A CLIA test kit for the quantitative determination of N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) in human whole blood, serum or plasma with the use of Automatic Chemiluminescence Immunoassay Analyzer.
【INTENDED USE】
The N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) Test Kit (CLIA) is intended for quantitative determine of the concentration of N-Terminal pro-B-type Natriuretic Peptide (NT-proBNP) in human whole blood, serum and plasma, as an aid in the diagnosis of heart failure.
For professional in vitro diagnostic use only.
【SUMMARY】
B-type natriuretic peptide (BNP) is a small peptide (32 amino acids) secreted by heart myocytes to augment regulation of blood pressure and fluid balance. This peptide is synthesized by ventricular cells and stored as ProBNP (108 amino acids). ProBNP is secreted into the bloodstream as the 32 (77-108) amino acids active BNP and the N-terminal fragment of 76 (1-76) amino acids designated NT-proBNP.
Determination of NT-proBNP can help to identify individuals with left ventricular dysfunction. Changes in NT-proBNP concen tration can be used to evaluate the success of treatment in patients with left ventricular dysfunction. Stability of NT-proBNP in whole blood samples is 72 hours. The European Heart Society Heart Failure guidelines recommend natriuretic peptide concentrations, including NT-proBNP, as a preliminary diagnostic test. Patients with NT-proBNP levels below the recommended non-acute and acute episodes of NT-proBNP cutoff values are unlikely to have HF and therefore need no echocardiography, and elevated NT-proBNP helps confirm patients requiring further cardiac examination.
The high sensitivity of NT-proBNP also allows it to monitor mild cardiac dysfunction in patients with asymptomatic organic heart disease.
【PRINCIPLE】
This product uses the double antibody sandwich method. In the first step, the sample, the NT-proBNP antibody labeled with alkaline phosphatase and the magnetic particles coated with the NT-proBNP antibody are mixed.
After incubation, the NT-proBNP in the sample forms an immune complex with the corresponding antibody. In the second step, magnetic separation and cleaning are performed to remove free enzyme-labeled antibodies.
The third step is to add the chemiluminescent substrate solution to the immune complex. Luminescence signal generated by the enzyme reaction is detected by Automatic Chemiluminescence immunoassay Analyzer and the detected luminescence intensity is related to the concentration of NT-proBNP in the sample. Automatic Chemiluminescence Immunoassay Analyzer can calculate the concentration of NT-proBNP in the sample.
【REAGENTS】
The reagent strip includes NT-proBNP antibody coated with magnetic particles, alkaline phosphatase labeled NT-proBNP antibody, wash buffer and substrate solution.
【INTERPRETATION OF RESULTS】
The NT-proBNP test result should be calculated by Automatic Chemiluminescence Immunoassay Analyzer and displayed on the screen. For additional information, please refer to the user manual of Automatic Chemiluminescence Immunoassay Analyzer.
【EXPECTED RESULTS】
According to the non-parametric method, this reagent performs a 90% median analysis on the NT-proBNP test results of 211 normal population samples with a 95% confidence level and the 95% percentile concentration value is less than 125pg/mL.
Due to differences in geography, race, gender, and age, it is recommended that each laboratory establish its own reference value (range).
