【INTENDED USE】

NT-proBNP Rapid Test Device (Colloidal Gold) is an in vitro diagnostic test for qualitative determination of the concentration of N-terminal pro-Brain Natriurtic Peptide in human serum,plasma or whole blood.

【SUMMARY】

NT-proBNP mainly comes from ventricular myocytes.When left ventricular volume overloads or the intensity of contraction increase,proBNP,the cardiogenic prohormone,is released, decomposed into 76 amino acids constituted NT-proBNP and biologically active BNP.When congestive cardiac failure,concentrations of BNP and NT-proBNP in blood are significantly increased.Therefore the detection of NT-proBNP can provide potent reference for clinical diagnosis, treatment and prognosis evaluation for diagnostic of congestive heart failure.Comparing to BNP,NT-proBNP has a longer half-life within1-2 hours,a higher concentration of blood (about 15-20 times than the concentration of BNP).Meanwhile,NT-proBNP is much stable in vitro blood specimen,it can be stored for seven days at room temperature,for several months at -20℃.

Diagnosis of heart failure:a large number of clinical studies have shown, NT-proBNP is very sensitive in detection of left ventricular dysfunction, its blood concentration is closely related to the severity of heart failure,is of crucial clinical significance for staging the risk of congestive heart failure,forecasting sudden cardiac death,and monitoring of treatment and prognosis of heart failure. Meanwhile,since over 50% of the acute respiratory difficulties could be treated as heart failure clinically though they are not caused by heart failure,therefore the detection of NT-proBNP is of important clinical significance of cardiac and non-cardiac differential diagnosis of cute dyspnea.

Treatment and Prognosis Evaluation: NT-proBNP test is of great assistance in evaluation of patient outcomes and adjustment of the treatment. Meanwhile,the detection of NT-proBNP can help assess the prognosis of patients with heart failure.Studies have shown that patients with heart failure have favorable prognosis when the blood concentration of NT-proBNP reduce more than 30% after treatment.

【DIRECTIONS FOR USE】

Allow the test, specimen,buffer and/or controls to reach room temperature (15-30℃) prior to testing.

1.Bring all materials and specimens to room temperature.

2.Remove the test device from the sealed foil pouch,put in a clean,level surface.

3.Place the Device on a clean and level surface.

For serum and/or plasma specimen:

Hold the dropper vertically and transfer 2 drops of plasma or serum (approximately 50μl) to the specimen area, then add 1 drop of buffer (approximately 40μl),and start the timer.

For Venipuncture Whole Blood specimen:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μl) to the specimen area,then add 2 drops of buffer (approximately 80μl),and start the timer.See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube:Fill the capillary tube and transfer approximately 50μl of fingerstick whole blood specimen to the specimen area of test device,then add 2 drops of buffer (approximately 80μl) and start the timer. See illustration below.

To use hanging drops:Allow 2 hanging drops of fingerstick whole blood specimen

(approximately 50μl) to fall into the specimen area of test device,then add 2 drops of buffer (approximately 80μl) and start the timer.

4.Wait for the colored band(s) to appear.The result should be read at 15 minutes.Do not interpret the result after 20 minutes.