TROP T Sensitive rapid assay Myocardial assessment

TROP T Sensitive rapid assay Myocardial assessment Saves valuable time! The TROP T Sensitive rapid assay is easy to use, and the result is easy to r...
Author: Ernest Hancock
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TROP T Sensitive rapid assay Myocardial assessment

Saves valuable time! The TROP T Sensitive rapid assay is easy to use, and the result is easy to read. The one-step test requires anticoagulated venous blood. It gives a reliable “yes/no” result within a 15 minute reaction time.7 Herkner H., Hirschl M.M., Laggner A.N., et.al (1997)

TROP T Sensitive rapid assay Reveals damage that other markers miss When myocardial damage is suspected, every minute counts. The TROP T Sensitive rapid assay allows rapid determination of the cardiac marker Troponin T from a single whole blood sample. A qualitative result is available within minutes – saving you precious time in emergency situations.

Troponin T is a highly specific and sensitive marker of myocardial damage. Numerous studies have confirmed this. 1–5 Determination of troponin T in the patients’ blood does not only allow detection of acute myocardial infarction but also recognition of minor myocardial damage (MMD). MMD is often missed using traditional diagnostic methods.5, 6

A positive troponin T test in a patient without characteristic ECG changes indicates increased medium- to long-term risk of a serious coronary event. This makes Troponin T an excellent prognostic indi­c ator of increased risk for further cardiac problems.3, 6, 8–12 > 0.1 ng/mL) Patients with an elevated troponin T value (− therefore require further testing, even if the ECG is unremarkable and symptoms are not clear-cut. Research has shown that the same seems to be true for patients with chronic renal insufficiency.16–18

Allows diagnosis even after several days Many patients only seek medical attention hours or even days after the onset of chest pain, especially on weekends. With the TROP T Sensitive rapid assay

you can make a diagnosis even after several days (up to 10 –14 days) after myocardial damage occurs.

Evaluation of test results from patients with chest pain and suspected myocardial infarction*: Emergency hospital admission with physician in attendance

Typical symptoms or ECG clearly positive

Atypical symptoms, ECG inconclusive

when TnT positive

Emergency hospital admission with physician in attendance

Atypical symptoms, ECG inconclusive

when TnT negative

Repeat ECG and TnT after 6 hours. If ECG normal, TnT negative and symptoms atypical: further outpatient investigation

* According to the recommendation by the German expert committee for inclusion and evaluation of TROP T Rapid Test in the Doctors’ Fees Tariff, January 10 th, 1996.

Troponin T as criterion for making a therapy decision > 0.1 ng/mL) can be used Elevated troponin T levels (− to select therapy for unstable angina. In patients with refractory unstable angina, it has been shown that treatment with a platelet aggregation inhibitor (GPIIb/ IIIa inhibitor)13, 14 or low molecular weight heparin11 is most effective in patients with increased troponin T values.

Further investigations show that using troponin T tests for determining treatment with a GPIIb/IIIa inhibitor is costeffective.15

TROP T Sensitive How to perform the test Remove the strip from the package and place it on a flat surface. Use either EDTA or heparinized venous blood!

Obtain the blood sample

Draw up 150 µL (± 15 µL) blood into the dispensing aid

Apply the sample to the test strip and read result after 15 minutes

or

a) Single line (control line) = negative test result (troponin T concentration < 0.1 ng/mL)

b) 2 lines (control and signal line) = positive test result (troponin T > 0.1 ng/mL). concentration − c) no control line = invalid test (repeat test)

Product specification Intended use

Qualitative immunological test for specific detection of cardiac troponin T in whole blood

Test principle

Rapid assay based on specific immunological reaction

Test material

150 µL anticoagulated venous whole blood (only EDTA or heparin can be used as the anti­coagulant)

Test performance time

15 minutes

Storage and stability

4 weeks at room temperature; at +2°C to +8°C until expiration date

Package sizes Art. No.

Description

Package contents

11 621 947 196 TROP T Sensitive rapid assay for 5 determinations

5 disposable test strips individually sealed 5 pipettes (150 µL) 5 documentation labels 1 package insert

11 621 904 193 TROP T Sensitive rapid assay for 10 determinations

10 disposable test strips individually sealed 10 documentation labels 1 package insert

Optional items 11 622 889 190 CARDIAC pipette

20 disposable pipettes for use with TROP T Sensitive rapid assay (pipettes are not included in the TROP T Sensitive 10-test pack)

11 937 553 193 CARDIAC control Troponin T

1 neg. control (lyophilized) 1 low pos. control (lyophilized) for 2×6 control determinations

Literature 1 Katus, H. A., Remppis, A., Neumann, F. J., Scheffold, T., Diederich, K. W., Vinar, G., Noe, A., Matern, G., Kuebler, W. (1991) Diagnostic efficiency of Troponin T measurements in acute myocardial infarction; Circulation 83 No 3, 902–912 2 Wu, A.H. (1994) Cardiac Troponin T: Biochemical, analytical, and clinical aspects; J. Clin Immunoassay 17 No 1, 45–48 3 O  hman, E. M., Armstrong, P. W., Christenson, R. H., Granger, C. B., Katus, H. A., Hamm, C. W., O’Hanesian, M. A., Wagner, G. S., Kleiman, N. S., Harrell, F. E. Jr., Califf, R. M., Topol, E. J. (1996) for the GUSTO IIA Investigators: Cardiac Troponin T levels for risk stratification in acute myocardial ischemia; N Engl J Med 335 (18), 1333–41  hristenson, R. H., Newby, L. K., Ohman, E. M. (1997) Cardiac markers in the assessment of acute coronary syn4 C dromes; Md Med J Suppl, 18–24  erhardt, W., Ljungdahl, L. (1997) Detection of myocardial damage by serial measurements of cardiac Troponin T, 5 G CK MB mass, and Trop T rapid test; Cardiovasc Drugs Ther Suppl 1, 227–40 6 Gerhardt, W., Ljungdahl, L. (1998) Troponin T, a sensitive and specific diagnostic and prognostic marker of myocardial damage; Clin Chem Acta 272 (1), 47–57  erkner, H., Hirschl, M. M., Laggner, A. N., Sylven, C., Rasmanis, G., Collinson, P. O., Gerhardt, W., Leinberger, R., 7 H Zerback, R., Müller-Bardoff, M., Katus, H. A. (1997) Analytical and clinical evaluation of an improved qualitative Troponin T rapid test (TROP T Sensitive) for whole blood samples; Poster presented at Medlab 97, 12 th IFCC European Congress of Clinical Chemistry  avkilde, J., Horder, M., Gerhardt, W., Ljungdahl, L., Pettersson, T., Tryding, N., Moller, B. H., Hamfelt, A., Graven, 8 R T., Asberg, A., et al. (1993) Diagnostic performance and prognostic value of serum Troponin T in suspected acute myocardial infarction; Scand J Clin Lab Invest 53( 7), 677–85  tubbs, P., Collinson, P., Moseley, D., Greenwood, T., Noble, M. (1996) Prospective study of the role of cardiac 9 S Troponin T in patients admitted with unstable angina; BMJ 313 ( 7052), 262–4  tubbs, P., Collinson, P., Moseley, D., Greenwood, T., Noble, M. (1996) Prognostic significance of admission 10 S Troponin T concentrations in patients with myocardial infarction; Circulation 94 (6), 1291–7  indahl, B., Venge, P., Wallentin, L. (1997) Troponin T identifies patients with unstable coronary artery disease who 11 L benefit from long-term antithrombotic protection; Fragmin in Unstable Coronary Artery Disease (FRISC) Study Group. J Am Coll Cardiol 29 (1), 43–8  hristenson, R. H., Duh, S. H., Newby, L. K., Ohman, E. M., Califf, R. M., Granger, C. B., Peck, S., Pieper, K. S., 12 C Armstrong, P. W., Katus, H. A., Topol, E. J. (1998) Cardiac Troponin T and cardiac Troponin I: relative values in shortterm risk stratification of patients with acute coronary syndromes, GUSTO-IIa Investigators; Clin Chem 44 (3), 494–501  eeschen, C., Hamm, C. W., Goldmann, B. U., Wohlrath, S., Deu, A. (1998) Recurrence of symptoms in patients with 13 H refractory unstable angina during treatment with abciximab before coronary revascularization – results from the CAPTURE trail. Circulation 1998 Supplement I-358, 1882  amm, C. W., Heeschen, C., Goldmann, B. U. (1998) Relation of angiographically visible thrombus and troponin T 14 H elevation in unstable angina, Circulation 1998 Supplement I – 4920, 2590  eeschen, C., Hamm, C. W., Goldmann, B. U., Wohlrath, S. (1998) Cost effectiveness in patients with unstable 15 H angina according to the troponin T status, Circulation 1998 Supplement I–358, 1884 16 Haller et al. (1997) Cardiac troponin T in patients with renal failure; JACC 29, No. 2, Suppl. A (Abstract)  orter et al (1998) Troponin T, a predictor of death in chronic haemodialysis patients; European Heart Journal Vol 19, 17 P Supplement N, and AMJ Kidney Diseases 31, A27  icchiuti et al. (1998) Cardiac Troponin T isoforms expressed in renal diseased skeletal muscle will not cause 18 R falsepositive results by the second generation cardiac Troponin T assay by Boehringer Mannheim; Clin Chem 44, 9, 1919–1924

COBAS, TROP T and life needs ANSWERS are trademarks of Roche.

Roche Diagnostics Ltd. CH-6343 Rotkreuz Switzerland www.roche.com

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