INTENDED USE

The NT-proBNP Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human NT-proBNP in whole blood, serum or plasma as an aid
in the diagnosis of heart failure.

SUMMARY

The N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) is a 76 amino acid N-terminal inactive protein that is cleaved from proBNP to release brain natriuretic peptide.Both BNP and NT-proBNP levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure, as both markers are typically higher in patients with worse outcome. The plasma concentrations of both BNP and NT-proBNP are also typically increased in patients with asymptomatic or symptomatic left ventricular dysfunction and is associated with coronary artery disease and myocardial ischemia.
The NT-proBNP Rapid Test is a simple test that utilizes a combination of anti-NTproBNP antibody coated particles and capture reagents to qualitatively detect NTproBNP in whole blood, serum or plasma. The minimum detection level is 0.45ng/mL.

PRINCIPLE

The NT-proBNP Rapid Test is a qualitative, membrane based immunoassay for the detection of NT-proBNP in whole blood, serum or plasma. The membrane is precoated
with specific capture antibodies in the test line region of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with specific antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with specific capture reagents on the membrane and generate a colored line. The presence of this colored line in the specific test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.