NT-ProBNP Rapid Test Kit Fluorescence Immunoassay Cardiac Testing

Product Specification

                                      N-terminal Pro-B-Type Natriuretic Peptide Test Kit Wwhs Fia Poct Fluorescence Immunoassay

【Description of Natriuretic Peptide Test Kit】
N-terminal prohormone of brain natriuretic peptide (NT-proBNP) Rapid Quantitative Test(Fluorescence immunoassay)
【Package specification】
25 Tests/kit,40 Tests/kit
【Intended use】
N-terminal Pro-B-Type Natriuretic Peptide Test Kit is used for quantitative determination of N-terminal prohormone of brain natriuretic peptide (NT-proBNP) in human whole blood and plasma,serum.
【Main components】

The components in different batches of N-terminal Pro-B-Type Natriuretic Peptide Test Kits cannot be used interchangeably.
【Applicable instruments】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
【Sample requirements】

1. The sample types of this N-terminal Pro-B-Type Natriuretic Peptide Test Kits are EDTA·K2 anticoagulant plasma, EDTA·Na2 anticoagulant plasma, sodium citrate (anticoagulant tube with the ratio of sodium citrate volume to blood collection volume of 1:9), EDTA·K2 anticoagulant whole blood, EDTA·Na2 anticoagulant whole blood and sodium citrate (anticoagulant tube with the ratio of sodium citrate volume to blood collection volume of 1:9).

2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.

3. After clinical samples were collected, the detection was completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored for 24 hours at 2℃~8℃; Plasma samples can be stored at 2℃ to 8℃ for 7 days; The plasma sample was at - 20℃. It can be stored for 30 days at room temperature.

4. Before testing, the sample must return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use, and repeated freezing and thawing should be avoided.

【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】

1. 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.

2. For samples with NT-proBNP concentration lower than 18pg/mL and higher than 35000pg/mL, the detection results are reported as "< 18pg/mL " and ">35000pg/mL ", respectively.

【Limitations of methods】

1. Natriuretic Peptide Test Pro-B-Type Natriuretic Peptide Test Kit is only used to detect human plasma/whole blood samples

2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.

3. The content of triglyceride in the sample shall not exceed 15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the content of bilirubin shall not exceed 0.5mg/ml, and the relative deviation of the test results shall not exceed ±15%.

4. When the concentration of NT-proBNP in the sample is less than 35000pg/mL, there is no hook effect.

5. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.

6. When RF concentration in the sample of Pro-B-Type Natriuretic Peptide Test Kit is less than 2000IU/ml, the relative deviation of the test results is within ±15%.
【Note】
1. N-terminal Pro-B-Type Natriuretic Peptide Test Kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and cannot be reused.
3. Please check the integrity and validity of the N-terminal Pro-B-Type Natriuretic Peptide Test Kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃~30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used N-terminal Pro-B-Type Natriuretic Peptide Test Kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
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