Intended Use:the quantitative in vitro diagnostic
determination of pyridoxal 5’-phosphate (PLP, vitamin B6) in
EDTA-Plasma. The device will be used to monitor PLP
concentrations in plasma for aid in diagnosis of vitamin B6
deficiency. The A/C Enzymatic Vitamin B6 Assay is for in vitro
diagnostic use only.
Principle of the A/C B6 Assay
assay is based on a PLP-dependent recombinant
homocysteine-α,γ-lyase (rHCYase), which is prepared in the apo-enzyme
form by stripping off the cofactor PLP (vitamin B6). The
restoration of enzymatic activity by reconstitution of the
holoenzyme depends on the amount of PLP in the plasma bound to
apo-enzyme and production of H2S by the enzymatic reaction. H2S
combines with DBPDA, the combination of which forms chromophore.
The absorbance of this compound is read at 675 nm (660- -680nm).
PLP in Plasma
+ H2S + NH3
2. Correlation of A/C Enzymatic B6 Assay with ALPCO B6 REA