【Product name】NT.pdf

N-terminal prohormone of brain natriuretic peptide (NT-proBNP) Rapid Quantitative Test(Fluorescence immunoassay)

【Intended use】

This kit is used for quantitative determination of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in human whole blood and plasma,serum.

【Inspection principle】

The principle of immunofluorescence chromatography was applied to the kit. The NT-proBNP antigen in the sample was first bound with the conjugated compound of fluorescent labeled NT-proBNP monoclonal antibody, then moved and combined with another NT-proBNP monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.

【Main components】

The components in different batches of kits cannot be used interchangeably.

【Procedure】

1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.

2. Start NIR-1000 dry fluoroimmunoassay analyzer according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the information card. The information card is inserted before use, so it is not necessary to calibrate again, and the test can be carried out only after the quality control is passed; Otherwise, the cause should be found out before testing.)

3. Remove the test card from the aluminum foil bag and use it within 15 minutes.

4. Place the test card on a clean horizontal table and mark it horizontally.

5. Mix 100µL of patient sample with 300µL of sample diluent. Apply 100µL of diluted samples to the well of the test card.

6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyzer, press the [timing detection] key, automatically time for 10 minutes, automatically judge the test results, and display the quantitative results on the screen. Or insert the test card into the analyzer after timing for 10 minutes, and press the [real time detection] key, and the instrument will automatically interpret the test results.

【Reference interval】

Healthy subjects under 75 years old have assay values below 347pg/mL. Healthy subjects over 75 years old have assay values below 449pg/mL.

【Interpretation of results】

This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.

【Performance】

1. Analysis sensitivity

No more than 18pg/mL.

2. Accuracy

The relative deviation from the target value is within ±10%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (20-35000pg/mL), the linear correlation coefficient R≥0.990.