Covalently linked thermostable kinase for decontamination process validation

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 is selected from a group consisting 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 1,000,000 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.

2. The biological process indicator of claim 1 , wherein said blood protein is a blood clotting protein, a serum protein, a platelet protein, a blood cell glycoprotein, or haemoglobin.

3. The biological process indicator of claim 2 , wherein said blood clotting protein is fibrin, fibrinogen, or a transglutaminase substrate.

4. The biological process indicator of claim 1 , wherein the nucleic acid is a DNA molecule or an RNA molecule.

5. The biological process indicator of claim 1 , wherein the carbohydrate is a exopolysaccharide or a lipopolysaccharide, a peptidoglycan, a chitin, a glucan, a lignin, a mucin, a glycolipid, a glycoprotein, a spore extract, a polysaccharide from yeast capsules, or an invertebrate secretion.

6. The biological process indicator of claim 1 , wherein the lipid is a glycolipid or a ganglioside.

7. The biological process indicator of claim 1 , wherein the indicator is part of a biological matrix.

8. The biological process indicator of claim 7 , wherein the biological matrix is a mimetic of the sample.

9. The biological process indicator of claim 7 , wherein the biological matrix comprises one or more components consisting of blood, serum, albumin, mucus, egg, neurological tissue, food, culled animal material, or a commercially-available test soil.

10. The biological process indicator of claim 1 , wherein the thermostable kinase is an adenylate kinase, an acetate kinase or a pyruvate kinase.

11. The biological process indicator of claim 1 , wherein the thermostable kinase comprises an amino acid sequence comprising SEQ ID NOS:1-25, 31, 32, 34-36, 38, 40, 42, 48-50, 52, 54, 61, 67, 72, or 73.

12. The biological process indicator of claim 1 , wherein the thermostable kinase is encoded by a DNA comprising a nucleotide sequence comprising SEQ ID NOS:26-30, 37, 39, 41, 42, 47, 49, 51, 53, or 60.

13. A biological process indicator of claim 1 , wherein the indicator further comprises an agent to stabilize the kinase.

14. The biological process indicator of claim 13 , wherein the stabilizing agent is a metal ion, a sugar, a sugar alcohol or a gel-forming agent.

15. The biological process indicator of claim 1 , wherein the biological component and the kinase are linked together in the form of a fusion protein.

16. The biological process indicator of claim 1 , wherein the biological process indicator is immobilized in or on the solid support by chemical cross-linking or adsorption.

17. The biological process indicator of claim 1 , wherein the solid support is an indicator strip, a dip-stick or a bead.

18. A kit for use in validating a treatment process in which the amount or activity of a contaminant in a sample is reduced, comprising:

(a) a biological process indicator comprising a thermostable kinase covalently linked to a biological component that mimics the sensitivity of the contaminant to the treatment process, consisting 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

i. the fungal protein is a hydrophobin protein, a fungal spore protein, a hyphal protein, a mycotoxin, or a fungal prion;

ii. the self-aggregating protein is a prion, a prion mimetic protein, a 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, and a barnacle cement-like protein; and

(b) a substrate for the thermostable kinase;

wherein the thermostable kinase has a reference activity, as measured by a luminometer or luminescent assay, of at least 1,000.000 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.

19. The kit of claim 18 , wherein the substrate for the thermostable kinase is ADP.

20. The kit of claim 18 , further comprising luciferin/luciferase.

21. The kit of claim 18 , further comprising a look-up table correlating the kinase activity of the indicator with the amount or activity of the contaminant.