One step test for NT-proBNPcTnI

Intended Use:

One Step Test for NT-proBNP/cTnI (Colloidal Gold) applies colloidal gold immunochromatography

to detect N-terminal B-type natriuretic peptide precursor/cardiac Troponin I (NT-proBNP/cTnI) in serum

and plasma samples semi -quantitatively or quantitatively. The combined detection of NT-proBNP/cTnI

can help doctors diagnose, prognose and grade Heart Failure and Acute Coronary Syndrome more

thoroughly.

Principle of the Procedure:

Two high specific and sensitive anti-human cardiac Troponin I monoclonal anti bodies, one high

specific and sensitive NT-proBNP monoclonal antibody and one NT-proBNP polyclonal antibody are used

for the test strips. Among other things, one cTnI monoclonal antibody and the NT-proBNP monoclonal

antibody are biotinylated, gold-l abelled and coated on the polyester film, the other cTnI monoclonal antibody

and the NT-proBNP polycolonal antibody are fixed on the test lines of the product. The antibodies form

sandwich complexes with any NTproBNP/cTnI in the blood sample. The sample passes through the

detection zone, in which the sandwich complexes gather along a line, appearing as a purplish red

streak (the test or signal l ine). Excess goldlabelled antibodies gather along the control line, signaling

visually that the test is valid. The intensity of the test line increases in proportion to the NT-proBNP/cTnI

concentration.

Test Procedure:

1. Restore the test card and the blood specimen to room temperature (20~25°C better).

2. Opening the pouch and label the strip with the patient specimen number.

3. Use the pipette to transfer blood from a sample collection tube.

4. Release the bulb slowly, dropping 3 to 4 drops (or 120 μl) of the sample.

5. Referring to the standard colorimetric card, get the semi-quantitative result by eye, or read the quantitative

result with the matching equipment. The result must be read within 10~30 mins.

Warnings and Precautions:

1. Use for in vitro diagnostics.

2. Use by healthcare professionals.

3. The best testing temperature is 15~30 C, and the best humidity is 40~60%.

4. Do not use the stri p beyond the expiration date printed on the outside of the box.

5. The strip must be used within 1 hour once its foil pouch has been opened.

6. The transfer pipette shoul d be used for one specimen only. Discard it after used.

7. Patient specimens, used strip and transfer pipettes may be potentially infectious. Proper handling and disposal

methods should be established by the laboratory direction in accordance with local regulations.

8. Proper laboratory safety techniques should be followed at all times when working with potentially infectious

blood specimens.