys Troponin T hs STAT assay (Elecsys
2010 analyzer; y) with the Elecsys Troponin T STAT assay, Cat. No.
Precision 04660307 (Elecsys 2010 analyzer; x), using clinical samples gave
Precision was determined using Elecsys reagents, samples and the following correlations (ng/L or pg/mL):
controls in a protocol (EP5-A2) of the CLSI (Clinical and Laboratory Number of samples measured: 155
Standards Institute): 2 runs per day in duplication each for 21 days Passing/Bablok54 Linear regression
(n = 84). The following results were obtained:
y = 1.05x + 0.028 y = 1.0x + 0.038
Intermediate
Repeatabilityb T = 0.867 r = 0.997
precision
Sample Mean SD CV SD CV The sample concentrations were between approx. 13 and 7000 ng/L
(pg/mL).
ng/L ng/L % ng/L %
(pg/mL) (pg/mL) (pg/mL) Analytical specificity
The Elecsys Troponin T hs STAT assay does not show any
Human serum 1 23.3 0.6 2.6 1.0 4.4
significant cross-reaction with the following substances (tested with
Human serum 2 50.0 0.5 1.1 1.1 2.1 TnT concentrations of approx. 18 ng/L (pg/mL) and 38 ng/L (pg/mL);
Human serum 3 75.8 0.8 1.1 1.4 1.8 concentration of cross-reacting substances 500 ng/mL): h-skeletal
muscle troponin T 0.003 %, h-cardiac troponin I 0.2 %, h-skeletal
Human serum 4 312 3.1 1.0 4.3 1.4 muscle troponin I 0.003 %, human troponin C < 0.001 %.
Human serum 5 943 8.1 0.9 13.7 1.4
Human serum 6 2718 21.1 0.8 35.5 1.3 Diagnostic sensitivity and specificity
One clinical center in Germany, one center in India, one center in
PreciControl Switzerland, and two centers in the US participated in prospective
25.6 0.5 2.1 0.9 3.6
TN1 studies in patients presenting with chest pain in the emergency
PreciControl department. 507 patients were ruled in for calculation of sensitivity
1819 27.2 1.5 39.4 2.2 and specificity as selected by the following criteria: Chest pain for
TN2
b) Repeatability > 20 minutes, assessment by 12-lead ECG, age > 20 years, no
= within-run precision
pregnancy, no previous MI within 3 weeks before admission and a
minimum of two blood draws. The patients were diagnosed for acute
Analytical sensitivity (lower detection limit)
MI by application of:
Limit of Blank (LoB), Limit of Detection (LoD) and Limit of
1. WHO criteria44 including ECG changes, symptoms characteristic
Quantitation (LoQ)
for ACS and elevation of cardiac troponin, and
2. Criteria defined by the Joint ESC/ACCF/AHA/WHF task force.16
Limit of Blank ≤ 3 ng/L (pg/mL)
Limit of Detection ≤ 5 ng/L (pg/mL) Sensitivity and specificity calculated with AMI defined according to
WHO criteria
Limit of Quantitation ≤ 13 ng/L (pg/mL) The optimal cut-off for the assessment of acute myocardial infarction
by troponin T was previously calculated by ROC analysis at
The limit of blank and limit of detection were determined in 0.1 µg/L (ng/mL)/100 ng/L (pg/mL) in a study with an earlier test
accordance with the CLSI (Clinical and Laboratory Standards generation of the Elecsys Troponin T assay.45,46 Sensitivity and
Institute) EP17-A requirements. The limit of quantitation was specificity in peak troponin T values with the Elecsys Troponin T hs
determined using the result of functional sensitivity testing. The limit assay were calculated at this ROC optimized AMI cut-off at
of blank is the 95th percentile value from n ≥ 60 measurements of 0.1 µg/L (ng/mL)/100 ng/L (pg/mL).
analyte-free samples over several independent series. The limit of
blank corresponds to the concentration below which analyte-free 95 % 95 %
samples are found with a probability of 95 %. The limit of detection is Sensitivity Specificity
N confidence N confidence
determined based on the limit of blank and the standard deviation of % %
interval (%) interval (%)
low concentration samples. The limit of detection corresponds to the
lowest analyte concentration which can be detected (value above 99 78/79 93-100 98 420/428 96-99
the limit of blank with a probability of 95 %). The limit of quantitation The sensitivity and specificity at 0.1 ng/mL (100 pg/mL) were in
(functional sensitivity) is the lowest analyte concentration that can be addition calculated for the Elecsys Troponin T hs assay at different
reproducibly measured with a between-run coefficient of variation of time intervals from admission to the hospital:

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Troponin T hs (high sensitive) STAT (Short Turn Around Time)

Time from
admission Sensitivity 95 % confidence Specificity 95 % confidence
(hours) % N interval (%) % N interval (%) References
1. European patent 394816 and US patent 6376206 by Roche
0 64 23/36 46-79 98 160/163 95-100
Diagnostics GmbH. Specific antibodies to Troponin T, their
0-3 83 54/65 72-91 100 385/387 98-100 production and use in a reagent for the determination of myocardial
3-6 90 37/41 77-97 99 320/324 97-100 necrosis.
2. Katus HA, Remppis A, Looser S, et al. Enzyme linked
6-9 97 32/33 84-100 100 218/219 98-100
immunoassay of cardiac troponin T for the detection of acute
9-12 100 11/11 72-100 100 50/50 93-100 myocardial infarction in patients. Mol Cell Cardiol 1989;21(7):1349-
> 12 100 21/21 84-100 100 66/66 95-100
1353.
3. Katus HA, Scheffold T, Remppis A, Zehelein J. Proteins of the
troponin complex. Laboratory Medicine 1992;23(5):311-317.
Sensitivity and specificity calculated with AMI defined according to 4. Alpert JS, Thygesen K, Jaffe A, White HD. The universal
the ESC/ACCF/AHA/WHF guidelines definition of myocardial infarction: a consensus document: Ischaemic
Patients with AMI were defined by routine cardiac troponin values heart disease. Heart 2008;94;1335-1341.
above the 99th percentile/10 % CV criteria, and presence of chest 5. Hamm CW, Ravkilde J, Gerhardt W, Jorgensen P, Peheim E,
pain or ECG changes. Sensitivity and specificity at peak troponin T, Ljungdahl L, et al. The prognostic value of serum troponin T in
high sensitive values were calculated at the 99th percentile of unstable angina. N Engl J Med 1992;327(3):146-150.
14 ng/L (pg/mL). 6. Ohmann EM, et al. Risk stratification with admission cardiac
95 % 95 % troponin T levels in acute myocardial ischemia. N Engl J Med
Sensitivity Specificity 1996;335:1333-1334.
N confidence N confidence
% % 7. Christenson RH, Duh SH, Newby LK, Ohman EM, Califf RM,
interval (%) interval (%)
Granger CB, et al. Cardiac troponin T and cardiac troponin I: relative
100 112/112 97-100 75 297/395 71-79 values in short-term risk stratification of patients with acute coronary
syndromes. Clin Chem 1998;44(3):494-501.
The sensitivity and specificity at the 99th percentile (Elecsys 8. Lindahl B, Diderholm E, Lagerqvist B, Venge P, Wallentin L, and
Troponin T hs assay)/10 % CV (Elecsys Troponin T assay, 4th gen.; the FRISC II investigators. Mechanisms behind the prognostic value
0.03 ng/mL) criteria were in addition calculated for different time of Troponin T in unstable coronary artery disease: a FRISC II
intervals from admission to the hospital: substudy. J Am Coll Card 2001;38:979-986.
Time from Test 95 % 95 % 9. Aviles RJ, Askari AT, Lindahl B, Wallentin L, Jia G, Ohman EM,
admission generation Sensitivity N confidence Specificity N confidence Mahaffey KW, Newby LK, Califf RM, Simoons ML, Topol EJ, Lauer
(hours) Troponin T % interval (%) % interval (%) MS. Troponin T levels in patients with acute coronary syndromes,
4th gen. 71 40/56 58-83 99 142/143 96-100
with or without renal dysfunction. N Engl J Med 2002;346:2047-2052.
10. Lindahl B, Venge P, Wallentin L. Troponin T Identifies Patients
Troponin T With Unstable Coronary Artery Disease Who Benefit From Long-
0 hs 93 52/56 83-98 76 109/143 68-83 Term Antithrombotic Protection. J Am Coll Cardiol 1997;29(1):43-48.
4th gen. 81 75/93 71-88 99 356/359 98-100 11. Hamm CW, Heeschen C, Goldmann B, Vahanian A, Adgey J,
Miguel MC, et al. Benefit of abciximab in patients with refractory
Troponin T
0-3
unstable angina in relation to serum troponin T levels. N Engl J Med
hs 98 91/93 93-100 79 282/359 74-83
1999;340(21):1623-1629.
4th gen. 83 53/64 71-91 100 300/301 98-100 12. Heeschen C, Hamm CW, Goldmann BU, et al. for PRISM study
Troponin T
investigators. Troponin concentrations for stratification of patients
3-6 hs 100 64/64 94-100 77 232/301 72-82
with acute coronary syndromes in relation to therapeutic efficacy of
tirofiban. Lancet 1999;354:1757-1762.
4th gen. 86 42/49 73-94 99 201/203 97-100 13. Lindahl B, Diderholm E, Lagerquist B, Venge P, Wallentin L.
Troponin T Effects on mortality of long-term treatment with l.m.w. heparin in
6-9 hs 98 48/49 89-100 76 155/203 70-82 relation to troponin T level and ECG findings - a FRISC 2 substudy.
Eur Heart J 2000;21(Suppl.):521.
4th gen. 83 15/18 59-96 100 43/43 92-100
14. Newby LK, Ohman EM, Christenson RH, Moliterno DJ,
Troponin T Harrington RA, White HD, et al. Benefit of Glycoprotein IIb/IIa
9-12 hs 94 17/18 73-100 72 31/43 56-85 Inhibition in Patients With Acute Coronary Syndromes and
4th gen. 83 25/30 65-94 98 56/57 91-100
Troponin T-Positive Status: The PARAGON-B Troponin T Substudy.
Circulation 2001;103:2891-2896.
Troponin T
15. The Task Force for the diagnosis and Treatment of Non-ST-
> 12 hs 100 30/30 88-100 60 34/57 46-72
Segment Elevation Acute Coronary Syndromes of the European
Society of Cardiology. Guidelines for the diagnosis and treatment of

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DJ. Prevalence and prognostic Significance of preprocedural cardiac KW, ten Duis HJ. Troponin I, troponin T, CK-MB-activity and CK-MB
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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 package inserts of all necessary
components.

COBAS, COBAS E and ELECSYS are trademarks of Roche. Other brand or product
names are trademarks of their respective holders. INTRALIPID is a trademark of
Fresenius Kabi AB.
Patent No. US 6376206 and US 6333397.
Significant additions or changes are indicated by a change bar in the margin. Changes
to reagent barcode test parameters which have already been read in should be edited
manually.
© 2008, Roche Diagnostics

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