Intended Use

LEPZI ® Quanti BNP/cTnI/D-Dimer Test is a fluorescence immunoassay for the quantitative determination of D-Dimer, Troponin I and B-type Natriuretic Peptide in EDTA anticoagulated whole blood or plasma specimens.

The test is intended for use as an aid in the diagnosis of myocardial infarction (injury), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes.

Clinical Application

The “Gold Standard (BNP)” for diagnosis of Heart Failure

The preferred marker (cTnI) for the diagnosis of myocardial infarction

Diagnosis and assessment of severity of congestive heart failure

Risk stratification of patients with heart failure and acute coronary syndromes

Evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic

Specification

Test Analytes：BNP, cTnI and D-Dimer

Specimen：EDTA anticoagulated human whole blood and plasma specimens

Reaction Time：15 minutes in Single Cartridge Mode, 55 seconds in Multi Cartridge Mode

Storage：2~8°C

Registration：NMPA

Advantages 

Fully Enclosed Test Area - Stable and reliable reaction

Ultrasonic Welded Seal - Tightly sealed and high precision

Easy to Use - No sample dilution and preparation