Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving virus or bacteriophage
Patent
1996-04-24
1999-03-23
Knode, Marian C.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving virus or bacteriophage
435 71, 435 693, 530300, 530324, 530326, 530806, 530826, C12Q 170, G01N 33569, A61K 3929, A61K 39295
Patent
active
058857710
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to an antigenic peptide compound and an immunoassay which are useful for measuring an antibody relating to HCV (hepatitis C virus).
BACKGROUND ART
Various kinds of viruses exist on the earth, and some of them are pathogens. For example, it is known that a hepatitis virus as a cause of viral hepatitis is transmissible at the time of blood transfusion, injection, childbirth, etc.
The blood transfusion is one of the important measures for maintaining the life of a human being. However, there have heretofore been reported a large number of cases such that the blood transfusion causes viral hepatitis. In general, the viral hepatitis is classified into hepatitis A, hepatitis B and non-A non-B hepatitis.
Conventionally, it is known that hepatitis B virus (HBV) also causes viral hepatitis at the time of the blood transfusion. In recent years, a diagnostic reagent for detecting the presence of the HBV has been developed, and it has become possible to easily confirm the presence of the HBV prior to the blood transfusion. Accordingly, the HBV infection of a human being due to the blood transfusion has entirely been prevented. On the other hand, it is also known the existence of another hepatitis (non-A non-B hepatitis) which is clearly viral, but is different from the hepatitis A caused by hepatitis A virus (HAV) and also different from the hepatitis B caused by HBV, while the HAV and HBV have heretofore been considered as the causes of hepatitis. However, it has heretofore been considered to be difficult to confirm the cause (virus) of such non-A non-B hepatitis.
In 1989, Choo, Q-L. et al. (Science, 244, 359-362, 1989) and Kuo ,G. et al. (Science, 244, 362-364, 1989) proved the existence of the non-A non-B hepatitis virus. This hepatitis virus was named "HCV" (hepatitis C virus). It has heretofore been reported that the HCV is selectively transmissible to a human being and a chimpanzee.
The above-mentioned paper describes the following experiments. That is, a preparation of blood coagulation Factor VIII which was the same as the preparation which had caused the non-A non-B hepatitis when administered to a patient, was administered to a Chimpanzee-No. 1 thereby to cause non-A non-B hepatitis. Further, a preparation extracted from the liver of the above Chimpanzee-No. 1 was similarly administered to a Chimpanzee-No. 2 thereby to cause non-A non-B hepatitis, and thereafter, the blood plasma of this Chimpanzee-No. 2 was extracted. The resultant blood plasma of the Chimpanzee-No. 2 was further administered to a Chimpanzee-No. 3, whereby the occurrence of non-A non-B hepatitis was confirmed. The resultant blood plasma which had confirmedly cause the disease, was subjected to a concentration procedure for virus particles (Bradley, D. W. et al.; Gastroenterology, 88: 773-779, 1989) under the assumption that the virus to be obtained was flavivirus, whereby RNA of the virus was extracted. Then, cDNA was synthesized on the basis of the thus obtained RNA, and a .lambda.gt11 library was prepared. With respect to the resultant .lambda.gt11 library, immunoscreening was conducted by using the blood serum of a convalescent chimpanzee or the blood serum of a chronic non-A non-B hepatitis patient, thereby to select a reactive clone. As a result, it was confirmed that only the clone named "5-1-1" was a cDNA fragment originated from HCV.
The above-mentioned procedure is also described in Japanese Patent Publication (KOKOKU) No. Hei 2-500880 (500880/1990), wherein the genetic sequence thereof is also shown. In addition, a genetic sequence of the HCV was also reported in Japan (Journal of Virology, 65(3), 1105-1113, 1991).
In the meeting of ACTA HEPATOLOGICA JAPONICA in June of 1990, a genetic sequence of the HCV structural region was shown by Okamoto of Jichi Medical School et al. (Proceedings of the 26th Meeting of ACTA HEPATOLOGICA JAPONICA in 1990). In the meeting of Japan Cancer Society in July of 1990, a genetic sequence of the HCV structural region was shown (Proceedings of the 49th
REFERENCES:
Choo et al, "Isolation of a cDNA Clone Derived from a Blood-Borne Non-A, Non-B Viral Hepatitis Genome", Science, Apr. 1989, vol. 244, pp. 359-363.
Kuo et al, "An Assay for Circulating Antibodies to a Major Etiologic Virus of Human Non-A, Non-B Hepatitis", Science, Apr. 1989, vol. 244, pp. 362-364.
Bradley et al, "Posttransfusion Non-A, Non-B Hepatitis in Chimpanzees", Gastroenterology, vol. 88, 1985, pp. 773-779.
Takamizawa et al, "Structure and Organization of the Hepatitis C Virus Genome Isolated from Human Carriers", Journal of Virology, 1991, vol. 65, No. 3, pp. 1105-1113.
Klyosawa et al, "The Clinical Usefulness of a New (the Second Generation) Antibody to Hepatitis C Virus", Japan Journal of Clinical Pathology 40, pp. 1245-1251, 1992.
Okamoto, KAN TAN SUI, vol. 24, pp. 7-14, 1992.
Choo et al, "Genetic organization and diversity of the hepatitis C virus", Proc. Natl. Acad. Sci. USA, vol. 88, pp. 2451-2455, Biochemistry, 1991.
Okamoto, "Nucleotide sequences of the genomic RNA of hepatitis C virus isolated from a human carrier: comparison with reported isolates for conserved and divergent regions", J. of Gen. Virol., 1991, vol. 72, pp. 2697-2704.
Okamoto et al, "Full-Length Sequence of a Hepatitis C Virus Genome Having Poor Homology to Reported Isolates: Comparative Study of Four Distinct Genotypes", Virology 188, pp. 331-341, 1992.
Proceedings of the 29th Meeting of Acta Hepatologica, Japanica, p. 55, 1993.
Kan Tan Sui, vol. 22, pp. 883-889, 1991.
Smith et al, "Infectious vaccinia virus recombinants that express hepatitis B virus surface antigen", Nature, vol. 302, No. 7, Apr. 1983.
Hopp et al, "Prediction of protein antigenic determinants from amino acid sequences", Proc. Natl. Acad. Sci. USA, vol. 78, 1981, pp. 3824-3827.
Kyte et al, "A Simple Method for Displaying the Hydropathic Character of a Protein", J. Mol. Biol., vol. 157, pp. 105-132.
Moriarty et al, Antibodies to Peptides Detect New Hepatitis B Antigen: Serological Correlation with Hepatocellular Carcinoma, Science, vol. 227, 1985, pp. 429-433.
Sakakibara et al, "Use of Anhydrous Hydrogen Fluoride in Peptide Synthesis. I. Behavior of Various Protective Groups in Anhydrous Hydrogen Fluoride", Bulletin of the Chemical Society of Japan, vol. 40, No. 9, 1967, pp. 2164-2167.
Machida et al, "Two Distinct Subtypes of Hepatitis C Virus Defined by Antibodies Directed to the Putative Core Protein", Hepatology, vol. 16, No. 4, 1992, pp. 886-891.
Simmonds et al. 1993 J Clin Microbiol. 30:6, Jun. 30, 1993.
Knode Marian C.
SRL, Inc.
Zeman Mary K
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