Table 1.
Commercial diagnostic tests | Capture antibody | Detection antibody | Standard material | FDA cleared yes/no/claim |
---|---|---|---|---|
Abbott Architect, AxSYM iSTAT |
NH2 terminus and part of the ring structure (Scios), murine monoclonal AB, aa 5–13 | COOH terminus, murine monoclonal AB, aa 26–32 | Synthetic BNP 32 | Assist in diagnosis of HF Assess severity of disease |
Alerea
Triage BNP |
NH2 terminus and part of the ring structure (Scios), murine monoclonal AB, aa 5–13 | BNP (Biosite), murine omniclonal AB, epitope not characterized | Recombinant BNP | Aid in diagnosis and severity assessment of HF Risk stratification of patients with ACS and HF FDA cleared |
Beckman Coultera
Access, Access 2, DxI |
BNP (Biosite), murine omniclonal AB, epitope not characterized | NH2 terminus and part of the ring structure (Scios), murine monoclonal AB, aa 5–13 | Recombinant BNP | Diagnosis HF Assess severity HF Risk ACS Risk HF |
Siemens (Bayer) ACS 180, Advia Centaur, Advia Centaur CP |
COOH terminus (BC-203) (Shionogi), murine monoclonal AB, aa 27–32 | Ring structure (KY-hBNPII) (Shionogi), murine monoclonal AB | Synthetic BNP | Aid in diagnosis and severity assessment of HF Predict survival and likelihood of future HF in ACS patients |
Siemens (Dade Behring) Dimension VISTA Dimension ExL |
Ring structure (KY-hBNPII) murine monoclonal AB, aa 14–21 | COOH terminus (BC-203), murine monoclonal AB, aa 27–32 | Synthetic BNP 32 | Aid in diagnosis and severity assessment of HF Predict survival and likelihood of future HF in ACS patients Pending FDA clearance |
Shionogi | COOH terminus (BC-203), murine monoclonal AB, aa 27–32 | Ring structure (KY-hBNPII), murine monoclonal AB | Synthetic BNP | Not FDA cleared |
Tosoh ST AIA-PACK BNP |
COOH terminus (BC-203), murine monoclonal AB, aa 27–32 | Ring structure (KY-hBNPII), murine monoclonal AB | Synthetic BNP | Not FDA cleared |
CHF congestive heart failure, ACS acute coronary syndrome, aa amino acid, AB antibody
aBoth the Alere and Beckman systems use the same two antibodies, but due to their different assay formats, designation of the monoclonal and omniclonal antibodies as capture and detection antibody is not absolute