PREPARATION OF HIGHLY CONCENTRATED ALLERGENIC INTERMEDIATE

1 . A process for preparing a highly concentrated allergenic intermediate from a dilute allergen extract, said process comprising:

providing a crude extract comprising biological material from an allergenic source, wherein the biological material comprises a solid phase portion and a liquid phase portion;

concentrating the crude extract using pervaporation;

adjusting the pH of the concentrated crude extract to 4.0-5.0;

treating the concentrated extract with a ketonic solvent to form a precipitate; and

recovering the precipitate by filtration to obtain a highly concentrated allergenic intermediate.

2 . The process according to claim 1 , wherein said providing a crude extract comprises:

contacting an allergenic source material with an extraction fluid;

extracting biological material from the allergenic source into the extraction fluid, wherein said extracting is carried out with no adjustment to pH; and

separating the biological material into a solid phase portion and a liquid phase portion to obtain a crude extract.

3 . The process according to claim 2 , wherein the allergenic source material is selected from house dust mite allergen, insect allergen, venom allergen, animal hair and dander allergen, food allergen, and combinations thereof.

4 . The process according to claim 2 , wherein said allergenic source material is contacted with the extraction fluid at a concentration ratio of 1:4 to 1:8.

5 . The process according to claim 2 , wherein said extracting is carried out for 2-6 days.

6 . The process according to claim 2 , wherein said extracting is carried out at a temperature of −5° C. to 30° C.

7 . The process according to claim 2 , wherein said allergenic source material comprises animal hair and dander allergen.

8 . The process according to claim 7 , wherein said allergenic source is contacted with said extraction fluid at a concentration ratio of 1:6-7.

9 . The process according to claim 7 , wherein said extracting is carried out for 3-5 days.

10 . The process according to claim 2 , wherein said extracting is carried out at a temperature of 0° C.-5° C.

11 . The process according to claim 2 , wherein said separating is carried out using filtration, centrifugation, or a combination thereof.

12 . The process according to claim 1 , wherein said concentrating is carried out in the absence of a conductivity test.

13 . The process according to claim 1 , wherein said concentrating is carried out to a concentration equal to or less than 20% of original volume.

14 . The process according to claim 1 further comprising:

repeating said treating.

15 . The process according to claim 1 further comprising:

subjecting the precipitate to lyophilization or vacuum drying after said recovering.

16 . The process according to claim 15 further comprising:

subjecting the lyophilized or vacuum dried precipitate to reconstitution to form a highly concentrated extract.

17 . A kit for compounding allergenic intermediate comprising:

a) a first container comprising a lyophilized allergenic intermediate,

b) a second container comprising a liquid diluent, and

c) optionally instructions for preparation and use,

wherein the content of first and second containers can be combined to achieve BAU/mL concentration of allergenic extract.

18 . The kit according to claim 17 , wherein the second container comprises a liquid diluent comprising glycerol-cocas fluid.

19 . The kit according to claim 18 , wherein the glycerol-cocas fluid comprises sodium chloride, 0.275% sodium bicarbonate, and 52.5% glycerin in water for injection.

20 . A method of diagnosing cat allergy in an individual by skin prick method using the kit according to claim 17 , wherein clinical parameters are selected from the group consisting of sensitivity, specificity, negative predictive value, and positive predictive value and wherein the sensitivity of said method is at least 90%, specificity is at least 60%, negative predictive value in a population having a cat allergy prevalence of at least 75% and positive predictive value in a population having a cat allergy prevalence of at least 80%.