About
AccuDX CQ NT-pro BNP Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of N-terminal B-type natriuretic peptide precursor (NT-pro BNP) in serum, plasma or whole blood. This test is used as an aid in the clinical diagnosis, prognosis and evaluation of Heart Failure (HF).
Summary:
N-terminal B-type natriuretic peptide precursor (NT-proBNP) is secreted from the left cardiac ventricle in response to volume and pressure overload. It’s an inactive N-terminal fragment that split from BNP prohormone. NT-proBNP can be used to evaluate heart contractile, diastolic dysfunction, and ventricular segmental wall motion coordination. Besides, it has high sensitivity and negative predictive value (>97%). As a gold standard recommended by the European Society of Cardiology, American Heart Association,and American College of Cardiology for the diagnosis and prognosis of heart failure, NT-proBNP is used to indicate heart failure patient
at the early stage, determine HF risk levels, monitor medical efficiency of HF drug, evaluate prognosis of HF patient and to distinguish dyspnea that caused by HF from other diseases. Furthermore, NT-proBNP is a risk assessment indicator for Acute Coronary Syndrome.
Specification
The test uses an anti-human NT-pro BNP monoclonal antibody conjugated with fluorescence latex and an anti-human NT-pro BNP polyclonal antibody coated on the test line. After the sample has been applied to the test strip, the fluorescence latex-label led anti-human NT-proBNP monoclonal antibody binds with the NT-proBNP in sample and forms a marked antigen-antibody complex. This complex moves to the test card detection zone by capillary action. Then marked antigen-antibody complex is captured on the test line by the anti-human NT-pro BNP polyclonal antibody. The fluorescence intensity of the test line increases in proportion to the amount of NT-pro BNP in sample. Then insert test card into ACCUDx CQ Immunofluorescence Quantitative Analyzer, the concentration of NT-proBNP in sample will be measured and displayed on the screen. The value will be stored in ACCUDx CQ Analyzer and available for downloading. The result can be easily transmitted to the laboratory or hospital information system.
1. ACCUDx CQ NT-pro BNP kit contains:
- ACCUDx CQ NT-proBNP test card in a sealed pouch with desiccant-25
- Disposable pipet
- Whole blood buffer
- SD/RFID card
- User manual
2. Whole blood buffer composition: Phosphate buffered saline, proteins, detergent, preservative, stabilizer.
3. A test card consists of: A plastic shell and a reagent strip which is composed of a sample pad,
nitrocellulose membrane (one end of the membrane is coated with a
fluorescence latex-labelled anti-human NT-proBNP monoclonal antibody, the test line is coated with another anti-human NT-proBNP monoclonal antibody and the control line is coated with rabbit anti-mouse IgG antibody) absorbent paper and liner.
Note: Do not mix or interchange different batches of kits,
Applicable Device:
ACCUDx CQ Immunofluorescence Quantitative Analyzer
Direction for Use
1. Collect specimen according to manual.
2. Test card, sample and reagent should be brought to roomtemperatureprior to testing.
3. Confirm SD card lot No. in accordance with test kit lot No.. Perform “SDCard Calib” calibration when necessary (Details refer to 8.5.2of Getein1100 User Manual).
4. On the main interface of Getein1100, press “”ENT”” button to enter testinginterface.
5. Remove the test card from the sealed pouch immediately beforeuse. Label the test card with patient or control identification.
6. Put the test card on a clean table, horizontally placed.
7. Using sample transfer pipette, deliver 100 μl of sample into one tube of sample diluent, mix gently and thoroughly. Then drop 100 μl (or 3dropsof sample when using disposable pipet) of sample mixture into the sample port on the test card.
8. After 10 minutes, insert the test card into Getein1100 and press “ENT” button. The result will be shown on the screen
Other Info
Store the test card at 4~30oC with a valid period of 24 months.
Use the test card within 1 hour once the foil pouch is opened.
Store the blood sample diluent at 0~30oC with a valid period of 24 months.
Store the blood sample diluent at 2~8oC for better results.
Amit –
quality product for diagnostic use