Novos testes para detecção precoce de anti-HCV

Pesquisadores anunciaram recentemente a criação de um novo teste para detecção do vírus da hepatite C (anti-HCV) que usa a tecnologia de eletroquimioluminescência (ECL), com resposta em 18 minutos.Os resultados dos testes, em comparação com outros resultados laboratoriais e informações clínicas, podem ser utilizados para ajudar no diagnóstico da infecção por HCV em pessoas com sinais e sintomas de hepatite C e em pessoas com risco de contrair a doença.

A Roche Diagnostics Corp. da Suíça anunciou que a Food and Drug Administration, dos Estados Unidos, pré-aprovou seu teste para detecção de anti-HCV denominado Elecsys Antibody. O novo teste in-vitro faz uma detecção qualitatitva do total de anticorpos para o vírus da hepatite C no soro ou no plasma do sangue humano, usando a tecnologia de ECL da Roche.

A Roche recebeu aprovação para seu teste em três plataformas: Cobas e 411 para testagem de pequenos volumes; Cobas e 601 e analisadores para Modular Analysis E 170. O teste, no entanto, não determina o estado da infecção no paciente com doenças associadas.

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Integra

Qualitative Anti-HCV Immunoassay Test Designed for Use on Three Analyzer Platforms
By Labmedica International staff writers
Posted on 23 Jun 2010

A new hepatitis C virus (anti-HCV) assay is an 18-minute test designed for use with electrochemiluminescence (ECL) technology. Assay results, in conjunction with other laboratory results and clinical data, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection.

Roche Diagnostics Corp. (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) granted Premarket Approval for its Elecsys Antibody to anti-HCV assay. The Elecsys Anti-HCV assay is an in vitro diagnostic test for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma using Roche???s ECL technology.

Roche received approvals for its test on three platforms: the stand-alone cobas e 411 analyzer for low-volume testing; and the Cobas e 601, and Modular Analytics E 170 analyzers, which are modules of consolidated immunoassay/clinical chemistry systems for mid- and high-volume testing, respectively. The test does not determine the state of infection or associated disease.

Roche received FDA 510(k) clearance for another immunoassay in its infectious disease portfolio, Rubella IgM, in April 2010.

Hepatitis C virus is the most common cause of posttransfusion and community-acquired non-A, non-B hepatitis worldwide. Infection with HCV frequently leads to chronic hepatitis and cirrhosis, and is associated with the development of hepatocellular carcinoma. Hepatitis C is primarily transmitted through contaminated blood and blood products and to a lower extent by human body secretions.

Roche is involved in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world???s largest biotech company with differentiated medicines in oncology, virology, inflammation, metabolism, and the central nervous system (CNS).