NT-proBNP FIA Test

The N-terminal-pro hormone BNP (NT-proBNP) Fluorescence ImmunoAssay (FIA) Test is a lateral flow chromatographic fluorescence immunoassay for the quantitative detection of NT-proBNP in human serum, plasma or whole blood,  using the RaFIA system. This test is intended for in vitro diagnostic use only.

NT-proBNP was advocated as a beneficial biomarker for evaluating heart failure by the American Association for Clinical Chemistry in 2007 and is allowed to be used for diagnosis and evaluation of heart failure and acute coronary syndrome by the USFDA. There is also evidence suggesting that NT-proBNP has prognostic value in evaluating the increased risk of cardiovascular disease and the mortality of stable coronary artery disease.

The NT-proBNP FIA Test was developed to detect circulating NT-proBNP in serum, plasma and whole blood within 15 minutes, without the use of cumbersome laboratory equipment, and requiring minimally trained laboratory personnel.

  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests

RANGES:

  • Working range: 15–35000 pg/mL

PRECISION:

  • Intra-lot Precision: Intra-lot precision was determined by testing of NT-proBNP reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of NT-proBNP reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 15%.

ACCURACY:

  • NT-proBNP control materials with two different concentrations were tested by every lot of test device, and the deviations were within ±15%.

LINEARITY:

  • A serial concentration of NT-proBNP reference materials at 15–35000 pg/mL was tested, and the correlation coefficient (R) is ≥0.9900.

 

REAGENTS AND MATERIALS PROVIDED:

  1. Individually sealed foil pouches containing:
    a. One test device
    b. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use

MATERIALS REQUIRED BUT NOT PROVIDED:

  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

Instructions for Use

Catalog #

Product

F3050

NT-proBNT FIA Test

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To learn about distribution opportunities or for additional product information, please contact info@ctkbiotech.com

FOR EXPORT ONLY