bioNexia® Troponin I First-step aid in the diagnosis of myocardial infarction* rapid one-step test

for the qualitative detection of human cTNI in whole blood, serum or plasma

TEST PROCEDURE

TEST INTERPRETATION

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Clinical Background

Cardiac Troponin I (cTNI) is a protein found in the myocardial muscle. It is the preferred biomarker for detection of cardiac injury in the diagnosis of myocardial infarction (MI).2,3

Cardiac troponin I levels increase within 3-6 hours after the onset of symptoms, peak at 18-24 hours and remain elevated for 4-7 days.4

Due to the high positive predictive value (PPV) of Troponin I for MI, a positive result can contribute to early triage/risk stratifi cation of at-risk patients.5

Early detection of myocardial damage is essential. Community-based studies have shown that the overall mortality rate of patients with presumed MI or acute coronary syndrome in the fi rst month is ~50%, and about 50% of these deaths occur within the fi rst 2 hours.6

bioNexia® Troponin I ?

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First-step aid in the diagnosis of myocardial infarction*

State-of-the-art test performance1

Results available in just 10 minutes

Easy-to-use, all-inclusive kit

Why choose

bioMérieux S.A.69280 Marcy l’EtoileFranceTel. : +33 (0)4 78 87 20 00Fax : +33 (0)4 78 87 20 90

www.biomerieux.com/bionexia 11-1

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Technical data

Reference: 410598 (10 Tests)

Performance vs another (state of art) Rapid test (n=308):Sensitivity: 96.27%Specifi city: 99.43%

Shelf-life: 24 months

Storage temperature: +2°C to +30°C

Content of the kit:- 10 test cassettes - 10 sterile lancets - 10 sterile pipettes- 1 buffer bottle (4 ml)- 1 package insert - 1 quick user guide

Dimensions of the kit

Length: 130 mm

Width: 105 mm

Height: 80 mm

Weight: 164 g

dial

* A positive test result indicates a high risk for myocardial infarction. However, a negative result does not exclude MI and further testing is required.

REFERENCES1/ bioNexia Troponin I Package insert. 2/ Thygesen K, Alpert JS, White HD. Joint ESC/ACCF/AHA/WHF Task Force for the Redefi nition of Myocardial Infarction. Universal defi nition of myocardial infarction. Eur Heart J. 2007;28:2525-38. 3/ Thygesen K, Mair J, Katus H, et al. Study Group on Biomarkers in Cardiology of the ESC Working Group on Acute Cardiac Care. Recommendations for the use of cardiac troponin measurement in acute cardiac care. Eur Heart J. 2010;31:2197-204. 4/ Morrow DA, Cannon CP, Jesse JL, et al. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines: Clinical characteristics and utilization of biochemical markers in acute coronary syndromes. Circulation. 2007; 115: 356-75. 5/ Antman EM, Tanasijevic MJ, Thompson B, et al. Cardiac-specifi c troponin I levels to predict the risk of mortality in patients with acute coronary syndromes. N Engl J Med. 1996;335:1342-9. 6/ Van de Werf F, Bax J, Betriu A, et al. Management of acute mycordial infarction in patient presenting with persistent ST-segent elevation. Task force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology. Eur Heart J. 2008; 29:2909-2945.