NT-proBNP iCLIA

Intended Use

NT-proBNP iCLIA Diagnostic Kit is intended for the in vitro quantitative measurement of NT-proBNP in human serum/plasma as an aid in the diagnosis of Cardiac Failure in conjunction with other laboratory and clinical findings. This kit is only operational in conjuction with J. Mitra CLIA Analyzer.

Salient Features

• Based on Sandwich chemiluminescent microparticle immunoassay
• Acridinium Ester (AE) based kit for more accurate results
• Test result within 15 minutes
• Linearity:30 pg/ml to 30000 pg/ml
• Long shelf life: 12 months at 2-8^oC
• On-board stability of reagents: 30 days at 2-8^oC
• Convenient pack size: 50 Tests
• Prompt service back-up

Principle

NT-proBNP iClia is chemiluminescent immunoassay based on the “Sandwich” Principle. The magnetic microspheres are coated with Anti-NT-proBNP antibodies. The samples are added in the assay cup containing assay buffer and Anti-NT-proBNP antibodies coated microspheres followed by addition of AE Conjugate (Anti-NT-proBNP antibodies linked to acridinium ester) to assay cup. A sandwich complex is formed wherein NT-proBNP (from serum sample) is “Trapped” or “sandwiched” between the microspheres coated antibody and antibody Labelled with AE conjugate. Unbound conjugate is then washed off with wash Buffer. The amount of bound AE conjugate is proportional to the concentration of NT-proBNP present in the sample. Finally pre-trigger and trigger solution Containing hydrogen peroxide and sodium hydroxide solution is added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is a direct relationship between the amount of NT – proBNP present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the established calibration curve.

Performance Characteristics

Limit of Blank (LoB) : ≤ 25 pg/ml

Accuracy:

The accuracy of NT-pro BNP iClia was detected with 60 clinical Specimen and compared with Roche CLIA. The co-relation co-efficient is ≥0.990.

Precision:

1. The test results are repeatable with NT -proBNP samples (Low and High) and kit controls in within run precision testing with CV <10%.
2. The test results are reproducible with NT -proBNP samples (Low and High) and kit controls in between run precision testing with CV <10%.
3. The test results are reproducible with NT -proBNP samples (Low and High) and kit controls in between instrument precision testing with CV <10%.

Ordering Information