Alere NT-proBNP for Alinity i

The Alere NT-proBNP for Alinity i is a chemiluminescent microparticle immunoassay that quantitatively measures N-terminal pro B-type natriuretic peptide (NT-proBNP) in human serum and plasma. It is used in emergency departments to aid diagnosis of heart failure in patients with suspected new or worsening heart failure, and for 12-month risk stratification of mortality and hospitalization outcomes in diagnosed patients.

The subject device uses chemiluminescent microparticle immunoassay (CMIA) technology, whereas the predicate uses electrochemiluminescent microparticle immunoassay (ECLIA). Both are sandwich immunoassays measuring NT-proBNP quantitatively. The subject device has an analytical measuring interval of 15.8 to 35,000 pg/mL compared to the predicate's 5 to 35,000 pg/mL, and shows no hook effect up to 372,620 pg/mL versus the predicate's 300,000 pg/mL.

Assay standardization is traceable to internal reference standards made traceable to the predicate device by transference using Clinical and Laboratory Standards Institute (CLSI) Document EP32-R. No international recognized reference method or reference material currently exists for standardization.

The subject device is substantially equivalent to the Roche Elecsys proBNP II predicate because both measure the same analyte using similar sandwich immunoassay principles with monoclonal antibodies and chemiluminescent detection in identical specimen types (serum and plasma). Though the detection mechanism differs (CMIA vs. ECLIA), the identical intended uses, clinical indications, and demonstrated clinical performance through a 12-month prospective follow-up study of 861 heart failure patients establish substantial equivalence.