High-throughput diagnostic assay for the human virus causing...

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid

Reexamination Certificate

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C435S004000, C536S023720, C536S024320, C536S024330

Reexamination Certificate

active

07547512

ABSTRACT:
The present invention relates to a high-throughput diagnostic assay for the virus causing Severe Acute Respiratory Syndrome (SARS) in humans (“hSARS virus”). In particular, the invention relates to a high-throughput reverse transcription-PCR diagnostic test for SARS associatedcoronavirus(SARS-CoV). The present assay is a rapid, reliable assay which can be used for diagnosis and monitoring the spread of SARS and is based on the nucleotide sequences of the N (nucleocapsid)-gene of the hSARS virus. The present method eliminates false negative results and provides increased sensitivity for the assay. The invention also discloses the S (spike)-gene of the hSARS virus. The invention further relates to the deduced amino acid sequences of the N-gene and S-gene products of the hSARS virus and to the use of the N-gene and S-gene products in diagnostic methods. The invention further encompasses diagnostic assays and kits comprising antibodies generated against the N-gene or S-gene product.

REFERENCES:
patent: 2004/0265796 (2004-12-01), Briese et al.
patent: WO 02/057302 (2002-07-01), None
Centers for Disease Control and Prevention, “Update: Outbreak of Severe Acute Respiratory Syndrome—Worldwide, 2003,”Morbidity and Mortality Weekly Report, Apr. 4, 2003, vol. 52, No. 13, pp. 269-296.
Cheung, C. Y. et al., “Induction of proinflammatory cytokines in human macrophages by influenza A (H5N1) viruses: a mechanism for the unusual severity of human disease,”Lancet, 2002, vol. 360, pp. 1831-1837.
Drosten, C. et al., “Identification of a Novel Coronavirus in Patients with Severe Acute Respiratory Syndrome,”The New England Journal of Medicine, May 15, 2003, vol. 348, pp. 1967-1976.
Rota et al., “Characterization of a Novel Coronavirus Associated with Severe Acute Respiratory Syndrome,”Science, 2003, vol. 300, pp. 1394-1399.
Yam, W. C. et al., “Evaluation of Reverse Transcription-PCR Assays for Rapid Diagnosis of Severe Acute Respiratory Syndrome Associated with a Novel Coronavirus,”J. Clin. Microbiol., 2003, vol. 41, pp. 4521-4524.
Yuen, K. Y. et al., “Clinical features and rapid viral diagnosis of human disease associated with avian influenza A H5N1 virus,”Lancet, 1998, vol. 351, pp. 467-471.

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