| 主权项 |
1. A biological process indicator for validating a treatment process in which the amount or activity of a contaminant in a sample is reduced, wherein the indicator comprises a thermostable kinase covalently linked to a biological component, wherein the biological component consists of a molecule that mimics the sensitivity of the contaminant to the treatment process and wherein the molecule consists of a blood protein, a fungal protein, a self-aggregating protein, a bacterial fimbrial protein, a bacterial toxin protein, a bacterial spore protein, a nucleic acid, a lipid, and a carbohydrate, with the proviso that the biological component is not an antibody, wherein:
(a) the fungal protein is a hydrophobin, a fungal spore protein, a hyphal protein, a mycotoxin, or a fungal prion; and (b) the self-aggregating protein is a prion, a prion mimetic protein, an amyloid fibril, beta amyloid protein, tau protein, polyadenine binding protein, lung surfactant protein C, a hydrophobin, a chaplin, a rodlin, a gram positive spore coat protein, or a barnacle cement-like protein; wherein the thermostable kinase has a reference activity, as measured by a luminometer or luminescent assay, of at least Relative Light Units (RLU) per mg kinase prior to the treatment process; wherein the thermostable kinase and the biological component are products of recombinant expression in bacteria; and wherein the biological process indicator is immobilized in or on a solid support. |
