# US 4,391,796 A · Hepatitis B testing and growth in tree shrew as animal model

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- Number: US 4,391,796 A
- Document ID: US4391796A
- Status: Granted
- Kind: A
- Application number: 06/370,399
- Filed: 1982-04-21
- Granted: 1983-07-05
- Earliest claimed: 1979-09-04
- Assignees: Battelle-Institut e.V.
- Inventors: Peter Lorenz; Anita Schwaier
- Web page: https://patentgrep.com/patent/US4391796A

## CPC

- G01N 33/5761: {Hepatitis B}
- G01N 33/5768: {Hepatitis A}
- A01K 2227/106: Primate
- Y10S 436/82: Hepatitis associated antigens and antibodies
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- A01K: ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

Tree shrews (Tupaia belangeri) are used as an animal model to test the inactivation of vaccines, the harmlessness of blood products and the effectiveness of chemotherapeutic agents and disinfectants against viral hepatitis. The antibody determinations are performed at specific intervals for a period of 150 days in the case of viral hepatitis type A and 60 days in the case of viral hepatitis type B.

## Claims

### Claim 1

Process for the growth and collection of viral hepatitis antigen type B from a tree shrew (Tupaia belangeri), which is used as an animal model, comprising:
(a) infecting said tree shrew with viral hepatitis type B;
(b) performing at least one antibody determination at specific intervals over a period of about 60 days after infection of said tree shrew; and
(c) obtaining said viral hepatitis antigen type B from said infected tree shrew.

### Claim 2 (depends on 1)

Process as claimed in claim 1 wherein the immune defense of said tree shrew has perviously been suppressed by adequate therapy.

### Claim 3 (depends on 2)

Process as claimed in claim 2 wherein said antibody determinations are conducted at weekly intervals over a period of 60 days after infection of said tree shrew.

### Claim 4 (depends on 2)

Process as claimed in claim 2 wherein said viral hepatitis antigen type B is obtained from an organ or organs or excretion or a mixture thereof of the infected tree shrew.

### Claim 5 (depends on 2)

Process as claimed in claim 2 wherein said viral hepatitis antigen type B is obtained from one or more cell cultures made from an organ or organs or excretion or mixture thereof of the infected tree shrew.

### Claim 6 (depends on 4, 5)

Process as claimed in claim 4 or 5 wherein said antibody determinations are performed twice in the first week after said infection of said tree shrew, such antibody determinations beginning at least by the fourth day after said infection of said tree shrew.

### Claim 7

Process for testing the effectiveness of a disinfectant against viral hepatitis type B comprising:
(a) admixing a specific quantity of said viral hepatitis type B to form a suspension;
(b) removing said viral hepatitis type B from said suspension;
(c) admixing said viral hepatitis type B from step (b) with a physiological buffer to form a suspension;
(d) vaccinating a tree shrew (Tupaia belangeri), which is used as an animal model, with the suspension from step (c); and
(e) performing at least one antibody determination at specific intervals over a period of about 60 days after infection of said tree shrew,
whereby said disinfectant is determined to be effective or ineffective against said viral hepatitis type B if said tree shrew, respectively, does not contract viral hepatitis or does contract viral hepatitis.

### Claim 8 (depends on 7)

Process as claimed in claim 7 wherein said removal steps (b) is achieved by means of centrifugation.

### Claim 9 (depends on 8)

Process as claimed in claim 8 wherein said antibody determinations are conducted at weekly intervals over a period of 60 days after infection of said tree shrew.

### Claim 10 (depends on 8, 9)

Process as claimed in claim 8 or 9 wherein said antibody determinations are performed twice in the first week after said vaccination of said tree shrew, such antibody determinations beginning at least by the fourth day after said vaccination of said shrew.

### Claim 11

Process for testing the antiviral effectiveness of a chemotherapeutic agent against viral hepatitis type B comprising:
(a) infecting a tree shrew (Tupaia belangeri), which is used as an animal model, with viral hepatitis type B;
(b) administering said chemotherapeutic agent to said infected tree shrew; and
(c) performing at least one antibody determination at specific intervals over a period of about 60 days after infection of said tree shrew,
whereby said chemotherapeutic agent is determined to be ineffective against said viral hepatitis type B if said antibody determination detects anti-HBcAg antibody in said tree shrew.

### Claim 12 (depends on 11)

Process as claimed in claim 11 wherein said antibody determinations are conducted at weekly intervals over a period of 60 days after infection of said tree shrew.

### Claim 13 (depends on 12)

Process as claimed in claim 12 wherein said antibody determinations are performed twice in the first week after said vaccination of said tree shrew, such antibody determinations beginning at least by the fourth day after said vaccination of said tree shrew.

### Claim 14

Process for testing for the absence of viral hepatitis type B in blood products comprising:
(a) administering said blood product to a tree shrew (Tupaia belangeri), which is used as an animal model, with viral hepatitis type B; and
(b) performing at least one antibody determination at specific intervals over a period of about 60 days after infection of said tree shrew,
whereby said blood product is determined to contain said viral hepatitis type B if said antibody determination detects anti-HBcAg antibody in said tree shrew.

### Claim 15 (depends on 14)

Process as claimed in claim 14 wherein said antibody determinations are conducted at weekly intervals over a period of 60 days after infection of said tree shrew.

### Claim 16 (depends on 15)

Process as claimed in claim 15 wherein said blood products was intraveneously administered to said tree shrew.

### Claim 17 (depends on 15, 16)

Process as claimed in claim 15 or 16 wherein said antibody determinations are performed twice in the first week after said vaccination of said tree shrew, such antibody determinations beginning at least by the fourth day after said vaccination of said tree shrew.

### Claim 18

Process for testing the antiviral ineffectiveness of a vaccine against viral hepatitis type B comprising:
(a) infecting a tree shrew (Tupaia belangeri), which is used as an animal model, with viral hepatitis type B;
(b) administering said vaccine to said infected tree shrew; and
(c) performing at least one antibody determination at specific intervals over a period of about 60 days after infection of said tree shrew,
whereby said vaccine is determined to be ineffective against said viral hepatitis type B if said antibody determination detects anti-HBcAg antibody in said tree shrew.

### Claim 19 (depends on 18)

Process as claimed in claim 18 wherein said antibody determinations are conducted at weekly intervals over a period of 60 days after infection of said tree shrew.

### Claim 20 (depends on 18)

Process as claimed in claim 18 wherein said vaccine was intraveneously administered to said tree shrew.

### Claim 21 (depends on 19, 20)

Process as claimed in claim 19 or 20 wherein said antibody determinations are performed twice in the first week after said vaccination of said tree shrew, such antibody determinations beginning at least by the fourth day after said vaccination of said tree shrew.
